ML19312B644
| ML19312B644 | |
| Person / Time | |
|---|---|
| Site: | 07100249 |
| Issue date: | 10/09/1979 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Michel C NUCLEAR FUEL SERVICES, INC. |
| References | |
| NUDOCS 7910220239 | |
| Download: ML19312B644 (9) | |
Text
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UNITED STATES
'n NUCLEAR REGULATORY COMMISSION h,
nC WASHINGTON, D. C. 20555 OCT 0 91979 FCTC: RHO l
71-0249 I
l Nuclear Fuel Services, Inc.
ATTN: Mr. C. J. Michel P.O. Box 218 Erwin, TN 37650 l
l Gentlemen:
This refers to your application received by the NRC on January 2,1979 requesting approval of your Quality Assurance (QA) program as meeting the QA program requirements of 10 CFR 971.51.
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 QA 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, Charles E. MacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety, NMSS
Enclosure:
Acceptance Criteria 7 910220 L 3 9 C-.-
ra 10 CFR 71 - APPENDIX E ACCEPTANCE CRITERIA - TRANSPORTATION PACKAGES FOR RADI0 ACTIVE MATERIAL
. xm The Organization (17.1.1) elements responsible for the QA program are acceptacle if:
N.
The responsibility for the QA program is retaiaed and exercised by the applicant.
1 I 2.
The CA/QC functions, ;erformed by the applicant's QA organization or delegated to otner organizations, are identified and described, ;roviding controls to assare all elements of Accendix (will be implemented, d 3.
Clear and ef'ective lines of corcunication between the CA organigstiens of the appli.
cant and his principal contractors are established to assure procer direction of the CA program and resolution of QA problems.
I4 Organization :narts identify the "onsite" and "offsite" organizational elements wnich f.nction 'ander the control of the CA program (suen as Oesign Engineering, Procurement, Manufacturing, Construction, Inspecting (CC), Testing, and QA] and demonstrate ade.
~
cuate control over cuality aspects within and between organizations.
h5.
The interface relationsnips and QA responsibilities of each organizational element identified in item 4 above are described and demonstrate assignment of responsibilities for recuirements of Appendix E.
$6.
A high level of managernent is responsible for establishing the corscrate or company CA policies, goals, and objectives and this management level maintains a continuing involvment in QA matters. Cocmunication through any inter ediate levels of management between this position and the Manager (or Director) of QA must be shewn to be effective.
N 7.
The applicant designates a position, to be filled by a qualf #ied individual, to retain overall authority and responsibility for the QA program.
M6.
The authority and independence of the individual responsible for anaging the CA program are such that ne can direct and control the organization's "A/QC program, 17.1-5 i
2.
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- an effectively assure the :enfomance to quality requirements, and is independent of undue influences and responsibilities for schedules and costs. An acceptable organt-Zational structure would have this individual report to at least the same organizational level as the highest line manager directly responsible for performing activities affect-ing quality.
k Positions oc groups respon31ble for defining and controlling the content of_.the CA program and related manuals and the management, level responsible for final review and approval.have appropriate organizational position and authority.
, 0."
The';erson responsible for 11recting and managing the QA program at the construction 1
m site has appropriate organizational position, responsibilitiet, and ' authority to exer.
cise proper control over these functions. - This ' individual is free of non-CA duties and can thus give, full attentiin to assuring that the QA pograir at the plant site is.being' effectively implemented.
kl.
The qualification requirements for the principal QA/QC management positions demonstrate corrpetence corrensurate 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 QA/QC functions have direct access to management levels which will assure accomplishment of quality affecting activities. These per.
sonnel have sufficient authority and organizational freedom to perform their CA/QC functions effectively and witnout reservation. They :an:
a.
Identify quality problems.
' ~.m b.
Initiate,'recomend, or provide solutions througidesignated channels.
l V Verify implementation of solutions.
m -
M4 Designated QA individuals have the responsibility and authority, delf:::ted in writing, to stop unsatisfactory work and centrol further orocessing, delivery, or installation of nonconforming material.
The Ouality Assurance Procrim (17.1.2) description is acceptable if:
1.
Feaises are provided by the aop1(cant and his principal contractors that demonstrate how their.QA-pregram meets 10 CFR Part 50, Appendix 8 criteria.
N2. Management (i.e., above or outside the CA organization) regularly assesses the scope, status, impletentation, and effectiveness of the QA program to assure that the program is adequate and comolies with 10 CFR Part"{$, Appendix E criteria.
M3.
Seasures are provided by the applicant to assure that trained, qual"' led ;ersonnel within his organization are assigned to determine that functions celegated to his principal contractors are teing properly accomolisned.
- 17.1-6 11/Z4
M. A brief suwary of the Company's corporste CA :olicies, goals, and objectives is given and a meaningful enannel for transmittal of these policies, goals, and ebjectives down tnrougn the levels of management is established.
5.
The CA progran procecures are certvet frem CA policies goals, and oDjectivet.
- p5. CA/QC responsioilities are designated for tre imolementatien of the major activities contained in the OA manuals.
)(4.
Drovisions are estaolisned to centrol the distributien of the CA manuals and revisions thereto.
)f8.
Provisions are estaolished for consnunicating to all responsible organtrations and individuals tnat qualtiy policies, QA manuals, and procedures are mandatory require-ments are procedurally controlled.
jf 9.
A listing of the CA procedures plus a matrix of these procedures cross referenced to eacn critecton of a cendix 60010 CFR PartM damonstrates that A;cendix 3 :rovisiens s
are fully tmolemented my documented crocedures.
Jf.0.
The safety relateo structures, systems, and ::m:enents centro 11eo by tne dA :rogesa see icentified.
g 11.
The s:plicant reviews and accuments agreement nitn the CA crogram provistens of his artect:a1 :entrsctors to the extent inat ne can be assureo that A;cendix 3 will be implemented.
Jp 2.
Provisions are estaclished for the resolution of disputas involving cuality, srising from a difference of pinion between OA/;C ;ersonnel and otser department (engineering.
procurement, manuf acturing, etc.) personnel.
A13.
An indoctrination and training program is establisned sucn that:
a.
Dersonnel res:ensible for ;erforming cuality-affecting sctivities are instructed as to the purcose, secpe, and implementation of the at.ality-related manuals, instructions, and procedures, b.
Personnel performing quality-affecting activities are trained and cua11fied in the principles and tecnniques of the activity being performed.
c.
The scoce *ne oDjective, and the method of implementing the indoctrination and training program are documented.
d.
Proficiency of :ersonnel performing cuality-affecting activities is maintained 3y retraining, reenamining, and/or recertifying.
14 Quality-related activities initiated prior to tPe suomittal of the 75AR, such as design, procurement, pre:aration of the PS*R and safety-related site ;recaratten activities are *:entified and controlled uncer a A rogram wnien satisfies the re uire-eents of 13 lFR 3srt 50, a: pen 1x 3 and tre ;uicance : ntained in tre Regulatory 3wi:es and ANSI standar:s listes 'n Section V of tnis 3tancard 7eview Plan.
17.1-7 l
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15.
Ouality-related activities are perfor9ed with specified equipment and under suitable environmental conditions, and prerequisites have been satisfied prior to inspection and test.
16.
The applicant and his principal contractors demonstrate that their QA pmgrams comply witn tne Regulatory ",uldes (current issue) and ANSI standards listed in Section V of this Standard Review Plan or describe acceotable alternatives in equivalent detail.
Additional Regulatory Guides dealing with QA shose implementation dates are prior to the SAR submittal date small be similarly addressed.
17.
A sunry description of advanced planning demonstrates control of quality-related activities including managegnt and technical fftterfaces between the constructor, 4/E, 1555 vendor, and utiltty during the phasecut of design and construction and during preoperational testing and plant turnover, k
W 18.
A corrtiwnt is ma:e to control the preoperational test program, formulated after PSAR submittal and prior to 25AR'submilial, in accor1anct-with the OA program.
19.
Provisions are orovided for keeping the QA program, cescribed in the SAa, current.
20.
Regulatory 3aice 1.23 (Ref. 2) is comolied.ith or acceptacle alternatives are provided.
Activities related to Desien Control (17.1.3) are acceptacle if:
M1.
"easures are establisned to carry out design activities in a planned, controlled, and orderly manner, k.
Seasures are established to correctly translate the apolicsble regulatory requirements 2
and design bases into specifications, drawings, written procedures, and instructions.
4,
- 3.
Quality standares are specified in the design documents, and deviations and changes from these quality stancards are controlled.
M4 Suitable design controls are applied to such activities as reactor physics; seismic, stress, ther el, hydraulic, radiation, and accident analyses; compatibility of materials; and accessibility for inservice inspection, maintenance, and repair.
M.
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 establisted. These controls include the review, approval, release, distribution, and revision of docsents involving design interfaces with participating design organizations.
17.1-3 11/24/75
Procer selection and accomplisnment of design verification or enecking crocesses such as by design reviews, alternate calculations, or cualification testing are :erformd.
'anen a test program is used to verify the adecuacy of a design, a :ualification test of a prototype unit under adverse cesign conditions small te used.
h 3.
Individuals or grouos res:ensible for design verification are other inan the ortginal designer and tre designer's 1 rediate supervisor.
- % 9.
Cesign and soecification changes. including field cranges, are suefect to tne same design controls and a;orovals that.ere apolicaole to the original dest;n unless the a;olicant designates anotrer cualified resocnsible organi:ation.
NO.
Errors and deficiencies in the design. including tne design process, that could adversely affect safety related structures, systems, and comoonents are doc: rented; and corrective action is taaen to ;reclude recetition, bl.
w terials, parts, sad ecu1prent wnien are standard, comercial (off the shelf) or =nich a
nave teen oreviously sacreved for a different soclication are reviewed for suitability prior to selection.
k12.
ine cositions or groucs resconsible for esign reviews and other cesi;:n stridicaticn activities and teeta aatecrity and resconsiollity are identified and controllec cy
.ritten croceourts.
b2.
essures are estselished for the selection of suitable taterials, carts, ecutorent, w
and crocesses for safety related structures, systems, and comoceents anien inclade tne use of valid incastry standards and specifications.
14 legulatory Guide 1.64 (Ref. 9) is complied with or accentacle alternatives are resented.
Activities related to 8-ocurrent Occument Control (17.1.4) are acceptante if:
kl.
Procedures are estantisned that clearly delineate the secuence of actions to te accom-311sned in the precaration review, acoroval, and control of procurement documents.
Y.
A review and concurrence of the scecuacy of ouality recuirements stated in procurennt 2
documents is cerformed by cualified personrel. This review should deteraline that cuality recuirements are correctly stated, inspectable, and controllable; there are adecuate acceptance and rejection criteria; and the crocurewet document has seen prepared, reviewed. and accroved in accordance with lA crogram recuirements.
k3.
The review led 3coroval of crocurement documents are documented prior to release and svallable #cr veriffCation.
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y4 Procureeent documents identify the applicable 10 CA Part y. Ascendix % requirements wnich s'ust be complied with and described in the supplier's CA program. This CA pro.
eram or portions the tof small be reviewed and concurred with by qualified personnel in CA prior to initiation of activities affected by tTie program.
- 5.
procurement documents contain or reference the design basis tecnnical requirements including the applicable regulatory requirements, material and component identification requirements, drawings, specifications, codes and industrial standards, test and inspection requirements, and special process Instructions.
kf.
Srocurement documents identify the documentation (e.g.. drawings, specifications, pro.
'rt cedures, inspection and fabrication plans, inspection and test records, personnel and procacure qualifications, and chemical and physical test results of material) to be prepared, maintained, and submitted to the perchaser for review and approval.
2 k7.
Procuremnt documents identify those records to be retained, controlled, and maintained by the supplier, and those delivered to the surenaser prior to use or installation of the ha*dware.
E.
Procurement doc.ments contain the procuring agency's right of access to supo11er's facilities and records for source inspection and audit.
M.
Changes and revisions to crocurement documents are subject to at least the same review and sporoval as the original :ocument.
MO.
- ocurement documents for spare or reolacement parts of safety-related structures, systems, and components are subject to controls at least eouivalent to those used for tne original ecuipment.
11.
The require-ents and guidelines of ANSI N45.2.13 (Ref.16) are complied with or
..arMr acceptante alternatives are provided.
Activities related to Instructions. Seceedures, and Orswings (17.1.5) are acceptable if:
- 1.
Activities affecting quality are prescribed and accomo11shed in accordance with docu-mented instructions procedu*es, or drawings.
. k 2.
Provisions are establ.ished unich' clearly delineate the sequence of actions to be accomplished in the preparation, review, approval, and control of instructions, pro.
Cedures, and drawings.
h3.
Methods for complying with each of the 18 criteria of 10 CR Partp Appendix {
are speciff ed in instructions. procedures, and drawings.
$4 Instructions, procedures, and drawings include quantitative (such as dimensions, tolerances, and operating limits) and qualitative (such as.ork:':anship saeoles)
(
acceptance criteria to verify that important activities have teen satisf actorily i
acc.--oli Ped.
17.1-10 t
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The OA organization reviews and concurs with inspection plansi test, Calibration,
/
and special process Drocedures; drawings and $;ecificatiCns; and changes thereto or acceptable alternatives are described.
Activities elated to Occument Control (17.1.6) are acceptable if:
)f l.
The review, accroval, and issue of documents (sven as listed in item a telow) and changes thereto, prior to release, are crocedurally controlled to assure tney are adecuate and the quality requirements are stated.
??1 hf2.
Provisions are established anien identify tnose individuals or grcups responsible for reviewing, soproving, and issuing documents and revisions thereto.
Yb3.
Changes to documents are reviewed and a: proved by the same organizations that performed the original review and approval or by other Qualified responsible organizations dele-gated of the acplicant.
hFA.
1:oroved cnanges are included in instructions, procedures, drawings, and otrer docu-rents : rice to imolementation of tne crange.
$ff.
Otsolete or su;erseced documents are controlled to orevent inadvertent use.
)C 6.
- ocuments see availacle at the location anere t5e sctivity mill te performec or?c* to COnnenCing ope dort.
(7.
A 9 aster list or equivalent is estaolisned to identify the current revision num er of instruc* ions, crocedures, specifications, drawings, and procurement documents. This list is updated ano distriouted to precetermined, responsible personeel to :reclude use of superseted documents.
. =q khS.
The dccurents tnat are Controlled under this sucsection are identified in the PSAR.
As a minimum this should include; 3.
Design specifications.
3.
Design, manufacturing, construction, and installation drawings.
C.
0A manuals.
e.
PSAR and related design criteria documents.
f.
wanufacturing, inspection, and testing instructions.
1 Test orocedures.
n.
Design :nange requests.
1.
Nonconformance reports.
Activities related to Control of purenised waterial iouiement, and Services (17.1.7) are acceptacle if:
l*.1-11
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N1.
Qualified personnel evaluate the supolier's' capability to nrovide acceptacle quality services and products before the award of tne procurement order or contract. The CA and engineering groups participate in the evaluation of those suppliers providing crt:1 cal components.
M2.
The evaluation of suppliers is based on one or more of the following:
a.
The sucolier's cacability to comply with the elements of 10 CFR 8 art 50. Appendix 8 that are applicaole to tne type of material, equipment. or serv:ce being procured.
c.
A review o'f previous records and perfomance of suopliers who have provided similar articles of the type being procured.
c.
A survey of the supplier's facilities and OA program to detemine his capability to supply a product which meets tse design, manufacturing. and quality requirements.
4 M.
The results of supolier evaluations are documented and filed.
3 6%
%4.
Surveillance of sucoliers during fabrication, inspection, testing, sno sniement of materials, equipment, and components is planned and performed in accordance with
.ritten procedures to assure confomance to the surenase order requirements. These procedures :Povide for:
a.
Instructions that specify the characteristics or processes to be aitnessed.
ins:ecteo or verified and ac:epted; the method of surveillance and the extent of ccumentation required; and those resconsible for implementing these instructions.
D.
Audits and surveillance wnich assure that the supplier complies nith the quality recuirements. Surveillance is performed on tnose items wnere verification of procurement requirements cannot be detemined upon receipt.
N5.
The supplier furnisnes the following records as a atinima to the purchaser:
' *W a.
Occumentation that identifies the purchased material or equipment and the specific procurement requirements (e.g., codes, standards and specifications) met by the iteas.
5.
Documentation that identifies any piccurement recuirements wnich have not been met together with a description of those nonconfomances dispositioned " accept as is" or " repair.*
The review and acceptance of these documefits shall be described in the purchaser's OA program and as a minimum shall be undertaken by a responsible QA individual.
Y.
Supplier's certificates of confomance are seriodically evaluated by audits, independent 6
insoections. Or tests to assure they are valid.
k7.
Receiving inspection of the supplier-furnished material equipment, and services is
- erfor ed to assure:
11.1-12 i
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. h.;
4
a.
The ?aterial, Comparent, or equipment is procerly jdentified and corres:Onds ditM 19e identification on receiving documentation.
m.
Wats 41, comConents, equi;eents, and acceptance records are inspected and judged acceptacle in accordance witn predetermined ins:ection instructions, prior to installation or use.
Inspection records or certificates of confor ance attesting to the sc:ectance of material, c:mponents, and equipment are available at tne nuclear power plant prior to installation or use, d.
Items accepted and released are identified as to tneir inspection status prior to forwarding them to a controlled storage area or releasing them for installation or furtMer work.
h.
The effectiveness of the control of Quality by suppliers is assessed by the apolicant at intervals consistent with tre importance, complexity, and quantity of the item.
3.
Scare or replace ent ; arts of safety related structures, systems, and ex:enents are swoject to controls at least equivalent to those used for the original ecutament.
10.
Tee recutrements and guidelines of ANSI N45.2.13 (Ref.16) are como11ed witn or ac:sota:1e alteraatives are provided.
Activities
- elated t: !1eati84:stion and *0ntre' Of wateri als, Plets. and Sr":ocents (17.1.3)
-e accestacle if:
Y'..
3rocedwres are ettaolisred to identify and Ocnt-01 materials, carts, and ::.moorents inclucing :artially facrtcated suoassecolies.
N.
Ide9tt ff cation require *ents are 3eteratined during generation of s:ecificatio9s and design desnings.
um M.
The identification and control procedures assure that identification is maintained eit.9er on the item or on records tracesele to the item to preclude use of incorrect or :efective items.
N4 Identification of materials and parts important to the function of safety.related structures, systems, and components can se traced to the appropriate documentation sucn as drawings, specifications, purenase orders, manufacturing and inscection documents, deviation reports, and physical and chemical mill test reports.
MS.
The loca' tion and the method of identification do not affect the fit, function, or quality of the item teing identified.
)(6.
Correct identification of material, ;srts, and ::moonents is verif! d and documented prior to release for fabrication, assemeling, snicaing, and instal"; tion.
Activities related to Control of toecial 2-ocesses (17.1.3) are accectacle if:
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N1.
Special processes such as nelding, heat treating, nondestructive testing, and cleaning-are procedurally controlled.
k2.
Procedures. equipment, and personnel connected with special processes are qualified in accordance with applicable codes, standards, and specifications.
$3.
Special processes are perform d by qualified personnel and ac:omplisned in accordance with written process sheets or equivalent witn recorded evidence of verification.
)f4 Qualification records of procedures, equipment, and personnel associated with special
~*1 processes are establisned, filed, and kept current.
5.
Aegulatory Guides 1.37 (Ref. 4), 1.39 (Ref. 6), and t.54 (Ref. 7) are complied witn or acceptaole alternatives are provided.
Activities related to Ins ectien (17.1.10) are acceptacle if:
- 1.
An inspection program hien verifies conformance of ovality-affecting a:tivities with recuirements is estaclished, documented, and ac::molished in ac:ordance with nritten controlled crocedures.
)(r2.
Ins:ection personrel are indeoendent from tne individuals :erforming the activity teing ins:e:ted.
)@.
Inspection procedures, instructions, and check lists provide for the following:
a.
Identification of characteristics and activities to be ins:ected.
b.
Identification of the individuals or groups resconsible for performing the inspection operation.
c.
Acceotance and rejection criteria.
m d.
A description of the method of inspection.
e.
Recording evidence of completing and verifying a manu'acturing inspection. or test operation.
f.
Recording ins:ector or data recorder and the results of the inspection operation.
-)Ir4 Inscection procedures or instructions are used with necessary drawings and specifi-cations when performing inspection operations.
g.
Inspectors are Qualified in accordance with applicable codes. Standards, and company training programs; and their qualifications and certifications are kept current.
Modifications, repairs, and replacements are inscected in ac:ordance with the original design and inspection requirements or accepta01e alter 9atives.
h Provisions are established that identify 9ancatory inspection hold points for witness by an inspector.
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ce 3.
The incividuals or grouDs wno perf rm receiving and process verification inspecticns at the c3nstruction site are identified and snown to have sufficient incependence and QualificatiCns.
N.
Provisions are establisPed for indirect Control by monitoring processing methods, equionent, and personnel if dire.. Inspection is not possible.
(
10.
Regulatory hides 1.30 (8.ef. 3),1.53 (Ref. 3),1.94 (Ref.13) and the requirements and guidelines of ANSI N45.2.3 (Ref.14), and N45.2.13 (Ref.16) are complied with or accept-able alternatives are provided:
Activities related to Test Centrol (17.1.11) are acceptacle if:
N1, A test program to demonstrate that the item will perform satisfactorily in service is establisted, documented. and accomolished in accordance with aritten controlled procedures.
w cifications, repairs, anc replacements are tested in acccedance witn the original f 2.
o design and testing requirements or acceptable alternatives.
,Vgl.
Written test rocecures inc:rporate or reference:
i s.
The require-ents and acce:tance Ifmits ::ntaineo in acclicaele :esi;n and pec-care-ent accueents, s.
Instructions for performing the test.
t.
Test prere:uisites suen as:
. Calibrated instrwentation.
Adecuate anc ap;ropriate soutament.
Trained. Qualified, and licensed or certified personnel.
. Ocmpleteness of item to :e tested.
tut table and controlled environmental conditions.
. provisions for data collection and st: rage, andatory inspection hold points for mitness by owner, contractor, or inspector.
d.
w e.
Acceptance and rejection criteria, w thods of documenting or rec:rding test data and results.
f.
e N.
Test results are cocumented, evaluated, and their acceptability determined ey a qualified, resconsible individual or group.
5.
Regulat:ry Guides 1.30 (Ref. 3),1.53 (Ref 3), and 1.94 (Ref.13) and the requirements and ;uidelines of AN51 N45.2.3 (Ref. "14) are complied witt Qr Westable alternatives are provided.
Activities related to Control of weasurino and Test [13 j ;
.1.12) are acceotaDie if:
Provisions, contained in procecures, describe the calibration tes ? ;ue and frequency, i
maintenance, and control of the Masuring and test equipment (instruf47ts. tools.
17.1-15 4
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gages #ixtures, reference and transfer standards, and nendestructive test equipment) antch is Jsed in the measurement, inspection. and monitoring of safety-related compo-nents. systems, and structures.
N2.
. easuring and test equipment is identified and traceasle to the calibration test data.
w M3.
Nasuring and test equioment is labeled or tagged to indicate date of the next calibration.
N.
."easuring and test instruments are calibrated at specified intervals based on tna
.4 required accuracy, puroose. degree of usage. Stability characteristics, and other conditions affecting tne measurement.
)(5.
"easures are taken and documented to determine the validity of previous inspections performed wnen measuring and test equipment is found to be out of calibration.
Oaliorating staccarcs have an uncertainty (error) requirement of no more than 1/4tn of ne tolerance of tne equioment being calibrated. A greater uncertainty may be acceptable anen limited oy tee " state-of-the-art."
k tne comclete status of all items nder tne calibrat on syste i is recorded and m.aintained.
i h
Reference and transfer standards are traceasle to natforally recogniced standar:s; cr.
mnere national stancards do not exist. provisions are establisned to document tne basis
'or calibration.
a tivities related to dandlias. Storice, and Shiocing (17.1.13) are accectable if:
c
)fri.
Scecial Mancif eg. preservation, storage, cleaning, cackaging, and snipping recuiremants are estas11sned and accomplisned by qualified individuals in accordance witn credetar-mined nors and inspection instructions.
$2.
3rocedures are precared.nien control the cleaning, Mandling, storage packaging, shioping. and preservation of materials. components, and systems in accordance with design and specification recuirements to preclude damage loss, or deterioration by environmental conditions sucn as temocrature or humidity.
3.
Regulatory Guide 1.38 (Ref. 5) is comolied with ar acceptacle alternatives are provided.
Activities related to insnactien. Tast, 4a<f Oeerstico Status (17.1.14) are acceptable if:
-)$.
Identification of the inscection, test and operating status of structures, systems, and corconents is known througnout manufacturing and installation.
p.
The scolication and removal of inscection and nelding stamos and status indicators such as tags, martings. lacels, and stamps are procedurally controlled.
17.1-16 u-A 11/21/75
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kl.
3ypassing of required inspections, tests, and other critical ocerations is procedurally controlled under tne cognizance of the OA organization.
7he status of nonconfocing, inoperative, or malfunctioning structures, systems, or comconents is identified to prevent inadvertent use.
tctivities related to Nenconforming Materisis, Parts or Ocmoonents (17.1.15) are accentacle if:
,vn XI.
- he identification, docueentation, segregation, review, disposition, and notification to affected organizations of nonconfoming materials, carts, components, or services are procedurally controlled.
%2.
Documentation identifies the nonconforming item; describes the nonconformance, the dis;osition of the nonconfora'ance, and the inspecti:n *ecuire ents; and includes signa-ture a: proval of the dis =osition.
M3.
Provisions are established icentifying those individuals or groucs delegated the res;cnsioility and authority for the disocsition and accroval of 9anconforming items.
p.
Nonconfor-ing items are segregated from sc:e:tsole ite-s and i:ent1'ied as discrecant antil ?ro:erly :is:ositt: red.
A45.
Acceota:ility of rework or repair of materials, : arts, :oraconents, systems, and struc-tures is verified oy reins:ecting and retesting t9e itam as originally inspected anc tested or oy a method wnien is at least e::ual to tne original inspection and testing metnod. Inspecticn, testing, rework, and re: air crocedures are doceented.
p.
Nanconfor?ance reocrts dis ositioned "ac:est as is" or " repair
- are mace : art of tne inspection records and for marded with the hardware to the utility for review and assessment.
)(- 7 Nonconferece recorts are :eriodically analyzed to show tuality trends, and the results are recorted to managenent for review and assessment.
Activities related to Corrective Action (17.1.16) are ac:ectacle if:
Evaluation of conditions adverse to quality (sucn as nonconformances, ' allures, mal-functions, deficiencies, deviations, and defective material and equicment) is con-ducted to determine the need for corrective actier, in accordance dith established procedures.
$ 2.
(cerective action is initiated following the deter tinaticn of a condition adverse to quality to preclude recurrence.
4 Follor*JC reviews tre tonducted to verify procer imolementation of cor*ective actions 3
and to c'ose out the cor'ective action documentation.
17.1-17
..y 11/24/75
}&4 Significant conditions adverse 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 Ouality Assurance Records (17.1.17) are acceptable if:
Er 1.
Su"':1ent records are maintained to provide documentary evidence of the quality of 4
i-. and the activities affecting quality.
)[ 2.
CA records include operating logs; results of reviews, inspections, tests, audits,
,,,3; and material analyses; monitoring of work performance; cualificatien of personnel, procedures, and equipment; and other documentation such as drawings, specif,1 cations, procurement documents, calibration procedures and reports; nonconformance reports; and corrective action reports, b
ff3.
Records are identifiable and retrievable.
)(4 Requirements and responsibilities for record transmittals, retention (such as duration, location, fire protection, and assigned responsibilities), and maintenance sut sequent to completion of work are c:nsistent witn asolicable c des, standards, and procurement documents.
ft 5.
Inscection and test records : ntain the following where acclicaole:
a.
A description of the type of Observation.
o.
Evidence of completing and verifying a manufacturing, inspection, or test sceraticn.
c.
The date and results of the inspection or test, d.
Information related to conditions adverse to cuality.
e.
Inscector or data recorder identification, w,.
f.
Evidence as to the acceptability of the results.
40 6.
Record storage facilities are c:nstructed, located, and secured to prevent destruction of the records by fire, flooding, theft, and deterioration by environmental conditions such 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) ara acceptable if:
Yfl.
Audits are performed in accordance with ; reestablished aritten 3rocedures or check lists and conducted by trained persennel not having direct responsibilities in the areas being audited.
17.1-18 11/24/75 0
~
M2.
Audit results are documented and then reviewed with management naving responsibility in the area audited.
M3.
Responsible management takes the necessary action to correct the deficiencies revealed by the audit.
)(4 Deficient areas are reaudited on a timely basis to verify implementation of corrective actions which minimize recurrence of deficiencies.
N.
Audits include an objective evaluation of quality-related practices, procedures, and wt instructions and the effectiveness of implementation.
N.
Audits include the objective evaluation of work areas, activities, processes, and items, and the review of documents and records.
l.-
g.
Audits to assure that procedures and activities are meaningful and comply with the overall GA program are perfomed by:
a.
The QA organization, to provide a comprehensive % dependent verification and evaluation of quality-related procedures and activities.
3.
The apolicant anc his principal contractors, to verify and evaluate their sucoliers' OA programs, procedures, and activities.
S.
Provisions are established requiring that audits be perfor ned in those areas wnere the requirements of Appendix 3 to 10 CFR Part 50 are being implemented. Areas which are of ten neglected include thosa activities associated with:
a.
The determination of site features which affect plant safety (e.g., core sampling, site and foundation precaration, and meteorology).
b.
The ; reparation, review, approval, and control of early procurements.
~*
c.
Indoctrination and training programs.
d.
Interface control among the applicant and the principal contractors.
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 avality assurance during the design, procurement, and contracting activities.
30.
Audit data are analyzed and the reports, which indicate cuality trends and the effectivenes' af the QA program, are reported to management for review and assessment.
11.
The requirements and guidelines of ANSI N45.2.12 (Ref.15) are complied with or acceptable. alternatives are provided.
17.1-19
~. ~
11/24/75
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