Regulatory Guide 1.144

Auditing of Quality Assurance Programs for Nuclear Power Plants.

ML13038A428
Person / Time
Issue date:	09/30/1980
From:	Office of Nuclear Regulatory Research, NRC/OSD
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References
RG-1.144, Rev. 1
Download: ML13038A428 (4)

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0 REGULATORY GUIDE

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REGULATORY GUIDE 1.144 AUDITING OF QUALITY ASSURANCE PROGRAMS

FOR NUCLEAR POWER PLANTS

A. INTRODUCTION

WASH-] 283, Revision I, 'Guidance on Qualtty Assurance Requirements During Design and Procurement Phase of Appendix B, "Quality Assurance Criteria for Nuclear Nuclear Power Plants," dated May 24, .1974 (Gray Book, Power Plants and Fuel Reprocessing Plants," to 1OCFR Revision I), and WASH-1309, "Guidance on Quality Part 50, "Domestic Licensing of Production and Utilization Assurance Requirements During the Construction Phase of Facilities," establishes overall quality assurance require- Nuclear Power Plants," dated May 10, 1974 (Green Book, ments for the design, construction, and operation of Revision 0), contain Draft 3, Revision 4, of proposed structures, systems, and components of nuclear power standard N45.2.12 (February 22, 1974), which is used by plants important to safety. Criterion XVIII, "Audits," of the NRC staff in the evaluation of applications for con- Appendix-.B to 10 CFR Part 50 establishes requirements struction permits and operating licenses. ANSI/ASME

for conducting audits of the quality assurance program. N45.2.1 2-1977 reflects development of the standard front This guide describes a method acceptable to the NRC staff the proposed version included in the above WASH docu- for complying with the Commission's regulations with ments.

regard to auditing of quality assurance programs for nuclear power plants. ANSI/ASME N45.2.12-1977, subject to the regula- tory exceptions in Section C of this guide, will replace The Advisory Committee on Reactor Safeguards has N45.2.1 2 (Draft 3, Revision 4) contained in WASH-1283 been consulted concerning this guide and has concurred in and WASH-1309 in the evaluation of proposed auditing.

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the regulatory position. procedures for the applicant's quality assurance program included in construction permit and operating license

B. DISCUSSION

applications.

Working GroupN45-2.12 of the American National An unqualified indication of conformance to the recom- Standards Committee N45, Reactor Plants and their Main- mendations of this regulatory guide in an application means tenance, has pr-pared a standard that provides requirements that the NRC staff will use the requirements of ANSI/ASME

and guidance for establishing and implementing a system of N45.2.12-1977 as supplemented or modified by the regula- internal and external audits of quality assurance programs tory position of this guide in its review of the application.

for nuclear power plants, including the preparation, per- formance, reporting, and followup of audits by both the

C. REGULATORY POSITION

auditing and audited organizations.

The requirements that are included in ANSI/ASMI

The proposed standard (Draft 4, Revision 3, dated N45.2,12-1Q77 for auditing quality assurance programs for November 29, 1Q76) was approved and designated N45.2.12- nuclear power plants are acceptable to the NRC staff and

19771 by the American National Standards Institute on provide an adequate basis for complying with the pertinent November 17, 1977. quality assurance requirements of Appendix B to 10 CFR

Part 50, subject to the following:

• Lines indicate substantive changes from January 1979 issue.

I. Section 1.5, "Referenced Documents," of ANSI/ASME

lANSI/ASMr,. N4.5.2.12-1977, "Requirements for Auditing of N45.2.12-1977 states that documents that are required to Quality Assurance Programs for Nuclear Power Plants," may he ohtained from the American Society of Mechanical Engineers, be included as a part of the standard *are identified at the

345 East 47th Street, New York, New York 10017. point of reference or described in Section 6 of the standard.

USNRC REGULATORY GUIDES Comments should be sent to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, Regulatory Guides are issued to describe and make available to the Attention: Docketing and Service Branch.

Public methods acceptable to the NRC staff of implementing specific parts of the Commission's regulations, to delineate tech- The guides are issued in the following ten broad divisions:

niques used by the staff in evaluating specific problems or postu- lated accidents, or to provide guidance to applicants. Regulatory 1. Power Reactors 6. Products Guides are not substitutes for regulations, and compliance with 2. Research and Test Reactors 7. Transportation them is not required. Methods and solutions different from those set 3. Fuels and Materials Facilities 8. Occupational Health out in the guides will be acceptable if they provide a basis for the 4. Environmental and Siting 9. Antitrust and Financial Review findings requisite to the issuance or continuance of a permit or 5. Materials and Plant Protection 10. General license by the Commission.

Copies of issued guides may be purchased at the current Government Comments and suggestions for improvements in these guides are Printing Office price. A subscription service for future guides in spe- encouraged at all times, and guides will be revised, as appropriate, cific divisions is available through the Government Printing Office.

to accommodate comments and to reflect new information or Information on the subscription service and current GPO prices may experience. This guide was revised as a result of substantive com- be obtained by writing the U.S. Nuclear Regulatory Commission, ments received from the Public and additional staff review. Washington, D.C. '20555, Attention: Publications Sales Manager.

The specific applicability of these listed documents has been (a) Relatively simple and standard in design, addressed in the latest revision of the following regulatory manufacture, and test, and guides:

(b) Adaptable to standard or automated ANSI Standard Regulatory Guide Inspections or tests of the end product to verify quality characteristics after delivery, and N45.2 1.28 N45.2.9 1.88 (c) Such that receiving inspection does not N45.2.10 1.74 require operations that could adversely affect the integrity, function, or cleanness of the item.

2. The Foreword and Section 1.2, "Applicability," of ANSI/ASME N45.2.12-1977 state: "The ASME Boiler and (2) For other procurement actions not listed in Pressure Vessel Cdde (hereafter referred to as the Code) as ltem C.3.b.(I), audits should be conducted as follows:

well as other American National Standards, have been considered in the development of this standard and this Elements of a supplier's quality assurance standard is intended to be compatible with their require- program should be audited by the purchaser on a triennial ments. However, this standard does not apply to activities basis with the audit implemented in accordance with covered by Section III, Div. I and 2, and Section Xi of the Section 4, "Audit Implementation," of ANSI/ASME

Code for those activities covered by the Code." While N45.2.12-1977. The triennial period should begin with Section Il1, Divisions I and 2, and Section XI of the ASME performance of an audit when sufficient work is in progress Boiler and Pressure Vessel Code address general require- to demonstrate that the organization is implementing a ments for quality assurance program audits, these sections Quality Assurance Program having the required scope for do not explicitly address all the activities described in purchases placed during the triennial period. When a ANSI/ASME N45.2.12-1977. ANSI/ASME N45.2.12-1977, subsequent contract or a contract modification that signifi- subject to the exceptions of the regulatory position, should cantly enlarges the scope of activities performed by the be used in conjunction with Section II1, Divisions I and 2, same supplier is executed, an audit should be conducted of and Section XI of the ASME Boiler and Pressure Vessel the increased requirements, thus starting a new triennial Code for auditing quality assurance programs where the period. If, at the time of the pre-award survey, the supplier ASME Code does not address the activities covered by is already implementing the same quality assurance program ANSI/ASME N45.2.12-1977. for other customers that he proposes to use on the auditing party's contract, then the pre-award survey, if it was

3. Section 3.5.2 of ANSI/ASME N45.2.1 2-1977 requires conducted in accordance with Section 4 of ANSI/ASME

that audits of quality assurance activities be regularly N45.2.12-1977, may serve as the first triennial audit, scheduled to ensure that the quality assurance program is Therefore, when such pre-award surveys are employed as adequate and that activities are being performed in accord- the first triennial audits, those surveys should satisfy the ance with the quality assurance program. The frequency of same audit elements and criteria used on other triennial the scheduling of audits is dependent on the status and audits.

importance of the activities to be audited, and the follow- ing is considered acceptable scheduling: A documented evaluation of the supplier should be performed annually. Where applicable, this a. Internal Audits evaluation should take into account (1) review of supplier- furnished documents such as certificates of conformance, (I) OperationalPhase Activities-Regulatory Guide non-conformance notices, and corrective actions, (2) results

1.33, "Quality Assurance Program Requirements (Opera- of previous source verifications, audits, and receiving tion)," should be followed. inspections, (3) operating experience of identical or similar products furnished by the same supplier, and (4) results of

(2) Design and Construction Phase Activities- audits from other sources, e.g., customer, ASME, or NRC

Applicable elements of an organization's quality assurance audits.

program should, be audited at least annually or at least once within the life of the activity, whichever is shorter. In deter- 4. The guidelines (indicated by the verb "should")

mining the scope of the audit, an evaluation of the area being of ANSI/ASME N45.2.12-1977 contained in the following audited may be useful. The evaluation may include some or sections have sufficient safety importance to be treated the all of the following: prior quality assurance program audits; same as the requirements (indicated by the verb "shall") of results of audits from other sources; nature and frequency the standard:

of identified deficiencies; and significant changes in person- nel, organization, or quality assurance program. a. The guideline concerning supplementing regularly scheduled audits for Sections 3.5.3.3 through 3.5.3.5.

b. External Audits b. Section 4.3.2.7-The guideline concerning correc*

(I External audits, after the award of a contract, tive action on program deficiencies identified during'

are not necessary for procurement actions when the items previous audits. In this regard, corrective action on program or services are all of the following: deficiencies identified during previous audits is construed to

1.144-2

mean "corrective action on program deficiencies in the area

D. IMPLEMENTATION

that is being audited."

The purpose of this section is to provide information

5. Regulatory Position C.3 provides guidance on sched- to applicants regarding the NRC staff's plans for using this uling internal and external audits. Section 1.3, "Responsi- regulatory guide.

bility," of ANSI/ASME N45.2.12-1977 states: "The work of establishing practices and procedures and providing' Except in those cases in which an applicant proposes the resources in terms of personnel, equipment and serv- an acceptable alternative method for complying with ices necessary to meet the requirements of this standard specified portions of the Commission's regulations, the may be delegated to other organizations and such delega- method described herein will be used in the evaluation tion shall also he documented." Where more than one ot the following applications that are docketed after purchaser buys from a single supplier, a purchaser may November 28, 1980;

perform an audit of the supplier on behalf of more than one purchaser in order to reduce the number of external 1. Preliminary Design Approval (PDA) applications and audits of the supplier. The results of this audit should be Preliminary Duplicate Design Approval (PDDA)

distributed to all purchasers for whom the audit was applications.

conducted.

2. Final Design Approval, Type 2, (FDA-2) applications

6. The guideline in Section 3.5.3.6 of ANSI/ASME and Final Duplicate Design Approval, Type 2, N45.2.12-1977 recommending an audit "when necessary (FDDA-2) applications.

to verify implementation of required corrective action"

does not meet the provisions of CriterionXVIII of Appen- 3. Manufacturing License (ML) applications.

dix B to 10 CFR Part 50. Audits as well as other methods of surveillance can be used to verify implementation of 4. Construction Permit (CP) applications except for required corrective action. those portions of CP applications that reference standard designs (i.e., PDA, FDA-I, FDA-2, PDDA,

7. The requirements of ANSI/ASME N45.2.12-1977 FDDA-l, FDDA-2, or ML) or that reference qualified contained in the second sentence of Section 5.2, base plant designs under the replication option.

"Audit Records," read "Records shall include the audit system plan, individual audit plans, audit reports, writ- 5. Operating License (OL) applications.

ten replies, and the record of completion of corrective actions." Additionally, these records should include If an applicant wishes to use this method in developing documents associated with the conduct of audits that submittals for applications docketed on or before support audit findings (for example, audit checklists or November 28, 1980, the pertinent portions of the applica- procedures). tion will be evaluated on the basis of this regulatory guide.

1.144-3

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