L-14-360, Firstenergy Nuclear Operation Company, Quality Assurance Program Manual, Revision 19

From kanterella
Jump to navigation Jump to search
Firstenergy Nuclear Operation Company, Quality Assurance Program Manual, Revision 19
ML14339A455
Person / Time
Site: Beaver Valley, Davis Besse, Perry
Issue date: 11/24/2014
From:
FirstEnergy Nuclear Operating Co
To:
Office of Nuclear Reactor Regulation
Shared Package
ML14339A419 List:
References
L-14-360
Download: ML14339A455 (36)
v • d • e


Text

FENOC nrc QualityAssuranceProgramManual BeaverValleyPorverStation Units1 8{,2 DocketNos.50-334& 50-412 OperatingLicenseNos.DPR-66 &, NPF-73 Davis-Besse NuclearPorverStation DocketNo. 50-346 OperatingLicenseNo. NPF-3 Perry NtrclearPoler Plant DocketNo. 50-440 Operating LiceuseNo. NPF-58 ApprovedBy: /1ilr-'l - FleetOversight Date:

Vice President I of36 Revision:19

FENOC Quali TABLB OF CONTENTS A. IVIANAGBI\,IEN'I-

l. Methodolog!' 5 2, Organization 5 3, Responsibility 8
4. Authority 8
3. Persorrnel Training and Qualification 9
6. CorrectiveAction 9 7, RegulatoryCommitments l0 B. PERFORMANCE/VERIFI C ATION Nlethodology l0 DesignControl il Dcsign Verificntion l2 Procurenretrt Cotrtrol t3 Procu renrent Verific ation l4 Identification and Control of Iteltrs t4 Handling, Storage' and ShipPing t4 Test Control l5 Measuring and Test Equipnrent Control l6 Inspectiort,Test, and Operating Stattrs t7 SpecialPt'ocessControl t7 Inspection T7 Con'eetiveActiott t8 Document Control l8 Records I9 C. ASSESSMENT I, h{ethodology r9
7. Audit 20 D. INDEPBNDENTSAF'E]'YREVIEW
1. Descr'iption 2 of36 Revision:19

f,FruOGQualityAssuranceProgramManual f r/slFrh,.gil ryuajc..,.O*r"rrrrna IABLE OF CONTENTS(Continued)

Table 1 - RegulatoryCommitnrents A, RegulatoryGuide1.8(Revision1) [Septenrber 19751' PersonnelSelectionand TrainingIANSI Nl8.1]

B. RegulatoryGuidc 1.30(Revisiort 0) lAugust19721' Quality AssHr$fice Requiyements for the Instollntiort, Inspectiott,und Testittgof Instrumentstiortsnd ElectricEquipmettlIANSI N45.2.41 C. RegulatoryGuide 1.33(Revision2) [February 79781, QanlityAssursnceProgramRequirenrcnts(Operrfiiansl[ANSI N18.71 24 D, RegulatolyGuide1.37(Revision0) [March 19731]

QualityAssurunceRequirements for Cleartittgof Fluid S,ys/ettts snd AssocistedCottrponents of ll/ster-Cooled Nuclesr Pox,erPlnntsIANSI N45.2.11 Ii. RegutatoryGuide 1.38(Revisiorr 2) [May 19771, QualiryAssursnce Requirements for Prckaging, Shrpping,Receiving,Storage,and Hortdling of fiems for Water-Cooled NuclearPowerPlants IANSI N45.2.21 F, RegrrlatoryGuide1.39(Revision2) [septernberl977lt Housekeeping Requiremeuts for lYuter-Cooled Nuclear PowerPlnntsIANSI N45,2.31 G, RegulatoryGuide 1.58(Revision1) lsepternber1980f' QuuliJicqtionof Nuclesr Pov'erPlcutthrspectiott, Examinutiottsrtl TestingPersonnelIANSI N45.2.61 I:I. RegulatoryGuide 1.64(Revision2) [June19761, QualityAssurunceRequirements for the Designof NuclearPowerPlantsIANSI N45.2'l1l I. Regulatory Guitle 1.74 {Revisiolt 0) [F-ebruarY19741, Quality AssuycrnceTerms and Detinitions IANSI N45.2.101 3 of36 I{evisionl 19

FENOG f ,';lfr:c'rgi' Nrr:'-.*' QualityAssuranceProglqmManual "ru.ntr,,,offiQQ TABLE OF CONTENf'S(Continued)

Table I - RegulatoryConttnittrrettts (Continued)

J, RegulatoryGuitle 1.88(Revisiort2) [October1976]'

Collectiotr,Storagesnd Maintenanceof Nuclesr Potver Plant QualityAssurunceRecordsIANSI N45.2.9f 30 K. RegulatoryGuide 1.94(Revisionl) [April 19761, Qualit.ltAssuranceRequirementsfor Instullatiott, Inspectionund Testittgof Concreteand Structufal Steel During the CortstructiottPhaseof NucleurPowerPlants IANSIN45.2.5J 3l L. RegulatoryGuide 1.116(Revision0) [May 19771, QuatityAssursnceRerluirements fot lrtstollatiort, Inspectiottsnd Testirtgof MechanicalEquiprnentand

^Sysferus IANSI N45'2.81 32 n{, RegrrlatoryGuide 1,I23 (Revision1) [July 19771, QuulityAssursrtceRequirements fot Control af Procurementof ltems snd Servicesfor NucleorPo*'er P4ants IANSfN45.2.13J 33 N. RegrrlatoryGuide1.144(Revisionl) [septernber' 1980],

Auditing of QualityAssursnceProgramsfor Nuclear PowerPlsntsIANSI N45'2.121 34

o. RegulatoryGtricle1.146(Revision0) [August19801' Qualilicationof QualityAssursnceProgrsmAudit Personnel for NucleqrPoner Plnnts IANSI N45.2'231 36 Revision: 19

FE'VOC t{tlLt:ttr)/Nrr..'e-n-f /pirdlr:a't-"r-T. QualityAssurancePrygl4ryManual A. MANAGEi\{BNT

1. Methodology
a. The QualityAssurance ProgramManual(QAPM)providesa consolidated oveliew of the quality programcontrolswhichgoverntheoperationand maintenance of FirstEnergy NuclearOperatingCompany's(FENOC's)quality relatecl itemsandactivities.This includesnuclearplantandFENOCfleet locations,aswell asFirstEnergy corporate locatiottsthatprovidesafetyrelated seruices.The QAPM describes the quality assurance organizational structure, ftinctionalresponsibiIities, levelsof autltority,and interfaces.
b. The requirements anclcommitrnents containedin the QAPM aremandatoryand mustbe implemented, enforcecl,andadheredto by all individualsand orgagizatioirs. Employees areexpected to activelyparticipate in thecontinued developrnept of theQAPM asrvellasits irnplementation. Changes areprornptly commullicated rvhenidentified.
c. T}e QAPM inrplernents l0CIrR50,AppendixB andappliesto all activities associatecl with structures,systenrs,andcomponsnts rvhicharesaf-ety related, T1e requirernents of the QAPM are applied to these iterns atrd activitiesto an extcntcom)Iensurate rviththeirimportance to safety.
d. The eApM alsoappliesto thepackagingandtransportation of radioactive rvaste activitiescontrolledby 10CFR71, as the quality assul'ance plogl'am required by IOCFRTI,Subpart H.
e. The QAPM alsoappliesto theinclependent storageof spentnuclearfuel and high-levelrajioactive rvasteactivitiescontrolled by 10CFR72, asthequality assurance progratnrequiledby 10CFR72, Subpart G.

The applicabilityof therequirements of theQAPM to othelitenrsandactivities is deterrnined on a case-by-case basis, The QAPM is implementecl throughtheuseof approved procedtn'es ii.e.,

policies,clirectives, procedul'es,or otherdocunrents) u'hichprovidervritten guidapcefbr the controlof qualityrelatedactivitiesandprovidefbr the ilevelopment of docurnentation to provideobjectiveevidenceof cotnpliartce.

2. Organization T6e organizirtionalstlucturerespor.lsible for in-rpletnentation of tlte QAPM is described belou,.Tlre specific organizationtitles for the quality assul'allcefi,tnctionsdescribedare identified in procechl'es.The authorityto accomplishthe quality assuraucefunctions 5of36 Revision: 19

FENOO QualityAssurance qryg1qry Manual describedis clelegatedto theincumbent's staffasnecessary to fultrll theidentified responsibility.

a. T[e PresicleptFENOC alcl chief nuclearofficer (CNO) is responsiblefor establishingexpeclationsancl providing top level direction of all aetivities associatedrvith the safeand reliable operationof FENOC's nuclearpower plants and activitiesof corpolatefunctions. The FENOC Presidentand CNO provides guiclancervith regardsto the companyquality assufancepolicy.
1. The executiveresponsiblefor oversightreportsto the PresidentFEG FENOC and chief nuclearofficer and is responsiblefor the audit and assessilrent of the quality assuranceproglatn of FENOC's nuclear activities,both site and corporate,and maintainingthis QAPM in accordanceu,ith regulatoryrequiremettts,This executiveis also responsible for establislringthe quality assurance prograrnpolicies,goalsand objectives,for irnplenrentationof the quality asslu'ance program,and for rnaintainingthe Quality AssurancePrograrnMattual. This executivealso has overall responsibilityfor the quality assllranceanclindependentoff-site safety revierv cornmittee functions, as rvell as supplier auditing.

a) The jndividual responsiblefor quality assurancerepofis to the exectitiveresponsiblefol oversightand has ovet'allautlrorityand responsibilityfor velifying the implementationand adequacyof the quality assuranceprogram (auditing) as describedirr this QAPM. The incliviclualresponsiblefor quality asstlrancehas the authority and responsibilityto reportnrattersdirectly to the prcsidentand chief nrclear offiser rvhenneerled.This individual is also responsiblefor ttrequality control frrnction,and receipt and suppliersoul'ce inspectiotts.

b) Theseinclividualsabovemay be respotrsiblefor a singleunit/location or for rntrltipleunits/locationsand rnay fttlfill more than one function desclibed.Corrvcrsely,responsibilitiestnay be fulfilled by nrore tlran one inclividual,Indiviclualsmay be locatedat the nuclearplant or FirstEnergycol'poratelocations.

b. T5e follolving nralragernent positionsreport to tJrePresidentFENOC and chief nuclearofficer:

I . T5e executiveresponsiblefor operationsprovidesa singularpoint of conlact rvith respectto the operationof the four FENOC porvel plants,arrdprovides operationaloversightof the fortl'plants.

a. The executiveslesponsiblefol overall plant nrtclearsafetyand operations supportat eaclrsite report to the exccutiveresponsiblefor operations' 6 of36 Revision:19

FENOG

,^ QualityAssuranceProgramManual Theseexecutives nlayreportthroughan additionallayerof management but shallrnaintainsufficientauthorityand organizational freedomto implementtheassigned responsibilities, Theseexecutives areresponsible for establishing andiurplernenting thequalityassurancs proglamat the respective site.

2. Theexecutiveresponsible for engineering is responsible for providing engineering servicesat all sites.
3. A managernent positionresponsible for licerrsing andregulatory affairs.

The individualsfulfilling thefollowingrnanagement functiorrs repottto the appropriate rnanagement positionidentifiedin Paragraphs .aor 2.b.2'above.

2.b.1 Theseindividualsmayrepofithroughan additionallayerof managetnent but slrallmaintain sufficient authority and organizational fi'eedom to implement the assigned responsibilities. Theseindividuals may be respotrsible for a single unitllocationor for multipleunits/locations andmayftllfill ll'Iol'ethanoue functiondescribed belorv.Conversely, responsibilities maybe fulfilledby more thanone indiviclual, The flinctionsclescribed belolv may alsobe irnplernented by nop-FENOCorganizations q,ithintheFirstEnergy Corporation horvever, FENOC nraintains respollsibility andauthority.

1. Tle individual responsiblefor plant operationsasstlresthe safe,reliable, a1c1efficient operationof the plant rvithin the coustraintsof applicable regrrlatoryreqnirementsand the operatinglicetlse.
2. Tle inclividualrestrronsible for plant ntodiflcatiou ptovides direction, control, ancloverall supclvisionof the implemetrtationof piant modifi cationsatrcltlssignedtnaitttenance.

n

-). The indivicluallesponsibletbr trairtiugproviclesdirection,control,and ovcrall supervisionof all tlairiingof personuelrequiredby regulatiotts.

4. The indiviclualresponsibletbr recordsruanagenrentproviclesdirectiott, control, anclgverall supervisionof the recordsmaltagementprogfatn and associatedactivities.
5. The indir.'idualresponsiblefor docutnentcontrol proviclesdirection, corrtrol,atrcloverall strpervisionof the documentcontrol ptogram and associatedactivities.
6. The inclivirlualresponsiblefor the cotlective actioit progratrtprovides dilectiop,coutrol,ancloverallsupervisiortof tlrc correctiveactionprcgraln and associatedactivities.

7 of36 Rcvision: l9

FE'VOG firs tEne/gy,\'dcl.OOroUnnO QualityAssurancePrograrnManual

7. The individualresponsible for engineering is responsible for the developrnent andmaintenance of engineering progralns,policies, and procedures attdfor providingengitteering services.
8. The inclividualresporrsible tbr materials, purchasing, audcoutracts is responsible for supplierevaluations, procurernent, services,receipt, storage, andissueof lnaterials, parts,andcomponents.

d, The on-siteandoff-sitesafetyreviewcornmittees independently revielvastivities to provideadditionalassurance thattheunitsareoperatedand maintained in accordance lvith theOperatingLicenseaudapplicable regulations rvhichaddrcss nuclearsafety. (Refer to Table 1, Item C.2 for additional details.)

3. Rcsponsibilit)'
a. F'ENOChas the rcsponsibilityfbr the scopeand implementationof an eflbstive quality assuranceproglatn, b, FENOC nray delegateall or part of the activitiesof planning,establishing,and implementingthe quality assuranceprogram to others,but retainsthe responsibi li ty for the program's effectiveness.
c. The adequacyof the QAPM's implernentationis cotttinuallyassessed by the individual(s) responsible for quality assurarlce and the associated executive for orrerallplant nuclearsafety,and is reportedto tlre executive responsible for' oversightand to the prcsidentand chief nuclearofficer.
d. FENOC is responsiblel-orensuringthat the applicablepoltion(s)of the quality assurarlccprograln is ploperly docurnented,approvecl,and irnplernented(people are trainedand resourcesare available)before an activity rvithirrthe scopeof the QAPM is undefiakenby FENOC or by others.
e. Responsi6leirrdiviclualsare to erlsurethat personnelrvorking utrtlertheir managementcognizanceare provided the necessal'ytraining and resottrcesto accomplishtheir assignedtasksrvithin the scopeof the QAPM.
f. Procetluresthat implerrerrtthe QAPM are approvedby the managetnent respolsible lbr the applicablequality ftinction. Theseprocedttresare to reflect the QAPM anclrvork is to be accomplishedin accordallcervith tlrern.
4. Authority
a. When FENOC delegatesresponsibilityfor planning,establishirrg, or irlplenrenting any part of the overall QA program, stt{ficietlt atrtholity to accomplishthe assignedresponsibilitiesis delegatecl, 8 of36 Revision:19

FFfVOG Irrsffrl.'rgilil'u..'c',.O^rrrtnffifr Quafity AssuranceProgramManual

b. Theindividualresponsible for qualityassurallce ltasthetesponsibility andthe authorityto stopunsatisfactory work (includingreactoroperationthrotrghploper channels) andcontlolftirtherprocessing, delively,installation, or useof non-conforrning itemsor selices. Costand schedule considerations lvill not overridesafetyconsiderations.

5, PersonltelTraining and Qualification A

Personnelassigrrcdto implement elemcutsof the quality assul'Allce progralnal'e capableof perfortning their assigrred tasks.

b, Training ptograltlsare establishedand irnplementedto ensttrethat personnel achieve and nraintain suitable proficiency.

Persomel training and qualificationrecordsare maitrtainedin accordancewith procedures,

d. Acklitionalcletailsconcerningpersonnelttaining and qualification nray be found in the RegulatoryGtridesanclassociatedStandardsas committed to in Sectiorr

'fable A.? aricl y u i d e s1 . 8 ,1 . 5 8 ,a n d 1 . 1 4 6 ) '

1 ( e . g . ,R e g u l a t o r G

6. Corrcctive Actiott
a. It is the responsibilityof eachindividual to promptly identify and reporl conditionsadverseto quality. Mauagernetttat all levels encotlragesthe identificationof conclitionsthat are adverseto quality.

b, A corective action plogtaln is establishedand inrplemetrtedthat incltrdesprompt icleptification,clocurnentation, significanceevaluatiotl,aud conection of conditionsaclverseto quality. For significantconditionsaclvemeto quality, the causeis cleteurrirrecl anclcomectiveactiortto precluderepetition is identifiecland trackeduntil it is contpletedand verified.

c. Specificresponsibilitieslvithin tlre correctiveaction plogranl llray be delegated, but FENOC maintainslesponsibility for the program'seffectivelless.
d. Nolt-conforrningitelns al'epl'operlyconttolledto prevent their inadvertetlttest, iustallation,or use, Tley are reviewedand eitheraccepted,rejected,repaircd,or reurorked.
e. Reportsof conclitionsthat are adverseto quality at'eanalyzerito identify trendsin qualityperfonnance,Significantconditiottsadverseto quality artdsignificant trenclsBrel'epol'tedto the appropriatelevel of tnanagetnent.

9 of36 Revision: l9

FF,VCIO QualityAssurancePrograrnManual Additionaldetailsconcerning conectiveactionactivities maybe foundin SectionB.l3 ancltheRegulatoryGuidesandassociated Standatds ascornlnitted to irrSection A.7 andTableI (e.g.,Regulatory Guides1.33andI ,144)'

7, RegulntoryConrndtments Exceptrvherealternatives areidentified,FENOCcomplieswith theQA guidance documents listed on Table 1. If theguidancein anyof thesedosuments is itt conflict with theQAPM, theguidance providedin theQAPM is thecontrolling guidance, Additionally,the follorvingclarifications applyto all guidancedocuments listedin TableI :

l. For rnoclificationsauclnonroutinemaiutenance,gttidanceapplicableto sonstruction-like activitiesis applicableto comparableplant activities, exceptthat the inspection of tnodifications,repaits,retl'otk, and replacementsshall be in accordancelvith the original designand inspection recluirernetrtsor a docutnentedapproved altetnative'
2. The {efirritions plovicleclby Itegulatory Guide 1.74 apply lvhereverthe defiped terrl is uscclin the QAPM and associatedguidancedocuments,
3. Clarificatiottsandalternatirres to a guidancedocumentapplywhereverthe guidanee docutrtent is invoked.
4. ln eachof the ANSI Standards, othel documents(e.g.,other Standards, Codes,Rcgulations,tables,or appendices) are t'eferenced or described' Theseother docurnentsare only quality assuranceprogtam requirementsif explicitly committeclto in the QAPM. If not explicitly committedto, these clocurlentsare not consideredas quality assuranceprogl'amrequiremettts, althoughthey may be usedas grridance'
5. Itegulatory guidanceoriginally intendedto apply to designor constutction phaseactiyitiesrvill be applieclto activitiesduring the operationsphasethat are coilparable in natureanclextentto cottsttuctionphaseactivities'
b. The NitC is to be notifieclof QAPM clrangesin accorclance r'vithl0CFR50.5a(a).
c. In casesrvherelicensercquirernentsciiffer fi'om the QAPM, the most stringeut lequirementsapply.

B. PBRF'ORh{ AN CE/V ERI FI C A TI ON

1. N{ethodolog},

l0 of36 Revision:l9

FENOG

,^ffi QualityAssuranceProgramManual

a. Personnel perfonningu,orkactivitiessuchasdesign,ettgineering, ptocurement, manufacturing, constluction, startup, instaIlation, maintenance, modification, operation, andclecomrnissioning areresponsible for achievingacceptable quality.
b. Personnel performingverificationactivitiesareresponsibletbr verifying the achievement e quality.

of acceptabl

c. Work is accomplished andverifiedusinginstructions, procedttt'es,or other appropriate meansthatareof a detailcommensurate with the activity's complexityandimportance to safety.
d. Cliteriathatdcfirreacccptable qualityarespecified, andqualityis verified agairrst thesecriteria.
2. DesignControl
a. The designcontrol proglarn is establishedand irnplementedto assurethat the activitiesassociatedwith the designof systems,components,sttuctures,and eqgipmelt and rnodifi.cationsthereto,al'eexecutedin a plamed, controlled,and orderly manner.
b. Tfuepragtam irrcluclesprovisions to control designinputs,pl'ocesses, outputs, chauges,interfaces,records,atrdorganizational interfaces.
c. Designilputs (e.g.,perforrnance,regulatory,quality,and quality verilication requirements)are to be correctly translatedinto designorttpttts(e.9.,

specifications,dra,,vings,procedures,atld instructions).

d. The final designoutput is to relateto the designinput in sutficient detail to per:rnitverification.

The desigtlprocessis to ensut'ethat itenrsand activitiesare selectedand ildepenclentlyvelifiecl consistentwith tlreir itnportauceto safety to ensurethey are suitablefor their intendedapplication, Changesto final designs(including field chatrgesand modifications)and clispositionsof non-conformingitenr.sto eitheruse-as-isor repair are to be subjecteclto <lesig1control lneasurescornnlensurate lvith thoseapplied to the origiual designand approvedby the orgatrizatiorr perfouned the original that designor a qualifiedclesignee.

llterface eorrtrols(internal and externalbetlveeuparticipatingdesign o;ganizatiols anclacrosstechnicaldisciplines)fbr the ptllposeof developing, 1 1o f 3 6 Revision: l9

FENOG f r.'Slfi't rg). r\ir /e.a. OO.n *ra* QualityAssuranceProgramManual reviewing,appt'oving, releasing, distributing,andrevisingdesigninputsand outputsaredefinedin procedures.

h, Designdocumentation arrdrecords,whiclrprovideevideuce thatthedesignand designverificationplocesswasperfonnedin accordance with thisproglam,shall be collected,stored,andmaintairred in aceordance with documented procedures.

This tlocurnentation includesfinal designdocuments, suchasdrawingsand specifications, andrevisions tlreretoanddocunrentation whichidentifies tire importantsteps,includiugsourcesof designinputsthatsupportthe final design.

Adclitionaldetailsconcelningdesigncontrolactivitiesmaybe fbundin the RegulatoryCuiclesanclassociated Standards ascomtnittecl to in SectionA.7 and Table 1 (e,g.,RegulatoryGuide1.64).

3. DesignVerification
a. A program is establishedanclirnplementedto verify the acceptabilityof design uriiuiti"* and documentsfor the designof items, The selectionand incorporation of clesigninputs ancldesignprocesses,outputs,and changesare verified'
b. Verification methoclsinclucle,but are not limited to, designrevieu's,altemative calculations,and qualificationtesting. The extentof this verification will be a fi.lnctio1of the importanceto safetyof the item, the cornplexityof the design,the degreeof stanclardization, the stateof the art, atrdthe sirnilariiy rvith previously prou*,r designs.Stanclardized or previor.tslyproveu designsrvill be revie$'edfor applicabilityprior to use.
c. Whep a test progranris useclto verify the acceptabilityof a specific design feature,the testprogram is to demonstrateacceptableperfonnallceunder corrclitionsthat simulatethe most adversedesigncor-rditions that are eKpectedto be encouutered,
d. Indepeldent tiesignverification is to be completedbetbre designoutptttsare used by oiher organizationstbr designu,ork and before they are usedto supportother o"tiuiti.r such as procurement,nranufacture, or coustructiott.trVhenthis timing ca6ot be aclieved, the unverified portion of the designis to be identifiedand contr.ollecl,Irr all cases,the designverification is to be completedbefore relying ou the itetn to perfotrn its fitrtction.

Ilclividuals or grol.]psresponsiblefor designreviervsor otherverification activities shall be iclentifieclin proceduresand their authority and responsibility shall be defined anclcontrolled, Desigrrverif-icationshall be perfonneclby any competentinclividuals or groups other than those u4ro perfonned the original 1 2o f 3 6 Revision: l9

FFruSG QualityAssuranceProgramManual Frrslfrc'tg/ i\'.JcleatO'n'r^r* m\

clesignbut who rnaybe fi'omtlresameorganization.The designer's irnrnediate supervisor mayperfornrthedesignverificationprovided:thesupervisor is the only teclinically qualifiedindividualcapable of perforrning theverification, the ncedis inclividually docuntented and approved in advattce by the supetvisor's rnanagement, andthe frequencyandeffectiveness of the supelisor's useasa designverifier areindependently verifiedto guardagainstabuse.

Designrrerification procedutes areto be established andirnplemented to ensure that an appropriateverificationmethodis used,the appropriate designpararneters to be verifiedarechosen,theacceptance criteriaareidentified,theverificationis satisfactorily accomplished, and the results areproperlyrecorded.

Adclitionaldetailsconcerning designverificationactivitiesmaybe foundin the RegulatoryCuiclesandassociated Standards ascommittedto in SectionA,7 and TableI (e.g.,Regulatory Guide 1.64).

4. ProcureltreutControl
a. A program is establishecl and implementedto ensurethat purchaseclitems atrd serices are of acceptablequality.
b. The prog'am inchrclesprovisionsfor evaluatingprospectivesuppliersattcl selectingonly qualified snppliers.
c. The program incluclesprovisions for ensuringthat qualifred suppliers cotltitrue to plovide acceptableproductsatrdseryices'
d. The program incluclesprovisions(e.g.,sollrceverification, receillt inspection, pre-installationand posrinstallation tests,and certificatesof confotrnance)for acceptingpurchasecliternsand seryices' Applicable teslurical,regnlatory,aclrninistt'ative,and reporling requiremettts

(".g., specifications, tests,inspectiotrs, codes,stanclarcls, specialprocesses, atrcl 10CFR2l) are invoketl for procuretnent of items and selices.

The progr.arninclndesprovisionsfor ensulingthat docutnentedeviclenceof an iteprisconfonnance[o procrlrernentlequirenrentsis availableat the site before the iterp is placed i1 serviceor used unlessothenvisespecifiedin procedures.

The prog1amincluclesprovisionsfbr ensuling that procuremetrt,inspection,and test requirernentshave beensatisfieclbefole an iten is placeclin serviceor used unlessothct'u'isespecifiedin procedures.

-l'he lr. procurementof conrponents,including spareanclreplacemetrtpafis, is subjectto quality and tecllricalrequircrnents suitablefor their intendedsert'ice.

1 3o f 3 6 Il.evision:l9

FEffOC FrrslFaergyrYrrle". Op.rr"n *n QualityAssuraneeProgrSmManual Appropriatecontrolsfor theselection, detenninatiott of suitabilityfor intended use(criticalcharacteristics), evaluation, teceipt,andqualityevaluation of col'nmercial gladeitemsareto be irnposedto ensurethattheitemsrvill perform satisfactorilyin sewice.

Aclditionaldetailsconcerning procurernent controlmaybe foundin the RegulatoryGuidesancl associatecl Standards ascommittedto in SectionA,7 and TableI (e.g.,Regulatory Guides1.33and 1.123).

5. Pro curernent Verific atiolr
a. A programis establishecl andirnplenrented to verify the qualityof purchased itemsandservicesat intewalsandto a depthconsistent with theitetrr'sor senrice's inpofianceto safety,cornplexity, andquantityandthefrecluency of procurernent.

b, Theprograrnis executed in all phasesof procurement. As necessary, thismay requireverificationof activitiesof suppliersbelowthe first tier.

c. Additionalcletailsconcerning proclx'ement verificationlnaybe foundin the RegulatolyGuidesanclassociated Standards ascommittedto in SectionA.7 and 1

Table {e,g., Regulatory Guides 1.123 ancl L144).

6. Identificatiott and Cotrtrol of Iterus
a. A prograrnis establishecl and implenrentedto identify and control itenrsto preventthe use ol'itrcotlector defectiveifetns' b, Iclentificationof each item is rnaintainedthroughoutfabrication,erection, installation,ancluse so that the itern can be tracedto its documetrtation' Traceability is maintainedto an extentconsistentrvith the item's importanceto safety.
c. concerningiclentification Aclditionalcletail.s and control of itetls may be found in the RegulatoryGuiclesanclassociatedStandarclsas corrlrnittedto in SectionA'7 andTable I (e.g.,RegrrlatolyGtride L33).

7 Handling, Storage,anclShiglpittg

a. A progran is establishedanclirnplenrentedto control the handling,storage, shipping,cleaning,anclirleservingof items to etrsttrethe iternsmaintain acccptablequality.

l 4 of 36 Rcvision: 19

FENOG QualityAssuranceProgr?ryManual

b. Specialprotectivelneasures (e.g.,contairters, shockabsorbers, accelerotneters, inertgasatmospheres, specificmoisfurecontentlevels, and temperature levels) arespecifiedandprovidedwhenrequiredto rnaintainacceptable quality.
c. Speci{icprocedures aredeveloped andusedtbl cleaning,handling,storage, packaging, shipping,andpreserving iternsrvltenrequiredto rnaintainacceptable quality.
d. Iternsaremarkedancllabeledcluringpackaging, shipping,handling,andstorage to identify,maintain,arrdpreserve theitems'integrityandindicatetheneedfor specialcotttrols.
e. Additionaldetailsconcerning lrandling, storage,andshippingactivitiesrnaybe foundin theRegulatoryGuidesarrdassociated Standards ascommittedto in SectionA.7 andTableI (e,g,,Regulatory GuideI '38).

8, Test Control a, A test control pro$'am is establishedand irnplementedto cletnonstrate that iterns will perform satisfactorilyin seryice,

b. Criteriaare dcfinedthat specitylvlrentestingis required.
c. The test control prograrninclucles,as appropriate,proof testsbefore installation, pre-operationaltests,post-rnaintertance tests,post-rnodificationtests,and operationaltests.

'lest

d. proceduresare developedthat irrclude:
l. instructionsand prerequisitcs to pertbrtnthe test,
2. useof propertestequiptnettt,
3. acceptance ct'iteria,attcl 4, tnandatoryinspectiorts as required.
e. Test resultsare evahratedto assurethat testobjectivesaud ittspectiort requiremetrtshave beetrsatisfied.

Unacceptabletest resultsshall be evaluated.

15 of 36 Rcvision:

FHruOC QualityAssurancePryglqryManual 4"s

g. Aclditionaldetailsconcerning testcontrolmaybe foundin theRegulatoryGuides andassociated Standards ascolltmittedto in SectionA.7 andTableI (e.9.,

Regulatory GuideI .33).

9. h{easurittgand TestEquipnrentControl
a. A programis establishedand irnplemerrtedto control the calibration, maintenance,and use of rneasuringand test equipmeut. Measuringand test equiprnentdoesnot include permanentlyinstalledoperatingequipmentor test equipmentuseclfor prelirninary checkswhere data obtainedwill not be usedto cletermineacceptabilityor be the basisfor designor engitteeringevaluation, AdclitionallS calibrationand control measuresare trot requiredfor rulers,tape measures,levels and other such devicesif norrral conrmercialtnanufacturing practicesprovide adequateaccuracy.
b. The typesof equipmentcovereclby the ploglalr (e,g., insttutnetlts,tools, gages' anclreferenceand trattsferstatrclards) are definedirr procedttres.

It4easurirrg ancltest equipmentis calibratedat specifiedintervalsor imttrediately befbregse ol1the basisof the itern'srequiredaccuracy,intetrdeduse, fi'equency of use, aud stability characteristicsand other conditionsaffecting its pertbnnance.

d. Measuringand test equipmentis labeled,tagged,or otherwisecontrolledto inclicateits calibrationstatusand to ensureits traceabilityto calibrationtestdata' Measuringancltest eqniprnentis calibratedagainststandardsthat irave atr accuracyof ut leastfour tiurestlre requiredaccul'acyof the equipnrentbeing calibrateclor, rvhen this is not possible,have an acclll'acythat ensttt'esthe equipmentbeitigcalibratedlvill be rvitlrinthe requilecltolcrance' If nationally recognizedstrindardsexist, calibrationstanclards are to be tfaceable to tlern. Except u4rerecalibrationstandardsrvith the sattreaccuracyas tlte ipstrumentsbeing calibratedare shown to be adeqnatefor the requiremertts, calibrationstandardsare to have a greateraccuracythan the standardsbeirtg calibratecl.

Measuringancltest equipmentfounclout of calibrationis taggedor segregated.

The acceptabitityshall be cleterrnined of items tneasured,inspected,or tested u,ith att out-oflcaliblatiotrdevice.

h. Aclclitionaldetailsconcenringlneasuringand testequipntetrtcontrolnraybe foun6 ir-rthe Regulatoly Guides anclassociatedStandardsas cornmittedto in SectiopA.l andTable I (e.g,,Regrrlatory GuidesI .30, 1.33, 1.94,1.116,and l . r2 3 ) .

1 6o f 3 6 Rel'ision: 19

FE'ruOG f rstEttttgyNt,ha".op*rt*O-rr-nT, QualityAssuranceProgramManual

10. Ins;reetion, Test,and OperatirrgStatus
a. The statusof requirecl inspections andtestsandtheoperatingstatusof itemsis verifiedbeforerelease, fabrication,receipt,installation, test,andLlse,as applicable.Thisverificationis to precludeinadvertent bypassing of inspectiotrs andtestsandto preventinadvertentoperationof controlledequipment.
b. The applicationanclrernovalof inspection, test,andoperatingstatusindicators arc controllediu accordance rvithprocedures.
c. Additionalcletails concerning inspection, test,andoperating statusconttolmay be founclin the Regrrlatory Gtricles audassociated Standards ascotnmittedto in Section A.7 andTableI (e.g.,Regulatory Guide1,33).
11. SpecialProcessControl
a. A program is establishedand irnplementedto ensttrethat specialprocessesare properlycontrolled.
b. The criteriathat establishrvhichproccsses are specialate describedirt procedures.

Specialprocessesal'eaccornplishedby qualified personnel,ttsittgappropriate eqpipmept,anclprocecluresin accordancervith applicablecoties,standards, specificatiorrs,criteria,attd other specialrequirements'

d. Additional detailsconcelningspecialprocesscontrol may be found in the RegulatoryGuidesanclassociatedStanclards as conrmittedto in SectiortA,7 and Table 1 (e.g.,RegulatoryGtride 1.33).
12. Inspectiotr
a. A progranris establishecl anclirnplenrentedfbr inspectionsof activitiesin order to verify confonnanccto the docurnentedinstructiotls,procedut.es and drau'ings

'l'he plogt'am may be implemented by fbr acconrlriishingthe activity, inspection or for the orgatrizationperforrningthe activity to be inspected.

b. Provisionsto ensgreiuspectionplanning is properly accomplishedare to be established. Planningactivitiesare to identify the characteristics attclactivitiesto be inspectecl,the inspectiontcchniques,the acceptance criteria, and the organizationresponsiblefor perfortnittgtlte inspection.

1 7o f 3 6 R e v i s i o n :l 9

FFTVOG QualityAssuranceProg-ramManual t"

c. Provisionsto identifoinspectionholdpoints,beyondwhichwork is not to proceedlvithoutthe consentof theinspectionorganizatioll, areto be defined'
d. Inspectionresultsareto be documented by the inspector andreviewedby qualified persottnel.
e. Unacceptable inspection resultsslrallbe evaluated andresolved in accordance with procedures.

Inspections areperfonnedby qualifiedpercorulel otherthanthosewho prr.-fornt*dor directlysupervised thervorkbeinginspected.Whileperforming ih" in*p"ctionactivitytheinspectors functionallyreportto theassociated individualresponsible for quality controlor an individualresponsible for matettals, purchasitrg,andcontracts asappl'opriate.

g. Adclitionalcletailscorrcerning inspections nraybe fbtrndin theRegulatoryGuides arrclassociated Stanclards ascommittecl in SectionA.7 arldTable I (e.g.'

to Ilegulatory Guides1.33and1.58).

1 3 . Corrcctive Actiolt

a. Proceduresslrall prot iclefor iclentilicatiort,er,aluatiott,and resolutionof conditionsadverseto qualitY.
b. Rervorkecl,repaired,and replacemeutitems are to be inspectedand testedin accorclan.**ith the original inspectionand test requirementsor specified alternatives.
c. Arlditiontrliietailsconcelrringcorrectiveactionactivitiesmay be tound in SectiopA.6 and the Rcgr,rlatory GuidesanclassociatedStarrdardsas collllnitted to irr SectionA,? andTablc 1 (e.g.,RegulatoryGuides1.33and 1.144).
14. I)ocurtrentControl a, A prograrnis establishecl anclirlplementeclto control the developrnent,revier,v, approval,isstte,use, and revisiotrof docutnetlts.
b. The docqmentcontrol proglanl shall be applieclto documentsthat prescribe activitiesaffecting quality of safety-relatedstructnres,systemsor colnpotrents.

Suchactivitiesincluileclesign,pl'ocurentettt, ntalerialcontrol,installation, ilspectiol, testing,nraintcnance, operatiott,refuelitrgarrd rnoclificzttiotr, decotnnrissioning.

1 8o f 3 6 Revision: l9

FFruOC f rst?ntrgy Nucle"ri.

O*r"r*a*n* QualityAssuranceProglqmManual

c. Revisionsof controllecl docunrents arereviewedfor adequacy andapprovedfor relcase by thesaffleorgarrization thatoriginallyrevicwedandapplovedthe clocuments or by a clesignated organization thatis qualifiedandknowledgeable.
d. Contrclleddocurnents areavailableto andusedby thepersonperfornringthe activity.

The distributionof nervanclreviseclcontrolleddocumentsis in accordance with procedures. Superseded documents arecoutrolledto preventinadvettent use' Arlditiolal detailsconceruing clocuurentcontrolrnaybe foundin theRegulatory Guiclesandassociated Standards A.7 andTable1 ascorlllnittedto in Sectiorr (e.9.,Regulatory Guide1,33).

15. Records
a. A prograrnis establishecl and irnplementedto eltsurethat sufficient recordsof itenrs lncl activities(e.g.,clesign,engitreeringprocuremeut,manufactttring, construction,inspectionancltest,installatiolt,preoperation,startup,operations, rnaintenance,rnodification,clecomrnissiotting, and audits)are generatedand rnaintainedto reflect cornpleted work,
b. TIte program pl'ovidesprovisiorrsfbr tlre adrnirristration,receipt,storage, preselatiott, safekeepiug,retrieval,and dispositionof records'
c. Aclditional cletailsconcerningrecordrequiretnentsmay be lbund in the Regulatory Guidesanclassociatecl Stanclardsas colnmitted to in SectionA.7 and Table I (e.9.,RegulatoryGuicle1.88).

t C. ASSESSJ\{ENT

l. l\'Icthoclology a, Pelsonnelresponsiblefbr carryingout auclitsal'emaintainedcognizatrtof day-to-dayactivitiesby the ongoinginvolvemetrtin the quality asstlrance pl.6gt'amrequirementsso that they can act in a tnanagetnentadvisory function'
b. Orgapizationsperfonling auditsarc to be technically and perfoltlatlce oriented con)rnensurate rvith the activity being revier,ved.
c. personnelperfonning auditshaveno direct responsibilitiesin the areatltey are assessing.

1 9o f 3 6 Rcvision:19

FFfUSG Frrslfnerot Nuc/eu.*t Utt

  • QualityAssuranceProgramManual
d. Auditsareaccomplished usingprocednres, or otherappropriate tneausthatareof a detailcornmeusurate with the activity'scornplexity and importance to safety.

I Audit

a. A prograrnof plannedandperiodicauditsis established andimplemented to confirmthatactivitiesaffcctingqualitycornplywith thc QAPM anclthatthe QAPM lrasbeenim;rlemented effectively.Auditswill be cotrducted asrequired by theapplicable Codeol'Federal Regulations, Tecltnical Specifications, safety analysisreports,andcommitments by variouscorrespottdence to the NRC.

Anditswill be conducted at a fi'equency in accotdance rvitheitherSectionC.2.a.1 or Sectio n C.2.a,2below.

l. Audit frequencieswill be determinedin accordancewitir a performance basedaudit schedulingpro$'am. The schedulingpl'ogram,through an expertpanel, usesassessrnent indicatorsto identiff and scheduleaudits basedon perfor:nanceresultsand irnportatrceof the activity relative to safety. Potentialaudit subjectareasare periodically assessed against appropriateperforrnancecriteria. Frotn thesereviervsa deterrlinatiottis rnadein regardto tlre depth,scope,and schedr.rling of specific audits, Frinctionalareasimportant to safetyat'eassessed annually (t 25%) ta iclentifystrengthsand weaknesses(if applicable)to deternrinethe level and focus of independentoversightactivities for the upcoming year, The basis tbr the assessment shall include the resultsof auditsand srtrveillance,NI{C inspections,LERs, self-assessments, and applicableconditionsleports (e.g.,non-confonrlanceand con'ectiveaction reports). Personnelchaltges, change/irlcrease in ftinctional arearesponsibil ities, indtrstryoperating experience,and INPO evalnationsrvill alsobe considered.Each arealvill be assigneda rating rvitlr a colltpalisotrto llreviousyears. This assessment rvill be docutrtented, revierved,and approvedby quality assulance rnanagemettt, This docnmentis considereda quality assul'altce record and will be availablefor NRC revien,. Audit subjectareasof SectionC,2.a,2shall confinueto be auditedon the fi'equenciesdesignatedunlessexpertparreljudgnent,basedon perfornlance results,cletemritres snch an audit to be nrulecessary.In such casesthe expertpattel basisshall be docunrettted.
2. Audit schedulesassul'ethat the follog,ing areasale auditedat the indicated li'equencies,or ntol'eli'equentlyas perfolllrancedictates.
a. Tlre conformalrceof'unit operationto provisiotrscontainedlvithin the TeclrnicalSpecificationsand applicablelicenseconditiortsat least once pl"r24 months.

2 0o f 3 6 Revision: 19

F'E'VOG b, The perforrnarlce,training and qualification of the statioirstaff at least once per 24 tnontlts, Tlre resultsof actiorrstakento correctdeficienciesoccurringin unit equipnretrt,sttuctures,systetnsor tnetltodof operationthat affect nuclearsafetyat leastonce per 24 months.

d. The performanceof activitiesrequiredby the QAPM to meet tlte requirementsof 10CFR50, Appendix B at leastonce per 24 months.
e. The fire protection progt'amcontrols and irnplementingproceduresat leastonce per 24 montlu.

The fire protectionequipmentand program implernentatiotrat least once per 24 monthsutilizing either qualified licenseepelsontlelor an outsidefi re protectiortcottsultant.

ct b' The file protectionequipmentarrdprograrnirnplementatiottat least orlcepel36 mottthsutilizing a qualifiedoutsidefire protection consultant, h, The RadiologicalEttvironmentalMonitorittg Program(REMP) and radiological efflueutsmottitoring astivities and implenrenting proceduresat leastoncc per 24 months.

The Offsite Dose CalculatiorrManual and implernentingprocedures at leastoltce per 24 montlrs, J. The ProcessControl Proglanrand irnplementingprocednresfor processiugartdpackagingof radioactivewastesat leastollce pet 24 nrontlts.

3. A gracelreriod of 90 claysnray be applied to the 24 rnonth fi'eqttencyfor internal auclits. For activiticsdefen'edin accot'dance rvith the 90 ttay gtace periocl,the next pelformancedue datervill be basedon their ortginally scheduleddate. I
4. Auclitssirallprovidean objectiveevaluatiottof quality relatedpractices, procectures, instnrctions,activities,and items atrda reviervof docunlents anclrecords,as applicable.
5. Auclitsshallbe pelforrnedin accoldance u,ithapprovecl rvrittenprocedures or checklists.Iternsfi'ompreviousauclitsshall be revierved andreaudited, asappropriate.The checklists alensedasgtridesto theauditor.
6. Schedulingand lesourceallocationare baseclon the statltsand safety importanceof the activityol processbeirrgassessed.

Schecltrlingis clynamicanclrcsoul'cesare srpplernentedlvhen the 4

effbctivenessof tlre quality asstlrallceproglanr is in doubt.

2l of36 Revision:19

FF,VOC QualityAssuranceProgjemManual

8. Audit reportsarervlittenanddistributedto theappropriate levelsof management for review. Follorv-upactioncanbe accornplished tlu'ouglr writtencomlnunication, rneans'asdeemed te-audit,or otherappropriate necessary.
9. Implementation of delegatedportionsof thequalityassurance progtamis assessed.

1 0 . Auditsareconclucted gsingpredetermined acceptancecriteria,whichare tlreindiviclualrequiretnentswithin theQAPM,applicableRegulatory Gqicles and ANSI procedures, Stanclards, anddocuments thatareusedto performthe auditedactivityor process.

ll. Additionaldetailsconcelningauditsmaybe foundin theRegulatory Guidesanclassociated Stanclardsascommittedto in SectionA.7 andTable 1 (e.g.,Regulatory Guides1.33and I .144).

D. INDEPENDIINTSAFETY REVIBW l, Description

a. Inclepenclentsafetyrevierv is pertbrmedto tneetthe individual ttnit's commitmentto perfbrrnthe ftinctionsdescribedirr NUREG-0737, Section LB. L2,'*IndependentSafetyEtrgineeringGroup."

22 of 36 Revisionl 19

FENCIC QualityAssuranceProg-ram Manual Table 1 - Regulatory Commitnreltts A. Rcgulatory Guicle 1.8 (Revisiolr 1) [Septcnrber 19751,PersonnelSelection snd Training

1. FENOC commitsto the regulatorypositionof this Guide with the following clarifications:
a. RegulatoryGuide 1.8 states"The RPM shouldhave a bachelor'sdegreeor the equivalentin a scienceor engineeringsubjectincluding solne formal tlaining in radiationprotectionand at least5 yearsof professionalexperiencein applied racliationprotection." It is FENOC's positiorrthat equivalentas nsed in this RegulatoryGuide for the bachelor'sdegleenreans(a) fbur yearsof post secondary schoolingirr scienceor engineering,or (b) four yeals of applied experienceat a nuclearfacility in the areafor rvhich qualificationis sottght,or (c) four yearsof operationalor technicalexperienceol training irt nucleal'power,or (d) any cornbinationof the above totaling foul years. The yearsof expelienceusedto meet the educationrequirementsas allowed by this exceptionshall not be used to also meet the experiettcerequitetnents.
2. F'ENOCcomrnitsto tlre requirernents of ANSI N18.1-19?I as moclifiedby plant-specific Technical Specifications.

B. Regulatory Guirle 1.30 (Revision 0) lAugust 19721,Qualitl,AssurgrtceReqt+irententsfar the Instrtllatiott, Inspection, snd Testing af Inslrumentfiion tnd Electric Equipment L FENOC commitsto the regulatorypositionof this Guide.

2, FENOC conrmitsto the lequirementsot'ANSI N45,2.4-1972 rvith the following clarificatiotts:

a. Section1.1 specifiesecluipmentto rvhichthis Standardapplies. In lieu of this, requircrnentsof this Stanclarclshall apply to tlrosesystemsand compotlentsthat are x,ithin the scopeof the QAPM. Eachplant nraintainsa list of equiprnentsubjectto cotnponents eApi\4 reqnirements.This Standardis also appliedto other systenrsand vvhenlcquileclby approveclprocedures, errgineeringspecifications, or otherrvork controllingtlocunrents.
b. SectionZ,Z rcquircsthat eviclenceof complianceby the tnanufactnrerrvith purchase requirernents,including quality assurancerequirements,be availableat the site prior to applying the requirernentsof ANSI N45.2,4. In lieu of this t'eqttirenretrt, installation,inspection,arrcltcsting activitiesof equiptnerrtlackirtg its quality documeltation rnay proceeclprovided that this equiptnenthas beenidentified and releasecl in accorclancervith non-conforrningmaterialirroceduresanctthat all reqnired qpality clocurnentatiorrhas beenreceivedand acceptedprior to the itein being placed in sewice.

23 of 36 R c v i s i o n :l 9

FFAJOG f :tjt f n.tgfN+: t'a' Oix'ral,irnffi*q QualityAssuranceProgramManual

c. Section3 requiresthat recordsof protectivetneasuresrnaintaineddurirrgstoragefor conformanceto storagerequirementsbe checkedto verify that iternsare in satisfactorycondition for installation. This check shall be rnadeonly if equiprnertt requiresspecialstorageor handlitlg as specifiedin proculementdocnrnents,
d. Sections5.2 and 6.2 list the testswhich are to be cotrductedduring consttuctionand post-constructionactivities. In lieu of thesetests,FENOC shall conductonly those testslecessaryto verify that wolk activities specifiedby work controlling documents have been satisfactorilyaccomplishedduring rnaintenanceor modification activities' Tlre requilernents of Sections5.2 and6.2 of ANSI N45.2.4shallbe usedas guidelines irt detertniningthesetestingrequiremetlts' e, Section6.2,1statesin part tlrat "ltems requiring calibrationshall be taggedor labeled on completionirrdicatingdateof calibrationand identity of persontlrat performedthe calibration." In lieu of this requirement,FENOC rnay alternativelyirnplemetrt programsthat requirethe eqnipmentto be suitably markedto indicatethe date of the pext calibratiol anrl the identity of the personthat pertbnnedthe calibration. Irt actclition,ipstalleclplant equiprnentthat is usedas measuringantl test equiptnent (M&TE) may be controlledto indicateits calibrationstatusand to ensllretraceability to calibrationtest databy alternaterneansin lieu of physically taggingor labeliilg (e.g.,preventivemaintetlallceplogram).

C, Rcgulatory Guide 1.33(Revision2) [February l9?81, Quali\, AssursnceProgrnm Il equ ire m en ts (Operat iorts)

l. FENOC comrlits to tfueregulatoryposition of this Guide rvith the follorving altenratives:

a, Regulatoryposition C.4 speciflesaudit fi'equenciesfor severalaudit topics. QAPM SectionC.2 (Audit) describesalternativesto thesefi'eqltcncies,

2. FENOC commitsto the reqnirenrents of ANSI N 18.?-1976/ANS3.2 rvith the follor,ving clarificatiousand alternatives:
a. SectiorrI reqnircsthat this Stanclard"apply to all activitiesaffectingthe safety-relatedfupctiops of nuclcal'powerplant structures,systetns,ttnd componellts."

F-ENOCslall apply the requirernentsof this Standarclto tltosestructut'es, systents, auclconrponentsiclentifieclas safety-relatedin the respective plant's USAR.

b, Section5.1 statesin part that "a sunlnraryclocunrentshouldbe cornpiledby eaclr owfler orgarrizationto iclentifythe sources,to index such sourcesto the requirernetrts of this Standard,anclto provide a consoliclated basefor the descriptionof the plograln." In lieu of this requirenrent,a tnethorlof cross-refereucing these i"q,,ir.tttents to the intplementitrgproceduresrvill be lnaintairred.

c. SectigrrS.Z.Zlcqlires that "ternporarychatrgesrvhichclearlydo not changethe intent of t5e approvedprocedureshall,as a rninilnurn,be approvedby tlvo trtetnbersof the 24 of 36 Revision:l9

a" FENOG QualityAssuranceProgramManual plantstaffknowledgeable in theareasaffectedby theprocedure.At leastotteof these shallbe thesupervisor in chargeof theshift andhold a senioroperatinglicettseon the gnit af-fectecl." Suchchanges shallbe documented andif appropriate,incotporated into therrextrerrisionof theaffectedprocedure.In lieu of theserequiretnents, FENOCcommitsto the follorving:

1 ) Temporary changesto procedureswhich do not changethe intent of the approved prccedure shall be approved for implementation by two members of the plant managementstaff, at leastone of whom holds a Seniol ReactorOperatingLicense for the unit affected. The ternporaryproceduresshall be approvedby the original approvalauthority rvithin 14 days. For chaugesto procedureswhich may involve a changein intent of the procedure,the original approvalauthority shall approve the changeprior to irnplernentatiou. OR

2) Tcrnporarychangesto procecluresrvill be approvedby two knorvledgeablemembersof the plant staff plior to irnplententation.At leastone of thesepersollsrvill be a menrber of snpervision. If tire changeaffectsoperationsprocedures,at leastone of these pet'sorlsn ill hold a seniorreactoroperatorlicensefor the unit affected. Prior to irnplementation,the OSC (PORC) shall revierv and recomtnendapproval of ternporary clrangesto proceduresrvhich require a 10CFR50.59safetyevaluation. Within 14 days of irnplernentation,ternporarychangeswill be reviervedby an independentqualified and approvedby the ResponsibleDiscipline Martagsl'tll'lrisclesignec.

revier,r,,er d . Section5.2.6 recluiresthat a log be maintainedto identify the cutrent statusof tentporarymodificationssuchasbypasslines,electricaljumpers,lifted electrical leacls,aud ternpol'arytrip point settings. FENOC takesexceptionto this requiremettt rvhclttlre institllationand rernovalof suchteurporarynrodificatiotts is specifically aclchcssecl in approvedprocedules. These pracedrtresellsrlrethat the circuitry is l'etumedto its original configurationrvhenthe operatiottis cornpleted,

e. Section5.2.7- Since ccrtain emergeltcysituationscould arisewhish rnight prel'ent preplaruringactivities,FENOC cortrpliesr,vithau altemativeto the first seutencein the secondparaglaphas follo\l,s: "Except uttderemergeltcyor abnonnaloperating conclitionsu,hereirnmecliateactionsare requiredto protectthe health and safetyof the public, to pt'otectequiprncntor personnel,or to preventthe deterioraticnof platrt conclitionsto a possiblyunsafeor unstablelevel,maintetrallce 01'nrodificationof equiprnentslrallbe preplannedarrdperfbnncdin accordancervith approved proccclures.When ivritten proceclulesu,oulclbe requiredand are trot used,the activitiesthat are accomplisheclare docutttentedafter-the-factanclteceil'e the satne clegrecof t'eviervsas if they had beenpreplatttted."

Section5,2.13(l) establishes tlrerequiretnentfor identifyingquality asslrrance progl'amrequirenrentsapplicableto the items or selices being proctrred. When purchasirlgcomlnercialgradeservicesfronr cerlain accreditedcalibration laboratories,the procurellrentdocurnentsare not requiredto irnposea quality asssl'ance pl'ogramconsistentrvith ANSI N 18.7. Altemative requiretnetttsdescribed 2 5o f 3 6 R e v i s i o n :l 9

FFruOC QualityAssuranceProgramManual f, f s/f ,l("gi,, r\tuctPar O*r rtna-in this QAPM for Regulatory Guide1.123may be implemented irr lieu of irnposinga qualityassut'ance proglalnconsistent with ANSI N18.7.

g. Section5.2.15contains a requirement for biennialreviervof plantprocedures. In lieu of this requirernent, FENOC nray use one of the following tnethods as altematives:

r) hnplernent processcontrolsthatensureprocedures arerevierved for possible revisioluponidentification of llewor revisedsourcetnaterial potentially affecting theintentof procedurcs.

2) Implementprocesscontrolsrelatedto proceduret'eview,a rlaximumsix year reviervperiodandbiennialauclitsof operatingorganizations thatincludea review of theirprocednres to assurethatcontrolsresultin timely procedure revisionin responseto operationsexpedence deficienciesandproceduredeficiencies iclentifiedby users.
h. Section4.3.4 (3) cliscusses the requirementfor the on-siteand off-site independent revies, bodies to revierv licensearnendrnents and technicalspecificationchartges.As an altenrativeto the requirenrentsfor the off-site review body to review license arpepdrnents and technicalspecificationchanges,FENOC will utilize the on-site lcvierv body firr thcsereviervs. To eusuretlrat the ort-sitereviervbody maintains ipdepeldenqecluringthesereviels, any voting member that has a potentialconflict of interestin a changeunder reviervu'ill be replacedby anothermeinberto achievea quorLlm, In addition, the off:site revieu'body rvill review on-sitereview body meetingminutes anclinclepenclent oversight(QA) audit and assessment resultsof on-site review body activitiesto evaluatetheir effectiveness.

D. Regulatory Guicle 1.37 (Revision 0) flVlarch 19731, Quality AssurqnceRerluirements for Cleuning of Fluid SystemsanclAssocirttedContponentso.f l\ater-Cooled Nuclear Pou'er PIants l . ITENOCcornmitsto the regulatolypositiorrof tlris Guide rvith tlie follolving clalit-lcations:

a. Regulatoryllosilion C.3 requiresthat rvaterquality for final flushesof fluicl systenrs anclassociatedcotnpollentsbe at leastequivalentto the quality requiredfor not'mal operatiol. Tfiis requireurentis not applieclto dissolvedoxygerlor nitrogen nor does ilfel that additivesnonnally in the systernlvater shall be addedto the flush water,
b. I{egulatory Position C.4 r'equiresthat chernicalcornponetttsthat cotrldcontributeto intirgranrrlur.,rurkirrg or stresscorrosioncracking shouldnot be usedrvith austettitic stainlesssteeland nickel-basedalloys. It is FENOC's positionthatrnaterialssuchas ipks, temperatureinclicatingcl'ayons,labels,rvrappingnaterials (otherthan polycthylene),u,atersolublematerials,dcsiccauts,lubricattts,andNDE penetrant materialsarrdcouplants,rvhichcontactstainlesssteelor nickel-basedalloy material sur.f'aces contain no lnole than trirceamountsof lead, zittc,copper,or lorver rnclting 26 of 36 Revision: 19

FE'VOC trrffi QualityAssuranceProgramManual alloysor compounds.Maximumallowablelevelsof waterleachable chlorideions, totalhalogens andsulfurcornpounds shallbe definedand irnposed on the aforenrentioned rnaterials.Thesernaterials will be controlledthroughadrninistrative procednres thatare,irr palt,designed to rnininrizetheireffectson intergranulaf crackingor stresscotrosioncracking.

2. FENOCcomrnitsto therequirements of ANSI N45.2.l-1973 rviththefollowing clarifications:
a. Duringmaintenance anclmodificationactivities,FENOCshallcontroltheopeningof cleansystemsandshallconductinspectionsto verify that affectedsystemcleanliness levelsshallnot be adversely affectedby themaitrtenance 01'rnodification activity.

Whensystemcleanliness is affected,specificcleaning procedures rvhich incorporate theappticable portionsof this Standaldshallbc developed andimplernented to systcmsleanliness.

rtraintaitt

b. Section2.4requrires thatpersonnel u,hopelfbnninspectiotr, exantination or testing activitiesrequiredby this Stanclard be qualifieclin accordance lvith ANSI N45.2.6.In lieu of this,personnel lvhoperformsleanliness inspections ffiay altematively be qualifiedin accordance lvithRegulatory Guide1.8-E. RegulatoryGuide 1.38(Revision2) [May 19771,QualityAssurunceRerluirements for Packaging,Shipping,Receivirtg,Storage, and Hsrtdting of ltemsfor ll/uter-Cooled Nuclesr PowerPlfints l . FENOCconrttrits to the legttlatorypositionof thisGtride-
l. FENOCcommitsto therequirenrents of ANSI N45.2.2-1918 the follorving clariflcations:
a. Sections3 and 4 specify a four level clas.sification systetnfor the packagingand shippingof items. Irr lieu of thesereqnilemettts, commercial gradeitents slrallbe packagedanCshippedin accordanceu,ith standardcommel'cialpractices.

b . Section5.2,l requirespreliminary visual inspectionor exarninatiottfbr shippittg clamageto be performedplior to unloading. In licu of this requirelnent,visual inspectionshall be perfbnned during unloading and unlrackiug.

c. Section5.5 proviclcsfor "re$,ol'k" and "nse-as-is"clispositionsfor uoucortlbtrning itcms. As au altenrative,tlre"repail'"dispositiotr(as definedby ANSI N45.2'l0-1973)tnay alsobe used.
d. Section6.5 requiresthat itemsreleasedfronr storageand placedin their'final locationsu,ithin the porverplant be in.spected and caredfor in accordatrcervith the requireurentsof Section6 of this Stanclardand other applicabieStandat'cls.In lieu of rvitlrin their'

_thisrequirement,FENOC shall,lvheneverfeasible,stot'eitettts 27 of 36 Revision:19

FEJ\JOG QualityAssuranceProgramManual l-:tt{t!"tlil ^1}:?r' OrU'n r,,rg, appropriate storageareaandrnovetheequiprnent to theplantal'easfor stagingonly in sutficieuttirneto supportits installation.Within theplarrt,theequipmettt shallbe stagedat locationswhichprovideequivalent environrnental conditionsunderwhichit is designed to operate.Materialsplacedin stagingat'eas shallbe storedin accordance rviththeapplicable requirements of Paraglaphs 6,1,6,3 and6.4.2of ANSI N45,2,2,

e. VariousSectiousof ANSI N45.2,2address theuseof notr-halegenated materials rvhenin contactwith austenitic stainlesssteelor nickel-based alloys. Theexceptions applicable to RegulatoryGuide1,3?regardingthis subjectalsoapplyto ANSI N45,2.2.
f. ScctionA.3.4.2addresses inertgasblankets.Theretnaybe casesinvolvinglargeor cornplexshapesfor which an inertor dry air purgef'lolvis providedratherthanstatic gasblanketsin orderto provideadequate protectiondueto diff,rcultyof providinga leak-proofbanier. In thesecases,a positivepressure purgeflorvmaybe usedasan altemativeto a leak-proofbarrier.

F. RegulatoryGuide 1,39(Revision2) [September19771, Housekeeping Requirententsfor IVster-Cooleil Nuclesr PowerPlants L FENOCcotnmitsto theregulatot'y positionof thisGuide.

2. FENOCsommitsto thc reryuirements of ANSI N45.2.3-1973 tviththefollowing alternatirte.
a. The ANSI five level zonedcsignationsysternmay not be utilized, btrt the itttentof the stanclarcl w,ill be nret for the areasof housekeeping,plant and pet'sonnelsafety,and fire protectiotr.

G. Regrrlatory Guicle 1.58 (Revision 1) [Septenrber19801,Quulilication of Nuclecr Power Plant Inspection, Excntinotion and Testing Personnel I . ITENOCcornnritsto the regulatorypositionof this Guide rvith the follorving clarifications:

a. The guidanceof this RegulatoryGuicleshall be follolved as it pertainsto the qualificationof personnelu,hoverify con{buuanceof rvork activitiesto quality lequirements.

b, Personnelr,villnot be certifiedas statedin this Guide in the follorvingareas:

1) Individualsthat handletestresultsol pelform documeutcorltrolactivities.
2) Quality assut'allceanclstaff personnelrespottsiblefor tlte revielv of docnmentsfbr clality and cotnpleteness, 2 8o f 3 6 Revision:19

FENOG f ,ts t7n eey l\\Er- ur O*"UrnC QualityAssuranceProgramManual

3) Test personnelutilizing gas test methodsfor infonnation or data collection activities(this includesthosepersor)nelperfonning local leak rate testing(LLRT) as statedin 10CFR50 Appendix J). The qualificationsof thesepersonxelshall corrfonnto the requiremettts of RegulatoryGuide 1.8.
4) Plant opelationpel'sonllelconcellteclrvith day-to-dayoperation,maintettance,and ceftaintecluticalservices(the qualificationsof thesepersonnelshall confonn to the requirernentsof RegrrlatoryGuide 1.8).
c. RegrrlatoryPositionC,2 indicatesthat SNT-TC-lA-1975 is to be usedfor the qualificationof nondestnrctiveexamination[NDE) personnelwho apply various NDE rnethods.It also indicatesthat personnelperformingnondesttuctive examinationsrequireclby SectionIII and SectionXI of theASME Code should be qualified to SNT-TC-lA-1975 as well as additionalprovision of the Code. For the qualificationof NDE personnel,FENOC commits to the ASME SectionXI requirenrentsspecifiedlvithin the applicablecode year edition(s)as defined by 10CFR50.55a.This altemativernay be applieilregardlessof lvhetherexaminations are of a tlpe requiredby the Code.
2. FENOC cornrnitsto the requirenrents of ANSI N45,2.6-1978as nrodifiedby the comrnitrnentsto RegulatoryGuide 1.58 rvith the follolving claritications:
a. Section2,5 of this Stanrlarddiscussesspecialphysicalcharactet'istics.FENOC cotnmits to the folior,ving:Examinationsto r,,crifythat personnelhave the required physical characteristicslvill be schecluledou an arutualbasisrvith a maximum allorvableextensionof 90 daYs.
b. Sectiol 3.5 of tfuisStandarddiscusses educationand experience,FENOC contmitsto thc follorving:The initial qualiticatiorrs of individnalsto Level I, II, or III B'ill generallybc to the educationand experiencelecontmendationsin the Standard' However, in cefiain instanccsas determinedby appropriatetnanagetnent, qualificationslrlay be altenrativelydetenttinedthrouglrtest resultsand/or clernonstration of capabilities. For Level I, FENOC lviil also accepta four year collegecleE"ee plus one month of relatedexperienceor eqtiivalentinspectiot:,

exalrinationor testingactivities.Individualrequaliticationrvill meetor exceetltlte recomlnenelation of this Standard.

c, Section2.3 of this Standardcliscusses evaluatingpel'sonnelrvho have not perfottned inspectionactivitiesfol rnorethan a year. A 90 day graceperiodis appliedto this evaluatiou.

H. Regplatory Guide 1.64 (Revision 2) [June 19761,Quality AssuranceRerluirementsfot the Design of Nuclear Potver Plottts 1, FENOC commitsto the regulatorypositionof this Guidervith the following clarifrcatiotts:

29 af 36 Revision:19

FENOG

,"*ffi QualityAssuranceProgramManual

a. Regulatory PositionC.2(l) adclresses theuseof a superuisor in clesignverificatiotl, If, irrexceptional circumstances, the supervisor is the only technically qualified indiviclualavailable,thedesignverificationor checkingshallbe conducted by the superuisor rviththe followingplovisiotts:

l) Theotherrequirements of RegulatoryPositionC.2of tlris Guideshallbe met.

2) Thejustificationshallbe individuallydocunrented andapprovedby the nextlevel of supervision.
3) Qualityassurance auclitsshallincludereviervof fi-equency andeffectiveness of theuseof theimmeciiate superuisor to assurethatthis provision is used only in exceptiottal circutttstauces.
b. An individualg'hocontributed to a givendesigrrrnayparticipatein a group verificationof thatdesign providetl thatthe individualwho contributed to thedesign doesnot (1) verify lris contributionto thedesign,or (2) selve as chairman or leaderof thegroupverificationactivity.

Z. FENOCcomrnits to thereqnirements of ANSI N45,2.ll-1974with theclarifications as for notedabove theuse of an immediate supervisor for design verificationactivities and conductof groupverificationactivities.

I. RegulatoryGuide 1.74fReyision0) {Febmral'y19741, QualityAssurnnceTennsand DeJinitions I . F'ENOCcomtnitsto theregulatot'y positionof thisGuide.

2. FENOCcomtnitsto thereqrtiretneuts of ANSI N45.2,l0-l9?3.

J. RegulatoryGgide 1.88(Revision2) [Octobcr'19761,Collectiort, Starugeand Mnintenilnceof NuclecrPotperPlunt Quulits' Assurance Records

l. FENOCconttnitsto the t'egttlatory positiorrolthis Guicle.
2. FENOCcornrnits to therecluiremeuts of ANSt N45.2.9- 1974lvifhthefollowing altenratives:
a. Sectiol5.6arlcllesses recorflsstoragcfacilities.In lieu of this,thedesigttand constnrctiol of quality assurarlcerecordstoragefacilitieswill follow thegrridance of ANSI/ASh4ENQA- I 1983,Supplenrent I 73-1 , Section 4.4. When temporary storage of recorcls is required, theguidarrce of ASIT4E NQA-l - 1989,Supplement l7S-l, Sectiort 4,4,3r,villbe follorvcd.Forstorage of specialprocessecl records (such as racliographs and rnicrofilm), hurnidity and ternperature cotrtrolsshallbe provided so asto nraintainan environnrental conclition as pl'escribecl in Paragraph 6'1.1 of ANSI PH 1.43-1979(Alsorequired by Section 5.4)'

3 0o f 3 6 Revision: 19

f,EtrOC Frrslfnc.rgyrVucle"rOOor^rO"O- QuafityAssuranceProgramManual

b. AppendixA of ANSI N45.2.9,requiresthatrecordsof measnring andtestequiprnent calibrationbe rnaintained "until recalibration."This irnpliestltatthe full storage requirernents of this Standard applyuntil theequipttrent is recalibrated. In lieu of this requirement, FENOCrnaystoremeasuring ancltestequipurent calibratiourecordsin one-hourfir'e rateclcontainers.This exceptiondoesnot applyto recordsof calibration requiredby theTechnicalSpecifications.
c. FormanagingQA recordsin electronicmediaFENOCcommitsto tlreguidance of RIS-2000-018, ThisNRC Regulatory IssueSnnrmary (RIS)endorses:

. NIRMA TechnicalGuide(TG) I l-1998,Auttrentication of RecordsandMedia o NIRMA TG 15-1998, Managetnent of Electronic Recorcls c NIRMA TG l6-1998,SoftwaleConfiguration Management atrdQuality Assurance c NIRMA TG 2l-1998,Electronic RecordsProtectiott antlRestoratiott K. Regulatory Guiclc 1.94 (Revision l) [April 79761,Quulity AssurunceRequirementsfor htstsllstiol, Inspectiort anl Testing of Structural Concrete snd Structurul Steel During the Construction Phnse of Nuclesr"Power Plants

1. FENOC comrnitsto the regulatorypositionof tlris Guide,
2. FENOC cornmitsto the requirernents of ANSI N45.2.5-1914rvith the follou'ing clarificationsand altentatives:
a. Sectiop2.2 requiresthat installation,inspection,and test proceduresbe kept ctttrent with the latestinfognation. This Standardrvasrvrittento addressrequit'etnents associatedlvith constructionphaseuctivities. However, dndng the operationsphase, actir.itiesassociatecl rvith installation,irrspection,and testitrgof strtlcturalconcrete agd structuralsteelare very minor in fi'equencyand extetrt, Consequently,procedures for fheseactivitiesshall only be revierveclot'updatedprior to cottrntencing the activity. The procetlnresfor structural concrete sttnctural attcl steel installation, inspection,and testingactivitiesrvill be developcdusingthe provisionsof ANSI N 4 s . 2 . 5- 1 9 7 4 .
b. Altenrativesto this Stanclarcl are taken rvith respectto fi'equencyof calibrationof iprpactrvrenches and bolt projection criteria. Inrpactand torquervrenchesshall be checkedat leastonce clailyper shift, and at leastone ftill threadof all bolts shall project beyonclthe nut of all tightenedcomections. Thesecriteria conrply rvith the recomfirendations of the ResearchCouncil on RivetedanclBolted StructuralJoints.

3 1o f 3 6 R c v i s i o r r :l 9

FENQC i, QualityAssuranceProgramManual

c. Section 4.9.1discusses thequalification requirements for rnechanical (cadweld) splice operators.In lieu of this,Davis-Besse andBeaverValleylvill complywith qualificationrequirements of ASME SectionIII, 1995Editiott,subparagraph CC-4333.4.

d . Section4.9.3discusses tensiletestingof mechanical (cadrveld) splices.In lieu of this, Davis-Besse andBeaverValleyrvill cornplywith therequiretnents of ASME Section III, 1995Edition,subparagraph CC-4333.5.2.

Section4.9.4discusses tensiletestingfi'equency.In lieu of this,Davis-Besse and BeaverValleyu,ill complywith ASME SectionIII, 1995Edition,subparagraph CC-4333.5.3.

f. Section4.9,4discusses testingof bothproductionandsistermechanical (cadweld) splices.In lieu of tlris,Davis-Besse andBeaverValleywill testsistermechanical (cadweld)splicesasdescribed in ASME SectionIII, 1995Editiotr,subparagraph CC-4333.5.2, g

a>' Section5.5discusses inspection steelrvelding.In lieu of this,Davis-of structnral BesseandBeaverValleyrvill cornplyrvithinspection requirements of theapplicable weldingcodesandanyexceptions.

h . Thc mecharrical splicellel'sonnel testingandtestingfrequency qualification, requircrnerrtstbr mechanical (cadrveld) splicesaddressed in K.2,ethroughK.2.f apply to otherfull positiveconnection technologies thatmeettlredesigucodeof record,The fiequencyof shearscrewandsleevesplicetestingshallnteetthesanrerequit'ements asswagedsplices, L, Regulatory Guirle 1.116 (Revision 0) [i\{ay 1977], Quality AssnrrttrceRequirementsfor hwtallation, fnspection afid Testing of Mechunicsl Eryuipment und Systems

1. F'ENOCconrmitsto the regulatot'ypositionof this Guide.

?, FENOCcommitsto thc requilernents of ANSI N45.2.8-lg75 rvith thc fbllou'ing clarifications:

a. Sections2.4 antj2.6 requiretlrat llrocedulcsdefine systemrestot'atiottrequirementsas neededto prevent contarninationafter cleanlinessclassis achievedin accordattcervitlt cornmitrnents to ANSI N45.2.1andANSI N45.2.3,
b. Section2.9 requiresthat evidenceof complianceby the mamtfactureru,ith purchase requirements,including qtrality assurancerequiretnertts, be availableat the site prior to applying the requirementsof this Stanclarcl.In lieu of this requirement,section8.4 (ProcurementControl) of this nranualdescribesthe controls for equipmentlacking quality docurnentation.

Revision:19 32 of 36

FE'VOC QuafityAssuranceProgramManual

c. Section4.5.1providesrequirements for thecleaning,flushing,ar:dconditioningof installedsysterns. FENOC'spositionon Regulatory Guide1.37andANSI N45.2.1 alsoapplyto this Sectionandtakeprecedence overtherequirements of ANSI N45.2.8rvhenconflictsexist.

M. RegrrlatoryGuide 7,723(Revision1) [July 19771, QualityAssuranceRequirementsfor Control of Procurementof ltems and Servicesfor Nuclear PowerPlants

1. FENOCcornmitsto theregulatory positionof this Guide.

2, FENOCconrrnits to therequirements of ANSI N45.2.13-1976 with thefollowing clarifications,exceptions andalternatives:

a. Subsection 3.2.3discusses qualityassural'rceprogt'amrequiretncnts for procurement docurnents.For thepurchasirrg gradecalibrationselices from of corllnlercial domesticcaliblatiotrlabolatories accredited by a nationallylecognizedacct'editing body,theprocurernent documents arenot requiredto imposea qualityassurance progranlconsistent rvitlrANSI N18.7.

In suchcases,accreditation maybe acceptable in lieu of thepurchaser imposinga QA progl'amconsistent u'ith ANSI N18.7,providedall thefollowingaremet:

1) The accreditationis to ISO/lF,C 17025,
2) The calibratiorrlaboratoryholds a clomesticaccreditationby orreof the following accreditingbodies,rvhich are recognizedby the InternationalLaboratory AccleditationCooperation(ILAC) MrrtualRecognitionAtrangement(MRA):

- NatiorurlVoluntaryLaboratoryAccreditationProgtarn[NVLAP), administered by NIST

- ArnericanAssociationfor LaboratoryAccreditatiort(A2LA)

- ACLASS AccreditationServices(ACLASS)

- IntemationalAccreclitationSer.rice(lAS)

- LaboratoryAccreditationBureau (L-A-B)

3) The publishedscopeof accrerlitationfor the calibratiottlaboratorycovrsthe neededmeastlrelnentparameters,ranges,atrdttncertainties.
4) The purchaseciocurnerrts tecltnicalanclaclministrative inrposeaclclitional requireurents, as ncccssary,to satistyFENOC QA Proglatnattdtechnical

't'liis rcquilernents. rvill includere<luiringthat the supplieridentify the laboratory equiilnent/stanclards usedand the as-fouttdanclas-leftdatain the calibration certificateh'e1;ort.

5) The purchasedocurnentsrequirereporling as-fountlealibrationdatarvhen calibrateditenrsare found to be out-of-tolerance.

Revision:19 33 of 36

FFAfOC t"

QualityAssuranceProgramManual b , The altenrative rnethodis applicableto sub-suppliers of calibrationselice suppliers, providedtheaboveconditions aremet.

c. Section4 providesfor theselection of procurelnent sources.For "sornmercial grade" itemsandfor non-safetyrelateditemswithin thescopeof theQualityAssurance Programfor whichtherearello qualityassurance prcgrarnor qualitydocunrentation requirements, the requirernentsof thisSectionneednot be adheredto. Howevet', the procurelnent documents shallspecifyrequirernents specific to the item being procured,sufficientto provideadequate certification or otherrecordsto ensurethat itetnsandactivitiesrneetthespecifiedlequirements, d . Section8.2 providcsrequirenrents for thecontrolof nonconfotmances, Suppliers qualifieclby FENOCasdesignagentsin accordance lvith Regulatory Guides1.64and 1.123maybe pernrittedunderspecificcontractnal provisionsto disposition nonconfonnances as"use-As-is" or "repair'"on behalfof FENOC. All nonconfolrnances dispositioned "use-as-is" or "repair"by suppliersqualifiedby FENOCasdesignagentson behalfof FENOCarerequiredto be submittedto FENOCfor engineeringalrprovalat thetirneequipnreutis receivedon site. If FENOCdetennines thata dispositionhasbeenincorectlytnade,a llonconfot'mance reportis generated on siteto documenttheproblemandeffectresolution.
e. Section10.2.dis interpletedas follou,s:Thepersoilattestingto a certificateshallbe anauthorized anclresponsible ernployee of thesupplierandshallbe identifiedby the supplier, N. RegulatoryGuideL,144(Revisionl) [Septcnrber 19801, Auditittgof QualityAssur'flnce Progruns for Nuclecr Power Plants L FENOCcommitsto theregulatorypositionof this Guider,viththe follorvingalternatives:

SectionC,3.b (2) outlines the requiremerrtsfor triennial auclitsand atuual evalnations of suppliers. A 90 day graceperiod nray be appliedto theseactivities, For triennial auditsand amrnalevaluationstlrat are defelled, the next perfonrrancedrtedatervill be basedon the origirrallyschcduleddate.

b . ScctionC.3.b (2) outlinesthe recluircnrcnts for triennialauditsatrdannualevalnations of suppliers. When purchasing colnnlercialgradecalibrationservicesfi'om don'restic calibrationlaboratoriesaccreditedby a nationallyrecognizedaccreditingbody, the accreditationprocessand accreditingbody may be creclitedr,vithcarrying ottt a portion of the purcliaser'sdutiesof verifying acceptabilityand elfective implementationof the calibratiorrservicesupplier'squality assurance prograln.

In lieu of perfbnning an audit, acceptingan audit by anotherlicensee,or performing a commercialgradesllrvey, a documentedrevien,of the supplier's accreditationshall be per'flontredby the pulchaser. This revieu,shall irtclucle,at a rnitrin]uln)all of the fbllotving:

Rcvision:19 34 of 36

FFIVOC f,6lE*rgy N).lea.OOrot ffi Quafity AssuranceProgramManual l) The accreditationis to ISO/IEC 17025.

2) The calibration laboratoryholds a domesticaccreditationby one of the following accreditingbodies,which are recognizedby the InternationalLaboratory Accreditation Cooperation(ILAC) Mutual RecognitionArrangement(MRA):

- National Voluntary LaboratoryAccreditationPlograrn(NVLAP), adrninistered by the National Instituteof Standardsand Techrtology( NfST)

- American Associationfor LaboratoryAccreditation ( zLA)

- ACLASS AccreditationServices(ACLASS)

- IntemationalAccreditationService(IAS)

- Laboratory Accreditation Bureau (L-A-BI

3) The published scopeof accreditationfor the calibration labolatory coverstlte neededmeasul'ement parameters,ranges,and uncertainties.
c. The alterrrativemethod is applicableto sub-suppliersof calibrationservicesuppliers, provicledthe aboveconditionsare urct,
d. SectionC.3.b (2) outlinesthe requiretnentsfor triennial audits and atmualevaluations of suppliers. Insteadof docurnentingevaluationsof supplierson an annualbasis, FENOC lnay documentevaluationsof supplierson an ongoing basis,using the guidanceof Section C.3.b of this Regulatoly Guide. The resultsof theseongoing evaluatioltsare reviewed and appropriatecomectiveactionstaken. Adverse findings resnltingfrom theseevaluationsare periodicallyreviervedin order to determineif, as a rvhole,they result in a significantcondition adverseto quality and to provide input to supporl supplier audit activitiesconductedby the licensee01'athird party auditing entity.
2. FENOC-conrnritsto the lequirernents of ANSI N45.2.12-1971u'ith the follorving clarification:
a. Section4.5.1of this Standarddiscusses fbllorv-upand cot:'ectiveactious. F'ENOC rnay utili ze tl'teprovisionsof the correctiveaction progranl outlined in SectionA.6 insteadof theserequirements,as long as the appropliatetirne lirnits are appliedto significantconditionsadverseto quality. Also, no additionaldocutnentatiotris necessal'yif neededcon'ectiveactiorrsare taken anclverified priol to audit report issnance.
b. Sections4.3.1 and4.3.3 of this StandarclcliscLtss pre-auditand post-auditconferences.

Pre-auditarrclpost-auditconferences llraybe fulfilled by a r.arietyof comtlnttications, suchas telephoneconvcrsation.

c. Section4.3.1and 4.3.3of this Standarcl cliscusspre-auclitatrdpost-auditconfbretrces, I,re-auditand post-auclitconfelencesare only hcld rvhettcleemedtlecessaryby quality assul'ance or rvhenreque.sted by the auditedorganizatiott.

Revision:l9 3 5o f 3 6

FENOG fr st Enery y N*:!ea!

l _ E Opera:;1g C..\rnpant, QualityAssuranceProgramManual

d. Section4.4 discusses auditreporting.Audit reportsshallbe issuedrvithinthirty workingdaysafterthelastdayof theaudit.Thelastdayof an auditshallbe considered to be thedayof thepost-audit conference.If a post-auditconference is rrotheldbecause it wasdeemedunnecessary, the lastdayof theauditshallbe considered to be thedatethepost-auditconference wasdeerned uru)ecessary as docurnented in the auditreport, O, Regulatory Guide 1,746(Revision0) [August 1980J,Qualificationof QuulityAssurance ProgramAuelitPersonnelfor NuclearPower Plants I . FENOC conlnits to the regulatoryposition of this Guicle.

2 . FENOC conrrrritsto the lequirerrrents of ANSI N45.2.23-1978rr,'iththe follorvins alternatives, a . Section2.3.1.3discusses othercredentialsof professionalcompetence.Holdersof NRC issuedReactorOperator/SeniorReactorOperatorLicensescomply rvith the tequirementsof this sectionand may be arvardedtrvo credits.

b. Section2.3,4 discnssesaudit participation, Prospectivelead auditorsshall dernonstratetheir ability to effectively implelnentthe audit processand lead an audit team. They shall have parlicipatedin at leastone nuclear audit rvithin the year precedirrgthe individual's effective date of qualification. Upon successftil derrtonstration of the ability to effectivelyIeadaudits,licenseen'lanagement may dcsignatea prospectiveleadauditoras a lcad auditor',

c . Sectiort3.2 requil'esan annualevaluationof lead auditors. A 90 claygraceperiocl may be appliedto the annualevaluation.For thoseevaluationsthat are deferred,the next performancedue date rvill be basedou the originally scheduiedate.

cl. Section5.3 requiresthat recordsfor leaclauditorsbe rnaintainedand updated annually. A 90 day graceperiod may be appliedto the arrnualupdate. For those rupdatesthat are defered, the next perfbrrlance due date n'ill be basedon tlre originally scheduledate.

R c v i s i o n :1 9 3 6o f 3 6

Retrieved from "https://kanterella.com/w/index.php?title=L-14-360,_Firstenergy_Nuclear_Operation_Company,_Quality_Assurance_Program_Manual,_Revision_19&oldid=2450628"