ML21237A305

NRC Staff Comments on Nuclear Energy Institute 17-06 Rev. 0, Guidance on Using Iec 61508 SIL Certification to Support the Acceptance of Commercial Grade Digital Equipment for Nuclear Safety Related Applications

ML21237A305
Person / Time
Issue date:	08/30/2021
From:	Eric Benner NRC/NRR/DEX
To:	Andy Campbell Nuclear Energy Institute
Sanders S, NRR/DORL/LLPB
References
NEI 17-06, Rev 0
Download: ML21237A305 (15)

Text

August 30, 2021 Mr. Alan D. Campbell Technical Advisor Nuclear Energy Institute 1201 F Street, NW, Suite 1100 Washington, DC 20004

SUBJECT:

NRC STAFF COMMENTS ON NUCLEAR ENERGY INSTITUTE 17-06 REVISION 0, GUIDANCE ON USING IEC 61508 SIL CERTIFICATION TO SUPPORT THE ACCEPTANCE OF COMMERCIAL GRADE DIGITAL EQUIPMENT FOR NUCLEAR SAFETY RELATED APPLICATIONS

Dear Mr. Campbell:

On February 23, 2021, the U.S. Nuclear Regulatory Commission (NRC) received a submittal from the Nuclear Energy Institute (NEI) requesting review and endorsement of Revision 0 of NEI 17-06, Guidance on Using IEC 61508 SIL Certification to Support the Acceptance of Commercial Grade Digital Equipment for Nuclear Safety Related Applications (Agencywide Documents Access and Management System (ADAMS) Accession No. ML21083A147). In this request, NEI stated that NEI 17-06 establishes guidance for an acceptable approach to procure and accept commercial grade digital equipment for nuclear safety-related applications, when the equipment has an accredited third-party safety integrity level (SIL) certification per International Electrotechnical Commission (IEC) 61508. The staff are currently engaged in evaluating NEI 17-06 for potential endorsement. If found acceptable, the endorsement would include the development of a draft regulatory guidance document and other necessary steps to develop a final regulatory guide. The staff have generated comments in the enclosed Open Items table that should be addressed by NEI in order for staff to continue its endorsement review.

For dedication of commercial grade digital equipment, leveraging the SIL certification process as described in NEI 17-06 in lieu of individual supplier surveys is considered a practical alternative to the commercial grade survey methodology currently used by dedicating entities.

However, the process as described in NEI 17-06 is currently informal and not specific enough to adequately define an approach that can be endorsed by the NRC without additional clarifications and exceptions. To have confidence in the accreditation process, a more formal quality assurance oversight process by a specified owner is necessary. The proposed inclusion of additional accreditation and certifying bodies that have not been adequately vetted by the NEI and NRC does not appear prudent or defensible; especially, given the shortcomings observed by the staff and NEI with the American National Standards Institute (ANSI) National Accreditation Board (ANAB) exida audit as discussed during the June 23, 2021 public meeting (ADAMS Accession No. ML21223A311). Unlike the agreements in place between the International Laboratory Accreditation Cooperation and NEI as a stakeholder member in the accreditation organization, there is no such formality described in NEI 17-06 Revision 0 for the international governing bodies responsible for International Standards Organization 17065 and IEC 61508.

These and other topics are further discussed in specific comments on NEI 17-06, Revision 0 are outlined in the enclosed Open Items table. The comments are binned and ranked according to their possible classification as an exception, clarification or suggestion; and, they broadly span the areas of QA oversight, NEI 17-06 scope, and use of EPRI 3002011817.

The staff has scheduled a phone call for September 9, 2021, if needed, to allow NEI an opportunity to ask clarifying questions to assist in understanding NRCs comments. To facilitate the review schedule established to develop a draft regulatory guide, responses to these comments are expected by September 24, 2021.

The next public meeting to discuss the final set of comments on NEI 17-06, Revision 0, and the proposed NEI resolutions to the staffs comments, is scheduled for September 28, 2021.

If you have any concerns or questions, please contact Ms. Serita Sanders, Project Manager, at (301) 415-2956, or through e-mail to Serita.Sanders@nrc.gov.

Sincerely, Eric J. Benner, Director Division of Engineering and External Hazards Office of Nuclear Reactor Regulation cc: Maria Assard Eric J.

Benner Digitally signed by Eric J. Benner Date: 2021.08.30 17:55:10 -04'00'

ML21237A305 (Letter)

ML21223A311 (NEI 17-06 Staff Review June 23, 2021 Public Meeting Summary)

ML21083A147 (NEI 17-06 Guidance Document)

OFFICE NRR/DORL/LLPB/PM NRR/DORL/LLPB/LA NRR/DEX/EICB/BC NAME SSanders DHarrison (RButler for)

MWaters DATE 8/25/2021 8/25/2021 8/26/2021 OFFICE NRR/DRO/IQVB/BC NRR/RES/ICEEB/BC NRR/DORL/LLPB/BC NAME KKavanagh CCook DMorey DATE 8/26/2021 8/26/2021 8/26/2021 OFFICE NRR/DEX/ELTB/BC NRR/DEX/D NAME JJohnston EBenner DATE 8/30/2021 8/30/2021

Enclosure NEI 17-06 Staff Comment Open Items STAFF COMMENTS ON NEI 17-06 REVISION 0, GUIDANCE OF USING IEC 61508 SIL CERTIFICATION TO SUPPORT THE ACCEPTANCE OF COMMERICAL GRADE DIGITAL EQUIPMENT FOR NUCLEAR SAFETY RELATED APPLICATIONS Comment No.

Page and Section Comment Comment Significance&Type 1

General Astheproposedcommercialgradededication(CGD)methodologywillbeconsidereda reductionincommitmentinaccordancewithTitle10oftheCodeofFederalRegulations(10 CFR)50.54(a)(4),thereportshouldaddanaction,thatthelicenseeuseofthisapproachwill requireachangetotheirapprovedqualityassuranceprogrammanual.Forcomparison purposes,NuclearEnergyInstitute(NEI)1405,states,inpart,Priortoalicensee implementingthemethodologyoutlinedinNEI1405A,Revision0,theU.S.Nuclear RegulatoryCommission(NRC)requiredalicenseetosubmitarevisiontoitsOperatingQuality AssuranceProgram(OQAP)forNRCacceptanceinaccordancewith10CFR50.54(a)(4)since implementationofNEI1405Arepresentedareductionincommitment.

PotentialException

QAOversight 2

Page3, Section 1.3 Section1.3,AcceptanceofSafetyIntegrityLevelasVerificationofDependabilityCritical Characteristics,"leveragestheresultsofthe AmericanNationalStandardsInstitute(ANSI)

NationalAccreditationBoard(ANAB)auditofexidaandthesupplementaleffortbytheNEI workinggrouptocompletethesupplementalauditchecklistrelatedtotheimplementationof theInternationalElectrotechncialCommission(IEC)61508technicalcriteriaatexida.The reportconcludesthattheSILaccreditationprocessissufficient,robust,andrepeatable,such thatotherABsthataresignatoriesoftheInternationalAccreditationForum(IAF)shouldalso beconsideredacceptableforthesepurposes.

TheNRCsapproachtoapprovingNEI1405regardinguseoftheILACprocessinlieuofCGD activities,werebasedontheNRCandtheindustryevaluatedmultipleaccreditationbodies (ABs)andcertifyingbodies(CBs)performingworkinaccordancewiththeestablishedILAC programsandagreementsasitpertainedtotheimplementationoftheInternational StandardsOrganization(ISO)17025standard,togainassurancethattheprocesswasstable, PotentialException

QAOversight Comment No.

Page and Section Comment Comment Significance&Type robust,andrepeatable.Thisreportisessentiallybasedonconclusionsdrawnfromasingle auditobservation(donetwice)ofoneABandoneCB,bytheNRCandNEI,andadditional inferencefromareportbyElectricPowerResearchInstitute(EPRI)thathasnotbeenformally evaluatedbytheNRC.

Asaresult,theNRCdoesnotconsideritappropriatetoincludeorsuggestthatother,non vettedABs,areacceptableinthereport.Giventheobservationsmadeduringthe implementationauditconductedbyANABofexida,whichwerediscussedattheJune23, 2021publicmeeting,andtheneedtoperformsupplementalverificationexternaltotheANAB process(supplementalchecklist),NEI1706shouldclearlylimittheapplicabilityofusingthis alternativecurrentlytoANABwithrestrictions,withprovisionsforpotentiallyaddingother ABsafteradequatevettingbyNEI,USNuclearlicensees,andtheNRC.

3

Page3, Section 1.3 Similarly,thesoleobservationofANABauditingthecapabilitiesandprogrammaticcontrolsat exida,andtheneedtoperformasupplementalchecklistduetoobservedweaknessesinthe ANABaccreditationprocess,shouldnotbeusedasthebasisforapprovalofotherCBswithout continueddirectobservationoftheaccreditationactivitiesofANABforthoseotherCBsand completionofthesupplementalchecklists.

PotentialException

QAOversight 4

Page20, Section 4.1 Thefirstsentenceintheparagraph,"Theapproachbeinglaidoutinthisdocumentfor performingcommercialgradededicationofdigitalequipmentisbasedontheconclusion pointedoutinSection3.3ofthisdocument"impliesthatEPRIresearchisthesolesourceof informationthatleadstoconclusionthatSILcertificationscanbeusedastheevidenceof acceptabilityofdependabilitycriticalcharacteristics(CC),asdefinedbyEPRITR106439.

Whereas,NEI'sobservationofANAB'sauditsofexidathatusedtheNEIauditchecklist(based onEPRITR106439dependabilityCC)isanalternativetotheEPRIresearch.SincetheNRC endorsementofNEI1706isnotrelyingonEPRIresearch,revisethisparagraphtoprovide adequatebasisforthestatedclaim.

PotentialException

UseofRef.8 EPRI3002011817 Comment No.

Page and Section Comment Comment Significance&Type 5

Page25, Section 4.4 Inthe"SILCertificationProcessMethodofVerification"columnreferenceismadetotheEPRI researchreport(Reference8).SincetheEPRIreportisnotbeingevaluatedbytheNRC, referenceshouldonlybemadetotherelevantIEC61508consensusstandardsections.In general,anyinformationfromtheEPRIresearchreportthatisnecessaryforthisCGDprocess (thatreliesonsafetyintegritylevel(SIL)certification)shouldbeincludedwithinNEI1706.

PotentialException

UseofRef.8 EPRI3002011817 6

Page30, Section 5.5 Section5.5,CompensatoryMeasures,identifiesalongtermandshorttermpathtoresolve theobservedaccreditationprocessweaknesses.ThelongtermpathistoworkwithANABto improvetheassessmentofSection7.1.2ofISO17065.However,thatactionhasbeennoted aspreliminaryinnatureandwilltakeanunspecifiedlengthoftimetoachieve,ifatall.Given thenatureofthisaspreliminary,atbest,theNRCcannotendorseacompensatorymeasure thathasnotbeenformalized.NEIshouldprovideamoredefinitivesetofactionsthathave beenagreedtoandacceptedbybothpartiesandatimelinetoachievefullimplementation.

PotentialException

QAOversight

7

Page30, Section 5.5 Furthermore,theshorttermcompensatorymeasuredescribedalsolacksadequatespecificity toenabletheNRCtoendorseasanacceptablemeanstomeettheregulatoryrequirements.

Specifically,theactiontohavetheU.S.nuclearindustrydevelopasupplementalaccreditation checklisttobeappliedtoeachCBthatwouldassesstheirschemescompliancewith IEC 61508withinthecontextofthedependabilityCCinTable41ofEPRITR106439.Details regardingthemethodsbywhichthiswillbeperformedandbywhommorespecifically(i.e.,

NEIworkinggroup,NuclearProcurementIssuesCorporation(NUPIC),individuallicensees),

andadescriptionofnecessaryandsufficientadministrativecontrolstoensureconsistent applicationofthechecklistshouldbeprovided.Thismayincludetheneedtoevaluateand accepttheEPRIreportaswellastheIEC61508standardasitpertainstothechecklist providedinAppendixD.

Clarification

QAOversight Comment No.

Page and Section Comment Comment Significance&Type 8

General TheintendedscopeofapplicabilityofNEI1706shouldbecleartosupportitsefficient potentialendorsementinaRegulatoryGuide(RG).ThestaffconsidersscopeofNEI1706to onlyapplyunderthefollowingconditions/circumstances.1)AppliesonlytodigitalI&C equipment,2)AppliesonlytoCGDforthecriticalcharacteristicofdependability,3)Applies onlyto10CFRPart50and10CFRPart52powerreactors,4)Appliesonlywheretheitemhas acertificationofcompliancetoanIEC61508SILbyafunctionalsafetycertifyingbody,and

5) Appliesonlywherethefunctionalsafetycertifyingbodyhasbeenaccreditedbysignatory totheInternationalAccreditationForum.If1through5abovedonotcorrectlysetthelimitof NEI1706sintendedapplication,wouldNEIclarifyandindicatewhetheraclarificationwould alsobeincludedinthebodyofNEI1706?

Clarification

NEI1706Scope Comment No.

Page and Section Comment Comment Significance&Type 9

General AlignmentonNEI'sintendedscopeofendorsementofNEI1706shouldbecleartosupportits efficientpotentialendorsementofaRG.ThestaffconsidersscopeofNEI1706tobe endorsedbytheNRCtoincludethefollowingitems.1)ForacommercialitemwithaSIL certification,theguidanceinNEI1706thatappliestheISO17065accreditationprocessas supplementedisacceptableforuseasacommercialgradesurveyofaSILcertificationservice providedbyanIEC61508functionalsafetycertifyingbody,2)Foracommercialitemwitha SILcertification,theguidanceinNEI1706thatappliesaSILcertificationbyanaccredited certifyingbodyisacceptableforusewhenassessingthesuitabilityofthecommercialitemfor itscriticalcharacteristicofdependability,3)WhenapplyingEPRITR106439andEPRI 30020002982toacommercialitemwithaSILcertification,theguidanceinNEI1706that appliesaSILcertificationbyanaccreditedcertifyingbodytoestablishthedependability characteristicsofthecommercialequipmentisanacceptablesubstituteformethods:2-CommercialGradeSurveyofSupplier,and4-AcceptableItemPerformanceRecordwhen performingaCGD.If1through3abovedonotcorrectlyrepresentwhatNEIseeksinanNRC endorsementofNEI1706,wouldNEIclarifyandindicatewhetheraclarificationwouldalso beincludedinthebodyofNEI1706?

Clarification

NEI1706Scope 10 General ItappearsthatNEI1706'sscopedoesnotincludeorreferenceamethodtodeterminetheSIL leveluponwhichaparticularpieceofdigitalI&Cequipment'sdependabilitywouldbe evaluatedusingNEI1706asguidance.NEItoclarifyifNEI1706'sendorsementshouldleave openthemethodfordeterminingtheSILlevelofthedigitalequipmentbeingdedicated?

Clarification

NEI1706Scope Comment No.

Page and Section Comment Comment Significance&Type 11

Page9, Section 2.1 Revisesecondsentencefrom"ThisaccreditationistypicallyinaccordancewithISO17065"to "ThisaccreditationistypicallyinaccordancewithISO17065supplementedbyIEC61508SIL certificationscheme."Changefourthsentencefrom"TheABperformsauditsandmonitors activitiesoftheCBinordertoconfirmthattheirprocessesandprocedures,andtheir correspondingimplementationfollowsISO17065"to"TheABperformsauditsandmonitors activitiesoftheCBinordertoconfirmthattheirprocessesandprocedures,andtheir correspondingimplementationfollowsISO17065supplementedbyIEC61508scheme."

Suggestion

QAOversight 12

Page21, Section 4.1 WhenprocuringaSILcertifiedequipment,thededicatingentityshouldreceivetheSIL certificatefromtheoriginalequipmentmanufacturer(OEM)andnottheCB.CBgrantstheSIL certificatetotheOEMandhasnoobligationofprovidingtheSILcertificatetothededicating entity.Inaddition,thededicatingentityshouldalsoreceiveasetdocumentfromtheOEM thatdescribestheapplicationlimitationoftheirSILcertifiedproduct.Pleaseupdatethis figuretocorrecttheserelationships.

Suggestion

NEI1706Scope Comment No.

Page and Section Comment Comment Significance&Type 13

Page22, Section3 NEI1706statesthattheestimatedfailureratesoftheobservedlogicsolverfailuredataare conservativesince323failureswereexpectedbutonly205occurred.Italsostates:"These resultsalsoillustratedhowtheprobabilisticfailureratesandthesystematicintegritycould bothbeevaluatedthroughthereviewoffieldfailuredata."Thedocumentalsostatesthat"it isvaluabletonotethatsystematicintegrityisaparallelconcepttothenuclearindustrys conceptofcommoncausefailure."TheNRCfindsthisstatementtobeunclearand potentiallymisleadingtopotentialusersofNEI1706.Theintegrityofacomponentdoesnot initselfestablishsystematicintegrityofthesystemssafetyfunction.Absentthisadditional considerationofsystemarchitectureandapplicationofsafetyfeatures,NRCunderstands suchindividuallogicsolverfailuredatacanatbestrepresentonlythereliabilityofthespecific platformdeviceconfigurationthatwasincorporatedintoasystemofdevicesdesignedto achieveaplantsafetyfunction.Pleaseclarifywhatismeantbystatingthatsystematic integrityofasingleplatformcanbeconsidereda"parallelconcept"tothenuclearindustry's conceptofcommoncausefailure,whichusuallyaddressesfailurecauseswhichcanoccur concurrentlyinredundantchannels.

Clarification NEI1706Scope 14

Page22, Section 4.2 ThisguidancelimitstheuseofSILcertifiedequipmenttoariskbasedselectionprocess.Does NEIintendtoprovideguidanceorexampleforselectionofaSILlevelthatisappropriatefora safetyfunctionapplicationusingadeterministicprocess,e.g.,canaSIL3certifiedcomponent beusedinanESFASwith3or4divisions?

Suggestion NEI1706Scope Comment No.

Page and Section Comment Comment Significance&Type 15

Page30, Section 5.5 Section5.5,CompensatoryMeasures,states,inpart,thatafterfiveyears,theseassessments wouldbereperformedtoensuretheCBsschemeshaveremainedcompliant,unlessthelong termpathhasalreadybeenrealized.Fiveyearsisanappropriateamountoftimebecausethe IEC61508standardisaverystabledocument,andtheaccreditationactivitieswillcontinueto happenannually."

Althoughtheaccreditationprocessmaybestable,theNRCconsidersa3yeartimeframe ratherthantheproposed5yearsisappropriate,givenindustryprecedentforsimilar evaluationsofthesupplychainsqualityprogramsataperiodnottoexceed3years.NRC suggestsitisappropriatetoreflectthislongstandingpracticeforthisactivityaswell.(see commenttoSection7.3,Paragraph2)

Suggestion

QAOversight 16

Page30, Section 5.5 ImplementationofthesupplementalchecklistwillrequireNRClicensees,ortheir representatives,tohaveaccesstotheANABprocessesaswellastheCBsinternalprograms, procedures,andspecificevaluationsofsampleproductsthathavebeenvettedbytheCB.

ThisdocumentdoesnotaddressanyformalagreementsbytheABs,CBs,andeitherNEI,other USlicenseeorganizations,suchasNUPIC,orindividualNRClicenseestohaveaccessto conductsuchauditactivitiesorgrantaccessduringauditperformance.Pleasedescribehow theimplementationofthesupplementalchecklistswillbeaccomplishedandhowhasthis beenformallyadopted?

Clarification

QAOversight Comment No.

Page and Section Comment Comment Significance&Type 17

Page32, Section 6.5 Section6.5,CorrectiveAction,statesinpart,thatthededicatingentityisrequiredtonotify licenseesandtheNRCofdeviations/defectswhichcouldresultinsubstantialsafetyhazardsas requiredby10CFRPart21.Inaccordancewith10CFRPart21thededicatingentityneedonly reporttotheNRCnotlicensees,andonlydefectsandfailurestocomplyassociatedwith substantialsafetyhazardsfordedicateditemsneedtobereported,notdeviations.Please revisethistoreflecttheregulationlanguage.

Suggestion

QAOversight 18

Page1, Section 1.1 Accreditationbody(AB)intheUnitedStatesisnowcalledANAB(ANSINationalAccreditation Board),awhollyownedsubsidiaryoftheAmericanNationalStandardsInstitute(ANSI).(see https://anab.ansi.org/).UpdateNEI1706accordingly(consistentwithSection5.3 identification).

Suggestion

QAOversight 19

Page3, Section 1.3 EPRI3002002982isendorsedbyRG1.164,whichisnotreferencedinNEI1706.Inthesame wayNEI1706includesareferencetotheNRCsafetyevaluationofEPRITR106439,NEI1706 shouldincludeareferencetoRG1.164.

Suggestion

NEI1706Scope 20

Page21, Section 4.1 Manufacturer'ssafetymanualandrelateddocumentsmayonlybemadeavailableupon procuringtheequipmentfromOEM.Thestepsshouldidentifywhereintheprocurement processoftheSILcertifiedequipmentthisinformationismadeavailableandanyadditional documentsthatshouldbeapartoftheprocurement.

Suggestion

NEI1706Scope 21

Page21, Section 4.1 ANABissuedCB'saccreditationcertificatesarepubliclyavailableontheirwebsite.Isthisalso trueofotherABs?Thestepsshouldclarifyhowtoobtaintheaccreditationcertificate.

Clarification

QAOversight Comment No.

Page and Section Comment Comment Significance&Type 22

Page23, Section 4.3 Thissectionsstates,inpart,"andmustbecertifiedtomeetorexceedtheSILthathasbeen establishedfortheapplication(asdescribedinSection4.3)."Thiswouldbetruewhenthe safetyinstrumentedsystem(SIS)isdesignedusingIEC61511methodology.However,noneof theoperatingreactor'ssafetysystemshavebeendesignedusingtheSISprocess.This"must" requirementwouldrequiretheplantstodeterminetheSILlevelofthesafetysystemspriorto usingaSILcertifiedcomponentintheirplants.Isthistheintentofthisguidance?

Clarification

NEI1706Scope 23

Page24, Section3 CertainstatementsmadewithinNEI1706implyageneralconditionexistsforallCBswhen thedataprovidedseemstosupportworkperformedbyaparticularCB.Forexample,in Section3.3itisstatedthatCB's"oversee"thecomplianceofavendortoqualitystandards.

SomeevidenceofthiswasobservedbytheNRCstaffatitsobservationsoftheANAB accreditationofaparticularCB,butnoevidenceisprovidedthatallCBsperformoversightof avendor'sselfvalidationprocess.NEI1706shouldprovideevidencethatallCBsperform oversightofavendor'sselfvalidationprocess.

Suggestion

QAOversight 24

Page27, Section4 RegardingtheSILCertificateandSafetyManual:Thestepstobefollowedshouldinclude actionsthataddresstheneedtoidentifywhetherthesafetymanualidentifiesany precautions,conditionsofoperation,orlimitationsintheuseoftheequipmentforwhichthe SILCertificateapplies.Specifically,tomaintaincertification,thesafetymanualspecifies implementation,configuration,ormaintenanceordiagnosticrequirementstobefollowed,to maintaincompliancewiththecertificatereliabilitystatements.

Suggestion

NEI1706Scope Comment No.

Page and Section Comment Comment Significance&Type 25

Page31, Section 6.1 Section6.1,Organization,states,inpart,thatthededicatingentityretainsoverall responsibilityforassuringthatpurchaseddigitaldevicesmeetapplicabletechnicaland regulatoryrequirementsandthatreasonableassuranceofqualityexists.Therearenospecial requirementsbeyond10CFRPart50,AppendixB.Itshouldbenotedthatthededicating entitymustalsomeettherequirementsof10CFRPart21.Thisshouldbeaddedfor completenessandaccuracy.

Suggestion

QAOversight

26

Page33, Section 7.2 Section7.2,VerificationthattheSILCertificationProcessContinuestobeConsistentwith NRCEndorsedPractices,states,inpart,thataspartofthecontinuedoversight,anuclear industryteam,throughNEI,willmonitortheIEC61508SILcertificationrequirementstoverify thattheycontinuetocovertheEPRITR106439DependabilityCriticalCharacteristics.Please describethecomplimentofthatteam,whetherthereisadocumentedcommitmentto supporttheseactivitiesamongtheteammembers,andthenatureofanycommitment.

Clarification

QAOversight Comment No.

Page and Section Comment Comment Significance&Type 27

Page33, Section 7.2 Section7.2,VerificationthattheSILCertificationProcessContinuestobeConsistentwith NRCEndorsedPractices,states,inpart,thatIfchangesadverselyimpactcoverageofthe EPRITR106439DependabilityCriticalCharacteristics,thenthenuclearindustrythroughNEI hastheabilitytoprovidefeedbacktotheIEC61508standardsdevelopmentcommitteeto changethedraftrevisiontoencompassthesecriticalcharacteristics.DoesthisrequireNEIto haveaformalagreementwiththeIECtoaffectsuchrevisions?

TheNRCsapprovalofthemethodologydescribedinNEI1405regardinguseoftheILAC accreditationprocessrelied,inpart,ontheformalrelationshipNEIandtheILACorganization hadcreatedthroughNEIsformalstakeholdermembershipintheorganization.Underthe proposedmethodologyoutlinedinSection7.2,VerificationthattheSILCertificationProcess ContinuestobeConsistentwithNRCEndorsedPractices,thereisnoparalleldiscussionof howNEIandthenuclearindustrywouldformallyaffectchangestotheISOorIECstandards centraltothisreportotherthanastatementthattheIEC61508standardwillbeperiodically reviewedandcommentsprovidedtoIECforconsideration.Thereisnodiscussionregarding ISO17065inthisregard.Describewhatformalmethodshavebeenestablishedtoensure issuesidentifiedbyNEI,NRClicensees,orthirdpartydedicatingentitieswillberesolvedby theISOandIECorganizations.

Clarification

QAOversight 28

Page34, Section 7.3 Section7.3,VerificationthatImplementationoftheIEC61508SILCertificationProcess ContinuestobeConsistentwithNRCAcceptedPractices,statesinpart,thattheU.S.nuclear industryobservationswillbeperformedinitiallyona3yearfrequencywiththepossibilityof reducingthefrequencyifitisobservedthattheprocessisdemonstrablyconsistent.The initial3yearfrequencyisconsistentwiththeguidanceinNRCRGs1.28and1.144for auditing.However,thisappearstobeinconsistentwiththerequirementfor5year assessmentsdescribedinSection5.5ofthereport(seecommenttoSection5.5,Paragraph3).

Suggestion

QAOversight