Regulatory Guide 1.144

Auditing of Quality Assurance Programs for Nuclear Power Plants.

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

[A! ;7-r f~Vj4/Revision 11 anonpi;RE,, U.S. NUCLEAR REGULATORY COMMISSION0 REGULATORY GUIDE****4 OFRCE OF STANDARDS DEVELOPMENTREGULATORY GUIDE 1.144AUDITING OF QUALITY ASSURANCE PROGRAMSFOR NUCLEAR POWER PLANTSI1~~~.'~A. INTRODUCTIONAppendix B, "Quality Assurance Criteria for NuclearPower Plants and Fuel Reprocessing Plants," to 1 OCFRPart 50, "Domestic Licensing of Production and UtilizationFacilities," establishes overall quality assurance require-ments for the design, construction, and operation ofstructures, systems, and components of nuclear powerplants important to safety. Criterion XVIII, "Audits," ofAppendix-.B to 10 CFR Part 50 establishes requirementsfor conducting audits of the quality assurance program.This guide describes a method acceptable to the NRC stafffor complying with the Commission's regulations withregard to auditing of quality assurance programs for nuclearpower plants.The Advisory Committee on Reactor Safeguards hasbeen consulted concerning this guide and has concurred inthe regulatory position.B. DISCUSSIONWorking GroupN45-2.12 of the American NationalStandards Committee N45, Reactor Plants and their Main-tenance, has pr-pared a standard that provides requirementsand guidance for establishing and implementing a system ofinternal and external audits of quality assurance programsfor nuclear power plants, including the preparation, per-formance, reporting, and followup of audits by both theauditing and audited organizations.The proposed standard (Draft 4, Revision 3, datedNovember 29, 1Q76) was approved and designated N45.2.12-19771 by the American National Standards Institute onNovember 17, 1977.*Lines indicate substantive changes from January 1979 issue.lANSI/ASMr,. N4.5.2.12-1977, "Requirements for Auditing ofQuality Assurance Programs for Nuclear Power Plants," may heohtained from the American Society of Mechanical Engineers,345 East 47th Street, New York, New York 10017.WASH-] 283, Revision I, 'Guidance on Qualtty AssuranceRequirements During Design and Procurement Phase ofNuclear Power Plants," dated May 24, .1974 (Gray Book,Revision I), and WASH-1309, "Guidance on QualityAssurance Requirements During the Construction Phase ofNuclear Power Plants," dated May 10, 1974 (Green Book,Revision 0), contain Draft 3, Revision 4, of proposedstandard N45.2.12 (February 22, 1974), which is used bythe NRC staff in the evaluation of applications for con-struction permits and operating licenses. ANSI/ASMEN45.2.1 2-1977 reflects development of the standard frontthe proposed version included in the above WASH docu-ments.ANSI/ASME N45.2.12-1977, subject to the regula-tory exceptions in Section C of this guide, will replaceN45.2.1 2 (Draft 3, Revision 4) contained in WASH-1283and WASH-1309 in the evaluation of proposed auditing.procedures for the applicant's quality assurance programincluded in construction permit and operating licenseapplications.An unqualified indication of conformance to the recom-mendations of this regulatory guide in an application meansthat the NRC staff will use the requirements of ANSI/ASMEN45.2.12-1977 as supplemented or modified by the regula-tory position of this guide in its review of the application.C. REGULATORY POSITIONThe requirements that are included in ANSI/ASMIN45.2,12-1Q77 for auditing quality assurance programs fornuclear power plants are acceptable to the NRC staff andprovide an adequate basis for complying with the pertinentquality assurance requirements of Appendix B to 10 CFRPart 50, subject to the following:I. Section 1.5, "Referenced Documents," of ANSI/ASMEN45.2.12-1977 states that documents that are required tobe included as a part of the standard *are identified at thepoint of reference or described in Section 6 of the standard.USNRC REGULATORY GUIDESRegulatory Guides are issued to describe and make available to thePublic methods acceptable to the NRC staff of implementingspecific parts of the Commission's regulations, to delineate tech-niques used by the staff in evaluating specific problems or postu-lated accidents, or to provide guidance to applicants. RegulatoryGuides are not substitutes for regulations, and compliance withthem is not required. Methods and solutions different from those setout in the guides will be acceptable if they provide a basis for thefindings requisite to the issuance or continuance of a permit orlicense by the Commission.Comments and suggestions for improvements in these guides areencouraged at all times, and guides will be revised, as appropriate,to accommodate comments and to reflect new information orexperience. This guide was revised as a result of substantive com-ments received from the Public and additional staff review.Comments should be sent to the Secretary of the Commission,U.S. Nuclear Regulatory Commission, Washington, D.C. 20555,Attention: Docketing and Service Branch.The guides are issued in the following ten broad divisions:1. Power Reactors 6. Products2. Research and Test Reactors 7. Transportation3. Fuels and Materials Facilities 8. Occupational Health4. Environmental and Siting 9. Antitrust and Financial Review5. Materials and Plant Protection 10. GeneralCopies of issued guides may be purchased at the current GovernmentPrinting Office price. A subscription service for future guides in spe-cific divisions is available through the Government Printing Office.Information on the subscription service and current GPO prices maybe obtained by writing the U.S. Nuclear Regulatory Commission,Washington, D.C. '20555, Attention: Publications Sales Manage The specific applicability of these listed documents has beenaddressed in the latest revision of the following regulatoryguides:ANSI StandardN45.2N45.2.9N45.2.10Regulatory Guide1.281.881.742. The Foreword and Section 1.2, "Applicability," ofANSI/ASME N45.2.12-1977 state: "The ASME Boiler andPressure Vessel Cdde (hereafter referred to as the Code) aswell as other American National Standards, have beenconsidered in the development of this standard and thisstandard is intended to be compatible with their require-ments. However, this standard does not apply to activitiescovered by Section III, Div. I and 2, and Section Xi of theCode for those activities covered by the Code." WhileSection Il1, Divisions I and 2, and Section XI of the ASMEBoiler and Pressure Vessel Code address general require-ments for quality assurance program audits, these sectionsdo not explicitly address all the activities described inANSI/ASME N45.2.12-1977. ANSI/ASME N45.2.12-1977,subject to the exceptions of the regulatory position, shouldbe used in conjunction with Section II1, Divisions I and 2,and Section XI of the ASME Boiler and Pressure VesselCode for auditing quality assurance programs where theASME Code does not address the activities covered byANSI/ASME N45.2.12-1977.3. Section 3.5.2 of ANSI/ASME N45.2.1 2-1977 requiresthat audits of quality assurance activities be regularlyscheduled to ensure that the quality assurance program isadequate and that activities are being performed in accord-ance with the quality assurance program. The frequency ofthe scheduling of audits is dependent on the status andimportance of the activities to be audited, and the follow-ing is considered acceptable scheduling:a. Internal Audits(I) Operational Phase Activities-Regulatory Guide1.33, "Quality Assurance Program Requirements (Opera-tion)," should be followed.(2) Design and Construction Phase Activities-Applicable elements of an organization's quality assuranceprogram should, be audited at least annually or at least oncewithin the life of the activity, whichever is shorter. In deter-mining the scope of the audit, an evaluation of the area beingaudited may be useful. The evaluation may include some orall of the following: prior quality assurance program audits;results of audits from other sources; nature and frequencyof identified deficiencies; and significant changes in person-nel, organization, or quality assurance program.b. External Audits(I External audits, after the award of a contract,are not necessary for procurement actions when the itemsor services are all of the following:(a) Relatively simple and standard in design,manufacture, and test, and(b) Adaptable to standard or automatedInspections or tests of the end product to verify qualitycharacteristics after delivery, and(c) Such that receiving inspection does notrequire operations that could adversely affect the integrity,function, or cleanness of the item.(2) For other procurement actions not listed inltem C.3.b.(I), audits should be conducted as follows:Elements of a supplier's quality assuranceprogram should be audited by the purchaser on a triennialbasis with the audit implemented in accordance withSection 4, "Audit Implementation," of ANSI/ASMEN45.2.12-1977. The triennial period should begin withperformance of an audit when sufficient work is in progressto demonstrate that the organization is implementing aQuality Assurance Program having the required scope forpurchases placed during the triennial period. When asubsequent contract or a contract modification that signifi-cantly enlarges the scope of activities performed by thesame supplier is executed, an audit should be conducted ofthe increased requirements, thus starting a new triennialperiod. If, at the time of the pre-award survey, the supplieris already implementing the same quality assurance programfor other customers that he proposes to use on the auditingparty's contract, then the pre-award survey, if it wasconducted in accordance with Section 4 of ANSI/ASMEN45.2.12-1977, may serve as the first triennial audit,Therefore, when such pre-award surveys are employed asthe first triennial audits, those surveys should satisfy thesame audit elements and criteria used on other triennialaudits.A documented evaluation of the suppliershould be performed annually. Where applicable, thisevaluation should take into account (1) review of supplier-furnished documents such as certificates of conformance,non-conformance notices, and corrective actions, (2) resultsof previous source verifications, audits, and receivinginspections, (3) operating experience of identical or similarproducts furnished by the same supplier, and (4) results ofaudits from other sources, e.g., customer, ASME, or NRCaudits.4. The guidelines (indicated by the verb "should")of ANSI/ASME N45.2.12-1977 contained in the followingsections have sufficient safety importance to be treated thesame as the requirements (indicated by the verb "shall") ofthe standard:a. The guideline concerning supplementing regularlyscheduled audits for Sections 3.5.3.3 through 3.5.3.5.b. Section 4.3.2.7-The guideline concerning correc*tive action on program deficiencies identified during'previous audits. In this regard, corrective action on programdeficiencies identified during previous audits is construed to1.144-2 mean "corrective action on program deficiencies in the areathat is being audited."5. Regulatory Position C.3 provides guidance on sched-uling internal and external audits. Section 1.3, "Responsi-bility," of ANSI/ASME N45.2.12-1977 states: "The workof establishing practices and procedures and providing'the resources in terms of personnel, equipment and serv-ices necessary to meet the requirements of this standardmay be delegated to other organizations and such delega-tion shall also he documented." Where more than onepurchaser buys from a single supplier, a purchaser mayperform an audit of the supplier on behalf of more thanone purchaser in order to reduce the number of externalaudits of the supplier. The results of this audit should bedistributed to all purchasers for whom the audit wasconducted.6. The guideline in Section 3.5.3.6 of ANSI/ASMEN45.2.12-1977 recommending an audit "when necessaryto verify implementation of required corrective action"does not meet the provisions of CriterionXVIII of Appen-dix B to 10 CFR Part 50. Audits as well as other methodsof surveillance can be used to verify implementation ofrequired corrective action.7. The requirements of ANSI/ASME N45.2.12-1977contained in the second sentence of Section 5.2,"Audit Records," read "Records shall include the auditsystem plan, individual audit plans, audit reports, writ-ten replies, and the record of completion of correctiveactions." Additionally, these records should includedocuments associated with the conduct of audits thatsupport audit findings (for example, audit checklists orprocedures).D. IMPLEMENTATIONThe purpose of this section is to provide informationto applicants regarding the NRC staff's plans for using thisregulatory guide.Except in those cases in which an applicant proposesan acceptable alternative method for complying withspecified portions of the Commission's regulations, themethod described herein will be used in the evaluationot the following applications that are docketed afterNovember 28, 1980;1. Preliminary Design Approval (PDA) applications andPreliminary Duplicate Design Approval (PDDA)applications.2. Final Design Approval, Type 2, (FDA-2) applicationsand Final Duplicate Design Approval, Type 2,(FDDA-2) applications.3. Manufacturing License (ML) applications.4. Construction Permit (CP) applications except forthose portions of CP applications that referencestandard designs (i.e., PDA, FDA-I, FDA-2, PDDA,FDDA-l, FDDA-2, or ML) or that reference qualifiedbase plant designs under the replication option.5. Operating License (OL) applications.If an applicant wishes to use this method in developingsubmittals for applications docketed on or beforeNovember 28, 1980, the pertinent portions of the applica-tion will be evaluated on the basis of this regulatory guide.1.144-3 UNITED STATESNUCLEAR REGULATORY COMMISSIONWASHINGTON, D. C. 20555OFFICIAL BUSINESSPENALTY FOR PRIVATE USE. $300POSTAGE AND FEES PAIDU.S. NUCLEAR REGULATORYCOMMISSION