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Departrnent of Energy (K.M,yQClinch River Breeder Reacter W -

k;~_ )~%Plant Project OfficeP.O. Box UOak Ridge. Tennessee 37830

March 6, 1981

s'4 VSecretary of the Commission

h:, ''';pf7 f p% g/ / /U. S. Nuclear Regulatory Commission

|g ., .7 ,% [Af)q'Washington, DC 20555~

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ATTN: Docketing and Service Branch } i.M ~:)'[.<

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S/g ;31'/ece* s

Gentlemen: ,, /'

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NJ '. s /yCOMMENTS ON PROPOSED REVISION TO REGULATORY GUIDE 1,33, " QUAL}TYQ'SQCFIPROGRAM REQUIREMENTS (OPERATIONS)"

Enclosed for your consideration are comments to the second proposedRevision 3 to Regulatory Guide 1,33, " Quality Assurance Program Require-ments (Operations).

Sincerely,

9 %*

R ..ond ' . Co .d

i PS:81:091 A ing ssista e irectorfor ublic Safety-

cc: T. G. ScarbroughOffice of Standards DevelopmentMail Stop 5650 NL

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Cen=ents en Regulatcry Guide 1.33, Revisien 3.

General Cc-ents

1. Tne ANS standard review process should be used where possible toresolve these issues.

2. With regard to the NRC request for specific cec =ent en the effec-tiveness of an crganizaticnal structure in which the ensitequality assurance crganizatien repcrts functicnally to cffsitequality assurance =anagec:ent as opposed to reporting functicnallyto the plant manager, the fc11cwing cec =ents are provided:

We agree that draft 5 of the Standard is unclear as to whichmethed of reporting is pe mitted er favored. Ecwever, Draft 6cf the Standard clarifies this questien, and we agree with thephilescphy of this Draft as quoted belcw.

"Tne persens er crganizations responsible fer establishingthe prcgram requirements and =easuring the everall effective-ness of the program shall be designated, shall be sufficient-ly independent frect cost scheduling censideratiens whencppcsed to safety consideraticns, shall have direct access toresponsible corpcrate c:anagement at a level where actionappropriate to the mitigation of safety-related quality,

assurance ccncerns can- be accceplished, and shall not fune-ticnaP.y report to ensite plant =anagement. Mcwever, theyshall report regularly en the effectiveness of the program tothe plant manager, as well as cognizant ccrporate management.

The plant manager shall have overall responsibility fer thei=plementation cf We administrative controls and qualityassurance presrm at the plant to assure safety.

Tce persons er crganizatiens responsible fer verifying that,-the administrative centrols and quality assurance pregram areimplemented or c? assuring that an activity has been correct-ly perfemed may report functicnally to an effsite crganiza-tien, or this responsibility can be divided between crgani a-tiens reporting cnsite and offsite. If this responsibilityis divided, the organization reporting effsite shall perfemindependent audits to verify progra ec spliance, whereas thecrganizatien reporting ensite shall perfem surveillance,inspecticn, and review activities for the purpose cf precesscentrol, product acceptance, and to -verify that varicusactivities cenfem to specifiec recuirements, i.e., thequality centrol functien.

Regardless of the crgani stional structure, persons erOrganica icns res;cnsible for verifying that the ad=inistra--ive centrols and quality assurance program are i=plementeder Of' assuring :na an activity has been ccrrectly perfcmec

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snall have sufficient authcrity and crganizaticna' % *~to: identify quality preelees; initiate, recc==end er pre-vide sclutiens thrcugh designated channels; and verify i=ple-=entatien cf sclutiens."

3. We recoc=end that careful consideratien be given to de use cf thewerd "shall" rather than "shculd" when used in cenjuncticn withwcrds like " typical" cr "si=ilar to". Specific exa=ples are citedlat$r.

Scacific Cmrents.

b rHate-v Pesitien

~ 1. No ecc=ent.

2. It is not clear in 2 s Regulatcry ?csition what the werds" independent frce: cperating pressures" imply. If it =eans thatthese grcups are not under te directicn of the plant =anager,then we de not agree with the pcsition. If it =eans dat 2eplant =anager gives thec: freedce free undue ecs: and scheculeccnstraints so that they can =cre effectively carry cut their jch,then we agree with the pcsitica.

We do not agree that Se quality assurance crganizatien, especial-ly if it is an offsite Organi:atien, shculd concur in the selec-tien of persennel who perfer reviews. 'Ihis shculd be 2e func-tien of 2e plant anager, with input er reccc=endatiens frec: 2equality assurance crgani:aticn.,

3 No cer:=ent.

4 The need fcr technical suppcrt te be available to prcvide techni-cal advice to the shif t superviser en a 23-heur-a-day basis isreccgnized. Mcwever, the =ini= :: ti=e fcr respending to a callshculd be- based en realistic conditicns. Tne 30-minute respensetime fer technical suppcrt persennel to arrive at the plant asspecified in NUREG-C654 and endersed by this Regulatory ?csitiendoes not appear to be- realistic fer all ccnditiens. 'nnile 2e2-hcur ti=e interval =ay be excessive, it appears that before aministan respense ti=e is given, censiderations such as adverseweather ecnditiens and rec:cte siting shculd be included.

.5. It appears that the Independent Safety ' Engineering Grcup (2iEG)is, in the =ain, performing safety review functions which areredundant to these reviews of the Plant Staff Review Grcup (FORC)

* and/cr the Independent Review and Audit Group (IR&AG). It aisc-appears' that ISEG will be an additienal five engineers dedicatedfull-ti=e tc these independent safety assessment functicns. Ifthe' ?JEC and IR&AG de nct enec= pass 2e entire safety assessmentarena pernaps 2eir areas cf respcnsibility can te increasec ::provide he extra review needed. While persennel and equi; tent

~ safety is :ne highest pr:.crity fcr the utilities, ene =ust aisc

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11. Nc cccrent.

12. We do nct agree ?.at 2.e quality assurance crganization, especial-ly if it is an effsite crganizatien, shculd cencur in 2.e selec-

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recccrendaticns fr:c the quality assurance crganizatien.

13. No ecczmnt. .

. 14. Tne words in 2.e Standard shculd be retained excer: to e.ar e 2.e.

sentence which ncw reads "A revisien te a precedure ecnstitutes aprecedure review;" to read "n'nen a procedure is revised, 2.e..4., ,-, e.ce,.4, . .... 3;..all *.e .-=v' ew ed "' s s. .d .'#. .d a.s *".e .-.,*".d..-= .e .*... . , .

fcr reutine fc11:w-up review."

~ 15. We do not agree vita 2.e use cf fixed =ini:== calibration inter-vals. I--- Standar 29c-19~5 prevides reascnable guidance end

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function cf the plant manager, with input er reccc:mendatiens frcathe quality assurance crgani::atien.

17. No cecment.

18. No coc: ment. - .

19. No c:xament.

' 20.INo comment.

- 21. No coment.-

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- 22. No cement.

23. No cement.

24. No cccment.

25. No cement.

26. No cement.,

27. No eccment.

28. We agree with changing "should" to "shall" except in a., e., f.,- h., and 1.(4). The reason fer disagreement in these cases is

given in General Comment (3).

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