Regulatory Guide 1.28

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Quality Assurance Program Requirements (Design and Construction)
ML13038A083
Person / Time
Issue date: 02/28/1979
From:
NRC/OSD
To:
References
RG-1.028, Rev. 2
Download: ML13038A083 (3)


Revision 2 PR REG" U.S. NUCLEAR REGULATORY COMMISSION February 1979 REGULATORY GUIDE

OFFICE OF STANDARDS DEVELOPMENT

REGULATORY GUIDE 1.28 QUALITY ASSURANCE PROGRAM REQUIREMENTS

(DESIGN AND CONSTRUCTION)

  • ° .-Q .;. ,

A. INTRODUCTION

Standards, of the American National Standards Committee N45 and the full N45 committee and Appendix B, "Quality Assurance Criteria for by Subcommittee N46-2, the full N46 committee, Nuclear Power Plants and Fuel Reprocessing and the N18 committee. It was subsequently Plants," to .10 CFR Part 50, "Domestic Licens- approved and designated N45.2-1977, "Quality ing of. Production and Utilization Facilities," Assurance Program Requirements for Nuclear establishes overall quality assurance require- Facilities," by the American National Standards ments for the design, construction, and opera- Institute on April 7, 1977.1 tion of safety-related structures, systems, and components. This guide describes a method The NRC staff has evaluated the guidelines acceptable to the NRC staff for complying with contained in N45.2-1977 and has identified the Commission's regulations with regard to those that are important to safety. The indica- overall quality assurance program requirements tion of conformance to this regulatory guide in during design and construction of nuclear an application without qualification means that power plants. the requirements of ANSI N45.2-1977 as sup- plemented or modified by the regulatory posi-

  • f The Advisory Committee on Reactor Safe- tion of this guide will be followed.

.1guards has been consulted concerning this guide and has concurred in the regulatory C. REGULATORY POSITION

position.

The overall quality assurance program re-

B. DISCUSSION

quirements for the design and construction phases that are included in ANSI N45.2-1977 Subcommittee N45-2.7 (formerly N45-3.7) of provide an adequate basis for complying with the American National Standards Committee the quality assurance program requirements of N45, Reactor Plants and Their Maintenance, Appendix B to 10 CFR Part 50, as supple- developed a standard designated ANSI N45.2- mented or modified by the following:

1971 that included general requirements for es- tablishing and executing a quality assurance program during the design and construction 1. Section 2, "Quality Assurance Program,"

phases of nuclear power plants. This standard of N45.2-1977 requires, in part, that "A docu- was endorsed by Regulatory Guide 1.28 mented Quality Assurance Program which (Safety Guide 28). To update the requirements complies with the applicable sections and ele- of the standard and to make it applicable to ments of this standard shall be established at other nuclear facilities subject to Appendix B the earliest practical time consistent with the to 10 CFR Part 50, the standard was revised schedule for accomplishing the -activities for by the N45-2.7 work group in cooperation with the nuclear facility." The following information the N46-2 subcommittee. should be used to clarify the requirement of Section 2 of ANSI N45.2-1977.

The revised standard was approved by Sub- committee N45-2, Nuclear Quality Assurance

'Copies may be obtained from the American Society of Me- chanical Engineers, United Engineering Center, 345 East 47th Lines indicate substantive changes from previous issue. Street, New York, N.Y. 10017.

USNRC REGULATORY GUIDES Comments should be sent to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, D.C. 20655, Attention: Docketing and Regulatory Guides are issued to describe and make available to the public Service Branch.

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

sting specific problems or postulated accidents, or to provide guidance to applicants. Regulatory Guides are not substitutes for regulations, and corn- 1. Power Reactors 6. Products pliance with them is not required. Methods and solutions different from those 2. Research and Test Reactors 7. Transportation set out in the guides will be acceptable if they provide a basis for the findings 3. Fuels and Materials Facilities 8. Occupational Health requisite to the issuance or continuance of a permit or license by the 4. Environmental and Siting 9. Antitrust and Financial Review Commission. 5. Materials and Plant Protection 10. General Requests for single copies of issued guides 1which may be reproduced) or for Comments and suggestions for improvements in these guides are encouraged at placement on an automatic distribution list for single copies of future guides all times, and guides will be revised, as appropriate, to accommodate comments in specific divisions should be made in writing to the U.S. Nuclear Regulatory and to reflect new information or experience. This guide was revised as a result Commission. Washington, D.C. 20555, Attention: Director, Division of of substantive comments received from the pub!ic and additional staff review. Technical Information and Document Control.

-1 -

For those safety-related activities that are patible with their requirements. However, this initiated by the applicant prior to submitting standard does not apply to the activities its application for a construction permit, the covered by Section III and Section XI of the requirements set forth in ANSI N45.2-1977 and Code." It is important to consider the rela- amplified in the applicable N45.2 series tionship of the quality assurance requirements standards should be in effect prior to included in Section III of the Code with those accomplishing the activities. Examples of such included in ANSI N45.2. Code-covered activ- activities that are or may be initiated prior to ities are primarily intended to ensure the submitting the application are: integrity of the pressure boundary of an item.

Section III of the Code does not address activi- a. Activities performed in establishing the ties necessary to ensure functional operability information to be included in the Preliminary of some Code-covered items such as pumps or Safety Analysis Report. valves. Therefore, to ensure the satisfactory performance of activities affecting the func- b. Activities pertaining to preparing de- tional operability of these items, the quality sign and procurement documents that affect assurance program for design and construction safety-related structures, systems, and com- should be extended to these other activities, ponents. and the requirements in N45.2 should be used, as appropriate.

2. The guidelines (indicated by the verb

"should") of ANSI N45.2-1977 contained in the

D. IMPLEMENTATION

following sections have sufficient safety impor- tance to be treated the same as the require- Except in those cases in which the applicant ments (indicated by the verb "shall") of the proposes an acceptable alternative method for standard: complying with the specified portions of the Commission's regulations, the method described a. Section 14, "Handling, Storage, and Ship- herein will be used in the evaluation of applica- ping," second paragraph - The guidelines on tions docketed after October 1979 for:

procedures for critical, sensitive, or perish- able -articles and on use and control of special (1) standard reference system preliminary or handling tools. Type-2 final design approvals (PDA orFDA-2),

b. Section 19, "Audits," third paragraph - (2) licenses to manufacture, and The guideline in the first sentence of the para- graph that indicates the three general areas of (3) construction permits (CP), except those evaluation to include in an audit. portions that:

(a) reference an approved standard ref-

3. In Section 19, "Audits," the second and erence system preliminary or final design (PDA

fifth paragraphs include general guidelines for or FDA) or applications for such approval, audit scheduling. Audit scheduling, including the guidelines of these paragraphs, is ad- (b) reference an approved standard du- dressed separately an'd in more detail in Regu- plicate plant preliminary or final design (PDDA

latory Guide 1.144, "Auditing of Quality As- or FDDA),

surance Programs for Nuclear Power Plants."

(c) reference parts of a base plant de-

4. The Foreword and Section 1.2, "Applica- sign qualified and approved for replication, bility," of ANSI N45.2-1977 state: "The ASME

Boiler and Pressure Vessel Code, as well as (d) reference a plant design approved or other American National Standards, have been being reviewed for approval for manufacture considered in the development of this stand- under a Manufacturing License or applications ard, and this standard is intended to be corn- for such approval.

1.28-2

UNITED STATES

NUCLEAR REGULATORY COMMISSION

WASHINGTON, D. C,- 20555 POSTAGE AND FEESPAID

UNITEDSTATESNUCLEAR

OFFICIAL BUSINESS REGULATORYCOMMISSION

PENALTY FOR PRIVATE USE,$300

120555011962 1 SN

US NRC

OFFICE OF THE COMMISSIONERS

DR JOSEPH HENDRIE

CHAIRMAN

H 1.149 WASHINGTON DC 20555