ML20214M747

Rev 3 to Reg Guide 1.28,Task Rs 002-5, QA Program Requirements (Design & Const)

ML20214M747
Person / Time
Issue date:	08/31/1985
From:	NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:
Shared Package
ML20214M635	List: ML20214M747
References
PROJECT-669A, TASK-OS, TASK-RS-002-5, TASK-RS-2-5 REGGD-01.028, REGGD-1.028, NUDOCS 8706010417
Download: ML20214M747 (14)

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, .

Revision 3'

[D U.S. NUCLEAR REOULATORY COMMISSION August 1985 g\,o..j i REGULATORY GU DE

• OFFICE OF NUCLEAR REGULATORY RESEARCH REGULATORY GUIDE 1.28 QUALITY ASSURANCE PROGRAM REQUIREMENTS (DESIGN AND CONSTRUCTION)

(Task RS 002 5)

A. INTRODUCTION B. DISCUSSION Nuclear power plants and fuel reprocessing plants Regulatory Guide 1.28 (Safety Guide 28) was issued include structures, systems, and compcnents that prevent in June 1972 and endorsed the general requirements and or mitigate the consequences of postulated accidents guidelines for estabushing and executing a quality that could cause undue. risk to the health and safety of assurance program during the design and construction the public. Appendix B to 10 CFR Part 50 establishes phases of nuclear power plants provided in ANSI N45.2-quahty assurance requirements for the design, construc- 1971,8 " Quality Assurance Program Requirements for tion, and operation of those structures, systems, and Nuclear Power Plants." This standard had been devel-components. The pertinent requirements of Appendix B oped by Subcommittee N45-2.7 (formerly N45-3.7) of apply to all activities affecting the safety-related func. the American National Standards Committee N45, Reac-tions of those structures, systems, and components, tor Plants and Their Maintenance, and provided general These activities include designing, purchasing, fabricating, requirements for establishing and executing a quality handling, shipping, stonng, cleaning, erecting, installing, assurance program during the design, construction, and inspecting, testing, operating, maintaining, repairing, operation of nuclear power plants. ANSI N45.21971 refueling, and mo6fying. was later revised to update its requirements and to expand its applicability to other nuclear facilities that This regulatory guide describes a method acceptable were subject to Appendix B to 10 CFR Part 50. That to the NRC staff for complying with the provisions of revised standard was subsequentl approved and Appendix B with regard to establishing and implement- designated ANSI /ASME N45.2-1977,{ " Quality Assur-the requisite quahty assurance program for the Cp ing design and construction of nuclear power plants. Guid-ance Program Requirements for Nuclear Facihties," by the American National Standards institute (ANSI) on ance for the establishment and execution of quality April 7,1977. Revision I to Regulatory Guide 1.28 was assurance programs dunng operation and decommission- issued for public comment in March 1978. With supple-ing of nuclear power plants have been or will be mental provisions, it proposed endorsement of the addressed in separate regulatory guides. Similarly, quality quality assurance program requirements in ANSI /ASME

. assurance provisions concerning fuel cycle facilities have N45.2-1977 for the design and construction phases of been or will be addressed in separate regulatory guides. nuclear power plants. In February 1979, the NRC issued Revision 2 to Regulatory Guide 1.28, which, with Any information collection activities mentioned in this supplemental provisions, also endorsed the quality regulatory guide that may be subject to the Paperwork assurance program requirements of ANSI /ASME N45.2-Reduction Act of 1980 (44 U.S.C. 3501 et seq.) have 1977 for the design and construction phases of nuclear been reviewed by the Office of Management and Budget power plants.

and were included in OMB Approval No. 3150-0011.

The American Society of Mechanical Engineers The Advisory Committee on Reactor Safeguards has (ASME) Committee on Nuclear Quality Assurance has been consulted concerning this guide and has concurred prepared a new standard that includes requirements and in the regulatory position. guidance for establishir.g and executing quality assurance 0: ,

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USF'4C REGULATORY GUIDES Comments should be sent to the Secretarv of the Commission, Regulatory Guices ,,re issued to describe and make available to the nt one het Se i e S ancA.

. oc parts of eC mi lo sr i tion , t ae The guides are issued in the following ten broad divisions:

D. ha ed oc I ent o t or ids u don'ce sip ts. tegu a or 1. Power Reactors 4. Products a hem s n r Quired ethSds$n[so ti s alNorebro ose a.' ue ad t r ais acii t es

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programs for the design, . construction, operation, and ments, and (3) Appendices. The Basic Requirements decommissioning of nuclear facilities. This standard is section sets forth basic requirements for establishing and based on the contents of ANSI N46.21978, ANSI / executing quality assurance programs. The Supplements ASME N45.21977, and the following standards in the section amplifies the individual requirements of the ANSI N45.2 series:8 Basic Requirements section. The Appendices section provides nonmandatory guidance for meeting the Basic N45.2.6 " Qualification of Inspection, Examina- Requirements and Supplements sections.

tion, and Testing Personnel for Nuclear Power Plants" The intent of ANSI /ASME NQA-1 1983 was to consolidate the quality assurance programmatic standards N45.2.9 " Requirements for Collection, Storage to reduce redundancy without changing the overall and Maintenance of Quality Assurance intent of the standard. This Revision 3 to Regulatory Records for Nuclear Power Plants" Guide 1.28 was developed to endorse ANSI /ASME NQA-I-1983. In its development, the NRC staff intended N45.2.10 " Quality Assurance Terms and Defmi- it to be equivalent to the methods described in Regula-tions" tory Guides 1.28 (Rev. 2),1.58 (Rev.1),1.64 (Rev. 2),

1.74,1.88 (Rev. 2),1.123 (Rev.1),1.144 (Rev.1), and N45.2.1 I " Quality Assurance Requirements for 1.146. To accomplish this equivalency, parts of the the Design of Nuclear Power Plants" "nonmandatory guidance" in ANSI /ASME NQA 1-1983 that were previously requirements in the ANSI /ASME N45.2.12 " Requirements for Auditing of Quality N45.2 series were included as regulatory positions in Assurance Programs for Nuclear Power Proposed Revision 3 to Regulatory Guide 1.28, which Plants" was issued in March 1981 for public comment. Also, several of the previous regulatory positions endorsing the N45.2.13 " Quality Assurance Requirements for ANSI /ASME N45.2 series standards were in:luded as '

Control of Procurement of items and regulatory positions in Proposed Revision 3 to Regula-Services for Nuclear Power Plants" tory Guide 1.28.

N45.2.23 " Qualification of Quality Assurance Based on public comments and further NRC staff Program Audit Personnel for Nuclear review, the regulatory positions have been reassessed to Power Plants" determine their value and impact on nuclear power plant safety. In this reassessment, the advantage of muumizing The standard that evolved was approved and desig- the nurnber of exceptions taken to a national standard nated ANSI /ASME NQA-11979,8 " Quality Assurance was considered. Consequently, a number of regulatory Program Requirements for Nuclear Power Plants," by positions that were intended as clarifications to provi-ANSI on July 24, 1979. Three addenda to ANSI /ASME sions of the standard were reconsidered and deleted NQA-l.1979 were developed by the American Society from the regulatory position. The guide now retains of Mechanical Engineers. These addenda, contained in positions in only those areas in which the staff believes ANSI /ASME NQA la-1981, NQA-lb-1981, and NQA-le- additional guidance is necessary. Retaining these positions 1982, were issued by ANSI on April 30,1981, January also attempts to avoid building in more differences 31, 1982, and December 31, 1982, respectively, follow- among facilities than already exist. The safety advantage ing approval by the Main Committee of the ASME of these positions will be to encourage greater stan-Committee on Nuclear Quality Assurance. On July I, dardization of quality assurance practices. Although the 1983, ANSI /ASME NQA-11983 was issued. It incorpor- standard contains general provisions covering the subjects ated ANSI /ASME NQA-t 1979 and the NQA la-1981, addressed in the regulatory positions, it does not pro-NQA lb-1981, and NQA-Ic 1982 Addenda into the vide detailed guidance for implementing its general 1983 edition without changing any of the previous requirements. Without these positions, detailed case-by-requirements, supplements, or appendices described in case reviews will be necessary in the licensing review ANSI /ASME NQA-11979 and addenda. On December 31, process, and the likelihood of unnecessary differences 1983, after approval by the Main Committee of the between facilities is increased, l ASME Committee on Nuclear Quahty Assurance, the ANSI /ASME NQA la-1983 Addenda were issued. They Although ANSI /ASME NQA t 1983 provides require-clarified previous sections of ANSI /ASME NQA I 1983. ments and guidance for the establishment and execution l The standard notes that addenda will be published up of quality assurance programs during the design, con-to the publication date of the next edition of the struction, operation, and deco.nmissioning of nuclear l standard. The NRC staff will evaluate addenda and facilities, this Revision 3 to Regulatory Guide 1.28, with subsequent editions of NQA 1 after their issuance to supplemental provisions, addresses only those portions of determine whether a revision to this guide would be ANSI /ASME NQA 11983 applicable to the design and appropriate, construction phases of nuclear power plants. Updated guidance for complying with the Commission's regula- l ANSI /ASME NQA-l.1983 has been organized into tions with regard to quality assurance program require- l three main sections: (1) Basic Requirements, (2) Supple- ments for the operations phase of nuclear power plants '

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will be provic'ed in Regulatory Guide 1.33, Revision 3, execution of quahty assurance programs during the

" Quality Assurance Program Requirements (Operation)," design and construction phases of nuclear power plants which is presently undergoing NRC staff review and is are acceptable to the NRC staff and provide an adeouate expected to endorse, with supplemental provisions, ANSI / basis for complying with the pertinent quality assurance ANS-3.2-198 2,2 " Administrative Controls and Quality requir<ments of Appendix B to 10 CFR Part 50, subject Assurance for the Operational Phase of Nuclear Power to the additions and modifications to ANSI /ASME Plants." NQA 11983 and the ANSl/ASME NQA-la-1983 Addenda identified below.

Regulatory Guide 1.8, " Personnel Selection and Training," provides guidance on personnel selection and I. QUALIFICATION OF INSPECTION AND TEST training, including the qualifications of certain operators, PERSONNEL technicians, and maintenance personnel who may perform inspections and tests during preoperational, startup, and Appendix 2A-1, "Nonmandatory Guidance on the operational testing. The requirements of Supplement Quahfications of Inspection and Test Personnel," pro-25-1 and recommendations of Appendix 2A-1 in NQA-1 vides guidance on the qualifications of inspection and also provide guidance on personnel quahfications. test personnel. The provisions of Appendix 2A-1 (or Personnel performing inspection and testing that are acceptable alternatives) should be met as part of Supple-qualified to the guidance contained in Regulatory Guide ment 2S-1, " Supplementary Requirements for the Quali-3 1.8 need not be quahfied in accordance with the fication of Inspection and Test Personnel" requirements of NQA-1. It is not the intent that such personnel be qualified in accordance with both Regu- 2. QUALITY ASSURANCE RECORDS latory Guide 1.8 and NQA-1.

Section 2.8, " Retention of Records," of Supplement in the development of Regulatory Position 2, "Quahty 17S-1, " Supplementary Requirements for Quahty Assur-Assurance Records," Section 3 of Appendix 17A 1 was ance Records," states that the retention penod for tsed in the preparation of Table 1 in accordance with nonpermanent records is required to be established the requirements for records classification defined in in writing. Programmatic nonpermanent records

• should paragraph 2.7 of Supplement 17S 1. Although Table I be retained for at least 3 years and product nonperma-provides a list of nonpermanent and Efetime records and nent records5 should be retained for at least 10 years their respective retention times, the emphasis should be or the hfe of the item if less than 10 years. For programmatic nonpermanent records, the retention O placed on the quahty of the productofperiod records generated.

rather shouldthan the to begin upon completion be considered the activity. For product nonpermanent records if an apphcant or licensee indicates to the NRC generated before commercial operation begins, the that it will conform to the recommendations of this retention period should be considered to begin upon regulatory guide and it does not qualify its wilungness completion of delivery. In addition, product and ta conform, it has agreed to comply with the require- programmatic nonpermanent records should be retained

, ments of ANSI /ASME NQA-I 1983 and the ANSI /ASME at least until the date of issuance of the full-power NQA-la 1983 Addenda, as supplemented or modified by operating license of the unit. Table I provides a hst of the regulatory positions in this guide. nonpermanent and lifetime records and their respective retention times. Although Table I is intended to be a An applicant or licensee that has committed itself to comprehensive hst, it is the responsibihty of the owner the recommendations of this regulatory guide is respon- to assure itself, in accordance with Criterion 17 of Cble for ensuring that the requirements of ANSI /ASME Appendix B to 10 CFR Part 50, that sufficient records NQA I 1983 and the ANSI /ASME NQA-la 1983 Addenda, are maintained to furnish evidence of activities affecting as supplemented or modifico by the regulatory positions quahty. It should be recognized that the nomenclature cf this guide, are met by its suppliers to the extent of these records may vary. For records not hsted in necessary. Table 1, the type most nearly describing the record in question should be followed with respect to its reten-C. REGULATORY POSITION tion period.

The basic and supplementary requirements that are 4 Pr grammatic nonpermanent records are those docu ments included in ANSI /ASME NQA-I-1983 and the ANSI / that were used to prescribe activitaes affecting quataty but that ASME NQA-la-1983 Addenda for the establishment and are not considered permanent records. such records include docu.

ments prescribing the planning, executson, and auditing of activnties affecting quably. Records such as audit checklists, audit results, and actual examinations used to quahfy inspection and test personnel 2 are included in this category.

Copies may be obtained from the American Nuclear Society,

$$5 North Kensington Avenue, La Grange Park,11hnois 60s2s. S Product nonpermanent records document that specific struc-3 tures, systems, and components of a nuclear power plant have been in response to Section 3o6 of Public law 97-425, the lessons designed and constructed in accordance with appucable require-C learned from the Three Mile Island accident, pubuc comments, ments but are such that it is not necessary to retain them as hfetime I and addit 6onal staff review, a third Proposed Revtsion 2 to Retu- records. These records include design venfication data, receiving i latory Guide 1.8 entitled "Quahfication and Training of Personnel records, cabbration tecords. maintenance records, inspection records, '

for Nuclear Power Plants" was issued for pubbe comment in radiosrephs not associated with inservice inspection, and test January 1985 with the identification number Task OL 403-5. records that are not otherwise designated as ufetime records.

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3. AUDITS

2. The applicant or licensee should perform or Section 2, arrange for annual evaluations of suppliers. This evalua.

"Schedulint." of Supplement 18S1,

" Supplementary Requirements for Audits," requires tion should be documented and should take into account, where applicable, (1) review of supplier-audits to be scheduled in a manner that provides coverage and coordination with ongoing quality assur- furnished documents and records such as certificates of conformance, nonconformance notices, and corrective ance program activities. The following guidelines are considered acceptable for scheduling audits:

actions; (2) results of previous source verifications, audits, and receiving inspections;(3) operating experience of identical or similar products furnished by the same 3.1 Internal Audits supplier; and (4) results of audits from other sources, e.g., customer, ASME, or NRC audits.

Applicable elements of an organization's quality assursnce program should be audited at least once each

3. If more than one purchner buys from a single year or at least once during the life of the activity, supplier, a purchaser may either perform or arrange for whichever is shorter. In determining the scope of the an audit of the supplier on behalf of itself and other audit, an evaluation of the activity being audited may purchasers to reduce the number of external audits of be useful The evaluation may include results of the supplier. The scope of this audit should satisfy the previous quality assurance program audits and the results needs of all of the purchasers, and the audit report of audits from other sources, including the nature and should be distributed to all the purchasers for whom frequency of identified deficiencies and any significant the audit was conducted. Nevertheless, each of the changes in personnel, organization, or quahty assurance purchasers relying on the results of an audit performed program.

on behalf of several purchasers remains individually responsible for the adequacy of the audit.

3.2 External Audits D. IMPLEMENTATION After the award of a contract, the applicant or licensee may determine, based on the evaluation con-The methods described in this revision (through ducted in accordance with Section 5.1 of Appendix 4A-1, that external audits are not necessary for procur- endorsement of ANSI /ASME NQA-1 1983 and the ANSI /ASME NQA-la-1983 Addenda) for complying with ing items that are (1) relatively simple and standard in the provisions of Appendix B to If1 CFR Part 50 with design, manufacturing, and testing and (2) adaptable to regard to the establishment and implementation of the standard or automated inspections or tests of the end requisite quality assurance program are considered to be product to venfy quality characteristics after delivery, generally equivalent, from a programmatic standpoint, to the methods described in Revision 2 to Regulatory For other procurement actions not covered by the above exceptions, audits should be conducted as Guide 1.28 and Regulatory Guides 1.58, 1.64, 1.74, described below.

1.88,1.123,1.144, and 1.146 (through endorsement of ANSI /ASME N45.2 and seven programmatic ANSI /

ASME N45.2 series standards).

1. The applicant or heensee should either audit its supplier's quality assurance program on a triennial basis or arrange for such audit. In either case, the audit Applicants and licensees that have committed to should be implemented in accordance with Supplement ANSI /ASME N45.2 and the appropriate ANSI N45.2-185-1 of ANSI /ASME NQA-l.1983. The triennial period series standards as addressed in the applicable regula-begins when an audit is performed. An audit may be tory guides may continue to follow ANSI /ASME N45.2 performed when the supplier has completed sufficient and the appropriate ANSI /ASSIE N45.2-series standards work to demonstrate that its organization is implement- instead of ANSI /ASME NQA-I-1983. Applicants and ing a quality assurance program that has the required licensees may commit to follow either the ANSI /ASME scope for purchases placed during the triennial period. If a subsequent contract or a contract modification signif- N45.2-series standards or the ANSI /ASME NQA t 1983 standard but not a combination of the two.

icantly enlarges the scope of or changes the methods or controls for activities performed by the same supplier, an audit of the modified requirements should be con-ducted, thus starting a new triennial period. if the Because ANSI /ASME NQA t-1983 consolidates ANSI /

ASME N45.2 and the seven programmatic ANSI /ASME supplier is tmplementing the same quality assurance N45.2-series standards, these standards have been replaced program for other customers that is proposed for use on with ANSI /ASME NQA-l.1983. Consequently, except in the auditing party's contract, the pre-award survey may those cases in which an applicant or licensee proposes an serve as the first1 triennial audit if conducted in accor- acceptable alternative method for complying with specified dance with the requirements of ANSI /ASME NQA 1- portions of the Commission's regulations, the method 1983. Therefore, when such pre award surveys are employed as the first triennial audits, they should described in this revision will be used in the evaluation 3 of all new (1) construction permit applications,(2) standard '

satisfy the same audit elements and criteria as those used on other triennial audits.

design approvals that can be referer.ced in construction Ml 1 permit applications, and (3) licenses to manufacture.

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TABLE 1 I Retention Times for Lifetime end honpermanent Records

%, 4 Nonpermanent' Record Type Lifetime 3 yr- 10 yr l 1. Design Records Applicable codes and standards used in design X Design drawings X Design calculations and record of checks X Approved design change requests X Design deviations and nonconformances X Design reports X Design verification data X Design specifications and amendments X Safety analysis report X

~

Certified stress reports for code items X System descriptions X System process and instrumentation diagrams X i

Technical analysis, evaluations, and reports X Master chsnge record X Reliability analysis, evaluation, and reports X Equipment qualification documentation X Design review reports X Design procedures and manuals X Design control procedures X Reports of engineering surveillance of field activity X

2. Procurement Records Procurement specification X Purchase order (unpriced) including amendments X Procurement procedures X

.. Purchaser's pre-award quality assurance survey X Receiving records X

Supplier's quality assurance program manual- X Source surveillance data plans, audit and surveillance reports X

3. Manufacturirg Records i

Applicable code data reports X

As-built drawings and records X 1 Certificate of compliance X Eddy-current examination final results X Electrical control verification test results X i Ferrite test results - X

, Heat treatment records X Liquid penetrant examination final results X 1 location of weld filler material X i Magnetic particle examination final results X MWor defect repair records X Material properties records X Nonconformance reports X Performance test procedure and results records X Pipe and fitting location report X

,C Pressure test results (hydrostatic or pneumatic)

Radiograph review records X

X l Ultrasonic examination final results X i )

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TABLE 1 (Continued) ~

Nonpermanent

• Record Type Lifetime , 3 yr 10 yr

3. Manufacturing Records (Continued)

Welding procedures X Radiographs not required by ASME Section XI X Certificate of inspection and test personnel qualification X Cleaning procedures X Eddy-current examination procedurc X Ferrite test procedure X Forming and bending procedure qualifications X Heat treatment procedures -X 1101 bending procedure X Inspection and test instrumentation and tooling calibration records (after last calibration) X 1.iquid penetrant examination procedure X Magnetic particle examination procedure X Packaging, receiving, storage procedures X Product equipment calibration procedure X QA manuals, procedures, and instructions X Radiographic procedures X Ultrasonic examination procedures X Welding materials control procedures X Welding procedure qualifications and data reports X Work processing and sequencing documents X Product equipment calibration records (after last calibration) X

4. Installation Construction Records 4.1 Receiving and Storage Nonconformance reports X Inspection reports for stored items X

. Receipt inspection reports on items X Receiving, storage, and inspection procedures X Storage inventory and issuance records X Vendor quality assurance releases X 4.2 Civil Checkoff sheets for tendon installation X Concrete cylinder test reports and charts X Concrete design mix reports X Concrete placement records X Inspection reports for channel pressure tests X Material property reports on containment liner and accessories X Material property reports on metal containment shell and accessories X Material property reports on reinforcing steel X Material property reports on reinforcing steel splice sleeve material X Material property reports on steel embedments in concrete X Material property reports on structural steel and bolting X Material property reports on tendon fabrication material X Pile dnve los X Pile loading test reports X Procedure for containment vezel pressure proof test and s leak rate tests and results X 1.28 6

e > e TABLE 1 (Continued)

Nonpermanent' Record Type Lifetime 3 yr 10 yr 4.2 Civil (Continued)

Reports for periodic tendon inspection X Reports of high-strength bolt torque testing X Soil compaction test reports X Aggregate test reports X Batch plant operation reports X Cement grab sample reports X Material property reports on steel piling X Mix water chemical analysis X Releases to place concrete X Slump test results X User's tensile test reports on reinforcing steel X User's tensile test reports on reinforcing steel splices X 4.3 Welding Ferrite test results X Heat treatment records X Liquid penetrant test final resul's X Material property records X Magnetic particle test final r.sults X Major weld repair procedule and results X Radiograph review records and final results X Ultrasonic test final results X q

Weld location diagrams X Weld procedures X Welding filler metal material reports X Ferrite test procedures X Heat treatment procedures X

. Liquid penetrant test procedures X

. Magnetic particle test procedures X Radiographic test procedures X

'; Ultrasonic test procedures X Welding materials control procedures X Welding personnel qualifications X

, Weld fitup reports X Weld procedure qualifications and results X

4.4 Mechanical Cleaning procedures and results X Installed lifting and handling equipment procedures, inspection, and test data X Lubrication procedures X Material properties records X Pipe and fitting location reports X Pipe hanger and restraint data X

' Safety valve response test procedures X l Code data reports X Pressure test results (hydrostatic or pneumatic) X Chemical composition user's test (grab semples) for thermal insulation X Chemical tests of water used for mixing insulation cement X Data sheets or logs on equipment installation, inspection, and alignment X 1.28 7

e o e TABLE 1 (Continued) t Nonpermanent * .

Recoed Type Lifetime 3 yr 10 yr 4.4 Mechanical (Continued)

Documentation of system checkoffs (logs or data sheets) X Material property test reports for thermalinsulation X Safety valve response test results X i Cleaning procedures X l Construction hiting and handling equipment test procedures X Erection procedures for mechanical components X Hydrotest procedures X 4.5 Electrical and Instrumentation and Control Cable pulling tension data X Cable separation data X Cable terminating procedures X Certified cable test reports X Relay test procedures and test results X Voltage breakdown test results on liquid insulation X Cable pulling procedures X Cable separation checklists X Instrument calibration results (after last calibration) X Documentation of testing performed after installation and prior to conditional acceptance of systems X Field workmanship checklist or equivalent logs X Reports of preinstallation tests X 4.6 General As built drawings and records X Finalinspection reports and releases X Nonconformance reports X Specifications and drawings X Index system to record file X Quality assurance and quality control manuals X Fire protection reports X Secunty plan procedures and activities X Emergency plan, procedures, and activities X Evaluation of results of reportable safety concerns as required by regulations X Calibration reports for measuring and test equipment and instruments (after last calibration) X Calibration procedures for measuring and test equipment and instruments X Certificate ofinspection and test personnel qualification X Field audit reports X Field quality assurance manuals X Quality assurance system audit reports and related correspondence X Special tool calibration records (after last calibration) X

5. 7. - .- _ c'z: and Staetup Test Recoeds Final system adjustment data X Initial plant loading data X Plant load ramp change data X Plant load step change data X 1.28 8

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TABLE 1 (Continued)

Nonpermanent

• Record Type Lifetime 3 yr 10 yr

5. Preoperational and Startup Test Records (Continued)

Preoperational test procedures and results X Reactor protection system tests and results X Startup test procedures and results X Inservice inspection reports X Records of reactor tests and experiments X Records and logs of maintenance activities, inspections, repair, and replacement of principalitems of structures, systems, and components X Automatic emergency power source transfer procedures and results X Initial heatup, hot functional, and cooldown procedures and results X Initial reactor criticality test procedures and results X Instrument AC system and inverter test procedures and reports X Main and auxiliary power transformer test procedures and results X Offsite power source energizing procedures and test reports X Onsite emergency power source energizing procedure and test reports X Primary and secondary auxiliary power test procedures and results X Startup logs X Station battery and DC power distribution test procedures and reports X Water chemistry report X Records of reviews performed for changes made to procedures or equipment or reviews of tests and experiments X Startup problems and resolutions X Flushing results X Power transmission substation test procedures and results X Surveillance activities, inspections, and calibrations required by the technical specifications records X System lubricating oil flushing procedures X

. Flushing procedures X Pressure test procedures X Periodic checks, inspections, and calibrations performed to verify that surveillance requirements are being met -

X 4 ' Table I as to be used in conknction with Regulatory Poaltion C.2. dich states that sonpermanent records should be retained at least matG the date of knu ance of the fun-power operstang license of the unit.

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REGULATORY ANALYSIS

1. STATEMENT OF THE PROBLEM on Revision 2 of Regulatory Guide 1.28 (which in essence means living with ANSI /ASME N45.2 1977 Appendix B to 10 CFR Part 50, " Quality Assurance and the seven daughter standards) or' develop its own Criteria for Nuclear Power Plants and Fuel Reproces- guidance or standard to achieve a corsolidated docu-sing Plants," sets forth the quahty assurance require- ment and minimize redundancy, ments for the design, construction, and operation of those structures, systems, and components that prevent 2. OBJECTIVES or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety Proposed Revision 3 to Regulatory Guide 1.28 cf the public. endorsing ANSI /ASME NQA-1-1983 focuses on the following three objectives:

Current guidance on controls the NRC staff con-siders acceptable for complytng with Appendix B to 1. Endorse the consolidation of ANSI /ASME N45.2 10 CFR Part 50 concerning programmatic quality and the seven ANSI /ASME N45.2-series standards into assurance requirements durmg design and construction one document, thus eliminating certain redundancies is provided in a number of regulatory guides that and certain activities.

_ endorse the standard ANSI /ASME N45.2-1977,

" Quality Assurance Program Requirements for Nuclear 2. Consolidate the eight applicable NRC regulatory Facilities," and seven N45.2 series standards that cover guides endorsing the above ANSI /ASME standards into specific quality assurance topics. A new standard, one document.

ANSI /ASME NQA-1-1979, approved by the American National Standards Institute on July 24,1979, con- 3. Reflect current NRC guidance, from a program-consobdates ANSI /ASME N45.2-1977 and these seven matic standpoint, concerning quality assurance during N45.2-series standards. The intent of ANSI /ASME design and construction of nuclear power plants and NOA-1 1979 was to consolidate the programmatic fuel reprocessing facilities.

standards to avoid redundancy without changing their intent. ANSI /ASME NQA t-1979 is a second genera- In developing Revision 3 to Regulatory Guide 1.28 tion standard in which industry experience is reflected (through endorsement of ANSI /ASME NQA-1-1983), it J in changing certam controls and also ehminating certain was the intent that Revision 3 would be equivalent activities considered to be ineffective in enhancing to the methods described by Revision 2 to Regulatory quahty or the overall effectiveness of the program. Guide 1.28 and Regulatory Guides 1.58, 1.64, 1.74, ANSI /ASME NQA t-1979 was developed through a 1.88, 1.123, 1.144, and 1.146 (through endorsement consensus agreed to by the American National Stan- of ANSI /ASME N45.2 and the programmatic N45.2-series dards Institute. On July 1,1983, NQA 1-1979 and the standards). In order to achieve this equivalence, parts

,' of the "nonmandatory guidance" of ANSI /ASME NQA-la 1981, NQA-lb-1981, and NQA-Ic-1982 Addenda were incorporated into NQA-1-1983 without NQA-11983 that were previously requirements in the changing any of the requirements, supplements, or ANSI /ASME N45.2-series standards will be treated the cppendices described in ANSI /ASME NQA-11979. same as requirements of ANSI /ASME NQA-I 1983, Le., a commitment to follow Regulatory Guide 1.28, As encouraged by the Office of Management and Revision 3, without exceptions will be a commitment Budget (OMB) Circular No. A-119, " Federal Participa- te follow the requirements of ANSI /ASME NQA-I-tion in the Development and Use of Voluntary Stan- 1963 and the endorsed "nonmandatory guidance" of dards," which was published as a final rule in the the standard. In addition, some of the regulatory Federal Register November 1,1982 (47 FR 49496), positions related to the ANSI /ASME N45.2-series several NRC representatives participated in the develop- standards were retained in order to achieve equivalence ment of ANSI /ASME NQA I-1983. Since ANSI /ASME and provide consistency in the quality assurance NQA-t-1983 represents a consolidation of the seven program review process. The guide does indicate that it programmatic N45.2 series standards, these standards describes a method acceptable to the NRC staff for along with ANSI /ASME N45.2-1977 will not be revised complying with the provisions of Appendix B to to incorporate any new positions and will eventually 10 CFR Part 50 with regard to the establishment and be replaced with ANSI /ASME NQA t 1983 and the implementation of a quality assurance program during design and construction of nuclear power plants. This ANSI /ASME NQA la-1983 Addenda. This standard is now published in its final form and the NRC must does represent a change from the guide issued for decide what action to take concerning endorsement of public comment since the present Regulatory Guide 1.28 (Revision 2) references only Appendix B to the standard. The consequences of the NRC staff taking no action in the development or endorsement 10 CFR Part 50, and the references to Appendix A to gf cf the standard would result in the NRC staff having 10 CFR Part 50 have been deleted from the proposed to either ignore the NQA-1 effort and continue to rely Revision 3 to Regulatory Guide 1.28. The NRC staff 1.28 10

< d e is currently examining on a generic basis the subject of regulatory positions endorsing the Basic Requirements, how to implement the quality assurance provisions of Supplements, and selected "nonmandatory guidance" of ANSI /ASME NQA-1-1983. Also, industry already has

( Appendix A to 10 CFR Part 50 for structures, sys-tems, and components important to safety. The subject of application of a quality assurance program for items important to safety but not safety related is being these guides and standards at their sites and shops, and their quality assurance manuals and implementing procedures have either incorporated or referenced them addressed separately by the NRC staff in connection in their documents. Consequently, little or no effort with the January 5,1984, generic letter to all holders would be required of the industry to update should of operating licenses, applicants for operating licenses, NRC include new positions to existing regulatory guides.

and holders of construction permits for power reactors concerning the use of the terms "Important to Safety" Consequences: ASME has initiated action for ANSI and " Safety Related." to withdraw the N45.2-series standards that have been consolidated into NQA-1; thus the N45.2-series stan-

3. ALTERNATIVES dards will be replaced with NQA 1. Also, as stated in OMB Circular No. A-119, policy and administrative The following alternatives were considered with guidance is provided to Federal agencies on usins respect to revising Regulatory Guide 1.28: voluntary standards for procurement and regulatory ,

purposes and participating with private sector organiza1 3.1 Alternative I tions to develop such standards as NQA 1. Finally. the 1982 Winter Addenda of the ASME Boiler and Pres '

Remain with the NRC regulatory guides presently sure Vessel Code has endorsed ANSI /ASME NQA-I-endorsing ANSI /ASME N45.2 and the seven program- 1979 in Sections 111 and XI and it is expected theyi matic daughter standards. Any new or revised quality will ultimately endorse ANSI /ASME NQA-1-1983.

assurance regulatory positions considered sufficiently important to ensure protection of the public health Costs: The format and subject matter of existing and safety could be incorporated through appropriate standards and regulatory guides are readily under-revisions to the applicable quality assurance regulatory standable and usable by the 79 licensees, 63 permit guides. holders, and their approximately. 700 vendors. Because the mWority of the industry has committed to the 3.2 Alternative 2 existing N45.2-series standards and regulatory guides, it would not result in any increased burden or cc:;ts to

Develop a consolidated version of quality assurance the industry to continue using these documents.

, guidance for design and construction in the form of a regulatory guide or NUREG-series document. 4.2 Alternative 2 3

3.3 Alternative 3 Benefits: From a regulatory viewpoint, this effort would represent precise methods for guidance on how Review NQA 1-1983 and revise Regulatory Guide the Commission's quality assurance provisions relating l 1.28 to ensure quality assurance program controls to the design and construction of nuclear power plants equivalent (from a programmatic standpoint) to those must be implemented.

previously endorsed by Revision 2 to Regulatory Guide 1.28. Consequences: This alternative is contrary to the policy expressed in OMB Circular No. A 119 and has

4. CONSEQUENCES, COSTS, AND BENEFITS OF the possibility of bureaucratic delays.

j EACH ALTERNATIVE Costs: The development of an initial draft of a 4.1 Alternative I consolidated quality assurance standard such as ANSI /

ASME NQA 11983 would take the NRC staff about Benefits: Alternative 1 eliminates the need to devote two rnonths. The resolution of both internal NRC staff NRC resources to the review and evaluation of ANSI / and public comments would take about one year for a ASME NQA 11983 in order to formulate NRC positions total cost of approximately 5120,000 (2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> x commensurate with current quality assurance require- $60/ hour).

ments. Licensees, permit holders, vendors, subvendors, l and NRC Headquarters and Regionalinspection personnel 4.3 Alternative 3 are presently familiar with the quality assurance regula-tory guides that endorse the N45.2-series quality assur- Benefits: Since current guidance for quality assur-ance standards. Also, industry presently has the ance programs is contained in a series- of different 4

N45.2-series standards and NRC regulatory guides that standards and corresponding regulatory guides, the endorse these standards in their possession. Industry and proposed action will be of value to the NRC staff i

NRC would not be required to spend considerable time, owing to the consolidation of a large number of effort, or resources to interpret and implement the

^

requirements and recommendations concerning quality 1

1.28 11 3

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a 5 e assurance into a single document consisting of sections seven programmatic ANSI / ASME N45.2-series standards, on basic requirements, supplemental requirements, and these standards will be replaced with ANSI /ASME nonmandatory guidance.

The previous eight quahty assurance standards and NQA-11983. Consequently, except in those cases in which an applicant proposes an acceptable alternative method for complying with specified portions of the

)

quality assurance regulatory guides that endorsed these Commission's regulations, the method described in standards consisted of approximately 85 pages ard the Revision 3 to Regulatory Guide 1.28 will be used in consolidated documents and proposed regulatory guide the evaluation of all new (1) construction permit appli-would consist of approximately 5 pages for a net cations, (2) standard design approvals that can be refer-reduction of about 80 pages. The previous eight regula- enced in construction permit applications, and (3) licenses tory guides endorsing the standards consolidated into to manufacture.

ANSI /ASME NQA 1 1983 consisted of 46 regulatory Consequences: Should members ot de industry positions. The proposed regulatory guide consists of 3 positions for a net reduction of 43 regulatory positions. (utilities, architect / engineers, nuclear steam s pply system suppliers, or vendors) wish to commit to this regula-The proposed action also provides an opportunity tory guide, indoctrination and training programs would to incorporate experience from the use of N45.2 and have to be developed to ensure that the regulatory its daupter standards. Additionally, consolidation of position of Revision 3 to Regulatory Guide 1.28 and design- and construction-phase quality assurance guid- the controls of NQA-1-1983 and how these controls are ance should provide a more effective evaluation of to be implemented are understood. Particular atten-compatibility between ANSI quality assurance require- tion would have to be focused on clarifying the poten-ments and the quality assurance requirements in the tial confusion in interpreting the degree to which the ASME Boiler and Pressure Vessel Code. Basic Requirements and Supplements Sections, which are addressed as mandatory, and the nonmandatory guidance ANSI /ASME NQA-1 1983 represents a consensus in ANSI /ASME NQA-1-1983 are to be implemented.

document on requirements for quality assurance programmatic action. In a letter dated March 10, 1980, Also, present principal contractors and utilities that from Jack E. Vessely, Chairman, ASME Main Committee wish to commit to this guide will have to (1) conduct on Nuclear Quahty Assurance to W. J. Dircks, Executive a detailed comparison of existing quality assurance Director for Operations of the NRC, early endorsement controls and determine what changes are necessary to by the NRC of ANSI /ASME NQA 1-1979 was requested comply with the new regulatory guide and NQA-1, since, according to the letter, many companies are which, as a minimum, will involve changes from the anxious to use the standard. However, some members regulatory guides that endorse N45.2 and its seven of the industry have mdicated reservations regarding daughter standards to Revision 3 to Regulatory Guide the usefulness of this document. 1.28 and ANSI /ASME NQA-1-1983;(2) make the neces-sary changes to their quality assurance manuals and The proposed action establishes an NRC position on detailed implementing procedures; (3) indoctrinate and

- an existing national standard and therefore reduces train the work force on the correct interpretation of the uncertainty as to what the staff considers acceptable in changes and how they are to be implemented;(4) review the area of quality assurance requirements for the their quality assurance programs with the NRC staff to design and construction of nuclear power p; ants. ensure that they are meeting the spirit and intent of the regulatory guide and NQA-1;(5) where necessary, inform The cumulative benefit of the consolidation effort contractors, subcontractors, vendors, and subvendors of will be to eliminate redundant controls md to the changes, including any appropriate indoctrination and incorporate current NRC quality assurance guidance training; and (6) determine the impact on these suppliers tnd practices for design and construction of nuclear relative to additional purchase costs. This may necessitate power plants. the utility having to maintain two sets of quality assur-ance manuals and two sets of implementing procedures The controls described in the regulatory position of (one set meeting the existing regulatory guides and stan-Revision 3 to Regulatory Guide 1.28 and the endorse- dards and the other set meeting ANSI /ASME NOA 1-ment of ANSI /ASME NQA 1-1983 are considered to be 1983). This problem will be compounded because record-generally equivalent, from a programmatic standpoint, to keeping, audits, and NRC inspecticns will have to keep the controls described in Revision 2 to Regulatory in mind which system is being used. Architect / engineers Guide 1.28 and Regulatory Guides 1.58, 1.64, 1.74, or nuclear steam supply system suppliers working with l 1.88, 1.123, 1.144, and 1.14/., which endorse N45.2 present contracts to existing regulatory guides and stan- j and its daughter standards. As a result, applicants or dards and ANSI /ASME NQA-1-1983 would have record- j licensees may commit either to this regulatory guide or keeping and implementation problems similar to the l to Revision 2 of Regulatory Guide 1.28 and the current above. l I

l issues of the regulatory guides that endorse the seven /

daugher standards. However, since ANSI /ASME Costs: For new applicants, committing to Revision NQA-t 1983 consolidates ANSI /ASME N45.2 and the 3 to Regulatory Guide 1.28 may result in lower costs 1.28 12

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e ee than committing to the regulatory guides presently 4.4 Conclusions endorsing N45.2 and the seven programmatic daughter standards. The reason is that some of the quality in consideration of the above three alternatives, the assurance requirements once considered important have NRC staff believes Alternative . 3 will be the ' most

( now been made nonmandatory guidance in ANSI /

ASME NQA-t-1983. Also, the fact that certain require-viable alternative from which to base future quality _

assurance guidance upon meeting the Commission's ments have been reduced or more clearly defined will regulations relative to quality assurance. This conclu-also result in lower costs to a new applicant, e.g., the sion is primarily based upon offering the industry the amount of radiographs to be retained for lifetime has choices of (1) committing to the N45.2-series stand-been reduced. Only radiographs required for inservice ards and appropriate regulatory guides that endorse inspections are to be maintained for lifetime pursuant these standards or (2) comnutting to comply with to ASME Boiler and Pressure Vessel Code require- Revision 3 to Regulatory Guide 1.28 endorsing ANSI /

ments. We regard this practice to be as stringent as or ASME NQA 1 1983. In either case, they have the more stringent than the practice for other nondestruc- flexibility to develop alternatives meeting the Com-tive examination records. Also, the records facility, mission's quality assu*ance regulations, regulatory guides, which previously had to have a four-hour fire rating, and standards.

now may have a two. hour fire rating provided certain provisions are met. 5. IMPACTS ON OTHER REQUIREMENTS Applicants who are presently committed to imple- As discussed earlier in this Regulatory Analysis, the ment the existing NRC quality assurance regulatory primary rationale for the proposed revision to Regulatory guides and ANSI /ASME standards and who elect to Guide 1.28 was to consolidate the programmatic stan-change and use Revision 3 to Regulatory Guide 1.28 dards without changing their intent, to eliminate certain and ANSI /ASME NQA-1-1983 sill benefit somewhat redundancies and certain activities, and to reflect certain from the examples in the above paragraph, but will NRC quality assurance dentrols corridered important by encounter additional costs to offset such benefits. The the staff to provide consistency in the quality assurance additional ' costs will be revising the Safety Analysis program review process. These new positions do not Report (SAR) (or quality assurance topical report), represent significant changes in regulatory practices. The quality . assurance manuals, and implementing proce- staff has evaluated the guidance included in ANSI /ASME dures and retraining personnel to accommodate this NQA-11983 and, coupled with the guidance included in change. In addition, considerable time, effort, and the regulatory position in Revision 3 to Regulatory 4 resources will be expended in maintaining an account-ability of outstanding pt.rchase orders, items, and activities already under way as opposed to new activ-Guide 1.28, finds this is equivalent to the guidance, from a programmatic standpoint, contained in the N45.2 series of documents and the regulatory guides that ities with respect to the appropriate application of the endorsed them. The staff also endorses this consolida-previous commitment and the new commitment to tion effort as an acceptable method of meeting the Revision 3 to Regulatory Guide 1.28. The average requirements of paragraph 50.34(a)(7) and Appendix B

- SAR revision to accommodate ANSI /ASME NQ A to 10 CFR Part 50. Consequently, any impact on 1983 and the revised Regulatory Guide 1.28 would existing NRC requirements should i minimal.

affect about 20 SAR pages and take about 16 staff hours for NRC review and acceptance or approxi- 6. CONSTRAINTS n4ately $960 per plant (16 hours1.851852e-4 days <br />0.00444 hours <br />2.645503e-5 weeks <br />6.088e-6 months <br /> x $60/ hour). It would take about 2 staff months for the average utility to Legal and M Mitional constraints, including issues

(

r eview and revise the quality assurance program and related to 4&r:e bility, were discussed in Section 3,

$ implementing procedures to incorporate the revision for "Alterr&

' ' a cost of approximately $25,600 (40 days x 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> at

$80/ hour). Retraining the plant and corporate staff 7. DECMON sudONALE would cost about $32,000 (400 people x $80/ hour).

Therefore, the total cost for the average plant to change 7.1 NRC

to Regulatory Guide 1.28 and ANSI / ASME NQA 11983 would be about $58,560 ($960 NRC fees, Since current guidance for quality assurance programs

$25,600 procedures review and reymon, and $32,000 is contained irt

• a series of different standards and a for retraining plant and corporate staff). The total cost corresponding regulatory guides, the proposed action will to industry, should they all adopt ANSI /ASME be of value' to the staff owing to the consolidation of a NQA 11983 and Revision 3 to Regulatory Guide 1.28, large number of tequirements and recommendations O could be in ,the range of $30,779,520 (79 licensees, 63 concerning quality assurance into a single document.

K permit holders, and 25 nuclear steam supply ~ system Additionally, consolidation of design- and construction-suppliers and architect / engineers = 167 x $58,560 = phase quality assurance guidance should provide a more

( ,j

$9,779,520 and 700 subcontractors x $30,000} =

i

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$21,000,000).

effective evaluation of compatibility between ANSI quality assurance requirements and the quality assu.ance s

1.28-13

o A e requirements in the ASME Boiler and , Pressure Vessel Addenda) for complying with the provisions of Appen-Code. By taking advantage of previous staff effort in dix B to 10 CFR Part 50 with regard to the estab-conjunction with approval of ANSI /ASME NQA-11983, lishment and implementation of the requisite quality ,

the proposed action estabbshes an NRC position on the assurance program are considered to be generally recently approved standard with minimum impact on equivalent, from a programmatic standpoint, to the the staff. methods described by Revision 2 to . Regulatory Guide 1.28 and Regulatory Guides 1.58, 1.64, 1.74, 1.88, 7.2 Industry 1.123, 1.144, and 1.146 (through endorsement of ANSI /ASME N45.2 and seven programmatic ANSI /

ANSI /ASME NQA-1-1983 represents a consensus docu- ASME N45.2-series standards).

ment on requirements for quality assurance programmatic action agreed to by the American National Standards Applicants and licensees who have committed to Institute. ANSI /ASME N45.2 and the appropriate ANSI N45.2- ,

series standards as addressed in the applicable regu-The proposed action estabhshes an NRC position on latory guides may continue to follow ANSI /ASME an existing national standard and therefore reduces N45.2 and the appropriate ANSI /ASME N45.2-series uncertainty as to what the staff considers acceptable in standards in lieu of ANSI /ASME NQA 1 1983.

the area of quabty assurance requirements for the Applicants or licensees may commit to follow the ,

design and construction of nuclear power plants. ANSI /ASME N45.2-series standards or the ANSI /ASME NOA-1 1983 standard, but not a combination of the 7.3 Public two.

The consohdation of quahty assurance criteria could Since ANSI /ASME NQA-11983 consolidates ANSI /

result in more effective reviews of nuclear power plant ASME N45.2 and the seven programmatic ANSI /ASME quahty assurance programs. N45.2 series standards, these standards will be replaced with ANSI /ASME NQA 1-1983. Consequently, except The consobdation document could also result in in those cases in which an appbcant proposes an improved quahty assurance programs at nuclear power acceptable alternative method for complying with plants and hence increased safety for the pubhc since specified portions of the Commission's regulations, the the standard has ehminated certain activities considered method described in Revision 3 to Regulatory Guide to be ineffective in enhancing the overall quahty or 1.28 will be used in the evaluation of all new (1) effectiveness of the quahty assurance program. The construction permit applications, (2) standard design financial impact on the pubbc will be a slight increase approvals that can be referenced in construction permit in the cost of generating power as a result of any apphcations, and (3) licenses to manufacture.

procedure modifications necessary to comply with this regulatory guide.

8.2 Relationship to Other Existing or Proposed

8. IMPLEMENTATION Requirements 8.1 Schedule for Implementing the Proposed Guidance The proposed Revision 3 to Regulatory Guide 1.28 does not represent an increase in regulatory require-The methods described in Revision 3 to Regulatory ments since it allows present applicants and licensees to Guide 1.28 (through endorsement of ANSI /ASME continue the use of the N45.2-series standards if they NOA I-1983 and the ANSI /ASME NQA-l a-1983 had previously committed to those standards.

s t

1.28-14

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