ML20147E360
| ML20147E360 | |
| Person / Time | |
|---|---|
| Issue date: | 09/05/1978 |
| From: | NRC OFFICE OF STANDARDS DEVELOPMENT |
| To: | |
| Shared Package | |
| ML20147E238 | List: |
| References | |
| REGGD-01.028, REGGD-1.028, NUDOCS 7810160210 | |
| Download: ML20147E360 (13) | |
Text
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i Draft 2 I
September 5,1978 1
REGULATORY GUIDE 1.28 REVISION 2 2
QUALITY ASSURANCE PROGRAM REQUIREMENTS 3
(DESIGNANDCONSTRUCTION) 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 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 Commission's 11 regulations with regard to overall quality assurance program require-12 ments during design and construction of nuclear power plants.
13 B.
DISCUSSION 7
14 Subconnittee N45-2.7 (.fomerly N45-3.7) of the American National 15 Standards Connittee N45. Reactor Plants and their Maintenance, developed 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
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19 was endorsed by Regulatory Guide 1.2S (Safety Guide 28). To update the l
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20 requirenents of the standard and to make it applicable to other nuclear 21 facilities subject to 10 CFR Part 50, Appendix S, the standard was revised 22 by the N45-2.7 Work Group in cooperation with the N46-2 subccomittee.
23 The revised standard was approved by Subconsittee N45-2, Nuclear 24 Quality Assurance Standards, of the American National Standards Connittee 25 N45 and the full N45 cosmittee and by Subconnittee M46-2, the full N45 26 connittee, and the N18 committee.
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 important to safety. Where confonnance 32 to the recoumendations of this regulatory guide 1: indicated in an applica-33 tion without further qualification, it indicates that the applicant will 34 comply with the requirenants of ANSI N45.2-1977, as supplemented or modi-35 fied by the regulatory position of this guide.
36 C.
REGULATORY POSITION l
37 The overall quality assurance program requirements for the design and 38 construction phases that are included in ANSI N45.2-1977 provide an l
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:
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42
%cpies may oe ootained from the American Society of Mechanical Engineers, I
43 United Engineering Center, 345 East 47th Street, New York, N.Y.
10017.
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44 1.
Section 2 of N45.2-1977 requires, in part, that "A documented Quality 45 Assurance Program which comg11es 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 fa'cility." The following information should be used to clarify 49 the requirement of Section 2 of ANSI N45.2-1977.
50Property "ANSI code" (as page type) with input value "ANSI N45.2-1977.</br></br>50" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process. For those safety-related activities that are initiated by the 51 applicant prior to submitting its application for a construction permit, 52 the requirements set forth in ANSI M45.2-1977 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 verty "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 -
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- critical, sensitive, perishable, or high-value articles and on use and 67 control of special handling tools.
68
[br~- Ses44en-4 b-sesond-pe n g n ph--De-g u ide44 m e-en-w hen-4e-perde m 69 aud44s,]
70 Me,]
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,--ses44en-4b-4444ApangFaph-De-gu4de44me-en-deWedep4ng-an 74 aud44-p4an,]
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[e,--Ses 44 en-4Gv-s4 x th-pa ng Fa ph--De-gW4de44 ne-en-s a hedul4 ng-ed 76 aud44s-and-the-gu4de44ne-4 hat-spee4f4es-the-eend444 ens-that-cequ4ee 77 sendue44mg-aud44s,]
78 3.
The second and fifth paragraphs of Section 19. " Audits." include 79 general guidelines for audit scheduling. Audit scheduling, includinc the 80 quidelines of these paragraphs 1s addressed separately and in more detail 3
81 in Requiatory Guide 1.XXX (RS 035-2)*.
84 4[3,3 The Foreword and Section 1.2, '" Applicability," of ANSI N45.2-85 1977 stata: "The ASME Boiler and Pressure Vessel Code, as well as 86 other American National Standards, have been considered in the development 87 1egulatory Guide 1.XXX (RS 035-2) endorses with certain exceptions ANSI 88 N45.2.12-1977, Recuirements 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' nuinter of the guide will be 91 filled in.
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gg of this standard, and this standard is intended to be compatible with 93 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 i
96 included in Section III of the Code with those included in ANSI N45.2.
Code-covered activities are primarily intended to ensure the integrity 97 98 of the pressure boundary of an itas.Section III of the Code does not 99 address activities necessary to ensure functional operability of some 100 Code-covered itams'such as pumps or valves. 'Therefore, to assure the 101 satisfactory cerformance of activities affecting the functional operabilit:y.
I 102 of these itans, the quality assurance program for design and construction 103 should be extended to these other activities, and the [3u4danee] reouirements 104 in M45.2 should be used, as appropriate.
105 O.
IMP 1.EMENTATION 106
[ h purpose-of-th4s-seetfen-4s-to-preyfde-information-to-sppffeants 107 and-ficensees regarding-the-NRS-staff's pfans-for-using-this regafatory 108 guide---Except-in-these-cases-in wMeh-the-sppffeant preposes-sa-af terne-109 tiv e-methed-for-eempfying-w+th-speefffed-pertiens-ef-the-sennis sie n's 110 regulat$eas,-the-eened-dessp4 bed hosetn-w411-h-used 4a-no-evaluatten-44 111 sube444ais-few-eenstpus44en-peas 44-app 34sattens-4esketed-aftes-Novembew-30, 112 4WS,--48-an-app 44sant-whosa-app 44catten fee-a-senstzustica-peaste 4s 113 desketed-en-ow-bedewe-Wevenber-30,-4S's,-wishes 48-use 34s-regulatevy 9u4de-4n-deve48P a9-subm4ttals fow-app 14sa44 ens,-ce-per*4aest-per*. tens 114 4
115 ei-th*-APP 44sation-w&4; be-evaluated.an-co-basts-of-34s-sut4a.]
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116 Except in those cases in which the acclicant creocses an acceptable 117 alternative method for complying with the soecified oortions of the 118 Commission's regulations, the method described herein will be used 4
119 in the evaluation of applications for construction : emits docketed 120 after (date to be filled in at time of issuance of guide).
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DISCUSSION OF ?UBLIC CCPNENTS Public commei:ts on Regulatory Guide 1.23, Revision 1,' Quality Assurance Program Requirements (Design and Construction)" were received from the following:
D. F. Hanlon i
Glenn G. Sherwood, Manager, Safety and Licensing Operation, General Electric Company John W. Gove, Jr., Chairman, Cannittee 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 Themal Power Organization, Bechtel Power Corporation J. E. Gilleland, Assistant-Manager for Power Tennessee Valley Authority A. J. Pressesky, Acting Assistant Ofractor for Safety and Quality Assurance, Division of Nuclear Power Development, Department of Energy R. E. Uhrig, Vice President. Flordia Power and Light Company S. Burstein, Executive Vice President, Wisconsin Electric Power Campany T. S. Sullivan, Executive Engineer, Consumers Power Company Resolution of the significant connents is attached.
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uG e Resolution of Public Connents
^
1.
Mr. Anderson reconnended that the verb "should" be replaced by "shall" in the regulatory guide to clarify requirenents of the regulatory guide.
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Response: Regulatory guides are intended to fonnalize and promulgate means of implementing the Cosmission'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 i
subaritted by an applicant and will be evaluated'by the staff in the review process. Confusion arises when a regulatory guide endorses a consensus standard as an acceptable method. These standards usually contain requirements (shall) and good practica guidelines (should) in the body of the standard. In endorsing the standard the staff indicates that the requirements, supplenanted by some of the more important guidelines,' provide an acceptable method for complying with the regulations. Since this may not be the only ac:aptable alterna-r tive, the staff reconnends this course of action. No change has been made.
2.
Mr. Hanlen questioned the use of the tenn "Nonconfonnance" and suggested that the term " Deficiency" be used in its place.
Response: While it is recognized that there may be some variation' from dictionary definitions in the use of tenns for quality assurance appli-cations, the subject tenn is consistent with use in 10 CFR Part 50,
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Appendix B and is defined in ANSI M45.2.10-1973, 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 charije has been made to the Regulatory Guide.
3.
Mr. Gors'and Mr. Violette won concerned that, since Section 1.2, Scope, of the endorsed standard did not restrict its use to safety-related 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.
L 4.
Mr. G111 eland, Mr. Gore, and Mr. Violette ccamented that Regulatory Position C.1 could be construed to require development of the entire QuaTity Assurance Program prior to initiating any activity which may provide input to the design of safety-related structures, systems, or components. They also connented 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, systems, and components.
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Response: The reconnendation of Regulatory Position C.1 reiterates the recessendation of WASH 1283, Revision 1. Guidance on Quality Assurance Requirements During Design and Pmcurement Phase of Nuclear Pcwer Plants, Section D.l.a. which has been used in the licansing pro-cess since May 1974. The regulatory position specifically relates the recommendation to safety-related activities and. applies only to those portions of the Quality Assurance Program affecting the activities initiated prior to submitting the application. The staff recognizes that the PSAR is not a design document,.but also feels that the need for accurate infomation on which to base initial decisions requires proper qualit;y assurance in establishing that infomation. Therefore no change has been made to the regulatory position.
5.
Mr. Gore and Mr. Violette connented that Regulatory Position C.2.a, which recommends that the guideline on procedures for critical, senst-t tive, perishable 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. Shanvood. Mr. Pressesky, and Mr. Sullivan consented that Regulatory P'.,sition C.2.b on when to perfom audits was excessive in that it required audits to verify corrective action in all cases. They added that verification can often be perfonned by other means.
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Response: The staff agrees and the Regulatory position has been j
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deleted. A regulatory position has been added stating that audit
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l scheduling is addressed in a separate regulatory guide. It is t
currently addressed in WMut 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.2ic should remain guidance.
i Response: The three areas addressed in the standard are considered the minimum areas of evaluation necessary for an effective audit and n
should therefore be treated as a' requirement of the standard [ No change was made.
s 8.
Mr. Burstein felt that, since written procedures or checklists are required for audits, an audit plan is not necessary for all audits,
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particularly for minor audits, Response: The staff agrees and has deleted the regulatory position.
9.
Mr. Pressesky and Mr. Uhrig commented th'at the guidelines for scheduling i
audits addressed by Regulatory Position C.2.e should not be treated -
as requirements.
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Response: As addressed in Response 6 the regulatory position has been deleted and a statement added that scheduling of audits is addrest.ed in other NRC docwners.
- 10. Mr. Sherwood, Mr. Anderson, Mr. Gore, and Mr. Violette ccamented on Regulatory Position C.3.
Their connents and the staff's responses are summarized below.
i a.
Mr. Shenvood commented that the QA program cannot ensure func-tional operability and recommended that the wording be changed to indicate the QA program assures the proper performance 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 activi ties".
Response: As discussed previously the introduction to the regulatory guide restricts the application to safety-related c.onsiderations. It is not necessary to include the restricting modifier at each point in the regulatory positicn. No change was made.
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Mr. Gore and Mr. Violette comented that a Quality Assurance c.
Program established to satisfy the ASME Code Section NA 4000 could be extended to cover functional operability without envoking ANSI M45.2.
liesponse: While a Code QA Program may provide the controls
'necessary for some activities, it is generally not adequate for controls of all non-Coda covered activities. Therefore it is recommended that the program estaclished in accordance with the regulatory guide be extended to these activities. If an applicant feels that his ASME Code QA Program provides adequate controis he may subnit it as an alternative to the reconnendations of the guide. Therefore no change has been made to the regulatory position in this area.
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