ML19312B643

Forwards Request for Addl Info to Complete Review of QA Program

ML19312B643
Person / Time
Site:	07100035
Issue date:	10/09/1979
From:	Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Mcdermott R ROCKWELL INTERNATIONAL CORP.
References
NUDOCS 7910220234
Download: ML19312B643 (9)

Text

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')}V sWE%q'o UNITED STATES e

I hpyy.r,( ",i NUCLEAR REGULATORY COMMISSION

., p WASHINGTON, D. C. 20555

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%,.... 5 OCT 9 s 1979 FCTC:RH0 71-0035 THIS DOCUMENT CONTAINS P00R QUAllTY PAGES Rockwell International Atomic International Division ATTN: Mr. R. J. McDermott 8900 DeSoto Avenue Canoga Park, CA 91304 Gentlemen:

This refers to your aoplication dated June 13, 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 infomation, 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, k

Charles E. MacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety, NMSS

Enclosure:

Acceptance Criteria 7910220 d i n

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s 10 CFR 71 - APPENDIX E ACCEPTANCE CRITERIA - TRANSPORTATION PACKAGES FOR RADI0 ACTIVE MATERIAL q

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The Oreanitation (17.1.1) elements respons131e for the OA program are ac:e tacle if:

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• he rescensibility f:r the OA ;rogram is retained and exercised by the 2:alf cant.

1.

4

$2.

Ne CA/CC f anctions, perd:r ed by One acclicant's OA dhanization or delegated to otner Organizations, are identified and descrited, ;roviding controls to assure all elements of 1::endix [*ill te implemented.

d3.

Clear and ef'ective Ifnes of ::munication tetween tne CA ceganizaticns of tre a:o11 cant and its ;rinci:a1 c:ntractors are esta011sned to assure srecer direction Of tt'e OA program ud resolation of CA ;rcolems.

I4, Organi:s icn : marts identify tre *:nsite* and "offsite* Organi:stional ef e-ents.nica fdneti:n 'ander tre c:ntrol of the CA ;regram {$uen as Oesign Engineering, Procurement.

• anufacturing Construction, Ins;ecting (GC) Testing, and 0A] and demcnstrate ace-

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cuate c:ntrol :ver quality ascects within and tedeen erganizations.

De inter ace relationsnt;s anc CA res:casibilities of eac*t ceganf rational element b5.

d identified in 1:em 4 accve are descrited and de 'enstrate assignment :f res;cnsibilities for requirements af A;pendia E.

55.

4 Nign level f managernent is rescensible for estantisning one c:r; crate or com:any CA ;olicies, 3:als, and cefectives and inis management level maintains a c:ntinuing involvment in OA matters. Corrununication tMrcugn any intermediate levels of management between Mis position and Oe "anager (or Of rect:r) of OA must be shown to be effective.

N.

S e scolicant designates a position, to be filled by a quali# fed Individual, :3 retain 7

overall autnority and res;cosittlity for !!'e OA Oregram.

N.

The autnerity and independence of the incivicual responsible f:r managing t3e OA crogram are sucn inat he can direct and c:ntrol :Pe organi:stion's OA/CC :r: gram, 17.1-5

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an effectively assure the ::nformance to quality recuirernents, and is indecencer.t of undue influences and responsibilities for schedules and costs. An acceptable or; ant-

stional structure would have this individual report to at least the same organizational level as the highest line manager directly responsible for performing activities affect.

j ing quality.

E Pisitforts oc groups responsible for defining and centrolling the content of_ths CA program and related manuals and the canagement level responsible for final review and accrovalhave appropriate organizational position and authority.

,101 The';erscrt-responsible for directing and managing the CA progra:n at the construction site has appropriate organizational positicn, responsibilitier, and authority to exer.

cise proper c:ntrol over these functions. - Thiffndividual is free of non.0A duties

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and can thuspAll-attention to assuring that the OA prograr at the glart site is betnfeffectively implemented.

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bl.

The :ualification reovirrents f:r the principal OA/QC managernent positions demonstrate ccmcetence corm".ensurate with the responsiht11 ties of these positions.

Al2.

Verificatica of conformance to estaolished requirements is ac:Omolfsned by individuals 4

or groups ho do not have direct res;cnsibility for performing the work being verified.

73.

Perscas and Organizations perf:rming OA/0C functions have direct ac:ess t's management levels wnich will assure acc:molishment of quality affecting activities. These ;er.

sonnel have sufficient auccrity and organizational freedom to ;er orm treir CA/0C d

functicns effectively and without reservation. They :an:

4.

Identify quality pr blems.

b.

Initiaterrecorvnend, or provide solutions througidisignates channels.

V Verify isolementation of soluticns.

M4 Oesignated OA indivicuals have De responsibility and authority, delineated in writing, to stop unsatisfactory work and c:ntrol further recessing, delivery, :r installation of nonconforming material.

The Ouality assurance o-eqem (17.1.2) description is acceptable if:

,1.

Meas' uhs' are prov4dect by t*e acgicant and his crincipal contras. tors that demonstrate hew their.0A-or geam wets 10 CFR Part 50, Accencir S criteria.,

N2.

Management (i.e., above or cutside ce OA organization) regularly assesses the sc:ce, status, imolementaticn, and eff?ctiveness of the OA program to assure that the =regram is adequate and comolies with 10 CFR Party, Aopendia E criteria.

h.

Measures are ;rovided :y the applicant to assure sat trained, ;uali fled ;ersonnel within his organt:ation are assigned to ceter nine that functions selegated to his principal c:ntract:rs are teing :recerly ac::mo11sned.

• 17.1 6 11/Za

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A :rief smry of :ne ::moany's ce: crate OA :olicies. goals, and cojectives is given and a meaningful :nannel for transmittal of eese ;olicies, goals, and : ejectives down

nrougn tre levels of management is estaclisnec.

5.

• he-;A. progras proceourts are certved 'reer0A :olicies goals, and oojectives..

0A/0C rescensisilities are destgnatad for tne imolementation of the majcr activities 5

contained in ce OA manuals.

-ma V7.

8.ovisions are estamitsned :o :entrol tne distributten of tne OA ianuals anc revisions tnertto.

A.

2*ovisions are estaolished for :onsnunicating to all respons131e organizations and 3

indivicuals inat :ualtiy :olicies. 0A manuals, anc precedures art mancatary eteu1re-

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ents are :rececurally centrolled.

k.

A listing of tne ;A Oracedures 21us a matrix of rese :rececures cross referencec to l

eacn criter*en of a::encix 6 to 10 *R 2 arty :enenstrates inat A::eacix 3 :revistsns are fully imple-ented :y dec.mentec :cocecures.

N.

"'*e safe *y *?Ilted struc*gres sys* ems. Inc :m:Crents :MtrClled by ee lA Or0ges::

Art

• entified.

kl.

• he 1:cif unt reviews and 3:cuments agreement dita tne OA :regram Orovisi:ns s' nis OrinC1:41 ::ntr3C* Ps 03 :*e extent ina ne can :e assured *at 2:Cenc14 3 etII :e

'molemented.

I 2*0Visiens Art estaClisned far :*e *ts01J:'Cn Sf fis:u'es involving Ouality, tr* stag frem a difftatect :f ::inton between ;A/ C :erscnnel and otner ce:ar*: rent (enginetHng.

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recurement, manuf acturing, etc.) Oersonnel.

A'* 2.

An incoctrinatien anc training program ts estaolisned sacs :nat:

2ersoncel rescens*tle 'er :er'ar-ting :ualt:y-a'fec tag setivities are instrue:e4 a.

as is ec :ur:cse, se::e and imclementa: ten af ee :uality-estated *anuals, instructi:ns, and ;recedures.

Derscnnel :erfor-ting :ualt:y-arfecting activities are tratned anc :ualif f ee f h 3.

t?e :rinciples and tec*nicues af :ne activity teing :erfor-ec.

Se sc::e. ce Oojective and

• e Setacd of imoiementing tne inccc rinaticn and

!*31Ning rtgram are dcCumented.

3.

3rSf'ctency O' *ersonnel :erformiag :uality-ef'ecting Ictivities is maintained

y *t'r3191"g, F? examining, and/3r ette*ti fying.

14 Ouaitty-related activities initia*e4 Ort:r :: *?e sw:mtital of we ;$AA. saca is est;n. :* :urt-en:, :rt:ars *:n af ee 2!AR tre tafety-ettates site :recarsti:n f

sc:vties are ':enti'iec are ::ntrolled anct* a OA r gram ani:n satts'tes : e -e: wire-l en:s e : :n :ir: 3: ::e*m

,ne we ;ut:anu ::nutsee in : e negaa:sry u:es i

anc a5: f unur:s its a: n ;ee:icn 7 sf et s 5:arcars 7eview 2?sn.

17.1-7

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%15.

Ouality-related activities are performed ith specified equi: ment and urcer suitante environmental conditions, and prerequisites have seen satisfied prior to ins:ection and test.

16.

• he ecolicant and his principal c:ntractors demonstrate tnat their CA pacgrams comply wita :ne Regulatory Lides (cur-ent issue) and AN$1 standards listed in Section V of

nis Standard Review Plan or descrite ac:ectacle alterna:1ves in ecuivalent detail.

Additional teplatory Lices dealing wita OA. nose imolementation cates are prior to

ne SAR submittal date small be si:nilarly accressed.

.m 17.

A sunnary description :f advanced :tanntng comonstrates ::ntrol af ;uality-rela:ed ac:1vities including unagement and teennical tnterfaces bat een :ne ::ns:ructor, A/E, 1533 vendce, and atiltty daring :ne snasecut of design and :enstruction and curing reocerational testing and plant turnover.

13.

4 ::mtTent is sace to c:ntrol ne yeocerati:nal test program ^:rmulated after PSAR saamitut and : rice to ~5A2 sa: mig 1, in ac::reante wita :P.e ;A ;regrai.

19.

Pr: visions are provicea for keeping.ae OA Orge:2, des:ribed in tse 5Aa, :arrent.

20.

tegulat:ry Li:e 1.23 ltef. 2l 1s ::molied.ita or acceptasle af ternatives are r:vided.

Ac:1vities related to Oesi n C:nt-et (17.1.3} are ac:eptacle if:

i M

• easures are estaolished to :ar7 Out :esign activities in a stanned ::nt-elled.

ana :eser!y unner.

N. ' Seasures are es:

2 4311shed :s ::r ectly translate :*e a:olicaele regulatory -tout-emnts ana sesign 34ses into s:ecificati:ns, drawings,.ritten :rocedures, and instrue:1:ns.

-,wd k.

Ouality 5:aecards are s;a:1fied in t.me :esign ::c ments, ard teviations and : manges 3

' rem :nese cuality stancards are ::ntrolled.

Ma.

Suitsele sesign ::ntrols are a:clied to sucn ac:1vities as react:r :nysics; seismic, stress, thermal, 9ydrau11c, radiati:n, and ac:1:ent analyses; :omcatibility of uterials; and ac:esstatlity for inservtce inscection, maintenance, and re: ate.

M.

esigns are reviewed s assure that (1) tesign characteristics can te c:ntrolled, 5

insoected, and tested and (2) inscection and test :riteria are identified.

5.

stemal and external :est;n interdace ::ntrols are estan11sred. *bese c:ntrois f.sclude tre revtew, a::reval, release, sistribution, and revision Of :cc.:nents involvirg sesign intar' acts ait.t sar:1ci:ating design organi:stions.

17.!.a 11/:Ai'5 N

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er selec*1cn and sc::melisnment of :esign verificati:e or 03ecking :r: cesses sucn as :y design reviews, alter

• ate calculations. Or :ualifi:ation testing are :erf N.

' Men a test Or: gram is used to verify Me acequacy of a design. a dalification test of a sretsty e unt: uncer severse :esign : nditions small :e used.

53.

Irdividuals :r ;rcu:s res:enstule f:e tesign vert ff cation are :tner inan :ne :r*gia.al destgree anc tre mesigner's 1 redI4:e sucervisor.

51.

Oesign anc s:ecificati:n :nanges inclucing 'f eld : Manges, are su: ject :: tse same

est;n ::ntr:Is and s::revals that.ere a:cli:2:le :: Me Original :esi;n unless tse

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30 licant aesigna*es anctner *ualified res;ensible Organi stien.

h0.

I"rers led :eficiencies in :Me design, including Se design Oracess, that ::uld adversely Af'ect safety *tlated strVC ures systems, and ::moceenta are ccumented; anc ::Prective scit:n is : sten :: :reclude et:etitten.

4 11.

atertals. : arts, and e ui; ment anien tre stardare, c:tmer:ial (c" Me snel') :r anica w

nave :een Ortvf eusly accrevec ':r a di"erent a::lication are reviewed for suita:ility art:r : selecti:n.

N'.

N e ::si:*:rs Or ;* u:s res: ens *:le *:e :estgn -twiews and : tree :est;n ser*'icatt:n sc:t et ties are :. e'r sutn:rity sac res:enst:llity are identi'f e: and ::ntr:ltec :y

.ritten :rece:ures.

'2.

"essures are esta lisrec 'er tae selec: ten :f suita le a:erials. : arts, ecui:eent.

a-a Or: cesses ':r sa'ety-etla:ed strue:ures, systeas, anc ::::ceemts anic't inclace

Ne use :f vali: 1-custry stancar:s and s:eci'!:stiens.

I la.

'egula::ry Lice 1.% (Ref. i} is ::eeltec nita er ac:ectacle si venatives are

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rssentec.

Ic t si:* es ett stec :: **acur** eat Ocew: Sntrol (17.1.4) are ac:enas' e i':

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8* cecures are esta:lissec :3at clearly delineate se secue-ce Of se:f:*s :: :e sc::m-slissec in se Ortsarati:n. review, acor: val, and conte:1 :f :r:curement Occaments.

NZ.

A review and ::ncuratnce of :te acecuacy :f Ouality recuirements stated tn :recurenn:

cuments is :eef:r9ed :y :ualified :ers:nrel. This review sneuls detemiae that

uality *ecuirements are cer*ectly stated. ins:ectacle, and cent

• lla:le; : Sere are acecuata ac:ectarce and rejection :riteria; and the :r: cure-ent :ccument nas :een 9 ecui rennts,

Ort: arts. *eviewec, sna a::reved in ac::r:ance ith 2A :r:ge:

kl.

• he "tview snc a::reval of :recurement eccureets are ecc*. rented :r*:r :: release and l

availa:1e 'or vec ft:s t:n.

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Procureent accainents identify the a;olicaole 10 CFR Parti $. accendix 6.recuirements wnica must :e ::molied witn and described in the sucolier's CA =regram. This

• ,A pro-grse r ;ortions thereof shall be reviewed and ::ncurred with by Ot.alified personnel in OA prior to initiatien of activities affected by the program.

Y.

P*ocurement :ccments contain or reference :ne :esign easts tecnnical requirements S

including :ne a:cif caole regulatory recuirements, material and :omeonent identification recuirements, drawings, scocifications, codes and industrial standards, tes and inscection tcuirements, and s:ecial process instructions.

YS.

3recurement cocwents identify the documentation (e.g., drawings, scecificattens, ;ro-cecures, ins;ection and faericatien plans, inscec:f =n and test Pte r:s, ;eesonnel and procedure cualificatiens, and :nemical and :nysical *es: results of ma*.arial) to be artpared, maintained, and suemitted to ve :ur:naser for review and a;oroval.

U.

8* curenn: tecteents identify pose records to :e retained, ::ntrolled, and maintained by ne su olier, and tnose delivered : ne Our:naser orier to use or instaliation cf De nar$4rt.

E9.

3*ocurren: 30cuments ::ntain the :rocuring sgency's r4gnt af ac:ess to su:olier's fscilities anc rec:rds for source ins:ecticn and audit.

$g.

Onanges and evist:ns to rocurement ccame9ts art suoject Oc a: less: Se sa.?e tview and s:crovat as tre original tocament.

E.

P-scuremt cc:sents for scare er remiscem..it parts of safety-relatae strac'. arts.

10 sys: ems, and ::m enents are sucject to cJnt-cis at least ecuivalent L : nose used 'er

ne 3riginal ecut:mnt.

11.

The recuterents and guidelines of AftSI St5.2.13 (Ref.16) are ::mplied wita r accentaoie sl:ernatives are provided.

=

Activities related to inst-ue: dens. 3*ecedures, and diwu s (17.1.5) art sc:e:: sole if:

s D.

activities af"ecttng Ouality art prescribed and se::molished in ac:ordance eita :ccu-mented instractions, recedures, or drawings.

k.

Provisions art establisned anicN 01early celineate the sequence of actions to :e sc:cmolf sned in the :resaration, etview, accreval, and c:nt*ol of instructiens, pro-cedures, and arswings.

h.

9 tscos for ::molying with esen of we 13 :riteria Of 10 0FR # set 50, 2:ce:< dix 3 are seeCied in instrue:1ces, 3rScedures, and feswings.

i l

4-s.

Ins: ructions, crecedures, and arswings inc?ude :uantitative (suen is timenti:ns,

!ersness, and s:e-sting Itmt:s) and :ualitative (suc9 is.ortmansnto samstes) se::::ance :riterta to verify tnat imoce:an: settaties mave een satt s'se::rity se: 21ft ed.

17.1 10 11/2a/75 l

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5.

The OA organization reviews and :ncurs witn inspection plans; test, calibration, sno special recess ;rececures; trawings and s:ecifications; and :nanges inerten or ac:entanle alternatives art gescri:ed.

Activities relatac s Cecumeat ~:ntrol (17.1.5) are ac:esta:1e if:

9kl.

The atview, a :roval, tnc issue of ::cuments (sues as lis:ec in i:en 3 tel:w) anc enanges inerets, :rior :s -elease. are :recacurstly ::ntrollec :s assure t ey are acecuate anc :ne :ualt:y recuirements are stated.

m4 hI2.

=atvistans art estaslisned.nics 1:entify tnese individuals :

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s aes:ensiale f:r P

reviewing, accrov+ng, anc t ssuing Accuments and revistons t9erets.

N3.

Changes ta d:cuments are reviewed and a;crevec by tne same Organiza:1ces :nat perfer=wd

ne :riginal review and a: roval Or :y otner :ualifiec rescensible organi:ations : ele-gates :y :Me a:211: ant.

)(s.

Accreved :nanges are incluced in instrue:1ons, :rececurts, :ramings, anc 3:ner docu-ments :rt:r to imclementati:n :f :ne :nange.

)fi.

solete se sa:erseced : cuments are ::ntrollac :s :reven: naevertant ase.

36 5.

Occuments are availacle at :ne iccati:n. cert :ne activity.ill :e :e**:crec :r?:r ::

mmea:ing ne.crt.

3(7 A aster list or ecuivalen: !s as:ssiisnec :s 4dentify :ne ur-ent revision rur:er of tqstruc:1:ns, :rececures, s ectf t:2:icns, drawings, and :recurement : cuments. This 1/s: is accated anc distriouta: :s :rece:erstnes, ess:enstale :ersoncel :s : recluse use of sa:erse:ec ccuments.

.+ e.as.ag M4.

Se dee m ts : 4: are ::n:-ollec under :nis sussec:1cn art identified in :ne :5AR.

As a minimum enis seculd feelude; 4.

esign s:ecifica:1cas.

3.

Design, manufacturing, ::nstruction, and inrea11atten :rawings, c.

8 : current :ccuments.

J.

0A manuals.

e.

8SAR anc related cesign criteria documents.

1 f.

• anufacturing, ins:e:: ten, anc testing instruc *:ns.

)

J.

Ies: Or0C ecu *ts.

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9

estqn :nange reques:s.

1.

'80-: r.f r5ance 't:CP:s.

f 2 ee-asec wata**st, i:uiement, arc ieav+ces (17.1.7) art Activittes cela:ec :: C:nt-s1 i 9

ac:e:: sole 'f:

17.1-11 11/2s/*3

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MI.

Cualified :ersonnel evaluate the supolier's ':apability to revice ac:ectacle cuality services and :reducts Sefert tre award of tse crocurement cecer or contract. The OA and engineering grcuss :articicate in the evaluation af those suppliers providing critical comocnents.

$4.

The evaluation of sucoliers is based en one ;;r more of the f 11cwing:

The sucolier's ca:acility to comoly vita the elements of 10 CFR 2 arty, Accendix &

a.

that are a:olicaole to tse type of material, ecutament, or service being :recured.

3.

A review of previous eteceds' and :erdermance of su: alters ano have ;rovides similar arti:!as of the type 3eing procured.

c.

A survey of the sucolier's facilities anc ".A :regram to determine mis casasility to sucoly a reduct.nica meets t*e design, manuf acturing, and t ality requirements, b.

The results of sucolier evaluati:ns are doc,pented and filed.

k.

Surveillance of su cliers d ring f abricati:n, ins:ection testing, and sniement of materials, ecui: ment, and :omcenents is planned and :e**

med in ac: rdance witn written :recedurts to assure :cnferaance to the OurcMase Orter escuirements. Dese 3roceducts rovide f:r:

a.

lnstr.ctions tnat s:ecify tne :naracte-isttes :r ; recesses t: te nitnessed.

ins:ected 3r vertffed, and ac:e:ted; the metnod of surveillance and tne extent f

ccumentation etcuired; and those res:cnsible f r imolementing t?ese instructions.

3.

Audits and surveillanct.nica assure that t*e sucolier c molies with tne cuality recui ren'en ts. Surveillance is :erfor9ed on those items.nere verificatien of

recurement *ecuirements cannot be detemined ucon etceigt.

I M.

Be su:olter 'urnisnes tne 'ollowing reccess as a minimum to the sur:nasar:

a.

Occwmentation tnat identtfies the ;urenased material or equi: meet and One s:ecific

rocureaent escuire-ents (e.g., : Odes, standarts, and s ecifications). met my tre i tems.

3.

Occur'entattcn that identifies any precurement requirements.nien ave not :een met together with a cescription of those nonconf r ances dis ositioned "accest as is*

cr

• toair.*

The atview and ac:estance of these documents shall te described in the surcMaser's OA program and as a minimum snall be undertanen my a res=onsible OA individual.

M.

Su clit**5 certificates of ::nformance are :eriodically evaluated by audits, indeceedent inscections, 3r tests to assure tney are valid.

N.

Recetving ins:ection af !?e sucolier-furstsmed material, ecuioment, and services is

erfor wd to assure:

17.1-12 11/4/75 w

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6 -

7%e material, :omeonent, or eculament is Orcee'rly identified and cor-es: ends witn s.

tse identificati:n :n etceiving :ocumentation.

aterial, cmcorents, equi:ments, and acceotance records are ins:ected and 'udged w

3.

se:entacle in ac:oreance wits receter91ned ins ection instructions, :rior to installation or Jse.

InsDec* ten PtCtris 3r Certificates 3f 03nfCFeance attesting to *Nt acce2 Lance 3f C.

material, ::mecneats, and ecutorent are availasle at *re auclear :cwer : tant rice to installation or use.

d.

Items sc:sstec and released art identified is to 15:1r ins:ection status :rf or to forwarding them 3 a centrolled s Orage trea Or releasing taem #cr installation Or fJPtrer mort.

3.

.me effectiveness of t.*e ::ntrol of :uality by su:aliers is assessed by One acolt an:

at intervals ::nsistent wit 3 the importance. Ocmolexity, and :uantity of the item.

1.

!: art 3r rt21aceaent : arts af safety-etlated structures, systems, and com:enents are sasject :o :cntrols at least ecuivalent Oc tacse ased 'cr tre seiginal ecuizaent.

10.

79e recatronents era uitelines of ENSI Na5.2.13 (aef.16) are com: lied its or a :::ta:1e sitarratt aes are scovicec.

I tivities *112*td :3 Ife**'#'!s*i:n 3rd

• at*01 Of Wa*e*'lls 39P*s, 1*1

• P:c* eats C

(17. i. 3) t-e ic:e:ta:!e if:

k.

-ecedures set esta:lisned to 1:en:1fy and ::ntrol materials, : arts, and : ecerents inc!waing :artially fs:rt:stes sa:assemel'es.

)h2.

. entificati0n PecairePents tre :etermined Ouring gtmer1*ien 3f 1:ecificatt ns 133

. I

est;n :rs ings.

+3

• ' t i entificatico ind 03ntrOl Or Cecures assure that identiff Cation is Saintained ei*rer On tre item :P :n rec:rts trice 421e t313e item *3 Oreclude use 3f incCr*tc; 1r defeC*1ve ittes.

kA.

Identi#i:sti:n 3f 9a*ertais and 33rts imccc ant 13 t?e #unct13n 3f safety-etlated structurts, systems, tnd 03mocrents :an :e traced to tSe 3:crt:r+ ate :ccamentation sucn as artwings, spectffca:1cns, urenase Orcers, marufacturing and ins:ec*ien

=ccuments, devia:1:n recerts, and 2nysical and :remical mill tes: racerts.

,\\ i.

The location and the retaca of identificatt:n :o not af#ect tse fit, func:1:n, Or

uality :f tre 1:em teing icentified.

Jgj.

• arrect identi#f esti:n 3f cater al, marts, anc :=nocnents 's verified and Oce; tented t ease #se 81:rica:t:n, assemolf eg, saf:cing, med ins:alla:icn.

i

rter ::

l a tivities related :: *:nt-et ef 5:ec's1 2-ecesses (17.1.7) set sc:estasle !!:

c 17.1-13 11/22/75

• b4

.-w

Ybl.

Special : recesses suen as =elding, heat treating, noncestructive testing, and cleaning are procedurally : ntrolled.

k.

Precedures, equipment, and :ersonnel connected witn scecial processes are :ualified in ac:creance with sco11 cable :: des, standards, and soecifications.

b3.

Special processes are perferned by qualified personnel and ac:3mo11sred in accorcance sitn written process sneets 3r ecuivalent with rec:rced evidence of verification.

kC4 Oualification recorcs of procacures, ecuipment, and :ersonnel associated with 5:ecial

-w-en processes are estaclisned, filed, and kept :urrent.

5.

Regulatery Guides I.37 (Ref. 4).1.39 (Ref. 5). and t.54 (Ref. 7) are comolied witn or accentaOle alternetives are ;rcvided.

Activities related t2 !"scection (17.1.10) are accectacle if:

Yhi. An ins:ection program enica verifies conformance 3f uality-effectirg activities mita recuirements is esta: lisped documented and at::colisnec in ac:Orcance witn eritten

entrolled rocecucts.

ff 2.

!nsce::1cn :erscncel are ince: ender; fr:m One individuals erf rning the activity

etng ins ected.

kil.

Ins:ection ;recedurts, instructions, and : neck lists provice for ne following:

n.

Identif1:stion of :naractaristics and activities 03 Se ins:ected.

3.

• dentification of ne :ndivicuals 3r groups res:onsibie for :erfer9ing tne j

ins:ectica :eration.

C.

Ac:sstance and rejection criteria.

4.

A description of the wethod of ins ection.

,f, e.

Recording evidence of :omoleting snd verifying a manufacturing, ins ection Or tes: Q eration.

f.

Recording ins:ect:r 3r tata rec rcer and 03e resu1*s of :Pe ins ecti:n oceration.

b.

Inscecti:n procedurts or instr actions are ased mita -ecessary teswings and saciff.

cations nee 9 perf:rsing inspecticn operations.

yhi.

Ins ectors sre ualified in ac: rtance eita acclicatie c: des, standards, and "emoany training Dregramm; and their :ualifications and certifications are kect eur-ent.

d$ 5.

=ccifications, rt: airs, and rtolacements are inscected in a:::rcance witn the artginal design and inspec: tan requirements or ac:e::aale 11:er atives.

)p 7.

)* visicas are estaclisned that identify sancatsry inscecti:n "old oints for witness l

by an inssect:r.

17.1 14 11/24/*5

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-n l

3.

The incividuals or gruucs nno perform receiving and process verification inspections at the construe:1on site are identifiec and snown to have sufficient independence anc Qualifications.

th@.

Provisions art estantisted for indirect control by monitoring recessing metnoes, ecutament, anc :ersennel if direct ins:ecti:n is not :ossible.

!3.

Regulatory Outtes 1.30 (Ref. 3),1.53 (Ref. 3),1.94 (Ref.13) and the recuirements 49c guteelines of AN5* N45.2.3 (Ref.14), and *(45.2.13 (2ef.16) are comollec wita or ac:e::-

sole altarr.atives are provideo-activities related to *est C:n=rel (17.1.11) are ac:estacle if:

I.

4 test program :o demonstrate that the 1:em will :erform satisfactorily in service is estacltshes. ::camentad, and ac:3molisted in ac: rcance wi n written : entec 11ed :r:cecures.

bb.

• ccificati:ns. tcairs. anc replacements are tested in se::rtance.t n Me original 2

esign anc tes:ing -ecuirements se ac:ectacle altar 9atives.

)(3. Written tas: :racecurts ine:r: crate :r refeatnce:

a.

The requirements anc a::e::ance limits c:ntat-ac in 3:31 ca:1e :esi;n and ;ro-curement ::caments.

3.

Instrue:t:ns for :er#crning :3e test.

. Test :rtrequisitas suca ss:

. C411 ra:ed instrumenta:icn.

. Acecuate and as:re:rf ste ecuipment.

i

. Trained. :ualified, and li:ensec or :ertif tec :ersonnel.

C: mole:eress of item to :e testac.

'"'"4

. Suitante anc :entrolled envir:nmental ::nditi ns.

7-ovisions '2r ta a :ollection sed storage.

2.

• ancat:ry ins:ec* ion old ::ints for eitaess by wner, : ntract3r. 3r ins ectar.

t.

AC 3 tance anc stjecti30 Cri:eef a.

f.

Se nods of accamenting or te:rcirg :ss: cata anc results.

fts.

Tes: results are ::cumentec evaluated, and tasir ac:e: 2:tlity :eterminec by a :ualif tec.

• es:enstalt indivtcual or grous.

5.

Requia:sry 3utets 1.33 (Ref. 3),1.58 (4ef. 31. and 1.94 (te.13) and :Pe recuirements r

~

and ;uidelines of :NSI 145.2.3 ltef.14) ars : mplied witn or a::sotatie alter 94:twes art ;revided.

Activities et14:ad ts *:nt-01 of weasurine tai *est I:uf eent (i*.1.12) are ac:ectasle + f:

96 3revisicas, ::ntained in prececurts, ces: ribe :ne : alt:rati:n toerni:ue and 'recuency,

?.atntenance, and ::ntrol 2f :ne Masuring and :sst equi:ren: (instruments. ::als.

I 17.1-15

.~.9 11/24/75 al.e.=<.

d

• w*

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u.

b a

gages, 81xtures, reference and tr3nsfer stancards, and nendestructive test equipment)

.niCn is used in the measurement, inspec*ien. And monitQring Of safety-related C:mDO-Pents, sys* ems and struC ures.

k.

Measuring ind test equipment is identified and trace 431e 03 the Cali3rst10n test data.

b.

Mesuring and test equipment is liceled or tagged 3 indicate date of One next Calibrition.

k4 Mesuring And *est instrunents tre Calitrated at s;ecified intervtIs :ased So tne e

recutred 10:Ur4Cy, "ur:Ose, degree Of usage, staatlity CMarscitristics, and Otner

nditions affecting tne *easurenent.

"etsures are taten Snd decunented t2 :etermine t*e validity of ;revious insceCtions fg.,

erf:r-wd.nen measuring and test ecuipment is found to be cut of :alibration.

k$.

• ali3rsting starcaris have an uncer'.ainty (erMr) requirement 3f no 7ere inan 1/4th af e tolerance of tne eculpment teing Calibrated. A greater uncertainty ?ay be ac:ectasie een limitad sy **e

• state-of-tne-art."

N7.

Ne ::r:lete su as of all 1:ams.ncer :ne : alt:rati:n system is rec:rted and rainuines.

N4.

Refteencs and transfer suncards are tracea:le to natforally ete gnt:ed suncar:s; or,

.nere naticnal sun = arts :o not exist :rovisicns are esunlished ts 2 cument tne : asis Ice caliersti:n.

a tivi:its reisted :: dand'iac. itersce. and Thie:9e (17.1.13) are ac:estante if:

c I

M1.

3: ectal sancting, Ortse-rati:n st: rage, : leaning. :acnaging, and sni: sing recuire-ents see esuslisned and ac::malisned by :ualified incivicuals in ac::rcance atta :receter-minec.crt anc ins:ection instructices.

N.

Ncscurts are :rt:ared nien ::ntrol ine cleaning, 94ndling, storage, sackaging.

2 sni:otng snd cresertation of materials, ::meonents, and systems in sc: reance itn

esign and s;ecification requirements : ;rectuce samage, f oss, se e eatort:icn ny envtrenmental ::nditions sucn as temoerature or numidity.

Regulatory n ide 1,38 (Ref. 5) is comalted ita or acceptante siternatives are srovided.

3.

au

.te-ivities related to !*s:ectien ?ast. ned Oeerstiec Status (17.1.!al are se:ectante if:

M.

! centi'lesti:n of :se ins:ecticn, sst, and 3:erating sutus :f structures, systems, in: ::e:crents is known :nreussout manufse:areg and installation.

Mt.

Ne s:ali:stien and atmoval of ins:ection and.elding stam:s and status indi:sters suen as ugs. artings,13:els. and s.am:s are :recedurally :entnited.

17.1-16 i!/:2/75

,m m

)(3.

Bycassing of recutred inspections, tasts, and stner :ritical coerations is :rececurally c:ntrollec ancer :Pe cogni:ance of tne ;A organt:ation.

35F.

The status of none:nferning, incoerative, Or malfuncti:ning structures, systems, or

m:enents is identified is Ortvent inadvertent use.

Ac tvities tiates s Neneen*:rming "ateet nis. 3srts. 3r ~ meerents (17.1.15) are ac:estacle if:

Y..

• >e icentification, documenta:1cn, segregation, review, dis:csi:icn, and nott'ication

s affected rgani:ations of nonconforming matarials, : arts, ccm:enents, :r services are :r:cecurally ::ntrolled.

%:st. -

-ht.

Occeenta:1:n iden:tfies :se nonc:nfor-ting itam; :es: rites :ne nonc:nf:rmance. :ne

-me L sis: cst:1:n of Ste none:nfor9ance, and :Me ins:ection stuirements; and incluces si;na-ture a::ecval :( :ne :is: cst:icn.

Yf3.

-ovist:ns are es:as11sned identifying :nese f acivi:uals sr ;rcues celegate: :se ' ' ~

-es:enst:111:y and aut?crity for ne :is: cst icn anc ac:reval of noncan' arming iteas.

)h.

Nenc:n :--$ g ' tens are segregatec ' rte ac:e:: :le 1:e.-s and i:enti"ec as :iscre: ant e

.nti r :ta'y :ts::st::: red.

MS.

Ac:so:a:1!i:y :7 *ewert :r rt: air af matertals, : arts, ::r:enents, systems, sac struc-tures is weat'iec sy reins:ecting and etasting :re item as Orig:nalif ins:ec ec sac testac :r :y a metrec.nien is at least e:ual s :ne origtnal ins:ec:t:n and testing me:nes. :ns:te:1:n, testing, rewert, anc re: ate :r::ecures are :ocumentas.

I 9f5.

Ncnc:n!:r an: recce s dis:csittenec "ac:e:: as ts' er "rt: air' are me:e :ar :f tre ins:ecti:n rec:ris and forwarced aits se aareware :s :Pe 2:1110-y fee revtew and assessment.

3b'.

Nonconf:maance re:cris art :ericcically analy:ed :s snew :uality trencs, and One results art et: cried s nanagement 8:r eevtew and assessment.

Ac tvities reisted to ::r-act've action (17.1.16] are ac:so:asle if:

bb.

Evaluation of ::ncitions adverse is cuality (sucn as nonconf:rmancas, 'silurts, 541-functions, :ediciencies deviations, and :efective material and equipment) is ::n-tuctec :s :eter91re tre need for c:rrective act'On in ac::rdance ith estaclisrec

recedures.

St2.

Carrective sc::an is initiatas foll: wing ine :eter91nati:n :f a ::ndtti:n severse is balt*y :: Ortcluce 'eCurre"Ce.

kl. F:11:w-us revtews are :Sncucted s verify :r:cer isolementa: ten :( :sr ective ac:fons and :s :Isse Out :ne :3r-ective ac:1:n ::cumentation.

17.1-17 11/25/75 D

O ka.

Significant :nditions adverse to uality, tse cause of the conditions, and ce cor-estive action taken are re:or*ed to cogni: ant levels of management for review and assessment.

Activities estated to Ouality assurance Secords (17.1.17) are ac:ectable if:

M.

Sufficient records are maintained to provide cocumentary evidence of the quality of items and 2e activities affecting quality.

M.

CA recorcs include cerating 1 cgs; results of nyiews, inspections, tests, audits, and uterial analyses; nonitoring of wort ;er#cnance; :ualificatien of :ersonnel, procedurts, and ecuipment; and at.*er fccumentation suca as 3rsuings, specifications, procurement doewents, calibration crocedures and rescrts; nonconfomnce reocr:s; and corrective action rtoorts.

k.

Records are identiff acie and retrievatle.

1. 4 tecuirements and res ensibilities for rec:rd tranrnit:als, ettention (sues as surstion, locati:n, fiat :retection, and assigned res:ensibilities), anc 9aintenance sucsecuent ts :xotetion sf.crx art ::nsistent aits a:clicamle ::ces, standards, and ::rocurtrrent documents.

Mf.

Ins:ection and test escords ::ntain tne fc11cwing. cert apolicaole:

a.

A cascrt: tion of tne type of :eservatten, b.

Evidence of :xcleting and verifying a manufacturing, inspection, or test 3:erstien.

c.

De cate and results of t*e inspection Or test.

d.

hfer9ation -elated to c:nditions adverse to :uality.

e.

Inspector se 24:1 *tesrder identificatien.

.. ~..

f.

Evidence as :s tse ac:eptability of tre results.

N6.

Record storsge facilities art c:nstructed, located, and secured to 3revent destruction of the raccros my fire, flooding, cef t, and deterioration by envtednmental c:nditions suen as temperature or numidity.

7.

Regulatory kide 1.38 (Ref.12) is conolied with er acceptacle altematives are J

provide 4.

Activities related to udits (17.1.18) are ac:estante if:

a 1

7(1.

Audits are seedsmed in ac:crdance with ;rtestabitsned ritten crocecures Or enect 1

lists and conducted :y trained ;ersoneel not *aving direct res ensitt11 ties in the areas :eiag audited.

17.1-18 11/24/75

• ew -*-

• gh aw mm,am a. - e

.mesg..%mmm 4

-- -. = *.=

m syn..,-e..%-

ws~ em+-

~

T

-1 F

M2.

Audit results are documented and then reviewed nith management having responsit.ility in the area audited.

M3.' Responsible mnagemnt takes the necessary action to correct the deficiencies revealed by the audit.

-)(4 Oeficient areas are reaudited on a timely tasts to verify implementation of corrective actions hicn minimize recurrence of deficiencies.

M.

Audits include an cbjective evaluatten of :uality-related ;ractices, ;rocedurts, and m

instructions and the effectiveness of implmentation.

I N.

a dits include the objective evaluation of ort areas, activities. ; recesses, and items, u

and the review of documents and records.

~

g.

Audits to assure that ;rocedures and activities are meaningful and comoly with the l

overall CA program are ;erformed by:

I a.

• he OA crganization, to ;rovide a c mprehensive tnde:endent verification and 4

evaluation of quality-related ;recedures and activities.

3.

The 1 :li: ant anc his ;rinciaal :entracters. Os verify and evaluate their su:311ers' OA ;rograms. ;recedures, and activities.

S.

rovisions are esta:11shed requiring cat audits te :erf:r ed in ecse tress anere the recairements Of A:cendix 3 to 10 071 Part 50 are being i.t.clemented. Areas.nien are often neglectes include tacse activities associated with:

a.I

• he detenination of site features nics affect plant safety (e.g., c:re saroling, site anc f:undation are:aration, and metecrology).

..w 3.

• he :re:aration, review, a roval, and c:ntrol of earl," precuramfnts.

Inc:ctrination and training programs.

d.

Interface centrol smerg the a:Alicant and De Jrincipal c:ntractors, i

h.

Audits are regularly seneduled on t*e basis of Oe status and safety imecrunce of 1

De activities being ;erformed and are initiated early enougn to assure effective tvality assurance during the design, peccurement, and c:ntracting activities.

4

@0.

a dit data are analy:ed and ce rescrts, which indicate cuality trends and the u

effectiveness of t*!e OA ;rogram, are re:crted to sanagement for review and assessment, j

11.

The recuirements and guidelines of ANSI Na$.2.12 (2ef.15) are c molice with or acceotaole altarr.atives are provided.

17.1-19

)

11/Za/75

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.