ML19312B642
| ML19312B642 | |
| Person / Time | |
|---|---|
| Site: | 07100179 |
| Issue date: | 10/09/1979 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Housholder W NUCLEAR CONTAINERS, INC. |
| References | |
| NUDOCS 7910220167 | |
| Download: ML19312B642 (15) | |
Text
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UNITED STATES
[Y NUCLEAR REGULATORY COMMISSION 9 C WASHINGTON, D. C. 20555 t
o OCT 0 91979 FCTC: RHO 71-0179 Nuclear Containers, Inc.
ATTN: Mr. William R. Housholder P.O. Box 1080 Elizabethton, TN 37643 Gentlemen:
This refers to your application dated March 22, 1978 requesting approval of your Quality Assurance (QA) program as meeting the QA program requirements of 10 CFR 571.51.
Your QA program description should include a discussion of how the applicable requirements of Appendix E to 10 CFR Part 71 will be satisfied. To assist you in preparing this information, we have enclosed the acceptance criteria the staff uses to evaluate a licensee's QA program for transportation packages for radioactive material. Please revise your ' A program description to address the asterisked items of the enclosed criteria and submit seven copies of the revised program within 60 days following receipt of this letter.
If you have any questions regarding this request, please feel free to contact Mr. Jim Conway at (301) 492-7741.
Sincerely, 1
Charles E. MacDonald, Chief Transportation Certification Branch Dhision of Fuel Cycle and Material afety, NMSS
Enclosure:
Acceptance Criteria
/ 6 7' 7910220
.4
e e
(
10 CFR 71 - APPENDIX E ACCEPTANCE CRITERIA - TRANSPORTATION PACKAGES FOR RADI0 ACTIVE MATERIAL l
The creanitation (17.1.1) elements responsible for the 04 progrant are acceptacle if:
k.
The responsibility for the QA program is retained and exercised by the appifcant.
l
- r-I2.
The CA/CC functions, ;erforwed by tne applicant's QA 5rganization or delegated to other organizations, are identified and described, providing controls to assure all elementsofAependia(willbeimplemented, d 3.
Clear and ef'ective lines of coreunication tetween the CA organizations of the appli-cant and nis principal contractors are establisned to assure croper direction of the QA program and resolution of CA problems.
Y 4.
Organi:stion : darts identify the "onsite" and "offsite" organizational elements wnich function ander the control of the OA program Isuch as Oesign Engineering, Procurement.
I Manufacturing Construction, Inspecting (QC), Testing, and 0A] and demonstrate ade-ouate control over quality ascects within and between organizations,.
h5.
The inter
- ace relationsnips ano QA responsiblitties of each organt:stional element identified in item 4 above are described and demonstrate assignment of responsibilities l
for requirements of Appendix 5
)
N6.
A high level of management is responsible for establishing the corporate or company j
QA policies, goals, and objectives and this management level maintains a continuing involvment in QA matters. Comunication through any intermediate levels of management between this position and the Manager (or Director) of OA must be shewn to te effective.
N7.
The applicant designates a position, to be filled by a quali# icd individual, to retain f
overall authority and responsibility for the QA program.
D.
The authority and independerce of the individual responsible for managing the OA program are such that ne can direct and control the organization's OA/0C program, 17.1-5 I
M 11/24/75-
. - ~ _
t
- an effectively assure the conformance to quality requirements, and is indepencent of undue influences and responsibilities for schedules and costs. An acceptable organi-zational structure would have this individual report to at least the same organizational level as the highest line manager directly responsible for perfoming activities affect-ing quality.
~
h Pisitions or groups responsible for defining and controlling the content of_the QA program and related manuals and the management level responsible for final review and apprgval have appropriate organizational position and authority.
10.*
Thelerson responsible for directing and managing the CA program at the constryction na site has appropriate organizational position, responsibilities, and authority to exer-cise proper control over these functions. - This ' individual is free of non-0A duties and can thus give, full-attention to assuring that the CA program-at the plant site
.. ~
is_betng 4ffectively implemented.
1.
The qualification requirements for the principal CA/QC management positions demonstrate competence comensurate with the responsibilities of these positions.
A12.
Verification of conformance to established requirements is accomplished by individuals 4
or groups who do not have direct responsibility for performing the work being verified.
13.
Persons and organizations performing CA/QC functier.s have direct access to management levels.hich will assure accomplishment of quality-affecting activities. These per-sonnel have sufficient authority and organizational freedom to perform their QA/QC functions effectively and with_out reservation. They can:
a.
Identify quality.pechlems.
Ns, b.
Initiaterricocinend, or provide solutions througn' designated channels.
- Verify implementation of solutions.
M4 Designated QA individuals have the responsibility and authority., delineated in writing,
-m to stop unsatisfact3ry work and control further processing, delivery, or instaliscion of nonconforming material.
The Ouality Assurance Program (17.1.2) description is acceptable if:
1.
Meashes are provided by the applicant and.his principal contractors that demonstrate how their.QA-oregram meets'10 CFR Part 50, Appenait 5 criteria.
N2.
Managemen* (i.e., above or outside the QA organization) regularly assesses the secoe, status, implementation, and effectiveness of the QA program to assure that the program is adequate and complies with 10 CFR Partp, Appendix E criteria.
M3.
Measures are provided by the applicant to assure that trained, qualified personnel within his organization are assigned to cetermine that ; unctions celegated to his principal contractors are teing properly accomolisned.
- 17.1-6 11/24:*:
..g
9 h.
A trief swerary of the Company's c:rporate CA policies goals, and cejectives is given
. and a meaningful channel for transmittal of these policies, goals and objectives down througn the levels of management is established.
5.
The CA program procecures are derived from OA policies, goals, and objective >.
NS.
CA/QC respons10111 ties are desi Mated for the implementation of the major activities contained in the OA manuals.
,re r.
M.
Provisions are established to centrol the distribution of the CA manuals and revision's thereto.
-)(S.
Provisions are established for conrtunicating to all responsible organizations and individuals that qualtiy :olicies. QA manuals and precedures are mandatory require-ments are crocedurally controlled.
A listing of the CA procedures Dlus a matrix of these ;rocedures cross referenced to eacn criterion of Appendix hto 10 CFR *artj( demonstrates that A;cendix 3 :rovisi:ns are fully imolemented my documented :cocedures.
k3.
The safety related structares, systems, and ::m:orents c:ntrolled by the OA =rogram are identified.
-)( 11.
- he a olicant reviews and documents agreement with the CA program provisions of his princical :entractors to the extent that he can te assured that Accendix 3 will be implemented.
k12.
Provisions are estaclished "ir the resolution of disputes involving quality, arising from a difference of opinion between ;A/0C ;ersonnel and other decart: rent (engineering.
procurement, manufacturing, etc.) personnel.
413.
An indoctrication and training program is establisned sucn that:
Persennel res;ensible for perfoming cuality-af fecting activities are instructed a.
as to the surcose, sco;e and implementation of the :n.ality-related manuals.
instructions. and precedures.
b.
Personnel ;erfcming quality-affecting activities are trained and qualified in the 3rinciples and tecnniques of the activity being perfomed.
c.
The sc:ce the Objective, and the method of implementing the indoctrination and training crogram are documented.
d.
Proficiency of :ersonrel :erforming ouality-affecting activities is maintained ty retrainteg, reexamining, and/or recertifying.
14.
Quality-related activities initiated prior to the summittal of the PSAR. such as design ;*ccurement cre:arati0n of the PSAR, and safety-related site creoaration activities are 'fentified and ::ntrolled under a ;A :rogram =ntes satisfies tne *ecuire-ments of i3 ;F1 : art 5;. 2:cen:1x ! and tre ;uisance ::ntsiced in the Regulatory Lt:ss and ANSI stancar:s listes in 3ection V of this 3:ancard 3eview ?!an.
17.1-7 i
Mi 11/2:/75
e 70 5.
Quality-related activities are performed with specified equipment and under suitante environmental conditions, and prerequisites have been satisfied prior to inspectier, and test.
16.
The applicant and nu principal contractors demonstrate that their QA pmgrams comply with the Regulatory Guides (current issue) and ANSI standards If sted in See:1on V of this Standard Review Plan or descrite acceptab"le alternatives in equivalent detail.
Additional Regulatory Guides dealing with QA nhose implementation dates are prior to the SAR submittal date shall ce similarly address'ed.
17.
A surinary description of advanced planning demonstrates centrol of quality-related activities including management and technical interfaces between the constructor, A/E, NSSS vender, and utility during the phasecut of design and construction and during preoperational testing and plant turnover.
18.
A comit eet is mase to control the preoperational test program, formulated after PSAR submittal and orf or to FSAR submitial, in accorcance with the CA program.
19.
Provisions are provided for keeping the QA crogram, described in the SAR, current.
20.
Regulatory Guice 1.23 lRef. 2) is comolied.itn or acceptable alternatives are provided.
Activities related to Desi n Control (17.1.3) are acceptable if:
t hl.
weasures are estaolisneo to carry out designs activities in a planned, controlled, and orderly m.anner.
N2.
easares are estaD11shed to correctly translate the apolicable regulatory requirements w
and design bases into specifications, drawings, written procedures, and instructions.
.<.9 3.
Quality stardards are spacified in the design documents, and deviations and changes from nese quality stancards are controlled.
t M4 Suitable design controls are applied to such activities as reactor physics; seismic, stress, thermal, hydraulic, radiation, and accident analyses; compatibility of materials; and accessibility for inservice inspection, maintenance, and repair.
35.
Designs are reviewed to assure that (1) design characteristics can be controlled, inspected, and tested and (2) inspection and test criteria are identified.
6.
Internal and external design interface controls are established. These controls include the review, approval, release, distribution, and revision of decuments involving design interfaces with particioating design organizations.
)
17.1 8 11/24 75
/
.c
t I7.
Proper selection and acc0mplishment of design verification or enecking : recesses sucn as by destgn reviews, alternate calculations. or cualification testino are performed.
'anen a test orogram is used to verify the adecuacy of a design, a qualification test of a prototype unit ander adverse design conditions snall be used.
k3.
Individuals or ;rcuss responsible for design verificaticn are otner thcn the original designer and the designer's 1 rediate supervisor, k9.
Oesign and soecification changes, including field changes. are subject to the same design controls and a:orovals that mere apolicaole to the original desi;n unless the a:plicant designates anctner cualified resacnsible ar;4ni:ation, kl0.
Errors and deficiencies in the design, including tne design process, that could adverseiy affect safety-ettated structures. Systems and comocnents are documnted; and corrective action is taken to preclude reoatition.
N, w tertals. car ts, and toutsment anich are standard, camercial (off the shelf) er which il a
have been oreviously scoroved f:r a different a:olication are reviewed for suitability orter to selection.
$12.
The costtices Or grea:s res:ensible for design eviews and etner :esign verificatice activittes and ta.ei-sutnority and res:ensittlity are icentified and conte:11ec :y aritten crocecures.
13.
Mensures are established for the selection of suitanle aterials. = arts, ecui: ment, and crocesses 'or safety-related structures, syste*s. and comoonents anich ircluce the use of valid incastry standards and s:ecifications.
14 Ngulatsry hide 1.M (cef. 9) is c:molied with or acceptacle alternatives see N
- resented.
Activities related to Seccur**ent heument 0 ntrol (17.1.4) are acceptable if:
N1, Procedures are estaclisned that clearly delineate the secuence of actions to te accom-olisned in the preoaration, review, approval, and control of crocurement documents.
M.
A review and concurrence of the adequacy of ouality recuirements stated in procureatnt documents is aerformed by qualified personnel. This review should determine that cuality recuirements are correctly stated, ins:ectacle, and controllable; there are adeouate accectance and rejection criteria; and the crocurement docurrent has been at:aared. reviewed, and accroved in accordance with CA crogram recuirements.
$3.
The review see a:oroval of Orecurement documents are dccumented orter to release and available 'or vertfication.
17.1-3 11/24C5
N4 Procurement docwents identify the applicable 10 CFR Partj(. Accendix & requirements which must te complied with and described in the supplier's CA program. This CA pro-gram or portions thereof shall be reviewed and concurred with by qualified personnel in QA prior to initiation of activities affected by the program.
MS.
Procurement doc eents contain or reference the design casts technical requirements including the applicaole regulatory requirements, material and comconent identification requirements, drawings specifications, codes and industrial stardards, test and inspection. requirements and special process instructions.
M6.
Drocurement documents identify the documentation (e.g., drawings specifications pro-ceduras. inspection and fabrication plans, inspection and test records personnel and procedure qualifications, and chemical and physical test results of material) to be prepared, maintained, and submitted to the purchaser for review and approval.
M7.
Procurement documents identify tnose records to be retained, controlled, and maintained by the sucolier, and those delivered to the purchaser ori:r to use or installation of the hardware.
%3.
Procurement documents c:ntain the procaring agency's rignt of access to supplier's facilities and records for source inscection and audit.
$9.
Changes and revisions to procurement documents are subject to st least the same review and sporoval as the original document.
$10.
D*ocuremer.t documents for spare or repiscement parts of safety-related structures, systems, and components are subject to controls at least equivalent to those used for tne original equipment.
11.
The requirenents and ;uldelines of ANSI N45.2.13 Pef.16) are complied with or m'
acceotaole alternatives are provided.
Activities related to Instructions, Deccedures, and Orswings (17.1.5) are acceptable, if:
%1.
Activities affecting quality are prescribed and accomolished in accordance with docu-mented instructions, procedures. or drawings.
. g 2.
Provisions are established which' clearly delineate the sequence of actions to be secomolished in the preparation. review, approval. and control of instructions, pro-cedures, and drawings.
h3.
Wethods for c0molying with eacn of the 18 criteria of 10 CFR Partp Appendia {
are specified in instructicns. procedures, and deswings.
$4 Instructions, procedures, and deswings include quantitative (such as dimensions.
tolerances, and operating limits) and qualitative (such as.orkmanshio samples) acceptance criteria to verify that important activities aave been satisfactority j
sc:~oli?*ed.
i j
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b Yb5.
The CA orgraization reviews and concurs niin inspection plans; test, calieration, sna special process procedures; drawings and s;ecifications; and changes thereto or ac:eptaols alterratives are describec Activities rel tied to Document Control (17.1.6) are sc:eptacle if:
-k 1.
The revies, accroval, and issue of documents (suen as listed in iten 3 telcw) and enanges thereto, :rior to release, are grccedurally controlled to assure tney are adequate and the cuality requirements are stated.
'J ia l
7T-2.
- rovisions are estacif sned anten identify tnose indivicaals or groups resconsiole for reviewing, soproving, and issuing documents and revisicas thereto.
)[ 3.
Changes to documents are reviewed and approved by the same organi:stions that performed the original review and approval or oy otner qualified responsible organi:ations cele-gated of the acol' cant.
i(a.
Accroved :nanges are included in instructions, procecures, drawings, and otner docu-ments prior to imolementation of tre ceange.
465.
^tsolete or su:ersedec :ccurents are :entrolled to ;revent inadvertent use.
j( 6.
Occaments are availacle at tne locatien enere tne activity nill ce performec or cr to c:mrencing tne nors.
3h 7.
A.9 aster list or eouivalent is estaclisnec to identify tne current revision numoe* of instructions, procedures, specifications, deswings, and procurement documents. This list is uccateo anc 31stricuted to predeterminea, res ensible personeel to creclu:e use of sacerseded :ccuments.
a9i Ih3.
The documents tnat are controlled under this suosection are identified in tne PSAR.
As a minimum this snould include; a.
Oesign specifications.
3.
Design, manufacturing, construction, and installation drawings.
c.
c.
0A m.anuals.
t.
PSAR and related design criteria documents.
f.
Manuf acturirg, insoection, and testing instructions, g.
Test crocecures.
n.
Design enange requests.
1.
Nonconformanca reocrts.
Activi;'es related to Control of Durchased w teeis1,'iouitment, and Services (17.1.7) are a
accept 3 Die if:
i 17.1 11 11/21/75
kl.
Qualified personnel evaluate the supplier's capability to provide acceptable quality
~
services and produc*s before the award of the procurement orcer or contract. The QA and engineering groups participate in the evaluation of those suppliers providing critical components.
k2.
The evaluation of suppliers is based on ne or more of the following:
a.
The suco11er's capability to comply with the elements of 10 CR Dart 50. Appendix B that are applicable to the type of material, equipment, or service being orocured, b.
A review of previous records and performance of suppliers who have provided similar articles of the type being procured.
c.
A survey of the supolier's facilities and OA program to determine his capability to suco1y a product ahich meets the design, manufacturing, and Quality requirements.
K3.
The results of supplier evaluations are documented and filed, p.
Surveillance of suppliers during fabrication, inspection, testing, and shipment of materials, equipment, and components is planned and performed in accordance with aritten procedures to assure conformance to the purchase order recuirements. TIese procedures provide for:
a.
Instructions tnat specify the enaracteristics or processes to te witnessed, inspected or verified, and ac:epted; the method of surveillance and the axtent of cocumentation recuired; and those responsible for imolementing these instructions.
5.
Audits and surveillance anich assure that the supplier complies with the quality reoutre=ents. Surveillance is performed on those items wnere verification of procurement requirements cannot be detemined uson receipt.
/Hi.
The sw ?1ier furnisnes the following records as a minimum to the purchaser:
W 3.
Documentation :nat identifies the purenased waterial or equipment and the specific procurement recuirements (e.g., codes, standarcs, and specifications) met by the items.
b.
Documentation that identifies any precurement requirements which have not been met togetner with a description of those nonconformances dispositioned " accept as is" or " repair."
The review and acceptance of these documents shall be described in the purchaser's QA program and as a minimum shall be undertaken by a responsible QA individual.
d6.
Sucolier's certificates of conformance are :eriodically evaluated by audits, indeoendent inscections, or tests to assure they are valid.
i
$7 Receiving inspection of the supplier-furnished material. equipment, and services is performed te assure:
17.1-12 11/24/75
@d
o fhe material, component, or equipment is Oroperly identified and corres0 ends with S.
the identification on receiving doc:. mentation.
4ter131, compo9ents, equipments, and acce:tance records are inspected and judged 3.
4 acceptable in accvdance with predetermined ins;ection instructiers, prior to installation or ase.
C.
Insoection records or certificates of confomance attesting to the ac:eptance of material, c moonents, and eculpment are avail 4 Die at tne nuclear pcwer plant prior to installation or use.
d.
Items accepted and released are identified as to tneir inspection status prior to forwarding t%e* to a c:ntrolled 5t:rsge area or releasing them for installation or fartter nort.
k3.
The effectiveness of the control of quality by sucoliers is assessed by the acclicant at intervals :onsistent with the importance, comolexity, and Quantity of the item.
3.
$sare or replacement : arts of safety-related stru:tures, systems, and com:enents are subject to controls at least equivalent to those used for the original ecui:rtent.
10.
Pe recairer:ents ard paidelines of ANSI W5.2.13 (Ref.16) are complied itn or acctota:la a'ternatives are orovioed.
of w ttainls, Darts, sed Ocmoceemts Activities -elated t: Mentf *4:stion and Ort *ol a
(17.1.3) s-e sc:e: tao e if:
-1(. l.
3roced;res are establisned to identify and :ent-ol materials, parts, and ::moonents inclading cartially faoricated sucassemolies.
$ 2.
Identification require-ents sre detemined during generation of s ecifications and design teswings.
-s k3.
The identificatien and control orocedures assure that identification is maintained ett9er on tne item or on records tracesole to the item to creclude use of incorrect or :efective items.
44 Identification of materials and parts important to the function of safety-related structures, tystems, and comoorents can te traced to the appropriate documentation suen as drawings, specifications, ;urchase orders, ma9ufacturing and insoection documents, deviation reports, and physical and chemical mill test recorts.
f5.
The locatica, and the method of identification do not affect the fit, function, or owality of the item teng identified.
$5.
orrect identificatten of material, parts, and ::moonents is verified and docut ented prior to _ release for fierication, assemoling, shi: ping, and installation.
Activities related to Cantrol of Soecial 3-ocesses (17.1.3) are ac:eptaole if:
17.1-13 9
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-)( 1.
Special stocesses such as nelding, heat treating, nondestructive testing, and cleaning-are procedurally controlled.
jf2.
Procedures, ecui; ment, and personnel conrected witn special processes are qualified in accordance with applicable codes, standards, and scecifications.
y3.
Special processes are performed by qualified personnel and accomplished in ac:ordance witn ritten process sheets or equivalent with recorded evidence of verification, g4 Oualification records of procedures, equipment, and :ersonnel associated with s:ecial processes are established, filed, and kept current.
5.
Regulatory Guides 1.37 (Ref. 4),1.39 (Ref. 5), and 1.54 (Ref. 7) are canplied with or acceptaole alternatives are provided.
Activities related to In nection (17.1.10) are acceptaole if:
f1.
An ins:ection orogram hten verifies confomance of :uality-affecting activities with recairements is established, documented, and ac::molished in accordance with aritten controlled procedures.
g2.
Ins:ection ;ersoneel are independent from tne individuals ;erforming the activity, tetng insee:ted.
Ins:ection procedures, instructions, and check lists provide for tne following:
a.
Identification of characteristics and activities to be insoecteo.
1 b.
Identification of the individuals or groups resconsible for performing tne insoection 3:eration, c.
Acceotance and rejection criteria.
d.
A description of the method of inspection.
e.
Recording evidence of completing and verifying a manufacturing, inspection, or test operation.
f.
Recording inspector or data recorder and the results of the inspection operation.
M.
Inseecticn procedures or instru'. ons are used witn necessary drawings and s ecifi-cations nnen perfoming inspection operations.
g5.
Insoectors are qualified in accordance with applicable codes, standards, and comoany training programs; and their qualifications and certifications are kept current.
%5.
Modifications, repairs, and replacements are inspected in accordance w1:n the original design and inspection requirements or ac:eptable alternatives.
h'.
Provisions are establisned that identify =andatory inspection hold points for nitness by an inspector.
17.1-14 11/24/75 n4
3.
The individuals or groups wno ;erform receiving and process verification inspections at tne construction site are identified and snown to have sufficient inde endence and QualificatiCns.
.)D.
Provisions are establisted fer indirect c:ntrol by monitoring processing methods, equipment, and :ersonnel if direct inspection is not possible.
10.
Regulatory Guides 1.30 (Ref. 3).1.58 (Ref. 3),1.94 (Ref.13) and the reoutrements and guidelines of ANSI N45.2.8 (Ref.14), and *i45.2.13 (Ref.16) are complied with or accept-able alternatives are provided.
Activities related to Test C:ntml (17.1.11) are acceptacle if:
A test program to temonstrate that the item will perform satisfactorily in service is esta31tsted, documen*ed, and accomplisned in accordance with written controlled precedures.
42.
wodifications, reasirs and replacements are tested in accordance with the original design and testing requirements or acceptable alternatives.
h.
Written test procedures inc:r: orate or reference:
4.
The requirements and acce:tance limits containes in acclica:le Oesign and pro-curement documents, b.
Instractions for perforating the test.
c.
Test arerequisites sucn as:
. Calibrated instrumentation.
Adecuate and accrecriate equipment.
Trained. qualified, and licensed or certified personnel.
. Completeness of item to :e tested.
P" Suitable and controlled environmental conditions.
Provisions for data collection and storage, andatory ins ection hold points for witness by cwner, contractor, or inspector.
d.
w e.
Acceptance and rejection criteria.
f.
Methods of documenting or recording test data and results.
K4 Test risults are documented, evaluated. and their acceptability determined by a qualified, resconsible individual or group.
5.
Regulatory Guides 1.30 (Ref. 3) 1.53 (Ref. 3), and 1.94 (Ref.13) and the requirements and guidelines of AN5! N45.2.3 (Ref. '14) are complied with or acceptable alternativ,es art provided.
Activities related to Control of weasurino and Test Ecutement (17.1.12) are accentasle if:
gl.
Provisions, contained in procedures. cescribe tne calibration tecnnique and frequency.
maintenance, and control of t*.e measuring and test equipment (instruments, tools.
17.1-15 M
11/24/75
gages, fixtures, reference and transfer standards, and nondestructive test equipment) wnich is used in tne measurement, inspection, and monitoring of safety-related comoo-nents, systems, and structures.
. easuring and test equipment is identified and traceable to the calibration test data.
)(2.
w
[ 3.
Measuring and test equipment is labeled or tagged to indicate date of the next calibration, I4.
Measuring and test instruments are calibrated at specified intervals based o,n the nw required accursey, puroose, degree of usage, stability enaracteristics, and other conditions affecting the measurement.
US.
Measures are taken and documented to detemine the validity of previous inspections ce*fo med when measuring and test equipment is found to be out of calibration, k-5.
Calibesting staccards have an uncertainty (error) recuireeent of no more than 1/4tn of tne tolerance of the eculpment being calibrated. A greater uncertainty may be acceotaole aren limited oy the " state-of-the-art."
)( 7.
!$e comolete status of all items ander the calibration system is recorded and maintained, g3.
Reference and transfer standards are tesceable to nationally recogniced standar:s; or, nnere national stancards do not exist, provisions are established to document tne basis for calibration.
Activities related to daneliac. Storage, and Shiccina (17.1.13) are acceptable if:
kl.
Scecial hanoling. : reservation, storage, cleaning, packaging, and snipoing requirements are estan11shed and accomolisned by qualified individuals 11 accordance witn credeter-mined nork and inspection instructions.
g2.
8cocedures are prepared unicn control the cleaning, nandling, storage, packaging, snipping, and preservation of materials, components, and systems in accordance with design and specification requirements to preclude damage, loss, or deterioration ny environmental conditions suen as temperature or humidity.
3.
Regulatcry Guide 1.38 (Ref. 5) is complied with or acceptable alternatives are provided.
Activities related to *nsoection, Test, and Oeerating Status (17.1.14) are acceptable if:
Kl.
Identification of the inspection, test, and operating status of structures, systems, and cococnents is known :nrougneut manufacturing and installation.
%2.
The application and removal of inspection and welding stam:s and status indicators such as tags, markings, labels, tr1 stamos are procedurally ecntrolled, i
17.1-16 11/21/75 43
k
-)( 3.
3ypassing of required inspections, tests, and other critical perations is procedurally controlled under tre cognizance of the OA cr;aniza in.
p.
The status of noncanfor'iing, inoperative, or malfunctioning structures, systems, or c:mconents is identified to prevent inadvertent use, a tivities relates to Nenc:nfor9tno Materis15. 8 arts. or Com:enents (17.1.15) are acceptable c
if:
.c4 kl.
The identification, documentation, segregation, review, dispositi:n, and notification to affected organi:stions of nonconfoming. materials, : arts, cora:enents, or services are procedurally controlled.
k2.
Occumentation identifies the conconfoming item; describes the nonc:nfomance, the dis:ositi:n of the nonconfor"ance, ano the ins:ecticn -eou'rements; and includes signa.
ture a:oroval of ne dis:ositi:n.
M3.
Provisions are estaolisned identifying those indivituals or grouss delegated the resconsioilit/ and autNority for the dis:csitic?. and accroval of nonconforming items.
p.
Nencen':r9ing items tre segregated f*om sc:e:ts le iteas snc icentied as siscrecant
.nt:1 :r::erly dis::st ti: red.
D.
Acce:tacility of rewort r recair of materials, : arts, c: corents, systems, and st uc-tares is verifiec ey reins:ecting anc retesting tNe item as originally inspected and tested or by a method anicn is at least ecual t: the original ins:ection and testing metnod. Inspecticn, testing, rewort, ano re: air crocedures are decamented.
h.
N0nconforaance reccets disocsitioned " accept as is* or " repair" are mace : art of ne ins:ectt:n ree:rds and forwarded witn the hardnare to the utility 'or review and assessment.
$7.
Nonconfomance re: orts are :eriodically analyzed to snew quality trends, and the results are reported to management for review and assess. ment.
Activities related to Careective Actien (17.1.16) are ac:ectacle if:
- 1.
Evaluation of conditions adverse to quality (such as nonconfermances, failures, mal-functions, deficiencies, deviations, and defective material and equicment) is con.
ducted to detemine tre need for corrective action in ace:rdance with estaolished procedures.
.{t2.
Corrective action is initiated following the detenination of a condttion adverse to qualtty to precluce recurrence.
'p.
Follow-so reviews tre conducted to verify procer imoleentation 3f corrective actions and to close out the corrective action documentation.
17.1-17 4
11/24/73
g4 Significant conditions aoverse to quality, the cause of the conditions, and the cor.
rective action taken are reported to cognizant levels of management for review and assessment.
Activities related to Cuality Assursnee s cords (17.1.17) are acceptable if:
e gl.
Sufficient records are maintained to provide documentary evidence of the quality of iterris and the activities affecting quality.
g2.
QA records include operating logs; results of reviews, inspections, tests, audits.
and material analyses; monitoring of work performance; ;ualification of personnel, procedures, and equipment; and etner documentation sucn as drawings, specifications, procurement documents, calibration procedures and reports; nonconfomance reports; and corrective action reports.
3.
Records are identifiable and retrievable.
g4 Requirements and responsibilities for record transmittals, retention (such as duration, location, fire protection, and assigned responsibilities), and 9aintenance subsequent to completion of wort are consistent nith applicaole codes, standa*ds, and procurement documents.
$5.
Ins:ection and test records :entain the following anere applicaole:
a.
A description of the type of ooservation, c.
Evidence of completing and verifying a manufacturing, inspection, or test operation.
c.
The date and results of the inspection or test.
d.
Infomation related to conditions adverse to quality.
e.
Inspector or data recorder identification.
^
f.
Evidence as to the acceptability of the results.
U 6.
. Record storage facilities are constructed, located, and secured to prevent destruction of the records by fire, flooding, theft, and deterioration by environmental conditions sucn as temperature or humidity.
7.
Regulatory Guide 1.88 (Ref.12) is complied with or acceptable alternatives are provided.
Activities related to audits (17.1.18) are acceptable if:
hl.
Audits are perforced in accordance with preestablished written crocedures or check lists and conducted by trained personnel not naving direct responsibilities in the areas being audited.
17.1-18 11/24/75
e
,=
=
4 M2.
Audit results are documented and then reviewed with management having responsibility in the area audited.
.' Responsible managemeet takes t*ie necessary action to correct the deficit. cies revealed by the audit.
Deficient areas are reaudited on a timely basis to verify implementation of corrective actions which minimize recurrence of deficiencies.
.y N.
Audits include an objective evaluation of avality-related practices, procedures.,and instructions and the effectiveness of implementation.
t N.
Audits include the objective evaluation of work areas, activities, processes, and items, and the review of documents and records.
-)$. Audits to assure that procedures and activities are eeaningful and comply with the overall GA program are perfomed by:
a.
The QA organization, to provide a comprehensive Tndependent verification and evaluation of quality-related proesdures and activities.
3.
The apolicant and his princioal contractors, to verify and evaluate their supoliers' OA ;rograms, procedures, and activities.
S.
Provisions are established requiring that audits be performed in those areas where the requirements af Appendix S to 10 0FR Part 50 are being implemented. Areas which are often neglected include those activities asscciated with:
a.
The determination of site features which affect plant safety (e.g., core sampling, site ano foundation crecaration, and meteorology).
w 4a b.
The creparation, review, approval, and control of early procurements.
c.
Indoctrination and training programs.
d.
Interface control among the applicant and the principal contractors.
-)[9.
Audits are regularly scheduled on the basis of the status and safety importance of the activities being perfomed and are initiated early enough to assure effective quality assurance during the design, procurement, and contracting activities.
$0.
Audit data are analyzed and the reports, which indicate quality trends and the
. effectiveness of the QA program, are reported to management for review and assessment.
11.
The reoutrements and guidelines of ANSI N45.2.12 (Ref.15) are complied with or acceptante alternatives are provided.
17.1-19
- N 11/24/75
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