ML20207A055
| ML20207A055 | |
| Person / Time | |
|---|---|
| Site: | 05000000, Comanche Peak |
| Issue date: | 03/31/1978 |
| From: | TEXAS UTILITIES ELECTRIC CO. (TU ELECTRIC) |
| To: | |
| Shared Package | |
| ML20206S800 | List:
|
| References | |
| FOIA-85-59 CQP-CS-1, NUDOCS 8607110401 | |
| Download: ML20207A055 (22) | |
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i PROCEDURE ISSUE
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TEXAS UTILITIES GENERATING CO.
NUMBER REVISION DATE PAGE CQP-CS-1 g
8/31/78 1 of 2 INDOCTRINATION AND TRAINING PREPARED BY: _ [/d[/e f/7//7/
OF TUGC0 QA PERSONNEL
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~~f DATE REVIEWED BY:
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OATE' APPROVED BY:
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Page No.
12 Effective Rev.10
1.0 INTRODUCTION
f NFm. :MAT!ON ONLYj
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1.1 Purpose To establish instructions to provide indoctrination and training to TUGC0 QA personnel who are not assigned to the CPSES Site.
l 1.2 Scope This procedure establishes the guidelines for the indoctrination and training of personnel performing activities affecting quality to assure '
that suitable proficiency is achieved and maintained. This procedure is intended to fulfill the requirements of the TUGC0/TUSI Quality Assurance Program and Criterion II of Appendix B to 10 CFR 50.
1.3 Definitions 1.3.1 None i
1.4 References i
TUGC0/TUSI CPSES QA Plan,10 CFR 50, Appendix B, Criterion II.
2.0 RESPONSIBILITIES 2.1 Manager, Quality Assurance - is responsible for the indoctrination and training of Quality Assurance personnel. The Manager, Quality Assurance may delegate to his designated representative the responsibility for the indoctrination and training activity.
2.2 Lead Engineer, Central Staff Function - is responsible for defining required QA reading, study and formal training assignments for QA Division
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8607110401 860627 PDR FOIA GARDE 8S-39 PDR
1 CQP-CS-1, Rev. O, 8/15/78 Page 2 of 2 personnel. He is responsible for assuring that required training is adequately documented.
3.0. PROCEDURE 3.1 Indoctrination & Training of QA Personnel 3.1.1' The indoctrination and training of QA personnel will ihvolve individual reading, on-the-job training and attendance at fomal industry training seminars.
By a combination of the above activities, QA' personnel will obtain a working knowledge of federal regulations, corporate Quality Assurance documents, industry codes and standards and techniques related to pre-award surveys, audits and inspections.
The QA Training Report Fom, Figure 1.1, defines the minimun training requirements applicable to QA personnel.
It also serves to document the training of QA personnel. This fom is maintained a
by the Manager, Quality Assurance or his designee.
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3.2 Time Limit to Complete Training and Indoctrination 'of 0A Personnel 3.2.1 The minimum training and indoctrination of QA personnel will be
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completed by each employee within two years after the date of empl oyment'. During the training period, the QA employee will perfom quality activities which, in the judgement of the Manager of QA, he is capable of carrying out correctly, based on the instruction or experience he has received.
3.3 QA Personnel Proficiency x,
3.3.1 The proficiency of CPSES QA Personnel will be maintained by their ongoing participation in pre-award surveys, audits, or inspections.
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TEXAS UTILITIES GENE NC COMPANY COMANCIE PEAK STEAM ELECTRIC STATION QA TRAINING REFORT FORM i
EMPLOYEE:
DATE ADDITIONAL TRAINING REMARKS COMPLETED VERIFIED h
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-COPY FROM WASH-1283, REV'.1 OR WASH-1309 (GRAY OR GREEN BOOK) s pi
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DRAFT 1
i Caution Notice. This standard is bein*g pre-pared or reviewed and had not been approved by The American National Standards Institute.
It is subject to revision or withdrawal before
. Issue.
American National Standard for Reactor Plants and Their Maintenance
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REQUIREMENTS FOR AUDITING OF QUALITY ASSURANCE PROGRAMS FOR NUCLEAR POWER PLANTS ANSI N45. 2.12.1974
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Sponsor The American National Standards Institute
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. Draft > Rev 4 Februa ry 22, 1974
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AMERICAN NATIONAL STANDARD An American National Standard impiles a consensus of those substantially concerned with its scope and provisions. An American National Standard is 5
inte5ded as a guide to aid the manufacturer, the consumer, and the general I
6 public. The existence of an American Nationa1 Standard does not in any respect 7
preclude anyone, whether he has approved the standard or not, from :nanu.
8 facturing, marketing, purchasing, or 2aing products, processes, or procedures 9
not conforming to the standard. American National Standards are subject to 10 periodle review and users are cautioned to obtata the latest editions, gi 12 CAUTION NOTICE: This American National Standard may be revised or 13 withdrawn at any time. The procedures of the American National Standards 14 Institute require that action be taken to reaffirm, revise, or withdraw this 15 '
standard no later than five years from date &f publiestion. Purchasers of --
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16 American National Standards may receive current 15 formation on all standards
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17 by calltag or writing the /.merican National Standards Institute.
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Draft 3 Rev 4 II February 22,107
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1 FOREWORD j
2 3
.(This foreword is not a part of American National Standard Requirements for 4
Auditing of Quality Assurance Programs for Nuclear Power Plants) 5 6
This standard delineates requirements for establishing and implementing a 7
. system of internal and external audits that wculd apply to quality assurance pro.
8 grams for nuclear power plants. The standard was developed under sponsorship 9
of the American National Standards Institute's Committee N45 on Reactor Plants 10 and their Maintenance. This committee has been chartered to promote the de.
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11 velopment of standards for the location, design, construction, and maintenance 12 of nuclear reactors and plants embodying nuclear reactors, including equipment, i
13 methods, and components.
14 n.~.
15 In April 1970, the N45 Committee of the American Nationa1 Standard Ynstitute
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16 estabitshed a subcommittee N45.3 to guide the preparation cf nuclear quality 17 assurance standards. This subcommittee is responsible for 'estabitshing guide.
18 lines and policy to govern the scope and content of the various standards; mont.
19 toring the status of standards in process; recommending preparation of additional 20 standards; and approval of standards prior to their submittal to the N45 Committee 21 for balloting.
22 i
l 23 In February 1972, the N45.3 Subcommittee of the American Nationa1 Standards 24 Institute estabitshed a work group N45 3.12 on Audits. The purpose of this work l
25 group was to prepare a standard for general Industry use that would define an l
26 auditing practice appilcable to quality assurance program activities used to assure 27 attainment o't quality construction. The work group was composed of representa.
28 tives of key segments of the nuclear Industry, including utt11ttes, reactor suppiters.
29 equipment manufacturers, arc.httect. engineers, constructors, and Insurance I
30 agencies. The standard contained herein was developed from this activity. The 31 initial draft of this standard was prepared in January 1973.
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Draft 3 Rev. 4 Ill Feb rua ry.1.1. 10 ~ :
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Working with the N45.3 Subcommittee and concurrently with the development
. of this standard, other working groups of N45 are developing a series of stand.
ards that set forth more detailed requirements for certain activities to assure quality of nuclear giower plants. These requirements will be coordinated with the requirements of this standard as they are developed.
In October 1972, the N45.3 Subcommittee was numbered N45.2, a d the work groups were renumbered accordingly. As of April 1973, the following associated standards were in preparation or tesned:
Work Group
' N45. 2 Quality Assurance Program Requirements for Nuclear Power Plants N45.2.1 N45. 2.1 Cleaning of. Fluid Systems and Associated Compaoents During the Construct,lon Phase.of Nuclear Power Plants
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N45. 2.
N45,2. 2.
Packaging, Shipping, Receiving, Storage, and Nandling of Items for Nuclear Power Plants (During the Construction
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Phase)
N45.2.3 N45. 2. 3 Nousekeeping During the Construction Phase of Nuclear Power Plants 2445.2.4 N45. 2. 4 Supplementary Quality Assurance Requirements for In.
sta11ation. Inspection and Testing of Instrumentation and
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Electric Equipment During the Construction of Nuclear Power Generating Stations N45.2. 5 N45.2.5 Supplementary Quality Assurance Requirements for In.
sta11ation and Testing of, Structural Concrete and Structura15 teel During the Construction Phase of.
Nuclear Power Plants N45 2. 6 N45. 2. 6 Qualifications of Inspection, Examination and Testing Personnel for the Construction Phase of Nuclear Power Plants l
N45.2.8 N45. 2.8 Supplementary Quality Assurance Requirements for In.
sta11ation Inspection and Testing of Mechanical Equip.
ment and Systems for the Construction Phase of Nuclear Power Plants N45.2. 9 M45.2.9 Requirements for Collection, Storage and Maintenance of Quality Assurance Records Draft 3 Rev. 4 Lv Feb rua ry 22. 1974
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1 N45.2.10 N45. 2.10 Quality Assurance Terms and Definitions 2
N45.2.11 N45. 2.11 Quality Assurance Requirements for the Design of
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3 Nuclear Power Plants '
4 N45.2.13 N45. 2.13 Supplementary Quality Assurance Requ'irements for 5
Preparation of Procurement Documents for Nuclear 6
Power Plants 7
N45.2. 4 N45. 2.14 Supplementary Quality Assurance Re*quirements During 8
the Manufacture of Class IE Instrumentation and Electric 9
Equipment for Nuclear' Power Generating Stations 10 Suggestions for improvement gained in the use of this standard will be welcomed.
11 They should be sent to American National Standards Institute.1430 Broadway. New 12 York. New York 10018.
13 14 The We'rk Group on Audits included the following personnel during-the develop.
15 ment of this standard.
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16 F.W. Knight. Chairman G.R. Hosack. Secretary
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17 Name of Representative Organizztton Represented
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18 H. R. Banks Carolina Power and Light 19 J. N. Babcock United Engineers and Constructors 20 T. L. Bonnough Offshore Power Systems 21 A. W. Crevas se Tennessee Valley Authority 22 A. E. Henderson, Jr.
Louisiana' Power and Light 23 C. R. Hosack General Electric Company 24
.\\. E Hasija Nuclear Energy Liability Insurance 25 Association / Mutual Atomic Energy 26 Liability Underwriters 27 F. W. Knight Westinghouse Electric Corporation 28 F. J. Long U.* S. Atomic Energy Commission 29 J. H. Marshall Niagara Mohawk Power Corporation
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Draft 3 Rev. 4 V
February 22. 1974
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TABLE OF CONTENTS Page No.
1 1.
INTRODUCTION
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8 8
2 1.1 Scope B
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- 1. 2 Appitcability 9
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- 1. 3 Responsib(1Ity
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- 1. 4 Dennitions 10 6
- 1. 5 Referenced Documents 7
10 2.' PERSONNEL 8
10 9
2.1 General
- 10 10
- 2. 2 Personne1 Qualification 11 11
- 2. 3 Tralnlag 11 12
- 2. 4 Maintenance of Proficiency 13 12 -
14 3.
AUDIT SYSTEM 12 15 3.1 General 12 16 3.2 Essential Elements 13 17
- 3. 3 Audit Planning 13 18' 3.4 Scheduling 19 14 20 4.
AUDIT IMPLEMENTATION 14 21 4.1 General 14 22
- 4. 2.
Preparation 23 4.3 Performance 15 16 24
- 4. 4 Reporting 17 25 4.5 Followup 26 17 27 5.
RECORDS 17 28 5.1 General 13 29
- 5. 2 Audit Records B
30 5.3 Personnel Records
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Draf t 3 Rev. 4 vi Fr.h rim ry.!2. 1473
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TABLE OF CONTENTS (Continued)
Page No.
6.
Revision of American National Standards Referred to B
la this Document
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Draft 3 Rev. 4 vit February 22. 1974
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1 Cautton Notice This standard is being pre.
2 pared or reviewed and has not been approved 3
by The American National Standards Institute.
4 It to subject to revision or withdrawal before 5
issue.
6 7
REQUIREMENTS FOR AUDITING i
8 OF QUALITY ASSURANCE PROGRAMS 9
FOR NUCLEAR POWER PLANTS 10 11
- 1. ' INTRODUCTION 12 1.1 Scope. This standard provides requirements and guldance for estab.
13 Itshing and,lmplementing a system of internal and external audits of 14 quality assurance programs for nuclear power plants,. Including th,e-15 preparatton, performance, reporting, afid folloh) of audits of. quality.-
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assueanEe. pr' geama.lo.r.nucleas. power plants. b:he acttuttles. cove med.
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17 by.this standa.ed include destgatag, pu.rchasing,.1abricating,.handilmg, 18 shipptag.sto: Lag, cleaatag,.e seting, lastalling, inspecting,.tssti,ng, 19 malatatalag, impatslag, and.modLLyLag of. Nuclear Powes.21 ants.
20 21 This standard amp 1 Lites the audit requirements of American 22' National Standard N45. 2 and shall be used in conjunction with that stand.
4 23 ard.
24 25 1.2 Appitcability. The requirements of this standard apply to both Internal l^
26 and external audits performed by or for the plant owner, contractors, and 27 other organizations participating in activities affecting the quality of l
1 28 structures, systems, and components of nuclear power plants which are 29 subject to audit In accordance with requirments of ANSI M45. 2.
This 30 standard is not applicable to surveillance or inspections for the purpose
'It 31 of process control or product acceptance.
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- 1. 3 Responstbility. The organisation or organisations responsible for Imple.
2 mentation of the appitcable requirements of this standard shall be identitled V
3 and the scope of thelt responsibilltles and authorttles shall be documented.
4 The work of estabitshing practlees and procedures and providtag the re.
5 sources In terms of personnel, equipment and services necessary to meet 6
the requirements of this may be delegated to othe*r organisations and such 7
delegation shall also be documented. It to the respossibility of each organt.
sation performlag any activity covered by this standard to comply witis the 8
9 procedures and Instructions Lassed for the project and to conform to the 10 requirements of this standard applicable to kla.wesk the'se settvlties.
11 12 The organtsational structure, functLonal responsiblittles, levels of 13 authority, And Itnes of laternal and external communication for management 14-direction of audits of the Qua.11ty A.sauranca qualtty ass'urance program, 15 shall be documented. Where multiple orga,atzational arrangements extst. -
the laterface responstbt11ttes of each organ!sationha~113e..learly" defined
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17 and documented. In no way shall the performance of audits by an organiza.
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18 tion dimisk dimtatsh the responsibility of the audited organisation or con.
19 tractor for audit of his designated portion of the Qua1 Ley.Assuranca quality
- 20 assurance program.
21 22 1.4 Defintttons. The following definitions are provided to assure a uniform 23 understandtag of select terms as they are used la this standards 24 25 Audit. A documented acttvity performed,tn accordance with written proce.
26 deres or checklists to verify, by examination and evaluation of objective 27 evidence, that applicable elements of the quality assurance Qualley.Aasar.
28 asee program ha$e been developed, documented and effectively implemented 29 in accordance with spectiled requirements. An audit does not include sur.
30 vettlance or inspeetton for the purpose of process control or product accept.
31 ance.
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February 22, 1974 we
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1 Internal Audits Audits of those. portions of an organization's Qualtt.y 2
Assuance quality assurance program retained under its direct control 3
and within its organizational structure.
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External Audits. Audits of those portions of an organization's Qua.1Lty 6
Asawance quality assurance program not retained under its direct control 7
and not within its organ'.ational structure.
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Other terms and their definittons are contained In ANSI N45.2.10.
N45.2.12 Work Group has petitioned N45.2.10 Work Group to 10 NOTE:
11 chagge the definttlons as indicated above.
52 13 1.5 Referenced Documents. Documents that are required to be included as a 14 part of this' standard are identified at the point of reference and described 15 la Section 6 of this standard. The issue or edition of the referenced docu.
ment that is required will be spectite,d either'at the point of reference or in
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16 17 Section 6 of this standard unless otherwise shelfled in the contract document.
18 19 2.
PERSONNEL 20
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21 2.1 General. The responsible audtting organtsation shall select and assign 22 quallfled auditors who are ladependent of any direct responsiblitty for per.
23 formance of the activttles which they will audit.
24 In the case of laternal audits, the persons having direct responsiblitty for 25 performance of the activittes betag audited sha11 not be involved in the 26 selection of the audit team.
27 28 2.2 Personnc1 Qualtftcation. The responsible auditing organization shall establish 29 the audit personnel quatttteations and the recutrements for the use of technt.
30 cal specialists to accomplish the audittng of the QualLty.Aasuaue quality 31 assurance programs. Personnel shall be selected for Clas11ty.Mm-w.e.
32 quality assurance auditing assignments based on expertence or training whteh
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33 establish that their quallftcations are commensurate with the complexity or
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I special nature of the activities to be audt'ted. In selecting personnel for auditing assignments, consideration shall be given to special abilities, 2
3 specialized techalcal training, prior pertinent expertence, personal 4
characteristics and education.
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2.3 Training. Auditing personnel. Including technical specialists, shall have, or be given, appropriate training or orientation to develop their competence 7
8 for performing required audits. Competer.e of pei'sonnel for performance of the various auditing functions shall be developed by one or more of the 9
10 following methods:
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11 2.3.1 Orientation to provide personnel with a working knowledge and understanding of both American National standard N45.2 and 12 13 this standard.
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14 2.3.2 Training programs designed to provide general an. d'specta!! zed
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15 tralning in audit performance. General training shall include fundamentals, c'bjectives, characteristics [ organtaation, perfor.
16 17 mance, and results of quality auditing. Specialtzed training shall include methods of examining, questioning, ayaluating, and 18 19 docurnenting spectile audit items and niethods. of closing out 20
/ audit fladtags.
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2.3.3 On.the. job training, guidance, and counseling under the direct 22 supervision of an experienced, quallfled auditor. Such tratalag 23 shall include planning, performing, repo-ting, and followup 24 acttod favolved in conducting audits.
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26 2.4 Maintenance of Profielency. IndLulduals..regula Ly..performlag.as Qua11.
fled auditors shall maintain their proficiency through one or more of the 27 l
28 following methodst 29 2.4.1 Regular, active participatton in the audit process,
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.4-February 22, 1974
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1 2.4.2 Review and study of codes, standards, procedures. Instructions, 2
and other documents related to Qualltf. Assurance quality assurance 3
programs and program auditing.
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2.4.3 Participation in training or orientatto.n programs as desertbed 6
13 Section 2. 3.
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3.
AUDIT SYSTEM
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3.1 General. This section establishes requirements for a comprehensive audit 10 system which shall be planned, documented, and implemented to verify The audtt
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11 compilance wbth the elements of a quality assurance program.
12 system shallbe desertbed in approved, written policies, plans, procedures, 13 instructions, or such other documents as appropriate.
14 The. objectives of the audit system pelorming.andits.cf.:he. quality 15 assusance.pzoge.am are:
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16 3.1.1'.To determine that a quality assurance program has been developed i
17 and documented in accordance, with spectited requirements:
18 3.1.2 To vertly by examination and evaluation of objective' evidence that 19 the documented program has been Implemented:
20 3.1.3 To assess the effectiveness of the quality assurance program:
21 3.1.4 To identify program nonconformances: and 1
22 3.1.5 To verify correction of identitled nonconformances.
23 24 3.2 Essential Elements of the Audit System. An effective audit system shall be 25 estabitsbed and maintained and shall include the following essenttal elements:
26 3.2.1 A management policy statement or procedure which establishes q
27 organizational Independence and authority and commits the organt.
j, 23 zation to an audit system meeting the requirements of this standard.
29 3.2.2 Manpower, funding, and factittles to implement the audte system 30 o f. audi ts.,
Draft 3 Rev. 4
.5-T kruary 22. 1974
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1 3.2.3 Identtiteation of those responsible for the audit system.
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2 including a deltneation of their authorttles, and responst.
- '3 bt11tles, and organizational Independence.
4 3.2.4 ' Provisions for reasonable and timely access of audit person.
5 nel to factittles, documents, and personnel necessary in the 6
plannlag and performance of the audits.
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3.2.5 Provistons for reporting on the effectiveness 'of the Qua1Lty.
8 As.suranca pitty assurance program to the responsible 9
management.
10 3.2.6 Proviston for access by audit teams to levels of management 11 of the audittag and audited organizations that have the responst.
12 blitty and authority to assure corrective action.
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3.2.7 Provision for vertf1 cation of corrective action on a timely.
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- 3. 3 Audit. Planning. The audit system, including both laternal and external audits.
17 shall be planned, documented, and conducted to assure coverage of the app 11.
18
' cable Qua1Lty. Assurance quality assurance program, and overall coordination 19 and scheduling of audit activities.' Assas.of astarltpaaverage, and.achedu.11ag 20 et.andita,ahalt be.desumented. The audit system shall be periodically reviewed 21 and revised as necessary to assure that coverage and schedule reflect current 22 activitie s.
23 24
- 3. 4 Schedullag, 25 3.4.1 Audtttag shall be initiated as early la the life of the activity 26 as practt' cable, consistent with the schedule for accompitshing 27 the activity, to assure timely implementation of Quality Assus.
28 ames quality assurance requirements. In any case, auditing 29 shall be inttlated early enough to assure effective Qualtty.
10 Amau.ranca quality assurance during the design, procurement t1 and contracting activite.s. activities.
Draft 3 Rev. 4
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February 22, 1974 6-wa s e
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3.4.2 Audits shall be regularly scheduled on the basis of the 2
status and importance of the activities to assure the ade.
3 quacy of, and conformance with, the program. Applicable 4
elements of the Quality Assutaaca. quality assurance program 5
shall be audited at least annually or at least once within the 6
Ille of the activity, whichever is shorter.
7 3.4.3 Regularly scheduled audits should be supplemented by audits 8
conducted of one or more of the following conditions:
9 3.4. 3.1 When it is necessary to determine the capabilit[
10 of a contractor's Quality.Assusance quality assur.
11 ance program prior to awarding of a contract or 12 purchase order.
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- 3. 4. 3. 2 When, after award of a contract, suffletent time has 14 elapsed for impismenting the.Qua2Lty. Assurance f, (
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15 quality assurance program and it is appropriate to 16 determine that the organization is ade,quately per.
17 forming the functions as defined in the-Quality Assur.
18 ance quality assttrance program description. codes,
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19 standards, and other contract documents.
20 3.4.3.3 When sigolficant changes are made in functional 21 areas of the Cus.11ty..A u"-*v.a. quality as surance' 22 program such as significant reorganization or pro.
23 cedure revisions.
l 24 3.4. 3.4 When it is sus pected that the quality of the item is 25 in jeopardy cse to nonconformances in the Quality f
26 Assurance quality assurance program.
27 3.4.3.5 When a systematic, Independent assessment of 28 program effectiveness is considered necessary.
29 3.4. 3. 6 When It is necessary to verify implementation of k
30 required corrective actions.
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1 4.' AUDIT IMPLEMENTATION 1
2 3
- 4.1 Ceneral. ' Individua1 audits shall be implemented as scheduled and planned 4
in Section 3.
The mechantes involved in implementation of an audit are
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5 preparation, pe'rformance, reporting, and followup.
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- 4. 2 Preparation. Preparation includes the development of a written audit 8
plan, the selection and orientation of the auditor (s), and notification of the 9
organization to be audited.
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- 4. 2.1 Written Plan An individual audit plan describing the audit to be 11 performed shall be developed and documented by the auditing organi.
12 sation. This plan shallidentify the audit scope, the requirements, 13 the activities to be audited, organizations to be notified, the app 11 14 cable documents, the schedule, and written procedures or checklists.
15 4.2.2 Team Selection. One or more individuals comprise an audit. teams
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16 however, it is preferable that a team of at leapt Mo quallfle'd indt ~
17 viduals perform an audit. One of the members shall be appointed 38 as'the leader for each audit team. His responsibilities include 19 orienta' tion of the team, coordinating the audit process, establishing 20 the pace of the audit, assuring communications within the team and 21 with the organization being audited, participation in the audit per.
22 formance, and coordinating the preparation and "=suance of reports.
23 4.2.3 Team Orientation. The team leader shall assure that the audit team 24 is prepared prior to initiation of the audit. Pertinent policies, proce.
25 dures, standards, instructions, codes, regulatory requirements, and 26 prior audit reports, shall be made available for information and re.
27 view by the auditors. Each auditor shall be provided with the audi.
28 plan and the procedures or checklists which are necessary to assure 29 orderly accomplishment of the audit. During the famillarization phase 30 of the audit, particular attention shall be directed toward an under.
31 standing of Internal and external organi=ational and contractual inter.
32 faces and responsibilitics of the organization to be. audited.
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'1 4.2.4 Audit Notification. Involved organizations shall be notified of a 2
scheduled audit a reasonable time before the audit'Is to be performed.
3' This notification should be in, writing and include g
--1 such infor.
4 mation en as the scope and schedule of the audit schaAde.of. meetings 5-and. method.of. audit. and the name of the audit team leader. Un.
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announced audits may be performed with prior agreement of the 7
parties involved.
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- 4. 3 Performance..
- s Pre audit Conference. A brief pre audit conference shall be con.
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ducted *at the audit site with cognizant organization management. The i[
12 purpose of the conference shall be to confirm the audit scope, present
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13 the audit plan, introduce auditors, meet counterparts, discuss audit 14 sequence and plans for the post. audit conference, and establish I
15 channels of communication.
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- 4. 3. 2 Audit Process.
B 4.3.2.1 Checklists or procedures sEall be used to ensure depth and 19 continuity of audits. The. audit checklist is intended for use 3
20 as a guide and should not restrict the audit Investigation i
21 when findings raise further questions that are not specif!.
!f 22 cally included in the checklist.
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23 4.3.2.2 Objective evidence shall be examined for compliance with I>l l
24 quality assurance ' program requirements.
25 4.3.2.3 Selected elements of the quality assurance program shall 6
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26 be audited to the depth necessary to determine.whether or 1
27 not they are being implemented effectively.
t 28 4.3.2.4 When a nonconformance is Mentified as a respit of an audit,
'f 29 further investigation shall be conducted by the audited 30 organization in an effort to identify the cause and effect of 31 the nonconformance and to determine the extent of the
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32 corrective action required.
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1 4.3.2.5 Elements found to be nonconforming should be acknow.
2 ledged by a member of the audited organization.
3 4.3.2.6 Nonconformances shall.be -^r-+.d.at.the-pos.t.audte.com.
4 fasence, requiring Immediate corrective action shall be 5
reported immediately to management immedia.t.ely of the 6
audited organization.
7 4.3.2.7 Specific attention should be given to corrective action of 8
nonconformances identified durIng previous audits.
9 10 4.3.3 Post Audit Conference. At the conclusion of the audit a post-audit 11 conference shall be held with mansgement of the audited organization 12 to present audit findings and clarify misunderstandings. The detailed 13 observations of the auditors should be reviewed and an understanding 14 reached as to the facts determined during the audit. This understanding 15 should be recorded and signed by bEth partitsr.^
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17 4.4 Reoorting. An audit report shall be written and signed by the audit team
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18 leader which providest 19 4.4.1 Description of the audit scope 20 4.4.2 Identification of the auditors 21 4.4.3 Persons contacted during pre audit, audit, and post. audit activities.
22 4.4.4 A summary of audit results, including an evaluation statement re.
23 garding the effectiveness of the CA quality assurance program ele.
24 ments which were audited.
25 4.4.5 Details of nonconformances. Identify and prepare a descriotion of 26 each nonconformance in sufficient detatt to assure that required 27 corrective action can be effectively carried out by the audited organi.
28 zation.
29 4.4.6 Recommendations for correcting nonconformances or improving the 30 CA quality assurance program as appropriate.
31 Distribution of the report shall include responsible management of both the 32 audited and auditing organizations., The audit report shall be issued within Draft 1 Ile v. 4 F
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I thirty days after the audit.
2 3
- 4. 5 Followup.
4 4.5.1 By Audited Organization, Management of the audited organization 5
or activity shall review and investigate tha any adverse audit
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6 findings to determine and schedule appropriate corrective action 7
including action to prevent recurrence and shall respond to the 8
report in writing within thirty days after receipt, giving results 9
of the review and investigation. The response shall clearly state 10 the corrective action taken to prevent recurrence. In the event that 11 corrective action cannot be' completed within thirty days, the audited 12
. organization reply shall include a scheduled date for the corrective
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'13 action. The audited organization shall provide a followup report 14 sta' ting the corrective action taken and the date corrective action 15 was completed. They shall also take appropriate action to assure 16 that corrective action is accomplished as scheduled.
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17 4.5.2 By Auditing Organization. Followup action shall be, performed by the 18 audit team leader or management of the auditing organization to:
19 4.5.2.1 Assure that. Obtain the written reply to the audit report.
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20 1.s.. receive d 21 4.5.2.2 Evaluate the adequacy of the response.
22 4.5.2.3 Assure that corrective action is identified and scheduled 23 for each nonconformance.
24 4.5.2.4 Confirm that corrective action is accomplished.as 25 s cheduled.
26 Followup action may be accomplished through written communication, 27 reaudit, or other appropriate means.
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28 29 5.
RECOR DS
..l 30 5.1 General. Records shall be retained by the auditing organizations responsible 31 for activitics associated with implementation of this standard. These records 32 shall be collected, stored, and maintained in accordance with American
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33 National Standard N45. 2. 9.
b Draft 3 Rev. 4
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1
- 5. 2. Audit Records. Records shall be generated and retained for all audits.
2' Records shall include audit progsmplans system plan, individual audit, P ans, audit reports, written replies, the record of completion of correc.
l 3
4 t!ve actions, And documents associEted with the conduct of audits which
. support audit findi~ gs and corre'ctive actions as~ appropriate.
5 n
6 7
- 5. 3 Peisonnel Records. Records.shall be.mainta.ined otalt personnel actively.
8 Po
- f** ming.sudits.and..tho s o.who.ha.ve. previ ous ry..pe.rfo rm-A- andits. m.11hin.
9 th.same-project.az.a. cal =1ty. Records shallinclude the qualifications and training of auditors *and shallb' retained for the same period'of time as 10 e
11 required for the audit report with which'the auditors are associated.
12 -
13 6.
REVISION OF AMERICAN NATIONAL STANDARDS REFERRED TO'IN THIS -
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15 DOCUMENT 16 Whe,n the following standards referred to in this~ document are superseded 17 by a revision approved by the American National' Standards Institute, the re.
18 vision shall apply.
19 N45. 2,
Quality Assurance Program Requirements for Nuclear 20 Power Plants 21 N45. 2. 9 Requirements for Collection, Storage and Maintenance of Quality 22 Assurance Records
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23 N45. 2.10 Quality Assurance Terms and Definitions I
Draft 3 Rev. 4 12 -
February 22, 1974 er g
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