ML20147E402

Preliminary Value/Impact Assessment on Rev 1 to Reg Guide 1.28, QA Program Requirements (Design & Const). Rev Should Be Prepared

ML20147E402
Person / Time
Issue date:	05/19/1978
From:	NRC OFFICE OF STANDARDS DEVELOPMENT
To:
Shared Package
ML20147E238	List: ML20147E233 ML20147E360 ML20147E393 ML20147E402
References
REGGD-01.028, REGGD-1.028, NUDOCS 7810160220
Download: ML20147E402 (6)

Text

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. Preliminary Yalue/kpact Assessment en Quality Assurance Pr: gram Requirements for Nuclear Power Plants

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I. The Procesed Action A. Descriction

• The applicant-(licensee) of a nuclear pcw' er plant is required by the Commission's regulations to establish and implement a quality assurance program. The proposed itction will provide updated guidance for establishing and implementing a quality assurance program for nuclear power. plants.

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Need for the Precesed Action - -

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, > Guidance on establishing and implementing the quality assurance program 1s c:ntained in Regulatory. Guide 1.28, " Quality Assurance Program Requirements (Design and C nstruction)," dated Jw.a 7,

'1972.

The regulatcry guide endorsed AMSI Standard N45.2-1g71. i On April 7, 1977, ANSI apprcved Revisien i to N45.2-1971 and designated the standard ANSI M45.2-1977. The revision =akas the standard appifcable to all nuclear fuel cycle facilities.

Present MRC guidance sh:uld be updated to reflect experience in I use of the present guidance and to establish an MRC positica en 1

the approved Naticnal Standard. - -i' C.

Value/Im:act of the Pncesed *cticn

1. HRC '  ;

' I Guidance en quality assurance pr:gra= requir:ments f:r ::e l design and c:nstructica phases for nuclear ;;wer plant.s is presen:ly contained in P.eguia::ry Guide 1.23 (54fasy Lide 23, 7g/o'/b O M O

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dated June 7,1972) and is being used by.the KRC staff in -

i ~ the evaluation of applications for construction permits as specified in Sections 17.1 and 17.2 of the Standard Review Plan.

Since the purpose of the proposed action is to provide updated guidance to reflect exparience with use of present guidance and to establish an NRC position on an I approved national standard, the value/ impact 4111 be based on changes proposed to the guidance contained in Regu Guide 1.23. - - * *

. Since the primary purpose of this revision of the ANSI standard was to make the standard applicable to both nucle power plants and other fuel cycle facilities, most changes were in this area. ,

Tne proposed action will be limited 'a application to nuclear pcuer plants and cocrdinated with other 50 ef" orts in other areas. Tnerefore, the impact of '

this chvige will be negligible.

The previous version of this standard, ;RSI Jt45.2-1971, contains both requirements and guidelines.

A letter was received frca General Electric (W. D. Etibert) to A. Gia=b dated February 20. 1975, asking for clarification of the- -

, intant when itRC endorses both require:::ents and rec::mend tions of a standard. The IRC replied (R. B. Minogue to t W. Gilbert, dated May 6,1975) to G.E. and in the reply r-, --v. -r-- -- n gm .., r-..,- ,- -- , , , - - - , , , . - , , - - ---,,,,,-,.,--,--,,--,----,,,.,r- -,,m-,, ,,, , , a ., , ~ w.. w,ne,,+,,e,,m-w e,

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stated that we were undertaking a reexamination of some of

• the regulatory guides which endorse #!SI standards, par-ticularly in the quality assurance area, to determine whether it might not be apprepriate to quaiffy our endorse-ment of at least some of the guidelines since not aTI have substantive safety importance.

A copy of this correspondence is attached.

Also attached.fs an N t from,the minutes of the January ZT,1976 interoffice Quality Assurance Task

' Force meeting which outlines the totaT project.

This area

> was considered by NRC personnel during the process of

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revision of the standard. Action, r.cnsistent with current Il i

ifcensing practice as specified in Sections 17.1 and 17.2 of

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the Standard Review plan, to r.esolve this problem was cada during revision of the standard and will serve as the basis for staff positic. s in the proposed action.

' Therefore, the impact to the NRC staff will be negligibTe.

Tne rescistion of this problem will ha of value to the staff in that a coenitment by the applicant to the propcsed action will be -

specific and will not require point-by-point analysis of each question in the ifcense,revien process.

The onTy other substantial change is in the requirements for records retantion.

Ratantion of records which cor:sctly identify the "as-buil ta condition of items in the nuciaar

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facility are r'equired by ANSI N45.2-1971 to be maintained for. the life of the facility.

Tne revision requires they be maintained only for the life of the particular itar .

' while it is installed in the nuclear facili,ty and stored for future use by *o r for the owner.

- - This change is con-

' sistent with current staff requirements and therefore the impact will be minimum.

Since record retention provisions

,must be, reviewed regardless of the change, .the ' time and .

• effort expended by the staff in the review will not be .

more or less than that previously expended.

2. Other Government Agencies

- Not applicable",'unless the goverr.=ent agency is an'ap ,

as TVA.

3. Industry The value/ impact of the changes to make the standard applicalile to fuel cycle facilities will be the same as-for the MP.C staff.

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The acticn to resolve the confusion existing due to endor ment of both the requirements and recommendations of the

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present standard will have no impact.ett the industry.

The applicant must comply with all requfr'ecents and reccm .

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mendations unTess an exception is granted in the license i review. \

The value to industry will be that those rec:m- t mandaticas which tre not considered to have sub

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The proposed change in the requirement ention for re \'

will have no impact on industry. Theadtihnwf11h value in that the licensee wf11 not he required records on items which have been removed from 4

no longer reflect the."as-bufit* I:nndition of the pla Public -

Since a1T requirements related to safetywill of the pla j

still be in effect, no impact to the pubite is foresee

- - The only identifiable values are a minorn esst decrease i 4 of nucia,r pc' der plants and a sifsht acceleration review process. .

D.

Decision en ths Prc esed Action _

Updated guidance should be furnished on quality assu rance program II.

. requirements for the design and construction phases.

Technical Accreach This section is not appifcable to this value/ impact st t a ement since the proposed actica is an update of previously issu d

, e guidance. The technical issues hmte been previcusly discussed . . t III. Precedural Aoyecach \

Since the preposed action is an update of infor=atio n centained in an i

existing regulatsry guide, the only appr:priate precedu s a revisica to *he existing guide. ral altarnative

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• IV. Statutor/ Considerations .

A. tiRC Authority ,

Tnis guide would fall under the authority and safety requirements of the Atomic Energy Act. In particular under 10 CFR Part 50, j

Appendix 8 which establishes quality assurance requirements for' i

the design and construction of nuclear power, plant structures,

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, , systems, and components. ' ' '

8. Need for NEPA Assessment

. The proposed action is not a major action,'as defined by 10 CFit 51.5(a)(10), and does not require an environmental impact statanent.

V. Relationship to Other Existino or Procesed Reculations or Policies .

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No existing or-proposed reguTations or policies, other than Regulatory Guide 1.28, will be affectad. L,plementation of the proposad action will be discussed in Section D of the proposed guide.

VI. Su=2ry and Conclusions

• A revision to Regulatorf Guide 1.28, " Quality Assurance Progra:::

Requirements (Design and Constr.:ction)," should be prepared. The revision should endorse, with cartain exceptions, N!sI Standard l M45.2-1977.

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Draft 2 September 5,1978 1 REGULATORY GUIDE 1.28 REVISION 2

. 2 QUALITY ASSURANCE PROGRAM REQUIREMENTS 3 (DESIGN AND CONSTRUCTION) 4 A. INTRODUCTION 5 Appendix B, " Quality Assurance Criteria for Nuclear Power Plants 6 and Fuel Reprocessing Plants,"' to 10 CFR Part 50, " Domestic Licensing of l 7 Production and Utilization Facilities," establishes overall quality-8 assurance requirements for the design, construction, and operation of ,

9 safety-related structures, systems, and components. This guide describes 10 a method acceptable to the NRC staff for complying with the Connission's 11 regulations with regard to overall quality assurance program require-12 ments during design and construction of nuclear power plants.

13 B. DISCUSSION 14 Subconnittee N45-2.7 (fonnerly N45-3.7) of the American National 15 Standards Connittee N45 Reactor Plants and their Maintenance, developed l 16 a standard designated ANSI N45.2-1971 that included general requirements ,

17 for establishing and executing a quality assurance program during the 18 design and construction phases of nuclear power plants. This standard 19 was endorsed by Regulatory Guide 1.28 (Safety Guide 28). To update the l .

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f 20 requirments of the standard and to make it app 1fcable to other nuclear 21 facilities subject to 10 CFR Part 50, Appendix 3, the standard was revised 22 by the N45-2.7 Work Group in cooperation with the N46-2 subcommittee.

23 The revised standard was approved by Sube::mmittee N45-2, Nuclear 24 Quality Assurance Standards, of the Anerican National Standards Ccemittee 25 N45 and the full N45 conmittee and by Subcomittee N46-2, the full N46 26 comittee, and the N18 connittee. It was subsequently approved and '

27 designated N45.2-1977, " Quality Assurance Program Requirements for 28 Nuclear Facilities", by the American National Standards Institute on '

29 April 7,1977.*

30 The NRC staff has evaluated the guidelines contained in N45.2-1977 31 and has identified those that are imlsortant to safety. Where conformance 32 to the recomendations of this regulatory guide is indicated in an applica-33 tion without further qualification, it indicates that the applicant will 34 comply with the requirements of ANSI N45.2-1977, as supp?emented or modi-35 fied by the regulatory position of this guide.

36 C. REGULATORY POSITION 37 The overall quality assurance program requirments for the design and

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38 construction phases that are included in ANSI N45.2-1977 provide an 39 adequate basis for complying with the quality assurance program require-40 ments of Appendix B to 10 CFR Part 50, as supplemented or modified by 41 the following:

42 *Cepies :nay oe occained from the American Society of Meenanical Engineers, 43 United Engineering Center, 345 East 17th Street, New York, N.Y. 10017.

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44 1. Section 2 of N45.2-1977 requi.res, in part, that "A documented Quality 45 Assurance Program which complies with the applicable sections and elements 46:

of this standard shall be established at the earliest practical time 47 consistent with the schedule for accomplishing the activities for the 48 nuclear facility." The following infonnation should be used to clarify 49 the requirement of Section 2 of ANSI N45.2-1977.

50 For those safety-related activities that are initiated by the 51 applicant prior to submitting its application for a construction permit.

52 the requirenents set forth in ANSI N45.2-1977 and amplified in the 53 applicable N45.2. series standards should be in effect prior to accomplishing 54 the activities. The following are examples of such activities that are

[ 55 or may be initiated prior to submitting the application:

56 a. Activities perfonned in the establishment of the information 57 required to be included in the Preliminary Safety Analysis Report.

58 b.

Activities pertaining to the preparation of design and procure-59 ment documents affecting safety-related structures, systems, and com-60 ponents.

61 2. The guidelines (indicated by the verb "should") of ANSI N45.2-1977 62 contained in the following sections have sufficient safety importance to 53 be treated the same as the requirements (indicated by the verb "shall") of 64 the standard:

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65 a. Section 14, second paragraph - The guidelines on procedures for 66 critical, sensitive, perishable, or high-value articles and on use and 67 control of special handling tools.

68 [b---Seet4en-493-seeend-paragraph---De-gu4de44ne-en-when-to-perform 69 awd44se]

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2 Section 19, third paragraph - The guideline in the first 71 sentence of the paragraph that indicates the three general areas of 72 evaluation to include in an audit.

73 [d,-See44 en-49,-f 4f th-pa ra g ra ph--ne-gu4 de44 ne-en-de vele p4 ag-a n 74 aud44-plan,]

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78 3. The second and fifth paragraphs of Section 19. " Audits," include 79 general guidelines for audit scheduling. Audit scheduling, includino the_

80 guidelines of these paragraohss is addressed separately and in more detail in Regulatory Guide 1.XXX (RS 035-2)*.

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83 84 42 [3;] The Fo N rd and Section 1.2, " Applicability," of ANSI N45.2-85 1977 state: "The ASME Boiler and Pressure Vessel Code, as well as 86 other American National Standards, have been considered in the development

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• Regulatory Guide 1.XXX (RS 035-2) endorses with certain exceptions ANSI l l

88 N45.2.12-1977, Requirements for Auditing of Quality Assurance Programs 89 for Nuclear Power Plants. It will be issued in the near future at which  !

90 time (prior to issuance of this guide) the' nuinder of the guide will be i 91 filled in.

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92 of this standard, and this standard is intended to be compatible with

, g'3 their requirements. However, this standard does not apply to the activities 94 covered by Section III and Section XI of the Code." It is important 95 to consider the relationship of the quality assurance requirements 96 included in Section III of the Code with those included in ANSI N45r.2.

97 Code-covered activities are primarily intended to ensure the integrity 98 of the pressure boundary of an item.Section III of the Code does not 99 address activities necessary to ensure functional operability of some 100 Code-covered items such as pumps or valves. 'Therefore, to assure the 101 satisfactory perfomance of activities affecting the functional operability 102 of these items, the quality assurance program for design and construction 103 should be extended to these other activities, and the [guidanse] recuirements 104 in N45.2 should be used, as appropriate. ~

105 D. IMPLEMENTATION 106 [h Pu r?es e-of- this-s ec tien-is- te-p re vid e-in fo rmatie n-te- a ppiita n ts 107 and-ficensees regarding-the-NRS staff's pians-for esing-this-regulatory 108 guide--Except-in-these-esses-in-which-the-appliennt prepeses-en-siterne-109 ti v e-methed-fo r-cempiyi ng-with-s p ecified-pe rtio n s-e f-th e-Eemis s ie n's 110 regw3a*4 ens,-the-sethed-dessr4 bed herein-will be-wsed 4a-the-tvaluation-of 111 EWbm44tals-for-senstrustien-pesmit-applicat$ons-desketed-after November-30, 112 4 WS,--4f-an-app 44sant-whose-app 14catien Ess-a-senstrustion-permit 4s 113 deske4Gd-en-Gr-before-Movember-30y-49 S t-W4shes-43-Wse-this- MgWla*GEy 114 gw4de-4n-develop 4ms-suba4ttais fsr-app!4sattens,-the-pertinent-practions 115 sf-the-app 44 sat 4en-w434-be-eva2wa:Gd-en-the-bas 4s-of-Ais-guide.]

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116 Except in those cases in which the applicant proposes an acceptable 117 alternative method for complying with the specified portions of the 118 Comission's regulations, the method described herein will be used 119 in the evaluation of applications for construction pennits docketed 120 after (date to be filled in at time of issuance of guide).

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d DISCUSSION OF PUBLIC COMMENTS Public comments on Regulatory Guide 1.28, Revision 1, " Quality Assurance -

Program Requirements (Design and Construction)" were received from the following:

D. F. Hanlen Glenn G. Sherwood, Manager, Safety and Licensing Operation, General Electric Company John W. Gove, Jr., Chairman.,Connittee on Power Plant Design, Construction and Operation, Atomic Industrial Forum.

T. M. Anderson, Manager, Nuclear Safety. Westinghouse Electric Corporation J. B. Violette, Manager of Quality Assurance, Thermal Power Organization, >

Bechtel Power Corporation 6

J. E. G111 eland, Assistant ^ Manager for Power, Tennessee Valley Authority A. J. Pressesky,; Acting Assistant Director for Safety and Quality Assurance, Division of Nuclear Power Development, Depart:nent of Energy R. E. Uhrig Vice President, Flordia Power and Light Company S. Burstein, Executive Vice President, Wisconsin Electric Power Company T. S. Sullivan, Secutive Engineer, Consumers Power Company Resolution of the significant comments is attached.

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4 Resolution of Public Coments

1. Mr. Anderson recomended that the verb "should" be replaced by "shall" in the regulatory guide to clarify requirements of the regulatory guide.

Response: Regulatory guides are intended to formalize and promulgate means of implementing the Commission's regulations which have been found acceptable to the NRC staff. They do not specify requirements, as other alternative methods of implementing the regulations can be submitted by an applicant and will be evaluated by the staff in the review process. Confusion arises when'a regulatory guide endorses a e

i consensus standard as an acceptable method. These standards usually containrequirements(shall)andgoodpracticeguidelines(should)in -

the body of the standard. In endorsing the standard the staff indicates that the requirements, supplemented by some of the more'-

important guidelines . provide an acceptable method for complying with ,

the regulations. Since this may not be the only acceptable alterna--

l tive, the staff reconsnands this course of action. No change has been made.

2. Mr. Hanlen questioned the use of the' tem "Nonconfomance" and suggested ,

i that the tem " Deficiency" be used in its place.

Response: While it is recognized that there may be some variation from dictionary definitions in the use of terms for quality assurance appli-cations, the subject tem is consistent with use in 10 CFR Part 50, i

Appendix 8 and is defined in ANSI N45.2.10-1973, which is endorsed by Regulatory Guide 1.74 It was also included in ANSI N45.2-1971 which is endorsed by the previous version of Regulatory Guide 1.28. No change has been made to the Regulatory Guide.

3. Mr. Gore and Mr. Violette were concerned that, since Section 1.2 Scope, of the endirsed standard did not restrict its use to ' safety-re.Sted activities, it could be assumed the NRC endorses the broader scope.

Response: The introduction to the regulatory guide specifically states that the guide applies to quality assurance requirements for the design and construction of safety-related structures, systems, and components.

Any application of the standard beyond this is at the discretion of the applicant. No change has been made.

4. Mr. Gilleland, Mr. Gore, and Mr. Violette commented that Regulatory Position C.1 could be construed to require development of the entire Quality Assurance Program prior to initiating any activity which may provide input to the design of safety-related structures, systems, or components. They also comented that preparation of the PSAR is covered in other sections of the regulations so that this represents a broadened of scope beyond application to safety-related structures, systens, and components.

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O - 4 M eWW4ps ah ph i Response: The reccamendation of Regulatory Position C.1 reiterates the reconsnandation of WASH 1283, Revision 1, Guidance on Quality

. Assurance Requirements During Design and Procurement Phase of Nuclear Power Plants, Section D.l.a. which has been used in the licensing pro-cess'since May 1974. The regulatory position specifically relates the recossmendation to safety-related activities and applies only to those portions of the Quality Assurance Prc3 ram affecting the activities initiated prior to sutssitting the application.. The staff recognizes that the PSAR is not a design document, but also feels that the need for ,

accurate infonnation on which to base initial decisions requires proper quality assurance inr establishing. that infomation. Therefore no change has been made to the regulatory position..

5. Mr. Gore and Mr. Violette consnented that Regulatory Position C.2.a.

which recomunends that the guideline on procedures for critical, sensi- ,

tive, peri:;hable or high-value articles be treated the same as the requirements, involves purely economic considerations by including controls for high-value articles.

Response: The words or high-value" have been deleted.

6. Mr. Sherwood, Mr. Pressesky, and Mr. Sullivan comented that Regulatory Position C.2.b on when to perfonn audits was excessive in that it required audits to verify corrective action in all cases. They added l l

that verification can often be perfonned by other means. j i

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Response: The staff agrees and tne Regulatory position has been l

deleted. A regulatory position has been added stating that audit scheduling is addressed in a separate regulatory guide. It is currently addressed in WASH 1283 and 1309 and is included in a

, draft regulatory guide which endorses, with certain exceptions, ANSI N45.2.12-1977, Auditing of Quality Assurance Programs for Nuclear Power Plants.

7. Mr. Pressesky, felt that the three general areas of evaluation to be

, included in an audit that are addressed by Regulatory Position C.2'.c should remain guidance.

Response: The three areas addressed in the standard are considered the minimum areas of evaluation necessary for an effective audit and should therefore be treated as a requirement of the standard. No change was made.

8. Mr. Burstein felt that, since written procedures or checklists are required for audits, an audit plan is not necessary for all audits, particularly for minor audits.

Response: The staff agrees and has deleted the regulatory position.

9. Mr. Pressesky and Mr. Uhrig comented that the' guidelines for scheduling audits addressed by Regulatory Position C.2.e should not be treated as requirements.

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• j Response: As addressed in Response 6 the regulatory position has been deleted and a statement added that scheduling of audits is addressed in other NRC documents. 1 1

, 10. Mr. Sherwood, Mr. Anderson, Mr. Gore, and Mr. Violette commented on Regulatory Position C.3. Their comments and the staff's responses are summarized below.

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a. Mr. Shenvood connented that the QA program cannot ensure func-tional operability and recommended that the wording be changed '

to indicate the QA program assures the' proper perfomance of -

activities necessary to assure functional operability.

Response: The requested change was made.

b. Mr. Anderson felt that identifying "other activities" was con-fusing and this should be clarified to read " safety-related activities".

Response: As discussed previously the introduction to the regulatory guide restricts the application to safety-related considerations. It is not necessary to include the restricting modifier at each point in the regulacery position. No change was made.

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c. Mr. Gore and Mr. Violette comented that a Quality Assurance Program established to satisfy the ASME Code Section NA 4000 could be extended to cover functional operability without envoking ANSI N45.2.

Response: While a Code QA Program may provide the controls

'necessary for some activities, it is generally not adequate for controls of all non-Code covered activities. Therefore it is recommended that the program established in accordance with the regulatory guide be extended to these activities. If an applicant feels that his ASME Code QA Program provides adequate controls he may submit it as an alternative to the recommendations of the guide. Therefore no change has been made to the regulatory position in this area.

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