ML20136B041
| ML20136B041 | |
| Person / Time | |
|---|---|
| Issue date: | 01/07/1977 |
| From: | Milhoan J NRC OFFICE OF STANDARDS DEVELOPMENT |
| To: | Gibbons W BECHTEL GROUP, INC. |
| Shared Package | |
| ML20126B025 | List: |
| References | |
| FOIA-96-214 NUDOCS 7908140200 | |
| Download: ML20136B041 (8) | |
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COMMITTEE CORRESPONDENCE !
4 SOCIETY / COMMITTEE: ADDRESS COP.RESPONDENCE TO:
ASME Section III James L. Milhoan ' "2 #~
Division 1 and 2 Reactor Systems Standards Branch Work Group on Quality Assurance Office of Standards Development SUBJE T: U.S. NUCLEAR REGULATORY COMMISSION Revision of the Code to Reflect WASHINGTON. D.C. 20555 Criterion I of Appendix B to '
' AGENDA ITEM: QA 76-27 ggy FILE NO.: N/A . DATE: 7 1977 TO: Mr. W. S. Gibbons, Jr.
. ; Co-Chairman ASME Section III Division 1 and 2 Work Group on Quality Assurance and Stamping Bechtel Corporation ,a >
50 Beale Street J \
P.O. Box 3965
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San Francisco, California 94119
Dear Mr. Gibbons:
Mr. Dobel in his letter to you of May 5,1976 stated the proposed revisions to NA-4133.1 (copy attached) did not passSection III as he was unable to provide a satisfactory answer to the question of: "How high a tranagement level must I go before I find someone who is considered sufficiently independent from cost and schedule considerations to satisfy the revised Code wording for this particular requirement?"
Mr. Dobel also stated someone on Section III provided the alternate below to the proposed wording (fifth sentence) of NA-4133.1. ;
"The persons and organizations performing quality assurance functions shall be provided this required authority and organizational freedom and independence frcm costs and schedules. They shall provide reports to responsible managament at a level where required corrective action can be mandated."
i I CMD3Eb T@
Mr. W. S. Gibbons, Jr.
- He asked that you see what you can do to
- 1) Develop an answer to the question based on proposed text of NA-4133.1 -
- 2) Revise text if answer indicates necessity l 3) Revise text per proposal ,
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! 4) Get NRC to agree that existing Code text is consistent. !
l with 10 CFR 50 Appendix B intent and leave the Code alone.
l Since the revision to NA-4133.1 is still being held up at the i i Subgroup General Requirements level even after Work Group reaffirmation of the proposed wording, I believe we should respond to Mr. Dobel in an attempt to get action moving on this item. I have attempted as a Work Group member to develop I answers to these questions. My proposed answers are attached.
Sincerely, n
a l.
mes L. Mi hoan MD Member, Working Group on Quality Assurance and Stamping
Enclosures:
As Stated cc w/encis:
R. E. Keever H. Dobel R. Bosnak
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RESPONSE TO H. 00 BEL REQUESTS CONCERNING REVISION TO NA-4133.1 (NOWDESIGMATEDNCA-4134.1) l . i I
Request Number 1 - Develop an answer to the question ("How high a management. level must I go before I find someone who is considered sufficiently independent from cost and schedule considerations to satisfy the revised Code wording for this particular requirement?")
- based on proposed text of MA-4133.1.
Response: The intent of the organizational requirements of proposed NA-4133.1 is to assure that those persons and organizations performing quality assurance functions have the required degree of freedom from other organizational responsibilities, such as cost and scheduling responsibilities, which could conflict with their quality assurance !
functions. '
It should be recognized in establishing the organizational requirements that the degree of separation or independence of the persons and organizations performing quality assurance functions can affect their ability to carry out these functions. While it is desirable from one point of view to have persons and organizations performing quality assurance functions completely separated, organizationally, from individuals who have significant responsibility for performance of the work (including but not limited to cost and schedule responsibility),
that same separation may in scme instances hinder the quality assurance persons and organizations in performing their functions. The greater the independence or separation, for example, the more difficult it may be in some instances to maintain lines of communication in identifying quality problems and initiating corrective action. A number of variables affect the establishment of a quality assurance organization that will be consistent with the proposed wording. I The variables include, but are not limited to, the size of the organization, its organizational structure, the type of activity being perfomed, and the location or 1ccations where the work is being. performed. Thus, the answer to the question "How high a management level must I go before I find scmeone who is considered sufficiently independent from cost and schedule considerations to satisfy the revised Code wording?" - is decendent on the individual
. organization. The proposed Code wording recognizes this situation and provides the necessary flexibility. .
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It should be recognized that the proposed wording regarding "orgenizational freedom including sufficient independence from cost and schedule considerations" is not a drastic departure from the present Code wording which states "The person or organization responsible for defining and for measuring the overall effectiveness l of the Quality Assurance Program shall be designated, shall be ;
sufficiently indeoendent from the s.essures of croduction, shall have !
direct access to responsible management at a level wnere appropriate action can be required, and shall report regularly on the effectiveness ,
of the Program"(emphasis added). If problems do not exist w'ith l present Code wording concerning " sufficient independence from the l pressures of production" then the proposed wording should not present ;
, a problem.
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Request Number 2 - Revise text if answer to question indicates necessity. -
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Response - Answer to question indicates a revision to the proposed text is not necessary.
Request Number 3 - Revise text per proposal:
Replace the sentence "Such persons and organizations performing i quality assurance functions shall report to a management level l such that this required authority and organizational freedom including sufficient independence from cost and schedule considerations are provided" with the following:
"The persons and organizations performing quality 1 assurance functions shall be provided this required authority and organizational freedom and independence from costs and schedules. They shall provide reports to be responsible management at a level where required corrective action can be mandated."
Response: The proposed alternative does not address the repcrting level of persons and organizations perfonning quality assurance functions; tnus the alternative does not satisfy Criterion I of Appendix B to 10 CFR part 50. The proposed alternative would appear to be acceptable if the second sentence is changed to read "They shall [previde-reperts] report to responsible management at a level.....".
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l Request Number 4 - Get NRC to agree that existing Code text (NA-4131) is consistent with 10 CFR 50 Appendix B intent and leave Code alone.
Response: J. L. Milhoan of Reactor Systems Standards Branch of the Office of Standards Development has provided the following coments as a work group member.
"In comparing the existing Code text with Criterion I of
. Appendix B to 10 CFR 50 it appears many subtle differences exist. Areas where differences exist are as follows:
- a. Criterion I of' Appendix B requires that those persons and organizations performing quality assurance functions shall report to a management level such that this required authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety are provided. The reporting level of those performing quality assurance functions is not addressed in NA-4131. (I am making the assumption the term
" quality assurance function" as used in the Code has the same meaning as used in Appendix B to 10 CFR Part 50, however, this is not specifically stated in NA-4131.)
NA-4131 requires that the individual or group assigned the responsibility of inspection, testing, checking, or otherwise verifying that an activity has been correctly performed, be independent of the individual or group directly responsibile for_ performing the specific activity and that the person and organization responsible for defining and for measuring the overall effectiveness of the Quality Assurance Program shall be designated, shall be sufficiently independent frem the pressures of production, shall have direct access to respo ;ible management at a level where appropriate action can be required, and shall report regularly on the effectiveness of the Program (reporting level not specified).
- b. Criterion I of Appendix B states that individuals assigned the responsibility for assuring effective execution of any portion of the quality assurance program at any location where activities subject to Appendix B are being performed shall have direct access to such levels of manage-ment as may be necessary to perform this function.
NA-4131 requires management access only for those responsible for defining and for measuring the overall effectiveness of the Quality Assurance Program.
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- c. Appendix B requires that the authority and duties of I persons and organizations performing activities affecting the safety-related functions of structures, systems, and ,
components shall be clearly established and delineated
- in writing. TIA-4131 requires that the authority and responsibility of persons performing activities affecting ;
quality shall be clearly established (no requirements '
fordocumentation). Of course, NA-4131 also requires that ;
the authority and responsibility of those in charge of i the Quality Assurance Program be established and documented. .
but this is required only for those in charge of the QA '
Program. !
NA-4131 also does not emphasize that the " activities affecting quality" include both the performing functions of attaining quality objectives and the quality assurance functions.
i The wording of NA-4131 has provided varying differences in wording i from that contained in Criterion I of Appendix 8. I see no :
incentive for +,he differences unless the intent is to allow the ,
practice to be different. The difference in wording raises questions of different practices, different interpretations and i different requirements."
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pg,g - p, gw 2,q/' 7ef 2/24/76 M (CR75-4) (N72-21)
,p> / Z PROPOSED RE'JORDING OF NA-4133.1 q
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. Y NA-4133,1 Organizstion NA-J D3 OMGAN!7.ATIO.N The authority and responsibility of those NA.Ji[1 Amhurity and unponsi:d:itt Persons and orzanizations perfo'rming acci-
'I bc authon.ty and responubility of inosein charee vitics affecting quality shall be cicarly cf the Quality Auerance Proyram >ha:1 he clearly established and docucienced. These acti-estab!na, rd and decumented. Pa son > and vitics include both the performi5:: acti-ganir.uions perfor:nmg quahiy as nrance funen,.H6or. vitics of attaining quality objectives sha!! have safhetent and wc!bdefined te pon.ubdi:y.
and the quality assurance functions, authority.and ergani/ation:liree.fo:n to:
(af fdentifyqu ditysautance problems The quality assurance functions vis;hin the Quality Ascsurance Pregram are those (b) initiate auien w nich tt aats m u.dcuom (c) verify irep!emer.tauvn of wl.aiuns to thosr of: Gassuring that an appropriats que:ity problents assurimcc pro;rso is established cnd effectively implemented, and 7.). verifyin;.
The perwn or cryanizauon respontible for defining such as checking. auditing, or inspectin::, I snJ for,measuriny the overall effeemenen of it.
that activitics affecting quality have Quality A%urarxc Pr. gram > hall be designated.>ha!! been correctly performed. Persons and be sufficiently mdeprndent from the prer.sures of organizations performing quslity assuran:e proJuction, shatt h.;te dircri accen to respo: ub!c functions shall have sufficient authority managerr.ent at a level where appa. pre.ne acuen can and organiestional freedom to: p identify be requireJ. and shan report repu!arly on the quality problers,,G initiate, rec:mmend, effectivenew of the Procran:. The authann and ~ or provide solutions,' S verify implements-tesponybility of perwr.[rerformin; actinun af. tions of solutiens, and O limit or centrol ferting qu:dity sh.dt be e:carly otabh hed. Ancrance further processing, delivery or installa-of quality requien management measures v.hicli tion of a nonconfor:.:ing item or unsatie-provide that the indhido.d or gn ,p anigned the factory condition until proper dispositien-tesponsibility of in3recuon. toung. cl.ecimp. er ing has occurred. Such persen: and err,sni-otherwise serifyme ~ that an actnitt~ h.n been correettv zations performing qus1itv assurance tun:-
perforrned. sa.in .. dependent of the indisidual or ern"P tions shall report to a management levtl direet:y tespomible for perf..cming the spenfic such that this reauired authoritf and activity. '.!anagement >h .!! rega!ariy resiew the status organizational freedom includinc suf fi:icnc and adequacy of ti:e Pro; ram. The sp.:::fic re. indcuendence frem cost and schc5ule3 h spon tbilh:o of the qu::!ity aunranev.irpm: uicu oi M:dd"'""C consideraticns, are pro-the .\lanufacturer or Ic t .l:er sna!! sh:Je t: e reuew victed. Becauce cf the c.any' vordsbles in-oly ri'!cn i' roe.c@;o anJ rnonitoring of u senunes volved, such as the number of personnel, the type of activity being perfor:acd, and rencerned with the Qu:dh) Assurance Pre g ram as cJtend ia : Lit.L;ie:e. the location or locations where activitie:
- are perforecd, the organizational structure
~ for executing the quality assurance pro;rsm may tske various form: provided that the M4 8/13l MNum8Med persons and organi:stions assi;;ned the g g 3 3, / id 8EfsN quality assurvnce functions have this r:'qu i re d authority and ' organizational freedon:. Irre--
g g.7 spective of the organi.stional structure, tl .- individual (s) assigned tht: responsibility for asnuring effective ewcut. ion of any portien of the quality ausurance prouram at any location schere activities subb et to this Section of the Code are belag performed shall i have direct ac:cus to r:uch levels of snane-ment as inay be necessary to perform thic I
- function. M.usagement t:h.all regularly ruvfcw the sta t un ..nd . deq.;acy o f the riual! L y ar'"ar-
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The applicant 3
- 1. UltGAWZATibfl f) p c shall he responubie for the estabhsh. ~2 2. -
ment arid execution of the cluahty astutance program.
. The applicant may dr. leg 4tc to others such as ,
sentractors, agents. or consultants, the work of establishing and executing the au&fity assurance program or any part th:rcof, but shall retain rv. son- ,
, sibility therefor. The authority and duties of persons
,and organizations perfotming actinties affectinti the safety 4 elated functions of structuies, systems t.nd components shall tw clearly estabbshed and dehne. .
sted in writieg. Thua actsvit es ir clude both the pwforming funetions of attaining quality obb-ct;ves and the cual;ty assurance fu.ict ice.g. The ovat.ty essuranca functions are t:sote v' fal assuring that an ,
. apptopriate 'r.:ality 3.r.rtr.co pro;rsm is established and offectively esecuted and Ibi serifyirg. such cs by ,
cFecking. auditir.g, anc insccction. that activities [
affecting the safety related functions have been cor.
- rectly .
. performed. Tne persons and organizations i performing cuality I anuncnce functions shall have '
i sufficient authority and organizational freedor i to identify cuality problems; to initiate. recommend,or
. provide solutions; and to vers'y implementatson of !
solutions. Such persons and organintions peticirming 6 quality assura9ce functions ihasi coort to a manage. ?
rnent level such that ship recuired authority end j
- organisational freedom, including sufficient inca-pendence from cost and sch dule when 0pposed to safety considerations, are provided. Because of the many vcriablas involved, such as the numQer of ,
personnel, the type of actinty being performed, .nd I
the location or locations where activities are per. ,
formed, the organizational structura for executing the , 1
- quality assurance program may take various forms ,
provided that the persons and organitations assigned ,
the quality asturance functions have this reovired '
. authosity and organisatiemal freccom. Irrespettive of the organizational structure, the indhidual(s) assagned the responsibilitir for assuring ef!-ctive execWion of any portton of the cuality assurar.ce progra.rn at any
- location where aetmties subject to this Append.x cra J. being performed shall have detect access to sucrt teveit
' of management as may be necessary to perform this function.
wa. a.ra ._,,. .J; .n ,,_ ers..r . ,n.
i r.o...n.-s .r.. ot _r,.. _.s.
- ..i.e .u.a . o.r on het erreswet1 a I.Crnte gg .rvnttruct and operate a ase ClfJr peuuerplant. IhfS4 Cftlffna vuest 48tn De v5ftf tot ejisstrenet in
- evoivating the uchacy of me.eisty astus.ince twogravens en use tre hoicers of heennes. construction peeeness and ouesateng t
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