ML20211G775
| ML20211G775 | |
| Person / Time | |
|---|---|
| Issue date: | 09/26/1997 |
| From: | Gormley O NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Coffman F NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| References | |
| NUDOCS 9710030245 | |
| Download: ML20211G775 (150) | |
Text
__.
September 26, 1997 MEMORANDUM FOR:
Franklin D. Coffman, Jr., Chief Generic Safety Issues Branch Division of Engineering Technology Office of Nuclear Regutatory Research FROM:
Owen P. Gormley, Engineer
/s/ OPGormely Generic Safety Issues Branch Division of Engineering Technology Office of Nuclear Regulatory Research
SUBJECT:
FIRST DRAFT REPORT ON ANALYSIS OF TWO VERSIONS OF ASME NQA 1 The attachment is a first draft of a report entitled " Comparative Analysis for Achieving Equivalence NQA 1, 1997 Edition Against NQA 1, 1983 Through la Addenda."
Its most important feature, and the reason for distributing it at this stage of completion, is that it contains a side by side (SXS) presenta-tion of the two documents arranged in the order of NQA 1 1983 through la Addenda in its aopendix. The appendix has been reviewed, and su..e minor changes may occur prior to final publication. You will recall that ASME NQA 1
" Quality Assurance Program Requirements for Nuclear Facilities" was last endorsed by the NRC in Regulatory Guide 1.28 Revision 3, " Quality Assurance Program Requirements (Design and Construction)," in August 1985.
This memo will place the draft report in the )ublic document room, and we may entertain comments from individuals known to 1 ave an interest and expertise.
Reviewers should concentrate on the SXS, since sone changes in the basic document are quite likely.
Attachment:
As stated cc:
B. Marguglio, ASQC D. Jenr.ings, ASME D. Brown, ASME C. Sanna, ASME R. Hartstern, ASME G. Grier, ASME R. Burns, ASME H. Nichol, ASME T. Dunn, ASME F. Hood, ASME w/o attechment J. Anderson, ASME J. Voigt, SEA DISTRIBUTION:
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OFFICIAL RECORD COPY (RES File Code) RES 1B-5 9710030245 970926 PDR ORQ NREBPM
NUREG/CR TBD SEA No. 97 3704.A:1 Comparative Analysis for Achieving Equivalence NQA-1.1997 Edition Against NQA-1.1983 through la Addenda Draft Report a'i Manusenpt Drafted: September 1997 l
Date Published: TBD Prepared By:
J. Anderson F. Sciacca, J. Voigt Science and Engineering Associates. Inc.
Performance Development Corporation 109 Jefferson Ave.
SEA Plaza 6100 Uptown Divd. NE Oak Ridge,TN 37830 Albuquerque, New Mexico 87110
., 6 O. P. Gormley, NRC Technical Monitor M. L. Marshall, NRC Task Manager Prepared for Division of Offke of U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 NRC Job Code - TBD Page I of 13
ABSTRACT The Nuclear Quality Assurance -(NQA)-Committee of the American Society for-Mechanical Engineers ( ASME) is responsible for developing-and issuing app revisions to NQA-1, " Quality-Assurance Requirements for Nuclear Power P Recent-NQA 1 consolidation efforts were undertaken by the NQA Committe
-were intended to reduce duplication and elimilate obsolete requirements. The However, because it
- this eTfor were presented in a draft 1997 Edition to NQA 1, appeared that impcrtant requirements were being eliminated, the Nuclea Commission (NRC) Committee representative voted to disapprove the 1997 Ed extensive changes to the proposed NQA 1,1997 Edition eliminated the traditio alignment of sections and requirements with the result that the simple determine revision compatibility was no longer possible.
analyzes the differencc3 between Part I of the 1997 Edition of NQA-1 r~
with the corresponding addenda la as endorsed by Regulatory Guide 1.28. Rev The major elements of this task included:
Preparing a reference tool that arranged the two NQA-1 versions and, as possible, aligned the requirements in a Side by Side table; Examining the two versions and assessing initial equivalency; identifying and evaluating the differences between the current and propose e
of the NQA-1 standards; Determining whether regulatory needs were meet; and Making recommendations to meet those regulatory needs not addressed.
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Table of Contents
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1.0 BACKGROUND
AND OBJECTIVE I.1 BACKGROUND Nuclear power plints and fuel reprocessing plants include structures, systems, and components that prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public.. Appendix B tol0 CFR Part 50 establishes quality assurance requirements for the design, constr'iction, and operation of w.se structures, sjstems, and components. Tl pertinent requirements of Appendix B apply to all activities affecting the safety-related functions of those stmetures, systems, and components. These activities include designing, purchasing, fabricating, handling, shipping, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, refueling, and modifying.
Regulatory Guide 1.28 was issued in June 1972 and describes a method acceptable to the NRC staff for complying with the provi3 ions of Appendix B with regard to establishing and implem. ting the requisite qu J.'.y assurance program for the design and construction of nuclear power plants. Guidance for the establishment and execution of quality assurance programs during operating and decommissioning of nuclear power plants have been addressed in separate regulatory guides. Similarly, quality assurance provisions concerning fuel cycle facilities have been addressed in separate regulatory guides.
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The third revision of Regulatory Guide 1.28 was issued in August 1985. Its provisions begin with the endorsement of the American National Standard on l
" Quality Assurance Program Requirements for Nuclear Facilities." ANSI /ASME l
NQA la 1983 Addenda. The regulatory guide then provides additions and modifications to ANSI /ASME NQA I 1983 and the ANSI /ASME NQA-la 1983 Addenda.
Since August 1985, no revisions of Regulatory Guide 128 have been issued. A draft of a proposed revision (Revision 4) was prepared and issued for review in November 1992. This draft Revision 4 was never issued; however, it does provide some insight on the regulating positions in Revision 3 and/or referenced standards.
Of significance is the addition of a new activity to be covered by Regulatory Guide 1.28 and that is decommissioning.
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Since 1983, the NQA-1 Standard has been revised and published in the 1986 Edition, the 1989 Edition, and the 1994 Edition. In 1983, the ASME NQA Standards Coinmittee also preparea md publisned tne ASME NQA-2-1983 Standard incorporating the requirements of the following quality assurance standards not included in ASME NQA-1:
N45.21-1980 - Cleaning of Fluid Systems and Associated Components for Nuclear Power Plants 2.1 N45.2.2 1978 - Packaging. Shipping, Receiving, Storage, and Handling of items for Nuclear Power Plants 2.2 Page 5 of 13
N45.2.31973 (R1978)- Housekeeping during the Construction Phase of nuclear power Plants 2.3 N45 2.51978 Supplementary quahty Assurance Requirements for Installation. Inspection, and Testing of Structural Concrete. Stmetural Steel.
Noils, and Foundations During the Construction Phase of Nuclear power Plants 2.5 N45.281975 (R1980)- Supplementary Quality Assurance Kequirements for installation, inspection and Testing al Mechanical Equipment ant' Systems for the Construction Phase of Nuclear Power Plants 2.8 N45.2.15-1981 - Hoisting, Rigging, and Transporting of items for Nuclear Power Plants 2.15 N45.2.20-1979 - Supplementary Quality Assurance Requirements for Subsurface Investigat!cris for Nuclear Power Plants 2.20 Since the 1983 Edition was issued, Parts 2.4,2.7,2.16, and 2.18 have been added.
NQA-2 was revised and published in 1986 and 1989.
In 1984, the NQA Subcommittee on Nuclear Waste management was assigned responsibility for developing a quality assurance program standard appropriate to site characterization of high-level nuclear waste repositories. This Subcommittee prepared ASME NQA-3," Quality Assurance Program Requirements for the Collection of Scientific and Technical Information for Site Characterizatio High-Level Nuclear Waste Repositories," which was issued in 1989.
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in the early 1990's, the NQA Committee recognized that the NQA-1, NQA 2, and NQA 3 Standards were not structured in a way to enable users and potential users t
to easily understand and apply them. The Committee decided to restructure the NQA standards into a single multi art document that would allow mori rapid response to varied applications of NQA provisions or measures. This initiative resulted in the publication of ASME NQA-t-1994.
This standard sets fonh requirements and nonmandatory guidance for the establishment and execution of quality assurance programs for nuclear facility applications. Quality assurance program requirements for the sting, design, construction, operation, and decommissioning of nuclear facilities are contained in 4
Part 1. Quality assurance requirements for the planning and execution of identified tasks during the fabrication, construction, modification, repair, maintenance, and testing of systems, components and structures for nuclear facilities are contained in Pan 11. Pan 111 ;ontains nonmandator, guidance and application appendices. Pan IV is reserved for future NQA position papers and application matrices. Guidance regarding application of NQA-3 type qc tiity assurance programs is expected to be included in future revistons to Part 111 or Part IV of NQA-1.
The arrangement of the requirements in Part I(from former NQA 1), requirements for work practices in Part 11 (from former NQA-2), and nonmandatory guidance and applications appendices in Part III (from former NQA-1 and NQA-2) permits F
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judicious application of the entire standard or portions for the standard. This four.
part format for NQA-1 was presented in the 1994 Edition. This format has been preserved in the new 1997 Edition.
Over the past 15 y:ars, the NQA standards have been revised and aucmented to address experience, feedback and user needs. These revisions generally have been developed to deal with a specific issue or new topic. Examples include computer softwa.., comme :al grade items configuration control, operational issues, and decommissioning. Although significant changes have been made, the basic requirements continue to redect quality assurance practices developed prior to 1970.
A number of new quality assurance standards and federal and state documents have been developed since the basic content of NQA was established. Examples of these include: the ISO 9000 Series and the U.S. Counterpa. ANSl/ASQC Q9000 Series, and DOE Regulation 10 CFR 830.120, which codifies DOE Order 5700.6C and the.1014000 Seno. While many of these attempt to reDect a more contemporary Total Quality Management (TQM) approach involving greater emphasis on management responsibilities, practices, and process controls, man the requirements of NQA-1 have been retained. Thus, current practices will incorporate the fundamentals contained in NQA-1,10 CFR 50 Appendix B, and th pre-1970 approaches used as input to them.
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10 CFR 50 Appendix B and NQA I are intended to emphasize quality assurance as a management system. NQA l contains practices that are intended to provide assurance of quality to a third pany not mvolved with day to-day inspection or surveillance. Accordingly, there tends to be an emphasis on documentation, procedures, and independence of inspection and assurance personnel. Although NQA-1 permits the use of a " graded approach" to implement quality assurance requirements, it has nr* been effectively applied in practice. Currently, these is a widespread perception that the industry is burdened with costly and ineffective quality assurance practices, primarily related to the misapplication and misinterpretation of quality assurance program requirements.
The above factors, combined with member input and user feedback, have resulted in a series of NQA Committee actions intendid toim reve the content and utility of the NQA standards arid to rdcognize and encourage use of quality management practices appropriate to the scope of these standards.
In 1993 the NQA Committee initia' J an action to further consider what might be done to enhance the usefulness of the standards in improving quality through performance. There was a thorough review by the Committee, and an extensive revision was prepared to emphasize performance-based, results oriented practices.
The screening criteria used for this review and revision were:
Is it performance-based related?
Does it contribute to safe and reliable plant operations?
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is the benefit commensurate with implementation costs?
e is it consistent with current technology and maturity of the nuclear e
industry ?
is the level of detail required to achieve (he desired results ?
e r the intended activity,is this a minimum requirement that applies to all applications?
is the requirement stated once and not duplicated?
e If the requirement did not meet the screening criteria, it could be modified or deleted. The intent was to revise the standard as necessary to support the principle of performance-based quality assurance program implementation. For example, under organizations, emphasis should be placed on senior management to establish overall expectations for effective implementation of the quality assurance program and for obtaiaing tne desired results. Likewise. individuals assigned responsibility for performing work need to be held accountable for achieving quality and maintainmg it. Under quality assurance records, for example, specific detail requiren..ts for storage and f. facilities need to be ie-emphasized and more emphasis placed on recoids furnishing documentary evidence that the performance criteria of items have been aw.nphshed and end results have been achieved.
The NQA Committee completed this review and revision in 1996, and the results have been prepared as the ASME NQA-1-1997 Edition of the standard. In this new edition of the standard the Committee has intended to provide users a Page 10 of 13
t performance oriented standard that can be used in a graded approach to assure
- quality achievement cffectively and efficiently.
L The NRC as a user of the NQ A standards has initiated an effort to evaluate the new 1997 Edition of the standard and assess in usability for their regulatory purposes.
$!nce Regulatory Guide 1.28, Revision 3, endorses the 1983 Edition of the i
standard, this evaluation is in the form of a comparative analysis of the 1997 l
- Edition with the 1983 Edition. Of particular importance for regulatory purposes aie the changes that have been made in the standard. These are commonly referred to as upgrades or downgrades in requirements of the standard. The NRC must assess these changes and determine their effect on the consistency and appropriateness of ll their guidance to staff and licensees.
110hjectives and Scope in 1994, the ASME issued the NQA Committee approved revision to NQA-1, which was a consolidation of NQA 1 and NQA 2, and was intended to eliminate-duplication and repetition. It was intended to maintain all requirements,' but in spite of this objective, some were lost. The NQA Committee has prepared and approved a further revision to NQ A-1, currently being referred to as the 1997 Edition. Part I, b
s generally equivalent to the old NQA-l_, has been re-worked to eliminate requirements the NQ A Committee determined to be unnecessary, and to make the j
1:-
remaining ones " performance-based."
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The NRC review process on the revised SQA 1 resulted in disapprovalin most cases because it appeared that important requirements were being eliminated. O the course of time the process involved sescral iterations with major changes in content and format w here requiremetns were remoted and, m some cases, later restored. The general changes in arrangement between the 1997 Edition and ea versions of the standard eliminated the traditional alignment between sections a requirements.
The primary objective pursued with this repon was to prepare a reference the NRC staff for use in future interactions with the ASME Nuclear Quality Assurance Committee. The reference tool is to be used to identify those changes needed to make toe requirements of the draft NQA-1,1997 edition generally equivalent to NQA 1 as endorsed by Regulatory Guide 1.28, Revision 3.
The specific elements of the methodology used in this study are discussed Section 2.0.
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2.0 Methodology for Equivalence Evaluation and Analysis The evaluation of ASME NQA 1 1997 kersus ASME NQA I 1983 including NQA la 1983 Addenda has been accomplished in a series of steps. First, a direct correlation of the provisions of both standards has been made. This has taken the form of a side by side matris of comparable provisions. From this side by-side I
comparison, ajudgment of equivalency was assigned. Second, each provision of ASME NQA-I-1997,in which there wasp.dged to be a non-equivalency with ASME NQA t-1983, was analyzed. An evaluation
. was performed to determine tne significance of the change to NRC guidance. Last,in those it. *ances where the change is of such significance that it does not support NRC needs for acceptable regulatory guidance,
_ proposed regulatory recommendations have been developed.
The analysis and its recommendation will provide the NRC with the basis for developing Revision 4 to Regulatory Guide 1.28 endorsing ASME NQA-t-1997.
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Appendix A NQA-1 Side by-Side Analysis of Requirement Equivalency Table of Contents Pages.
Criterion Title P
1-3 I
O rg ani zati o n.....................................................................
I-19 2
Qu ality A s su ra n ce Prog ram............................................
I-16 3
De s i g n Co n t ro l...............................................................
1-4 l
4-Procurement Document Control.....................................
I-1 5
Instructions. Procedures, and Drawings..........................
1-3 6
Doc u me a t C o r ' rol..........................................................
1-12
.7 Control of Purchased Items and Services........................
1-2 8
Identification and Control of items..................................
1-4 9
Control of (Special) Processes.........................................
l -
10 Inspection, Test, and Operating Status............................
1-6 11 Te st Co ntro l.....................................................................
1-5 12 Control of Measuring and Test Equipment.....................
Handling, Storage, and Shipping.....................................
1-3 13 1-1 14 Inspection,- Test, and Operating Status............................
1-4 15 Control of Nonconforming Items...................................
1-1 16 C orrectiv e Action............................................................
1-14 17 Qu ality As su ranc e R e c o rd s..............................................
1-7 18 Audits.................,............................................................
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NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 1 - ORGANIZATION I
NOA 1,1983 la I
NOA 1,1997 7
EQUIVALENCY l
Wording does not constitute a requirement.
i ORGAN 17ATION REQUIREMENT 1 ORGANI7ATIOff Wordmg does not constitute a requirement.
100 B AslC Requirements of NQA 1,1997 relate to Responsibihties for the establishment and ction iS 1,3.1 of NQA 1,190 ta and implementation of the quality assurance e not cauivalent. Proposed 97 wording se proFram shall be defined.
an upgrade, variance is significant. No ar is hange to NQA.1,1997 is recommended.
c The creanizational structure. functional The creanizational structuremfynqugna)
Requirements gr. identical esponsibihties. levels glag.t'ority. and t
[gsrmsibilities. levels of authority. and r
knes of communication for activities lines of communications for activities ffectine cuality shall be documented.
affectine cuahty shall be documented.
a Persons or organizations responsible for (d) Those responsibicfor verifyine quality Requirements of NQA.1,1983 la are overed in section I,210, I,d of NQA 1, acniesement have su/Neient our6orirv.
c ass tring that an appropriate quality 1997 and they are not cauivalent.
assurance p-om is established and direct access to management, verttving ti..
< tiviues affccting quality oreanizational freedom and access to Variance is a downgrade,it is not ignificant. No change to NQA 1, !997 is have been cotiectly performed shall have work to perform theirfunction.
s recommended.
sufficient authority, ascess to work areas, (l. 2 /0, I, dl i
and omrnizational freedom to The organi:ation shall estaotish and Requirements of NQA-1,1997 gg not (1) identify quahty problems; implement processes to detect and correct tguivalent with NQA 1,1983-1a.
quality problems. (2, i10, 9 >
Requirems.~ts of NQA 1,1983 la are covered in uction 2, ID, ir of NQA 1,
!997. No change to NQA I, I997 is recommended.
(2) initiate, recommend, or provide The organi:stion shall establish and Requirements of NQA 1,1997 are not couivalent with NQA 1,1983 la.
solutions to quality problems through implement processes to detect and correct Requirements of NQA 1,198? la are designsted channels; qu.dity problems. (2, i10. 9) represented in section 2,1, 9 of NQA.I,
!997, Downgrade is vet s,*nificant, intent of 83 edition is maintained. No change to NQA l, !997 is recommen&d.
(3) verify implemertation of solutions; and Completion of correcrbe actions shall be Requirements of NQA-1,1997 ss not couivalent with NQA-1,1983-la.
verified. (16,100,4)
Requirements of NQA 1, !983 la are covered in section 16,100,4 of NQA 1,
!997. Change is not significant. No change to NQA 1,1997 is recommended.
Requirements of NQA 1,1997 gg not (4) assure that further processing, delivery further processing, delivery, insanen,
- t. uivalent with NQA 1,1983-1a.
installation, or use is controlled until or use of a nonconforming item shall be q
l, auirements of NQA.I,1983 la are proper disposition oi a nonconformance, controlled pending the evaluation and on deficiency. or unsatisfactory condition has approved disposition by authori:ed represented in section 15,410,2 of NQA I,1997. Change is not significant. No personnel (15,410,2) change to NQA 1, I997 is recommended.
occurred.
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NQA-1 SIDE BY-SIDE ANALYSIS OF REQUIREMENT EQUIVA REQUIREMENT 1 ORGANIZATION I
NOA.1,1983 la i
NOA.1,1997 i
EQUIVALENL Y Such persons or organizations shall hase (d) Those responsiblefor senfung qualsty Requirements of NQA 1.1983 la are direct intgtiLLo respn;ible manacement' achsen ement has c :ufficarnt authonts.
coscred in section 1. 210. /. d of NQA 1.
1997 and are not couivalent Pariance is a at a level where appropriate action can be direct accerr to a<anareminJ organs:atwnalfreedom and access to downgrade itis not signs)1 cant. No etfected change to NQA 1,1997 is recommended.
. sort to perorm thetr functwn
' I, 214 i, Jo Such persons or organitations shall report iJJ Those responsibiefor seri/png qualits Requirements of NQA 1.1983.la are coscred in section /. 2/0. l. d of NQA 1.
to a management les el such that required achiri ement hat e sufficrent authorits.
1997 nd are not cauivalent. Pariance is a authorit) and creamratmnal freedom are direct access m management.
oreantiational freedom and acccss to downgrade, it is not significant. No provided. including suflicient change to NQA.1,1997 is recommendes'.
independence from cost and schedule work to perform theerJimctwn.
il. ?lo. /. di considerations.
Wording v s not constitute a requirement.
SUPPLEMENT IS 1 -
SUPPLEMENTARY REQUIREMENTS FOR ORGANIZATION Wording does not constitute a requirement.
IGENERAL Wording does not constitute a requirement.
This Supplement provides amplified requirements for organization.
Wording does not constitute a requirement.
It supplements the requirements of Basic Requirerwnt I of this Standard and shall be used in conjuncion with that Basic Requirement when and '.o the extent specified by the organiNion invoking this Standard.
Wording does not constitute a requirement.
2 RESPONSIBILITY 200 STRUCTURE AND RESPONSIBILITY Wording does not constitute a requirement.
210 General 2.1 Purpose The creanizatic%.gture and the The creamzational structure and Requiremem2 e gldefugf.
r
. esconsibility assumments shall be suc'
, turonsibility assigr_ nts shall be i;igh th.&
Lb&
ta) Senior management establishes oserall Requirements of NQA 1.1997 ;tre not eauivalent with NQA 1,198bla.
expectations for effective implementation Pariance is an upgrade, and it is of the quality assurance program and is significant. No change to NGA.1,1997 is responsible for obtaining the desired end recommended.
resulti (a) quality is achieved and maintamed by (b) quahty is achieved and maintamed by Requirements are cauivalent with editorial / diction differences only. No those who have been assigned those asstened responsibilitv for change to NOA.I,1997 is recommended.
responsibihty for performine work; and rerformme work; (b) quality achievemed is verified by The organizational structure and Requirements are cauiva!ent with
. persons or organizations not directly responsibility assignments shall be such editorial / diction differences only. No change to NQA.I,1997 is recommended.
resoonsible for oerformine the work.
that: fl,210,1)
(c) auality achievement is verified by those not directly responsible for performine the work. and Page 2 of 3
NQA-1 SIDE BY-SIDE ANALYSIS OF REQUIREMENT EQUlVALENCY REQUIREMENT 1 ORGANIZATION I
NOA 1,1983 la l
N0/.1,1997 l
EQUIVALENCY tdi Those responsible for serifying quality j Requirements of NQA.1,1997 relate to achiesement hase sufficient authonty.
Basic sect.u,i 1. 2; l. 3. and I,4 of NQA-Jirect access to management, I,1983 la and are not coun alent, crga.urational freedom and access to erk Variances are nc. sigmficant. No change to perform their function.
to NOA 1, t997is recommended.
2.2 Deleration of W ark 220 Deleration of Work Wording does not constitute a requirement _
The indnidual W or otranization m The individualm or organira%nm Requirements are identical, tesconsible for establishine and executing responsible for etiablishine and_ executing ganhtyJssurcnce procram under this a cuality assorance program under this Standard may delerate any or all of the Standard may delerate any or all of the cork to o hers out shall retain work to others but shall retaiD responsibility therefor.
resm nsibility therefor.
2.3 Nonconfornung items Wording does not constitute a requirement.
Responsibility for the control of further Resoonsibeltry for the control of further Requirements of NQA 1,1983 la are I
meessine. deliverv. installation. or vrocessine. deliverv. snstallation. or use of covered in section l$,420,2 of NQA 1, operation of nonconformine items shall be nonconformine items dall be dessenated 1997 and are couivalent with nunor word I
desienated in writtne.
in wrttine (15 420. 2) changes. No change to NQA 1,1997 is recommended.
(
3 MULTIPLE ORGANIZATIONS Wording does not constitute a requirement.
3.1 Responsibility Wording does not constitute a requirement.
.t Where more than one ornamration is Where more than amevred itionit Requirements of NQA 1,1983-la.Je involved in the execution of activities involved in the execution of activities. @g covered in section 1,300, I of NQA 1, covered by this Standard, thg re monsibrIitics. interfaces, and authority 1997 and are couivalent when combined responsibilitv and authonty of ordi of each orranization shall be clearly with 83 la,1,3.2.2 below, No change to otranitation shall be clearly established defined and documented (I,300, !)
NQA 1,1997 is recommended.
- Lnd documented.
3.2 interface Control 300 INTERFACE CONTROL Wording do:s not con..tute a raquirement.
Whe-note than ormnitation is Requirements of NQA 1,1997 :. late to invol,eiin the execution of activities, the sections 1,3.1, I and I,3.2.2 of :4QA 1, responsibilities, interfaces, and authority 1983 la and are equivalent when of each organization shall be clearly considered collectively, No change to defined and documented.
NQA 1,1997 is r"omme....J.
3.2.1 The extempt interfaces between ne external interfaces between Requiren,ents dejentical.
organizations and the internalinterfaces otranizations and the internal interfaces between otranizational units. and chanres between organizational units. and chag1m thereto. shall be documented.
thereto. shall be documented.
3.2.2 Interface responsibihties shall be Where more than one organi:ation is Requirements of NQA-1,1983 la are ddned and documented.
involved in the execution of activities, the covered in section 1,300, I of NQA-1, responsibilities, interfacu and authority 1997 and are couivalent when combined of each organi:ation doll be clearly with 83-1a,3.1,1 above. No change to defined and dxumented i1. 300. I)
NOA 1,1997is recommended.
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NQA-l SIDE 4Y-SIDE AN Al.YSIS OF REQUIREMENT EQUIV REQUIREMENT 2. QU ALIT) WURWCh PROGRAM
~ ~ T ] [ 3 [1) k ],$ [' ] [ "
EQCIVALENCY i
l NOA.1,1983.la Rordmg does not consutute a j
RE QUIRE A!ENT ;
aOUALITY ASSURANCE OU Al ITl' ASSUR ANCl; PROCM_dequirement Wordmf xs not consuture a PROGRAM d
100 B ASIC reauirement Requirements are eaunalenj wsch i10 iMeumented suahn Jourang editonal/ diction differences or.1) No A dneumented auahn aourance procram sh.dk rianned tmriementcJ.ind chaner to NQA 1, l997 is recommended.
netam shall be rianned impkn antad mamtained m acenfjance with thty Part < Part a
Fr d maintamed m accordance with this an Standard. or portmnTtherect It or nortions therent The rrocram shall identifs the I tivities and Requirements are identical The procram shall identif y the aetnities items to which it arches nd items in which it applies _
Requirements of NQA l.1997 are not The program shallinclude mondottag cauivalent with NQA 1,19831a, The a
_The estabhshment of the program shall acarities against acceptance ;rderia in a variance is an upgrade in requirement include consideration of the technical man ner sufficient to provide assurance that that is significant. When technical spects oi the aetmtics affectmg the activities affecting quality are s ;ects of activities ejecting quality are a
quahtv.
r.:l tmed satujac orily. (2, lla..fI examinea, the key attribute is r
determining adequate acceptance criteria that demonstrate satisfactory performance. The 97 edition clarifies this position. No change to NQA.I, iG7 is recommended.
Requirements are idenucal.
The procram shall crovide control oser 3e crocram shall crovide control mer activines affectine auahty to an extent actmties affectine auahty to an extem consntent with their importance consistent with their imponance Requirements of NQA 1,1997 arr not The program shall melude mcmtormg equivalent with NQA.I 1983 la. The acuvines against acceptance entena m a variance is an upgrade to the 83 manner suf6cient to provide assurance that requirementfour. din 2(Basic),3. See the activities affecting quahz are performed abovefor an explanation. No change to satisfactanty.
NOA.I,1997 is recommended.
(
The procram shall be estabbshed at the Requirements are identical.
Jbe procram shall be estabhshed at the carbest time consistent wt'h the schedule for gQpt time consistent with the accomphshme the activities j
schedu for accomelnhme the t
Requirements ge_ identical
__The procram sh " provide for the j The proctam shall provide for the plannme actmties_
'ffecAng plannine and accoi: dent of r yLMonphsment of actiut e5 activities affectine cuality imdet
~ auahn under suitalv cortri tieJ condition I
sujtably controlled conditions; Controlled conditions include the use of Requirements are idenocal.
Cgyrolled conditions mclude the use of aiate eaumment. suitabk approcriate equmment. suitable gnnronmental conditions for accomehshine 3
environmental conditions for the actmtv. and assurance that crereauisites accomekshmg the activiturd for the civen actmtv have been satis 6ed, assurimee that crerecuisites for the civen actmtv hase been satn6ed The procram shall crovide for any special Requiremen:s of NQA 1,1997 gg tquivalent with mort presenpthe The crocram shall provide for any controls. processes. test eaumment. toolsm wecial controls. crocesses. test and skills io attam the reautred cuahty of spec 6 city. No change to NQA.1,1997 s recommended.
eaummerit. tools. and skills to attain theactmties and items and for senfiggen of timEI auahtv and for sgn6catmn of d
that _qualtty Requirements of NQA l.1997 are not quahtL The orgamzation shall estabhsh and equivalent with NQA 1.1983 la. The implement processes to detect and correct variance is an upgrade in requirement quality problems.
that is significant. I983 Section i Rasic 2 in conjunction with (!) and (2) form Dre 1919
NQA 1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUlv ALENCY REQUIREMENT 2. QUALITY ASSURANCE PROGRAM i
NOA 1,1983 la l
NO A 1,1997 EQUIVALENCY the basisfor thu 91 requirement. The 97 requirer sent captures the larger picture in requiring the establishment and implementation of Prxesses to detect and correct quality problems, No change to N04 1,1997 is recommended.
The program sh.ill croside for 1:0 The procram shall crovide for Requirements of NQA 1,1997 are not indoctrination and traming, n mdoctrination. Lummg, and quahticatmn as gguivaknt with NQA 1.1983.la. The necessary. of nersonnel nerformine necessart of personnel performme or variance is an upgrade and is significant.
activities affecting auahty to awure that managing aptivities affectine cualits to Addition of 'and qualification ' and 'or suitable pro 6ciency is achiesed and any;c that suitable proficiency is achiesed managing'provides more specificity ma_intained.
and mamtained clarsfying the requirement. No change to NOA 1, !997 is recommended.
Management of those organizations 130 Manacement, shall recularly assess the Requirements of NQA 1,1997 att impicmentisg the quahty assurante Adequacy and effective implementatl2D of eauivalent with les, prncriptive piogram, or portions thereof,ihall the quahty assurance program.
specificity. No chaste <o a t/A.,,17 a,
recommended.
regularly assess the adeauacy of that part of the program for which they are responsible and shah asstire its giftgnvg implementatio_D.
Wording does not constitute a SUPPLEMENT 2S 1 -
SUPPLEMENTARY requirement.
REQUIREMENTS FOR THE QUALIFICATION OF INSPECTION AND TEST PERSONNEL
' GENERAL Wordmg does not constitute a h
requirement.
Wording does not constitute a This Supplement provides amplified requirements for the qualification of requirement.
' petsonnel who perform inspection and
'i testma to vetify conformance to specified requirements for the purpose of acceptability.
Wordmg does not constitute a 3
It supplements tre requirements of requirer.:.:nt.
Basic Requirement 2 of this Standard i and shall be used in conjunuion with
' that Basic Gequirement when and to the estent specitied by the organtratio.,
invoking this Standard.
Wordmg does not constitute a The! ;uirements of this Supplement do requirement.
not apply to the qualification of personnel for performance of nondestructive examination.
Wording does not constitute a
- 2. CERTIFICATION requirement.
Wording does not constitute a g
2.! Ouahfication Reautrements requirement.
Damp?nf14
k NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUlVALENCY REQUIREMENT 2 - QUALITY ASSURANCE PROGRAM EQUIVALENCY NO A.1,1997 l
NQA.1,1983.la 1
i l
REGUL ATORY GUIDE (RG) 128.
Requirements of NQA l,1997 are not REE 3 equnalent with NQA L NGla i
' C REGULATORY POSITION i
I QUALIFICATION OF i
INSPECTION AND TEST I
(
PERSONNEL.
l Appenda 2A 1. "Nonmandatory l
Guidance on the Quah0 cations et l
Inspection and Test Perrm.ncl."
Provides guidance on the qualifications of mspection and test personnel. The e
provisions of Appendix 2A 1 (or l
acceptable alternatives) should be met as part of Supplement 2S 1.
i
" Supplementary Requirements for the Qualification of Inspection and Test Personnel "
The responsible otranization shall The responsible organtration shalldesrrnate Requirements of NQA-1,1983 la are j
desicnate those activities that reavire those actneries that reautre qualification of cosered in section 2,300, I of NQA-1, quahfied inspection and test nersonnel versonnel and the minimum reauirements for 1997 and are not cauivalent. Application iLndthe minimum teautrements for sus _b stach revsonnel i2 900 (i of the 97 edition is an upgradefrom the 83 requirement, in that the 97 provides a versonnel.
broader rangefor personnel qualification and meets the intent of 83.
i Change is not significant. No change is recommendedfor the 97 edition.
Further, the responsible orcanization The reinonsible orcanuation shall establish Requirements of NQA 1,1983 la are i
shall establish written procedures for wrirren procedures for the qualificarron of covered in section 2,300,2 of NQA 1, the auah6 cation of inspection and test vervonnet and for the assurance that onh 1997 and are not cauivalcal. The same personnel and for the assurance that those versonnel who meet the reausrements logic presented above applics for this only those personnel sho meet the are vermitted to r.*rform these actn stirs requsrement. Application of the 97 edition is broader in scope fapplies to all j
reautrements of this Supplement yg i2, Jt$ 2 6 instances whre personnel must be permitted to perform ksrection and vst qualified) and neers.' : 83 'ntent.
asttvittes Change is not sign?can'. N % 'iange is
\\
recommendedfor the 97 edition.
j Requirements of NQA-1,1997 Es3qi When a smgle mspection or test cauivalent with NQA 1,1983-la. This requires unplementation by a team or a variance is a downgrade, and is not group personnel not meeting the significant. No change is recommended requirements of this Standard may be for the 97 edition, fthe 83 requirement is used in data taking assignments or in prescriptive and defines a unique plant or equipment operation, provided situation wherein unqualifiedpersonnel they are surenised or oserscen by a may be used to perform activities that do quahfied mdividual.
not require specific training. If as defined in 2,300, I the activity does not require qualification as for a ' data recorder' then this downgrade is not significant.)
Wording does not constitute a 2.2 Personnel Selection requirement.
Page 3 of 19
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 2. QUALITY ASSURANCE PROGRAM I
NOA 1,1983 la i
NO A 1,1997 I
EQUIVAl.ENCY Requirements of NQA 1,1983.la are Personnel selected for performmg -
Indoctrinatton and fromme shallbe overed m section 2,200, i of NQA 1, inspection and test aetnities shall have commensierate with recce. comAirs.
c 1997 and are not counalent The importance of the actn tries, and the arsance is a downgrade un requirement the expenence or traimng cJucation. e trenence, andpro?c:r:so of the v
r 'mmensurate uith the wore.,
that is not signsficant. Personnel complevtv. or special nature of the person *:. :W Ii election is not aabessed in the 97 The responssble organnatwn shall dition, however, sections 2,200, I and 2, s
actnines e
designate those acnnties that requste 00, I together support the intent and 3
quahfication ofpersonneland the cope of the 83 requirement. No change minimum requirementsfor such personnel, or NQA.I.1997 is recommended.
s f
12,300,la 200 INDOCTRINATION AND TRAINING Wordmg does not constitute a requirement.
ind( ctrmation and trammg shall be Requirements of NQA 1,1997 relate to ection 2,2.2, I of NQA 1,1983 la and commensurate with scope, complexity, re not couivalent. See " 1,2.2, I above.
s imponance of the asuvities, and the Variance is a downgrade, change is not a
education, expenence, and pronaency of the ignificant. No change is recommended s
person.
for the 97 edition.
Wordmg does not consutute a 210 Indoctnnauon 23 Indoctrmation requirement.
Provisions shall be made for the Personnel performing or managmg actmties Requirements of NQA 1,1997 are not couivalent with NQA 1,1983 la. The indoctrination of personnel as to the affecting quality shall receive indoctrmation variance is an upgrade in requirement technical objectives and reesitements in their job responsibsbues and authority; that is not sign (ficans. No change is of the applicable codes and standards general critena, including applicable codes recommendedfor the 97 edition, and standards, regulatory commitments, and the quality assurance program elements that are to be employed.
company procedures, and quality assurance program requirements s Wording does not constitute a 220 Trammt 2 A Tramine requirement.
The need for a formal tramme procram for Requirements of NQA 1,1997 are not couivalent with NQA 1,1983 la. The The need for a formal trainine croctam shall be determined. ard such training personnel performing or managing activities variance is an upgrade in requirement acuvities shall oc conducted as required affecung quahty shall be deteemmed.
that is not significant, No change is to quahfy personnel who perform recommendedfor the 97 edition.
inspections and tests.
Proposed 97 wording is broader in application than the -
Trammy..all be pr.de. if te Jed to Requirements of NQA,, IW F uni equivalent with NQA 1,1983 la. The achiese,aitial proticiency, maintain vadance is an upgrade in requirement pro 6ciency, and adapt to changes in that is not significant. No change la technology, re.ethods, or job responsibilities.
NOA.I,1997 is recommenaed.
Requirements of NQA.1,1997 are not On-the-job traming shall also be epuivalent with NQA-1,1983 la. The-included in the program, with emphasis variance is a downgrade in requirement on first-hand expenence gained through that is significant. 'On the-job' training actual performance of mspections and has been an important aspect of programs requiring formal training.
tests.
While a case may be made that 2,220,2 l
(
above combines auforms of training,
\\ including on-the job, it is not clear that this option may stiu be considered.
Recomrsend reviewing the continued application of 'on-theniob' training.
Wording does not consti ute a t
2.5 Determination of Iniual Capabilitv n...m
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREM REQUIREMENT 2 - QU AU TV ASSUH ann PROGRAM
'I EQUIVALENCY
~~susi,W9f'
~
^"
I N OA 1,1983 1 1
}
reg,uvement. _
I kequ'rements of NQA 1.198314 are He insteal capabilstra er a i arMMe. m;jt aWd in section 2. 320. ! of NQA l.
The canabihties nf a candidate for
[g determmed h an rialuaticn af fh 9C :ird are coun alent 2
vert 6 cation shall be mittally candidate s education etverg.nce t ames
% ch age is recommendedfor the 97 determined bs a suitaNe esaboon of yt_nJ erther test results ar caramitry edstwn.
the candidate's educatisn. esrenencL dem m turn s 22.3 N /,
tramine and either test results a l
Wording does not constitute a l
earaNhtv demonstranon requirement.
2.6 Esalurion of IYrformance Requirements of NQA l.1983 Ia are The 106 performance of msrection and res1 coscred in section 2. 320,2 of NQA L The sob nerformance of inspection and versonnel shall be reevaluated at veriolic 1997 and are eaun alen No change is ter,t personnel shall be reevaluated at mtersals not to ricced 3 scary 2,320. 9 recommendedfor the 97 edstion.
nenodic mtervals not to etcced three Requirements of NQA 1,1983-la are FresalAarion shaII be bs evidence of covered in saction 2,320,3 of NQA 1, seaes Esevaluation shall be by evidence of l co"cyed sattefactory perforence or i997 and
' cautv31en1. No change is centmued satisfactory nerformance or
' redetermination of cat antlity m accordanct recommendedfor the 97 edition, tedetermination of carabihts m yrth the reouirements of 200 abmt.
accord 2nce with the reautremeJntLol 2.5 o
- 12. 320.3)
Requirements of NQA 1.1983 la are above.
//durtne this esaf watson or at ans other time covered in section 2,320,4 of NQA 1, m
If durtne this evaluanon or at any other
<t is determmed hv the responnb/c 1997 and are cauivalent. No change is time. tt is determined bs the reinonsible organcation that the carichihties of art recommendedfor the 97 edition.
orcanuation (1at the canabdines of an mdividualare not in accordance wh_t g h
individual are not in accordance with auahticarron reautrements specified for the qualificat:an reauirem*nts spectGed for job. that verson shall be r_emmed from that the iob. that person *, hall be remmed acttsatt unt#1 ruch nme as the reautred from that activity until such tin,e as the capability has been demimstratea (2,320. 41 tqautred canabihty has been Requirements of NQA 1,1983 la are pmanstrated Any verson who has notic_r[pr ned covered in section 2,320,5 of NQA 1, l b,y nerson who has tot perfor.ngd intrection,r testme activiacs in the The msnection or testine aetmties m his guahfied area for a neric< Lot / sear thajLhg 'l 1997 and 2n not eou i
' ouahfied area for a period of one vear reesaluateg < 2. 320. 9 thas is not significant. The 97 f
redetermination of required capabihty
}
, requirement reflects a concise version o shallbe reevaluated by a in accordance wtth the requirements of f the 83 requirement. No change is recommends 3 for the 97 edition.
{
j 2.5 above.
}
/ Wordmg does not constitute a
_]
, 2 7 Certificate of Q.icalon
' requirement.
Requirements o' NQA-1. '983 la are 410 The awahticarron of_msre non. test and covered in section 2,410. I of NQA-1, Eg.gnh6 cation of nersonnel shall ee
, lead auditor versonne s a 1997 and pre not cauivaleni The m 1nce 1
l h ll be cerrdi.g1.cn v
e UJu{ied in wntmg m an appropnate (2,410.i) 2nd include _th is a downgrade in requirement that is form, meludmg the following
, followme mormation:
hsignificant. The generalformat of the 83 informatton:
wording is preferred. The specific
, wording added to the 97
- inspection, test and lead auditor'is significant in a.tsessing this downgrade because of the limitingfactorimposed. Itis recommended that the new wording added to the 97 edition,
- inspection, test and lead auditor' be deleted.
i I Requirements of NQA 1,1983-la are t2,J!O./)
covered in section 2,410, I of NQA 1.
J tai Empimer's name Ia) emplogr's name; 1997 and are couivaleni. No change is
, recommendedfor the 97 edition.
Pace 5 of 19
NQA 1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUlVALENCY REQUIREMENT 2-QUALITY ASSURANCE PROGRAM l
NOA.1,19831a l
NOA 1,1997 l
EQUIVALENCY (b)ident:0 cation of person beinn (blldentrticarron of verson beinggy,rgird Requirements of NQA 1,1983 la are coscred in section 2,410, i of NQA 1, iemfied.
IJ, JN. / >
1997 and are eaun alent. No change is recommendedfor the 97 edition.
te > aetnities certined to netterm-.
w Actniten certised to servrm Requirements of NQA 1,1983 la are coscred in section 2,410, I of NQA 1, s2. J /0. h 1997 and are couivalent. No change is recommendedfor the 97 edition.
(d) basis used for certilication. which (d)(lasts ofqualification r2, J/0.1; Requirements of NQA 1,1983-la are l
cosered in section 2,410, I of NQA 1, includes such factors as; 1997 and are not couivalent. The variance is a downgrade in requirement that is slenificant. The generalformat of l
the 83 rding is p eferred, The specific wording deletedfrom the 97 'w'*
- includes such factors as:' connects with thefollowing three requirements and provides clear examples of the qualification basis, it is recommended that the 83 wording 'which includes such factors as:' be retained.
(1) education. eteenence. and training h education. crverier,ce. andoctrination, gn,d Requirements of NQA l,1983 la are covered in section 2,410, I of NQA 1, trainins (2,410,11 1997 and are couivalent. No change is recommendedfor the 97 edition.
(2) test results. where acclicable
- 2) test results. w here appltrable Requirements of NQA-1,1983 la are covered in section 2,410, I of NQA 1, (2,410,1) 1997 and Mr gouivalent. No change is recommendedfor the 97 edition.
O) results of capability demonstration
.h capabelati demonstratton results Requirements of NQA 1,1983 la are covered in section 2,410, I of NQA 1, (2,J10.1) 1997 and are couivalent. No change is recommendedfor the 97 edition.
(e) results of cenodic evaluation:
f r) Results of venodic e atuation Requirements of NQA 1,1983 la are covered in section 2,410, I of NQA 1, (2,Jl?,li
' 1997 and are couivalent. F change is recommenaedfor the 97 essition.
tii results of nhysical esaming9ns.,
(f) Results of rhisical examinations. w hen Requirements of NQA-1, id3 la are covered in section 2,410, I of NQA l.
when
- quired.
required (2.t J.1) 1997 and gr gouivalent No change n recommendedfor the 97 edition.
(en signature of emoloser's designated f ri Sienature of emploser's desienated Requirements of NQA-1,1983 la are reversentatne who is responsible for such covered in sectic.n 2,410, I of NQA 1, fspresentaine 1997 and Ms.nuLgauivalent. The variance certification (2,410,1) is an upgrade in requirement that is not significant. No change is recommended for the 97 edition. Proposed 97 wording identifies responsible parts.
th) date of certi6 cation and date of (h) Date of certification or recertification Requirements of NQA-1,1983-la are covered in section 2,410, I of NQA 1.
certi6 cation expiration, g.nd certi# cation croiration.
1997 and are not couivalent. The variance (2, 4/0,1) is an s.pgrade in requirement that is not significant. No change is rccommended
-}'
for the 97 edition. Proposed 97 wording a
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUlV ALENCY j REQUIREMENT 2. QUALITY ASSURANCE PROGRAM I
NOA.1,198t3la i
NQ A.1,1997 I
EQUIVALENCY I
is broader in applicarnon than the 83.
l Wording dxs not constitute a r
2.8 Physical requirement.
The responsible Oreanitation sn.sil The responssble organi:.atson shallidentsfy
":q:::: :1 :' NQ ' '
'?' =
a' identsf\\ ans special t'hv. scal any specialchssicalcharacterestres needed
- q : h"
" ' N Q ' ' ' ' ' '
(Correction l Requsrements are identical characteristics needed in the
\\in the rirformance of each acrurstv, verformance of each actinn. sncludine yeludiser the need for instial and the need for mitial and subseaucal tujsectent ph ysical examination.
phvsical examinannn (2, st20.1)
E Wording does not constitute a 3 RECORDS
\\
requirement.
Wording does not constitute a 3.1 Record Files
.\\
requiremeni.
Records of personnet aushfication ihitJ1 Records o'f oualdication, including
- : v..:r : " " N Q ? ', "'"' - - 1 be estabhshed who is responsible for reaualificat5on,for auditors and lead
- q :&"
NQ? ', '"" =
such cerufication; and maintained by auditors, andfor inspectson and lest Requirements cf NQA.1,1983 la art the emplover.
personnel ghglI be established g.nd coveredin section 2,300,2 of NQA.1, maintained by ne emolover andfor 1997 and are not rouivalent. The indoctrination aFd trainsng. f2,500,21 variance is an upgrade in requirement that is not sign (ficant. No change is recommendedfor the 97 edition.
300 OUALIFICYI10N REOUIREMENTS Wordmg does not constitute a requirement.
The responsible organtution shall designate Requirements of NQA 1,1997 relate to those actmties that require qualineation of section 2S 1,2.1.1, I of NQA 1,1983 la personnel and the minimum requirements for and are not cauivalent. The variance is such personnel.
an upgrade in requirement that is not significant. NQA.1, I997 provides a broader rangeforpersonnel qualificatian and meets the intent of 83.
No change is recommendedfor the 97 edition.
The responsible organization shal; estabhsh Requiretnents of NQA 1,1997 relate to written procedures for the quali0 cation of section 2S 1,2.1,2 of NQA 1,1983 la personnel, and for the asst.rance that only and are not couivalent, The samt logic those personnel who meet the r ;uirements presented abvc appliesfor this
- are permitted to perfor m these activities.
requirement.. ppiscu. sos. of the 97 edition is broader sn scope lay; its to all instances where personnel must be qualified) and meets the 83 intent. The variance is an upgrade in requiremer.;
that is not significant.. No change is recomnsendedfor the 97 edition.
Specific qualification requirements for Wording does not constitute a personnel performing nondestructive requiremem, examination inspection and tests to verify quality and auditing are as follows:
SUPPLEMENT 25 310 Nondestructive Examination (NDE)
Wording does not constitute a requirement.
SUPPLEMENTARY REQUIREMENTS FOR THE i QUALIFICATION OF NONDESTRUCTIVE EXAMIN ATION PERSONNEL Page 7 of 19
,-v%
w; wr-
NQA 1 SIDE-BY-SIDE. ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 2. QUALITY ASSURANCE PROGRAM I
NOA 1,1983 la l
NQA 1,1997
{
EOLflVALENCY IGENERAL Wording does not constitute a requirement.
This Supplement proudes amplified This section specifies Ltquirements for the -
Requirements of NQA l.1997 are not reauirements for the cuahficauon of cuahfication of nersonnel w ho netterm (qmalent with NQA 1,1983 lJ. The Personnel who perform rad ographic radiactachietRTt maenene cameled1Pt variance is an upgrade in requirement t
(RTL marnene carticle 61L ultrasome {T. hsuid renetrano PT s that is not significant. The upgrade i
ultrasome ti!TL hauid penetrant tPTL electromagneur ETi. neutron reflectedin the 97 rdition adds 1 eddy current (ET), nigtum radiocraphic radiocrachictNRh leak testinctLD, aeoustie elements of NDE not disc ssedin 83; (NRT), and leak tesune tL ri emissiont AEh and visual testmitVT) t.g acoustic emission (AE) r.ad visualtesting
{ hereinafter referred to as venfv conformance 'c the specified (FT). No changefor NOA l.1997 /*
recommended.
nondestructive e samination (NDE)) 12 ttquirements, verify conformance to specified reauirements.
It supplements the requirements of Wording does not constituta a requirement.
Basic Requirement 2 of th s Standard and shall be used in conjunction witn that Basic Requirement when and to the estent specified by the organization invoking this Standard Wording does not constitute a 2 CERTIFICATION requirement.
Wording does not constitute a 2.1 Applicable Documents requirement.
The Amencan Societs of The Amenean Society of Nondestructive Requirements of SQA 1,1997 are not Nondestructive Testine Recommended Testine Recommended Pracuce No, eouivalent with NQA-1,1983 la. Results Practice No. SNT-TC-1 A. June 1975 SNT-TC-1 A, Decembet 1988 Edition. and of the review of SNT.TC 1A is discaissed Edition. and its apolicable suoolements its acclicable surelementsahall acolv as in Appendir C.
shall acolv as reouirements toEDE reauirements to NDE...
personnel covered by this Supplement.
320 lnspection and Test Wordmg does not constitute a requirement.
'The mmai capabilities at a candidate shall be Requirements of NQA-1,1997 relate to determined by an evaluation of the section 2S-1,2.5.1 of NQA 1,1983-la candidate's education. esperience, traimng, and are couivalent. No change to NQA l.
and either test results or capability 1997 is recommended.
Jemonstrat on.
Thejob;.formance u mapecir and Requirements of NQ+1,19's7 tm'c to test personnel shall be reevaluated at section 2S 1,2.6, I of NQA-1,1983-la penodic intervals not to escced 3 years.
and are couivalent. No change to NQA 1, 1997 is recommended.
Reevaluation shall be by evidence of Requirements of NQA 1,199i relate to continued satisfactory performance or section 2S-1,2.6,2 of NQA 1,1983 la 1
redeternunation of capabili'y in accordance and are couivalent. No change to NQA 1, with the requirements of 200 above.
1997 is recommended.
If dunng this evaluation or at any other time, Requirements of NQA 1,1997 relate to it is determined by the responsible section 2S-1,2.6,3 of NQA 1,1983-la organization that the capabilities of an and are couivalent. No change to NQA l.
individual are not in accordance with the 1997 is recommended, qualification requirements specified for the job, that person shall be removed from that activity until such time as the required capability has been demonstrated.
Any person who has not performed Requirements of NQA-1,1997 relate to mspection or testing activities in the section 2S-1,2.6.4 of NQA-1.1983-la
%. Q.4 4 0
NQA-1 SIDE BY-SIDE ANALYSIS OF REQUIREMENT EQUlv ALE REQUIREMENT 2. QUALITY ASSURANCE PROGRAM l'
I l
NO A.1,1983.la NOA 1,1997
{
EQUIVALENCY and are not coun alent. The vanance is a quahfied area for a period of I year shall be downgrade in requirement and is not reesaluated signsficant. The 97 requirement reJ1rces i
concise sersion of the R3 requirement. 1 a
No change is recommendedfor the 97 l
edition.
Wording does not constitute a 12 Program requirement.
The remonsible creancarmn shall esuhItsh Requirements of NQA 1,1983.la are
'~
sered in section 2,300. 2 of NQA l.
The responsible creanttation shall w ntren procedures for the quahficatwn of 991 and are not cautvalent. The vanance co esabbsh written procedures for the I
control and adminisnation of NDE personnel, andfor the tssurance that onh an upgrade and is not significant.,
is personnel training, etamination and those personnel a ho meet the requirements pplication of the 97 edition is broader A
are permused to perform these actnaties, scope (applies to allinstances where certsfication.
in Q,300.2) rocedures must be establishedfor p
ualifyin* r>ersonnell and meets the 83 q
intent. ho change is recommendedfor the 97 edision.
l Wording does not constitute a 2.3 Records requirement.
Requirements of NQA-1,1983 la are Records of persannel cualification shall Records of awahncarmit mcludmg overed in section 2,500,2 of NQA 1, be estabbshed and maintained by the requalsfication. for audnors and lead 991 and are not cauivalent The c
i auditors. andfor inspectwn and test ariance is a downgrade in requirement emploser.
person:cel shall be estahtished and nd is significant. The generalformat of v
maintamed by the emolmer anafor a
endocinnation and trumng. (2, 500, 2)
NQA 1,1983.la is preferred. The pecific wording changefor NQA.1, s
t997 that added ' auditors and lead auditors, andfor inspection and test personnel' is significant in assessing this downgrads bnuse of the limitingfactor imposed h s recommended that the identified 97 wording be deleted and replaced with
- personnel'.
wording doo not constitute a I 330 Lead Auditor SUPPLEMENT 2S 3 -
requirement J
SUPPLEMENT /.?V REQUIREMENTS RR 1HE QUALIFICATION OF QUALriv f
ASSURANCE PROGRAM AUDIT PERSONNEL
~
Wording does not constitute a
- 1. GENERAL requirement.
The lead auditor orgamzes and directs audits.
Requirements of NQA 1,1997 att This Supplement proudes amplified recons audit findinet and evaluates testinj with less prescriptise requirements for the quahfication of an specificity. No change to NQA.1,1997 is audit team leader, henceforth identified correctne action, recommended.
as a Lead Auditor, who otranizes and directs audits. recorts audit findines, and evaluates corrective action.
Requirements of NQ A-1,1997 ue not j
I This Supplement also provides tquivalent with NQA-1,1983 la. The amplified requiremeats for the variance is a downgrade in requirement !
qualificauons of individuals, henceforth and is significant. The generalformat of '
referred to as Auditors, who participate NQA.1,1983 la wording is not a m an audit, such as technical specialists.
requirement. The specific wording in manatement representatives. and Page 9 of 19
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 2 - QUALITY ASSURANCE PROGRAM I
NO A 1,1983 la l
NO A.1,1997 I
EQUIVALENCY audstats in traimng.
question here is the definition of
' auditor
- which is significant in assessing this as a downgrade because no simdar descrsprion is in NQA.1,1997, it is recommended that wording sdennfying audaors be added to NQ4 1,1997 secnon 2. 340.1.
It supplements the requirements of R:4-.. :T " NQ ' ' "" :: "
Easic Requ:tement 2 of this Standard
- 4 r i ^' MQ? ' """ k and shall be used in conjunction with Wording does not constitute a that Basic Requirement when and in the requirement.
extent specified by the organizatic.,
invoking this Standard.
- 2. QUALIHCATION OF AUDITORS Wordmg does not constitute a requirement.
Il Respons bility of Auditing Wording does not constitute a Organization requirement.
The responsible auditing orgamzation Requirements of NQA 1,1997 are not shall establish the audit personnel tqmvalent with NQA 1,1983 la. The quahfications and the requirements for variance is a downgrade and is not the use of techmcal speciahsts to significant, theformat of NQ4./,1997 accomplish the auditing of quality eliminates duplication of wording. This section relates to sections 2,340,2 and 2, assurance programs.
340,3, (a) through fc). No chantre to NQA.1,1997 is recommended.
personnel selected for quahty assurance Requirements of NQA.1,1997 are not cauivalent with NQA 1,1983-la. The auditing assignments shall have variance is a downgrade and is not t xpenence or training commensurate with the scope, complexity, or special significant, theformat of NGA./,1997 nature of the activities to be audited.
eliminates duplication of wording. This section relates to sections 2,340,2 and 2, 340,3, (a) through (c), No change to NQA.1,1997 is recommended.
Ayditors shall have. or be eMD.,
Auditornh"I hate or he eisen approoriarc Requirements of NQA-1,1983 la are aprocriate traimne or onentapon la tramine or orientation to s dop their covered in section 2,340,2,i NQA-1, deseloo their competence for cc verence for ver*rmin e aMrI.
1997 and are couivaleni...a change to yrformine recuired audits (2. 3J0, 2)
NOA.1,1997 is ret ca..n: ' ' +d.
farpy nee of personnel for Competence of ersonncI for verforr mcc cf Requirements of NQA 1,1983 la are t e various awarrine functioni shall be covered in section 2,340,3 of NQA l.
h performance of the vanous auduine functions shall be developed by one or develoved by one or more of the following 1997 and are eauivalent. No change to more of the methods given in(a) methods NQA.I,1997 is recommended.
through (c) below' e2,340,3) ta) orientation to provide a worbne ta) Orientation to providt,g working Requirements of NQA-1,1983 la are knowledge and understandine of this knowledee and understandine of this covered in section 2,340,4 of NQA 1.
Standard and the auditing Standard and the auditine orcanization's 19?7 and ige couivalent. No change to gumration's crocedures [g procedures for smolementine audits and NQA.1,1997 is recommended.
implementine audits and recortine reportine results.(2. 340. 4) results; (b) fif_. eral and wecials:gd trainine in audit Requirements of NQA-1,198bla are
__(b) trammg programs to provide general n
and specialized tr:.imne in audit performant c where the general training covered in section 2,340,5 of NOA 1, performance.
shall include fundamentah, objectives.
1997 and are eauivalent rhen combined characteristics, organizatton, performance, with celIs below. No change to NQA.1, and results of qualary auderine and the 1997 is recommended.
NQA 1 SIDE BY SIDE ANALYSIS 01: REQUIREMENT EQ REQUIREMENT 2. QUALITY ASSURANCE PROGRAM i
NOA 1,1997 i
LQUIVAl.0NrY
[,,,,,,,
NOA.I.1983.la c
l spr.talt:rd tratnme shall mclude methods of r.namunmt. questwnm t. et aluatme. and Jocumentme spectic auda arms and methods of c!sstne out auJa rinJmes s[ iJO b
<lso (I Mt'?d' and syfilJa:cJ !'J!nm2 in audil NcQuirementb of NQA'l l'#N.hla alt c'.ered in secuon 2, JJR 5 of NQA4 Gtner3l trair\\1r\\ e shall 1% lude t
c pretormance uhrte the gearral tratame 997 and are counalt0j when combined l
f undamentals. obicetn e s, 1
gha// int /ude fu eglamentals. objectn ts.
ith cell below. No change to NQA*l.
char.icteristics. ore amratga w
a haracter stics verontranon. rrtwomance.
performance. and resultLnt.gmthty and results of aualth audinne andthe 1997 is recommended.
AudLLLOL spectalt:rd tramasg shall mclude methnJs of r tammmt. questioning, rialuatmg. and documentine srectfic auda stems and methods of clostng out audafindungs.
.: : "' rI Speci.'lized tramSei.all includy
<bl GeneralJ td specsaurs d trmnmg m audet Requirements oiNQA 1,198314 ar overed in section 2,340, $ of NQA 1, c
tntibods of o.aminmc. cuestioning performance u hrte the untral trainmg 997 and are couivalsnt when combined 1
evaluatine. and documenting specific s hall include fundamentals, oh/crtii rs, with cell above. No change to NQA*l, audit stems and methods of enosine out characterestacs, organi:ation, performance, and results of qual t. JuJame and the 1997 is recommended.
Aqd. it findener gg,rialterd tramme shallinclude methods of r tamment. aurstronmr. n atua';nryst documennne st'ectfic audit trems and nr%Is of closent out auda findmes 42.340.$1 Requirements of NQA l.1983 la are tcJ On.thr. fob tratntE eurd4mcr. an.d covered in section 2,340,6 of NQA 1, (c) on t:ie.iob trainina. euidance. and counseline under the direct supervision v/ a 1997 and are cauivalent when combino counscime unds.1 the direct supgrsision ' Lead Audnor. Such frammg shallinclude with cell below. No change to NQA<l, of a lead Auditor.
plannmg, performing, trportsng, and
} 997 ls recommended, follow up actwn involved m conducting audits r2. 340. 66 (cf On.thr. job framsng, gundance, and Requirements of NQA 1, IW3 la are covered in section 2 340,6 of NQA te Such trainine shall include clannine.
counscluir under the direct supersismn of a 1997 and att.,gounnient wheni,ombined performm c. renoranc. god [oll.ow:pp Lead Auditor. Such tramine shallincludt with above cell. No change to NQA*l, action involted in conductine audits.
planntnr. Performme. ec.wrtant,q,nd follow up action mvoh tsigen ducting 1997 is racc..enended.
judas t2 3an q Wording does not consatute a 3 QUALIFICATION OF LEAD requirement;,
An mdnidual&[mect thg An inda dual shall meet the following Requirements are cautsalent with AUDITORS tiquunutn11oi3 J through 3.4 below t guirements crior to beine desicnated a lead editorial / diction differences only. No change to NQA.1,1997 is recommended.
ormt to beme_ designated a t tid Lud&L Auditor.
Wordir g does not constitute a 3.4 Communication Stills
- 33) (nmmunteauon Skills t equirement.
The crosocctive lead Ag@ tor shall The prosocctne Lead Audttouhall be Requirements are cou_ivalent with editorial / diction differences only. No have the capability to communicate capable of communteaung effectively. both change to NOA.1,1997 is treommended._
effectiselv. both m wnting and oralty.
in ununc 2ind ora!!r These skills shall be attested to m writine by Requirements are identical.
Jhtse skills stall btattesttd to m writune by the Lead Auditor's the Lead Auditor's emploser.
- emplover, Wording does not constitute a 332 Tramine 3.2 Tratrung requirement.
Requirements are counalent with Prospective Lead Auktors shall recene gocctne f. cad Audstors shall hate Page 11 of 19
NQA 1 SIDE BY SIDE ANALYSIS OF REQUIREMENT EQUIV ALENCY REQUIRESlENT 2. QUAL.lTY ASSURANCE PROGRAS1 I
l'OUIVALENCY NO A.I.1983.la i
NO A.1,1997 trainine to the entent neceturi to gainine to the estent neceuan to aupf.I editoriaUdictioN ditterences only No anyte, their :omnetence in auditing auditing enre'ence including-changt to NQ4.I,1997 is recommended.
dihs T raining in the following areas shall be l Requirementi et NQA.I.1997 gs El edunJfent with NQA l.1%31.i The gnen bascJ upon manJgement esaluation of the particul.it neeJi of iananct as a don ngrade and is not each prospectne Lead Auditor-ssgnificant. NG4.l.1997 r/iminates duplicated wording, intent of NQ 4 1, I983.la is maintained in 2,332, I and 2, 3M, I, No change to NQ.4 1, I997 is recommended.
3 2.1 Anowledit.pnd understandine of a Knowledce and undentanding of this Requirements ge identical, thn Standard and other nuclear-related Standard and other nuclear related codes codes. standards. reculatient and standards. resulations. and teculatori aidth terulatory cuides. 35 annN aNe as uppheab'r_
3.2.2 General structure of ouahty
- b. Ocneral structure of ouahts as,urance Requirements are identical assurance proctams as a whole and proerams as a whole and archcable elements archcable elements as dgfmed in this as denned in this Standard.
Standard l
3 2.3 Auditine technioues of
- c. Audittne technioues of esamining Requirements are identical eiamirunt uuestientnc. es aludWL.3nd ouestioning. evaluatinc. and reportigt reonttine: methods of identifsine and tpethods of identifying and followine un on follocine un on cortectne action items:
an.tetne action items; and closine out audit and closing out audit Ondings Ondinr5 3 2.4 Audit planning in the quahty.
- d. Planning audits of activities aticcting Requirements of NQA l,1997 are not relcted functions for the followmg quahty.
equivalent with NQA.I.1983.la No change to NQA.1,1997 is recommended, acuvities, design, purchasing, fabncotion, handling, st ipring, rtotage, All examples providedin FQA.I. I983
- leaning, etection, snstallation.
let are ' activities affecting quality,' NQA-I, !997 consolidates she wording and inspertion, testing, statnstnes, nondestructne esaminatmn, intent is equivalen;.
maintenance, repair, operation.
modification of nuclear facihties or associated components, and safety aspc - s of the nuclear facihty.
3 2.5 On the tohitanning to incl.je i c On thedob trainine to mclusje_gy ieable Requirements are idet J.
I r;1tg.gble elements of ths audit drmtnL the api E Jn.
i prograitt 3 3 Mdit ParticipatioD 333 A_udh Panicip3ED Wording does not constitute a req tement.
The proteccine I cad Auodor iball Prospectne Lead Auditors shall particingt Requirements are eQRllahu *ith editonal/ diction differences only. No hase Danicicated in a minimum of fhe in a minimum of fhe (5) ouahtv assutiimg W.guahty assurange audits withm a pudits within a oenod of time not to exceed 3 change to NQA.1,1997 is recommended.
ceriod of time not io exceed three (3) gars pnot to ths date of ouahtitttion. one icars pnor to the due of ouah0 cation.
audit of which shall be 1tlySJfALaual.111 ene audit of which shall be a nucleg assurance audit within the scar pnor to gahty assurance audit within the star quali0 cation onor tn his cuali0 cation 14 E3 amination 334 hamination Wording does not constitute a requiremmt.
ne prospective Lead Auditor shall Prosnectne Lead Auditors shall pass an Requirements ge equivaletti with pass an esammation which shall gammation which shall evaluaig editonal/ diction differences only. No evaluate his comprehension of and tomorehension of and abihts to apply thg change to NQA.1,1997 is recommended, abihty to apply the body of knowledge bods of _ knowledge identified abose.
om o no n
NQA 1 SIDE BY SIDE ANALYSIS OF REQUIREMENT EQUlvALENCY REQUIREMENT 2. QUALITY ASSURANCE PROGRAM l
NOA.1,19183.la i
NQ A.1,1997 i
EOUlvALENCY ident:0ed m 3 2 abose.
Requiremants are eaun alent w tth l
Dg test may be oral written. Practical.
D.g esaminauen mas be oral. wrmen.
editoriavdiction dif ferences only No l
or ans combinatity of the three t) pes praetreal or ans combmatmn thereof changes to NQA.I.1997 are recommended.
Requirements et NQA 1.199' are net T he desclopment and adminatratun et c.gunalent with NQA.I.190 Ia The the esaminatmn shall be n werdance ianance is a don ngrade and is not with Section 5 of ittnr Supplement.
gnificant. No change to NQA.I.1997 si is recommended. Developmentand administration of e.cominations are discussed in 2,420, I through i This ection is a reference pointer rather than s
(
a re_ quirement.
Wordmg does not constitute a 4 %1NTENANCE OF requirem QUAll!'lCATION Wording does not comtitute a 4.1 Maintenance of Pronciency 335 Mamtenance of Proncienev requirement Lead Auditors shall matatain their Ilid Auditors shall maintain their Requirements are identical.
nroncienev through one or more of the proficiency through one or more of the followinr terular and active followinritigular and active canicioatwn in the audit erocess.resiew and study of codes, Daniematmn in the audit process; review and study of codes. standards.
Mapdards.erocedures instructions and other documents related to uuality assurance procedures. instructions. and other documents related to cuahty assurance prettam and erottam auditine. or program and erottam auditing: and partiemation in tramine crocram(s),
participation in tiatMnr crocrams.
P-la) 11ased on annual am ssment. inanagement Requirements are idenneal.
Based on annual assessment.
manaaement may estend the may estend the cuahncation. reautre aunhfication. teouire retraininc. or retrainine. or troutre recuahfistion teomre recuah0 cation These es aluations shstl be documented.
Records of quai:Jicarmn mcludme Requirements of NQA 1,1983 la are requalsficatwn, for auditors and lead covered in section 2,500,2 of NQA 1.
audutors, andfor mspection and test l991 and are mt cauivalent. The variance
. permner'shall be estabisshed and is a downgrade andis not signifnant.
mamtemed by the ermloser en ifor No change to NQA*I, lui es mdoctrmatwn and trammg t: %CO, 2) recommended. iscussio on documentation has been consolidated in section 2,500, I and 2 of NOA.1,19M.
Wording does not constitute a 4.2 RecuahficatiCD 336 Reauah0catmn requirement.
Lead Auditors who fail to mamiam Lead Auditors who f aito maintam then Requirements are identig.at their cronciency for a ocnod of two pronciency for a cenod of 2 scars or more sears or more shall teamre shall reouire recuahncatlGD-recush0 cation _
Recuah0 cation shall inclu.ductraintne in Requirements are couivalent with Requahfication shall melude retraining accordance wtth the reautrements of 332 editonal/ diction differences only. No in accordance with the reautrements of change to NOA.1,1997 is recommended.
3 2 above. renstronation m accordance above. reesaminatmn m accordance with 334 wntL.4 gbove. and parttemation as an abose, and partiemation as an Auditor m at 3
Auditor in at least one nuclear cuahty least one nuclear quahty assurance audit.
Stance audit.
Wording does not constitute a
- 5. ADMINISTRATION requirement.
Page 13 of 19
NQA 1 SIDE BY SIDE ANALYSIS OF REQUIREMENT EQUlVALENCY r
REQUIRE $ LENT 2. QUALITY ASSURANCE PROGRAhl 4
I I NO A.1,19tt).la NOA.t.1997 l
1:Ql'lY A1.):N(T Wordmg does not ec 9titute a 5 i Organtrational Responsibihty requirement Traning of auditors shall be the The program shallproisdefor Requirements of NQA.I.1997 are not 4
serrannhhty of the emptner indoctnnation. trasnsng, and quahficatwn eaunalent sith NQA.I 196Ia The 1
a: necessary, ofpersonnelperformsng or variance es a dom ngrade and is not s
ignificant. No change to NQ4*l,1997 managsng actusties affecting quahty to s
assure that suuable profittency is achste rd is recommended. Discussion on tratnsnt l
and maintained. 42,120. II has been consolidatedin sectwn 2,120, I f SQA el, I997.
o i
The tesnonsible auditing organitation (d) Thost responsablefor ernfysng quahty Requ'itements el NQA.1,1997 sq.nl shall select and assign personnel who achievement have sufficient authonty, EquWaknt sath NQA 1,1983.la. The variance is a downgrade and is tcot are sndependent of any direct dirr~t access to management, ignificant. No cm.nge to NQ 4 1 1997 tesponubihty for performance of 1he organi:ationalfreedom and acms to work s
l actnities uhich they sill audit.
to perform thestfunction. (1,210, I, di is recommended. Discussion on independence has been consolidated in
}
ection 2, 210,1, d of SQA.1,1997.
s l
The Lead Auditor shall, pnor to Indoctnnatwn and trasning shall be Requiremen's of NQA.I.1997 are not commenesng the audil. concut that commensurate wuh scope, compte.tay, coun algM ssth NQA.1,19831a. The asusned personnel collectacly hase importance of the actsvities, and the variance is a downgrade and is enpenence or training commensurate education, esperience, andproficiency of significant. Thefollowing change to sith the scope. complesity. or special the person. (2,200,I)
NQA.), lH7 is recommended:
Discussion on training may hefound in natute of the activities to be audsted.
NQA 1,1997 section 2,llo, I and to
[
effect equivalence thefollowing wording change is recommended: ' Prior to commencing quality affecting activities a
l the responsihte organi:ation shallconcur i
that assigned personnel have received indoctrination and training commensurate with scope, complexity, importance of the activities, and the education, experience, and proficiency of 4
the person.
Woiding does nct constitu l
M Quahfication Exammation requirement.
3E desetopment and admtmstration of The responsible organhation shallidentify Requirements of NQA l.1997 Et. net the es,iiiiination for a Lead Auditor any specialph,calcharacterntics nrrded taunalent with NQA.1,1983.la with 1
tequired by 3.t abose is the in the performance of each activity, more spectficity. No change to NQA.I, responubility of the employer.
including the need for initial and 1997 is recommended.
subsequent physical examination.
l
{2,420.I)
The emplover may delerate this activity The rmslover may deltrare quahfication Requirements of NQA l,1997 ut. net ig_;in independent certifyine acency. but examination activities to an independent -
tguivalent with NQA.1,1983.la. No
}
shall retain responstbility for certifying aerney, but shall retain change to NQA*l,1997 is recommended.
L gpc. formance of the_tlamination and its responsibility for conformance of the 4
n pdministration to thts Standaid.
examination and its administration.
(2, 420, 21 l
Inteenty of the examination shall be Interrity of the examination shall be Requirements of NQA.1,1997 ut. net eauivalent with NQA.1,1983.la No j
maintained by the emplover or maintained by the emplover or certifyins certifrine acency throuch approcu;i.t.t amenev throuth a:mropriate confidentiality change to NQA.),1997 is recommended.
of fi/re and, where avalicable, proctorine of i
confidentiahty of Gles and, where o m 1.1 4 5 o
E 1
NQA 1 SIDE BY SIDE AN ALYSIS 01: REQUIREMENT EQL N ALENC REQUIRES!ENT 2. QUAL.lTY ASSUllANCE l'ROGRASI h
NOA.1,1997 iglV Al. INT NQ 4 1,19N.tla i
arrlicable_ rroctorier of rtaminanons eram#nanone t), 410,.lj N
forte.t o/ the phrchic rudence rrrardenf Requiternents of NQA 1,1997 EtX" l
Cortes of the obleetne cudence trerding the Drengd content of the the tirr< t! and rontent of the tgunaled with NQ01 l*I Id esammationm shall be retained k the riamsnanonesi shall be retained bs thg change to NQ41,1V97 as recommended.
emrloser in motJa%e inth 'he rmeloirr in accordance with the sequstements vt 8ecuen s het a
. requerrments of %I belom 12, 4l0. 4 Wording does not snsutute a 6RLCORD5 requirement WorJing does not constitute a j
6 i General requirement Eerds el personnel gyahtscanons for kererdi of Jualthcotmq Inc'udog' Requirernents of NQA 1.194Ia are ieted in section 2 MM of NQA 1, Auditors and_Ltad Auditets performing requahticahon. for oudvor and Irad w
1997 and guntIqun alent The audits dall be estabhshed and audiret, and/or sneprctmn and trat ariance is a
- ungrade in requirement t,rrsonnel Lh.d U.uRgbh: hrd ad V
I mana,ard b1 thuu s r r endfor and is sigro ' a~t. The generalformat maintained by the emr\\m mdoctrsnatwn cnd travune 42, $tu. 21 for appl >ing quahfica* ion tecords is referred. The specific wording added to p
NQ4.I, I997, ' inspection and test'is ignificant in assessing this dow ngrade s
because of the linsitingfactor imposed. It is recommended that this section read:
Records of quahfication, including equahfication, for person nel s hall be r
stablished and maintainrJ by the e
mployer andfor indoctrination and e
training.
Wordmg does not constitute a S 2 Certification el Qual.lication requirement.
liach L. cad Auditor Shall be certified by The quahfication ofinspection, test and Requirements of NQA 1,1997 Et.M his employer as being qualified to lead
/ tad auditor personnel shall be censfied in rounalent with NQ A 1,19831a No change to NQA.I,1997 is recommended.
u ntsng and include the following audtts.
information: 12.410,it The quahfication ofinspectmn, test and Requirements of NQA 1,1997 guel lead auditor personnel sIall be ertsfied in ignuhm woh NQA l,19831a The
'Ihis certification shall, as a minimum.
variance is an.pgt at.r in requirement drument the follo-
~g-w niing and include the follow sng and is not significr ** NL
1*
'tto
' *iformation: (2,410,oo NQA.), IV97 is recomr^tnded.
Discussion on records has been consolidated in section 2, 410, I of NQA
- 1,1997.
fa) Fmploscr's namet (2,410,I,a)
Rest **tne*4NQA4r4 WIN ian terloser 3 name;
- t*** WAND W*
Requirements are identical.
(b) Identification of ptrson bring cenified Requirements of NQA 1,1997 are not equivalcul with NQA 1,1983-la. The tb) Lead Auditor's name, (2,410,l b) variance is an upgrade in requiremerit and is not significant. No change to NQA.I,1997 is recommended, Discussion on recorded name has been consolidated in section 2, 410, I, b of J
NOA.1,1997.
th) Date o/ ccrrification or recenificativet Requireinents of NQA 1,1997 are not and cenification crpiration. (1,410, I, h) couivalent with NQA l.1983 la The (c) daitof certification or recenificattern Osao9C-84Q
W l?
l NQA 1 SIDE BY SIDE ANALYSIS OFllEQUIREMENT EQUlvALENCY REQUIREMENT 2. QUAL.lTY ASSURANCE PROGRAM NQbl,19N3 la NO A.1,1997 1:Ql'lV 411NCY wanance is an upgrade sn requsrement andis not sitnuficant. No change to NQA.I 1997 is recommended.
Discussion on certificatson espsratwn has born adJed to the requartment un i
sectwn 2. 410.1. h of NO4*l,1997.
'd t' asis ol quahtkation 'i e.
(dlliaju of qualification Requiremer'.s et NQA 1,19u7 MLnd educatmn. c sperien(c. (ommunicatmn
/J edricatwn, tapenence, andoctnnatmn.
Nunalent with NQA.l.19K3 la The anance is an upgrade in requartment aills. tt aining. c taminatmn. etca.
and trasning v
- 2) test results, w here applicable and h not significant. No change to
- 3) capabilsty demonstration results NQ4 1,1997 is recommended.
(2,410,I,d)
Ducussion on qualsfic.ation bash has born espandedin sectwn 2,410. I, J.
ic) 5.ignMgrigismploy er's deugna'1 (g) Sirnature of emelvier's deternatnt Hatw+meaW44-MJA4HW41ttd L
,eymient-*ANQA-4
'4 W LG.IIKulative *ho ts WFt. sit'le for errresentarire aho it retcnn5iN* for such e
such certification certificatwn. 12, 4111, I, eI Requirements are identical.
ft3 Updating of Lead Auditors' Hatw+menw44-NQe 5 !""' =: "
Records atmwdentwW.QA4WEW-Wording does not constitute a requirement.
Records for each Lead Auditor shall be liased on annual assessment, management Requirements of NQA 1,1997 ;tre nel maintained and updated annually.
may extend the qualification, require mainlint with NQA 1,1983 Ia. The retraining, or require requalification. (2, variance is a dow ngrade in requirement 335,2) and and is not significant. No change to Records of qualsfication including NQA.1,1997 is recommended.
requalsfication, for auditors and lead Ducussion on annualrecords may be auditors, andfor inspection and test inferred in sections 2,335,2 and 2,500, personnel shall be estilblishet* eria 2 of NQA l, I997.
maintained by the employer as. for indoctnnation and training. (2,500,2) 340 Auditors Wording does not constitute a requirement.
Auditors are participants in an audit Requirements of NQA 1,1997 MI.Dd munalent with NQA 1,1983 la, The variance is a downgrade in requirement and is significant. Th,eneralformat of NQA.I, I983.la wording is y trl< tred.
The specific wording of NQA.I, a v97,is significant in assessing thh downgrade because of the lack of options It is recommended that the won.ost to NQA.
I,1997 be revised as follows: 'A uditors, including technical specialists, managemtnt tepresentasivcs, and auditors.in. training, are participants in an audit. '
Auditors shall hase, or be gtsen, appropnate Requirements of NQA 1,1997 relate to traming or onentation to desclop their section 2S 3. 2.1,3 of NQA 1,1983 la competence for performing audits.
and attnennuisalent No change to NOA.I,1997 is recommended.
Competence of personnel tot performance of Requirements of NQA 1,1997 relate to the sarious auditing functions snall be section 2S 3,2.1,4 of NQA 1,198) la deseloped by one or more of the following and artnennuivalent No change to methodv NOA.I, !997 h recomme:sded.
om < c -e n
NQA-1 SIDE BY SIDE ANAL.YSIS 01 HEQM AtM EQUlVAL REQUIREMENT 2. QU41.lTY WM RW 7 PWIGRAM I
7 ~ ~ 7 ;A Q gi
'}
recivAltNoy E
g
[
Nor.1,19s3.la
.r~-
j.
.. 9 _cJ. trements of NQA.I.1997 relate to j
f._
ta Onentatvn te prostJe a armr3 a of NQ A l. IRt.la oton 250,21. 4 knowledge and understanJmg Mino and gr. net coun aletti No change to Standard and the auJiting organuatwn,
procedures tot smplemenung ndets and A Q 4 1,1997 is recommended.
reporting re,uita ibt General and specialited training in audit Requirements of NQA.'.1997 relate to sc tson 25 3. 2.1, J. b; 25 3. 2.1. J. b.1
~ a-performance where the general training shalland 254. 2.1,4.b. 2 of NQA 1.198314 melude fundamentals, objectnes, and are not counWent The variance is chataeteratics. or ganitaticn, performanic, an upgrade in requirement and the and tesults of quality auditing and the change is not significant. No changt to speciahred traming shall include methods ofNGA./,1997 is recommended.
e samiumg, questiomng. evaluating, and l>iscussion on generaltraining has been documenting spect(ic audtt stern and consolidat*4 in section 2,340,3, b of metuous of clostng ou e adtt hnding NOA.I, In1 Requirements of NQA 1,1997 relate to sc i On the. job training, guidance, and section 25 3,2.1. 3,e of NQA 1,1983 la counscimg under the direct supervnion of a and ap.-,,m!:S identical.
i cad Auditor.
Requirements of NQA 1,1997 telate to Such training shallinclude plantung, section 25 3,2.1,4 of NQA 1,19831a performing, reporting, and follow.up actmn and am v "':M identical.
inn.hed in conductmr audits.
p Wording does not constitute a 400 CERTIFICAllON OF requirement.
QUALII1 CATION Requirements of NQA 1,1997 telate to 410 The qualification of inspe4: tion, test ami section 251,2.7.1 of NQA 1,1983 la lead auditor personnel shall be certified so and are not couivaltal. The variance is a writing and include the follwng downgrade in requirement and is 1 tienificant. The generalformat ofNGA*
informanote I,1983*Ia wording is preferred. The
- specific wording added to NQA.I. I997,
' inspection, test and lead auditor'is significant in assessing this downgrade because of tl,1limitingfactor imposed. It is recommended that the new neding j
added to NQA.I,1997
- inspection, test I
and lead auditor
- be deleted.
Requirements of NQA 1,1997 relate to tai Employer's name:
section 2S l.2.7,1 of NQA 1,1983 h and are tw=t:+ identical (b) idenutication et person bemg certified Requirements of NQA 1,1997 relate to section 251,2.7,1 of NQA 1,198) la and utnet equivaleDi. No change to NOA.I, I997 is recommended.
1 i
I Requirements of NQA 1,1997 relate to i
(c) Actiuties certified to pettorm section 2S 1,2.7.1 of NQA 1,1983 la and Etnet.tquivalent No change to NOA.I,1997 is recommended.
Requirements of NQA 1,1997 relate to (d) 13 asis et qualtlicanon section 251,2.7,1 of NQA 1,1983 la and are not couival.tal. The tariance is a downgrade in requirement andis significant. The generalformat of NOA-Page 17 of 19
NQA 1 SIDE-BY SIDE ANALYSIS OF REQUIREMENT EQUlVALENCY REQUIREMENT 2 - QUAL.lTY ASST'RANCE l'ROGRAM NO 4.I.19tl3.l a l
NQA 1,1997 EQUIVAl.ENcy i
),1983.la m'ording is preferred. The specsfic mording dr.*rtedfrom NQ4.l.
I997 'w hich includes such factors an '
connects m sah thefollowtag three requstements andprossdes clear i
examples of the quahficatwn basss. It as l recommended that NQ4 1. I9t).la mordsag 'mhich includes suchfactors as:' he retained.
I 1 educatmn. e sperienc e, indoctrination. and Requirements of NQA.I.1997 relate to training section 251,2.7.1, d. I of NQA 1,194.L la and anet equivakal No change to N04 1, I997 is recommended.
I
- 2) test results, where applicable Requirements of NOA 1,1997 relate to section 251,2.7, I, d. 2 of A'QA 1
'0 4 l
la and n==t --q=i" identical, l
l
- 3) capability demonstration results Requirements of NQA l.1997 relate to section 251,2.7,1, d,3 of NQA l.1983-la and neat equnalent. No change to NQA.1,1997 is recommended.
ic) Results el permdie evaluation Requirements of NQA 1,1997 relate to section 251,2.7, i e of NQA l.1983 la and anot cauivalent. No change to NQA.I, I997 is recommended.
tI) Results of physical examinnons, when Requirements of NQA.I.1997 relate to required section 2S 1,2.7. I f of NQA l,1983 Ia and gnes cauiva'ent. No change to NQA.I, I997 is recommended.
t g) Signature et employcri designated Requirements 01 NQA 1,1997 relate to representatne who is responsible for such section 2S 1,2.7. I g of NQA.1,1983 la ecrtification and are not couivalent. The variance is i an upgrade in requirement and the change is not significant. 4 changeto NQA.I,1997 is rec n,...su.
. t th) Date of certitication or recertification and Requirements of NQA 1,1997 relate,
certification e spiratmn.
section 2S 1,2.7. I h of NQA-1,1983 la and are not equinknl. The variance is an upgrade in requirement and the ci-ange is not significant No change to NOA.I, I997 is recommended.
420 The responsibie organitatmn shall R:q..:: :. ? NQ? '. l'3"? W**4 identify any special physical characteristics etm @ "
""'"4 needed in the performance of each activtty,
{ Correction} Requirement is identical to meluding the need for initial and subsequent
- J,2S l,2.8 I. No change to NOA l.
physical e samination.
1997 is recommended.
The employer may delegate qualification Requirements of NQA 1,1997 anet examination activities to an independent Engiva,eni with section JS.J. 5.2. 2 of certifying agency, but shall retam NQA l.1983 la. No changr to NOA l.
responsibility for conformance of the 1997 is recommended.
.a.,
NQA 1 SIDE BY SIDE ANALYSIS 00 REQUIREMENT EQUlv ALE REQL 1RES1ENT 2 - QU Al.lTY ASSUR ANCl: PROGR AS1 7 $ 3,,1993,_ [ ~' {
EQl'lV Al.l:N(T N Q 4 1,1983_.!a esamination and its aJrninntration Requirements of NQA 1 IVV7 dLLN8 intertits of the etartunauen shall he NpHA[A] with settMn JS ),313 o[
l maintJined h the emplo)et Dt sertifyirig agenc) through ippriTriJte.onfidenu ihl)
NQ A j 19's.b la No (h1ngr td TQA* /.
. I tiles and. 4hete apphs at le. ptNt( ring of 1997 is trcommtnded, c ommanons Requirements el NQ \\.l. ivc attet Cities et the hjectne cuJense regarding equn ahn! *nh srrtion 1S 3, $ 1. 4 v/
l the typeisi and wntent of the cuminauensis NQA 1.19014 No chaner to AGA l, shall be retained by the emplo3ct in accerdance with the requirements of. 0 1997 is trrommended.
4 below Wording does not constuute a 90RLCORD5 require ment RMw:^-
e!#QA ', 'FM weM l Records of the implementation for Nwwlen4 ~~*NQA44"' l*-
'.nl - atmn and traiairw may take the Wording does not constitute a form vi attendanse sheets, h aitung togs. ot requirement but states options asailable personnel training teevtJe for training records.
Requirements of NQA-1,1997 relate to Records of quahticatmn, including sectmn 251..t1.1; 25 2. 2 3. I,and 254 tequahricanon, for auditors and lead 6.l. I of NQA.I.190 ta and are nut auditors, and for inspecuon and test coun alent The ariance is an upgrade personnel shall be estabhthed aad in requirement and is not significant. No maintained by the employer and for change to NQA.1,1997 is recommended, indoctrination and traitung.
l>iscussion on records has been consolidated in section 2,500,2 of NQA*
1, f 997.
Page 19 of 19
NQA 1 SIDE BY SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT.4 DESIGN CONTROL.
I NOA l.1983 la j
NOA 1,1997
[
EOt'IV A1.ENCY
~
Wording does not constitute a 3 DESIGN CONTROL REQUIRLMENT }
requirement DFSinN cnNTRA Wording does not constitute a 140 B ASIC requirement
[
The desten shall hc7etined contfolled.
Ihc deuen shall he Jtlined. 'mrNied.
Requirements are identicaj and sert 0ed and serthed Applicable design inputs shall bc Desren inputs shallbe gret0cJ on a Requirements of NQA 1,1997 gII appropriately greined on a timch b. isis timeh basis and translated into deuen eaun alent with less prescripine pec 0 city. No change to NQ.41,1997 h and correctly translated into deuen doc umentt s
irrommended.
documents Denian interf aces shall be identified and Design Interf aces shall be idett 6cd tDd Requirements are identical.
J controlled contrnlled Desten adeauacy shall be scrshed by Design adecuacy shall be serified by Requirements of NQA 1,1997 af.1 couhalent with more prescripthe persons other than thqig 3)n desi (d thg mdnidush other than those w ho daiened pecincity. No change e NQA.1,1997 h tht. Item or ccmp ater prograw s
tig.m.
recommended.
Desten cha_0&ti. including held changes, Design changes. shall be roserned by Requirements of NQA 1,1997 MI outvalent with less prescriptise shall be reverned by control measures control measures commensurate with c
pecificity, No change to NQ41,1997 h commensurate w th those arched to the thestprolied to the orteinal deuen s
recommended.
oriemal deuen Wording does not constitute a SUPPLEMENT 351 -
requirement.
SUPPLEMENTARY REQUIREMENTS FOR DESIGN CONTROL Wordmg does not constitute a IGENERAL requirement.
Wordmg does not constitute a
'this Supplement provides amplified requirement.
requirements for design control.
a Wordmg does not constitute a It supplements the requirements of Basic requirement.
Requirement 3 of this Standard and shall be used in conjunction with that Basic' Requirement when and to the estent specined by the organitation invokmg this Standard 2 DESIGN INPUT 200 DEstGN INPUT Wording does net constitute a requirement.
A9pb 'able design input' such asI [
6pple ible deur -
qu's iribs Requirements et NQ.. I IW7 M1 l
, ases, performance requirements,-
idstt ed and documentedddhrit equital with less prescriptit.
regulatory requirements, codes, and trJIf. hen teviewed an.d pprnud.
specincity. No change to NQA l.1997 is treommended.
standards, shall be identified ogd desumented. and their selection reviewed and apprard by the responsible design organizatmn.
The desian inout shall be specified and He deuen input shall be stTEiftsd ig.1hg Requirements of NQA 1,1997 Et approved on a timely basts and to the lesel lesel of detail necessary to permit the (qutvalent with less prescriptive of detail necessary to permit the destag design activities to be camed out in a specifkity. No changt to NQA.1,1997 h activity to be camed out in a correct cortect manntLand to provide a consistent treommended.
manner and to provide a conustent basis bmis for makme desien decisions.
for makine desian decisions.
gecomplishine dssten serincation accomolishina desien verif1EalicD Uteasures. and es aluttine denen changes.
measures. and evaluatine desten changes Chanert to desten incurt finaldesigns, Requirements of NQA 1,1983 la are Ghanges from approved desien inouts, including the reason for the changes,ihall field changts, and temporan and cosered in section 3,601, I of NQA 1, 1997 and are not couivalent. The be identined, approved, documented, and permanent modificarmns to operarmg facnhties t all be justsfied and subject to variance is an upgrade in requirement h
controlled P ca 1 of 16 t
m
NQA.1 SIDE BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY 4
REQUIREMENT 3. DESIGN CONTROL.
I NQ h.1,19tl3.l a l
NO A.1; 1997 i
EQUIV A1.ENCY l
dessen centrol measures wmmensurate that U significant. No change to NQA.I.
i n oth those appised to the ettemalJesien.
I997 is recommended.
o.4 MI I -
3 DES GN PROCESS 3m DESION PROCESS
%rdmg does not constitute a requirement.
The resnonsible desirn orcanitation shall 310 I_he re reiNe Jeuen arcamNtle_n Requirements of NQA.I.1997 gg c[nenbe and document the design ihad rrescribe and d vumer4t the Jesign cauts alent alth less prescriptne activities on a ume$ basis and to the lesel aetmiles to the lesel of detail necessan to specificity No chance to NOA.1,1997 ts of detail necessary to permit the dessen permit the deuen process to he carned out recommended.
a in a correct manner. and to permit p[pgess to be carned out m a correct
)
manner. and to permit sen0 cation.thEthg serification that the denen meets desien meets trout.emena reautrements Design documents shall support f acihty Requirements of NQA 1,1997 are not i
d sign, construction. and operation.
Equivaknt with NQA 1,1983 la. The variance H an upgrade in requirement that is r'* significant. No change to N04 1, )997 is recommended.
Requirements of NQA 1,1997 are not Appropriate quahty standards shall be cauivalent with NQA 1,19831a. The identined and documented, and their variance u a downgrade in requirement selection reviewed and approved.
that is not sigt'ificant. No change to NOA.1,1997 is treemmended.
j Changes from specified quahty standards.
Chaners to design snputs.finaldesogns, Requirements of NQA.1,1983 la are j
including the reasons for the changes.
field changes. and temporan and cosered in section 3,601, I of NQA 1, 1997 and are not cauivalent. The shall be identined, apprmed, documented, permanent moddications to operating variance is an upgrade in requirement and controlled.
facthtses shall bejustofied and subject to that k signylcant. No change to NQA 1, design control measures commensurate noth those applied to the artginaldesign.
I997 is recommended.
?
O MI 1) j, Design methods. matenals, carts.
320 The dgngn memods. matenals. carts.
Requirements of NQA 1,1997 ut j
cautement. and crocesses that are euuipment. and nrocesses that are gat ivalent with less prescriptive spenual to the function of the structure, gne_ntial to the function of the items shall specificity. No change to NQA.1,1997 is system. or component shall be selected be selected and resiewed for suitabihty of recommended.
and reviewed for <uitabihty of ancheatmn arnheation 6pphcable information denved from Apolicable mio[mation derned from Requirements are identical.
einenence. as 5" T,tp, eenorts or oth, jpt ence. as set forth in atlLor other Jocumentation. shall be made availablL12 do.umentauonghall he n nie available.L2 menirant design personnel commtant deuen scrsonnel The final desien (approved design output l 330 lhe final dolen shall:
Requirements of NQA 1, l997 un tauivalent with less presenptive documents and approved changes thereto) specincity. No change to NQA.1,1097 is l
shall:
recommended.
j tal be relatable to the desien input by guh_tglatable to the dessen mg.it.hy Requirements are identical.
documentauon in sufficient detail to documentation in sufficient detail to ocrmit deuen ven0 cation; and permit depen sen0 canon:
(b) specify required inspections and tests Requirements of NQA 1,1997 E1_n21 and melude or reference appropriate equivalent with NQA l.1983 la. The acceptance enteria; and variance is an upgrade in requirement that is significant. No change to NQA.I.
l997 is recommended.
(b) tdgalifv assembhes and/or comnonents (c)idenufs assembhes and/or comnonents Requirements ggfquivalent with that are eart of the item beine desiened.
that are eart of the item beine desicned.
editorial /dicticn differences only. No change to NOA.1,1997 is recommended.
Wnen suc h an auembiv or component Requirements of NQA 1.1997 are not t
When such an assembly or component Pace 2 ef 16
1 t
l NQA 1 SIDE BY SIDE ANALYSIS 01; REQU:lREMENI EQUIVALENCY REQUIREMENT 3. DFSIGN COVI Hot f
~
~
I I
NOA.1,1983.la i
NO A.1,1997
_j EQUlyAIINcy 1
part is a commercial crade tiern that, part is a commercial crade itenl, the mujvaient with NQA.I.1983.la.
characterisucs of the stem to be sentsed The variance is an upgrade in f
equirement that is signsflcant. No for acceptance and the aa eptance critena r
hange to NQA.I.1997is recommended. }
i for those characteratics shall be c
i Jocumented I
nnor to its mstalf anon. n modined or
//a commercial pade nem shai. prmi to Requirements of NQA.I.1943.la are r
osered m section 3,330,3 of NQA.I.
stie. cted by special inspecten and/or ris installation tr moddied or irlect d M e
]
testing to reuuirements that are more si rciat inspection an.i'or temne to 1997 and are tJuivalent. The variance is n upgrade in requirement that is not
}
restnctne than the Surriser's rubhshed reautrements that are more restractn e a
ignsficant. No change to NQ A.1,1997-than the Surriter's rmbtsshed product s
1 product descrtornon. the component part shall be terresented as diffetent from the descrtorion. the comtument part shall be is recommended.
commercial trade item in a mannet terresented as different from the traceabic to a documented dennition of commercial evade item in a manner i
traceable to a documented derintrion of the dalfetence.
the ddference (3. 330. 31.
Characteristics to be serthed are those Requirements of NQA.1,1997 are not 1
ouivalent with NQA.J.1983.la. The which provide reasonable assurance that c
the stem asll perform its intended variance is an upgrade in requirement thatis not significsnt. No change to functuon.
NOA.I,1997 it recommended.
11 a commercial grade item that, poor to Requirements of NQA.I.1997 telate to its installation,is modined or selected by section 351,3,6, b of NQA.I.19831a and are cauivalent. The variance is an special mspection and/or testing to upgrade in requirement that is not requirements that are more restrictive than significant, No change to NQ the Supplier's published product description, the component part shall be is recommended.
represented as different frun the commercial grade item in a manner traceable to a documented de6nition of the difference.
4u0 DESIGN ANALYSES Wordmg does not constitute a 31 Dgpen Analnes requirement.
Requirements of NQA.1,1997 are nc!
Design analyses shall be performed in a cauivalent with NQA.1,194 la. The phnned, controlled, and documented variance is a downgrade s,.rquirement manner.
that is not signifiernt. % isange to NOA.I,1997 is recommended.
Requirements of NQA 1,1997 are rmi Design analysis documents shall be cauivalent with NQA.1,1983.la. The J
legible and in a fortn suitable for variance is a downgrade in requirement reproduction,61ing, and retneval.
that is not significant. No change to NO A.),1997 is recommended.
Design analyses shall be sufficiently Requirements of NQA.I.1997 art They shall be sufficiently detailed as to deatitd such that a person techmeally equit.altDI withless presenptive purpose, method, assumpuons, design qualifted l.n the subicet can review and specificity.- No change to NQA l.1997 is input, references, and units such that a understand the aga)3ses and verify the treommended, pgnon technically cuali ed in the subiett fi can review and understand the analyses adeauacy of the results without recourse and senfv the adecuacy of the results to the oncinator, without recourse to the originator.
Requirements of NQA l 1997 are not Calculations shall be identifiable by tquivalent with NQA.1,19831a. The subject (including structure, system, or variance is a downgrade in requirement component to which the calculatnon u
m..
.c.-.-
ym-.r...-.-
_,mmm..,.,-y
--r m
. ~
. _ - _. ~ _ - -
NQA 1 SIDE BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 3. DESIGN CONTROL i
I NOA.I.1983.la i
NOA 1,1997 i
EQUIVAlINCY i
that is not signsficant. No thange to appliesh originator, reviewet, and date; or NQA./,1997 h recommended.
by other data such that the calculations are fctrievable.
410 be et Computer Programs Wording does not constitute a requirement.
To the ettent required in t ai and,bi i Requirements of NQA 1.1997 ggm!
below e.>mputer pregram acceptabihty counalent with NQA l.1983.la The shall be preactitied of the results setitied variance is an upgrade in requirement with the design analpis for each that h significant. No change to NGA./,
l997 is recommended.
atpheation Preactined computer programs shall be Requirements of NQA l.1997 are not gguivalent with NQA.I.1983.la. The controlled in accordance with the~
requi.ements of this standard variance is an upgrade in requirement that is signiffrant. No change to NQA /,
1997 is recc~ nended.
Requirements of NQA.1,1997 attnel
~
~
(a) computer programs may be utthred for gguivf:D1 with NQA.I.1983.la. The design analym without individual variance is an upgrade in requirement versiication of the program tot each that h not significant. No change to application provided:
NOA l, !997 h recommended.
(1) the comouter program has been tal the computer croctam shall be seti6ed Requirements are causvalent with venfied to show that it produces correct to show that it produces correct solutions editoriaVdiction differences only. No solutions for the encoded mathematical for the encoded mathematical modtj change to NQA./,1997 is recommended.
Inodel within defined limits for eact) with n de6ned hmits for each earameter narameter emoloved; and emplosed; (2) the encoded mathematical model has tb) the encoded mathematical model shall Requirements attequtyaltal with been shown to produce a valid solution to be shown to produce a valid solution to editoriaUdiction differences only. No
'he ohvsical oroblem assegipled with the the physical proble9 2pociated with the change to NQA./,1997 is recommended.
particular anchcation carticular acclication.
Requirements of NQA 1,19973e not Computer programs shall be controlled to cauivalent with NQA.1,1983.la. The assure that changes are documented and variance is a downgrade in requirement approved by authorited personnel.
that h not significant. No change to NOA.I,1997 is recommended.
Requirements of NQA.I.1997 are not Wh:re changes to prmously verified tauivalent wim NQA 1,1983.la. The computer prograre are made, verific mn variance is a downp e in.* y 'rement hall be required for the change,includs that h not significant. Ao ches,s to e
evaluation of the effects of these changes
.NOA.I,1997 is recommended.
on iI ) and i2) abme.
40 D-eument;uon of Design Analysis Wording does not consutute a requirement.
(b) Documentation of desten analyses Documentation of desten analpes shall Requirements strouivalent with shall.in@4t(1) through (6) below; intlydt (a) throuch tei below:
editoriavdiction differences only. No change to NOA.1,1997 is recommended.
(1)detinition of the obiective of the (a) the obtective of the analv313; Requirements gt cautvaleni with editoriaVdiction differences only. No analyses:
change to NOA.1, !997 is recommended.
(2) definition of dg3:en inouts and their (b) desien inouts and their sources; Requirements are eautvalent with editoriaVdiction differences only. No sources:
change to NOA.1,1997 is recommended.___
(3) results of literature searches or other (c) tesults of hterature searches or other Requirements are identical.
acolicable background data:
anchcable backcround data:
(4) identification of assumotions and (d) assumptions and indication of those Requirements are equivalent with indication of those that must be verified as that must be ven6ed as the desicn ed.toriaVdiction differences only. No Page 4 of 16
NQA-1 SIDE BY SIDE ANALYSIS OF REQUllWMENT EQUlVALEN REQUIREMENT 3-DESIGN CONT ROL
_NOA-1,1997_[,(([
EQUIV Al.F.NCY I
NOA.1,19183la 1
j rhan7e to NOA./,1997 is recommended
~
proceedt l the desten proceedt Requiremeris att_tauivalent with i
j (5)identificanon of any computer
<ci identtrhatmn of ans comrutes editonaPdietwn differences only No aliplahon. includine cemouter tsrc.
ialculanon tncludme sdenliharmn ef the change to NQA.I,1997 is recommended.
1 aggyter rrocryg te g, Mmti. temwn ymruter tsve amt' uter precram name, l
idenufication. t@utt outputs eudence nf andr m icn mtatt 'u'rutt cuJence d or reference ta comrutet prNtam 1
or ref erence to computer prNtam sertficahon. and the bases ter ref erence serificahon. and the bees mr *ef eren,e thereto) supporting appJication et the thereto'surnortine archcation of the 4
computer proctam to the specific chuical computer procram to the seccific rhuical q
rroblem i
ornblem:
Requirements of NQA 1,1997 gre not j
(N reuew and approsal equnalent with NQA,1,1983 la. The variance is a downgrade in requirement that is not significant. No change to NOA.I, I997 h recom...
dre 4 DESIGN VERIFICATION
$00 DESIGN VERIFICATION Wording does not conetttute a requirement.
ittguirements of NGA.I,1997'gg.ng(
DestFn control measures shall be apphed rouivalent with NGA.1,1983.la. The to venfy the adequac) of design, such as variance is a downgrade in requirement i
by one or more of the fallowing; the that is not significant. No change to j
performance of design reuews, the use of NGA.1,1997 is recommended alternate calculations, or the performance ne responsible desian orcanization shall
$0i The resnonsible desten orcanization Requirements are couivalent with of qualification tests identify and document the carticular shallidenufv and document the paruculu editonal/ diction differences only. No change to NOA.1,1997 is re*ommended _
design venfication methodN used desten ser:6 canon method 4) ysti The results of design veglication shall be The results of destenJerificMign shall be Requirements are cauivalent with editorial / diction dillerences only. No documented *tth the sdentif anon of the change to NOA.I.1997 is recommended. _
clearly documented wita the *dentification venfier clearly indicated of the senfier clean indicated Desien venfica' ion shall be nerformed b.y Desten ven0catmn shall be performed by Requirements are_ identical.
any comt.etent indiuduaksi or crourm any comnetent indinduaks) or crouem other than those who performed the other than those who performed the ortemal desien but who may be f rom the enemal desten but who may be from the ume orcaniranon same orcanitatinn Requirements of NQA 1,1997 are not Rin.cnfication may be performd by the tauivalent with NQA.19R? la. The
- origin,r's supervisor, r-vided the variance is a downgrade in requ *rment
' m,ervisor did not speciiy a singular that is not signyicant. No change to design approach or rule out certam design NGA.1,1997 is recommended.
considerations and did not establish the design inputs u ed in the design or, f
provided the supervisor is the only individualin the organitation competent to perform the venfication.
Requirements of NQA 1,1997 are not Cursory supervisory reuews do not cauivalent with NQA 1,1983 la. The satisfy the intent of this Standard.
variance is a downgrade in requirement that is not significant. No change to NOA.I,1997 is recommendre Requirements of NQA 1,1997 are not Verification shall be performed m a umely squivaknt with NQA l,1983 la. The variance is a downgrade in requirement manner.
that is not significant. No change to NOA.I,1997 is recommended.
Requirements of NQA.1,1997 an 502 Deyen senficahon shall be
_, Desien senficanon. for the lesel of design S 4O O
NQA 1 SIDE BY SIDE AN AL.YSIS 01 REQUIREMIWT EQUlVALENC REQUIRBlFNI 3.MMO COVlRot
,,,[,]@,1,k[ []((
EQt'lY A1.ENCY I
NQ A.l.1983 1a t '44VallLnl with less prescriptne g
actnity accompinhed, shall be Bertormed - lit.lti.!DdIntClO n n+N tr Jf UP !@
tst.'10citv. No changt to NQA l.1997 0 r
prior to release for erocuremenL plogtrment.minhMI.4mitei I etemmended.
manyf act.ia. construction. or release to ci ng by another Jtyn VM ?.pc etcert ahere t'in termnwntelftr.un another orgamration for mg in other such as when insuffkient dattnist.
design actaities except in those cases where tha timine cannet be met su,h.a l
- hen msuf 6cient data et nt.
In those cases. the itmeritied partionni in +hme c. net the unsen6cd rettien ?!
Requirements are identical the design shall be identified a,nj the desi26 shafl be ideMilled anj l
i contrnHed l
in all cases the desten senfication shalQg In all cases the deuen sen6catyn sh g,lh Requirements of NQA 1,1997 are not l
controlled i
comricted enor to reh sne unon thg ggunalent with NQA.I.198bIa. The completed tior to rehine upon the varusnce h an upgrade in requirement component, sutem. pruaure. vt iott,puter that h significant. No changt to NQA./.
compot
, system. ot structure to orrfortn in func9ng, program to octform its functing 1997 h recommended.
11 the design n modifici, to resohe Requirements of NQA l.1997 telate to
'W section.wI, l.1,6 of NOA.1,198kla scrification 6ndmps, the madshed deugn and are not caynalent The variance h a shall be seri6ed prior to release for use.
downgrade in requirement that k not significant. No change to NQA.1,1997 is recommended.
4.1 htent of fiesten Ven6 cation 504 Ustent of Deuen Ven6 canon Wording does not constitute a -
requirement.
1he ettent of the deuen ser:6 cation shall Requirements are causvalent with be a function of the tmoortance to safett editorial /dicuon differences only. No The extent of the desien senficat 2D J
required is a function of the importance to the compleuty of the desicn. the decree of changt to NQA.1,1997 h recommended.
init1% of the item under consideration, the nandardiration the state of the art. and complexity of the desien.the derree of sandardiration. tho state of the art. and the similarity with eteuousiv oteg (L umilanty with creviousiv e oven desient Where the desten has been subiected to a
% here the dden has bee n ghected to _a Requirements are euuivalent with desiens-editorial / diction differences only. No senfication crocess m accordance with senfication eroecss in AAEr.dar,.g_wnh r
chang, to NQA.I 1997 h recommended.
tha Standard, the venfication vta.tM lbn Part iPart it the ser:6 cation crow need not be ducheated for identical need not be ducheated for tdgnt.!s;ij deurns Requirements ge identical.
desient However.the ar%btity of standardized ; [loweser.the ggitsethly.o_Lugndatatd l
r.~egnni,tngmq.dym sth resprgi ctyleviousiv eroset hici s. with reggs.1 to rueetme ocrtu M doigrag!.Ldal) to meetMr pertinent design (nputs. All be sen6cd for exh archunon Entwn eroblems atiecung the l Known eroblems allectmfibg standard et Requirements are euuivalent with be sen6ed for each ancheation editorial / diction differences only..b standardized or oreviously oroven deuens pi.uousiv erosen deuens and1hgit change to NQA.J.1997 is recommtaded, gnd their effects on other features shall be effects on other features shall be conudered_
The ontmal desien and, associated The enemal desien and associated Requirements Me cautvalent wtth i conudered cdttorial/ diction differences only. No s enfication documentation s'iall be changt to NQA.I.1997 h recommtaded.
mifts,ation measures shall be adequately documented and referenced in the 6tes r,.f referenced m records of subseauent subseauent a:Dhcation of the deuen apphcanon of the desien Where r,hanges to preuously sen6ed if the deugn n modified to resobe Requirements of NQA.1,1983 la are seri6 cation 6ndings. the modihed design cosered in section 3, $03, I of NQA 1, 1997 and are not couivalent. The designs hase been made, design shall be s en6ed prior to release for use O.
tariance h a downgrade in requirement j
sen6 cation shall be required for the changes,includmg evaluation of the 503,IL that b not signylcant. No change to effects of those changes on the overall NOA.1,1997 h recommended.
design.
Wording does not constitute a
$10 Methah 4 2 Methods Page 6 of 16
NQA 1 SIDE BY SIDE ANALYSIS OF REQUIREMENT EQUlVALENCY REQUIREMENT 3 DESIGN CONTROL I
NOA.I.190 ta i
NO A.1,1997 i
EQt'lV A1.ENCY
[
requirement Acceptable serificatioitriethods include.
Acceptable scritkation methods inclade.
Requirements are identical but are not limited to. ans one or a but are not htmted to ans one or a combinaton of the followinc desien cnmbination -t the Mioaint l
reuewt alternate calculattent and deuen reuew s. alternate.alcubn 'ns and l ouahficannn teurne waktk inon te nnt 411 Deuen Reuewi
$ll Deuen Reuews Wording does not constitute a requirement lhese are critical renew s to proude Deugn reucas shall proude,my,tanit Requirements are couis alg31 with assurance that the final deurn is cortect that the final desien is correct anj editoriaUdiction differences oni). No and satisfactory.
unstactors change to NOA.I,1997 h recommended.
Where archcable. (a) throuch t fl below.
- 13) addresung where appheable. (a)
Requirements are cautsalent with l
l Shall be addressed.
[ht,eygt1(g) bgka editortaUdiction differences only. No l
change to NQA.1,1997 h recommended.
tal Were the desien inputs correcily tat Were the deuen inputs e +tectiv Requirements arc identical, selected?
tel_ceted ?
tbl Are assumpuons necessary to perform (b) Are aoumruons necewars to perform Requirements g. identis.pl e
the design activity adequately desenbed the deuen actiuts ageouatch descrittd and reasonable
- and reasnr.able '
Where necessarv. are the assumptions Where necessary. are the aoumntions Requirements are idenligt.l.
Identified for subscGuent rescri6 Canons idlntibed for subseduent rescriOCations when the detailed desten actiuties are when the detailed denen acttuucs are completed' comrleted]
W Was pAarrrernate desien method W Were arnrernate deuen methods and Requirements of NQA.I.1997 g1 W3d?
computer programs ygd?
couivalent with more prescriptive specificity No change lo NQA l.1997 h recommended.
idl Were the desian inputs correctly (d) Were the deuen innuts correctiv Requirements are identical.
incorporated into the deurn
incorporatM mto the deuen '
(c)is the design output reasonable tei is the deuen cumut reasonable Requirements are identical.
compared to deuen mouts' compared in deuen inputs '
(f) Are the necessary desien innotapj (f) Are the neceuary denen inputs {d Requirements ge cautvalent with sen6 cation requirements {pr IMtdaGES LMtdacin.g orcantratmnupeci0cd in the editoriaVdiction differences only. No l evanizations specined in the31nig!1 doien usey_ments or it.
- nutting change to NQA.1,1997 h res ummended.
h,MmtML2Unygrorting procedures or
~octJures or instrygtions '
ystructions' (g)liase suitable matenals. parts.
Requirements of NQA 1,1997 are not processes, md inspection and testing equivalent with NQA 1,1983 la. T1.
cutena been specified '
variance h an upgrade in requirement that h significant. No ekange to NQA.1, I997 h recommended.
4 2.2 AllHDate Calculations.
$12 Alternate Calcylations Wording does not consutute a requirement.
These are calculations or analy ses that are Alternate cale_ulatio_ns shall use alternate Requirements are cautvalent with made with alternate methods to senfv methods to senfv correctness of the editoriaUdiction differences only. No correctness of the onrinal calculauens or engtrialgalculations or analnqi change to NQA.1,1997 h recommended, analyses The approonateness of assumptions. inout 1he appropriateness of assumptions:innut Requirements of NQA 1,1997 mi data used. and the computer program m data used: and the computer procram. its gguivalent with more prescriptive other calculation method used shall also assoetated computer specincity. No ch.1nge la NQA.I.1997 (8 be reviewed.
hardware and sy stem software or other treommended.
galculation method v3ed shall also be om, a 4e
NQA 1 SIDE BY SIDE ANALYS6 OF REQWREMENT F,QUIV ALENC RF.QUIREMFNI 3. IMON r DNTHOi
~T[,((,hd@@],[,((,['
EQUlvALENCY i
NO A.I.1983 1a I
twesel
... -. y
$13Quah6c e.le
- Woribng does not constitute a 12.3 Ouahrication Tests.
mtunement
..a1 Requirernents of NQA.I.1997 are not
% here deugn adequxy is to be tentied GunakDI with NQA.1,1983.la. The by quahneation testo the tests shall be sanance o a downgrade in requsrement ident 6ed.
that is not significant. No change to NQA.1,1997 is recommended Requirements of NQA.I, l983.la are Test procedurrs shallim-tuJr at reference emered in section i1,310, I of NQA.I.
The test con 6gutation shall be ciently Ihr test (vnticurarmn and less obpcto rs 1997 and are causvalent in intent. No dc6ned and documented.
(//,J/0,//
change to NOA.I,1997 is recommended.
Testine shall dememtrate adcapan o,f Requirements are identical.
Testina shall demonstrate adeauacy of oerformance under conditions that Derformance under conditions that simulate the mon adverse du!L.
am. i the mod adZa design condshom conditions.
Requirements of NQA.1,1997 are not qyivalent with NQA.1,1983 la. The Operating modes and environmental t
conditions in which the item must perform ariance h a downgrade in requirement v
satisfactonly shall be considered in that is not significant. No change to determining the most adverse conditions NQA.I, I997 is recommended Where the test is intended L Mnfv only Requirements are identical.
Where the test is intended to verify only socetne desten features the other features specific desien features the other features of the desien shall be seri0ed by other of the desian shall be senned by other Test results shaft be documented and Requirements of NQA.1,1983.la are means means.
overed in section i1. 500,1: and 2 of Test results shall be documented and rea/uated bv_a.rupmssNf_guthonry to NQA.1,1997 and are not couivalent. The c
evaluated by the _ responsible desuta hra!L.nc br.cn h
assure that test reg.t uraaniution to assure that. lid variance is an upgrade in requirement sortsfied, III,. % /I that is significant. No change to NQA*1, Itautrements have been met.
Test result _sfor dessan qualdicatwn tests 1997 is recommended.
and software design senficatwn M]h l
esaluated bs the r_estwnubleif}J.gn areancarmn t iI. !no.'i Requirements of NQA.I.1997 are not if quahficauon testing indicates that qquivalent with NQA.1,1983.la. The modifications to the i'm are nectssary to variance is a downywde in requirement obtain acceptable p.for nance, the shat is not sign @can' Nc r.m
-r to
.aodineation shall be documented and
- NQA.1,1997 is recomm.nded.
f item modined and retested or otherwise
, venned to assure satisfactory performance.
When tests are beme nettormed on Requirements are identical.
1
%Jen tests are being nerformed on medels or mockuns. sealine laws shall be models or mockuns. scahne law s shall be established and venned_
established and venned The results of model test work shallbe Requirements are identical, The results of model test work shall be subiect to error analysis. where anpheable, hubiect to error analysis. where anchcable, orior to u',e m the Onal desten.
Requirements are couivalent with onor to use in Onal design work.
f(x) CH ANGE CONTROL editorial / diction differences only No 5 CHANGE CONTROL change to NOA.1,1997 is recommended.
Requirements of NQA.I.1997 are not Channes to final destens. Including [tgM 601 Chances to design inputs,linal cauivalent with NQ A.1,1983.la.
channes, shall be iustined and subiected 12 designs, field chances, and temporary and Requirements of NQA.I.1997 relate to permanent modi 0 cations to operating section 351,2, I and 351,3,3 of NQA.
desian control nwasures commensurate facihties ghall be iustified and subiect to 1.1983 la and are not cauivalent.
with those anolied to the oneinal design de<ien control measures commensurate and apprmed by the same affected croups Pace 8 of 16
NQA 1 SIDE BY SIDE ANALYSIS OF REQUIREMENT EQUlVALENCY REQUIREMENT 3 DESIGN CONTROL l
EQUlvA1.ENCY j
or organtiations which reviewed and with these ar'phed to the ortrinal desien_
The varianct is a downgrade in requirement that is not signylcant. No an ros ed the ortesnal desugn documents:
change to %Q 4 1,1997 is recommended.
escept where an orgamtation which
.i onginally was responsiNe for approsing a particulat design document is no longer responsible, then the ow ner er his designee shallde58Fnate a new responsible organization which could be the Owner's engineenny organitation The>c measures shall inslude es aluation Requirements of NQA 1,1997 are not of ellects of those changes on the userall eduit alent with NQA 1,1983.la. The design and on any analpes upon which variance 4 an upgrddeir' requirement the desiin is based that are af fected hv thethat is significant. No changt to NQ.41, 1997 is recor imendeJ.
change.
T:.. <aluation shaU ir:lude f acihty Requireme of NQA 1, iv97 are not configurations that occur during operation.
tquisalent with NQAd,198kla. The maintenance. test. sutscallance and variance st an upgrade in requirement that is sign (ficant. No change to NQA.I, inspectson actinties I997 is recommended.
The destenated orcanization shall hase The desten otrantra #on approung the Requirements of NQA 1,1997 gt demonstrated competence in the soccl6e change shall hase demonstrated coutvalent with more prescriptise desian area of interest and have an comoettuce in the socetfic desten area of specs 6 city. No change to NQA./,1997 is adeauate understandinr 2Libg interest and have an adeuuate recommended, reautrernents and intent of the oririnal understanding of the reauirements and intent of the one naldesien desian 602 When a design change is approved Requirements of NQA 1,1997 are not other than by revision to the afvetted tquivalent with NQA 1,1983 la. The design documents, measures wall be variance is an upgrade in requirement estabhshed to incoiporate the change into that is significant. No change to NQA l.
these documents, where such 1997 is recommended.
incorporation is appropriate.
Where a sienificant desien chance is 603 )Xbere a sientlicant dessen chance is Requirements are idemiLal.
necessary because of an incertect desten.
necessary because of an incorrect desien, the desien crocess and senfication the desien croccu and serification crocedure shall beIrviewed and modt td procedure shall be teuewed and mmhfied 6
w nee, tv.
't 6io Cunnguration M.:nagement et Requirements of NWI,199" it di pect nary Operat ng Facibucs Procedures equivalent with NQA 1,198313. The implemenung configaration management variance is an upgrade in requirement require usnts shall be estabi,shed and that is significart. No change to NQA.1, documented at the cathest practical time 1997 is recommended, prior to facihty operation.
These procedures shall include the Requirements of NQA 1,1997 ut.n21 V alwith NQA 1,198Fla. The responsibilities and authority of the t
s is an upgredt in requirenient orgamrations whose functions affcct the
~.
In(ficant. No change to NQA.l.
configuranon of the facihty including 1.
ac'ivities such as operations, design.
1997 recommended.
maintenance, construction. heensing, and procurement Requirements of NQA 1,1997 are not bil Configuration management taubBital with NQA.1,1983 la. The requirements shallinclude me:.sures to variance is an upgrade in requirement ensure changes that may atfeet the that is significant. No change to NGA 1, approsed configuration are recognized and processed 1997 is recommended.
NQA 1 SIDE BY SIDE ANALYS'S 0" REQUIREMENT EQU REQUlHEMENT 3. i>ESIGN CONT HOL NOA.b 1997 [ [ ] '
1:Q('iV Al.ENcf i
I NO A.1,198tla Requirements of NQA.I.1997 MWJ til21 he contipEion shall be estabinhed counalent sttb NQA 1,19lt3 la. The and apprm ed at the cathest praeucal time sarsau s o an upgrade in requirement ptwr o \\nsual cretatwn et the facthsy and that is significant. No (hangt to NQ4*l.
hJanlained f-'t the infe M the factht) t I997 is recomm.rided.
Requatentnis of NQA.I.1997 are not 6131he << ntiguraten hallinclude,.n aunalent atih NQA l.1983 la, The c
arphcaNe. charadetancs derncJ trom artance o an upgrade in requsrement e
tegulatory requirements and hat is signtficant. No change to NQA*l, t
commitments. calculanons atd analpew 1997 h trrommtaded, design inputs, i ntallatmn and test requirements. suppher manuals and instructions. operating and maintenence requirements, and other arpheable sources Requirements of NQ. 1,1997 are not
' ' ' interf ace controk shall.nelude the auivaletu alth NQA 1,1983 la. The mtegration of aetmues of organisations ariance is an upgrade in requirement c
that can atfeet the approsed configuration.
hat h significant. No change to NQA.I, s
t I997 is recommended.
615 Documentation shall identify the Requirements of NQA 1,1997 are not ounalent with NQA 1,1983 la. The c
design bases and the approsed ariance is an upgrade in requirement conngurauon f or the approud modes of hat is significant. No change to NQA.1, v
t
- operanon, I997 h recommended.
bib Measures shall be established and Requirements of NQA 1,1997 are not cauivalent with NQA 1,1983 la. The implemented to assure that proposed rariance is an uPfrede in requiramtat changes to the connguration are evaluated that h significant. No change for thest confor.'snee wtes tue design l997 h recommended.
bases
._ n ation sequence for Requirements of NQA 1,1997 art.unt 617 The imp.
equtvalent with NQA 1,1983.o The approsed conh, ation chaares shall be variance is an upgrade in requirement tessesed to determme that the that h significant. No change to NQA*I, conngutauon a m conformance with the 1997 h recommended.
l desi:n bases Requirements of NQA 1,1997 are not j
, bin Appros al by the design authority shalltguivalent with NQ,.1, '?81 'a. The be required prmt 'o implementation of a variance is an upgrade in v:quirement chas, r to the des fn bases that is significant. No change to NQA 1, 1997 is recommended.
l_
ons Inc connguralion of thf facility shall Requirements of NQA 1,1997 are not t
equivalent with NQA4,1983 la. The be documented in drasings, rariance h an upgrade in requirement Specincations, procedures and other that is significant. No change to NQA 1, l
documents shich reticet the operational 1997 is recommended.
status of the facihty.
9equirements of NQA 1,1997 are not The process utilized to control the current egnvalG.! with NQA 1,1983 la. The revismn and issuance of these documents varianer k an upgrade in requirement
(
shall take into account the use of the that h significant. No change to NQA document and the need for resiuon in 1997 is recommended.
i support of operation Wording dxs not constitute a 700 INTERFACE CONTRQL 6 jmERFACE CONTROL requirement.
Requirements ef NQA 1,1997 relate to Design mformanca transmuted across secuon 3S 1,6. 3 of NQA 1,1983 la and mterfaces shallidentify the status of the are not couivaltg j ne variance is an design information or document provided o
,a $ r -# $ g
NQA ! SIDE BY SIDE ANALYSIS _ OF REQUIREMEN1 EQUIVALENCY REQUIREMENT.b DESIGN CONTHOL l
NO A.1,11i9[~((,]
EQUIVA11NCY NQA.1.1983.la i
.ind sdentely mcomplete items stuch upgrade in requirement tkatis require further esaluation. reuew. or sign (ficant. No change to NG.4./. /997 h recommended.
3rrtes al Requirements of NQA.I. lv97 lt.act il Da!pt mterlaces sitall be identified and coululen1 aith NQA.I.1983.la. The conUetkd and the deugn e(forts sh# he sonance is a downgrade in requirement coor&M'5d tmong the par 1scipantng that is not significant. No change to tvganetauont.
NO4 1, I991 h recommended.
Requirements of NQA.I,1997 atf ac.t Interface contiott tul!it.gt st euuivalent witi. NQA 1 1983.la. The auignment of respon.iNhrj w sne variance is a downgrade in requirement 1
eslobiishment of pwcedures awsg that is not significant. No change to participating design otpnitations for the NOA.1,1997 h recommended j
te vice, approve.l. release, distnbution, and l
revision of documents involving design interfaces.
Denen infoimauon transmitted across Drurn enformarron tranmutted across Requirements of NQA 1.1983 la are initJDgs.1 s%11 he documented and interfacts shallidentify the status of the cosered in section 3.700. I of NQA 1, l
controlled.
desten enformation or document pt nided i997 and are not cauivalent. The andidennfy encomplete arms shich variance is an upgrade in requirement j
requstefurther evaluatwn. reurw. or thatis not significant. No change to apprmal t3. 700. Ib NOA.I,1997 is recommended Where it is necenary to initially transrd Requirements are idenut.al.
, here it is necenary to initially transmit W
desien information orally or by other desten information oralls or by other informal nwans. the transmittal shall be informal means th.t,_ transmittal shall be confirmed riggetly bv a controll s E.gnfirmed otomeily by a controlled t
docaa=at
- document, 800 SolTW ARE DESIGN CONTROL Wordmg does not constitute a requirement.
The requitements of 800 apply to m.
computer softw are design control and
- __ W JS NO ""O b shall be used mstead of 200, Design Wording does not constitute a input; 300. Design Process: 500. Design requirement.
Verification; and 600. Change Control.
810 Software Design Process Wording does not constitute a requirement.
The mfture desi;n procco shall be i Requirements of NQA 1 97 ;ts.nel
~
documented. approsed by t% responsible tainvaltal with NQA 1.1. J.la. The destgn orgamration. and conuolled.
variance is an upgrad. in requirement that is significant. No change to NQhl.
I997 is recommended.
This process shallinclude the actiuties Requirements of NQA 1,1997 are not described in the following subparagraphs.
equivalent with NQA l.1983.la. The variance is an upgrade in requirement that is significant. No change to NQA 1, i997 is recommended.
8)i Identification of Software Design Wording does not constitute a Requirements requirement.
Software design requirements shall be Requirements of NQA 1.1997 are not identified and documented and their.
tguivalent with NQA 1,1983 la. The scleenon res tewed and approsed.
variance is an upgrade in requirement that is significant. No change to NQA 1
!997 is recommended.
The software requirements shallidentify Requirements of NQA 1,1997 are not the operating ustem. function. interfaces.
cautvalent with NOA 1.1983 la. The
NQA 1 SIDE BY SIDE ANALYSIS OF REQUIREME REQlilREMENT 3. DESIGN CONTROL, NOA.I.1997 j
EQUlvAISNCY l
NO A.1,19:131 sarsance h an upgrade in requirement perf ormarne requsrements. mstallatson at h significant. No change to NQA 1, th
,onuderations, deugn inputt and any i997 is recommended.
deugn constrasnu ot' the eemruter rrogram Word.9; does not consutute a
< l.' Sof tw are Deugn repuirement, Requirernents of NQA*l. IVV7 att not The witware Jeugn hau *e Jrume.ded Uhalent with bQA*l, 1983 14. The cu nd shall de6ne the compuuuonJl rsance H an uppade in requirement j
a va i
equence nectuary to meet the software at h signtftcant. No change to NQA 1, s
th requirements
)997 h recommended.
i Requirements of NQA.1,1997 are not 1
The documentauon shallinclude as.
ausvalent with NQA+1,1983 la. The c
pplicable. numerical memods.
ariance h an upgrade in requirement J
a mathemaucal models. phy neal nwdcls.
dfict.nt. No change to NQA.I.
v that is sigi
- nl now. control logne. data now.
1997 h recommended.
process Dow, data structures. process a
i Structures. and the applicable re'ationships between data structures and process Requirements of NQA 1,1997 are not uructures.
This documentahon may be combined ausvalent with NQA 1,1983 la. The c
with the documenlahon of the software ariance h an upgrade in requirement v
design requirements. or the computer hat h significant. No change to NQA*l, t
progtam hstings resultmg from 1997 is recommeaded.
implementation of the mitware deurn Wordmg does not consutute a til3 Implementauon uf the Sof tware requirement Deugn Requirements of NQA 1,1997 are not The sof tware deugn shall be transtated tauivalent with NQA 1,1983 la. The into computer prog *am(si using the variance h an upgrade in requirement
]
programtmng organization's or design that is significant. No change to NQA 1, organization's programming standards and 1997 is recommended.
4 i
consentions Wordmg does not constitute a til4 Sottware Deugn Ver:6eauon requirement.
j Requirements of NQA 1,1997 are nel Sottware design scriticauon shall be cguivalent with NQA 1,198? la. The performed by competeni individual (s) or variance is an upgrade in requirement gnup, s uiber than those who deseloped that h significant. No c' rne to NQA.I, and doenmemed tb : ommal design. but 1997 h recommend.
who may be from the
- ime,rganirauon.
Requirements of NQA i,1997 are not The results of serificauon shall be egylyaltal with NQA-1,1983 la. TI-8 with the iJenti6cahon of the variance is on upgrade in requirement j
doeu 1ent serifiet indicated.
that is significant. No change;o NQA.I. l 1997 h recommended. -
Requirements of NQA 1,1997 are not Software serincanon methods shall tgavalent with NQA 1,1983 la. The indude any one or a combination of variance is an upgrade in requirement design reviews. alternate calculations. and that h significant. No change to NOA.1, tests performed during computer program 1997 h recommended.
i
- Jevelopment.
Requirements of NQA 1.1997 are not I The estent of seri6 canon and the method s
equivalent with NQA 1,1. 33 la. The chosen are a funeuon of:
variance h an upgrade in requirement that is significant. No change to N2 A 1, 1997 h recommended.
Requirements of NQA l.1997 are not __
a The completity of the software.
Page 12 of 16
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+w+-
NQA 1 SIDE-BY SIDE AN ALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 3. l)ESIGN CONTROL l
NOA.I.1983.la NO A.1,1997 i
EQUIVAIJNCY counalent with NQA.1,1983 la. The sanance es an upgrade in requirement that is sigrificant. No change to SQA*1.
1997 is recommended.
l
'a The degree 'l stanJatJvation.
Requirements 01 NQA 1,1997 att not equnalent with SQA 1.1983 la. The anance b an upgrade in requirement s
that is signtflcant. No change to NQ.41, 1997 is recommended.
c.1he umilarity with preuously prosen Requirements of NQA 1,1997 gg.fim sof tw are. and equnalent with NQA 1,1983 la. The arsance is an upgrddsin requirement v
hat is significant. No change to NQA 1.
t l997 is recom<nendrJ.
- d. " importance it elety Requiremen,fNQAi, 97 gg Dal squivalent with NQA 1.1983 la. The i
ariance is an upgrade in requirement v
that is significant. No change to NQA 1,
!997 is recommended.
815 Computer program Testmg Wording does not constitute a requirement.
Computer program testing shall be Requirements of NQA.1,1997 are not performed and shall be in accordance with couivalent with NQA 1.1983 la. The Requirement i1-variance is an upgrade in requirement hat h significant, No change to NQA.I.
t 1997 is recommended.
820 Software Configuration Wordmg does not constitute a Management requirement Sof tware contiguration management
%.r : n " 'Q A ', "? = =A u o " " NO.^ ', ' * ' :.
includes, but is not limited to, contiguration identificatmn. change Wording does not constitute a control. and status control requirement.
ContiFuration items shall be maintained Requirements of NQA 1,1997 are not under contiguratian management until the couivalent with NQA 1,1983.la. The software is retired vanance is an aggrad* in requirement that is significant. No cm nge to NQA.I, I997 is recommend *
- 821 Configuration Id:ntitication Wordmg does not constitute a requirement.
A sottw.re basehne shall be estabhshed at Requirements of NQA 1,1997 are not the completmn of each actiuty ofia (quivalent with NQA 1,1983 la. The softwate design proccu.
variance is an upgrade in requirement thatis significant, No change to NQA I, 1997 is recommended.
App.osed chanfes created subsequent to a Requirements of NQA 1,1997 are not baseline shall be added to the baseline.
couivalent with NQA 1,1983 la. The variance is an upgrade in requirement that is significant. No change to NQA.I, 1997 is recommended.
A baseline shall detine the most recently Requirements of NQA 1,1997 are not approsed software contiguraa an_
couivalent with NQA 1,1983.la. The variance is an upgrade in requirement -
that is significant. No change to NQA I 1997 is recommended.
NQA-1 SIDE-BY-SIDE AN ALYSIS 01 REQMREMENT EQUlV ALENC REQt'IRlWl?.NT.4 IlESIGN CmTHOi, l
[Nd,[139[,[ ],_ ]
i:QCIV AI.1:NCY i
l NOA*l.19N3.la
[kIquirements of NQA l.1997 die not f
A labehng i)sicm b r, i hgeatni te n's The l [Jun alent with NQ A 1, lud+lJ sh.ill be implemenicJ ! rat
, artance is an upgrade in requvement l thatis sognificant. No change to NQ4 l. '
l i 1997 se recommended.
Requirements et NQA l.199'.tre nel i ; anweh 3dermhes e.n. nhpratwn cdun alent with NQA l. IVO la The
, ccm.
sartance is an upgrade in requirement that is signtficant. No change to NQ41.
I997 is recot.smended.
Requirements of NQA l 199; gre net b identihes changes to antiguranon tqunalent with NQA l.190 ta. The stems by resision..ind arsance is an upgrade in requirement v
hat h significant. No changt to NQ4 l.
t 1997 h res ommendes..
- c. prosides the aNI.t> to uniquely idenuty Require....ats of NQA l.1997 ;tre nel qWitd with NQA l.190 la. The cach con 6guration of the tesned software Eariance is an upgrade in requirrment v
as atlable f or use hat is significant. No changt to NQA.I.
t 1997 is recommended.
C Cor.tipurauon Change Control Wordung does not constitute a requirement Changes to sof tw.tre shall be f ormally Requirements of NQA l.1997 are net equngity with NQA 1.1983 la The Jocumented variance is an upgrade in requirement that is significant. No change to NQA*l.
I997 is recommended.
The documentatmn shall Wde Requirements of NQA 1, I"97 are not cauivalent with NQA 1,1983 la. The variance is an upgrade in requirrment that is signifscant. No change to NQA 1, 1997 is recommended, Requirements of NQA l.1997 Et.nd a a Jescripuon of the change.
tau,n;ilent with NQA l.1983 la. The variance is an upgrade in requurment that is significant..%.na.sge to NQA l.
1997 is recommended.
- b. the rationale (oIthe change..ind Requirements ut NQA l. <Y97 Et.DH1
~
eaunalent with NQA 1.1983 Ia. The
)
vartance h an upgrade in vrquirrment that is significant, No change ia NQA l.
i I997 is recommended.
the identineation et attected sottware Requirements of NQA l.1997 are not j
camits with NQA l.1983 la. The e
baselines variance is an upgrade in requirement that is significant No changt to NQA*l.
1997 is recommended.
The change shall be tormally esaluated Requirements of NQA 1.1997 are nel equnalts with NQA 1,1983 la. The and approsed by the organitanon variance is an upgrade in requirement re>ponsible for the attginal design. unic>s that is significant. No changt to NQA 1.
an alternate organttalion has been gnen the authority to approse the chances.
1997 is recommended.
Only authorited changes shall be made to Requirements of NQA 1.1997 are not equiglent with NQA-l.1983 la. The sof tw are basehnes.
l Ogap 4 ) es i r.
NQA 1 SIDE BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 3. DESIGN CONTROL I
NO 4 1,19831a NOA.1,1997 j
EQUlvALENCy J
~
vanance is an upgrade in requirement that is signsficanL No change to bQA*I, I997 is recommended.
Requirements of NQA 1,1997 ate nel Appropriate scrithation actiut es shall be counalent with NQA.J.1983 la The performed let the change vanance is an upgrade in requirement that h significant. Nu shange to NQA.I, 1997 is recommended.
Requirements of NQA 1,1997 are not The change shall be appropriatei) counalent with NQA-1,1983 la. The reDected m documentation and variance is an upgrade in requirement traceabshty of the change to the software that is significant. No change to NOA.1, design requirement shall be maintained.
I997 is recammend*d.
Appropriate acceptance test.ng shall be Requirements of NQA 1,1997 are not cauisalent with NQA.1,1983 la. The performed for the chan;e.
variance is an upgrade in requirement that is signylcant. No change to NQA.1, 1997 is recommended.
H23 Con 0guration Status Control Wording does not constitute a requirement.
The status of con 0Furation items resulting Requirements of NQA.1, W97 are not from software design shall be maintained couisalent with NQA 1,1983 la. The variance is an upgrude in requirement current.
that is signyicant. No change to NQA.I, I997 is recommended Con 6gurauon item changes shall be Requirements ol' NQA 1,1997 alt.ll21 controlled until they are incomorated into tuninitalwith NQA 1,1983 la. The the approved product baseline.
variance is an upgrade la requirement that is significant. No change to NQA.),
1997 is recommended.
The controls shallinclude a process for Requirements of NQA 1,1997 are not maintaming the status of changes ahich couivaig with NQA 1,1983 la. The variance is an upgrade in requirement are proposed and approsed. but not that is significant. No change to NQA.I, imolemnted.
1997 is recommended.
are not The co..trols shall also prou it for Requirements of NQA 1, i-notincahon of this mformatioii to affected tquivalen with NQA t t983 la. The variance is an upgrade in requirement organitauorn that is significant. No change to NQA.'
I997 is recommended.
7 DOCUMENTATION AND RECORDS 900 DOCUMENTATION AND Wording does not constitute a requirement.
RECORDS Requirements of NQA 1,1997 are not Design documentation and records, which equivaltnt with NQA 1,1983-la. The provide evidence that the design and variance is a downgrade in requirement design venGcation processes were that is significant. No change to NOA.I, I
performed in accordance with the 1997 is recommended because this requirements of this Standard, shah be requirement is realigned with collected, stored, and masntained in equirements in Crittrion NOA./,17.
accordance with documented procedures.
The d2OlmtDtation thsdl include net only Design dmmentauori and records @all Requirements of NQA.I.1997 att final desian documents. such as drawine,$
include not only final desien documents-Equiultal with trote prescriptive speci6 city. No change to NGA.I.1997 is i
and soecifications, and revisions thereto such as drawines and but also documentation which idenunes soeci6 cations. and revisigns to those recommended.
the important steos. includme sources of -
documents but also documen;ation which
NQA-1 SIDE BY SIDE ANAL. ISIS Of RLQUIRE.6.11 REQUIREMEN'l i Ill.51GN CONIWt TT iiO A i.,1997
[_
EQUIVAIINCY i
I No4 1,198.t.i.
l t enti6es the impotuttgg J
dmen inputs that supcott the Gnal desitn in the design prwrw LSJyJnhym2) !
Je*,in ierue;lh t sorryrt 'he nnal Je< ten _ {
l DSaa1A^41A
NQA-1 SIDE BY SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIRES 1ENT 4. PROCURES 1ENT DOCUSIENT CONTROL L
1983 NQA 1 AND la l
1997 NQA 1 l
EQUIVALENCY j
J PROCUREMENT DOCI'hlEM "EQUIREMENT 3 Wordmg does not constitute a CONTROL PROCUREMENT DOCUMENT requirement.
l CONTRot IN B ASIC Wording does not constitute a requirement.
Aeoheable detien bases and other AeolicaNe design bases and other Requirements Mr.1knDM l
tiquirements necessary to assure adeaujttt reautrements necessary to assure adeauatj cuahty shall be included or referenced in uuahty shall t - inch;Jed or referenced in l
documents for crocurement of items and documents for procurement of items and I
services services To the extent necessarv. Drocurement To the ettent necessarv. procurerne.nl Requirements ge identical documents shall reoutre Sunchef: 3have documents shall teoutre Supphers to han Lqpahty assurance program consistent sality assurancc c:ortam consistent eith the aoolicable teouirements of this with the acolicable reautrements of this Standard Standard SUPPLEMENT 4S 1 -
Wording does not constitute a requirement.
SUPPLEMENTARY REQUIREMENTS FOR PROCUREMEN1 DOCUMENT CONTROL Wording does not constitute a i GENERAL requirement.
'this Supplement provides amplified Wordmg does not constitute a requirements for procurement document requirement.
control.
It supplements the reqmrements of Basic Wording does not constitute a Requirement 4 of this Standard and shall requirement.
be used in conjunction with that Basic Requirement when and to the estent specified by the organization invoking this Standard.
2 CON'ENT OF THE PROCUREMENT 200 (,QNTENT OI Tile Wording does not constitute a D'V'UMENTS PROCUREMENT DOCUMFNTS requirement.
ELo.gurement docunn ots issued at.11m hurement documents inued at all tiers Requirements are ids tal.
f crocurement shall incwde provisior glyt gement shallittglyh crovisions for the following. as deemed ntcessan av for the followine as.sleemed tecessary by the Purchaser the Purchaser
__2.1 Scoy of Work 210 % oc of Work Wording does not constitute a requirenwnt.
A statement of the scope of the work to be Procurement documents shallinclude a Requirements are causvalent with performed by the Sucolin shall be in the statement of the scooc of the work to be editorial / diction differences only. No procurement documents.
Derformed by the Sunclier, change to NOA 1,1997 is r_ commended.
2.2 Itchnical Reautrements 220 Technical Reautrements Wording does not constitute a requirement.
Technical reautrements shall be specified Technical _ _reautrements shall be specified Requirements are identical in the procurement documents, in the crocurement documents, Where necessary, these reauirements shall These regyttements shall be soecified. as Requirements guttayivalent with be specified by reference to specific approonate by reference to specific editorial / diction differences only, No drawines. specifications. codet standards, drawines. speciflEAli2nid3 des, standards, change to NQA.1, f 997 is recomaAended.
i terulationt procedures. or instructions.
te rulations. crocedures. or instructionL including revisions thereto that desenbe including revisions thereto that desenbe Page 1 of 4
NQA 1 SIDE-BY SIDE ANALYSIS 01 REQUIREME REQUIREMENT 4 PROCI.'REMENT DOCFMEv) CONTR
[
1983 NQA l AND la l
]{5[hi],]((
EQUIVALENCY
)
l
... = -
the items er struceupltfanushed the items or ser ices to be furnatttd, The crocurement documents shallidentsfy Requirements of NQA.I.1997 gr coun alent with less prescriptne
)
The procurement Jocuments shall proude apprornate gst. msocction. and No change to NQh/ /99? st for idenh0 cation of git,inwetmn..ind Fecotance entena for deter *mning recommended.
spectikity xcentance requirements of the Purchaser asceptabihty of the item or seruce Emphash h placed on identufving for monitormg and evaluaung the technical acceptance requirements of Supplict's perIormance.
product;for contract specific assessment of Supplier performance see Criterian 7, Wording doce no's sonstitute a 230 Ouahty Assurance Procram 2.3 Ouahty Assurance Procram requirement.
R eauirements Rroutrements Procurement oncuments d all reautre that Requirements ggf,ug.a],
j3ocurement documeDts shall reautre that Sunolier havu documented auahty the succher have a documented auahty assurance crocram that imolements u
assurance crocram that imolementa portions or all of the reautrements of this pertions or all of the reautrements of thisStandard Requirements of NQA 1.1997 gr Standard The extent of the program required shall couivalent with more presenptive The extent of the ororiam reauired shall be consistent with importance and/or specificity. No change to NQht,1997 h depend upon the type and use of the item complexity of the item or scruce being recommended.
or service beine crocurel procured.
Graded program wording in 97 replaces
- 83. ' depend upon use' 83 is equivalent to %e consistent with importance' 97 and
' depend upon type
- 83 h equivalent to
+e consistent with complexity
- 97.
The procuremes i doeutuents shall reqmts 1 Requirements are identtca l
lne procuument documents shall reautre the Suncher to incoronrate appfppngig the Succher to incormtate acerconate cuahti anurance creeram reQuitements th auality assurance crogram recuirements in subtier procurement dxumenit Wording does not constitute a subtier crocurement doctimenty 240 Richt of Access requirement.
2.4_ icht of Access Requirements are cautvaletti wnh R
De procutement documents shall orovideeditorial / diction di... ( 4e' aly. No at each tier of a emurement tht procurement docunwnts shall(Lvjdi.Lg fp,Laccess to the SuophrQ and sub-tier change to NQA./,1997 L recammended.
i ccess to the Sucolieta plant [ng' es and sui het 's fagjmes and records for surveillance, intoection or audit bv the i
a tgcords for insocction or addith.mg ttg.chutL ts drsienmed representative.
I i
BgghntL s desienated representatise.
pd others authquied by the Purchaser.
hi RDWor other parties authonred by the Wording does not constitute a Purchaser.
250 Degumentatter r(couiremeDu 2.5 Documentation Reautrements requirement.
The otocuremenMocuments shall identify Requirements of NQA 1,1997 gg cauivalent with less prescriptive De procurement documents at all tiers the documentation reouired to be specificity. No change to NQel 1997 shall identify the documentation reauired simitted for mformation. review.01 recommended.
to be submuted for information reviewag approval bv the Purchaser.
97 wording addressos alllevels of approval by the Purchasti procurement docume.
'at alltiers'in 83 is not reeutred.
Requirements are identical De time of submittal shallatso be The time of submit:al shall also be establishel established Page 2 of 1
NQA-1 SIDE BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIRE 51ENT 4. PROCUREhtENT DOCUMENT CONTROL i
1983 NQA 1 AND la l
1997 NQA 1 l
EQUIVALENCY l
%Ian the Purchaser reauires the Suncher When the Purchaser reauires the Furrher Requirements of NQA.I.1997 Et to mamtain see:jfis quahty assurance to maintain seccific records t' c retention tg'm alent with less prescripme records, the retention times and times and disnosition reuuirements shall specificity. No change to NG4 /,199? ts,
disposition reautrements shall be M.presenbed recommended.
prescribed
- quality assurance
- deleted in 8.1; records'is defined as quahty assuranct 1
related documents.
~
2 0 Nonconfnnnances 260 Nonconformances Wording does not constitute a requirement.
. he procurement docurnents shall specify Requirements of NQA 1,1997 are not T
The procurement documents shall include quivalent. No change to NQA 1,1997 h b!!S aser's reautrements for reportinc and the PurchaseA reuuirements for the e
h approving disposition of Suppher's renortme of nonconformances.
recommended.
nneconformances.
Nonconformances... shall be submitted Duposttion approvalis discussedin 7 to the Purchaserfor approvalof the 600, I and in conjunction with 4,260. I recommended disposition, f 7, 600, I, b, intent is equivalent.
2) 2.7 Spare and Reclacement Parts 270 Spare and Renlacement Parts Wordmg does not constitute a requirement.
The oroctuement documents shall require The procurement documents shaQ specify Requirements are couivalent with the identification of appropnate seate and the supplier's requirements to identify editorial / diction differences only. No replacement earts or assemblics and the gare and replacement earts or assemblies change to NQA 1,1997 is recommender.
d appropnate delineation of the technical and the telated data reouired for ordenne and quality assurance related data teouired these carts or assemblies J ordenne these carts or asscrnhhes 3 EROCUREMENT DOCUMENT 300 f.BOCUREMENT DOCUMEKr We.dtng does not constitute a REVIEW REVIEW requirement.
A review of the procurement documents A reuew of the procurement documents, Requirer.cnts are cautvalent with and channes thereto shall be made to an(. hances thereto. sh'tll be made and editorial / diction differences only. No assure that documents transmitted to the documented pnor to award to assure that change to NQA 1,1997 is recommended.
prospective Sueolier(s) include documents transmitted taprosnective NQA 1,1997 wording " documented pner grp.r.coriate orovisions to assure that items S.'mphe 'o include aoorennate provisions to award" is addressed in the next cell.
or semees will met J e rectfied to auute that items or seruies will meet teouirements.
the specified recuirements Renews shall be performed god A resitw of the procuremen documents, Requirements of NQA. 1983 la are deua_ '.l.cd to provide objective evidence and changi. ' hereto, dtalthe made and covered in section 4,300, I of NQA 1 of satisfactory accomplishment of such oocumented prior to award to assure that 1997. Requirements :.re couivalent wit.
review pnor to contract aw_Ald documents transmitted to prospective editorial / diction differences only No Suppliert sl include appropriate provisions change to NQA 1,1997 is recommended, to assure that items or services will meet the specified requirements. (.t. 300. I)
Chances made as a result of the bid Technical or quahty assurance program Requirements of NQA-1,1997 att evalugignt.ot precontract Decotiations chances m.ade as a result of bid couivaltniwith more prescripti e shall be incorocratedjnto the crocurement evaluations or necotiatiorn shalLM specificity. No change to NQ^ 1,1997 is documents.
incorocrated into the procumntal recommtaded.
documents pnor to their issuance to the supplier.
The review of such EhaData and their Technical or quality assurance program Requirements of NQA l. 1997,4,300.2 effects shall be completed pnor to contract chanres made as a result of bid are not equivalent with NQA l.1983 la award.
craluations or negotiations shall be when used in combination with 4. 400.1.
Page 3 of 4
PQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVAL REQUIREMENT 4 PROCUREMENT DOCUMENT CONTROL l
l 1983 NQA 1 AND la l
1997 NQA l l
EQUIVALENCY which addresses the degree of control l
encorporated onto the procurement documents r>rior to theur ossuance to the (including reviews) of procurement document changes No change to NQA-i
- l. I997 is recommended.
~;
suppher to KO. : 1 i
Requirements of NQA l.1997 are net This reuew shall snel.de the following equivalent with NQA 1,1983 la /ntent considvrauons.
ofperforming reviews is accomplished with 97 wording in 4,400, I, Procurement document changes receive same degree of control as original l
documents. No change to NQA 1,1997 is recommended.
Requirements et NQA 1,1997 are not l
tal appropriate requirements specified -
equivalent with NQA 1,1983 la when l
Section 2 of this Supplernent; the 97 sections 4, 400, i and 4, 300, I are usedin conjunction. No change to NQA.I,1997 is recommended.
Requirements of NQA 1.1997 are mes (b) determmation of any additional or equivalent with NQA 1,1983 la when modified design criteria; the 97 sections 4,220, I and 2, and 4, 400,1 are usedin confunction. ' Design l
criteria
- 83 wording and ' technical requirements' 97 wording are considered equivalent. No change to NQA 1, J997 is recommended.
Requirements of NQA 1,1997 are not (c) analysis of except ons or changes equivalent with NQA 1,1983 la when requested or specified by the Supplier and the 97 sections 4,400, I and 4,300, I are determination of the effects such changes used in conjunction. No change to may have on the intent of the procurement NOA 1,1997is recommended.
documents or quality of the item or service i
Reviews required by this Section shall be Procurement document review ilip,ilig Requirements are cautvalent with to be furnished.
editorial / diction differences omy. No nerformed le"annel who have access nerformed bv nersonnel who have access to ocetinent information and who have pjl
,o nc.nnent infor nation and who have an change to NQA 1, la97 is recommended, adequata.yndet >. -din of tbs a(lequee undersundine 3f the II2uir:ments and intent of the Igquirements and intent eithe nrocurement documents.
4 r nUCUREMENT DOCUMENT 400 ffloCUREMENT DOCUMFg Wording does not constitute a requirement.
l.
CHANGES Procurement document channes shall be i Procurement document changes affectmg Requirements of NQA 1,1997 att CHANGES sebiect to the same decree of control as the technical or quality assurance program equivalent with more prescriptive specificity, No change to NQA l,1997is i
utilized in the nreoaration of the or,einal requirements shall be subiect to the samt decree of control as utilized in the recommended.
documents.
preparation of the original documents.
t I
Page 4 of 4
j NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY l
REQUIRE 5 TENT 5. INSTRUCTIONS, PROCEDURES, AND DRAWINGS l
1983 NOA.1 AND 1a l
1997 NOA 1 l
EQUIVALENCY d
WordinF oes not constitute a REQUIREMENT 5 INSTRUCTIONS. PRCCiDURES. AND INSTRUCTIONS PROCEDURES. AND requircraent.
DR AWINGS DR AWINGS 100 B ASIC Wording does not constitute a 5
requirement.
l Activities attestine cuahts shall bg Activities affectine auaMs and >ersiees Requirements of NQA 1,1997 gg prescribed by and rierformed in shall be presenbed bs and nerformed in eaunalent with more ;4escriptne j
)
accordance with documented instructions.
accordance with documented instructions.
specificity. No change to NQA.1,1997 is j j
procedures. or drawines procedures. or tjniwings recommended.
Requirements of NQA 1.1997 relate to paragraph 5,2 of NQA 1,1983 la and as j
that include or reference appropnate couivalent. No char.gr to NGA 1,1997 is quantitative or qualitative acceptance recommended.
enteria for detertratang that presenbed j
results base been satisfactonly attained.
Requirements of NyA 1,1983 la relate to paragraphs 5,100,2 and 5,100. 3 of of a type appropnate to the circumstances.
The activity shall be desenbed to a level NQA 1,1997 and are couivalent with l
ofdetad commensurate mth the more presenptive specsficity. No change
}
complexstr of the acto un and the need to to NQA.1,1997 is recommended.
assure consistent and acceptable results.
6 100.D
+
The needfor, and level of detail, in wntten procedures or mstructions shall be a
s determsned based upon complexity of the i
task, the significance c,'t1e, tem or activity, work enstronment, and worker proficsency and capability (education.
traintne. etperiencel IS,100 ll
)
These documents s?allinclude or that include or reference ornronriate Requirements of NQA 1,1983 la are i
reference anoroonate cuahtative or auanterarn e or auaIirarise accerrance covered in paragraph 5.100, I of NQA l.
auantitative acceptance entena for cnteria for determining that presenbed 1997 and are cauivaleg No change to kerminine that presenbed t'vitieslug results hase been satisfactonly attained.
NQA.I,1997 is recommended.
(.* Md ll i
baen satisfactonh ;oraphshed.
T..e tetmty shall' c dessabed to a level Requirement of NQA 1, l'"' elates to l
of detail commensurate with the paragraph L 1 of NQA 1,1983 la and u complexity of the activity and the need to cautvalent with more presenptive i
assiist :onsistent and acceptable results.
requirement. No change to NQ41,1997 I
is recommended.
The need for, and evel of detail,in wntten Requirement of NQA 1,1997 relates to j
procedures or instructions shall be paragraph 5, I of NQA-l.1983 la and a determined based upon r omplexity of the cauivalent with more presenptive task, the significance of the item or requirement. No change to NQA.I 1997 4
actmty, work environment, and worker is recommended.
proficiency and capability (education, training. expenence) 4 I
j
\\
)~
NQA-1 SIDE-BY SIDE ANALYSIS OF REQUIREMENT EQUlVALENCY REQUIRDIENT 6 DOCD1ENT CONTROL j
l l
1983 NOA.1 AND 1a I
1997 NOA 1
{
EQUIVALENCY I
1 k
REQUIREMENT t l Wording Joes not constitute a DOCINENT rnNTROI DOCi' MENT CONTROL.
I requirement l N B ASIC Wording Joes not consutute a i
requirement Ihe preraration mue anLtance t TN rrer tranon mue and charee si l Requirement 3 et NQA 1.144's Joeuments that specits Juahn Jxuments that reetts cualm i counalent with more pre 3eripuse reautrements or rrescribe aetnities requirements or cressribe actiuties speettietty No change to NQA./. /99* ti affecting auahts shall be controlled to affectine aualin such as mstrueuons.
recommended.
assure that correct documents are beine procedures and drawings shall be emplosed controlled to as3ure that (orrec' Jacuments are beine emplosed Such documents. includine changes Such documents. meludine chances Requirements arridenneal thereto. shall be reviewed for adeauaeg j thereto. shall be rgnewed for adecuae!
and arrrowed for release by authorire(j i and apernse i fo, rrleam bv authonted personnel tvrsonnel SUPPLEMENT 6S 1 200 DOCt'MEST CONTROL Wording does not constitute a requirement.
SUPPLEMENTARY REQUIREMENTS FOR DOCUMENT CONTROI IGENERAL Wording does not constitute a requirement.
This supplement proudes amphtied Wording does not constitute a requ.ements for a document control requirement.
system.
It supplements the requirements of Basic Wording does not constitute a Requirement 6 of this Standard and shall requirement.
be used in conjunction with that Basic Requirement wher. and to the estent specified by the organisation invokmg this Standard
- 2. DOCUMENT PREPARATION.
Wording does not constitute a REVIEW, APPROVAL, AND requirement.
ISSUANCE Documents shall be controlled to assure
- b. The specified J strOution of controlled Requirements of NQA 1,19834a are d +nticable d'eumen' ~ are documentsfor use at the appropriate covered ir paragraphs 6,200,1, b and 6.
- hat correct an available at the 1% anon where.hes te to
% cation. r 6. 291 1. A 200,1, e of NQA-i,.991 and als be used.
, A method to ensure :ne correct cauisalent. '.> changs o V2A 1, I997is documents air betne used-46.200.1.el recommended.
The controls shall be documented.
- b. The specified distnbution of Requirements t NQA 1.1997 are not controlled documents for use at the equivalent with NQA s,1983 Ia.
appropriate location. t6,200. I, b; Requirements of NQA.I,1983 la are
- e. A method to ensure the correct covered in paragraphs 6,200, I, b and 6.
documents are being used. (6,200, I, el 200, I, e of NQA 1,1997. The controls will be documented by defining a method and by specifying distnbution for use at the appropriate locations. No change to NQA.1,1997 is recommended.
Document controls shall proude f or iai The follow ang controls shall be applied to Wording does not constitute a through te > below:
documents and changes thereto.
requirement. Wording i_s cautvalent to
<6.200.Ir NQA-1,1997 - 6,200,1. No change to NQA.I,1997 is recommended.
The following controls shall be applied to Wording does not constitute a documents and changes thereto:
requirement. Wording is eaunalel to NQA 1,19831a - 6S 1. 2,3. No change
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 6. DOCUMENT CONTROL l
1983 NOA.1 AND 1a l
1997 NOA.1 l
EQUIVALENCY to NQA.I 1997 is recommended, The identifkanon et eentrolled Requirements are eaun alent with w identification at Joeuments to be a
editonal/dietion differences only No controlled JNuments hange to NGA.I.1997 is recommended.
c ts The specified distnbution of controlled Requirements of NQA.I.1997 relate to documents for use at the arprepnate paragraph 651. 2, I of NQA.I.1983-la and E couisalent. This requirement location relates to controlled distribution and sailability. No change to NOA./,199?
a is recommended.
(b) identification of assignment of c The identification of individuals Requirements are eaun alent with editoria!/ diction differences only. A responsibility [gtpreparing, re viewing, responsible Lotthe preparation, review.
hange to NQA./,1997 is recommended.
approving, and issuing dxuments apprrve, anc distribution of controlled c
documents.
Consider corrs cling typo ' approve '
should be ' approval.'
tc) review of documents M adequacy, d, The resiew of controlled documents M Requirements of NQA.I.1997 are not auivalent. The variance is a downgrade completeness, and correctness crior to completeness, and approval enor to c
approval and issuance distnbution.
In requirement that is significant, Such documents, including changes Reviewfor adequacy is discussed in thereto, shall be reviewedf or adequacy section 6,100,2. A reviewfor correctness is redundant s hen an and approvedfor release by authori:ed personnel. 16,100,2) adequacy review is bemg performed; a document is adequate ifit is also correct.
The review of approved documents for completeness does not seem appropriate, reviewing during approval cyclefor completeness does, Thefollowing change to NQA.I,1997 is recommended: 'd, The review of controlled documents for completeness, prior to approval and distribution.
tcp review of documents M adequacy,
- d. The review of controlled documents M Requirements of NQA 1,1997 ate 3,o1 eauivalent. The variance is a downgrade comeleteness, and correctne s prior to completeness, and approval pnot to appros al and issuance dioribution.
in requirement that is significant.
.%uch documents, including changes Reviewfor adequacy 4 discussed in I
thereto, shall be reviewed for adequacy section 6,100,2. A res..wfor and approvedfor release oy authori:ed correctness is reau..Jant when an personnel. i6,100,2) adequacy review is being performed; a document is adequate ifit is also c. rect.
The review of approved documents for completeness does not seem appropriate, reviewing during approval cyclefor completeness does. Thefollowing change to NQA.I, l997 is recommended: 'd. The review of controlled documents for completeness, prior to approval and distribution.
- e. A method to ensure the correct Requirements of NQA 1,1997 relate to documents are being used.
paragraph NQA 1,1983-la,6S-1,2. I and are eauivalent. No change to NOA.1, 1997is recommended. This requirement relates to controlled distribution.
- 3. DOCUMENT CH ANGES 300 DOCUMENT CHANGES Wording does not constitute a
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIRCMWI EQ REQUIREMENT 6 DOC (NFNr CONTHOL I_
1983 NOA 1 AND 1a l
1997 NOM,[,[',]{
EQUIVALENCY
~
.. j requnrement.
i Wording does not constitute a 310 Major Chances
..31 hiaior Changes requirement.
Requirements are eaun alertt with Chances to documents 3ther th.sn thnse editonaFdiction dif ferences on!s. No Chantes to dacuments. other than those defined as minor chances are considered change to NQA.I,1997 is rerommended defined as minor channes in 12 below, ar_3 as mator channes and shall be resiewed considered as maior channes and shall beand accrosed bs the same creanizations reviewed and accrosed by the same t_ hat performed the nnemal resiew and o_tgantiations that performed the ortemal annroval unless other orcanizations are resiew and accrosal unless other specifically destenated Reqvirements are identical orcanizations are specifically desienated The reviewine creaniratan shall base The reviewing creanization shall have
. recess to pertinent backeround data or access to certment backeround data or i_nformation upon which to base their information upon which to base their
.aeroval acotoval Wordmg does not :onstitute a 320 Minor Changes 3.2 Minor Chances requirement.
Mmor channes to documents. such as Requirr - nts are identical.
317nor changes to documents. such as inconseavential editonal corrections. shall i_nconsecuential editortal corrections. shajjnot reautre that the revised documents not recuire that the revised documents receive the same review and anorovai as receive t'y same review and accroval as the original documentsm the oneinal documentt Requirements are identical To avoid a possible omission of a reauired I_o_ avoid a nossible omission of a reauired review. the type of mmor channes that do review. the tvoc of minor changes that do not reouire such a review anjapgtgv31 not reouire such a review and anorovaland the ocrsons who can authenre sugh.a and the eersons who can authonze such a
. decision shall be clearly delineated decision shall be clearly delineated-
....m.~m
.ma..wa_m
...um
.._4.,~
._-.u.-.__...m_.._
a4w.m_
m
.u..
NQA-1 SIDE-BY-STDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 7 CONTROL OF PURCHASED ITEMS AND SERVICES l
1983 NQA 1 AND la l
1997 NQA 1 l
EQUIVALENCY 7 CONTROL OF PURCHASED REQUIREMENT I Wording does not constitute a ITEMS AND SERVICES CONTROL OF PURCH ASED l'ITMS requirement.
~
AND SERVICES 100 B ASIC Wording does not consutute a requirement.
The crocerement of items and services The Drocurement of items a id sersiees Requirements are identical shall be controlled to assure conformance shall be controlled to assure conformance eith speci6ed reautrements with tecci6ed reautrements t
Such control shall orovide for the Such control shall provide for the Requirements are identical, followine as anoropriate source f2]!owine as anoroonate: source evaluation and selection. evaluation of rvaluation and selection. evaluation of obiective evidence of ouality furnished by obiective evidence of auality furnished by the Sunolier. source inspection. audit. and the Sunoli". source insocetion. tudit. and I
examination of items or seryttes upon riammation ofitems or services upon delivery or completion Jm.verv or complethn SUPPLEMENT 751 Wording does not constitute a SUPPLEMENTARY REQUIREMENTS requirement.
FOR CONTROL OF PURCHASED ITEMS AND SERVICES IGENERAL Wording does not constitute a requirement.
This supplement provides amplified Wording does not constitute a requirements for control of purchased requirement.
items and services.
It supplements the requirements of Basic Wording does not constitute a Requirement 7 of this Standard at Basic requirement.
Requirement when t.nd to the extent specified by the organization invoking this Standard.
This Supplement includes requirements Wording does not const.tute a for source selection, bid evaluation, requirement.
Supplier performance evaluation, and verification of conformance.
' PROCUREMENT PLANNING Wording does not constitute a requirement.
Requirements of NQA 1,1997 are not Procurement activitica shall be planne.
couivalent with !QA 1, IU la. The and documented to assure a system-t variance is a downgrade in requirement approach to the procutement process.
thatis significant. Planning of procurements is not addressed in the 9/
edition, although the 83 edition may be prescriptive in nature the elementsfollow a basic strong pwtice and good logic, While some of the elements are intuitively obvious, inherent in an effective procurement is the advance planning necessary to address a uniform approach. Itis recommended that Procurement Planning be reinstated in the 97 edition.
4 Requirements of NQA-1,1997 are not Procurement planning shall result in the couivalent with NQA-1,1983 la.
documented identification of procurement See 7,2, Ifor an explanation of the methods and organizational analysisfor this section.
responsihilities.
o, e 4.s 4 o
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 7. CONTROL OF PURCHASED ITEMS AND SERVICES l
1983 NQA 1 AND la l
1997 NQA 1 l
EQUIVALENC[
i Planning shall determine the followmg:
Requirements of NQA 1,1997 are not couivalent with NQA 1,1983 la.
See 7,2. Ifor an explanation of the analysisfor this section.
ial what is to be accomphshed:
Requirements of NQA 1,1997 are not couivalent with NQA l,1983 la.
See 7,2, Ifor an explanstion of the analysisfor this section.
(b) who is to accomplish it:
Requirements of NQA l.1997 are not eauivalent with NQA 1,1983 la.
See 7,2, Ifor an explanation of the analysisfor this section.
(c) how it is to be accomphshed; Requirements of NQA 1,1997 art not cauivalent with NQA 1,1983 la.
See 7,2, Ifor an esplanation of th_e analysisfor this section.
(d) when it is to be accomphshed.
Requirements of NQA 1,1997 ins pfc1 eauivalent with NQA l,19831a.
See 7,2, Ifor an explanation of the analysisfor this section.
Planmng shall be accomphshed as early as Requirements of NQA 1,1997 are not practicable and no later than at the start of couivalent with NQA 1,1983 la.
those procurement activities which are Sec 7,2, lfor an explanation of the required to be controlled, to assure analysisfor this section.
interface compatibility and a uniform approach to the procurement process.
Planning shall result in the documented Requirements of NQA 1,1997 are not identification of methods to be used in couivalent with NQA 1,1983 la.
procurement activities, sequence of See 7,2, Ifor an explanatisa of the actions and milestones indicating the analysisfor this section-completion of these activities, and the preparation of apphcable procedures prior to the initiation of each individual activity listed below.
"lanning shall provide for the mtegranon Requirements of NQA 1,1997 are not eauivalent with NvA.i. ~ 933 la.
of (a)through (i) tv.ow.
See 7,2, Ifor an explanatio~ of the analysis for this section.
(a) procurement document preparation.
Requirements of NQA 1,1997 are not eauivalent with NQA 1,1983 la.
review and change control; See 7,2, Ifor an explanation of the analysisfor this section.
Requirements of NQA-1,1997 are not (b) selection of procurement sources; cauivalent with NQA 1,1983-la.
See 7,2, Ifor an explanation of the analysisfor this section.
(c) bid evaluation and award; Requirements of NQA 1,1997 are not couivalent with NQA 1,1983-la.
See 7,2, Ifor an explanation of the analysis for this section.
(d) Purchaser control of Suppher Requirements of NQA-1,1997 are not cauivalent with NQA 1,1983-la.
performance, See 7,2, Ifor an explanation of the analysisfor this section.
Page 2 of 12
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 7 CONTROL OF PURCHASED ITEMS AND SERVICES l
1983 NQA 1 AND la l
1997 NQA 1 l
EQUIVALENCY I
t el venfication (surveillance, inspection, Requirements of NQA 1,1997 are not or auditi activines by Purchaser, including couivalent with NQA 1,198312.
notificauon for hold and witness points:
See 7,2, Ifor an explanation of the analysisfor this section.
if) control of nonconformances, Requirements of NQA 1,1997 are not counalent with NQA 1,1983 la.
See 7,2, Ifor an explanation of the analysisfor this section.
(g) corrective action; Requirements of NQA 1,1997 EEf n21 eauivalent with NQA 1,1983 la.
Set 7,2, Ifor an n :planation of the analysisfor this section.
th) acceptance of item or service, Requuements of NQA 1,1997 are not cauivalent with NQA-1,1983 la.
See 7,2, Ifor an explanation of the analysisfor this section.
)quahty assurance records.
Requirements of NQA-1,1997 are not cauivalent with NQA 1,1983 la.
See 7,2, Ifor an explanation of the analysisfor this section.
3 SUPPLIER SELECTION 200 SUPPLIER EVALUATION AND Wording does not consutute a SELECTION requirement.
3.1 Source Evaluauon and Selecuon Wordmg does not constitute a requirement.
The selection of Supphers shall be based Pnot to award of a contract, the Purchaser Requirements are couivalent with on evaluation of their caoability to orovide shall evaluate the supplier's capability 12 editorial / diction differences only, items or services in accordance with the provide items or services in accordance No change to NQA 1,1997 is
.eauirements of the crocurement with the reauirements of the crocurement recommended-documents prior to award of contract.
documents.
Procurement source evaluation and Requirements of NQA 1,1997 gr ngi selection measures shall be implemented cauivalent with NQA 1,1983-la. The by the Purchaser and shall provide for variance is a downgrade in requirement identification of the Purchaser's that is not significant. The intent of the organizational responsibilities for 83 edition is accomplished in detennining Supplier capability.
combination af 7,200, I and the rest of Element 7, where basi resps asibilities are defined. No change s. NQA 1,1997 is recommended.
Measures for evaluation and selection of Suppher evaluation and selection and the Requirements are equivakn1with procurement shall be documented sources, results therefrom, shall be documenigd editorial / diction differences only, and the results therefrom. And shall iLrld shall include one or more of (a)
No change to NQA 1,1997 is include one or more of(a) through (c) through (c) below:
recommended.
t$elow-(a) evaluation of the Sueolier's historv 91 (a) Sucolier's history of croviding an Requtrements are couivalent with providing an identical or similar oroduct identical or similar oroduct which editorial / diction differences only, which nerforms satisfactonly m actual performs satisfactorily in actual use.
No change to NQA 1,1997 is use.
recommended.
The Sucolier's history shall reflect current The Succher's history shall reflect current Requirements are identical.
cacability.
capability (b) Sunolier's current ouality records b) Sucolier's current aualitv records Requirements are identical st'onorted by documented oualitative and sucoorted by documented oualitative and auantitative information which can be cuantitative information which can be obiectivelv evaluated:
obiectively evaluated:
(c)Sunolier's technical and auality (c) Succher's technical and auality Requirements are cauivalent with l
l l
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVA REQUIREMENT 7. CONTROL OF PURCHASED ITEMS AND SERVIC l
1983 NQA 1 AND la l
1997 NQA 1
,i EQUIVALENCY editorial / diction differences only, canabihty as determsned bs a direct capabihty as determined by a direct saluation of the facihtieg nersonnel jLnd No change to NQA /, /997 is l
n evaluation of his facihties and personnel he imetementation of the supphet's e
recommen ed, I
d and the implementation of his cuahty t
auahtv mutance nrocram Wording does not constitute a assurance crocrant 300 BID EVALUATIOS 1 BID EV ALU ATION requirement.
Requirements of NQA l.1997 Mg
!! bids are sohcited, the bid evaluation uivalent Aith more prescriptive Bid evaluation shall determine the estent gla!] include a determination of the Fa of conformance to the procurement Supplier's capabihty to conform to the specificity.
A change to NQA./,1997 is documents.
technical and quahty assurance commended, see 7S l,4,2 below.
re requirements.
Requirements of NQA 1,1997 are not This evaluation shall be performed by ouivalert with NQA 1,1983-la. The c
individuals or organizations design:ted to ariance is a downgrade h* reoutrement v
hat is significant. Thefollowing evaluate the followis.g subjects, as t
applicable to the type of procurement:
ewording change to NQA 1,1997 r
ection 7,300, I is recommended. *lf s
bids are solicited, the rurchaser or ualyied designer performing the bid q
valuation shallinclude a determination e
of the Supplier's capability to conform to the technical and quality assurance requirements including as applicable personnel, production capability, past performance, alternatives, and exceptions.'
f if bids are solicited, the 5d4 evaluation Requirements of NQA 1,1997 gg. nee couivalent with NQA 1,1983.Ia.
~
(a) techmeal consideratiot.s shallinclude a detertnination of the No change to NQA 1, !997is Supplier's capability to conform to the recommended.
technical and quality assurance requirements. (7,300.11 Requirements of NQA 1,1997 gg net If bids are solicited, the bid evaluation cauivalent with NQA 1,19831a.
(b) ouahty assurance requirements shallinclude a determination of the No change to NQA 1,1997 is Supplier's capabilits to sonform to the recommended.
urs assurance technicaland m I requirements. (7,300, h Requirements t f NQ..
1997 are not (c) Suppher's personnel cauivalent with !NA 1,1983-la.
See 7,4,2for an explanation of the analysis for this section.
Requirements of NQA-1,1997 are not (d) Suppher's production capability couivalent with NQA 1,1983 la.
See 7,4,2for an explanation of the analysis for this section.
Requirements of NQA 1,1997 are not (e) Supplier's past performance cauivalent with NQA 1,1983 la.
See 7,4,2 for an explanation of the analysis for this section.
Requirements of NQA-1,1997 are not (f) alternates equivalent with NQA 1,1983 la.
See 7,4,2for an explanation of the analysis for this section.
Requirements of NQA 1,1997 are not couivalent with NOA l.1983-la.
(g) exceptions l
l Osmo gg at t 7
NQA-1 SIDE BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 7 CONTROL OF PURCHASED ITEMS AND SERVICES l
1983 NQA 1 AND la l
1997 NQA 1 l
EQUIVALENCY l
Ser 7,4,2for an explanation of the analyshfor this section.
Pnor to the award of the contract the Pnor to the amard of the contract. the Requirements of NQA-1,1997 Eg Purchaser shall resolve or obtain Purchaser shall resolve or obtain gruivalent with more presenptise i
commitments to resolve unacceotable E2mmitments to resche unacceotable spec 0 city.
auality conditions resultinc from the big techmcal and quahty assurance conditions No change to NOA 1,1997 is evaluation resultine from the b!d culuatmn recommended.
5 SUPPLIER PERFORMANCE Werdmg does not constitute a EVALUATION requirement.
The Purchaser of items and services shall Requirements of NQA 1,1997 are not establish measures to interface with the cauivalent with NQA 1,1983 la. The Supplict and to verify Supplier's variance is a downgrade in requirement performance as deemed necr<tary by the that is sigs '" cant. Performance Purchaser.
evaluation of suppliers is not addressest in the 9;.Jition. Application of this section of the 83 edstion while generally prescriptive, provides positivefeedback on a critical aspect of nuclear quality, the levelofperformance ofsuppliers. It l
is recommended that a section be added j
to the 97 edition on Supplier Performance Evaluation.
The measures stall include (a) through (f)
Requirements of NQA 1,1997 are not below:
equivalent with NQA 1,1983 la.
See 7,5, Ifor an explanation of the analysisfor this section.
(a) establishmg an understandmg betwen Requirements of NQA 1,1997 are not Purchaser and Supplier of the provisions couivaltD1 with NQA 1,1983 la.
and specifications of the procurement See 7,5, ifor an explanation of the documents:
analysisfor this section.
(b) requinng the Suppher to idenufy Requirements of NQA 1,1997 gr_ngi planning techniques and processes to be couivalent with NQ A I,1983 la.
utilized in fulfilling procurement See 7,5, Ifor an explanation of the document requirements; analysis f* this section.
(c) reviewing Sur er documents which Requiremeia o. NQ A-1,1997 EE.n21 are generated or processed during couivalent with NQA 1,1% la.
activities fulfilling procurement See 7,5, Ifor a,. explansa.sn of the requirements; analysisfor this section.
(d) idenufying and processmg necessary Requirements of NQA 1,1997 are not change information; couivalent with NQA l 1983 la.
See 7,5, Ifor an explanation of the analysisfor this section.
(e) establishing method of document Requirements of NQA 1,1997 are not information exchange between Purchaser cauivalent with NQA 1,1983 la.
and Supplier; See 7,5, Ifor an explanation of the analysis for this section, (f) establishing the extent of source Requirements of NQA 1,1997 are not surveillance and inspection activities, cauivalent with NQA 1,1983-la.
See 7,5, Ifor an explanation of the analysisfor this section.
These venficauon acuvities shall be Requirements of NQA 1,1997 are not conducted as early as practicable.
couivalent with NQA 1,1983 la.
See 7,5, Ifor an explanation of the analysisfor this section.
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 7. CONTROL OF PURCHASED ITEMS AND SERVICES l
1983 NQA.I AND la l
1997 NQA.I I
EQUIVALENCY Requirements of NQA.I.199? are not The Purchaser's serification actaities.
counalent with NQA.I.19831,i howeser. shall not relieve the Supplict of See 7,5, ifor an esplanation of the his responsibilities for sen6 cation of anaissisfor this section.
quahty achiestment.
I Wording does not constitute a 5 I Estent of Aetnities requirement Requirements of NQA-l.1997 are not The extent of senheation activities.
cauivalent with NQA l.1983.la. T1.e including planning, shall be a function of variance is a downgrade in requirement the relative importance. compic uty. and that is not significant., No change to quantity of the item or services procured NQA.),1997 is recommended.
g and the Supplier's quahty performance.
Intent of 83 requirement is demonstrated in other NQA.I elements 5,2 and10, 100, I.
Ven0 cation activities shall be The program shallprovidefor Requirements of hvA.1,1983.la are accomplished by qualified personnel indoctrination, training, and covered in paragraphs 2,120, i and 10.
assigned to check, inspect, audit, or qualification as necessary, ofpersonnel 100,4 of NQA.1,1997 and att eauiva ent=
witness the activities of Suppliere performing or managing activities affecting quality to assure that suitable No change to NQA.I.1997 is proficiency is achieved and maintained.
recommended.
f2,120, !)
Inspectionfor acceptance shallbe performed by qualified persons other than those who performed or directly supervised the work being inspected.
(10.106,46..,s
~
-~
Wording does not consutute a 5.2 Records requirement.
Activities performed to venfy,,
See NQA.1,1997 Sectione ',520, Ifor
": _' :r t :MO A !, !" := ::
1 MOA !. !"211 methods (activities)and 7,530; 7,540; 7 / m:P conformance to requirements of procurement documents shall be recorded.
550; and 7,560for how recorded.
Requirement of NQA.I.1983.la relates to paragraphs 7,520, !; 7,530; 7,540;*
550; and 7,560 of NQA.I, I997, which are eaulvalent with the intent of NQA.I, 1983.la. No change in NQA.I,1997 is recommended.
~
Requirements of NQA.I, im are not Source surveillances,and inspections, ecuivalent with NQA.1,1983.la. The audits, receiving inspections, variance is a downr e in requiremen d
nonconformances, dispositions, waivers, that is not significant. No change to and corrective actions shall be NQA.1,1997 is recommended.
documented.
Intent of 83 requirement is demonstrat< \\
in other NQA.! elements 7,520; 7, 550; 10; 14; and 15.
Requirements of NQA 1,1997 are not The Purchaser shall assure that this t.quivalent with NQA.1,1983-la. The documentation is evaluated to determine variance h a downgrade in requiremes the Supplier's quality assurance program that is not significant. No change to effectiveness.
NQA.1,1997 is recommended.
Intent of 83 requirement is demonstra.
in other NQA.! elements. 7; 10; 14; s 15.
6 CONTROL OF SUPPLIER 100 CONTROL OF SUPPLIER Wording does not consutute a GENERATED DOCUMENTS GENERATED DOCUMENTS requirement.
Omanaaf1?
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 7 CONTROL OF PURCHASED ITEMS AND SERVICES l
1983 NQA-1 AND la l
1997 NQA 1 l
EQUIVALENCY l
Suncher renerated documents shall be Controls shall be implemented to assure Requirements of NQA 1,1997 Et not controlled, handled, and approved in that the subraittal and evaluation of riuivalent with NQA 1,1983.la.
accordance uith estabhshed methods.
Suncher renerated documents are In addition to this requirement 4,250
"= =:
!! H =:!:z: :h===
accomohshed in accordance uith the and Criterion 17 in general of NQA.1, h: & =t-?:':/&:: L::v== =
orocurement document recuirements.
1997 provide established methods to control, handie, cand approve supplier
.....La.2.........a....."""
generated documents.
(7E !,',2:
No change to NQA 1, !997 is recommended.
Means shall be implemented to assure that Controls shallbe implemerded to assure Require nents of NQA 1,1983 la are Lh.igbmittal of these documents is that the submittal and evaluatiorr of' covered in section 7,400, I of NQA 1.
t accomplished in accordance with the Susalier sene'sted documents are 1997 and are couivalent.
nrocurement document reauirements.
accomslished in accordance wit's ihr No change to NQA.1, !997 is crocurement document reauirements. (7, recommended.
400,!)
Ih. tit measures shall orovide for the lhgit controls shall orovide for the Requirements of NQA 1,1997 gs not acauisition. processine. and recordtd acouisition. orocessine. and recordtd eauivalent with NQA 1,1983 la and evaluation of technical. insocction. and evaluation of the quality assurance, enhance the contens relative to the 83 test data against acceotance criteria.
technical. insocction. and test edition.
documentation or data against acceptance No change to NQA.1,1997 is criteria.
recommended.
7 CONTROL OF CHANGES IN ITEMS Wording does not consutute a l
OR SERVICES requiremeat.
The Purchaser and Supplier shall assure Procurement document changes
": p..c/:-d NO.i !, !"*"'
l that measures to control changes in affecting the technical or quality
- ). I ' i NQ.\\
,1"*
i=-
procurement documents are established, assurance program requirements shall be Requirement ofNQA 1,1983 la reintes
,mplemented, and documented and are in subject to the same degree of control as to paragraph 4,400,1 ofNQA 1,1997,
.:cordance with this Standard.
utili:ed in the preparanon of the original which is eeulvelent to and meets the documents. (4,400,1) intent of NOA.I,1983 la.
O ACCEPTANCE OF ITEM OR 500 ACCElrTANCE OF ITEM OR Wording does not constitute a SERVICE SERVICE requirement.
8.1 General 510 General Wording does not constitute a requirement.
Methods shall be estabhshed for the
. Purchaser methods used to accept an "42 : " : :! NQ ^. !, !"" ;= ='
acceptance of an item or service being item or servicefrom a Supplier shall be a
- # d;; "o NQ ^ 1, !"*J !:.
furnished by the S.r. 'ici Supplier Certificate of Conformance, Requirement of NQA.l, I96.la relates source verification, recesving inspection, to paragraph 7,520, I of.iQA 1,1997, ne post. installation test at the nuclear which is equivalent to and meets the i facility site, or a combination of these intent of NQA 1,1983 la.
methods. (7, $20,1)
Prior to offering the item or service for Prior to offering the item or service for Requirements are identical, accentance. the Sucolier shall verify that acceptance. the Sucolier shall verify that the item or service beine furnished the item O service beine furnished complies with the orocurement comolies with the orocurement reouirements.
reauirements.
Where reouired by code. regulation. or Where reauired by code. regulation. or Requirements are identical.
contract reauirement. documentary contract reauirement. documentary evidence that items conform to evidence that items conform to orocurement documents shall be available crocurement recuirements shall be at the nuclear facility site crior to available at the nuclear facility site crior installation or use to installation or use.
i 8.2 Methods of Acceptance 520 Methods of Acceptance Wording does not constitute a requirement.
Purchaser methods used to acceot an item Purchaser methods used to accept an item Requirements are couivalent with
-~
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUlVALENCY REQUIREMENT 7. CONTROL OF PURCHASED ITEMS AND SERVICES I
1983 NQA 1 AND la l
1997 NQA 1 l
EQUIVALENCY OI related service from a Supoher shall be or sersice from a Supoher shall be a editonal/ diction differences only, hypoker Certificate of Conformance.
Suppher Certificate of Conformance.
No change to NOA4,1997 &
source senfication. receiving insocction.
source sen6 cation. regeivine inspection.
recommended.
or nost.mstallation test at the nucles or post installauon test at the nuclear facihty s'te. or a combinauen thereof.
facihtv site. or a combination of these methods.
8.2.1 Certifiepe el Conformance.
530 Certi6cate of Conformance.
Wording does not consutute a requirement.
When a Certi6cate of Conformanew When a Certi6cste of Conformanew Requirements are idenocal used. the minimum criteria of(a) tlE2MED used. the mitumpn enteria of(a) throuch (f) below shall be met (f) below shall be met.
(a)The certi6cate shallidentify the (a) The certincate shall identify the Requirements are idenucal, purchased :natenal or cauipment. cuch as purchased masenal or cauioment. such as by the purchase order number.
by the purchase order number.
t b) The certi6cate shall idenufy the (b) The certificate shall identify the Requirements are identical soecific procurement reauirements met by specific orgs.grement reautrements niet by the ourchased material or cauipment. such thtgprehased matenal or cautoment. sudl 4
as codes. standards. and other as codes. standards. and other speci6 cations.
speci6cationt This may be accomolished by includine a This may be accomokshed by includme a Requirements are identical list of the specific reauirements or by list of the specific reautrements or by orovidine. on site. a coov of the ourchase providine. on-site. a copy of the purchase order and the procurement specifications order and the crocurement specifications or drawines. together with a suitable or drawings. together with a suitabh certificate eeruncate.
The crocurement reouirements identi6ed The orocurement reauirements identified Requirements are identical shall include any accroveJ chantes.
shall include any aooroud chanres.
waivers. or deviations aceticable to the waivers. or deviations acclicable to the subiect material or cauioment.
subiect material or cauirment.
(c)The certi6cate shallidentify any (c) The certi6cate shall idenufv any Requirements are identical.
procurement reauirements that have not orocurement reauirements that have not been met. together with an exolonaugn been met. together with an explanation and the means for resolvine the and the means for resolving the nonconformances.
nonconformances (d)The certincate shall be attested to by,f WLThe certificate shall be signed or Requirements are cauivalent with l oerson who is responsible for this cualits otherwise authenucated pv a persor whc editorial / diction differem:es only, assurance function and whose functiQD is responsible for this auhlity assurance No change to NQA.s, u97 h and cosition are desenbed in the function and whose function and position recommended.
Eurchaser's of Supplier's cuahty are described in the *)urchaser's or Sucolier s cuahty assurdnce prozram.
Jssurance program.
(e) The certification system. includme the (e) Thc. certification system. includini the Requitn6ents are icenucal procedures to be followed in filline out a procedures to be follow 6d in fillme out a certificate and the administrative certincate and the administrative crocedures for review and approval of the crocedures for review ar.d accroval of the certi6 cates. shall be described in the certificates. shall be des ~cribed in the Purchaser's or Sucolier's cuahty Egrchaser's or Supolier's cuality assurance program (f) Means shall be provided to verify the M Means shall be orovided to venfv the Requirements are identigah assurance orcaram.
validity of Sucolier certi6 cates and the validity of Sucolier certi6 cates and the effectiveness of the certification system.
effectiveness of the certification system, tuch as dunne the performance of audits such as durine she oerformance of audits of the Sucolier or independent insocction of the Sunctier or indeoendent insocction or test of the items.
or test of the items.
Such venficatmn shall be conducted by Such vert 6 cation shall be conducted bv Requirements are identical penaAnf17
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 7 CONTROL OF PURCilASED ITEMS AND SERVICES l
1983 NQA l AND la l
1997 NQA l l
EQUIVALENCY I
the Purchaser at intervals commensurate the Purchaser at intervals commensurate with the Sunolier's cast cuality with the Sunolier's cast anh performance yrformance 822 Source Venfication 510 Source veri 6 cation Wordmg does not constitute a requirement.
When source serification is used. it M When source verification. is used. it M Requacments of NQA 1,1997 grg be octformed at intervals consistent with be performed at intervals consistent with couivalent with more prescriptive the importance and complexity of the item the importance and complexity of the item specificity, or service and it shall be implemented gg o.r service. and M instructions ig Change to NQA 1,1997 is recommended momtor. witness. or observe activities include monitonng. witnessing cI to correct typo. The text is not clear and observing selected activities should read as follows: " and shall include in. actions to m4wde monitoring witnessing or observing.
Source ven6 cation shall be implementedlource ven6catic n shall be implemented Require...cnts are identical.
in accordance with clans to perform in accordance with clans to perform insocctions. esaminations. or tests at insocctions. examinations. or tests at credetermined coints predetermined points.
Upon Purchaser acceptance of source Upon Purchaser acceptance of source Requirements are identical verification. documented evidence of verification. documented evidence gf acceptance shall be furnished to the acceptance shall be furnished to the receivine destination of the item. to the receivine destination of the item. to the Purchaser. and to the Sucolier.
Purchaser. and to the Sucolier.
j 8.2.3 Receivine insocetion.
550 Receivmr insocetion.
Woromg does not constitute a l-requirement.
When receiving inscection is used.
When receivmo inspection is used.
Requirements are identical.
ourchased items shall be insoccted as purchased items shall be insoccted as l
necessary to verify confortnance to necessary to verity conformance to seccified reauirements. taking into specified reauirements. taking into account source verification and audit account source verification and audit activities and the demonstrated ouality activities and the demonstrated auality performance of the Sunoliu.
performance of the Suoolier.
Receivmr insocction shallbe performed Receivine insocction shall. venfv by Requirements of NQA-1,1997 ats.
in accordance with established prut lures obiective evidence such features as eauivalei.. with less presenptive j
and inspection it.,ctions, to ysn[yhy conficuration id-tification: dimensional.
specificity # edation sectio'n 5, i pbiective evidence such festyrm as ryr physical. and other characteristics:
identifies activities affectim guality to be conn euration: identification: dun.Lngt freedom from shionine damare: and performed in accordance with c
physical. and other characteristi; cleanlingit procedures and instructions, freedom from shioning damare: and No change to NQA 1,1997 is cleanness.
Actavities affecting quality and services recommended.
shall be prescribed by and performed in accordance with documented instructions, procedures, or drawings.
(S, !)
Receiving insocction shall be coordinated Receivine insocetion shall be coordinated Requirements are identical.
with review of Sucolier documentation with review of Sunolier documentation when crocurement documents reauire when crocurement documents recuire such documentation to be furnished prior such documentation to be furnished orior to receiving inspection.
to receiving inso iion.
8.2.4 Post Installation Testi.ng.
560 Post-Installation Testmr.
Wording does not constitute a requirement.
When oost installation testing is used.
When cost-installation testmr is used.
Requirements are identical, cost-installation test recuirements and post-installation test reauirements and acceptance doc 3tmentation shall be acceptance documentation shall be
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUlvALENCY REQUIREMENT 7. CONTROL OF PURCHASED ITEMS AND SERVICES l
1983 NQA 1 AND la l
1997 NQA 1 l
EQUIVALENCY mutually estaMished by the Purchaser and mutt: ally estaNished by the Purchaser and Supplict.
Suppher 8.3 Acceptance of Services Only 570 Acceptance of Services Only Wording does not constitute a requirement.
J.0 certain ag3 insolvine procurement of in cases invnivine crocurement of services Requirements of NQA 1,1997 Es services only. such as third carty oniv. such as third earty incoection:
causvalent with more presenptne inspection: enrineenne and consultine encineenre and consultine services; specificity, services; and installation, repair. overhaul.
auditing; and installation. recair. overhaul. No change to NQ t.l.1997 is or maintenance work. the Purchaser shall or maintenance work. the Purchaser shall recommended, accent the service by any or all of the ascent the service by any or all of the following methnds:
followine methods:
(a) technical venfication of data oroduced:
(a) technical venfication of data produced: Requirements ge identical.
(b) surveillance and/or audit of the (b) surveillance and/or audit of the Requirements are identical, activity:
aciivity; (c) review of obiective evidence for (c) review of obiective e vidence for Requirements of..QA 1,1997 Et conformance to the crocurement conformance to the procurement couivalent with less prescriptne document reauirements such as document reouirements.
specificity.
certifications, stress reports, etc.
No change to NQA 1,1997 is recommended.
9 CONTROL OF SUPPLIER 600 CONTROL OF SUPPLIER Wording does not consutute a NONCONFORMANCES NONCONFORMANCES requirement.
The Purchaser and Supplier shall establish htethods [qt control and disposit19ILgf Requirements of NQA 1,1997 Et and document methods for disoosition of Supplier nonconformances for items and cauivalent with more presenptive items and services that do not meet services that do not meet procurement specificity, crocurement document reauirements.
documentation reauirements shallinclude Based on " control" wording in NQA 1,
{.g) throughle).below:
- 1997, No change to NQA 1,1997 is recommended.
These methods shall contain protiston for Aferhodsfor control and disposition of Requirements are cautvalent with (a) through (c) below:
Supplier nonconformancesfor items and editorial / diction differences only.
services that do not meet procurement No change to NQA 1,1997 is
~
documentation requirements &g)!! include recommended.
la p through le) below- (7, 600.11 (a) evaluation of nonconforminr items:
(a) evaluation of nonconforrrunn items:
Requirements are identical.
(b) submittal of nonconfoto nss *_. ice to (b) submitt?'p(,nonconform" ice notice to Requirements gg. identical Purchaser by Sucolier as direued av the Pitrchaser bv aucotier a directed by tbs Purchaser.
e itchaser.
These submittals shallinclude Supoher.
These submittals shall include Requirements are identical.
recommended disposition (e n.. use-as is Supolier recommended disoosition (e em or recair) and technical iustification.
use as-is or recair) and technical iustification.
Nonconformances to the crocurement Nonconformances ta the crocurement Requirements are identical, requirements or Purchaser acoroved reouirements or Pur:haser-acotoved documents. which consist of one or more documents. which consist of one or more of the followine. shall be sybmitted to the of the followine. shall be submitted to the Purchaser for aooroval of the Purchaser for anoroval of the recommended disoosition:
recommended disysition:
(1) technical or matenal reautrement is lLtechnical of ttvittnal reautrement is Requirement; are identical violated; violated:
(2) requirement in Supplier documents.
(2) reauirement in Sucolier documents.
Requirements are identical.
which has been approved by the which has been accroved by the Purchaser, is violated:
Purchaser, is violated:
(3) nonconformance cannot be corrected (3) nonconformance cannot be corrected Requirements ge identical, by continuation of the original by continuation of the cricinal Page 10 of 12
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 7 CONTROL OF PURCHASED ITEMS AND SERVICES l
1983 NQA 1 AND la l
1997 NQA 1 l
EQUIVALENCY l
manufacturing process or by rework:
manufactuttne process or by rework:
(4) the item does not conform to the (4) the item does not con. form to the Requirements are identical original reautrement even though the oririnal reautrement eve < though the item item can be restored to a condition such can be restored to a cot.htion such that the that the capabihtv of the item to canabihtv of the item to function is function is unimpatred:
untmeaired:
(c) Purchaser disposition of Suncher (c) Purchaser disposition of Suncher Requirements are identical, recommendation:
recommendation:
(d) ven6 cation of the implementation of Wjyenfication of the implementatl204 Requirements are identical.
the disposition:
the disposition:
(c) maintenance of records of Suncher-(e) maintenance of records of Requirements m: identical submitted nonconformances Sucolier. submitted nonconformances 10 COMMERCIAL GR ADE ITEMS 700 COMMERCIAL GRADE ITEMS Word;ng does not constitute a requ rement.
Where the design utihres comroercial Whngjhe desten utihres commercial Reo urements of NQA 1,1997 Et crade items. the followine reauirements gade.wms. the Purchaser can utilize thg sqi,ivalent with less presenptive are an acceptable alternate to other followine reauirements as an spscificity.
reauirements of this Supplement,except acceptable alternative to other No change to NQA 1,1997 is as noted in (b) below and the requirements
[touirements of this section for procuring recommended.
of Supplement 4S l.
and accepting items.
(a)The commercial grade item is identined (a) The commercial grade item is Requirements are identical.
in an aooroved design output document, identified in an accroved design output document An alternate commercial trade itegg,g}g An alternate commercial trade item mav Requirements are identical.
be anolied. crovided the cornizant desten be acclied. orovided the cornizant design otranization orovides verification that the organization orovides venfication that the alternate commercial trade item will alternate commercial trade item will perform the intended function and will perform the intended function and will meet design reouirements aoolicable to meet desian reauirement.; anolicable to both the replaced item and its anolication both the replaced item and its acclication.
(b) Source evaluation and selection. where (b) Source evaluation and selection. where Reqmrements are eauivalent with determined necessary by the Purchun determined necessars by the Purchaser editorial / diction differences only, based on complexity and imoortance to based on cometeuty and importance to No changa to NQA 1,1997 is safety. shall be in accordance with safety shall be in accorc'ance with 200 of recommended, paragraph 3.1 of this Supplement.
this Requirement.
(c) Commercial awa ite ns shall be (e t Commercial trade items shall be Requirements are iden aal Wentined in the purchase order by the identified in the purchase order by the manufacturer's oublished eroduct manufacturer's oublished eroduct description (for etample. catalor number). I desenotion (for example. cataler number).
(d) One or a combination of the following Requirements of NQA l 1997 M.t met methods shall be utilized to provide couivalent with NQA-1,1983 la.
reasonable assurance that the item meets Requirements of NQA 1,1983 la are the acceptance criteria for the covered in persgraph 75 1,10,1, (d), (3) charactenstics identified to be verified for and are equivalent with. NQA 1,1997, acceptance:
No enange to NQA 1, I997 is recommended.
(!) Special test (s) or inspection (s) or i s..C :fNQA!,!""27::t both; y i ;:.i N Q A 1,!? e 12.
Requirement of NQA 1, !997 relate to Paragraph 7S l,10,1,(d),(3)of NQA 1, 1983 la and are equivalent to NQA l, 1983 la.
No change to NQA 1,1997 is recommended.
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQ RFQUIREMENT 7 CONTROL OF PURCHASED ITEMS AND SER l
1983 NQA.! AND la l
1997 NQA 1 l
EQUIVALENCY (2) Commercial grade surse, of the R;;;!:::::t :f NQA !, != ::: :::
s
- .r '
- : di NQA ', !"aN supplier; Requirement of NQA.1, !997 relate to aragraph 7S 1,10, I, (d), (3) ofNQA.I.
p I983.la and are eauivalent to NQA.1, 1983.la.
No change to NQA.1,1997 is recommended.
i R;
- ;;t
- f NQA-1, !=
- :: :::
(3) Source ser:Geation:
- .r a n
- !i NO A !, !"*312.
Requirement of NQA.I. I997 relate to aragraph 7S 1,10,1,(d),(3)ofNQA 1, p
1983 la and are rauivalent to NQA.1, 1983.la.
No change to NQA.I,19"7 ss recommended.
R;;_.x;;r :f NQA 3, !"^ ::: 29.
(4) Acceptable Suppherhtem
- o
- !i NOA !, !"*? !:.
performance records Requirement of NQA 1,1997 relates to paragraph 7S.1,10,1,(d),(3)ofNQA 1,
!983 la and is eauivalent to NQA 1, 1983 la.
No change to NQA.1,1997 is recommended.
(d) After receipt of a commercial grade (c) Prior to acceptance of a commercial Requirements of NQA 1,1997 m cauivalent with more prescriptive erade item. the Purchaser shall determine item. the Purchaser shall determine that:
SPecincity.
!!all No change to NQA.I,1997 is recommended.
(1)damare was not sustained during Requirements are identical.
(I) damare was not sustained during shioment:
(2) the stem has satisfied the specified Requirements of NQA 1,1997 m shioment:
couivalent with more prescriptive
_(2) the item received was the item acceptance criteria and; ordered; specificity.
No change to NQA 1,19,7is recommended.
"'T :: m See 7, 700,1, (d), (1) through it)
":q=.:: ~:::: ef NC q:.rA-'
" F2 * ' "'93 !
(3) inspection and/or testing ts accomplished, as required by the Requirements of NQA 1,1983.la are Purchaser, to assure conformance with the covered in paragraphs 7,700, I,I ~,t1)
.. nufacturer's published requirements; through (4) and are cauivalent with.
NQA-1,1997 with less prescriptive specificity. No change to NQA.1,1997 i
recommended.
(3) specified documentation. as acolicable Requirements are cauivalent with editorial / diction differences only, (4) documentation. as anoticable to the to the item. was received and is No change to NQA 1,1997is item. was received and is accectable.
accectable,
. recommended.
Page 12 of 12
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 8 IDENTIFICATION AND CONTROL OF ITEMS l
1983 NOA4 AND 1a l
1997 NOA.1 l
EOUlVALENCY l
8 IDENTIFICATION AND CONTROL REQUIREMENT 3 Wording does not coristitute a OF ITEMS IDENTIFICATION AND CONTROL OF requirement.
ITEMS 100 BASIC Wording does not constitute a requirement.
Controls shall be estabhshed to assure that Controls shall be established to assure that Requirements are identical.
only correct and accepted items are used only correct and accepted items are used or installed.
or. installed.
Identification shall be maintained either Identification shall be maintamed on the Requir:ments of NQA 1,1997 ms on the items or in documents traceable to items or in documents traceable to the couivalent with more prescriptive the items.
ilsms., or in a manner which assures that specificity. No change to NQA l 1997 is identification is established and recommenhd.
maintained.
SUPPLEMENT BS 1 -
Wordin. scs not constitute a SUPPLEMENTARY REQUIREMENTS requirement.
FORIDENTIFICATION AND CONTROL OF ITEMS IGENERAL Wording does not constitute a requirement.
This Supplement provides amplified Wording does not constitute a requirements for identification and control requirement.
l of items.
l It supplements the requirements of Basic Wording does not constitute a Requirement 8 of this Standard and shall requirement.
be used in conjunction with that Basic Requirement when and to the extent specified by the organaation invoking this Standard.
- 2. IDENTIFICATION METHODS 200 IDENTIFICATION METHODS Wording does not constitute a requirement.
2.1 Item identification 210 Item Identificauon Wording does not constitute a requirement.
Items of stoduction (batch. Iot.
Items of oroduction (batch. tot.
Requirements us.sauivalent with comoonent. cartI wil be identined from component. oart) : 311 be identified from editorial / diction differences c ly. No the initial receiot and fabrication olt' the initial receiot end fabrication of items change to NQA.F.19M is e6ommended.
items un to and includme inst.tllation and un to and includin<r installation and use.
use.
This it'entification shall relati an item to Thi5 identification shall relate an item to Requirements are identigal.
an anolicable design or other pertinent an aoolicable design or other certinent soecifying document.
soecifying document.
2.2 PhysicalIdentification 220 Physical Identification Wording does not constitute a requirement.
Physical identification shall be used to the Physical identification shall be used to the Requirements are identical, maximum extent possible.
maximum extent oossible.
Where ohvsical identification on the item Where ohysical identiScation on the item Requirements are identical, is either imoractical or insufficient.
is either imoractical or insufficient.
ohysical seoaration. orocedural control. or ohysical seoaration. orocedural control. or other anorooriate means shall be other anorcoriate means shall be emoloved.
emoloved.
2.3 Markings Wording does not constitute a requirement.
/
Identification markings. when used shall Identification markings. shall be acoltsd Requirements of NQA l.1997 us be anolied usine materials and methods usine materials and methods which cauivalent 2 'zz x:-ti:
Page 1 of 2 1
1
i 1
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALE REQUIREMENT 8 IDENTIFICATION AND CONTROL OF ITEMS I
1983 NOA 1 AND 1a l
1997 NOA 1 l
EQUlVALENCY 1
ai. with editorial / diction which provide a clear and ferible
[ orovide a clear and leriNe idenufication w
ditierences only. No change to NGA 1, ident:6 canon and do not detrimentally and do not deFrede the funcuon or seruce 1997 h recon mended.,
affect the functwn or service life of the life of the item item Markines shall be transferred to each part Markmes shall be transferred to each part Requirements are eaurvalent with of an identified item when sub divided of an ident Ged item when subdivided and editonal/dicuon differences only. No and shall not be obbterated or hidden by shall not be obliterated or hidden by change to NGA.1,1997 h recommended.
surface treatment or coatings unless other surface treatment or coatmg unless other means of identification are substituted means of identi6 cation are substituted 3 SPECIFIC REOUIREMENTS 300 SPECIFIC REOUIREMENTS Wordmg does not constitute a requirement.
3.1 Idenufication and Traceability of 310 Ident:6 cation and Traceability of Wording does not constitute a requirement.
Items items When codes. stacidards. or specifications Requirements ut..anLe.at with Whg} specified by g, odes. standards. or editorial / diction differences only. No sxcifications that include speciGC melude specific identifica: ion or identification or traceability reauirements g;g( Jity reauirements (such as change to NQA 1,1997 h recommended.
(such as identification or traceabihtv of identtiration or traceabihty of the item to the item to applicable soecification and anchcable specification and grade of crade of materiah heat. batch. tot. cart. or upteriah heat. batch. lot. cart. or serial serial number: or specified inspection.
number: or specified inspection. test. or test. or other records) the ororram shall be other records). the proeram shall provide designed to provide such identificatiott such identification and traceability control.
and traceability control.
Wordmg does not consutute a 3.2 Limited Life Items 320 LimLted Life items requirement.
Where specified, stems hr.vmr limited items hivine limited calcadar or operating Requirements are eauivalent with calendar or operatiw life or cycles shall life or cycles shall be i lentified and editorial / diction differences only. No controlled to preclude use of items whose charge to NQA 1,1997 h recommended.
be identified and controlled to ereclude use of items whose shelf life or coerating.
shelf life or coeratine life has expired, life has etoired.
3.3 Maintaining Identt ication of Stored 330 Maintainine Identification of Stored Wording does not constitute a f
requirement.
Items Provisions shall be made for 'hg (ont9LI Pigvisions shall be made for the control of Requirements are identical.
items
,. tem identification consistent w -hfe
, item identifie ; OLrensistent with the
~
pt"mdduration and condsions of planned duration and conditior.. of st are. such as-storue. such as:
Requirements are identical.
(a) provisions for mamtenance or (1) provisions for maintenne or reolacement of markines and identification rectacement of markings and identi6 cation records due to damace ycords due to damare durine handline or aging:
during handling or aeme:
(2) protection of identincations on items (b) protection of identi6 cations on items Requirements are identical.
subiect to excessive deterioration due to subiect to excenive deterioration due to environmental exposure:
environmental exposure; (3) provisions for updatme existine clant (c) provisions for undatine existine clant Requirements are identical.
records records Page 2 of 2
NQA-1 SIDE-BY SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 9 CONTROL OF (SPECIAL) PROCESSES l
1983 NQA 1 AND la l
1997 NQA 1 l
EQUIVALENCY
]
~
9 CONTROL OF PROCESSES REQU!REMENT 2 Wordmg does not coratute a CONTROL OF SPECIAL PROCESSES requirement.
100 D ASIC Wordmg does not constitute a requirement.
Processes affectmg quahty of items or The program ;hallprovide control over Requirements of NQA 1,1997 are ne4 services shall be cElrolled, activities affec>ing quality to an c.rtent equivalent with NQA 1,1983 la.
consistent with to irimportance.
Requirements of NQA-l I983 la are ne 4,110,3) related to sectio 12, i10,3 of NQA l.
1997. ' Processes' and ' activities' are interpreted as having the same intent. No change to NOA 1, !997 is recommended.
Soccial processes that control or verify Special orocesses that control or verify Requirements are identical.
auality. such as those used in weldir.r.
auality. such as those used ir welding. heat heat treating. and nondestructive treating. and nondestructive examination.
g.xamination. shall be perform-d by shall be performed by aualified oersonnel cualified personnel usina aualified usine cualified procedures in accordance crocedures in accordance with specified with soccified reauirements.
reauirements.
SUPPLEMENT 9S Wordmg does not constitute a SUPPLEMENTARY REQUIREMENTS requirement.
FOR CONTROL OF PROCESSES I GENERAL Wording does not constitute a 4
requirement.
This Supplement provides amplified Wording does not constitute a requirements for control of processes.
requirement.
It supplements the requirements of Basic Wording does not constitute a acquirement 9 of this Standard and shall requirernent.
be used in conjunction with that Lasic Requirement when and to the extent specified by the organization inveking this Standard.
2 PROCESS CONTROL 200 PROCESS CONTROL Wording is identical and does not constitute a requirement.
Processes shall be controlled by A7tnities a[fecting quality and services Requirements at NQA 1,1997 are not instructions, proccoum. u.awings, shall be prescribed by and performed in equivalent with NQA-1, 983-ia-checkli:;ts, ttavelers, or other avpropriate accordance with documented This requirement is found atletedfrom means.
in ' ructions, procedures, or drawings that the 97 edition because it is redundarct.
Include or reforence appropriate Criterion 5 discusses the control of quanntative or quaktative acceptance generalprocesses (activities). Criterion 9 criteria for determining that prescribed in the 77 edition is limited to 'Special results have been; satisfactorily atttined.
Processes *; general.rocesses may be I
(5, I) foundin Criterion 2. No change to NOA.1,1997 is recommended..
These means shall assure that process C:di:= re ::; yf::::: ;?ie:-'
Requirements of NQA 1,1983 la are parameters are controlled and that af:'e p:x::: :S?! ': ' !;3:1.
related so section 9r444rt 2,110,3 of specified environmental conditions are l9, 2!0. ?!
NQA-1,1997 and section 9r400r3 2 maintained.
" :: : --di:.c= :b!! ::!:J: p::;:-
110,7 of NQA 1.1997. They g;noe
- ui;
- -'. :: '::!i:1;:::=::::::l:h:
eauivalent.
- ,
- p
- ::l:2 :n+:z.:-', :.-l This requirement isfound deletedfrom eekbr::::- :q :::=:=::. l9, l'#. 2:
Criterion 9 of the 97 edition because it is redunaant. Criterion 9 in the 97 edition Page1of4
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVAL REQUIREMENT 9. CONTROL OF (SPECI AL) PROCESSES f
19f3 NQA.: AND la l
1997 NQA 1 l
EQUIVALENCY j
is !!mited to 'Special Processes '; general Deletion effected because references are rocesses may befound i:s Crsterion 2 as applicable to *SpecialProcesses'only.
p noted.
The variance is a downgrade in The program shallprovide control over equirement that is not significant No i
r actintias affect ng quality to an extent hange to NQA.1, !997 is recommended.
c consistent with theirimportance.
(2,110.31 Controlled conditions include the use of appropriate equipment, suitable envimamental conditionsfor accomplishing ti,e activity, a sd assurance that prerequisitesfor the given activity have been satisfied. (2, i10, 7)
Wording does not constitu'e 1 3
SPECIAL PROCESSES requirement.
Requirements of NQA 1,1997 9,210, I Each special process shall be performed in 210 Special processes shall be controlled are eauivalent with more prescriptive accordance w,th appropriate instructions by instructions. procedures.,, drawings,
{
which include or reference procedure.
checkhsts, travelers, or other appropriate specificity. No change to NQA 1,1997 is recorr. mended.
personnel. and cauipment aualification means.
recuirements.
Speciol process instructiens shall includ Requirements are cauivalent with or reference procedure. nersonnel. and editorialldiction differences only. No change to NQA 1,1997 is recommended.
eauipment auolitication reouirements
!0.210.2>
Requirements of NQA 1,1997 rela,e to Special process instructions shall include sections 95-1,3,1 of NQA-),1983 la or teference procedure, perscnnel, and and 9S 1,3.1.1, I of NQA 1,1983-la and equipment qualification requirements.
they gg cauivalent. No change to NQA.
j 1, !997 is recommended.
Conditions necessary for accomplishment Requirements of NQA 1.1997 re'. ate to section 9S 1,3.2.1,1 of NQA 1,1983 la of the process shall be included.
and they are met equivalent. No change is recommended.
Wording does not consuthte 2 220 Acceptance Cnte- '
requirement. Wording relate = to seetion l
95-1,3.2 of NQA 1, IG, l a.
The requirements of apphuble codes and Requirements of NQA 1,1997 relate to standards, including acceptance criteria for section 9S 1,3.2, I of NQA 1,1983-la.
They are eauivalent with editorial /d....on the procca, shall be specified or differences only. No change to NQA-1, referenced in procedures or instructions.
1997 is recommended.
Wording does not consutute a 230 SpecialRequirements requirement. Wording relates to section 9S-1,3.4, of NQA 1,1983-la.
Requirements of NQA 1,1997 relate to For special processes not covered by section 9S-1,3.4, I of NQA 1,1983-la.
existing codes and standards or where They are cauivalent with editorialldiction quality requirements specified exceed differences only. No change to NQA 1, those of existing codes or standards, the 1997 is recommended.
necessary requirements for qualifications of personnel, procedures, or equipment shall be specified or referenced in Page 2 of 4
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 9 CONTROL OF (SPECIAL) PROCESSES i
l l
1983 NQA 1 AND la l
1997 NQA 1 l
EQUIVALENCY l
procedures or instructions.
3.1 Responsibihty 300 RESPONSIBILITY WordinF oes not constitute a d
requirement.
It is the responsibihts of the organtration it is the responsibilits of the orranuation Requirements are identical.
Derformine the special process to adhere performme the special process to adhere to to the anoroved procedures and processes the approved orncedures and orncesses 3.1.1 Qualification of personnel, Specialprocesses that controt or verify Requirements of NQA 1,1983 la are procedures, and equipment sha'i comply quality, such as those usedin welding, covered in section 9,100,1 and 9,210,2 with specified reauirements.
heat treating, and nondestructive of NQA 1,1997 and m not cauivalent.
examination. shall be performed by qualujied personnel using qualtfied Intent of 83 requirement is met by procedures m accorda'sce with speciRed spec { fled refmnces. No change to reauirements,19,100. IJ NQA 1,1997 Ir recommended.
bpecsalprocess inst s,ctions shallinclude or reference procedure, personnel, and equipment qualification requirements.
(),210,2) 3.1.2 Conditions necessary for Special process instructions shall include Requirements of NQA 1,1983-la are accomolishment of the nrocess shall be or reference procedure, personnel, and covered in sections 9,210,2 and 9,210,3 included in procedures or instructiqua.
equipment qualification requiremenu.
of NQA 1,1997, and are eauivalent. No (9,210,2) change to NQA 1,1997 is recommended.
Conditions necessary for accomplishment of the process shall be included.
(9.210,3) l These condit ons shall include proper These conditions < hall ine!ude crocer Requirements of NQA-1,1997 m couipment. controlled parameters of the cauinment. controned carameters of the cauivalent with more prescriptive process. and cahbration recuirements.
process, specified environmentarld specificity. No change to NQA 1,1997is calibration reauirements.
recommended.
Specific wording of NQA-1,1997 "specified environment" also relates to section 9S-. 2dof NQA 1.1983-la.
3.2 Accentance Criu.,ia 220 Acceptance C Mg (9. 220)
Requirements are equivalent v4 h editorial / diction differences v.,y. No change to NOA 1, !997 is recommended.
The reautrements of anolicable codes and The reauirements of applicable codes and Requirements of NQA-1,1983-la are standarsh. includine acceotance criteria stando+ includine acceptance criteria covered in section 9,220, I of NQA i, for the Process. shall be specified or far,the process. shall be speci6ed or 1997 and they are cauivalent with referenced in the crocedures or reyrenced in procedures or instructions.
editorial / diction differences only. No instructiont (9.220.1I change to NOA 1,1997 is recommended.
3.3 Records 400 RECORDS Wording does not constitute a requirement.
Records sh.all be maintained as Records shall be maintained as accrocriate Requirements are identical.
accropriate for the currently aualified for the currently aualified personnel.
retsonnel. nrocesses. and couiement of crocesses. and cauiement each special process of each special procest 3.4 Seccial Reauiremesi 230 Special Reauirements (9,230)
Wording does not constitute a requirement.
For special orocesses not covered by For special processes not covered by Requirements of NQA 1,1983 la are existing codes and standards or where cristine coder and srandards or where covered in section 9. 230. I of NQA l.
Page 3 of 4
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALEN REQUIREMENT 9. CONTROL OF (SPECIAL) PROCESSES 1983 NQA 1 AND la l
1997 NQA 1 l
EQUIVALENCY j
l_
1997 and they are causvalent with ouahty reautrements soecified for an item cuality recurrements spectned -Unid those o/eristine codes or standards the editorial / diction differences only. No exceed those of existine codes or change to NQA.1,1997 is recommended.
standards. the necessary reautrements for necessarv reautrements for auali6 cations auah6 cations of personnel. orocedures. or of rersonnel. Procedures or routoment cauiement shall be spectned or referenced shall be specided or referenced in procedures or inerructions (9. 230. / r Ln the orncedures or instructions
'.:ts b
- e 4
%w Page 4 of 4
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 10 INSPECTION I
NOA 1,198?.la l
NOA 1,1997 l
EQUIVALENCY 10 INSPECTION REQUIREMENT 19 Wording does not constitute a INSPECTION requirement.
100 B ASIC Wordmg does not constitute,i requirement.
Insocctions reautred to verify inspections reautred to sentv conformance Requirements of NQA 1,1997 m conformance of an item or activity to of an item or actnity to soeci6ed couivalent with more presenptise spectfied reauirements shall be olanned reauirements or continued acceptability of specificity. No change to NQA 1,1997is,
and executed items in service shall be planned and recommended.
j executed.
I I
Charactenstics to be inspected g Charactenstics subject to inspection d Requirements are cauivalent with inspection methods to be employed }Ml inspection methods shall be specified.'
editorial / diction differences only. No be specifled.
change to NOA.I,1997 is recommended.
Lntocction results shall be documented.
Inspection results shall be documented Requirements are identical.
l Lqsocction for accectance shall be Inspection for acceptance snall be Requirements of NQA 1,1997 m performed by persons other than those performed bs qualifiedg.ce ons other than cauivalent with more presenptive y
cho performed or directly supervised the those who performed or directly supervised specificity. No change to NQA 1,1997 is eork beine inspected.
the work b6 e inspected recommended. Cross reference NQA 1, 1983 la,10S 1,2.2,1.
" SUPPLEMENT 10S 1 -
Wording does not constitute a SUPPLEMENTARY REQUIREMENTS requirement.
I FOR INSPECTION IGENERAL Wording does not constitute a requirement.
His Supplement provides amplified Wording does not consutute a requirements for inspection of items and requirement.
l activities.
l It supplements the requirements of Basic Wording does not constitute a
.tequirement 10 of this Stanuard and requirement.
shall be used in conjunction with that Basic Requirement when and to the extent specified by the organization invoking this Standard.
- 2. PERSONNEL Wording does not constitute a requirement.
2.1 Reportmg Independence Wording dt es not constitute a l
requirement.
Inspection personnel shall not report inspectionfor acceptance hall be Requirements of NQA-1, ;983-1a are directly to the immediate supervisors performed by qualified persons other than covered in section 10,100,4 of NQA 1, who are responsible for performing the l unose who performed or directly supervised
- 1997, work being inspected.
.ne work being inspected. (10,100,4)
An interpretation has been made in the changes reflected in the 97 edition, it is conceivable that an individual could have performed the work, yet not reported to the supervisor responsible for performing the work and still be able to inspect the work per the 83 wording. His is clarified in the 97 edition those that perform the work can not inspect the work. From this it is judged that the 97 edition exceeds the 83 requirements. No change to NQA 1, 1997 is recommended.
2.2 Qualification Inspection la.83 Wording does not constitute a requirement.
Each person who 3rifies conformance inspection for acceptance shall be Requirements of NQA-1,1983-1a are of work activities for purposes of performed by cualified persoru other than covered in section 10,100,4 of NQA-1, acceptance shall be qualified to perform those who performed or directly supervised 1997 and are couivalent.
the assigned inspection task.
the work being inspected. I10.100 8)
" qualified' added to Basic requirement
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 10. INSPECTION I
NOA 1,1983 la l
NOA.I.1997 l
EQUfVALENCY and accomphshes the intent of the 83 wording. No change to NQA.1, !997 is recomm =nded.
Inspections by persons dunng on the job Requirements of NQA 1,1997 are not eauivalent with NQA 1,1983 la.
training for qualification shall be Performed undet the direct observation The 97 edition is silent with respect to -
and supervision of a qualified person and I inspection and test penannel on the job verification of conformance shall be by training. Training on the specifics ofjob the qualified person until certification is performance is performed, andthe 97 edition does not allow unqualsfied achieved. Ia.83 penonnel to be responsiblefor activities that require prior training. This should not preclude the direct oversight of an inspection activity by u,uc"? "
inspectorhresner of a troiser performing the inspection as a training nercise.
The 97 edition does align with the 83 by requiring conformance verification be perfor;ned only by a qualified person properly trained or cernfied. Absence of this segment does not appear to create any negative impact. No change to NQA 1,1997is recommended. It should be noted that allpersonnel quakfications have been consolidated in Criterion 2.
200 INSPECTION REQUIREMENTS Wording does not constitute a requirement.
Inspection requirements and acceptance Requirements of NQA 1,1997 relate to criteria shall include specified requirements section 10S 1,6.1,2 uf NQA 1,19831a contained in the applicable design and are couiv.gism with more prescriptive documents or other pertinent technical snecificity. No change to NQA 1,19is7 is documents approved by the responsible recommended.
design organization.
3 INSPECTION HOI.3 POINTS 300 INSPECTION HOLD POINTS l Wording does not cor,stitute a requirement.
If r3nnantory insoection hold ooints art
- f maAarney insnectior, hold ooints are Requirements are idertligal.
reouired beyond which work shall not recuired bevond which werk shall not proceed without the soecific consent of riro~d without the soecific consent of the
~
the desinvanad reoresenentive. the ilesiparad reoresentative. the soecific hold swific hold ooints shall be indicated in ggints shJ1 be indicated in noorooriate
&oo.uudate documents.
documents, Consent to waive specified hold points Consent to waive soecified hold ooints shall Requirements are identical.-
shall be recorded orior to continuation of be recorded orior to continuation of work work bevond thGesin=:=4 hold ooint.
bevond the desinn=ted hold ooint.
4 INSPECTION f.LANNING 400 INSPECTION PLANNING Wording does not constitute a requirement.
4.1 Planntr$
410 Planning Wording does not constitute a requirement.
Planning for inspection activities shall be Inspections required to verify conformance Requirements of NQA-1,1983 la are accomplished and documented.
of an item or activity to specified covered in section 10,100, I and 10. 700 requirements or continued acceptability of I of NQA-l,1991 and are coulvalent items in service shallbe planned and establishing the same intent oi planning executed. (10,100.1) and documenting inspection :.ctivities.
Appropriate records shall be established, No change to NQA 1,1997 is
-&' and, as a minimum, identify recommended..
(al throunk (1) below: (10,700,1)
The documentation shall identify Characteristics to be inspected. methods of Requirements are cauivalent with o..
o a r
l NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUlvALENCY REQUIREMENT 10. INSPECTION I
NOA.1,1983.la -
l NOA.1,1997 l
EQUIVALENCY charactenstics, methods, and acceptance inspection, and acceptance entena shall be editonal/ diction differences only.
cnteria.
identified dunng the inspection planning process.
and shall proude for recording objectne
/nspecnon results shall be documented.
Requirements of NQA 1,1983 la are evidence of inspection results.
t/0./00.3) covered in section 10,100,3 of NQA 1, 1997 and intent is cauivalent.
No change to NQA.), !997 is recommended.
4.2 Sampline 420 5.ameling Wording does not constitute a requirement.
Where a sample is used to venfy Sampling procedures, when used, shall be Requirements of NQA 1,1997 Et acceptability of a group ofit s, the based upon valid statistical methods.
cauivalent,,4th less prescriptive sampling piecedure shall be based on specificity. The 97 edition was reworded recognized standard practices.
and the satent of the 83 requirement is n,aintain.d, no change to NQA.),1997 is recommended.
5 IN-PROCESS INSPECTION 500 IN PROCESS INSPECTION Wording does not constitute a requirement.
5.1 Inspection Wording does not constitute a requirement.
Insocction of items in-process or under Insocetion of items under construction or Requirements are cauivalent with construction shall be performed for work otherwise in-process shall be performed as editorial / diction differences only, No activities where necessary to verify necessarv to verifv anality.
change to NQA.1,1997 is recommended, cuality.
If insocction of crocessed items is if insocction of oncessed items is Requirements ge identical.
impossible or disadvantaneous. indirect impossible or disadvantaneous. indirect control by monitorinz of orocessing control by monitoring of oroceging methods. cauiement. and oersonnel shall methods. cauioment. and oersonnel shall be be provided provided.
Both insocction and process monitonna Both insocction and process monamng Requirements are identical.
shall be provided when control is shall be orovided when control is inadeauate without both.
inadeauate without both.
5.2 Combined Inspection and Wording as not constitute a Monitonns requirement.
5.2.1 A combination of inspection --d The program shallinclude monis.> ring Requirements of NQA 1. I A are.itM process monitonng method <, whca,ed, activities against acceptance crit, ria in a couivalem with NQA 1,1983-la. The shall1.e performed in a systematic manner suficient to provide assurance variance is a downgrade and is manner to assure that the specifled that line activities affecting quaaty are significant. Process monitoring methods requirements for control of the process performedsatisfactorily. (2,110,4) are discussed in the 97 edition (2, i10,4) and quality of the item are being but how they will be integrated with achieved throughout the duradon of the inspection processes is not clear.
process.
It is recommended thatfurther dialogue be developed to define the integration and controls to be implementedfor these two activities.
5.2.2 Controls, where required, shall be The prograni shall provide control o ver Requirements of NQA 1,1997 are not established and documented for the activities affecting quality to an extent cauivalent with NQA-1,19831a.
coordination and sequencing of these consistent with their importance.
The varsance is a downgrade and is activities at established inspection points (2,i10,3) significant. Controls are discussedin the during successive stages of the 97 edition (2,110,311 how they should be conducted process or construction.
integrated with monitoring and inspection processes is not clear.
It is recommended thatfurther dialogue be developed to define the integration and controls to be implementedfor these activities.
1
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQ REQUIREMENT 10 INSPECTION EQUIVALENCY I
NOA 1,1983 la f
'NOA 1,1997 e
Wording does not cons itute a 6 FIN AL INSPECTIONS 600 flNAL INSPECTIO's
, requirement.
610 Resolunon of Nonco'n'toimancu ! Wordmg does not constitute a 6.1 Resolution of Nonconfortnances requirement.
Fmal msocetions shall include a records l Emalinsocctions shah include a records
' Requeements are identical.
i p
I renew of the results and resolution of review of the results and resolution of nonconformances identified by onor nonconformances identified by enor I
insocenons.
Requirements of NQA 1,1983 la are insocctions.
The final inspection shall be planned to inspection requirements and acceptance osered in section 10,100, /; 10. 200. l.
critena shallinclude spec 4fied nd 10, 700, I, e of NQA 1.1997.
c arrive at a conclusion regarding conformance of the item to specitied requirements contained in the applicable a
Requitement5 of NQA 1,1997 ut design documents or other pertment ouivalent with more prescriptise requirements.
technical documents approved by the c
specificity.
responsible design organs ation.
No change is idet...,ledfor this f10.200.IJ requirement.
Insoretions reauired to verify conformance of an item or activity to saecifled reauirements or continued acceptability ofitems in service Lhalk olanned and executed. f10,100,1)
Wording does not constitute a 620 Insoretion Reauirements 6.2 Insocction Recuirements requirement.
Completed items shall be insoccted for Completed items shall be insoccted for Requirements are identical.
completenest markings calibration.
comoletenet anarkings. calibratiqm adiustments. orotection from damane. or adiustments. orotection from damane. or other characteristics as reauired to venfv other characteristics as reauired to venfY the cuality and conformarces of the item the cuahrv and conformance of the item to y
.r specified reauirements.
Quahty records shall be examined for i Completed items shall be inspectedfor The quahty records referred to in this to soecified reauire ments.
requirement is interpreted as meaning 4
ompleteness, markingr, cahbranon, those records submitted by a vendor as adequacy and completeness if noi' c
djustments, protectionfrom damage, or previously so examined.
other characteristics at required to verify directed by a contract.
a Requirements of NQA 1,1983 la are he quality and conformance of the item to covered in section 10,620, I of NQA 1, t
specified requirements. (10,620,1) 1997 and are not couivalent.
it is recommends.* tl.ct 10, 620, I be
\\
modified asfollows: ' Completed items, including quality records, snailbe inspectedfor adequacy, completeness, Wording does not constitute a
,6.3 Acceptance requirement.
The acceptance of the item shall be Inspectionfor acceptance sha!/ be Requirements of NQA 1,1983-la are covered in section 10,100.4 and 10,700.
documented and approved by authorized performed by qualified persons other than those who performed or directly supervised
- 1. c of NQA 1,1997.
personnel.
the work being inspected. I10,100. 4)
No change to NQA 1,1997 is recommended. Finalinspection Appropriate records shall be established, acceptance when documented by maintained and, as a minimum, idennfy la) autheri:ed personnel equates to appron of the item / work..
through (f) below:
Iel results or ecceptability i10. 700.1. e1 Wording does not constitute a 630 Modifications. Reoairs. or 6.4 Modifications. Reoairs. or requirement.
Rentacements Requirements ne identical Reolacements Any modifications. reoairs. or replacements Modifications. repairs. or replacements of items performed subseauent to final of items nerformed subscouent to final inspection shall reauire reinsocction or insocction shalltcouire reinsocction or retest, as accropriate. to verify retest. as anemMate. to verify Pace 4 of 5-
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 10 INSPECTION l
NOA 1,1983 la i
NQA 1,1997 l
EQUIVALENCY acceptability.
accertability 7 INSERVICE INSPECTION Wordmg does not consutute a requirement.
-7.1 Planning and Performance Wording does not constitute a requirement.
R quired mservict.anspection or Requirements of NQA 1,1997 Es.ap.!
surveillance of structures, systems, or cauivalent with NQA 1,19831a.
components shall be planned and The verwace is a downgrade andis executed by or for the organization significant. This section has been responsible for operation, deletedfrom the 97 edition, Although inservice inspection could be considered a specialprocess,,further discussion in Criterion 9 and/or2 would be necessary
?o establish equivalency.
it is recommended that this requirement be reinstated in NOA 1,1997.
7.2 Methods Wording does not constitute a requirement.
inspection methods shall be established Requirements of NQA 1,1997 Ef_Il21 eauival :11 with NQA 1,1983 la.
and executed to verify that the t
characteristics of an item continue to See above 83 10, 7.1, I.
remain within specified limits.
Inspection methoos shallinclude Requirements of NQA 1.1997 EF 021 evaluations of performance capability of couivalent with NQA 1.1983 la.
essential emergency and safety systems See above 83 10, 7.1,1.
and equipment, verification of cdibration and integrity ofins.ruments and instrument systems, and verification of maintenance, as appropriate.
8 RECORDS 700 RECORDS Wording does not constitute a requirement.
Records shall. as a minimum. identify (a)
Appropnate records shall be established, Requirements of NQA 1,1997 Es throuah (f) below:
maintained and, as a minimum. identify (a) eauivalent with more prescriptive throuah (f) below:
specificity. The 97 edition exceeds the 83 requiremrnt by specifying thes records be maintained. Establis':ng w cumentatian s
(records) and recording.he appropriate results are discussed above in other secaens. There is no impact to ti. 33 intent. No change to NQA.1,1997 is recommended.
(a) item insnected (a) item insnected Requirements are identical.
(b) date of insnection (b) date ofinsocction Requirements are identical.
(c) in=~ctor (c) ice =ctor Requirements are idenucal.
(d) tvne of observation (d) tvec of observation Requirements are identical.
P) results or accentability (e) results or accentability Requirements are identical.
(f) reference to information on action (f) reference to information on action taken Requirements are identical, taken in connection with in connection with nonconformances nonconformances
/
s
NQA 1 SIDE BY SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 11. TEST CONTROL i
NO A.1,1983.la l
N Q 4 1,1997 j
I:QUlvALI:Ncy 2
II TEST CONTROL REQUIREMENT j.1 Wording don not constitute a TEST CONTROL requirement.
100 B ASIC Wording does not constitute a requirement Tests reautred to serifs conformance of Testi reauired to collect data such as for Requirements of NQA.L 1997 are not an item to specified reauirements and 1.g siting or design input. itftfy conformance eaun alent u tth NQA.I.1983.la.
demonstrate that items will perform of an item or computer program to spectfigd The terianet is an upgrade 0:
satisfactorily in service shall be planned reautrements, or to demonstrate satief actory requirementthatis significant. Addition gpd etecuted.
performance for struce shall be clanned of 'or computer program
- and ' collect ud e tecuted.
data such as for siting or design input' enhances depth of appikation of 97 edition requirement. Replacement of the 83 wording 'that items willperform satisfactorily W with th? n1 ~* ding
' satisfactory performance for ' implies that the items tested willmeet requirements prior to scrske rather than in serrke.
Substitu' ion of 'or' in 97 edition for 'and' in 83 edition provides.m $My.for broader aprikation of the requirement.
There is no impart to the 83 intent. No change to NOA.I.1997 is recommended. j Characteristics to be tested and test Charactenstics to be tested and test Requirements are identical.
methods to be emoloved shall be methods to be employed shall be soefjflgd specified Test results shall be docuinented and Test results shall be gum;Jed and their Requirements of NQA.I.1997 Es their conformance with acceptance conformance with test requirements and cauivalent with more prescriptive enteria shall be evaluated.
acceptance entena shall be evaluated.
specificity. The 97 edition is enhanced with the addition of
- test requirements psa' whkk adds an elementfor
\\ conformance evaluation. There is n impact en the 83 intent. No change to NOA.1, !997 is recommended.
Wordmg does not constitute a SUPPLEMENT 11 S.I.
requirement.
SUPPLEMENTARY REQUIREMENT 5 FOR TEST CONTROL Wordmg does nw constitute a
- 1. GENERAL requirement.
Wordmg does not constitute a
~ lnis Supplement provides amplified requirement.
requirements for test control.
Wording does not constitute a It supplements the requirements of Basic requirement.
Requirement il of this Standard and shall be ut.ed in conjunction with that Basic Requirement when and to the -
ettent specified by the organization invoking this Standard.
2 IEST REOUIREMENTS 200 TEST REOUIREMENTS Wordmg does not constitute a requirement.
Requirements of NQA.I.1997 mi Test reautrements and accectatt 210 Test requirements. and acceptance couivalent with less p'rescriptive criteria shall be orovided or approved by enteria shall be crovided or anorovdhy tbs organization responsible for the tbg responsible design orgarutation.
specificity. Replacement of the 83 edition wording 'organi:ation design of the item to be tested.mless responsiblefor the design of the item to.
othttwise designated.
e%, 4 ae
NQA 1 SIDE BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 11. TEST CONTROL l
I NOA l.19113 la l
NOA.I,1997 I
EQUIVALENCY be tested
- by the 97 edition wording
' responsible design organistion'is assessed as an equivaient replacement.
Deletion of 83 edkn wording 'unless i
otherwise designated
- Juts not affect the 97 edhn in that the de sign organiwtion has the responsibilityfori<st requirements and may determine that another organtution is better qualyled i
to provide test requirements and l
acceptance criteria. There is no impact to the 83 intent. No change to NQA.!,
I997 is recommended.
Reauired tests. includmr. as mcroonste.
Reautred tests. incld nr. as acoropriate.
Requeements of NQA.I.1997 ate not prototvoc aualification tests. ernduct&d
.: atvoc oualificatian tests. production equival,. with NQA 1,1983 la. The tests. croof tests crior to installation.
tests. croof tests enor to installation.
variance h an upg. ade in reguirerent construction tests. cre operational tests.
construction tests. cre.coerational tgig andis signylcant. Add &n of the 97 and oncrational tests shall be controlled oncrational tests. and computer program editics words 'and computer program tests such as software design ve ification, tests such as soAware design renfication.
J l
factory acceptance tests, site acceptance factory acceptance tests, site acceptance tests, and in use tests thall be controlled.
tests, and in use tests' enhances the requirement by providing descriptions of
?
other areas that may require controlled tests. There is no impact to the 83 intent.
i No change to NQA.I, I997 h recommended.
Required tests sh411 be controlled under Requirements of NQA 1,1997 grs.nct appropriate envitonmental conditions using tauivalen_t with NQ A 1, i983 la.
the tools and equipment necessary to The ursance h an upgrade in conduct the test in a manner to fulfill test requirement sad is signyicant. The 97 requirements and acceptance critena.
edkn exceeds the 83 requirement by specifving addknal controls for tests.
No change to NQA.1, !997 is recommended.
The tests performed shall obtain the Requirements of FQA 1,1997 ELilal necessary data wit. ufficient accuracy for cauivalent with NQA 1,19P%la.
cvaluation and acceptance.
The variance is en upgree
.4 requirement andis signyicant. The 97 i
edkn exceeds the 83 requirement by spec (fying addknal controls for test desa. No change to NQA.I, !997 is recommended.
Test reautrements and acceptance 220 Test reauirements and acceptance Requirements of NQA 1,1997 Et criteria shall be based upon specified entena shall be based upon soecified couivalent with more prescriptive reautrements cantained in applicable requirements contained in acclicable dtliSD specificity. AdditiJa of the 97 edition desien or other pertinent technical documents. or other certinent technical words 'that provide approved documenk documents that provide approved requirements
- enhances the requirement requirements.
by spec (fysag that only approved requirements are to be used to establish test requirements and acceptance criteria. There is no impact to the 83 intent. No change to NQA 1,1997is recommended.
230 if temporary changes to the approved Requirements of NOA 1,1997 are not I
i 1
NQA 1 SIDEoBY SIDE ANALYSIS OF REQUIREMENT EQUlVAL REQUIREHlWT 11 TEST ( DNTHOI.
I NOA.l 1983 la l
[*] g iv97~~'{
EQUlvAI.ENcy j
configuration of a facility are teqwred fu l tquivalent with NQA.I.1963 la, testing purposes, approval tu the design The variance is an upgradein equirement andis significant. The 97 auth 'rity h tequired prwr to performin; the r
dition exceeds the 8) requirement by e
test.
pecihing additionalapprovalcontroh s
for testfacility changes. No change to NOA.I, I997 is recommended.
3 TEST PROCEDURES 3001T:ST PROCEDURES (Other than for Wordmg does not constnute a requirement.
computer programu Tests procedures shallinclude or 310 Test pro edures shallinchide or Rrquirements of NQA 1,1997 gg.ncf referrnee the test configurauon and Igil g.auivalent. =^ m: 7:n.::pm r '::17. The variance is an upgradr
{
reference test obiettives obiecttves.
in requirement andis sign (ficant.
l The 97 reition escsres the 83 equirement by re piring that test r
procedures include the test onfiguration. No change to NQA.I, c
1997 is recommended.
and orovisions for assuring that Test procedures rhallalsoinclude Requirements of NQA l.1983.la are orereauisites for the given test have been rirm tsions for assurins errreauisiter and covered in section iI,310,2 of NQA 1, 1997. Requirements of NQA l.1997 ut ig, that adeaunte instrumentation is suitab/r environmental conditions arr ettl, adeaunte instrumentation is available and agt cauivalent. "
= p.n:np M monitorina is octformed, and that gitt appropriate tests and equipment are 17:"::g. Also teference 35 1,4.2.3,2.
available and used, that necessary The variance is an upgrade in suitable envitonmental conditions are used, and necessary momrovine is requirement and is signyicant. The 97 maintained.
gtrformed. (lI,))0.2) edition escreds the 83 requirement by requiring that test procedures spec (fy appropriate test and equipment. No channe to NOA.I, I997 is recommended.
s Test procedures shall aim include Requirements of NQA l.1997 relate to provisions for assunng prerequisnes and section 1151,3,1 of NQA.1,1983 la
- ^
suitable environmental conditions are met.
and are not cauivalent.
=
sdequate instrumentation is available 2nd
,. : mph: :i: t::y.
See abort. No change to NQA.1,1997 is used, appropr
'a tests and equipment are a
used, and necensy inomteing is recommended.
pe ormed.
Prereauisites shall include the followine. as Requirements are identical.
Pretcouisites &@ Delude the fo' lowing.
neolicable: cahbrated instrumentation.
as acclicable: caltipird instrumentgipa ape.qgnate caignent. traliad appmerinte cauioment. trained personnel, eersonnel. condigen of test gmdpgm condition of test coumment and the item to and the item tq,ht.ingLsuttablg
' be tested. suitable environmental environmental conditions. and orovhjp31 ' conditions. and provisions for data acauisition.
In heu of specially prepared written teat 320 As an alternative to 310, accropnate Requirements are cautvalent with for data acauisition editorial / diction differences only. No sections of related documents. such as change to NQ41,1997 is recommended :
procedures, aggspriate sg,tip.nLq{
ASTM methods. Sunolier manuait related documems. suchas,ASIM cauiement maintenance instructions or methods. Sucolier manupk,gggigmtg maintenance instructionh,pf_ggp.vfd approved drawines or travelers with accentance entena. can be used.
drawines or travelers wistynggstssi critena. can be used.
Requirements of NQA l.1997 are not Such documents shall include adequate cauivalent with NQA l.1983 la.
instructions to assure the required quality The variance is a downgrade in of work.
Pano 1 nf A
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NQA-1 SIDE-BY SIDE ANALYSIS OF REQUIREMENT EQUlVALENCY REQUIREMENT 11 TEST CONTROL l
NOA.I.1983 la l
NOA.1,1997 l
EQUIVALENCY requirement and is not signyicant.
While it h up to the approving organi:stion to determine the appropriate level ofinstruction, the 1
I deletion of thh segment does not appear to advently affect the intent of the 83 edkn. The substitution of alternative instructionsfrom other sources defined l in segment 320 of the 97 edkn must s
still mort the established content as defined in 310. The intent of thh section is also supported in Requirement 5 of the 97 edition sentences 2 and 3. No change to NOA.I,1997 is recommended.
~
400 COMPIITER PROGRAM TEST Wording does not constitute a PROCEDURES requirement.
The requirements of 400 apply, mstead of Requirements of NQA 1,1997 Aff 021 300, Test Procedures, to testing of cautvalent with NQA.I.1983 la.
computer programs, and as appropriate, the The variance is an upgrade la computer hardware and operating system.
requirement and h signVicent. The 97 edkn escreds the 83 requirements by applying computerprogram control measures. There is no impact to the 83 intent. No chang
- to NQA.1,1997 h recommended.
410 Computer program test procedures Requirements of NQA 1,1997 are not shallprovide for demonstrating the eauivalent with NQA.1,1983 la.
adherence of the computer program to The verdance is an upgrade in documented requirements.
requirement and h significant The 97 edkn exceeds the 83 requirements by applying computerprogram control measures. There is no impact to the 83 intent. No change to NQA.!,1997 h recommended.
For those computer proft am> used in Requirements of NQA.I.1991 af.LD21 design activities, computer program test cauivalent with NQA.' 1031a.
procedures shall provide l0r assuring that The vernance is an upgrrfe in the computer program produces correct requirement andis signyicanL The 97 l sesults.
edition exceeds she 83 requiren....ts by mylying computerprogram esntrol measures. There is no impact to the 83 intent. No change to NQA.1, I997 is recommended.
For those computer programs used for Requirements of NQA 1,1997 are not operational control, computer program test cauivaltal with NQA.1,1983 la.
procedures shall provide for demonstrating The variance is an upgrade in required performance over the range of requirement and is significant. The 97 operation of the controlled function or edhn eseerds the 83 requirements by applying computerprogram control process.
measures. There is no impact to the 83 intent. No change to NQA.1, I997 is recommende.1.
The procedures shall also provide for, Requirements of NQA l 1997 are not evaluating technical adequacy through cauivalent with NQA 1,1983 la.
NQA 1 SIDE BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 11. TEST CONTROL I
NOA.I.1983 la l
NO 4 1,1997 l
EQUlvA(f.NCY comparison of test results from alternatisc The rariance is an upgrade in methods such as: hand calculatsons.
requirement andis sign @ cant. The 97 calculations usmg comparable pros en edhn exceeds the 83 requirements by programs, or emparwat data and applying computer program control mformatson from technscal hterature.
measures. There is no impact to the 83 intent. No change to NQA.1,1997is recommended.
4:0 in u>e test procedures shall be Requirements of NQA 1,1997 are not descloped and documented to permit cauivalent with NQA 1,1983 la.
confirmation of acceptable petformance of The variance is an upgrade in the computet program sn the opet. sting requirement andis sign @ cant. The 91 edition escreds the 83 requirements by system.
applying computer program control measures. There is no impact to the 83 intent. No shange to NQA 1, IV97 is recommended.
In use test procedures shall be performed Requirements of NQA 1,1997 are not after the computer program is installed on a coulvalent with NQA l.1983 la.
different computer, or when there are The variance is an upgnade in significant changes in the operating system. requirement andis signtAcant. The 9 edkn escreds the 83 requirements by applying computer program control measures. There is no impact to the 83 intent. No change to NQA.1, I997 is recommended.
Periodic in use manual or automatic Requirements of NQA 1,1997 are not self check in use tests shall be prescribed cauivalent with NQA 1,1983 la.
and performed for thow computer programs The variance is an upgrade in where computer program errors, data errors, reguirement sadis siga@ cant. The 97 computer hardware fmilures or instrument edition exceeds she 83 requirements by driit can affect required perf ormance, applying computerprogrem control measures. There is no impact to the 83 intent. No change to NQA.1, I997 is recommended.
4 TEST RESULTS 500 EST RESUL7.
Wording does not constitute a requirement.
Test results shgil be documented and Test results shall be.@camented and Requirements are ia _al.
evaluated by responsible authonty to evaluated by a resoonsibb authority to assure that test reautrements have been assure that test reouirements have begJg
, sfied satisfied Test results for destgn quahfication tests Reqmrements of NQA 1,1997 relate to and software design verification shall be section 3S 1,4.2.3,6 NQA 1,1983 la evaluated by the responsible design and with 3,500, I above and Mt. net organisation.
equivaltal.
The variance is an upgrade in requirement and is sign @ cant. The 97 edition exceeds the 83 requirements by applying computerprogram con ~ol measures. There is no innpact to the 83 intent. No change to NQA.I,1997 is recommended.
5 TEST RECORDS 600 TEST RECORDS Wording does not constitute a requirement.
Page 5 of 6
NQA-1 SIDE-BY SIDE ANALYSIS OF REQUIP.EMENT EQUIVALENCY REQUIREMENT 11. TEST CONTROL-I NOA.I.1983.le l
NOA.I.1997 I
EQUIVALENCY Test records shall, as a minimum.
Test records shall be estaNished and Requirements of NQA.I.1997 pre not identify (a) through(g) beluw:
maintained to indicate the ability of the cauivalent uith NQA.I.1983 la.
Item of computet program to satisfactorily The variance k e downgredc 5 perform ats intended f unction or to meet its requirement endis sign (/lcent. The 97 documented requirements.
edition does not address the minimum content entriesfor a test record. The sperffic reasonfor detering these
' Test records shall be established and minimum entries k not known however maintained to indirete the ability of the the (e) to (g) entries to be documented kom or computerprogram to satisfactorily per the 83 edkion appear to be goed besic perform its intendedfunction or to mort its practice. It k recommended that the 83 documented requirements and as a wording be added to the 97 edition (see minimum shallidentyy (e) through fg) wording et leR) to maintain equivalency.
below:*
And also add to the 97 edhion the 83 ~
ediden s.. tents of(a) through (s).
(a) item tested Requirements of NQA.I.1997 sta
equivalent with NQA.I.1983.la.
See comments eben.
t (b)date of test Requirements of NQA l.1997 ss ned equivalent with NQA 1.19831a.
See comments above.
(c) tester or data recorder Requirements of NQA 1.1997 arsJlci equivalent with NQA.I.1983 la.
See consmener above.
(d):ype of observation Requirements of NQA.I.1997 Es ngi equivalent with NQA l.1983 la.
See commener abere.
(e)results and acceptat ihty Requirements of NQA l.1997 us.ng!
equivalent with NQA l.1983 la.
See commener abere.
(f) action taken in connection with any Requirements of NQA l.1997 us.ngi deviations noted equivalent with NQA 1,1983 la.
See commener abere.
(g) person evaluating test results Requirements of NQA l.1997 ut n91 equivalent w' h FQ bl.1983 la.
See comments abere.
I
NQA 1 SIDE BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREhtENT 12. CONTROL OF SIEASURING AND TEST EQUll'hlENT I
l NOA.I.1983.la l
NOA l,1997 I
I QUIV Al1NCY Wording does not constitute a l
I? CONTROL OF MEASURING AND REQUIREMENT.1; TEST EOUIPMENT CONTROL OF MEASURING AND requirement.
TEST FOl'IPMFVT 100 D ASIC Wording does not constitute a requirement.
Tools. cares. mstruments and ether Tools. cares. instruments. and other Requirements gr counalent mth ditorial/ diction datferen,:es only.
mtasurmi and test cautoment used for measunne and test cautoment used for e
activities affectine auahty shall be actnities affecting auality shall be ontrolled. calibrated at soecined oenods.
Wording of the 97 edition di broader i,t controllgd and at sr ecified ornods c
pplication, esponds scope to include calibrated and adtusted to mamtsin adivited, and maintained to required a
aintaining Af&TE. Thereis noimpart m
accuracy within necessary hml.11 accuracyhmus.
to the 83 intentt No change to NQA.I.
1997 is recommended.
Wording does not constitute a SUPPLEMENT 12S 1 requirement.
SUPPLEMENTARY REQUIREMEh a S FOR CONTROL OF MEASURING AND TEST EQUIPMENT Wordmg does not constitute a IGENERAL requirement.
Wording does not constitute a This Supplement provides amphfied requirement.
requirements for control of measuring and test eq:.jpment.
Wordmg does not constitute a It supplements the requirements of Basic requirement.
Requirement i 2 of this Standard and shall be used in conjunction with that Basic Requirement when and to the extent specified by the organization invoking this Standard.
200 SELECTION Wording does not constitute a 2 SELECTION requirement.
Selection of measunni and test cautorhent Selection of measunge and test cautoment Requirements of NQA 1,1997 us couivalent with less prescriptive shall be controlled to assure that such shall be based on the tyoe. ranne.
accuraev. and tolerance needed,LQ specificity No change to NQA.),1997 is items are of proper tm. ranee. accuraev.
and tolerance to accomolish the function accomolish the required measurements for recommended.
of determinine conformance te n;d deterrmnine c"fganance to specified The 97 wording is n. ore representative of vautremets t, uirements.
thefunction of this section. The 83 wording 'thefunction of' and the 97 wording 'sne required measurements for' have the same intent. 'Thefunction'is to obtain ' required measurements.'
There is no impact to the 83 intent.
3 CAllBRATION AND CONTROL 300 CALIBRATION ANDCONTROL Wordmg does not constitute a requirement.
3.1 Calibration 310 Glitation Wordmg does not constitute a requirement.
Measunne and test cauiement shall be Measunne and test cautoment shall be Requirements of NQA.1,1997 are not calibrated, adiusted. and maintained al calibrated. at presenbed equivalent with NQA 1,1983 la.
crescribed Tools, gages. instruments, and other Requirements of NQA.!, I983 la are measursng and test equspment usedfor covered in paragraph 12,100, I of NQA l activsties afecting quality shall be 1,1997.
controlled. cahbrated at specsfied periods.
[
Page 1 of 5
NQA 1 SIDE BY SIDE ANALYSIS OF REQUIREMENT EQUlVALENCY REQUIREMENT 12. CONTROL OF MEASURING AND TEST EQUIPMENT i
l N OA.1,19113 la l
NOA.I.1997 I
EQUIV A1.ENCY l
I ad!usted. and "taintained to requsted i
accuracy Ismots. I12.100. h I
inters als or, prior to use, time periods or usage and Requirernents of NQA.I.1997 att.n*4 j
ggun alent with NQA.I.1983.1a.
Wording of the 97 edition provides the t
same degree of control as imposed by 83.
The 83 wording 'intenah'is consistent with the 97 wording ' time periods '; and the 83 wording ' prior to use'is morr restrictive that the more general 97
)
l wording ' usage'. This action is viewed as a positive change. There is no impact to the 83 latent. No change to NQA*l, I997 is recommended.
Requirements of NQA l.1997 relate to whenever the accuracy of the equiprnent is paragraph 12S.1,3.2.$ of NQA.I.1983 suspect.
la and are cauivalent. No change to NQA.),1997 is recommended.
anainst certined cauioment havinn known Calibration shall be ggghist errrified Requirements of NQA l.1983 la are valid relationships to natiogglh rgwitiment havins known valid covered in paragraph 12,310,2 of NQA-tscornized standards.
relationshios to nationally recornized I,1997. Requirements are cauivalent standards. f /2,310. 2) with editorial / diction differences only.
No change to NQA.1,1991is recommended.
Calibration shall be seminst certified Requirements of NQA l.1997 relate to cauiement havinn known valid paragraph 12S l. 3.1. I of NQA 1.1983-relationshios to nationally reccanized la and are eauivalent. No change to standards.
N041,1997 is recommended.
If no nationally recognited standards if no nationally recornized standards Requireme..ts are identical.
esist. the bases for cahbration shall bc
- yitt. the basis for calibrepon shall be ilocumented.
d vumented.
3.2 Control 320 Control Wording does not constitute a requirement.
g.ahbration procedures shallidentify or
".:p
- NQ.^. ! '""' P He reference required accuracy.
ic..,-! ! M ' 3.2. ' e' MO ^ ', '""1-4e, Requirements of NQA.I, I997 QLt.
not naudvalent with NQA.I, I983.la.
NQA.I,1997 enhances standard by requiring that calibration procedures include checking accuracy. The venance is an upgrade in requirement thatis signylcant. No change to NQA.I.
!997 is recommended.
Methods and frequency of checking Requirements of NQA 1,1997 are not accuracy shall be defined in procedures.
cauivalent with NQA 1,1983 la.
The 97 edition exceeds the 83 rsquirement by requiring that calibration procedures include checking accuracy.
There is no impact to the 83 intent. The
NQA 1 SIDE BY SIDE ANALYSIS OF REQUIREMENT EQUlVALENC REQUIREMENT 12. CONTROL OF MEASURING AND TEST EQUIPMENT I
NO A.1, its.bla l
NOA.1,1997 I
EOUlvAl.ENcy j
rsence is en upgrade in requirement ve that is signyicent. No change to NQA.I.
1997 is recommended.
Requirements of NQA 1, I997 sitt Ihg rnethod and interval of cahbration for Iht cahbeation rnetnod and intervalg[
coun alent with more prescriptne each item shall be defined. based on the dibration for measuring and test troe of couiernent stabihty charactertsues. equipment shall be denned. based on the specs 0 city.
reautred accuraev. intended use. and other troe of cautornent. stabihty characteristics. The addition of 97 edition wording
'celibration' end ' measuring and fest conditions af fecting measurement control.
(Igmted accuraev. intended use. and other quipment* edd clerky. The 83 wording conditions affectine capabthly.
e measurement control'is replaced wkh the 97 word 'cepobilky
- which provides a ore accurate functional description, No m
hanne to NOA.I,1997 is recommended.
c H han measunne and tes' commment art Aeguirements,if NgA.f 198 h M are When measunna and test equiptnent is overedin peregraph 12,321, I of NQA*
found to be out of cahbration. an c
evnluation shnli be made and documented et alMallon, commensurate with the ls 1997. Requirements of NQA.l,1997 found to be out oi cahbtntion. nn re not eenivelent The variance is an of the vanditv of orevious insoection or ngntl1cance of the condition, shall be pgrade in requirement that is significant.
a test results and of the accentability of made and documentedincluding thC u
items oreviousiv insoected or tested.
vahdurv of previous intrrction or test 97 editica enkencesflexibilky in greding results and of the accrvtabihty ofitems Ike essessment of signyleencefor the out errviously inspected or tested f12,32), I) of celibretion condidon when developing en evaluation. In the 97 edition adding the word ' including
- expends the scope of the documented erelaation. Changes to the 97 appear to impreve skis requirement. No change to NQA.I, I997 is recommended.
Out of-cahbration devices **tt be tassed Out of cahbration devices aall be.lagad Requirements of NQA 1,1997 att or seere=='aA and not used unul they have or seereented. of both, and not used until equitalent with more prescriptive they have been recalibrated.
specificity. The 97.eddison addhion of been recabbrated,
'or book' provides another ehernetter for out of calibration devices. No change to NOA.I,1997 is recommended.
I Measurine or test comoirat countentiv Requirements are eauivalc$ with If any measunng or test equil ment is (cri to be out of caltreon shall be editorial / diction differences only. No consistently found to be out of calibration thenee to NQA.l,19'
- is recommended.
it shall be repaired or replaced.
' tenaired or reolaced I A cahbration shall be performed EhtB the Measurung and test egmpment shallbe Requirements of NQA.I.1983.la are calibrated, at prescribed timt periods or covered in paragraph 12,310, I of NQA.
1,1997 and requirements are equi JInt accurney of the cautoment is susoect.
usage c d drarver the occuraev ofinc with editorial / diction differences only. No rauipment is ruscect (12 J10,1) ekanne to NOA.I, !997 is recommended, Wording does not constitute a 321 Corrective Action requirement.
When measunng and test equipment are Requirements of NQA 1,1997 relate to section 1251,3.2,2 of NQA 1,19831a.
found to be out of calibtation, an evaluation, commensurate with the Requirements are not eauivalent, The varience is en upgrade in significance of the condition, shall be requirement that is signylcent. The 97 --
made and documented including the edition exceeds the 83 requirement by validity of previous inspection of test formalizing the process of evaluating results and of the acceptability of items previously inspected or tested.
out of calibration MATE, There is no impact to the 83 intent. No change to NOA.I.1997 is recommended.
o Page 3 of 5
NQA 1 SIDE BY SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 12. CONTROL OF hlEASURING AND TEST EQUIPhlENT l
NO A.1,1983 Is _
l NOA 1,1997 I
I:OUlVAlfNCY I
322 Handing and Storage WordinF does not constitute a requirement-Measuring and test equipment shall be Requirements of NQA 1,1997 telate to properly handled and stored to maintain section 1251, J. I of NQA 1,1983 la accuracy.
and are couivalent. No change to NQ.41, 1997 h recommended.
323 Status indication Wording does not constitute a requirement.
Equipment shall be suitably rnarked or Requirements of NQA 1,1997 relate to otherwise identified to indicate cabbration section 1251,5. I of NQA 1,1983 la.
t status.
Requirements of NQA.I.1997 att gguitals with neless prescriptne specsficnty More pexibility is p*ovidre!
in the 97 'itson with the addition of 'or I
otherwise identified No change to NQA.
1 1, I997 is recommended.
3.3 Commeretal Devices 330 Co.nmercial Devices Wordmg does not constitute a requirernent.
Cahbration and control measures may g Cahbration and control measures are g Requirements of NQA l 1997 are not be troutted_for tylers, tape meuures.
Irguired for commercial equipment such cauivalent with NQA 1,1983 la.
[ nth, and other such devices, d normal as rulers. tane measures. levth, etc., d The variante is an upgrade in commercial augment provides adequate such cautoment provides the required requirrment that is not sign (/icant. The j
t accuracy ACtMlaG 97 edition changes the bias of the requirement by replacing the 83 word
'may not'(guidance) to the 97 word
- art not* imandatory) The qual (fying '(f' 1
phrase sopens thh bias. The basic intent for this unique application of Ma TE is not significantly affected. No change to NOA.I, I997 is vreommended.
4 HANDLING AND STORAGE Wording does not constitute a requirement.
Measurine and test cauipment shall bg Mrasurint and test rautoa ent shall br Requirements of NQA 1,1983 la are properly handled wi stored to maintain orcorrly handled and stored to maintain covered in satira 12,322, I of NQA 1, accuraev.
accurag (12, J2.1) 1997 and are identical. No s angt to NOA 1, !997is a..ommen ed.
5 RECORDS 400 RECORDS Wording does not constitute a requirement.
Records shall be maintained &Bd Records shall be established and Requirements of NQA 1,1997 are not t
inatntained to indicate calibration status couivalent with NQA 1,19831a.
and the capability of measuring and test The variance is an upgrade that h equipment to satisfactorily perform their sign (ficant. Th(97 edition exeteds the intended function.
83 requirement byformalizing the spec (fic reasons records are estabikked.
There is no impact to the 83 intent. No change to NQA.I, !997 h recommended.
couipment shall be suitably marked to Eauirment shall be suitably marArd or Requirements of NQA 1,19831a are indicate cahbration status.
otherwhc identified to indicate rahbration covered in section 12,323, I of NQA l, trarg (/2,323,1) 1997. Requirements of NQA l 1997 att r
tauisalent with more prescriptive specificity.
The addition of 97 wording 'or otherwist
NQA 1 SIDE BY SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 12. CONTROL OF MEASURING AND TEST EQUIPMENT l
NQA.I.1983.la l
NO4 l.1997 I
EQUIV Al ENCY identified'provides additionalfirxsbility in Ihr way celsbration status may be induteted. There is no impact to the 8.3 intent. No change to NQA.I. I997 is treommended.
i I
.'.,, s
~
(
Page 5 of 5
__.J
NQA-1 SIDE BY SIDE ANALYSIS OF REQUIREMENT EQUlVALENCY REQUIREMENT 13 HANDLING. STORAGE, AND SHIPPING 4
l NOA 1,19831a l
NOA.1,1997 l EQUlVALENCY I
I 13 HANDLING. STORAGE. AND REQUIREMENT.lj Wording does not constitute a SHIPPING HANDLING. STOR60E. AND requirement.
SHIPPING 100 B ASIC Wording does not constitute a requirement Handime storace. cleaninc. nackarint.
Handlinc. storace. cleaninc. nacktring.
Requirernents are identical.
shineine. and presers atton of items shall shinctnc. and preservation of items shg[1 i
be controlled to present damare or lost be controlled to orevent damare or loss and to mimmire deterioration, and to minimite deterioration =
4 4
1 i
Handling, marking, labeling, storage, Adding ' marking, labeling
- resolves cleaning, packaging, shipping, and change recommended in 13,600, l.
preservation ofitems shad be controlled to prevent damage orloss and to minimite deterioration.
l SUPPLEMENT 1351 -
Wordmg does not constitute a SUPPLEMENTARY REQUIREMENTS requirement.
FOR HANDLING. STORAGE AND SHIPPING i
l 1 GENERAL Wording does not constitt>* a requirement.
This Supplement provides amplined Wording does not constitute a requirements for handling, storage, and requirement.
shipping.
It supplements the requirements of Basic Wording does not constitute a Requirement 13 of this Stancard and shall requirement.
be used in conjunction with that Basic I
Requirement when and to the estent specified by the organisation invoking this Standard 2 INSTRUCTION Wording does not constitute a requiremot.
Handling, storage, and shippmg of items These activities @lLbg rnnducted in Requirements of NQA 1,1997 att shall be conducte.'jarrordance with ccordance with es'abhd ed work and equivalent with more p ascr',-tive gytablished work and insocction insocction instructions. ' mines.
specificity, 83 wurding freludes only irrtructions. drawin es. specifications.
specifications. shioment instructions. or Handling, storage, end shipping while shipment instructions or e her pertinent
,.ther oertinent documents or procedures 97 wording refers to shefollowir'a degyngnts or orocedures specified for us.
gecified for use in conducting the activities #andling, storage, cleaning, PP ng, and preservation.
in conducting the activity.
activitt packaging, shl i
The additionallisted activities enhance 83 position by providing broader application in 97. No change to NQA.I,
!997 is recommended.
3 REOUIREMENTS 200 SPECIAL REOUIREMIEI3 Wordmg does not constitute a requittment.
Wording ":; '::- ::: of NQA 1,1997 iLt.quivalent with more presenptive specificity.
Wording does not constitute a 3.1 General requirement.
When reauired for particular items, special When reautred special ecuipment (lugh.as Repirements are cauivalent with couioment (such as containers. shock containers. shock absorbers. and editorial / diction differences only.
___ 7 NQA-1 SIDE BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 13. HANDI ING, STORAGE. AND SHIPPING l
NOA 1,19831a l
NOA.1,1997 l EQUIVALENCY i
i absorbers. and accelerometers) and socetal accelerometerst and special protecttic 97 deletes phrase 'for persicular itemt
- orotective environments (such as inert ras environments (such as inettgg andleaves application more atmosohere. specific motsture content atmosphere. snecific moisture content encomposting with wording 'When l
lesels. and temocrature lesels) shall be lesels, and temocr ture lesels) shall be reguired.' No change to NOA 1,1997 /s specified. crovided. and their esistence specified. Provided. and their ettstngs recommended.
verified senfied 3.2 Procedures 300 PROCEDURES Wording does not constitute a requirement.
When reautted for entical.snulut, When reautred for critical. sensitive.
Requirements are couivalent with censhable. or high valut articles. soccific certshable. or high value items, specific editonal/ diction differences only.
orocedures for handhns. stgagg.,
procedures for hodline. storare.
33 word 'erricles' replaced with 97 word packaging. shmpmn, and preservation packaning. shiocine. and preservation
' items' which k more consistent with shall be used, shall be used.
opening requirement. No change to NQA.1,1997 h recommLnded.
3.3 Tools and Eauipment 400 TOOLS and EOUIPMENT Wording does not constitute a requirement.
Snecial handhne 'cols and cautoment shall Special handling tools and cauioment shall Requirements are cauivalent with be utilized and controlicd as necessary to be utilized and controlled where necessary editonAl/ diction differences only. No ensure safe and arleannte bandlins to ensuie safe and adeaunte handline chante to NQA.I,1997 ts recommended.
Sagetal handhne tools and cautoment shall Soccial handling tools and cautoment shall Requirements are identical.
ll be insoccted an([gggd be insoccted and tested Requirements of NQA 1.1997 gg. net equivalent with NQA.1,1983.la.
in accordance with procedures and Akkongh reference to ' procedures
- is included above in NQA.I, !997 I3, 100,2 and i3,300, I; and Criernia 1I and i2 deel wah preceduresfor inspecalon and testing; use ofprocedures is not specylcelly applied to special handling tools and equymem. It would seem important that sophhticated equipment have unique ' procedures' specyletodetermininge4 uate t
operoning status and it k recommended that this wording be r innained.
Requirements me not eouivalent. The 83 at specified time ir,'ervals periodically or prior to use as necessary wording "At specyled time interve'<"
and the proposed 97 repiscoment "periodicelly or prior to use es necessary,"inlainte the same actions, however, the 83 implies documented specyics whiit 97 is more vague.
Recommend adding thefollowing wording: 'et specyiedintervek or prior to use es necessary
- Requirements of NQA 1,1997 are not to venfy that the tools and equipment are to assure performance.
eauivalent with NQA 1,1983 la. The 8.2 ader,,sately maintained, version "to verify that the took and equipment see adequately maintained" t ;
being replaced in 97 with "to assure Page 2 of 3
NQA 1 SIDE BY-51DE ANALYSIS OF REQUIREMENT EQUlVALENCY REQUIREMENT 13 IIANDLING STORAGE AND SillPPING
[
NOA 1,19831a l
NOA 1,1997 l EQUIVALENCY
}
performance;" while essentially the same, the replacement is not as robust.
\\'ernfying implies more involvement with Recommend modifying wordingfor this physicalrzamination and section asfollows:
documentation.
'Special handling tools and equipment shallbe inspcted and tested ut Recommend wording atIrfL accordance with procedures at specified intervah or prior to use as necessary to veryy that the tools and equipment will adequately perform.
- 3.4 Qperators 500 OPERATORS Wording does not constitute a requiremer
- Operators of soccia'hndhne and liftig (merators of spectAl handher and hftine Requirer ~nt: are identical.
gauipment shall be e urienced or trained cautoment shall be einerienced or trained in use of the cauipment in use of the cauipment 4 MARKING 600 M ARKING OR LABELINO Wording does not constitute a requirement.
Instructions for markirr and labehne for Makine or labehne shall be utthred n Requirements of NQA 1,1997 usagi packaging, shipment, handling, and neces.sarv to adeauntely maintaund t2uivalent with NQA 1,1983 la.
storage of items shall.bg established n r reserve the iter.i includine indication of The variance is a downgrade endis necessary to adeountely identify, muntain the presence of special environments or sign (/lcant. The 83 version requires pnd preserve the item. includme indication the need for special controls.
Instructionsfer marking and labeling of the presence of soccial environments or whereas 77 deletes the reference to Lbs.need ior soccial controls.
Instructions. It is recommended that section 100
- Procedures
- of NQA.I,1997 he expanded to include marking and Recommend mod {fying wordingfor this labeling, easily resolving this non.
section asfollows:
equivalence. Deletion of'forpackaging,
' Marking orlabeling shallbe used as shipment, handling, and storage of necessary to adequately identify, preserve items *from 83 version does not affect and maintain isems, including indication requirement. Substituting
- utilized *in of the presence of special environments the 97for
- established
- in the 83 is more or the nordfor special controls.*
occurate i,. directing thefunctional activity. Dr.etion of the word 'Wentify*
from t s 83 versinn remos. a singulasr i
h important aspect of this section, to identyy items by marking or labeling. It is recommended reinstating this word, consider rewording at left.
s
~-
NQA 1 SIDE BY SIDE ANALYSIS OF REQUIREMENT EQUIVAL REQUIREMENT 14. INSPECTION. TEST. AND OPERATING STAT U l
NOA 1,19831a i
NOA 1,1997 l
FQUIVALENCY I4 INSPECTION. TEST. AND REQUIREMENT 14 Wording does not constitute a OPERATING STATUS INSPECDON. TEST. AND requ.tement.
OPERAllNG ST ATUS Wording does not constitute a 100 requirement.
The status of insocction and test activities The status of insocction and test actnities Requirements are idej)1tgj shall be identified either on the items or in shall be identified either on the items or in docunwnts traceable tu the items w here it dggitents traceable to the items where it is necessary to assure that trautred iLDfaingy to assure that reauired insocethns and tests are performed and tg insocctione and tests are performed and [g assure that items which have not cassed assure that items which have not cassed the reauired insoceSons and tests are not the reautred insocctions and tests are not inad.ertently installed. used. or onerate<f inadver*ently instal!ed used. or oocrated.
Status thall be maintained thrwh Status shall be _ maintained throuah Requirements are IC.atical indicators. such as ohysical location and indlDICp. such as ohvsical location and tant. markinns. shop travelers. stamos.
tans. mariines. shop travelers. stamos.
insocction records. or other suitable insocetion records. or other suitable means
' Die authority for acclicatl2!Lind removal The authority for anchcation and removal Requirements are idential,
- means, of taen. markinns. labels and stamos shall of tans. markmas. labels. and stamos shall be toccified be soecified Status indicators shall also of ovide for Status indicators shall also orovide for Requirements are tdenocal indicatina the operatina status of systems indicating the oncrattnr status of sistems and components of the nuclear facility, and comoonents of the nuclear facility, such as by taneine valves and switches.to such as by tannine valves and switches. to orevennnadvertent ooeration.
orevent inadvertent oneratiott 4
O 4
Page 1 of 1
NQA-1 SIDE BY SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 15. CONTROL OF NONCONFORMING ITEMS I
NOA.I.19113 la l
NOA.1,1997 I
EQUIVALENCY M
REQUIREMENT M Wording does not constitute a CON' TROL OF NONCONFORMING CONTROL OF NONCONFORMING requirement.
ITBiS ITEMS 100 ilASIC Wording does not constitute a q
requirement-j ltems that do not conform to speciDed items that do not conf orm to speci6ed Requirements are identical.
reuuirements shall be controlled to crese.g (gguirements shall be controlled to pints
}
i inadsertent installation or use inadvertent installation or use Controls shall provide for identt0 cation.
Controls shall provide for identificating Requirements are identical.
1 d2Eumentation. e valuation. serre ration documentation. e valu ation. se rre ration l chen oractical. and disposition of
- y. hen practical. and dispositicn el -
nonconformine items. and for notification nonconformine items. and for notification gaffected otranizations to affected otranizations SUPPLEMENT 1551 Wording does not constitute a 1
SUPPLEMENTARY REQUIREMENTS requirement.
FOR THE CONTROL OF j
NONCONFORMING ITEMS
]
I GENERAL Wording does not constitute a requirement.
l This Supplement provides amphfied Wording does not constitute a requirements for the control of tequitement.
nonconforming items.
It supplements the requtter.icnts of Basic Wording does not constitute a Requirement 15 cf this Standard and shall requirement.
I be used in conjunction with that Basic Requirement when and to the estent specified by the organization invoking this s
itandard.
3 IDENTIFICATION 200 IDEN~lelCATIQff Wording does not constitute a requirement.
Ta') Identification of nonconformine items Nonconformine items shall be rdentified Requirements of NQA.I.1997 RLt shall be b, marline. tarrine. or other h legible marline. tsrrint. or etner cauivalent with more prescriptive methods which shall not adversely affect methods not detnmental to the item. either specificity, the end use of the item, on the item. container, or package Wording of the 97 edition U broaderin a nt.nining the item.
application. skere appears to Ie no impact so the 83 intent Ne. hange is recommendedfor the 97. dition.
The identification diall be lecible and Nonconforming trems shall be identped Requirements of NQA 1.1983 la are l
casily recognizable.
i.,,, lettbIt marking. tagging, or other covered in section 15. 200, I of F. bl.
v.ethot not druimental to the item, either i997.
on the item, container, or package Requirementof NQA.I I997is get containing the item. Ii5,200. I) eauivalent with NQA.1,1983.la.
Variance is a downgrade, and is not signi)icant.
Wording af the 97 edition is determined to provide the same degree of control os imposed by 83. However, the wording
- easily recognizable
- was deleted in the 97 Edition,(f an NCR isem can be ident(fiedfrom legible markings then
' easily recognnable* is redundant.
There appears to be no impact to the 83 intent. No change is recomme,sdedfor the 97 edition.
4 i
- ~ _ _ _
__-a
DRAFT NQA 1 SIDE.BY SIDE ANALYSIS OF REQUIREMENT EQ REQUIREMENT 15. CONTROL OF NONCONFORMING ITEMS l
l NOA 1,1983.la l
NO A.1,1997 I
EQUIVALENCY J
Nonconformmg stems shall pr sdennfied Requtrements of NQA.I.19831a are mered m section 15. 200. I of NQA 1 tbt if sdents6 cation of each nonconforming stem is not practical. the by legible marking. taggmg. or other e
methods not httimental to the stem. enther 1991.
Lchtuutl. raahtt. ot stittgated stos age on the stem. contamtr, or tw Aart auivalent with NQA.I.1983 la Requirements of NQA l.1997 gre not area, as appropriate. shall be ident:6cd contammg the stem. ill 200. //
Varsarer is a downgrade andis not c
ignnficant. Wording of the 97 edition is s
determined to provide the same degree of ontrolas imposed by 83. The wording c
or segregated storage arra'has been l
deleted. This action is viewed as a i
ositive change, since the option to label p
i n area rather than the discrepent items o
is no longer provided. There appears to be no adverse impact to the 6.o sment.
No change is recommendedfor the 97 edition.
300 SEGREGATION Wording does not constitute a 3 SEGREGAllQM requirement.
(a) Nonconformine items shall be 310 Nonconformme items shall be Requirements are identical.
serrerated, when practical. by placing
}ecterated. w hen practical. by placing them in a clearlv identified and designated them in a clearly identified and designated hold area until oronerly dispositioned hold area until properf v di positioned (b) When serreration is imoractic1Lgt 320 When serreration is imoractical or Requirements are identical.
Impossible due to chvsteal condal0D1 iHipossible due to chysical conditions such as size. weight. or access limitations.
jach as size. weight. or access limitations, other precautions shall be employed to g}her precautions shall be (ggtoved to preclude inadvertent use of a l
preclude madvertent use of a nonconfornunn item.
nonconformine item, Wordmg does not constitute a 400 DISPOSmON 4 DISPOSmON requirement.
Wordmg does not constitute a 410 Cgaggi 4,1 Control requirement.
Requirements are cautvalent with Nonconformine items shall be evaluated editorial / diction difference, only. *ltem Nonconformme charactenstics shall be reviewed and recomrntaded dispositions EDirceommended d: 3sitions shall be in 97 replaces ' characteristics'in the 83 pronosed.
, of nonconformmg items shall be provose<'
edkn; *rvalua*rd'l~ ' replaces
'rrviewed'in the G.o versions also 'of I
nonconforming items'in the 83 edition is dritted. There is no impact to I..
53 intent. No change is recommendedfor the 97 edition.
Further processing. delivery. installation.
Requirements of NQA.!,1983.la are andnocroved or use of a nonconformmg item shall be covered in section 15,410, 2 of NQA.1, controlled pending the evaluation and an 1997 and requirements of NQA 1,1997 are raulvalent with more prescriptive armvoved disposition by authori:rd specificity. There is no impact to the 83 personnel. (13. 410. 2) intent. No change is recommendedfor the 97 edkn.
Activities afecting quality and services Requirements of NQA.1,1983.la are shall be prescribed by and performed kl covered in section 5,100, I of NQA.I, In accordance with documented 1997 and requirements are raulvalent.
procedures.
accordance with documentedinstructions.
Par;e 2 of 4
NQA 1 SIDE BY SIDE ANALYSIS OF REQUIREMENT EQUlVALENCY REQUIREhfENT 15 CONTROL Or NONCONFORhllNG ITE5tS I
NOA.I.1983 la l
NOA.I.1997 I
EQUIVAIINCY vrocedu'el, or draw uits... t3.100. II There a no impact to the 83 intent. No change is recommendedfor the 97 edkn.
Funher processing deliverv. Installation.
Funher procenine. dehserv. installation.
Reguartments gry,jasiratant with o or use of a nonconforming ttera shall be or use of a nonconformine item shall be mfAor diction change. There is no controlled oending an evaluation and an controiled pending the evaluation and an impact to the 83 intent. No change is approved disoosition by authonzesi amrosed disposition by authortred recommended /or the 97 ed&s.
Dersonnel ocrsonnel 4.3 Responsibihty and Authonty 420 Responsibility and Authonty We' ding does not constitute a i
I requirement.
The responsibility and authority for the The responsibihty and authonty for the Requirements are identical.
evaluation and disposition of evaluation and disposition of nonconformine items shdi b defined nonconfortrune step shall be defined pesponsibihty for the cotitrol of further Requirements of NQA.1,1997 are not processing, delis cry, installation. or use of equisalent with NQA 1,19831a.
nonconforming items shall be designated The 97 ed&n exceeds the 83 sn writing.
requirement byformelking in writing the responsibility assignment to overste NCR item controlforfurther processing.
There is no impact to the 83 intent. No change is recommendedfor the 97 ed W n.
4.3 ['in2DDgj 430 Personnel Wording does not constitute a requirement.
Personnel performinn evaluauons eg Personnel nerfortiuna evaluahons to Argedrements are eamitaient with a determine a dianogpon shall have determine a dimensition ahmtl have
=siner dicaden change. There h no demonstrated competence in the snecific demonstrated comnetence in the snecific impact to the 83 indent. No change is stem they are evaluatina. have an adeaniate area they are evaluatimand has e an recommended /or the 97 edillion, understanding of the reauirements. mad adeaunte undere-ime of the have access to certinent backaround reautrements, and have access to certinent information bacLaround information.
4.4 Final Discosinon 440 Disposinon Wordmg does not consutute a requirement.
The final disposition. auch as usbl&
A disposition. such as use.as-is. reiect.
Requi enscts ggf auivalent with reiect. renair. oi.. vork. of repair. or rework _{ nonce.iformine items editorial /dicoon ditferences mly, nonconformine items shall be identF su shall be made el documented.
There is no impact to the K3.ntent. No and documen'*d.
change is recommendedfor the 97 edhn.
4.5 Technical justilica'. ion Wording does not consutute a requirement.
Technical iustification for the Technic al iustification for the Requirements are identical.
acceptability of a nonconformine item.
acceptability of a nonconformina item.
dispositioned repair. or use as is shallk dispositioned reonir or use as is shall be documented.
documented.
Nonconformances to design requirements Requirements of NQA.I.1997 are not dispositioned use as is or repair shall be eauivalent with NQA.I.1983 la. This is subject to design control measures an upgrede and is signGIcent.
commensurate with those applied to the The 97 edition exceeds the #3 original design.
requirement by applying 4 sign control measures to NCR mffected items changed from their originaldesign. There is no impact to the 83 intent. No change is recommendedfor the 97 edkn.
Application of NCRs to design h new, in
DRAFT NQAol SIDE.BY SIDE ANALYSIS OF REQUIREMENT EQUlVALENC REQUIREMENT 15. CONTROL OF NONCONFORAIING ITEMS I
NO A.I.1983.la I
NOA.1,1997,
((3 EQUIV A1.ENCY
) the post e Correcthe Action from
~~
l
' Element I A wnuld here been usurd.
I I, Presumebly the NCR is imposed on the
' item opplying the design requirement end not the design requirement itself. If thh is true, the section could be ciertfied; (it is dyficult to hang en NCk sJg on e requirement.I The as built recotds,if such records are Required as.burh reords. shall refleci the Requirements of NQ41,1997 gtg required, shall reflect the accepted use as.ts or repair condition.
esuirelent with mort pr.scriptive specylcity. The 97 wording "the use.es.
deviation.
is or repeir condition" replaced the 83 wording "the eccepted deviation"t more emphasis is placed on the type of NCR disposition that nould generate en es*
built record.
There is no impact to the 83 intent. No change is recommendedfor the 97 edition.
Wording does not constitute a 4.6 Repaired or Reworked items requirement.
Wording does not constitute a 450 Re Exammation requirement.
Recaired or reworked items sha][hg Reentred ite'ms shall be reetamined in Requirements of NQA 1,1997 ggg.jpg(
reeramined in accordaec with acoj,igabjg accordance with neolieglie crocedures ggh with NQ41,198.l.1e.
orocedures and with the onubal and with the estrinal acceptance critens Ferience is e dewsgrade endis unlesn'the dienonti6n { i established signylcent The 97 wording deletes the
~
ggsentawe entens unless the use of she word "reworted." la the nonconlorming attm_disoosition has alternate acceptance a 1tena.
contest of this section rewor&ed items established alternate accentance enteria.
- else receive e re examination. In
, addshon the text of 97 vlointes the definition of repaired items repelred items wiu not use the original eccepsence criteria, ((k did the action would be e rework. Recommend revising this section to read asfollows:
' Repaired or reworked kem* sheH be er examined in accordance with oppucebit procedurest the orirl ' <l acceptance crkerie wiu be opplied against t: worked kems, and the ehernate eccepience erkreia, recorded in the NCR dispositior esplied eseinst repaired items.*
o,~,, A no a 1
NQA-1 SIDE-BY SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 16. CORRECTIVE ACTION I
l NOA 1,19831a l
NOA.1,1997 l
EQUIVALENCY l
16 CORRECTIVE ACTION REQUIREMENT 1b Wording does nci sonstitute a 9
CORRECTIVF ACTION requirement.
100 B ASIC Wording does not constnute a d
reqwrement.
I Conditions advrue to cuality shall be Condtuans adserse to cuality shall be Requiremenu are identical.
identified promotiv and cortected as soon identified promotiv and cerrected as soogi as oractical as oracticals jn the case of a sinnificant condition in the case of stanificant conditions Requires:nts are ident:131 adverse to cuality. the cause of the adverse to auality, the cause of the t
condition thall be determined and condition shall be determined and corrective action taken to orglgk cortective action aten to oreclude resurrence.
recurrence
- Ihe identification cause and correctiva The identification. cause. pnd corrective Requirements nLe identical.
getion for sinnificant conditions adverse to action for sinnificant conditions adverse to anality shall be documengd and reported anality shall be documented and reported to anoropriate levels of manneement:
to anoropriate levels of nunneement.
'i follow up a: tion shall be taken to verify Completion of corrective actions shall be Requirements of NQA l.1997 Ituid implementation of this corrective action.
verified. (/6 /00. 4) cauivalent id ': : p::- :i;-f r
- 2, See belowfor recommendation.
Completion of correcuve actians shall be Requirements of NQA 1,1997 glag verified.
equivalent it ': :,:: :.;.. n
'i;. See NQA l.1983 la 16,3.
m W variance is a downgrede andis
~
.er. s W 97 regesinnent does not sigg^:m e
l appear to be as robust as 83. When cornedre nedensfor signyieent problems are compione, what willbe veryled? Correction ofimmediate problems, investigated problems, cause remedietkn and assessreent of efectiveness are typices esemples.
Recommended wording: ' Completion of corrective actions shall be veryled I'.
ensure that appropriate corrective actions were taken and were enerrive.'
Page 1 of 1 cy
-s-+ - - -
w-w,n
.s 9
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--.v.-
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~-._ -_-___--
NQA 1 SIDE-BY SIDE ANALYSIS OF REQUIREMENT EQUIVA REQUIREMENT 17. QUALITY ASSURANCE RECORDS I
NO A 1,19113 la l
NO A,1,1997 l
1:OUIgl.ENCY
'I7 OUAllTY ASSURANCE RECORDS REQUIREMENT 17 OUALITY Wording does not constitute a requirement.
ASST'R ANCF RECORDS l
Wording does not constitute a ilo ll ASIC i
requirement.
i Quaht) assuratice records shall furnnh Requirements of NQA 1,1997 us Records that turnish documentary causvalent with more presenptive I dgcumentary endsmg thu stems or pecincity. No changr to NQA./ is guding.t activities meet speci6cd quality s
i recommended.
requittments.
Requiremtats of NQA 1,1997 ut of quahty shall be specified. prepared, and Quahry assurar.tr records shall br auivalent with more prescriptive ident(fied. generated, authenticated.
pecificity, No change to NQA.Iis c
maintamed unnantained, and theirfinal disposition s
treommended.
specified. (17.100. 2I Quahty assurance records shall be Requirements of NQA l.1997 relate to section 17,1; 17,2; 1751,2./, a of identined, generated, authenticated, NQA 1,1983 la and are cauivalent with maintained, and their final disposition less presenptive specificity. No change specified.
o NOA.I is recommended.
t Records shaII be IreibIr. (17, 210, il Requirements of NQA 1,1983 la are guahty assuranct records shallbe covered in section 17,100,2; 17,210. I Records shall be lectble, and 17,820, I of NQA,I,1997 and gs identifiable and idemified.... (17, /00. 21 tgdtgl. No change to NQA.Iis Records shall be retrievable (l7,820. ])
tetrievaMt.
recommended.
Records shall be protteredfrom damaze Requirements of NQA 1,1983 la are covered in section 17,810, I of NQA 1, Records shall be protected against damast. deterioration, or loss.
cden (17, #10. //
1997. Requirements of NQA 1,1997 Et couivalent with less presenptive specificity. No change to NQA*lis recommended.
Requirements ano responsibthties for BIgutrements and responsibihties for Requirements of NQA 1,1997 are not
'1ese activities shall be documented.
rquivalent with NQA ',1983 la.
record transmittal, distnbution, retention.
The variance is a downgrade in maintenance, and e isposit on shall be requirement and is significant. It is i
established and <'oeume'.dtd.
recommer 4rd that discussion on requiremenss and respons,bilisirs for the transmissal of records and distribution records be added to n "on 17,100,2 in NQA.1, !997 to maintain agstivalency.
(
Some of this requirement, NQA l.1983-Ia relates to sections 17,500;70v nd I
800_of NOA 1,1997.
Wording does not constitute a SUPPLEMENT 1751 -
requirement.
SUPPLEMENTARY REQUIREMENTS FOR QUALITY ASSURANCE RECORDS W ording does not constitute a l GENERAL requirement.
Wording dxs not constitute a This Supplement provides ampitfied requirement.
requirements for quality assurance records.
Wording does not constitute a It supplements the requirements of Basic requirement.
Requirement 17 of this Standard and shall be used in conj action with that Basic Requirement when and to the extent Pace 1 of 14
_~
NQAol SIDE BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 17 - QUALITY ASSURANCE RECORDS I
NOA 1,19'l3 la l
NO A.1,1997 I
EQUIVALENCY specined by the orgamsation mvokmg this Standard.
i The requirements of this Supplement Requitements of NQA 1,1997 are not apply to quahty assurance records which couivalent with NQA 1,1983 la.
have been completed The variance is a downgrade in requirement andis sigmficant. The 97 Edition does not address the usur that i
quality assurance records are skose i
records that have been completed. It h i
recommended that section 17,100, 4 in l
NQA.1,1997 he revised to include the word ' completed.
- j ne term records. used throumoyuhn ne term records..iwd throughout this Requirements are equn alenj witn i
Supplement. is to be interoreted as Ouality section. is to be interoreted as Ouality editorial / diction differences only. See i
Assurance Records.
Assurance Records:
change recommended to 17,100,4 above.
4
- 3. RECORDS ADMINISTRATION Wordmg does not constitute a requirement.
4 J
3.1 Rect rds System:
Woiding does not constitute a requirement.
A records system (s) shall be established The program shall be essablished at the Requiremenn of NQA 1,1997 are met by the organis.ation responsible at the earliest time consistent with the schedsle cauivals.nl with UQA 1,1983 la.
catliest practicable time consistent with for accomplishing the activities.
Requirements of NQA 1,1983 la are the schedule for accomplishing work (2, 110,5) covered in secanon 2,110,5 o/NOA 1,
~
activities and in compliance with the 1997. No chsafe to NOA 1,1997l' recommended.
general requirements of this Supplement.
De records system (s)'shall be denned, Activitics agertmg quahry and services Requirements of NQA 1,1983 la are implemented, and enforced in accordance shall be prescribrd by and performed ki covered in section 5,100, I of NQA 1, Eith written P.Edutti, Instructions, or accordance with documentedinstructions.
1997, Requirements of NQA 1,1997 mt other documentation.
rirocedures. or drawings that include or couivalent with less prescriptive reference appropriate quantitative or speciDcity, No change to NQA.1 is qualitative acceptance crin viafor recommended.
determining that pre " bed results have 1
been satisfactority attained.
l(5.100,1)
_ 2.2 Generation of Records 200 GENERATION OF RECORDS Wording does not constitute a requirement.
) ~,'he applicable design speciGcations, Guahry assurance records shallbe Requirements of NQA 1,1983 la are procurement documents, test procedures, identified, generated, authenticated, covered in section 17,100,2 and 17,100, operational procedures, or other maintained, and theirfinal disposition 3 of NQA 1,1997 and us e cauivalent.
documents shall speciiy the records to be specified. (l7,100,21 No change to NQA 1,1997is generated, supplied. or maintained by or Requirements and responsibilities for recommended.
these activities shall be documented.
for the Owner, (17,100.31 Documents that are designated to become 210 Records shall be legible.
Requirements of NQA 1,1983 'a are covered in section 17,210, I sul 17,220, mords shall be legible, accurate, and completed appropriate to the work Records shall be tractable to associated I of NQA 1,1997 and gsjauivalent in ggcomolished.
items and activities and accurately reflect intent. No change to NQA 1,1997is the work accomr>Iished or information recommended.
required. (17. 220. Il 220 Records shall be traceable to Requirements of NQA 1,1997 relate to associated items and activities and section 17S 1,2.2,2 of NQA 1.1983 la
_ = _ _ - _
NQA-1 SIDE-BY SIDE ANALYSIS OF REQUIREMENT E REQUIREMENT 17. QUALITY ASSURANCE RECORDS I
f:0UIVALENCY I
NQh.1,1983 la l
NOA 1,1997 I accurately tellect the work accompfahed~ l and are coutvalent N I997 is recommended.
or miormation required 300 ALTHENTICATION OF Wording does not constitute a 2.3 Record Validation requirement.
RECORDS Documents shall be conglered salid Requirements are idenocal Documents shall be conn, red s afid record. on:v if stamned. imtiated or i
tycords only if stamned. initialed. or steneo and dated bv authorized personnel i
sinned and dated by authorited personnel or otherwtse authenticated or otherwise authenucated "re.x : n :" NO.' ' """ = M This authenucauon may take the form of a
- p c.
- "
^ NQ.' ', "'" ! 1 statement by the responsible individual or Information in thh section of NQA 1, organitation-I983.la provides guidance and is not a requirem...t.
Requiremer,ts of NQA 1,1997 are not Handwntten signatures are not requred if couivalent with NQA 1,1983 la. The the document is clearly idenufied as a variance is a downgrade in reguirement statement by the reporting individual or andis significant. Information in this organitation.
NQA.1, I983.la section provides clarification on the use ofhandwritte signatures, which is not repeated in NQA.I,1997. It is recommended that this wording be retained to provide similar clar(fication in section 17,300, I of NOA.!, I997. -
' " :P,4^. ', ' ~"-erHM H +" id MQ^ ','?" !=
These records may be ongmals or reproduced copies.
Igormasson in this section of NQA 1, 1983.ha provides guidance and, not a requirement.
Wording does not constitute a 2.4 Indea requirement.
The designer shall be respons4ble for Requirements of NQA 1,1997 are not The records shall be indexed organi:ing and implementsng a sys~em oftauisniens with NQA.),19831a.
The var *~nce is a downgende in i
i receipt control of recort for permanent requireme Ithatis not sis:nificant. No ge.Ii7,300.4) change to NOA.t, I9_9,7 iz_ commendre.
s and tempor,. :
9 Requirements of NQA 1,1997 ars D.9.1 The indeung system (s) shall include, as a j Record retention periods shall be couivalert with NQA 1,1983 la.
documented (17, 710,1)
The variance is a d
.grale in minimum, record retention times and the Records shall be retrievable. (l7,820,1J requirement that is not significant. No location of the record within the record
_ change to NOA.!,1997 is recomm system.
Wording does not onstitute a 2.5 Dutnbuuon requirement; Requirements of NQA 1,1983 la are The records shall be distnbuted, handled, The designer shall be responsiblefor ccivned in section 17,500,4 of NQA 1 '
and controlled in accordance with wTitten organi:mg andimplementing a system of 1991. Requirements of NQA 1,1991 0; receipt control of recordsfor permanent not cauivnlent with NQA.1,19831a.
procebres.
and temporary storage. (17,500,4)
The variance is a downgrade in requirement that is sign (fIcant. It is recommended that i7,500,4 he expanded to include distributien and handling of records.
Wordmg does not consutute a 2.6 Idennlication Page 3 of 14
NQA-1 SIDE BY SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 17 - QUALITY ASSURANCE RECORDS I
NQ. 1,19tt3.la l
NQA.1,1997 I
EQUfVALENCY requiiement.
Recoru nd/orlndesing s) stem (s)shall Quality assuran r records sha$)ltnesh Requirements of NQA l.1983 la are provide sufGesent information to permit decumentart ri edence that stems or covered m section 17.100. I and 17. 220.
identincanon between the record and the actasters mcrt specified qualitt i of NQA l.1997 and are cauivaleg itemis) or aetmtyics to which it apphes.
requsrements. t / 7.100. li escept for reference to indeanng system.
Records shall be tractable to assocsated The sariance is a downgrade in I
stems and actmtsrs and accurately tr)7tct requirement that is not signyicant. No the work accomplished or information change to NQA.),1997 is recommended.
requsted. fI7. 220. II 2.7 Classification 400 CLASSIFICATION Wording does not constitute a requirement.
. Records shall be classified as Lifetime or Records shall be classified as Lifetime or Requirements are cauivalent with l Noncermanent by the Owner. or his arent Nonnern.anent by the Owrier. or his arent editorial / diction differences only, when authorired. in accordance with...e wben authorized. in ace:rdance with the Fa change to NOA.l.1997 is entena riven in 2.7.1 and 2.7.2 below.
sntena riven in 410 and 420 below, recommended.
2.7.1 Lifetime Records.
410 Lifetime Records.
Wording does not constitute a requirement.
Lifetime records are those that meet one 411 Lifetime records are those that meet Requirements are eautvalent with gLmore of the following entena.
one or more of the followine entena:
editorial / diction differences only. No change to NOA.I,1997 is recommended.
(A) those which would be of sienificant (a) those which would be of stanincant Requirements are identical.
Il ue in demonstratine capability for safe yalue in demonstratine capability for safe l
operation:
operation:
(b) those which would be of sienificant (b) those which would be of significant Requirements Muhn11 sal value in maintaining. rewolkmg, value in maintainine. reworkine.
g airine. reolacine. or modifv'ne an item:
reoninnt. replarmyg,gggdifyine an item:
tc) those which would be o/ sientMeant (c) those whrch would ;) of sienificant Requirements gudgiltigal.
value in determining the cause of gn value in determinine the cause of an accident or malfunction of an item accident or mnlfunction of nn item:
(d) those which erovide reautred baseline (d) those which provide reauired baschne Requirements are identical.
data for inservice insocctions data for in service inspections Lifetime records are reautred to be 412 Lifetime records are reautred to be Requirements are identical.
maintained b > or for the plant owner for maintained by or for the plant owner,[gt the life of the cartic Q ttrm while it is tbr life of the cartisglattttm
- hilt.11.H installed in the olant or stored $1ods installed ird Ir' et stored for future
- use, p
2.7.2 Nonnermanent Records.
420 Noncermanent Records Wording does not constitute a requirement.
Nonocrmanent records are those reautred Nonocrmanent records are those reauired Requirements are id( _.1 to show evidence that an activity was ta show evidence that an activity was performed in accordance with the performed in accordance with the aoolicable reouirements but need not be acclicable reauirements but need not be retained for the life of the item because retained for the life of the item because Ibey do not meet the enteria for lifetime thev do not meet the enteria for lifetime records records.
2.8 Retention of Records 500 RECE!!T CONTROL AND Wording does not constitute a RETENTION OF RECORDS requirement.
Records shall be retained in accordanet Records shall be retained i i accordgItst Requirements are identical. Requirement with the above classifications.
wi6 the above classifications, is supplemented by NQA l 1997 section Records shall be maintainedfor their 17,720.1.
retention prriods. 4I7. 720. II The retention oenod for nonnermanent The retention oenod for nonnermanent Requirements ut tdentical, records shall be established in writing.
records shall be established in writing.
NQA 1 SIDE lW-SIDE ANALYSJS OF REQt'ULD1EM EQUlVA REQUIREMENT 17 - QL AL.1lT ASR.Il W T.HD:ORDS
~[,[M.M657
_ a,,]
EQUlvA1.ENcy
~ ~ ~ ~ ~
i I
NOA 1,19831a
- t. Position 2 REGULATORY GUIDE I.28. REV 3
[
Section C. REGL'LATORY POSITION
%QA.I.1997 does not address an) of it:e j
prosides implementation guidelines for T reposed guidehnes from this Regulatory l nonpermanent record tetention See Positmn Attachment -l QU ALITY ASSURANCE h
I RECORDS.
4 i
Wordmg does not constitute a 1
2.9 Corrected information in Records requirement.
Requirements of NQA 1,1983.la are Records rnay be corrected in accordance The methodsfor record rhangrs shall be cos ered in part in section 17. 830. I of l
documented I/7,830. //
NQA l.1997 ':q=: : a / NQ? '
with procedures which provide for 4W ;ir m.de2 ^ NQA4, ypropriate review or approval by the 5
origmating organization.
4%A4e sformation is this section of NQA.1, t183.la provides guidance and j1 is not a requirement.
Requirements of NQA l.1997 are not The correction shallinclude the date and counalent with NQA 1,1983 la.
the identification of the person authonted The variance is a downgrade in to issue such cortection.
requirement that is significant. It is recommended these details for correcting i records be added to section 17,830 of NOA 1, !997.
i Wording does nct constitute a 3 RECE!VT requirement.
Wordmg does not constitute a 3.1 Responsibility requirement.
The mdividual or organization responsible Records shall be protected 6om damage Requirements of NQA 1.1997 am. net couivaknt with NQA 1,1983 la.
a or (oss. (17, BIO,1) for receivmg records shall provide Requirements of NQA 1,1983 la are protection from damage or loss during 'he covered in section 17,810, I of NQA 1, time that the records are in their 1997.
possession.
Wording does not constitute a 3.2 Receipt Contral requiremes.t.
Each orcanization resper _ible for the Requirements ut dentical Each orcanirttion tesponsible for the greipt of records shall desicnate a person
. receipt of records shall_desicnate a perton
' or orgar..uion responsible for receivine or v.cantration responsible for receivmc
> the records the records The desience shall be responsible for Requ:rements are idenpeal.
The desicnee shall be responsible for orcanirine and implementine a system of orcanirme and implementine a system of receint control of records far octmanent receipt control of records for permanent and tementary storace and temporary storage, Requireme us of NQA 1,1997 ge not As a minimum, a receipt control system tquinkD.I with NQA 1,1983 la.
shallinclude the followmg:
The variance is a downgrade in requirement that is sign (ficant, it is recommended that thefollowing be added to the end of section 17,500,.I of NQA.1,1997:... including methods for: designating the required records, identifying records received, and inspecting incoming records for legibili Dace 5 of 11
NQA 1 SIDE-BY SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 17. QUALITY ASSURANCE RECORDS I
I NQA.1,1983 la l
NOA.1,1997 l
EQUIVALENCY andfor agreement wah the transmutos'~
and errected required records. '
ic) a method for designating the required Requirements of NQA l.1997 are not records; eauivalent with NQA.1,1983 la.
See NQA.I, I983.la section !?S l. 3.2. 3 I
. abovefor recommendation.
(b,' a method for identifying records Requirements of NQA l.1997 gr.El recei.ed; eauivalent with NQA.l.1983.la.
See NQA.I,1983.In section 17S 1,3.2. 3 '
abovefor recommendation.
l (c) procedures for reccept and inspection R quirements of NQA l.1997 EI.nl l
ofincoming records, g., gy.Al.tal with NQA.I.1983 la.
Ea NQA.),19831a section i151,3.2. 3 abo efe scommende&ns.
i 3.3 Status Wording does not c.anstitute a requirement.
Each receipt control system shall be Requirements of NQA.I.1997 gr ml i
l structured to permit a current and accurate eaulvalent with NQA.I.1983 la.
assessment of the status of records during The cariance is a downgrade in the receiving process.
requirement thatis sign #lcant. No change is recommended because ekonges recommended above in NQA.I, I997 section i7, $00,4 willstructure a receipt control system that proeides current status of records brins received.
4 STORAGE. PRESERVATION AND Wording does not constitute a SAFEKEEPING requirement.
4.1 Storage 600 STORAGE Wording does not constitute a requirement.
De records shall be stored in Requirements of NQA.I.1997 ut. net piedetec runed location (s) that meet the cauivalent with NQA.I.1983 la. This requirements of applicable standards, requirement is met in NOA.),1997 codes, and regulatory agencies.
section 17, 610, I where records are to be stored in facilities, etc., meeting this Standard. No cbsnge to NQA.I,1997 is recommended.
~"
Prior to storage of records, a written" Qualary assurance records shallbe Requirements < f NQ A.1983.la are storage procedure shall be prepared and identyled, generated, authenticated, covered in section 17.100.2 and 17.100, responsibility assigned for enforcing the mas,. rained, and theirfinal dispositior' 3 of NQA l.1997. Requirements of requirements of that procedure.
specified. (17.100, 2)
NQA.I.1997 ut net _eauivalent with Requirements and responssbilities for NQA.!,19831a. No change to NQA.!,
these nctivities shall be documented.
1997 is recommended.
II7.100.3) his procedure shall include, as a Requirements of NQA l.1997 are not minimum,(a) through (g) saiyj 2nlwith NQA l 19831a.
below:
The' ante is a downgrede in regunement andis significent, Minimum elementsfor a storage control procedure are not included in NQA I,
!997. It is recommended that the following be added to the end of NQA.I, 1997 sectionli,610, I, c: 'A storege controlprocess defining the enforcement responsibilities as a minimum shall
NQA 1 SIDE BY-SIDE ANALYSIS OF REQUIREMENT EQUlVALENCY REQUIREMENT 17. QUALITY ASSURANCE RECORDS I
NOA.I.1983.la i
NOA.1,1997 I
LOUlvAI.ENCY snelude: a description of the storage facility, thefiling system to be used, the ules governing access to and controlof r
thefiles, a process for maintaining ontrol of and accounsabilityfor records c
emotedfrom the storagefacility, and a r
processforfiling corrected or upplementalinformasion and disposing I
s f superseded reconts.
o Requirements of NQA l.1997 gug.1 Ia) e dentiption of the storage faciht);
ouivafent with NQA.I.19831a. The c
ariance is adowngrade in requirement v
ndis significant. Recommendthis a
equirems,,t be added to NQA.1, I997.
r See 83 1751,.),3 abase.
Requirements of NQA l.1997 gugJ (b) the fihng system to be used; ouivalent with NQA 1,1983 la. The c
variance is a downgrade in requirement andis sign (ficant. Recommend.his requirement be added to NQA.1,1997.
Set 83 17S 1,4.1,3 above.
Requirements of NQA J.1997 are not (c) a method for verifying that the reconds couivalent with NQA l 1983 la received are in agreement with the The variance is a downgrade in transmittal documei.t and that the records requirement sad is sign (ficant.
are legible; Recommend this requirement be added to NQA.I, I997. See 83. I7S.1,3.2,3
\\
above.
Requirements of NQA l.1997 are not (d) a method of vertfying that the records eauivalent with NQA 1.1983 la.
are those designated (see 3.2 abovel; The variance is a downgrade in requirement and is sign (ficant.
Recommend this requirement be added to NQA
- I997. See 83. I151,3.2,3 above.
Requirements of NOA l. I 17 MupJ (e) the tules governing access 'o and couivalent with NQA l.1983 la.
control of the files; The variance is a downgrade in requirement a.sd is significant.
Recommend this requirement be added to NQA.I, I997. Set 83 I151,4.1,3 above.
Requirements of NQA l 1997 are not (f) a method for mamtaming control of gainisal with NQA 1, l',83 la, and secountability for records removed The variance is a downgrade in from the storage facility; requirement and is sign (ficant.
k'ecommend this requirement be added to NQA.I,1997. See 83 1751,4.1. 3 above.
Requirements of NQA 1.1997 are not (g) a method for filing supplemental couivalent with NQA 1,1983 la.
information (see 2.9 above) and disposing The variance is a downgrade in of superseded records, requirement and is :ltnificant.
I Page 7 of 14
NQA 1 SIDE BY SIDE ANALYSIS OF REQUIREMENT EQUlVALENCY REQUIREMENT 17 - QUALITY ASSURANCE RECORDS I
NQA.1,1983la
{
NQA.1,1997 EQUlVALENCY Recommend this requirement be added to NQA.I, !997. Set 83. I1S.1,4.1,3 above.
l 2 Presersation l
Wording does not constitute a f
requirement.
Records shall be stored m a manner Each organs: arson respons bit for the Requirements of SQA 1,1983.la are approved by the organisatson or recespt of records shall dessgnate a person covered in section I7. $00. 3 and 17,610, ;
organizations responsible for storage.
or organi:ation respemssble for rectning 4 of NQA 1,1997 and att. net cautsaknt the records (l7. $00,3)
No change to NQA.), I997 is recommended.
In order to preclude deterioration of the Records shall be stortd an facetatics.
Requirements of NQA 1,1983 la are records the requirements of(a) through (c) containers. or a combinarmn thereof.
ccvered in section 17,610,1 of NQA 1.
below shall apply, constructed and maintained in a manner 1997 and are couivalent.
which minimi:e the risk vidamage or No change to NQA.I,1997 ss destructionfrom thefollowing:
recommended.
(17. 610. II (a) Provisions shall be made in the storage Ib) environmental condstrons such as high Requirements of NQA 1,1983 la are arrangement to prevent damags from and low temperatures and hunildsty; covered in section 17,610,1, b of NQA-moisture, temperature, and pressun..
(17, 610, I, b)
I,1997.
Requirements of NQA 1,1997 Et.Act cauivalent with NQA.I.1983 la. The variance is a downgrade in requirement and k not signylcant. No change to NOA.I,1997 is recommended.
(b) Records shall be firmly attached in Requirements of NQA 1,1997 er.t.nc1 binders or placed in foHers or envelopes cauivalent with NQA 1,1983 la.
,0r storage in steel file cabinets et on The variance is a downgrede in shelving in containers.
requirementandit signylcant. Itis recommended that this requirement be added to the sect on on record storage in i
NOA.!, !997 section 17,6l0, I.
(c)j'rovtsions shall be made for snectgj Prottssons shall be made for specially Requirements of NQA,1983 la are pyy essed records (such as radiographs.
processed records tsuch as radiorraphs.
covered in section 17,*.40, I of NQA 1, chotorraohs. negatives. microfonn. and photorraphs. neratives. micro p,fs 1997 and are couivalent. No change to r
. n1..l. Correct mnenetic media) ta t. tynt armsgt 'm.u) marnetic and entical media ) to vervent NQA.1,1997 is recom e tcessive 1inht. stacking. electtumanetic damane from s ~ rs.,,,e I.gH. statking.
typo ' microform
- skuuld I t ' microfilm.
- fields. temocrature. and humidnty-tju tromannetic fields. temperature and humidsrv (17. 840. I1 4.3 Safekeeping Wording does not concaute a requirement.
Measures shall be established to preclude Reqmrements of NQA 1,1997 ut.n I the entry of unauthorized personnelinto couivalent with NQA 1,1983 la, the storage area.
The variance is a downgesde in requirement and is signylcant. It is recommended that this requirement be added to the section on record maintenance in NQA.I,1997 section 17, 8I0, i by adding *unauthorhed access
- ngfter 'prosectedfrom *.
These measures shall guard against Records shall be protected from, damage Requirements of NQA 1,1997 ut_not larceny and vandalism.
or loss. (17,8I0, I) tguivalent wi h NQA 1,1983 la. No change to NOA.1,1997 is recommended.
Measures shall be taken to provide for Requirements of NQA 1,1997 EtAo1 replacement, restoration. or substitution of couivalent with NQA 1,1983 la.
-. ~..
NQA-1 SIDE BY-SIDE ANALYSIS OF REQUIREMENT EQUIVA REQUIREMENT 17. QUALITY ASSURANCE RECORDS
[
NO A.1,198.bla l
NO A.1,1997 l
EQUIVA1.ENCY J
? e variane is a downgrade in l
lost or damaged records,
- irement and is sign (ficant. It is
\\
t recommended that this requirement be i
added to the section on record
}
maintenance in NQA.1, I997 after section 17,810, l.
t Wordmg does not constitute a 4.4 Facility requirement.
MO Records shall be stored in facihties.
Requirements of NQA.I.1997 section 17 B.tmt s shall be stored in facilitieg containers, or a combination thereof, 610, I are cauivalent with more d
t which minimires the risk of damare or constructed and maintain a in a manner prescriptive specificity, No chan;r constructed and maintained in a mg.nptI m
which minimire the risk of damare or NQA.] is recommended.
s d_estruction from the following:
destruction from the following:
(a) natural disasters such as winds. Goods.
(a) natural disasters such as wmds. Goods. Requirements are identical.
or fires; Cf htf1 (b) environmental conditions such as hech
@) environmental conditions such as high Requirements are identical.
4 and low t.cmperatures arid humidity; and low temperatures and humidity:
(c) mfestation of insects. mold. or rodents =
(c) infestation of insects. mold. or rodents, Requirements are identical.
&g:- -:: ef NO.^ '. "M7 = M There are two satisfactory methods of
- p d"
" MQ^ ','9B? b.-
j providing storage facilities, single or dual.
This section is not a requirement but presents storagefacility options. No chante to NQA 1,1997 is recommended.
Wording does not constitute a 4.4.1 Single Faciiity.
requirement.
Sections 4.4.1 and 4.4.2 relate to a single facility storage area, the details for designing, constructing and various other alternatives available are not presented in NQA.1, !997, Section 17, 620,1 of NQA.1,1997 does provide the optionfor single sts.gefacilities, f
1 however, no der.'is are provided. It is recommended that an industry standard 1
defining the specific requiremes s for single storage area facilities be r rovided in section 17,620,1 of NOA.i,1997.
Requirements of NQA 1,1997 are not Design and construction of a single record couivalent with NQA 1,1983 la.
storage facility shall meet the criteria of See Section 4.d.1 of NQA.1,1983.la.
(a) through (1) below: (I a 83)
Requirtments of NQA 1,1997 are not (a) - reinforced concrete, concrete block, equivalent with NQA-1,1983 la. See masonry, or equal construction; Section 4.4.1 of NOA.I, I983 la.
Requirements of NQA 1,1997 are not (b) Door and roof with drainage control.
cauivalent with NQA-1,1983 la.
See Section 4.4.1 of NOA.1, I983 la._
Requirements of NQA 1,1997 are not If a Goor drain is provided, a check valve couivalent with NQA l.1983 la.
(or equal) shall be included.
Page 9 of 14 a
NQA-1 SIDE BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 17. QUALITY ASSURANCE RTCORDS l
N OA 1,1983 la l
N OA 1,1997
~ ],~ I EQUIVALENCY See Section 4.4.1 ofNQA.!,1983.Ia.
(c) doors. structure and frames, and Requirements of NQA l.1997 are not l
hardware shall be designed to comply counalent with NQA 1,198311 l
with the requirements of a minimum 2 hr See Sectian 4.4.1 ofNQA l.1983 la.
l fire rating; (d) scalant applied over walls as a Requirements of NQA 1,1997 gtng.1 moisture or condensation barrier; eauivalent with NQA 1,1983 la.
j See Section 4.4.1 ofNOA 1,1983 la.
(c) surface scalant on Door providmg a Requirements of NQA 1,1997 MLn21 hard wear surface to minimize concrete cauivalent with NQA 1,1983 la.
dusting:
See Section 4.4.1 ofNOA.I, !983 la.
(f) foundation scalant and provisions for Requiremei,ts of NQA 1,1997 giant drainage; cauivaler.ith NQA 1 '98t' '
See Section 4.4.1 of NOA 1,1983 la.
(g) forced air circulation with filter Requirements of NQA 1,1997 are not system; g.auivalent with NQA 1,1983 la.
See Section 4.4.1 of NOA 1,1983 la.
(h) fire protection system; Requirements of NQA 1,1997 are not cauivalent with NQA 1,1983 la.
See Section 4.4.1 ofNOA 1, !983 la.
(iWly those penetrations used Requirements of NQA 1,1997 gr.A21 usim:ly for fire protection, couivalent with NQA 1,1983 la.
! cn'.nu, cation, lighting.or See Section 4.4.1 of NQA 1,1983 la.
tm,venure/ humidity control are allowed; ah en penetrations shall be scaled or dampered to comply w.'.t the minimum 2 hr fire protection rating. (la-83)
The construction details shall be reviewed Requirements of NQA-1,1991 are not for adequacy of protection of contents by rauivalent with NQA 1,1983-la.
a person who is competent in the technical See Section 4.4.1 of NQA 1,1983 la, field of fire protection and fire extinguishing.
If the facility is loc"ad mthin a building Requirements of NQA 1,1997 are not or structure, the :nvironment and couivalent with NQA-1,1983 la, See Section 4.4.1.f NQA ',1983 la.
construction of that building can prm a
portion or all of these criteria 4.4.2 Alternate Single Facilit.es.
Wording does not constitute a requirement.
The followmg are accep*.able alternatives Requirements of NQA 1,1997 are not to the criteria of 4.4.1 above for a single eouivalent with NQA-1,1983-la.
facility:
See Section 4.4.1 of NOA 1,1983 la.
(a) 2 hr fire rated vault meetmg NFPA Requirements of NQA 1,1997 ar: not 232 1975';
couivalent with NQA 1,1983 la.
See Section 4.4.1 of NOA I, !983.Ia.
(b) 2 hr fire rated Class B file containers Requirements of NQA-1,1997 are not meeting the requirements of NFPA 232-couivalent with NQA 1,19831a.
I975' tor See Section 4.4.1 of NOA I, !983-Ia.
(c) 2 hr fire rated file room meeting the Requirements of NQA 1,1997 are not requirements of NFPA 232197S I with couivalent with NQA 1,1983 la.
the following additional provisions:
See Section 4.4.1 of NOA 1,1983 la.
(1) early warning fire detection and Requirements of NQA 1 1997 are not tutomatic fire suppression capability with cauivalent with NQA 1,1983-la.
electronic supervision at a constantly See Section 4.4.1 ofNOA 1,1983 la.
NQA-1 SIDE-BY-SIDE AN ALYSIS OF REQUIREMENT EQUlv ALENCY l
l REQUIREMENT 17 - QUALITY ASSURANCE RECORDS I
NOA 1,1983 la j
NOA.1,1997
{
EQUIVALENCY l
attended central station; I
Requirements of NQA 1,1997 are not (2) records storage in fu'ly enclosed metal '
ounalent with NQA t.1983 la.
c cabinets; See Section 4.4.1 of NOA.I, I983 la.
Requirements of NQA 1,1997 are not (3) adequate access and ante ways; auivalent with NQA 1,1983 la.
c See Section 4 4.1 of NOA.1,1983 la.
Requirements of NQA 1,1997 ars p.cl (4) prohibition in the room of work not auivalent with NQA 1,1983 la.
c directly associated with record storage or See Section 4.4.1 ofNOA 1,1983 la.
retrieval:
Requirements of NQA 1,1997 are not (5) prohibition in the room of smoking, equivalent with NQA 1,1983 la.
eating, or drinking; See Section 4.4.1 of NOA 1,1983 la.
Requirements of NQA 1,1997 are nt' (6) 2 hr fire rated dam ers Joors in all a
cauivalent with SQA 1,1983 la.
boundary penetrations.
See Section 4.4.1 of NOA 1, !983 la.
[NFPA 2321975 is contained in Volume Wording does not constitute a 9 of the National Fire Codes published by requirement. Reference to NFPA is not the National Fire Protection Association, repeated in NQA 1,1997.
See Section 4.4.1 ofNGA 1,1983 la.
470 Atlantic Avenue, Boston, MA 0221 0.)
Wording does not constitute a 4 4.3 Dual Facihties, requirement.
Requirements of NQA 1,1997 are not If storage at dual facilities for each record cauivalent with NQA 1,1983 la.
is provided, the facilities shall be at The variance is a downgrade in locations sufficiently remote from each requirement and is significant. It is other to eliminatt the chance of exposure recommended that this requirement be to a simultaneous hazard.
added to the end of the section on dual facilities in NQA.!, I997 after section 17, 620, l.
Each facility is not required to satisfy the 620 Dual facilities, contamers, or Requirements of NQA 1,1983 la are requirements of either 4.4.1 or 4.4.2 combination thereof shall be provided for covered in section 17,620, I of NQA 1,
, above, but shall meet the othst records storage if a single facility, 1997 and are not cauivalent. The requirements of this Standard container, or combination thereof is not vadanc. is a downgrade in requirement spable of prov *;ng adequate protection.
that is not insigmficant braisse in NOA-1,1997 the equivalent 83..'tions 4.4.1 and 4.4.2 have been deleted. NQA.1, I997 section 17,620, I provides option for single storagefacilities. See NQA l, 1983 la, section 4.4.1for commentary.
No change to NQA 1,1997 is recommended.
Wording does not constitute a 5 RETRIEVAL requirement.
Requirements of NQA 1,1997 are not Storage systems shall provide for retrieval cauivalent with NQA 1,1983 la.
of information in accordance with planned The variance is a downgrade in retrieval times based upon the record type.
requirement and is significant. NQA l.
1997 does address estrieval of records (17,820, !); the detail of retrieving information (records) within establishe planned times in the storagefacility is not address. It is recommended that l' Paae 11 of 14
-m._
NQA-1 SIDE BY SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 17 - QUALITY ASSURANCE RECORDS I
NOA.1,1983.le I
NQ 4 1.1997 i
EQUIVALENCY 1
820, I be modified to read ' Records shall i
be retrievable in a timely manner. ', _
l A list shall be maintamed designating i
i Requirements of NQA.I.1997 arg_cci those personnel who shall have access to
' eauivalent with NQA l 1983.la.
1 the files.
The variance is a downgrade in requirement andis signsficant. NQA.I.
I997 does not address the requirement
?
for listing those personnel having access to quality records. Itis recommended that this requirement detailfor developing an access list be added to section 17, g10, I of NOA.),1997.
Records maintained by a Suppher at his The procurement documents shall Requirements of NQA 1,1997 ars. net facility or other location shall be providefor access to the Supplier's and couivalent with NQ..1,19831a.
accessible to the Purchaser or his sub tier supplier'sfacilities and records Requirements of NQA.I.1983.la are designated alternate. e.g., the Os ner.
for surveillance, inspr' tion or audit by covered in paragraph 4. 240, i of NQA 1, the Purchaser, its designated 1997. No change to NQA.1, J997 is representative, and others authori:ed by recommended.
the purchaser. (4,240, !)
i 6 C*SPOSITION 700 DISPOSITION Wording does not constitute a requirement.
4 710 Record retenuon penods shall be Requirements of NQA.1,1997 relate to i
documented.
section 17S-l 2 4,2 of NQA l 1983 la and are cauivalent. No change to NQA.1, i
1997 is recommended.
l 720 Records shalj be mtntained for their Requirements of NQA 1,1997 relate to l
retention periods.
section 17S 1,2.8, I of NQA 1,1983-la and are couivalent. No change to NOA 1, 1997 is recommended.
" Records accumulated at vanous locations, The procurement documents shall Requiremems of NQA-l.1997 grs_not prior to transfer, shall be made accessible providefor access to the Supplier's and couivalent with NQA 1,1983 la.
to the Owner ditectiy or through the sub-tier supplier'sfacilities and records Requierments of NQA.), !983.la are procuring organit.ation.
for surveillance, inspection or audit by covered in pa.-agraph 4,240, I of NQA 1, the Purchaser, its designated 1997. No change to NnA.! l997is representativ<
nd :he s authorhed by recommended.
th. Purchaser. (4,240, I>
J Requirements of NQA 1,1997 are not The custodian shall inventory the i
submittals, acknowledge receipt, and couivalent witr.N(e 1.1983 la.
The variance is e downgrade in process these records in accordance with requirement andis significant. NQA.!,
this Standard.
1997 does not address the requirement for acknowledging receipt of quality records. It is recommended that this l
requirement detailfor acknowledging receipt be added to section 17,500,4 of NOA 1,1997.
Sr.x x x" ^' NO A ', "" c: "
Various regulatory agencies have
- _c 6 :' " NQ? '. "'" 3 !:.
requirements concerning records that are This section is not a requirement,it within the scope of this Standard.
presents informatson concerning other regulatory agencies. No change to NQA.
I,1997 is recommended.
Requirements of NOA-1,1997 are not The most stringent requirements shall be
.~.a..
.m
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 17. QUALITY ASSURANCE RECORDS l
NOA.I,19113 la l
NOA.I,1997 I
EQUIVALENCY used in determining the Onal disposition.
cautvalent with NQA 1,1983 la.
The variance is a downgrade in requirement andis not significant. Final disposition of records is accomplished under section 700 ofNQA.I,1997 shere retention periods are defined and under i
section 600 where storage requirements
~
are defined. No change to NQA.1, I997 is recommended.
The Suppher's nonpermanent records Requirements of NQA 1,1997 art.nni eauivalent with NQA 1,1983 la.
shall not be disposed of until the The variance is a downgrade in applicable conditions listed in (a) through l
(c) below are satisfied:
requirement andis significant. NQA.I.
1997 does not address the requirement for listing nonpermanent records. These records are considered to be in addition to contractually required documentation.
a Ifprocessing ofsuch nonpermanent records is necessary, then consideration should be madeforplacing this requirement or equivalent in seciton4, Procurement Document Control. Itis recommended that this requirementfor handling nonpermanent Supplier records be added to a new section 17,850 of
, QA.!,1997, Maintenance by Supplier 2
of Nongermanent Records.
Requirements of NQA-1,1997 att.ngi (a) items are released for shipment, a cauivalent with NQA 1,1983-1a.
i Code Data Report is signed, or a See NOA.1,1983.lat 17S./,6,5 above.
Code Symbol Stamp is affixed:
(b) regulatory requirements are satisfied; Requirements of NQA 1,1997 are not couivalent with NQA 1,1983-la.
i See NOA.1,1983<la: 17S 1,6,5 above.
^
Requircinents of NQA 1,1997 mu191 (c) operational status pernuts; couivalent with NQA 1,1983 la.
See NQA 1,1983 la: 1751,6. 5 above.
Requirements of N(,-1,1997 are not (d) warranty consideration is satisfied; cauivalent with,' QA 1,1983 la.
See NOA.], !9831a; I7S 1,6. 5 above.
te) Purchaser's requirements are satisfied.
Requirements of NQA 1,1997 a : not cauivalent with NQA 1,1983-la, See NOA l,19831a; I7S.],6,5 above.
800 MAINTENANCE OF RECORDS Wording does not constitute a requirement.
810 Records shall be protected from Requirements of NQA 1,1997 relate to section 17,3 of NQA 1,1983 la and att damage or loss.
ggvivalent Changes to this section have been recommendedfrom other sections of this standard See 1751,4.3, I and 17S 1, 4.33.
820 Records shal: be retrievable Requirements of NQA 1,1997 relate to section 17,2 and 17S 1,2.4,2 of NQA-l 1983-la and are eauivalent.
Page 13 of 14
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 17 - QUALITY ASSURANCE RECORDS i
l NOA 1.1983 la l
NQA 1,1997 I
EQUIVALENCY Changes to this section have been recommendedfrom other sections of this standard. See 17S 1, S.1.
830 The methods for record changes shall Requirements of NQA 1,1997 relate to l
be documented.
section 17S 1,2.9, I of NQA 1,1983 la and are cauivalent Changes to this section have been recommendedfrom other sections of this standard See 175 1,2.9,2.
840 Prc isions shall be made for Requirements of NQA 1,1997 relate to speciaisy processed records (such as section 17S-1,4.2. 2, e of NQA 1,1983-radiographs, photographs, negatives, la and are cauivalent.
i microform, magnetic and optical media)
No changes to NQA 1,1997 are to prevent damage from axcessive light, recomme...d.
stacking. electromagnetic fields, Typo ' microform
- should be ' microfilm. '
temperature and humidity.
l 4
5
.-=. -_.
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 18 - AUDITS l
NO A-1,198Ala l
NOA 1,1997 l
EQUIVALENCY 18 AUDITS REQUIREMENT 18 AUDITS Wording does not constitute a I
requstement.
100 BASIC Wording does not constitute a regiurement.
Planned and scheduled audits shall be Audits shall be performed to senfy that Requirements of NQA 1.1997 are w quivalent with NQA l.198hla.
performed to venfy cornpliance with all performance entena are met and te e
deterrrune the effectneness of the Wording of 97 edition provides a more aspects of the quality assurance proFram eneric approach; rather than Tianned g
and to determing nts t((cctiveness.
program.
r scheduled audits'in the 83; 97 o
wording is ' Audits' which may ncompass more thanjust the planned e
r scheduled add.*ts. In addition the 83 o
wording nyliance with allaspects of he quality ossuranee program
- is more t
estrictive that the more general 'that r
performance criteria are met
- in the 97 edition. Theproposed 97 wording would appear to be moreflexible and general in nature. No change to NQA 1,1997is :
recommended.
These audits shall be performed in These at,dits shall be nerfmmd in Requirements are identical.
accordance with wntten procedures or accordance with written procedures or checidists by personnel who do not have checidists by personnel who do not have direct responsibility for performine trig direct resoonsibility for performine the activities beine audited activities beine audited Audit results shall he documented and Audit results shall be documented and Requirements are identical.
reported to and rc~iewed by r,g}p2H}iD}g reported to an(4 icvityd by responsible manacement.
Follow-up action shall be taken where Follow-up action shall be taken where Requirements are identical.
management.
indicated indicated Wording does not constitute a SUPPLEMENT 18S-1 requirement.
SUPPLEMENTARY REQUIREMENTS FOR AUDITS Wording ds not constitute a I GENERAL requirement Wording does not constituw This Supplement provides amplifica requirement.
requirements for quahty assurance audits.
Wordmg does not constitute a It supplements the audit requirements of requirement.
Basic Requirement 18 of this Standard and shall be used in conjunction with that Basic Requirement when and to the extent specified by the organization invoking this Standard.
Wording does not constitute a 200 SCHEDULIN_Q 2 SCHEDULING NQA 1,1997 does not address any of th REGULATORY GUIDE 1.28, REV. 3 proposed options for this Regulatory Section C. REGULATORY POSITION Position. Additional options for audit provides guidelines for implementation scheduling and implementation are of scheduling audits. See Attachment 3 presented.
AUDITS.
Pace 1 of 7
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 18. AUDITS l
NOA.I.1983la l
NOA 1,199'i l
EQUIVA1.ENCY l
Internal or external quahty assurance Audits shall be scheduled in a manner to Requirements of NQA.1,1997 gg not audits, or both, shall be scheduled in a provide coverace and coordination with cauivalent with NQA l.1983 la.
manner to provide coverare and oncoine actmties, based on the status and The more generic wording used in the 97 coordination with oncoing quahty importance of the activity.
edition 'audiss'is equivalent to the 83 wo* ding ' Internal or external quality assurance program actmttes assurance audits, or both '; the same applies to 97 wording ' ongoing activities' as opposed to the 83 wording
' ongoing quality assurance program I
activities'. No change to NQA.1, I997 is i
recommended.
l Audits shall be scheduled at a frequency Audits shall be scheduled in a manner to Requirements of NQA ' 1983 la are commensurate with the status and provide coverage and coordination with covered in section IP 100, I of NQA 1, importance of the activity, ongoing activities based un the status and 1997. Requirements of NQA-1,1997 gg importance of the activetv. I18. 200, I) cauivalent =i& '= p:::i %
7
- prif:::n.
97 wording is such that the 83 intent is i
captured, the 83 wording 'at afrequency commensurate with* accomplishes the same action as the 97 wording 'in a manner to provide coverage and coordination with ongoing activities *. No change to NQA 1,1997is recommended.
He audit schedule shall be reviewed Audits shall be scheduled in a manner to Requirements of NQA 1,1997 are not a riodically and revised as necessary to provide c8veran hnd coordination with cauivalent with NQA 1,1983 la.
assure that coverage is maintained ongoing activities. based i the status and However, a portion of requirements of current.
importance of the activity. (18. 200.1)
NQA 1,1983 la are covered in section 18,200, I of NQA l.1997.
The variance is a downgrade andis significant. It is not clear {f the 83 i
edition should be interpreted to mean that a physicaldocument, an audit schedule,is to be generated. The quality i
record section (8) doe i n Uentify an
' Scheduled au., o sh 'lbe reviewed audit schedule as a record generated by pcri dically and revised as necessary to assure that coverage and coordination this set ofrequirements. The 97 does not
'*h oregoing activities, based on the address reviewing or revising the audits status and importance of the activity, is to be conducted. Reev..... send revising the 97 edstion to establish equivalency.
maintained.'
See wording at left.
- Regularly scheduled audits shall be Scheduled audits shall be sucolemented by Requirements of NQA 1,1997 gg suoclemented by additional audits of additional audits of soecific subiects when equivalent with less prescriptive soecific subiects when necessary to necessary to orovide adeouate covernae.
specificity.
Deletion of the 83 edition word provide adeouate coverag
' Regularly' does not impact the requirement. No change to NQA 1,
!997 is recommended.
3 PREPARATION 300 PREPARATION Wording does not constitute a requirement.
3.1 Audit Plan 310 Audit Plan Wording does not constitute a requirement.
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 18. AUDITS I
NOA 1,1983 la l
NOA 1,1997 l
EQUIVALENCY The auditine orcsnization shall develpr The audittne creanization shall develop an Requirements of NQA 1,1997 gg b
anu document an audit olan for each audit plan for each audit, couivalent with less presenptise pecificity.
s ggd1L The 97 edkn deletwn of the 83 wording 'and document'is acceptable based on thefact that the audit plan is defined as a quality record in section 18, 800. I of the 97 edition. No change to NOA.1,1997 is recommended.
This clan shall identify the audit secoe.
This clan shall identify the audit scope.
Requirements are identical.
reouirements. audit oersonnel. activities reouirements. audit personnel. activities to to be audited. otranizations to be be audited. oreanizations to be notifici rmtified. acclicable documents. schedule.
apolicable documents. schedule. and and written omeedures or checklists, written procedures or checklists.
3.2 Personnel 320 Personnel Wording does not constitute a requirement.
These audits shall be performedin Requirements of NQA 1,1991 are not accordance with written procedures or equivalent with NQA l,19831a.
The vanance is a downgrade andis checklists significant. Deleting the 83 wording The auditing organization shall select by personnel who do not have di.rt.cl
- The auditing organi:ation
- is accepted and assign auditors who are independent responsibility for performing the activities because in 97 18,330,3 it is the Lead of any direct responsibility for being audited. (18.100,3)
Auditor who is designated to organize the au/it team, (f a team is required.
performance of the activities which they The 97 wording ' direct responsibility for will audit.
performing the activities
- when compared to the 83 wording
- direct respc.sibilityforperformance of the activities
- creates an interpretation gay, The 83 may be more broadly applied to all management and stafflevels involved with the activity, while the 97 seems more restrictive to the staff actually performing the activity. It is recommenard that the 97 wording be changed asfollows: y personnel who are independent ~lany direct responsibilityfor performance of the activities being audited.' It is understood that the 83 also uses the 97 wording in 18 BR 2, this wording change is seen as improving both the 97 and the 83.
In the case of internal audits, These audits shall be performedin Requirements of NQA l.1997 are not accordance with wrinen procedures or cauivalent with NQA-1,1983-1a.
The variance is a downgrade and is not checklists significant. The 83. edition wording 'In the case of internal audits
- is deleted in the 97. The 97 version is generic to both internaland external audits and no change is recommended.
personnel having direct responsibility for by personnel who do nht have direct The audit team is selected by the Team Pano 't nf 7
. ~ _ _. -
1 l
NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 18. AUDITS l
NQA.1,1983la l
NQA.1,1997 l
EQUIVALENCY l
j perforrmng the actsvntses besng audited responstbslityfor performung the actsverses Leader (18,330,2) who has thejob of shall not be nnvohed in the selectson of being audsted. f18.100..h ensuring that the auditors do not have the audst team.
'by personnel who are independent of any responsibilities in the activities being direct responsibility for performance of audited. If Lead Auditorindependence the activities being audited '
is maintained then selected auditor's independence should also be maintained. No change to NQA.1, !997 is recommended.
3 Audit personnel shall have sufficient Audit eersonnel shall have sufficient Requirements are identicaj.
authority and otranizational freedom to authority and organizational freedom to make the audit process meaningful and make the audit process meanincful and effective.
effective.
3.3 Selection of Audit 'leam 310 Selection of Audit Team Wordmg d~s not constitute a requirement.
An audit team shall be identified prior to An audit team shall be identified orior to Requirements are identical.
the beninning of each audit.
the beginning of each audit.
his team shall contain one or more This team shall contain one or more Requirements of NQA l.1997 ats not auditors and shall have an individual auditors, one being designated Lead cauivalent with NQA 1,1983 la.
appointed to lead the team who organiret Auditor who organizes and directs the and directs the audit, gudiL Requirements ofNQA.1,1983 Ja are i
covered in section 18,500, I and IR, l
coordinates the preparation and issuance The audit repon shallbe signed or 600,2 ofNQA.I,1997, Specifics cf the audit teport, otherwise endorsed by the I. cad Audaor concerning lead auditor responsibilities and issued to the audited organi:ation, are not as clear but actions to be (18,500. !)
performed are defined and overall direction is met. No change to NQA 1, tad evaluates responses.
Audit responses shall be evaluated by or 1997 h recommended.
l for the audinng organization. f18, 600. 2)
' He audit team leader shall ensure that Requirements of NQA 1,1997 ars no.1 Ac audit team is prepared pnor to couivalent with NQA 1,1983-la.
it.itiation of the audit.
The variance is a downgrade in i
requirement and is signflicant. 97 edition does not address the team leader's responsibility to ensure that the audit team is prope ed.
Recommend this be re.a.. sted in i997 by adding to the and of section 18,330,2 thefollowing: 'and selects and prepar*s the team prior to iniaanon of the audit. '
4 PERFORMANCE Ia 83 400 PERFORMANCE Wording does not constitute a requirement.
Audits shall be ocrformed in accordance Requirements of NQA 1,1983-la are with written crocedures or checklists.
These audits shall be otrformed in covered in section 18,100,2 of NQA 1, accordance with written orocedures or 1997 and requirements are identical, checklists by personnel who do not 'save No change to NQA 1,1997 is direct responsibilityfor performing the recommended.
activities being audited. f18.100. 2)
Auditing shall begin as early in the lite of Requirements of NQA 1,1997 are not the activity as practical cauivalent with NQA-1,1983 la.
NQA 97 - 18,200, I provides a comparative starting point.
and shall be continued at intervals Audits shall be scheduled in a manner to The variance is a downgrade in consistent with the schedule for provide coverage and coordination with requirement that is not significant.
. ~
NQA-1 SIDE BY-SIDE AN ALYSIS OF REQUIREM REQUIREMENT 18. AUDITS l
~~I EQUIVALENCY i
l N QA.I.1983 fa l
NOA.1,1997 1
i ongoing acttuttes, based on the status and Equivalency is e 200,1 that provides audit coverage accornplushing the activaty.
portance of the actiutt TIS. 200, / b Im aligned with the activi:y and based on e status and importance of the activity, th hile not as prescriptive as NQA 1, i
w j
1983.la the intent of the 83 requirement is met. No change to NQA.1,1997is recommended.
Requirements are cauivalent with ements selected for audit shalibe editorial / diction differences only. No El Elements that have been selected for aluated aramst specined reautrementt hange to NQA.1,1997 is audit shall be evall,lged arainst specified ev c
recommended. =
reaukrementL Requiremea'< are identical.
Obiective evidence shall be exarruned to Obiectise evidence shaljlkg_etanuned to e deoth necessars to determine if these th the depth necessary to deter..une if these lements are beine imolementtd clernents are beine imolemented e
eficctively.
Requirements of NQA 1,1997 gt effectively _,
udit results shall be documented _and auivalent with less prescriptive A
Audit results shall be documented by eported som!d reviewed by responsiblepecificity, No change to NQA 1,1997 c
auditing personnel add shall be reviewed monocement. (18,100, 3) r s
by manauement having responsibility for is recommended.
Requirements are identical.
the area audited, Conditions reauirine otomet corrective Conditions reauirine cromot correctivg action shall be reported immediately t_o action shall be reported immediatelv to manaeement of the audited otranization_Wording does not constitute a manamncnt of the audited creacization.500 REPORTING 5 REPORTING requirement.
Requirements of NQA 1,1997 Et The audit reoort_tl gl.1 be siened or gauivalent with more prescrigive i
The audit report sl nji be sinned by the otherwise endorsed hit Lead Auditor specificity, No change to NQA 1,1997 i
audit team leader.ind issued and issued to the audited organization.
is recommended.
The contenss of the report shall;(18. 500.
Requirements are cauivaltniwith editorial / diction differences only.
and shallinclude the following 2)
Requirements of NQA 1,19831a 2re information, as appropnate:
covered is, paragraph I8,500,2 of NQA-t,1997, No ska :e to NQA. t. I997 is 1
rwcommended.
Requirements of NCA 1,1197 relate to The contents of the seport shall; paragry,k 1851,5,1 of NQA.1,1983-la. Requirements ne_eouivalent with editorial / diction differences only. No change to NQA.!,1997 is recommended.
Requirements are eauivalent with (a) desenbe the audit scoce; editorial / diction differences only. No (a) description of the audit scoce change to NQA 1,1997is recommended.
Requirements are cauivalent with (b) identify auditors editorial / diction differences only. No (b)identincation of the auditors change to NQA 1,1997 is recommended.
Requirements of NQA 1,1997 Et and cersons contacted; eauivalent with less presenptive (c) identification of cersons contacted during audit activities Page 5 of 7
_ _..~ _._ _ _.._.
4 NQA-! SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY REQUIREMENT 18 AUDITS I
NQ A.1,198.t la l
NQA.I.1997 l
EQUIVALENCY l
s a
specn0 city, No change to NQA 1,1997 is recommended.
(d) summary of audit results. including a (c) summarize audit results. includine a Requirements of NQA-l.1997 m statement on the effectiveness of the statement on the effectiveness of the eauivalent with less presenptive quality assurance program elements elements audited; and specincity. No chante to NO41.1997 which were audited is recommended.
l (e) desenption of each reported adverse (d) desenbe each reported adserse audit Pr luirements of NQA l. !997 E J 21 audit finding in suf0cient detail to enable Anding Winlent with NQA 1,1983 la. The variance is a downgrade in requirement corrective action to be taken by the that is significant. To establish audited organization.
equivalency it is recommended that the directional details deleted by NQA.1, j
1997 he maintained t"follows:
' describe each reported adverse audit i
finding in sufficient detailto enable correction action to be delIned.'
6 RESPONSE 600 RESPONSE Wording does not constitute a requiremert.
i Mananement of the audited otranization Mananement of the audited organization.DI Requirements of NQA 1,1997 are not or activity shall investinate adverse audit activity shall investigate adserse audit cauivalent with NQA 1,1983 la. The findines. schedule corrective action.
findines. schedule corrective action.
variance is a downgrede in requirement including measures to orevent includine measures to prevent recurrence that is significant. To establish recurrence. and notify the noorooriate of signincant conditions adverse to quality, equivalency it is recommended that the oreanization in writine of action taken or ud notify the anorooriate organization in prescriptive wording added by NQA./.
]
- planned, writing of action taken or clanned.
1997 he removed. It seems to be more appropriate to address measures to prevent recurrencefor aufindis gs when
- '~
t applicable,notjustforsignyk st i
conditions adverse to quality.
Recommend deleting 'ofsignyicant conditions adverse to euality'.
i l
The adequacy of audit responses shall be Audit responses shall be evaluated by or Requirements of NQA 1,1997 m l
evaluated by or for the auditina, for the auditmc ornanization eauivalent with less prescriptive specificity, No change to NQ41,1997 ornanization.
is recommended.'
CONSIDERATION:
NQA.1,1997 wording remains vague on l
criteria to evaluate audit responser. To I
enhance application, cunader revising i
NQA.I,1997 to read: ' Audit responses shall be evaluated by orfor the auditing organizationfor such elements as i
appropriateness of actions, completeness, and timeliness.
l 7 FOLLOW-UP ACTION 700 FOLLOW UP ACTION Wording does not constitute a requirement.
Follow-uo act:en shall be taken to venty Follow-uo action shall be taken to verify Requiremer.ts are identical.
that cctrective action is accomolished as that corrective action is accomolished as -
CONSIDERATION:
scheduled, scheduled.
ISO 9001 wording may provide better direction. 'Fo!!aw up audit activities than verify and record the implementation and of ectiveness of the corrective action taken.'
i r
"v
-r n
8"'t'
=r""'
=
T'
NQA-1 SIDE BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALE REQUIREMENT 18. AUDITS
~
-l NQ A.1,1943.la l
NOA.1,1997 l
EQUIVALENCY 8KECORDS 800 RECORDS Wording does not constitute a requirement.
&idit recoids shall include audit olans.
Audit records shall include audit clans, Requirements are identical, i
audit reports. *Titten replies. and the audit recorts. uritten replies. and the record of completion of correctise record of completion of corrective action.
action 1
I l
i I
l i
I l'
e i.
Page 7 of 7 z
Appendix B NQA-1 Side-by-Side Analysis of Equivalency with Recommendations
._NQA-1 SIDE-BY-SIDE RECOMMENDATION Slf55
~~~
CRITERIA 1 to 18. QUALITY ASSURANCE PROGRAM REQUIREME EQUIVALENCY.
NOA 1,1997 I
NQA 1.1983 la RECOMMENDATION REQUIREMENT 1 ORG ANIZATION Ne changes are bemF recommended l'or i
1 1 ORG ANIZ ATION -
this critenon a
REQUIREMENT 2 2 QUALITY ASSURANCE OUALITY ASSURANCE PROGRAM PROGRAM 220 Training i
251. 2 A Tiaming Requirements of NQA 1,1997 are not i
On the job trammg shall also be included ouivalent_with NQA 1,1983 la The c
]
in the program, with emphasis on first-ariance is a downgrade in requirement v
hand enperience gained through actual hatis significant. 'On thejob' training t
i performance of inspections and tests.
has been an important aspect ofprograms equiring rnemal training, While a case i
r ay be made that 2,220,2 above m
combines allform if training, including n the job training, it is not clear that this o
ption may still be considered.
o Recommend reviewing the continued pplication of 'on the job
- training.
a
~
2S-l. 2.7 Certificate of Quah6 cation Requirements of NQA 1,1983 la are t/0 The auahtication ofinspection, test covered in section 2,410, I of NQA 1, The auahncation of personnel shall be and lead auditor versonnel shall be 1997 and are not cauivalent. The varia certified in writing in an appropnate form, crrrified in writing andinclude.!Ag is a downgrade in requirement thatis including the followine information:
followine information: 12,410,I) signyicant. The generalformat of the 83
\\
wording k preferred. The specyic wording added to the 97
- inspection, test and lead auditor'is signyicant ::'
assassing this downgrade because of the limitingfactorimposed. Itis recommended hat the new wording added to the 97 edition,
- inspection, test and lead auditor' be deleted.
(d) Basts of quali6 cation (2,110.1)
Requirerne..s 0: NQA L 1983 la are
. 2S 1,2.7 Certificate of Quahficaten covered in section 2,410, I 'NQA1, td) basis used for certification whict.
I
,aciudes such factt.. as:
1997 and are not cauivalen' The varia is a downgrade in requirement cleat is significant. The generalformat of the 83 wording is preferred. The specific wording deletedfrom the 97 'which includes suchfactors ast' connects w thefollowing three requirements and provides ciccr examples of the.
qualification basis. Itis recommended that the 83 wording 'which includes suct factors as:' be retained.
Requirements of NQA 1,1983 la are 25 2.2.3 Records Records of awaNScation, including covered in section 2,500,2 of NQA 1, Records of personnel quahncation shall requalification. for auditors and lead 1997 and are not couivalent The v be established and maintained by the auditors, andfor inspcction and test is a downgrade in requirement and is
- emolover, personnel shall be established and significant. The generalformat of NQi maintained bv the emolover and for Page 1 of 24
1 l
NQA 1 SIDE-BY-SIDE RECOMMENDATION
SUMMARY
CRITERIA 1 to 18. QUALITY ASSURANCE PROGRAM REQUIREMENTS NQA.I.1983.la NOA 1,1997 EQUIVALENCY I
RECOMMENDATION sndoctrsnatson and trasnsng. I2. 300. 2)
I, I983.la is preftexc. The specyic wording eksagefor NQA.1,1997 that added 'auditon and lead auditors, andfor j
inspection and test penonnel'is significant in assessing this downgrade because of the limiting factor imposed. II l
is recommended that the idenafied 97 wording be deleted and replaced with
- penannel'.
2S 3.1. GENERAL t
This Supplement also provides amplified Requirements of NQ bl,1997 are not i
requirements for the goalifications of couivalent with NQA 1,1983.la. The individuals, henceforth teferred to as variance is a downgrede in requirement Auditors, who participate in an audit, such and is signQicant. The genersiformat of as technical specialists, management NQA./, JP83.la wording is not a representatives, and auditors in training, requirement. The specyle wording in question here is the definition of ' auditor
- which is signficant in assessing this as a downgrede because no similar description is in NQA 1,1997, it is recommended that wording idengfying sudators 6e added to NOA.I,1997 section 2,340, l.
5.1 Organizational Responsibility l
N Lead Auditor shall, prior to Indoctrimanon Mdirsining shall6e Requirements of NQA 1,1997 anung!
,1 commencing the audit, concur that commensuretiivdA sco;,, complexity, eauivalent with NQA.I.1983 la. The assigned personnel collectively have importance of the activities, and the venanceis a downgrede andis enperience or training commetsurate with education, experience, andproficiency of signficant. Thefollowing ekange to j
the scope, complexity, or special nature of the penon. (2,200,1)
NQA.1,1997 is recommended:
Discussion on training snay befound in l
the activities to be audited.
NQA.1,1997 section 2,210, I and to i
efect equivalence thefollowing wording
{
change is recommended: ' Prior to l
commencing quality be:nmg activities the responsiMe organit,ation shall concur i
that assigned re-sonnel have received indoctrinnalen and training commensurate with s.,., complexity, importance of the activities, and the education, experience, and proficiency of the renon.
6.1 General i
e I
t m
-m.
NQA-1 SIDE-BY-SIDE RECOMMENDATION
SUMMARY
CRITERIA 11218. QUALITY ASSURANCE PROGRAM REQUIREMENTS NOA 1,1997 EQUIVALENCY NQ A.I.1983.la RECOMMENDATION Records of ouahficatien, meiudmg Requirements of NQA l.1983.' = re Records of personnel aualifications for overed in section 2,500. 2 of NQA.I.
Auditors and 1 ead Auditors performing requahfication. /or auditors and lead c
audits shall be estabitshed and maintamed auditors, and/or mspectwn and test 1997 and are not cautvalent. The variance personnellhoII be estabitshed and is a downgrade in requirement and is mamtamed b e the emplour andfor significant. The generalformatfor b\\ the emplorer.
pplying qualification records is mdoctrmatwn and tramme. I2. 500. 2 o a
'*~
preferred. The spec (fic wording added to NQA.1, !997,
- inspection and test
- is significant in assessing this downgrade because of the limitingfactor imposed. It is recommended that this section read:
Records of qualification, including equalification, for personnel shall be r
stablished and maintained by the e
mployer andforindoctrination and e
- training, s
340 Auditors Auditors are participants in an audit.
Requirements of NQA.1,1997 are not cauivalcat with NQA 1,1983 la. The variance is a downgrade in requirement and is significant. The generalformat of NQA.I,1983 la wording is preferred.
The speci)lc wording of NQA.I, I997, is signyl cant in assessing this downgrade because of the lack of options. It is recommended that the warding to NQA.1, 1997 be revised asfollows: ' Auditors, including technical specialists, management representatives, and-auditors.in. training, are participants in an audit
- l 400 CERTIFICATION OF Q'ALIFICATION 410 The qualification or inspection.12st Requirements of NO A.I,1997 relate to and lead auditor personnel shall be section 2S-1,2.7,1 in NQA 1,1983.la an are not couivalent. The variance is a certified in wnting and include the downgrade in requirement and :
, ;ollowing information:
significant. The generalforma. of NQA 1,1983 la wording is preferred. The spec (fic wording added to NQA.1, !997,
' inspection, test and lead auditor' is significant in assessing this downgrade because of the limiting factor imposed.
is recommended that the new wording added to NQA.1,1997
- inspection, test and lead auditor' be deleted.
Requirements of NQA l 1997 relate to (d) Basis of qualification section 2S-1,2.7,1 of NQA.1,1983-la :
are not cauivalent. The variance is a downgrade in requirement andis significant. The generalformat ofNQ 1,1983.la wording is preferred. The Pace 3 of 24
m - _ _.. _ _. _ _ _. _ _ _ _ ___. _ _.._ __. _ _._._.. _ _ _ _.._._ _ _...__ _ __ _ _
NQA-1 SIDE.BY-SIDE RECOMMENDATION
SUMMARY
CRITERIA 1 to 18. QUALITY ASSURANCE PROGRAM REQUIREMENTS NQA 1,1983.la NQA.1,1997 EQUIVALENCY j
~
RECOMMENDATION specific wording deletedfrom NQA 1, j _
I997 'which includes suchfactors as:'
connects with thefollowing three
]
requirements and provides clear examples of the qualification basis. Itis recommended that NQA.1,.*983 la wording 'which includes such factors as:'
be retained.
1 3 DESIGN CONTROL REQUIREMENT 3 No changes are being recommended for -
DESIGN CONTROL this criterion.
f 4 PROCUREMENT DOCUMENT REQUIREMENT 4 PROCUREMENT No changes are being recomme ded for CONTROL DOCUMENT CONTROL this criterion.
5 INSTRUCTIONS, PROCEDURES, REQUIREMENT 5 INSTRUCTIONS, No changes are being recommended for i
l PROCEDURES AND DRAWINGS this criterion.
AND DRAWINGS 6 DOCUMENT CONTROL REQUIREMENT 6 DOCUMENT CONTROL
- 2. DOCUMENT PREPARATION, 2
REVIEW, APPROVAL, AND ISSUANCE (b) identification of assignment of
- c. The identification ofindividuals Requirements are eauivalent with j
responsibility {gtprepanng, reviewing, responsible M,the preparation, review, editorial / diction differences only. A l
approving, and issuing documents approve, and distnbution of controlled change to NQA 1,1997 la recommended.
documents.
Ccerect typo ' approve
- should read
'approvsL '
i (c) review of documents 19.I adequacy,
- d. The review of controlled documents Requirements of NQA l.1997 are not completeness, and correctness pnor to h completeness, and approval pnot to couivalent. The variance is a downgrade l
approval and issuance distnbution.
in requirement that is sign (ficant.
Such documents,inekding changes Reviewforadequacyisdis ussedin thereto, shall be reviewedfor adequacy section 6.100,2. A reviewfor and approvedfor release by authorized correctness is reundans wa.sn an l
personnel. f6,100,2) adequacy review is being performed; a document is adequate ifit is also correcs.
The review of approved docuneents for 1
completeness does not seem appropriate,
}
reviewing during approvalcyclefor l
completeness does. Thefollowing l
change to NQA.1,1997 is recommended:
i
'd. The review of controlled documents for completeness, prior to approval and distribution.
l 7 CONTROL OF PURCHASED REQUIREMENT 7 CONTROLOF ITEMS AND SERVICES PURCHASEDITEMS AND SERVICES l
l 2 PROCUREMENT PLANNING Requirements of NQA 1,1997 are not Procurement activities shall be planned cauivalent with NQA-1.1983-la. The and documented to assure a systematic 4
f NQA-1 SIDE-BY-SIDE RECOMMENDATION SUMM ARY CRITERIA 1 b 18. QUALITY ASSURANCE PROGRAM REQL(REMENTS 1
NOA 1,1997 EQUIVALENCY NQA 1,1983 la.
RECOMMENDATION
,2 t
ariance is a downgrade in requirement V
hat is significant. Plannisi af approach to the procurement process.
t (1. 2, ! )
rocurements is not addressed in the 97 p
dition. although the 8.1 edition may be r
prescrsprive in nature the elements follow a basic strong practice and good 1
logic. While some of the elements are Intuitively obhus, inherent in an ffectiveprocurementis the ndrance e
lanning necessary to address a unsform p
pproach. It is recommended that a
i Procurement Planning be reinstatedin the 97 edition.
Requirements of1. JA 1,1997 gg_Il21 Procurement planning shall result in the couivalent with NQA 1.1983 la.
do-umented identification of procurement See 7,2,1for an explanation of the methods and ceganizational analysk for this section.
tesponsibilities.
Requirements of NQA 1,1997 are not Plannmg shall deternune the following:
couivalent with NQA l.1983 la.
See 7,2, Ifor an explanation of the analysk for this section.
Requirements of NQA 1,1997 are not (a) what is to be accomplished; eauivalent with NQA 1,1983 la.
See 7,2, Ifor en explanation of the 4
snaissisfor this section.
Requirements of NQA 1,1997 are not (b) who is to accomplish it; eauivalent with NQA l.19831a.
See 7,2, Ifor en explannaan of the e 1 sisforthis section.
3 Requirements cf NQA 1,1997 are not (c) how it is to be accor.phshed; cauivalent with NQA 1,1983 la.
See 7,2, Ifor an explanation of the analysic for this section.
1 Requiren. ats o' NQA 1,1997 are not (d) when it is to be accomphsbed.
cauivalent with NQA 1, I t3 la.
See 7,2,1for an explanat.sn of the analyskfor this section.
Requirements of NQA l.1997 are not Planning shall b'c accomplished as early as eauivalent with NQA 1,1983 la.
practicable and no later than at the start of See 7,2, Ifor en explanation of the those procurement activities which are analysis for thh section.
required to be controlled, to assure interface compatibility and a uniform approach to the procurement process.
Requirements of NQA-1,1997 are not Planning shall result in the documented eauivalent with NQA l. 1983 14.
identifica'ior of methods to be used in See 7,2, Ifor an explanation of the procurement activities, sequence of analysufer this section, actions and milestones indicating the completion of these activities, and the preparation of applicable procedures prior to the initiation of each individual activity listed below.
Requirements of NQA 1,1997 are not Planning shall provide for the mtegration Pace 5 of 24
i NQA-1 SIDE-BY-SIDE RECOMMENDATION
SUMMARY
I CRITERIA 1 to 18. QUALITY ASSURANCE PROGRAM REQUIREMENTS NQA.1,1983 la NQA 1,1997 EQUIVALENCY RECOMMENDATION i
of (a)through til below:
couivalent with NQA 1,1983 la.
See 7,2, Ifor an explanation of the analysisfor this sectwn.
(al procurement document preparanon.
Requirements of NQA 1,1997 grs_(Ici i
review and change control; couivalent with NQA 1,1983 la.
See 7,2, Ifor an explanation of the analysisfor this section.
(b) selection of procurement sources; Requirements of NQA 1,1997 pre not couivalent with NQA 1,1983-la.
See 7,2, Ifor an explanation of the analysisfor this section.
(c) bid evaluauon and award; Requirements of NOA 1,1997 are not eauivalent with NQA 1,1983 la.
b See 7,2, Ifor an explanation of the I
analysis for this section.
(d) Purchaser control of Supplier,
Requirements of NQA 1,1997 are not i
performance, euuivalent with NQA 1,1983 la.
See 7,2, Ifor an explanetson of the analysisfor this section.
l (c) verification (surveillance, inspection, Rettuitements of NQA 1,1997 are not or audit) activities by Purchaser, including spuivalent with NQA 1,1983 la.
u 2
notification for hold and witness points; See 7,2, Ifor an explanation of the e=='ysisfor this section.
Requirements of NQA 1,1997 arsJ19.1 (f) control of nonconformances;
,y eauivalent with NQA 1,1983 la.
See 7,2,1for an explananon of the anaissisfor this section.
+
(g) corrective action; Requirements of NQA 1,1997 are not eauivalent with NQA 1,1983-la.
See 7,2, ifor an explananen of the analysis for this section.
f (h) acceptance of item or service, Requirements of NQA 1,1997 a[ulp.1 eauivalent with NQA.' loM-la.
i See 7,2, Ifor an expla,s-tion of the
- I sisfor this section.
s i) quality assurance records.
Requirements of NQA 1,1997 are not eauivalent with NQA
- 19831a.
l See 7,2,1for an explanation of the analysisfor this section.
4 BID EVALUATION 300 BID EVALUATION i
Bid evaluation shall determine the extent if bids are solicited, the bid evaluation Requirements of NQA-1,1997 aff of conformance to the procurement shallinclude a determination of the equivale31 with more prescriptive documents.
Supplier's capability to conform to the specificity.
technical and quality assurance A change to NQA 1,1997 is 1
recommended, see 751,4,2 below.
requirements.
This evaluation shall be performed by Requirements of NQA 1,1997 are not couivalent with NQA 1,1983-la. The
}-
individuals or organizations designated to yariance is a downgrade in requirement i
evaluate the following subjects, as.
applicable to the type of procurement:
thatis significant. Thefollowing rewording change to NQA 1,1997
^
section 7. 300. I is recommended. *1f
NQA-1 SIDE-BY. SIDE RECOMMENDATION :
SUMMARY
CRITERIA 1 to 18. QUALITY ASSURANCE PROGRAM REQUIREMENTS NOA 1.1997
~[
EQUIVALENCY NQA 1.19831a
_ ___,1 RECOMMENDATION 4
bids are sohcited, the Purchaser or qualified designie perforrning the bid evaluation shall include a detertrunation f the Supplier's capability to conform to o
the technical and quality assurance equirements including as applicable r
personnel, production capability, past performance, alternatives, and exceptions.*
Requirements of NQA 1,1997 are not (c) Supplier's persor nel auivalent with NQA.I,1983 la.
c See 7,4,2for an explanation of the analysisfor this section.
Requirements of NQA 1,1997 are not (d) Suppher's production capability cauivalent with NQA 1,1983-la.
See 7,4,2for an explanation of the analysh for this section.
Requirements of NQA 1,1997 ate not (e) Supp"er's past performance cauivaler.t with NQA 1,1983 la.
See 7,4,2for an explanation of the analysis for this section.
Requirements of NQ&l,1997 are not (f) alternates cauivalent with NQA 1,1983 la.
See 7,4,2for an explanation of the analysisfor this section.
Requirements of NQA 1,1997 are not (g) exceptions cauivalent with NQA 1,1983 la.
See 7,4,2for an explanation of the analysis for this section.
i SUPPLIER PERFORMANCE EVALUATION Requitetaents of NQA 1,1997 are not The Purchaser of items and services shall ggniyphnt with NQA 1,19".3 la. The establish measures to interface with the vasiance ss a downerede in requirement Supplier and to verify Supplier's thatis significant. verformance performance as deemed necessary by the evaluation of wppliers is not addressed Purchaser.
in the 97 edition. Application e'this section of the 83 edition while, nerally prescriptive, provides positivefeedback on a critical aspect of nuclear quality, the level ofperformance of suppliers..
is recommended that a section be adde, to the 97 edition on Supplier Perfornsance Evaluation.
Requirements of NQA 1,1997 are not The measures shall include (a) through (f) couivalent with NQA 1,1983 la.
below:
Set 7,5, Ifor an explanation of the analysis for this section.
Requirements of NQA 1,1997 are not (a) establishing an understanding between cauivalent with NQA 1,1983 la.
I Purchaser and Supplier of the provisions See 7,5, Ifor an explanation of the and specifications of the procuremer.t analysis for this section.
documents:
j o,-o, a u
_ _ _ ~
NQA-1 SIDE-BY-SIDE RECOMMENDATION
SUMMARY
CRITERIA 1 to 18. QUALITY ASSURANCE PROGRAM REQUIREMENTS l
NQA 1,1983 la NQA 1,1997 EQUIVALENCY RECOMMENDATION 4
I dh requinng the Supplier :o identify Requirements of NQA 1,1997 are not i
planning techniques and processes to be causvalent with NQA 1,1983 la.
utilized in fulfilling procurement Set 7,5, / for an ciplanation of the document requirements; analysisfor this section.
(c) reviewing Supplier documents which Requirements of NQA 1,1997 gu.ql i
are generated or processed dunng cauivalent with NQA 1,1983 la.
(
activities fulfilling procurement See 7,5, Ifor an explanation of the requirements; analysis for this section.
l (d) identifying and processing necessary Requirements of NQA 1,1997 Et.D21 change information; gquisalent with NQA 1,1983 la.
l l See 7,5, Ifor an explanatiore of the analysisfor this section.
l (c) estabhshing method of document Requiren ents of NQA 1, Ivy,.ue not information exchange between Purchaser couivalent with NQA 1,1983 la.
and Supplier; See 7,5, ifor an explanation of the analysis for this section.
l (f) establishing the extent of source Requirements of NQA 1,1997 are not i
surveillance and inspection activities.
(quivalent with NQA 1,1983 la.
1 See 7,5, ifor an explanation of the analysisfor this section.
Ihese verification activities shall be Requirements of NQA 1,1997 are not l
conducted as early as practicable.
cauivalent with NQA 1,1983 la.
l See 7,5, Ifor an explanation of the i
analysisfor this section.
The Purchaser's venfication activitics, Requirements of NQA 1,1997 Et_not however, shall not relieve the Supplier of cauivalent with NQA 1,1983 la.
his responsibilities for verification of Cet 7,5, ifor an explanation of the i
quality achievement.
analysisfor this section.
822 Source Venfication.
540 Source Venfication When source venfication is used. it th.igl When source venfication is used. it shall Requirements of NQA 1,1997 ut be nerformed at intervals consistent with be performed at intervals consistent with cauivalent with more prescriptive l
the importance and eqplexity of the item the imoortance and complexity of the item specificity.
1 or service. and it thall be implemented 12 or service. gg shitt.nstructions 1g Change to NQA 1,1997 is recommended monitor. witness. or observe aq1tv.itig include monitoring. witt.igising gI to correct typo. T'ie text is 'ot clear and observing selected activities should read as follo...
"...and shall J
laciude instructions to im4wie momtonng, witnessmg or observine i
i 8 IDENTIFICATION AND REQUIREMENT 8 IDENTIFICATION No changes are being recommended for i
CONTROL OF ITEMS AND CONTROL OFITEMS this criterion.
i
}
9 CONTROL OF PROCESSES REQUIREMENT 9 CONTROL OF No changes are being recommended for i
SPECI AL PROCESSES this criterion.
I 10 INSPECTION REQUIREMENT 10 INSPECTION 2.2 Qualification Inspection Ia 83 Inspections by persons dunng on-the job Requirements of NQA 1,1997 are not couivalent with NQA 1,19831a.
training for qualification shall he The 97 edition is silent with respect to performed under the direct ctv.,:rvation 1
and supervision of a qualified person and inspection andtestpersonnelon thejob tmininr. Training on the specifics ofjob verification of conformance shall be by 1
NQA-1 SIDE-BY-SIDE RECOMMENDATION
SUMMARY
CRITERIA 1 to 18. QUALITY ASSURANCE PROGRAM REQ
=
NOA 1,1997 7
EQUIVALENCY NQA.1,1983.la l
RECOM\\fENDATION performance is performed, and the 97 the quahfied person until certification is edition does not allow unquahfied rsonnel to be responsible for activities achieved.' Ia 83 pe that require prior training. Thi.t thould ot preclude the direct oversight of an n
inspection activity by a qualified inspector / trainer of a trainet performing the inspection as a stainirt exerche.
j i
he 97 edition does align with the 83 by T
i quiring conformance verification be re erformed only by a qualifiedperson i
p roperly trainid or cernfied. Absence of p
his segment does not appear to creap t
ny negative import. No change to a
NOA.I. I997 is recommended.
l 5.2 Combined Inspection and Requirements of NQA.I.1997 are not l
Monitoring The program shallinclude monitoring auivalent with NQA 1,19831a. The l
5.2.1 A combmation t,f inspection and activities against acceptance criteria in a variance is a downgrade andit c
process monitoring methods, when used. manner sufficient to provide assuraner significant. Process monitoring methods i
shall be performed in a systematic that the activities affecting quality are are dhcussed in the 97 edition (2,110,4) manner to assure that the specilled performedsatisfactorily. (2,110,4) but how they willtoe integrated with requirements ior control of the process and quality oithe item are being inspection processes is not clear, achieved throughout the duration of the It is recommended thatfurther dialogue l
be developed to define the integration i
process.
and controls to be implementedfor these i
two activWs.
Requirements of NQA 1,1997 are nol j
S.2.2 Controls, where tequired, shall be The program shallprovide controlover cauivalent with NQA 1,1983 la, activities affecting quality to an extent The d~e is a downerade and is established and documented for the consistent with their importance.
d-iP-' Ce,w.e.'s are discussed in th_t coordination and sequencing of these activitiet at established inspection points (2, 110,3) 97 edition (2.110. 3): how they should he l
during successive stages of the intearetes w.jlb.ponitorinn and insaectior conducted process or cons'.*uction.
arocesses as nok It is recommended thatfurener dialogue I
be deve*oped to define the.ntegration and controls to be implementedfor thest l*
activWs.
1 620 Insocetion Reautrements The quality records referred to in this 6.2 Insocction Reaurrements Completed items shall be inspectedfor requirement are interpreted as meanin Quahty records shall be examined for completeness, markings, calibration, those records submitted by a vendor as I
adequacy and completeness if not adjustments, protection from damage, or directed by a contract.
previously so exammed, other characteristics as reghired to verify Requirements of NQA 1,19831a are the quality and conformance of the item to covered in section 10,620. i of NQA specified requirements. (10,620,1) 1997 and are not eouivalent.
i it is recommended that 10,620, I be i
modified asfollows: ' Completed item:
including quality records, shall be j
inspected for adequacy, completeness i
i i
i Page 9 of 24
NQA-1 SIDE-BY-SIDE RECOMMENDATION
SUMMARY
j CRITERIA 1 to 18 - QUALITY ASSURANCE PROGRAM REQUIREMENTS I
NQA 1,1983 la NOA 1,1997 EQUIVALENCY l
RECOMMENDATION t
j J
7 INSERVICE INSPECTION 7.1 Planning and Performance Required inservice inspection or Requirements of NQA 1,1997 are not i
surveillance of structures. systems. or equisalent with NQA l.19831a.
components shall be planned and The rariance is a downgrade andis 1
executed by or for the organization significant. Thh section has been responsibic for operation.
deletedfrom the 97 edition. Although inservice inspection could be considered
~
a specialprocess,,further discussion in Criterion 9 and/or2 would bmeessary to establish equivalency.
It is recommended that thh requirement be reinstatedin NOA 1.1997.
t 7.2 Methods Inspection methods shall be established Requirements of NQA 1,1997 EE.n9.1 and executed to verify that the couivalent with NQA 1,1983 la.
characteristics of an item continue to See above 83 10, 7.1,1, remain within specified limits.
Inspection methods shallinclude Requirements of NQA 1,1997 are not evaluations of performance capability of guiyTigni with NQA 1, lo83-la.
See abore #3 10, 7.1, l.
essential emergency and safety systems cnd equipment, verification of ilibration and integrity of instruments
/
~
and instrument systems, and verification of maintenance, as appropriate.
REQUIREMENT 11 TEST CONTROL 11 TEST CONTROL 5 TEST RECORDS 600 TEST RECORDS Test records shall, as a minimum, Test records shall be established and Requirements of NQA-1,1997 are not identify (a) through(g) below:
maintained to indicate the ability of the eauivalent with NQA 1,1983 la.
item or compm r program to satisfactorily The rariance h a down--a4 in perform its ints...ed,ancti. i or to meet its requirement and h signsfi' ant. The 97 dosamented requirements.
edition does not address the minimum content entriesfor a test record. The specyle reasonfor deMag these
' Test records shall be established and minimum entries is nm known however maintained to indicate the ability of the the (a) to (g) entries to be documented item or computer program to satisfactorily per the 83 edition appear to be good basic perform its intendedfunction or to meet its practice. It is recommended that the 83 documented requirements and as a wording be added to the 97 edition (see minimum shallidentify Ia) through (g) wording at left) to maintain equivalency.
And aho add to the 97 edition the 83 below:'
edition contents of(a) through (2).
Requirements of NQA 1,1997 are not (a) item tested cauivalent with NQA 1,1983 la.
See comments above.
Requirements of NQA 1,1997 r.re not (b)date of test couivalent with NQA 1,1983-la.
See comments above.
_.__ _ _ _. -... - ~. - _ _. _ _._ -. _ _ _ _. _
NQA-1 SIDE-BY-SIDE RECOMMENDATION
SUMMARY
CRITERIA 1 to 18. QUALITY ASSURANCE PROGRAM REQUIREMENT a
NOA 1,1997
~T EQUIVALENCY NQA't.1983 la L,
RECOMMENDATION i
Requirements of NQA l.1997 are not (c) tester or data recorder couivaient with NQA 1,1983 la.
I See comments above.
Requirements of NQA l.1997 are not f
(ditype el observation eauivalent with NQA 1.1983 la.
l See comments above.
Requirements of NQA 1,1997 are not (c)results and acceptabihty couivalent with NQA 1,1983-la.
4 See comments above.
l Requirements of NQ A 1,1997 intt.nq!
j (Oaction taken in connection with any couivalent with NQA l.1983 la.
deviations noted See comments above.
Requirement of NQA 1,1997 are not (g) person evaluating test results eauivalent with NQA 1,1983 la.
See comments above.
12 CONTROL OF MEASURING AND REQUIREMENT 12, CONTROL OF No changes are bemg recommended for this criterion.
MEASURING AND TEST TEST EQUIPMENT EQUIPMENT 13 HANDLING, STORAGE, AND REQUIREMENT 13 HANDLING.
STORAGE, AND SHIPPING SHIPPING 100 BMIC Handline. storane. cl anineaggbsms.
Requirements are identical.
Handlinn storane. cleaninP. Dackaging.
shinoine. and preservation of items shall shiocine. and oreservation ofitems shall be controlled to orevent damane or loss be controlled to orevent damane or loss and to minimire deterioration and to minimize deterioration.
Adding ' marking, labeling' resolves
'llandling, marking, labeling, storage, cleaning, packaging, shipping, and change o ecommended in 13,600,1.
p:eservation ofitems hallbe controlled
- to prevent damage or I.uss and to minimi
- e deterioration.'
100 TOOLS and EOUIPMENT T.3 Tools and Eauioment 4
Soccial handlina tools and cauiement Reqmrements are identical.
Special handline tools and cautoment shall be insoccted and tested shall be insoccted and tested I
l Requirements of NQA 1,1997 are not l
equivalent with NQA 1,1983 la.
Although reference to ' procedures'is in accordance with proccoures and I
included above in NQA 1,1997 13, 100,2 and 13,300, it and Criteria !!
and h deal with proceduresfor inspection and testing; use of procedu is not specifically applied to special handling tools and equipment. It won.
seem important that sophisticated equipment have unique ' procedures' Page 11 of 24
NQA-1 SIDE-BY-SIDE RECOMMENDATION
SUMMARY
_ CRITERIA 1 to 18 - QUALITY ASSURANCE PROGRAM REQUIREMENTS l
NQA.I.1983.la NO A.1,1997 EQUIVALENCY RECOMMENDATION a
spectfic to determining adequate operating status and it is recommended that th.'s wording be maintained.
at specified tire intetvals renodically or prior to use as necessary Requirements are not couivalent The 63 i
wording "At specified time intervals" and the proposed 97 replacement
" periodically or prior to use as
}
nect"ary," initiate the same actions, howsver, the 83 implies documented specyics while 97 is more vague.
Recommend adding thefollowing wording: ; specs) led lnte.
- seprior to use as necessary.'
j to verify that the tools and equipment are to assure performance.
Requirements of NQA 1,1997 attn 9.1 adequately maintained, cauivalent with NQA 1,1983.la. The 83 Versioti "to verVy that the tools and equipment are adequately maintained"is being vrplaced in 97 with "to assure l
performance;" while essentially the same, the replacement is not at robust.
Veryying implies more involvement with physical examination and documentation.
Recommend mad $ying werdingfor this section asfollows:
'Special handinng tools and equinment shallbe inspected and testedin accordance with procedures at specified intervals orprior to use as necessary to verify that the tools and equipment will adequately perform.'
Special handling tools and equipment Special handling toals and equipment Requirements are ientical.
shall be inspected and tested shall be inspected and tested Requirements of NQA 1,1997 are nat equivalent with NQA.1,1983-la.
Although reference to *pacedures'is included above in NQA.1,1997 13,100, in accordance with procedures and 2 and 13,300, i use ofprocedures is not specifically applied to special tools and equipment. It would seem important that sophisticated equipment have very specific ' procedures' to determine adequate operating status, at specified time intervals periodically or prior to use as necessary Requirements are not couivalent. The 83 wording "At specified time intervals"and the proposed 97 replacement
" periodically orprior to use as necessars," initiate the same actions.
i NQA-1 SIDE-BY-SIDE RECOMMENDATION
SUMMARY
CRITERIA 1 to 18. QUALITY ASSURANCE PROGRAM REQUIREM NQA 1,1997
'[
EQUIVALENCY RECOMMENDATION NQA 1,1983 la however, the 83 implies documented specifics while 97 is more vague.
Recommend: *at specified intervah or prior to use as nec*ssary, Requirements of NQA l 1997 are not to assure performance.
quivalent with NQA 1,1983 la. The 83 to venfy that the tools and equipment are e
adequate;f traintained.
ersion "to verify that the tools and v
quipmens are adequately maintained"is e
being replaced in 97 with "to assure erformance;" while essentially the same p
intent, th eplacement is not as robust.
Veryying implies more involvement with
'Special handling tools and equipment physical examinat. 4and documentation.
shall be inspected and tested in accordance with procedures at specified Recommend wording at left, intervals or prior to use as necessary to verify that the tools and equipment will adequately perform?
600 MARKING OR LABELING 4 MARKING Marbne or labeline shall be utilized u Requirements of NQA 1,1997 are not Instructions for marbne and labeling for gssnary to adeauntelv maintain and equivalent with NQA 1,1983 la.
83 version requires instructionsfor packaging, shipment, handling, and preserve the item. including indication of marking and labeling whereas 97 deletes storage of items shall be established g the cresence of soechl environments or the reference to instructions. It is necessary to adeauntely identify, Jnanntain, the need for sLteial coninh recommended that section 100 and preserve the_ig m. including indication of the oresence of soecial environments or
' Procedures' of 97 he expanded to the need for special controls.
include marking and labeling, easily resolving this non equivalence. Deletion of 'for packaging, shipment, handling, and storage ofitems'from 83 version
.'oes no* "ffect requirement. Substituting
' utilized'i th< 97for ' established'in the 83 is more accus e in dire *ing the
' larking or labeling shall tie used as functionalactivity, Delerian of the word
'idennfy'from the 83 version removes a necessary to adequately identify, preserve singularimportant aspect of this section, and maintain items, including indication to identyy items by marking or labeling.
of the presence of special environments o It is recommended reinstating this word, r
the need for specialcontrols:
> consider rewording at left.
' No changes are being recommended for REQUIREMENT 14 INSPECTION, l this criterion.
' 14 INSPECTION, TEST, A%
, TEST, AND OPERATING STATUS
, OPERATING STATUS REQUIREMENT IS CONTROL OF 15 CONTROL OF NONCONFORMING ITEMS NONCONFORMING ITEMS 4.5 Technical justification couivalent with NQA-1,1983 la. This dispositioned use as-is or repair shall be an upgrade and is significant.
subject to design control measures
< The 97 edition exceeds the 83 requires commensurate with those applied to the o,- m.a v
l I
NQA-1 SIDE-BY-SIDE RECOMMENDATION
SUMMARY
4 CRITERIA 1 to 18 - QUALITY ASSURANCE PROGRAM REQUIREMENTS NQA 1,1983 la NOA 1,1997 EQUIVALENCY RECOMMENDATION
}
ongsnal dessgn.
by applying design control measures to l
NCR affected items changedfrom their i
originaldesign. There is no impact to the 83 intent. No change is recommendedfor k
the 97 edition. Application of NCRs to design is new, in the past a Corrective
}
Actionfrom Element 16 would have been issued. Presumably the NCR is imposed
~
on the item applying the design requirement and not the design requirement itself. If this is true, the z
section could be cirified; (it is difficult to l
hans an NCR tag on a requirement 3 i
I 4.6 Repaired or Reworked items 450 Re. Examination Reoaired or reworked items shall be Repaired items shall be reexamined in Requirements of NQA 1,1997 gggjgg reexamined in accordance with aoolicable accordance with anolicable omcedures famivelent with NQA 1,1983 la, procedures and with ti. Original and with the oririnal acecotance criterig Variance is a downgrade andis acceptance critens unless the unless the disposition has established sign (/icant. The 97 wording deletes the nonconfort:ung item disposition has alternate acceptance enteria.
use of the word " reworked." In the established alternate acceotance enteria.
context of this section reworked items also receive a re examination. In i
addiaan the text of 97 violates the definsnen of repaired items. repaired items will not use the original acceptance
~
crsterna, (fit did the actier would be a l
rework. Recommend rarising this section to read asfollows:
' Repaired or reworked items shall be re-examined in accordance with applicable 4
p;ocedures; the original acceptance cris: ria will be apphed against reworked i
iten and the alternate acceptance criteria, recorded in the iC.1t disposition applied against repaired items.'
16 CORRECTIVE ACTION
' EQUIREMENT 16 CORRECTIVE ACTION 100 B ASIC
't The identification. cause. and corrective The identification. cause. and corrective Requirements are identical.
action for sinnificant conditions adverse to action for significant conditions adverse to auality shall be documented and reported auality shall be documented and reoorted to aoorooriate levels of management:
to acorooriate levels of management.
follow up action shsti be taken to verify Completion of corrective actions shall be Requirements of NQA 1,1997 are not implementation of this corrective action.
s enfied. (16.100, 4) eauivalent " !:= pxxdp:!r:
- =in
- i
- y. See belowfor i
recommendation.
4 Completion of corrective actions shall be Requirements of NQA 1,1997 are not verified.
equivalut ri^ !:= pxxd;: :
- xin
- !
- y. See NQA 1,1983 la 16,3.
The variance is a downgrade and is 4
I-
_~
CRITERIA 1 lo 18. QUALITY ASSURANCE PROGRAM REQ li241.1997 EQUIVALENCY NQ A+1.19183.la Rf'COMM END ATION signsficant. The 97 regnarement does not appear to be as robust as 83. Hhen corrective actions for significant problems are complete, what willbe vert) led? Correction ofimmediate problems. investigated problems. cause remediation.snd assessment of effectiveness are typicalraampirt.
Itecommended wording: ' Completion of corrretive actions shall be verified to ensure that appropriate corrective actions were taken and were effective '
1 REQUIREMENT 17 Ol' ALITY 17 QUALITY ASSURANCE ASSUR ANCE RECORDS RECORDS.
REQUIREMENT l_ OUAllTY 7
17 QUALITY ASSURANCE RECORD 3 ASSUR ANCE RECORDS 100 B ASIC Requirernents of NQA.I.1997 are not
~
Recurrements and responsibthties for autvalent with NQA.I.1983.la.
Reauirements and responsibilities for these activat:es shall be documented.
c
_ecord transmittal, distribution, retention.
The variance is a downrrade in m m nance, and disposition shall be ggjrement and is sirr.ticant. It is r
est.nhed and documented, ecommended that discussion on r
eautrements and responsibilities for the r
ggsmittal of records and distribution of records be added to section 17.100. 2 NOA 1 1997 to maintain eauivalency, Some of this requirement, NQA l.1983.la islates to sections 17. $00; 70G; and 800 NQA.I.1997.
SUPPLEMENT 17S.1 SUPPLEMENTARY REQUIREMENTS FORQUALITY ASSURANE I
VECORDS I GENERAL Requirements of NQa.i,1997 are not The requirements of this Supplement taulultal with bQA.I.1983.la apply to quahty assurance records uhich The variance is a downerade in requirement and il sienificant. Tu 91
- ..e been completed.
Edition does not address the issue tha a
ouahty as<Lurance records are those rec l
(
that have been completed It is recomniended that section 17.100.
NO A l.1997 be revised to include th word ' completed
- 300 AUTHENTICATION OF 2.3 Record Vahdation RECORDS Requirements of NQA l.1997 are not Handwntien signatures are not required if couivalent with NQA.I.1983.la. The the document is clearly identified as a variance is a downgrade in reguiremens :
statement by the reporting individual or and is signyicant. Information in this NOA.1,1983.la sectionprovides organitation.
Page 15 of 24
NQA 1 SIDE BY SIDE RECOhih1ENDATION SUhth1ARY CRITERIA 1 to 18. QUALITY ASSURANCE l'ROGRAM REQUIREMENTS NQ A.),1983.la NO A.1.1997 EQUIVALENCY RECO%fhlENDATION
~
clarsfication on the use of hendwntten signatures, which is not repeatedin NQA.
I, I997. It h recommended that this wording be retained to provide similar clartficatior, in section 17, 300, I of NQA.
1.1997, 15 Distnbution The secords shall be distnbuted, handled.
The designre shall br irsponsibItfor Requirements of NQA.I.1983 la are and coMrolled in accordance with written organaging and implementing a system of coveted in section 17 $00.4 of NQA 1, procedres.
receipt control of records for permanent 1997. Requitr nents of NQA 1,1997 ut and temporary storage. I17. 300. 4) not causvalent with NQA 1, I9831s.
The venance is a downgrade in j
requirems.., that is signtficao,s. at is recommende,: that in, 500, 4 he rspanded to include dhtribution and handling of records.
19 Cortected Information in Records The cortection shall include the date and Requirements of NQA 1,1997 gml the identification of the person authorited cauivalent with NQA 1,1983 la.
The variance is a downgrade in to issue such costection.
requirement that is sign (ficant. It h recommended these desnik for correcting records be added to section 17,830 of NOA.I, I997.
^
3.2 Receipt Control Requirements of NQA 1,1997 ut D21 As a minimum, a receipt control system couivalent with NQA 1,1983 la.
shallinclude the following:
The variance k a downgrade in requirement that is sign (ficant. It h recommended that thefollowing be added to the end of section I7,300,4 of NQA.1, I997: *... including methodsfor:
designating the reouired trenrds, I
identifying recreds r -
'vra, and inspecting incoming records for legibility andfor agreement with ska transmittal and expreted treuired records.*
Requirements of NQA 1,1997 are not (a) a method for designating the required cauivalent with NQA 1.1983 la.
records; See NQA*l,19831a section 175 1,3.2,3 abovefor recommendation.
Requhements of NQA l,1997 are not (b) a method for identifying records tgunalent with NQA 1,1983 la.
received; See NQA.I,1983 la section 17S l,3.2,3 above for recommendation.
Requirements of NQA l.1997 are not (c) procedures for receipt and inspection aauivalent with NQA 1,1983 la.
of incoming records.
See NQA.I,1983.la section 17S.1,3.2,3 abovefor recommendan'on.
3.3 Status
NQthl SIDE.BY SIDE RECOhth1ENDATION SUhth1ARY CRITERIA 1 t318. QUALITY ASSURANCE JWOGRAM REQUIRE EQUIVALENCY NO A.I.1997 NQ A.I,1983.la NECOhl%fENDATION Requirements of NQA.l.1V97 ge not Each receipt control system shall be uivalent with NQA l.1983 la.
ca tructured to permit a current and accurate The tariance is a downgrade In s
quirement thatis sign (ficant. No assessment of the status of records during re the receistng process.
change is recommended because changes commended above in NQA.), )977 re ctior 17,500,4 will structure a receipt se ntrol system that provides current status co ofrecords brint received.
600 S'IORAGE 4 1 M EAgt Requirements of NQA 1.1997 are nd quivalent with NM l.1983 lu.
I This procedure shallinciu.., a e
minimum. (a) through Ig)
The variance is a downgrade in equirement andis sign (ficant. Minimum below:
r l
lementsfor a storage controlprocedure e
re not included in NQA.I,1997. It to a
ecommended that thefo!!owing be added r
o thr end of NQA.),1997 sectionli,610.
t
% storage controlprocess defining 1, c:
he enforcement responsibilities as a t
minimum shallinclude: a description of the storagefacility, the filing system to be used, the rules governing access to and controlof thefiles,a processfor maintaining control of and accountability for records reviewedfrom the storage
(
facility, and a process forfIllng corrected or supplementalinformation and disposing of superseded records.
Requirements of NQA l.1997 are not couivalent with NQA l.1983 la. The g (a) a description of the storage Nihty; variance se a dnscagrade in requirement andis segnificc=*. Recom end this requirement be added to hyA.1, I997.
Ser 83 175.l. 4.1,3 abo..'.
Requirements of NQA l.1997 are not (b) the filing system to be used; couivalent with NQA.I.1983 la. The variance is a downgrade in requirement and is signfficant. Recommend this requirement be added to NQA 1,1997.
Ser 83 1751,4.1,3 above.
Requirements of NQA l.1997 gre not (c) a method fer verifytng that the records couivalent with NQA 1.1983 la.
received are in agreement with the The variance is a downgrade in r
i transmittal document and that the records requirement andis significant.
Recommend this requirement be adde are legiblc; NQA.!, I997. Ser 83. I75.!,3.2. 3 above.
Requirements of NQA l.1997 Etn01 a
(d) a method of verifying that.the records
. cauivalent with NQA 1.1983 la.
are those designated (see 3.2 aboven:
Page 17 of 24
NQA-1 SIDE BY SIDE REC 0hthiENDATION SUhth1ARY CRITERIA 1 to 18. QUALITY ASSURANCE PROGRAM REQUIREMENTS NQA.1,19113.la NOA.1,1997 EQUIVALENCY RECOMMENDATION The vanance is a downgrade in requirement andis significant.
Recommend this requirement be added to NQA.), !997. Set 83. I1S.1,3.3,3 a bo rt.
(c) the rules gosermng access to and Requirements of NQA.I.1997 grant controlof the files; couivalent with NQA.I.198).la.
The variance is a downgrade in requirement and is signyl cant.
Recommend this requirement be added to j
NQA*l,1997. Set 83 1751,4.1,3 1
above.
(O a method for maintaining control ol Requirements of NQA.1,1997 MLnci cnd accountability for records removed equh altal with NQA.I,1983.la.
l from the storage facility; The variance ls a downgradr in 1
requirement andis signylcant.
Recomn:end this requirement be added to NQA.1,1997. Ser 83 17S.1,4.1,3 above.
(g) a method for filing supplemental Requirements of NQA.1,1997 ate not information (see 2.9 above) and disposing tauiralent with NQA l.19831n.
of superseded records.
The variance is a downgrade in requirement and is signyicant.
Recommend this requirement be added to NQA.I, !997. Set 83 1751,4.1,3 above.
4.2 Preservation (b) Records shall be Ormly attached irr Requirements of NQA.I.1997 g.tnct binders or placed in folders or envelopes couivalent with NQA.1,1983.la.
for storage in steel file cabinets or on The variance is a downgrade in shelving in containers, requirement and is signylcant. It is recommended that this requirement be added to the section an treerd storage i.,
NQA.1, I997 section 17,610. I.
(c) Provmons shall be made for soccial Provisions shall be made for soccially Requirements of NQA.I.1983.la are processed records Quch as radiographs.
processed records (such as radiograohs.
covered in section 17. R40, I of NQA.1, chotorraohs. ne ratives. =leroform. and chotorraohs. neratives. nderoform.
1997 and att equlYlltBl. No change to magnetic media) to orevent damare frein Inagnetic and cotical media) to prevent NQA.1,1997is recommended. Correct estessive light. staqbne. electromagnetic damane from eteessive licht. stackint typo ' microform'should be ' microfilm.'
fields. temocrature. And humidity.
electromacnetic fields.temocrature and humidity. (17,840.1) 4.3 Safekeeping Measures shall tis established to preclude Requirements of NQA.I.1997 Etact N entry of unauthorized personnelinto equivalent with NQA 1,1983.la.
the storage ates..
The variance is a downgrode in requirement andis signyicant. Itis recommended that this requirement be added to the section on record maintenance in NQA.I,1997 section 17, 810, I by adding ' unauthorized access '
1 after 'protectedfrom'.
_..m-
..m
-. - NQA 1 SIDE BY-SIDE RECOMMbNDATION. SUMM
~~
~
CRITERIA 1 to 18. QUAL ITY ASSURANG PROGH.4 M 7'~
EQUIVALE.NCY NQA t 1997 RECOMMI'NDATION NQA.I.1983.la
--._.__...i.__
Requirements of NQA 1,1997 are not unalent with NQA.1,1983 la.
Measures shall be taken to provide for eq The variance is a dow tgrade in j
n placement, restoration. or subststution of quirement andis significant. Itis re lost or damaged records.
re commended that this requirement be re added to the section on rec.>rd aintenance in NQA*1,1997 after section
"~
m 17, al0, I.
Sections 4.4.1 and 4.4.2 relate to a single 4 4.1 Single Facchty.
cility storage area, the detailsfor faesigning, constructing and various other d
lternatives available are not presented in a
QA 1,1997, Section 17,620, I of NQA N,1997 does provide the option for single 1
toragefacilities, however, no details are s
rovided, itis recommended that an p
ndustry standard defining the spec (fic i
equirementsfor single storage area racilities be provided in section 17,620, I fof NOA.I, !997.
Requirements of NQA.1,1997 are not
)
Design and construction of a single record equh alent with NQA.I.198'.la.
storage f acility shall meet the criteria of See Section 4.4.1 o/NgA.1,1983.la.
)
(a)through (1)below: (I a 83)
Requirements of NQA 1,1997 are not (a) reinforced concrete, concrete block, IDhnical with NQA.1,1983.la. Ser masonry,or equal construction; Sersion 4.4.1 of NQA.), J983.la.
Requirements of NQA.1,1997 are not (b) floor and roof with dramage control.
cauivalent with NQA.1,1983 la, See Section 4.4.1 of NOA.!, I9831a.
Requirements of NQA.1,1997 are not If a floor dram is provided, a check valve couivstent with NQA 1,1983.la.
See Section 4.4.1 of NQA.I, I983.la.
(or equal) shall be included.
Requirements of NQ,. I,1997 are not cauivalent with !!QA,1,1983 la.
(c) doors, structure and frames, and See Section 4.4,1 o/NQ41, JF '.la.
hardware shall be designed to comply
. Ja the requirements of a minimum 2 ha j
Requirements of NQA 1,1997 are not fire rating:
couivalent with NQA.1,1983 la.
(d) scalant apphed over walls as a See Section 4,4.1 of NOA.I,1983.la. _
moisture or condensation harrier; Requirementsof NQA.I.1997 atinni cauivalent with NQA 1,1983.la, (c) surf ace scalant on floor providing a Ser Section 4.4.1 of NQA.I,1983 la. -
hard wear surface to minimite concrete Requirements of NQA.1,1997 are not dusting:
couivalent with NQA.1,1983.la.
(f) foundation sealant and provisions for See Section 4.4.1 of NOA.I, I983 la.
drainage; Requirements of NQA 1,1997 are not (g) forced air circulauon with filter tquivalent with NQA.1 1983 la.
Ser Section 4.4.1 of hDA.!, I9831a.-
system; Requirements of NOA 1.1997 are no!
(h) fire protection system; Page 19 of 24
NQA 1 SIDE BY SIDE RECOMMENDATION
SUMMARY
CRITERIA I to 18 - QUAL ITY ASSURANCE PROGRAM REQUIREMENTS l
NQA.I.1933.la NOA.1,1997 EQUlYAl.ENCY RECOMMENDATION cauivalent with NQA.I.1983 la.
See Sechen 4 4.1 of NOA.1,1983.la.
O) only those per.vtrations used Requirements of NQA l.1997 are not esclusively for 6te prottetion.
couivalent with NQA.I.1983 la.
communication, lighting. ot See Section 4.4.1 off,QAel. 1983 10.
temperature / humidity control are allowed; til such penettations shall be scaled or dampe'ed to comply with the minimum 2 hr fire protection rating (Ia 83)
,J, The construction details shall be revicwed i Requirements of NQA.I.1997 are.rto.1 for adequacy of protection of contents by.
eauivalent with NQ A.I.1983.la, a person who is competent in the technbi l See Section 4.4.1 o/NOA 1,198310.
field of fire protection and fire eatinguishing.
If the facility is located within a building Requirernents of NQA.I.1997 t!!.021 or structure, the environment and equivalent with NQA.I.1983.la.
construction of that building can provide a See Secnon 4.4.1 e/NQA.J.1983.la.
portion or all of these critena 4.4.2 Alternate Single Facilities.
The following are acceptable alternatives Requirements of NQA l.1997 af3_D21 to the criteria of 4.4.1 above for a single equivalent with NQA.I.1983 la.
facility:
See Secuen 4.4.1 of NOA.I, 1983 10.
(a) 2 hr fire rated vault meeting NFPA Requirernents of NQA 1.1997 are not 232 1975';
equivalent with NQA l.1983 la.
See Secnon 4.4.1 elNOA.I. I983 la.
(b)I hr fire rated Class B lile containers Requirements of NQA l.1997 a[E.D21 meeting the requirements of NFPA 232 equivalent with NQA l 1983 la.
I975';or See Scenen 4.4.1 of NOA.I, I983.le.
(c) 2 hr fire rated file room meeting the Requirements of NQA l.1997 att_D21 requirements of NFPA 232197S I with couivalent with NQA l.1983 la.
the following add *ni. provisions:
See Secnon 4.4.1 of NOA.1,1983 Ja.
(1)early warmng fire detection and Requirements of NQA l 1997 are not equivalent with SQA l. It.3.Ia.
automatic fire suppression capabili y i..
electronic supervision at a constantly See Secnon 4.4.1 of AglA.1,19831s.
attended central station:
(2) records storage in fully enclosed metal Requirements of NQA l.1997 are wt cabinets; equivalent with NQA l.1983 la.
See Secnon 4.4.1 of NQA.I, !983.Is.
(3) adequate access and aisle ways; Requirements of NQA l.1997 lit B21 equivalent with NQA 1.19831n.
See Seenen 4.4.1 of NOA.I, I983.la.
(4) prohibition in the room of work not Requirements of NQA.I.1997 are not directly associated with record storage or equivalent with NQA l.1983 la.
retrieval:
See Seenen 4.4.1 of u'QA.I,1983.la.
(5) prohibition in the room of smoking, Requirements of NQA i 1097 are not eating, or drinking; eauivalent with NQA.I.1983 la.
See Seedon 4.4.1 of NOA.I, I98310 (6) 2 hr fire rated dampers or doors in all Requirements of NQA 1.1997 are not boundary penetrations.
eauivalent with NQA l.1983 la.
See Secnon 4.4.I of NOA.I, I983 1s.
[NFPA 232 1975 is contained in Volume Wording does not constitute a requirement.
-~
NQA-1 SIDE BY-SIDE RECOMMENDATION
SUMMARY
CRITERIA 1 b 18. QUALITY ASSURANCE l'ROGRAM REQUI'A
~~ LQUIVALENCY NQ A 1,1997 NQA.1,1983 la RECOMMF.NDATION rieferer:e to NFPA is not repeated in 9 of the National Fire Codes pubhshed by NQA l.1997.
the National Fire Protection Association.
Ser Section 441 o/NQA.),1983 la.
470 Atlantic Asenue. Boston, M A 0:21 01 4 4.3 Dual Facilities.
Requirements of NQA 1,1997 are not uinkat with NQA 1,1983.la.
If storage at dual f acilities for each record m
is provided, the facihties shall be at The variance is a downgrade in quirement andis significant. Itis locations sufficiently temote from each re other to climinate the chance of enposure commended shat this requirement be re to a simultaneous hatard.
dded to *'
- end of the section en dual a
cilisirs in NQ41,1997 after section I7, fa 620, l.
equirements of NQA 1,1997 are not 5 RETRihVAL R
Storage systems shall provide for retrieval guisalent with NQA 1,1983 la.
of information in accordance with planned The variance is a downgrade in tetrieval times based upon the record type.
equstementandis significant. NQA 1, r
997 does address retrieval of records (17, 820,1); the detailof retrieving nformation frecords) within established i
planned times in the storage facility is not address, it is recommended that 17,820, i be modified to trad ' Records shall be retrievable in a timely manner.*
Requirements of NQA 1,1997 are not l
A hst shall be maintained designating cauivalent with NQA 1,1983 la.
those personnel who shall have access to The variance is a downgrade in requirement and is signylcant. NQA.1, the files.
1997 do*s not address the requirementfo listing those personnel having access to quality e rords. It is recommended that this requir me tt detal!for developing an access list be aaard to serto n 17,810,1 N 04 l,1997.
700 DISPOSITION 6 DISPOSITION Requirements of NQA 1,1997 are not The custodian shallinventory the rouivalent with NQA 1,1983 la, submittals, acknowledge receipt, and The variance is a downgrade in process these records in accordance with requirement and is significant. NQA 1 1997 does not address the requirement this Standard.
acknowledging receipt of qualisy recors it is recommended that this requiremer detailfor acknowledging receipt be ads 17,500,4 of NOA I, !997..
to section Requirements of NQA 1,1997 are not The Suppher's nonpermanent records equivaltat with NQ A 1,1983 la.
The variance is a downgrade in shall not be disposed of until the l
requirement and is significant. NQA-h applicable conditions listed in (a) throug l
!997 does not address the requiremen (el below ase satisfied:
I Page 21 of 24
_ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ - _ _ _ _ _ - _ _ _ _ _ _ _ - _ _ _ - _ _ - _ _ _ _ _ _ _ _ - _ _ _ _ _ - _ _ _ _ _ _ _ _ _ - _ _ - _ _ _ _ _ _ _ _ ~
4 1
i NQA 1 SIDE BY SIDE RECOhih1ENDATION SUhih1ARY CRITERIA 1 to 18. QUALITY ASSURANCE PROGRAM REQUIREMENTS 4
NQ A.1,1983.la NQA.I.1997 EQUlYALENCY RECONtNtENDATION i
i listent nonpermanent records. These records are considered to be in addition to j
contractually required documensasion. If processing of such nonpermanent records is necessary, then consideration should be madeforplacing this requirement or equivalent in socitond, Procurement Document Control. itis recommended that this requirementfor handling nonpermanent Supplier records be added j
to n new section 17,850 of NQA.I,1997, i
Maintenance by Supplier of 7
Nonsermanent Records.
}
1 (a) items are released for shipment, a Requirements of NQA 1,1997 are not 1-Code Data Report is signed, or a cauivaltal with NQA.I.1983 la.
4 Code Symbol Stamp is affined:
See NOA,1,1983 le: 1751,6,5 above.
l (b) regulatory requirements are satisfied; Requirements of NQA 1,1997 are not i
cauitalent with NQA.1,19831a.
Ser NQ4.I,198310: 1751, 6, 5 above.
?
(c) operational status permits:
Requirements of NQA.I.1997 EE.'121 cauivalent with NQA.1,1983 la.
5 See N OA.I, 1983 10: 1751, 6, 5 above.
(d) warranty consideration is satisfied; Requirements of NQA 1,1997 Et.n21 i
cauivalent with NQA.1,1983 la.
See NOA.1,1983.le; 17S.1,6,5 above.
[
l
~
Requirements of NQA 1,1997 us_021
"" * ~ '
i (c) Purchaser's requirements are satisfied.
equivalent with NQA 1,19831a.
See NOA.1, I983.le: 1751, 6, 5 above.
MX) MAINTENANCE OF RECORDS b
Bl0 Records shall be protected from Requirements of NQA.I.1997 relate to damage or loss.
section 17,3 of NQA 1,1983 la and gg couivalent.
j Changes to this section have keen i
recommendedfrom othe.nections of this ssendard. See 17S.!,4.3, i end i7S.!, l.3 l
3.
1
.'20 Records shall be retrievable Requirements of NQA l.1997 relate to section 17,2 and 17S t,14,2 of NQA 1, 1983 la and are eauivalent.
Changes to this section have been recommendedfrom other sections of this seendard See 17S l,5, I.
830 The methods for record changes shall Requirements of NQA 1,1997 relate to be documented.
section 17S 1,2.9, I of NQA 1,1983 la and are eauivalent.
Changes to this section have been
]
recommendedfrom other sections of this
~
standard See 17S.1,2.9,2.
840 Provisions shall be made for Requirements of NQA 1,1997 relate to 1
specially processed records (such as section 1751,4.2,2, c of NQA 1,1983 la radiographs, photographs, negatives, and are eauivalent.
microform, magnetic and optical media)
No channes to NOA l.1997 are
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1 NQA 1 SIDE BY-SIDE RECOMMENDATION SUMMA CRITERIA 1 b 18. QUALITY ASSURANCE PROGRAM i
EQUIVAL.ENCY N051,1Nf~~~ T RECOMMENDATION NQ A.I.1983.la i
recommeh4t.5L i
to present damage from escessne hght.
Typo *mkroforw,'saould be ' microfilm.'
4 stacking. electromagnette fields.
}
temperature and humidity j
REQl'IREMENT 18
- Al'DITS
?
15 AUDITS Im SCHEDUI.ING 2 SCHEDULING Requirements of NQA.I.1997 are not
~
Audsts shan br schrdulrd in a manner to usvalent with NQA l.1983 la.
l The audit schedule shall be reviewed provide C21mE 08d coordination with owevet a portion'of requirements of ca periodically and revised as necessary to ongosng activitnes. based on the status and QA.l, l983.la are covered in section 18.
H i
assure that coverant ss maintained importance of the activity. I18, 200. IJ N
200. I of NQA.I.1997.
i current.
he variance is e downgrede andis T
signflicent it is not clear ythe 83 edition houM be interpreted to mean that a hysteel document, en sedu schedu s
?
p be generated. The quakry reced section i.
' Scheduled endus shallbe reviewd (8) does not identyy en audit schedule as ecord genereced by this set of r
i periodicouy and errised as necessary to ngo erments. The 97 does not address t
essure that coverage and coordination eviewing or revising the endits to be i
with ongoing activkies, based on the onducted. Recommend revising the 97 r
status and importance of the activity, h odkion to eseablisk equivalency. See c
j maintained. '
wordins etlek
- 320 Personnel Requnrements of NQA.I, I991 are not 3.2 Personnel These audits shall be performedin equivalent with NQA.1, t9831a.
l accordance with written procedures or The variance is e downgrade andis l
checklists significent. Delenne the 83 wording *T endedag,,q_ E " n'is accepted because l t
The auditing organitation shall select b.) prisonnri who do not larve dur.t.t in 97 18,330,2 kis the land Andkor rewonsibuhrv for performing she attivtties who ds designated to organize the nudit and asslgn auditors who are independent bring audard. il8 IlKl 2) team, ye seem is required. The 97 3
of any direct resoondbilitv for wording
- direct responsibuityfor performance of the activities which they performing the ecdrities* when com to the B3 wording
- direct responsibuity wilI audit.
performance of the e'*tivkies' creates en interpreenden gap. s he 83 may be more i
breedly applion to su management a i
y stafflevels involved with the ac*
- y, wh ;
the 97 seems more restriedre ectueuy performing the activky, it is recommended that the 97 wording be
{
changed asfoUows: 'by personnel wh laderendent of any direct responsibu l
performance of the acdvides being endited.* It is understood that the uses the 97 wording in 18 BR 2, this wording change is seen as improvin the 97 end the g3.
330 Selection of Audit Team Requirements of NQA 1.1997 are not J
3.3 Selection of Audit Team The audit team leader shall ensure that cauivalent with NQA l.1983 la.
The verdance is a downgrade in the audit team is prepared prior to reesirement and is sisnificent. 97 ed u
initiation of the audit,
~
Page 23 of 24
NQA 1 SIDE BY SIDE RECOhth1ENDATION SUhthfARY CRITERIA 1 to 111. QUALITY ASSUMNCE PROGRAh! REQUIREhlENTS NQA.1, IPN3.la NQA.1,1997 EQUIYALENCY RECOh!NfENDATION does not address the team leader's j
responssbihty to ensure that the audit team is prepared.
Recommend this be reinstated in !997 by adding to the end of section 18,330, J the foUowing: 'and selects andpreparts the team prior to initiation of the audit. '
$ REPORTING SOO REPORTINO j
(e) destnption of each trootted adverse (d) describe each reported adverse audit Requirements of NQA 1,1997 ALLnc!
audit findine in sufficient detail to finding.
equivalertl with NQA 1.1983 la. The enable correctivt action to be taken variance is a downgrade in requirement by the audited organitation.
thatis significant. To establish equivalency st is recommendra Inat the directional detaus deleted by NQA.1,1997 be maintained asfollows: ' describe rach reported adverse auditfinding in sufficient detail to enable correction action to be defined
- 6 RESPONSE 600 RESPONSE Management of the audited otranization Manatement of the audited otraniration or Requirements of NQA.1,1997 are not or activity shallinvesticate adverse audit activity shall invettirate adverse audit equivalent with NQA 1,1983 la. The findings. schedule corrective action.
findines. schedule corrective action.
rariance is a downgrade in requirement includine mea 3ures to orevent including measures to prevent recurrence that Is sign (/icant. To establish recurrence. and notify the approonate of significant conditions adverse to quality, eguiralency it is recommtaded that the otranization in writine of action taken or and notify the acoroongg otranization in prescripiirs wording added by NOA.1,
- planned, wntina of action taken or planned.
1997 he removed, it seems to be more appropriate to address measures to prevent recurrencefor aufindings when applicable, notjust for significant conditions adverse to quality. Recommend deleting 'of sigon(fIcant conditions adverse to quality'.
The adequacy of gudit responses shalf Audit responses shaII tg evaluated bv or Requirements of NOA.I.1997 are evaluated by or for the auditint for the auditine otranganen.
equivalent with 'ess r- *iptive specificity.
CONSIDERATION:
organtratton.
NQA.1,1997 wording remains vague on criteria to evaluate audit responses. To enhance application, consider revising NQA.I, !997 to read; ' Audit respo'sses shan be evaluated by orfor the auditing organi:ationfor such elements as appropriateness of actions, completeness, l
and timeliness.
7 FOLLOW.UP ACTION 700 FOLLOW UP ACrlON Follow-up act on shall be taken to venfv follow.up action shall be taken to verify Requirements are identical.
that corrective action is accomolished as that corrective action is accomplished as CONSIDERATION:
ISO 9001 wording may provide better scheduled.
scheduled, direction. ' Follow up audit activities shall verify and record the implementation and effectiveness of the corrective action taken. '
_, -