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Regulatory Guide 1.33 - Quality Assurance Program Requirements (Operation)

Revision 2
February 1978

Availability Notice

A. Introduction

Appendix B, ''Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," to 10 CER Part 50, "Licensing of Production and Utilization Facilities," establishes quality assurance requirements for the operation of nuclear lower plant safety-related structures, Systems, and components. This regulatory guide describes a method acceptable to the NRC staff for complying with the Commission's regulations with regard to overall quality assurance program requirements for the operation phase of nuclear power plants. The Advisory Committee on Reactor Safeguards has been consulted concerning this guide and has concurred in the regulatory position.

B. Discussion

Subcommittee ANS-3, Reactor Operations, of the American Nuclear Society Standards Committee developed ANSI N18.7-l972, which contained criteria for administrative controls for nuclear power plants during operation. This standard, along with ANSI N45.2. 1971, ''Quality Assurance Program Requirements for Nuclear Power Plants," was endorsed by Regulatory Guide 1.33. The dual endorsement was necessary in order for the guidance contained in the regulatory guide to be consistent with the requirements of Appendix B to 10 CFR Part 50; however, this dual endorsement caused some confusion among users. To clarify this situation, ANSI NI 8.7-1972 was revised so that a single standard would define the general quality assurance program "requirements" for the operation phase. This revised standard was approved by the American National Standards Committee N IS, Nuclear Design Criteria It was subsequently approved and designated N18.7-1976/ANS-3.2, "Administrative Controls and Quality Assurance for the Operational Phase of Nuclear Power Plants,"⁽¹⁾ by the American National Standards Institute on February 19, 1976.

There had been some uncertainty with regard to the NRC staff's position when a regulatory guide endorses, as an acceptable method, the "guidelines" as well as the "requirements" included in a standard. The NRC staff has evaluated the guidelines contained in N18.7-1976/ANS-3.2 with respect to importance to safety. Revision I of this regulatory guide clarified the NRC staff's position on the "requirements" and "guidelines" included in ANSI N 18.7- 1976/ANS- 3.2. Where conformance to the recommendations of this regulatory guide is indicated in an application without further qualification. this indicates the applicant will comply with the ''requirements'' of ANSI N18.7- 1976/AN5-3.2, as supplemented or modified by the regulatory position of this guide.

Section I, "Scope," of ANSI N18.7-1976/ANS-3.2 states that this standard contains criteria for administrative controls and quality assurance for nuclear power plants during the operational phase of plant life and that (his phase is generally considered to commence with initial fuel loading, except forcer-lain preoperational activities. In this regard, a separate regulatory guide addressing the quality assurance program for the preoperational phase will be issued. Other regulatory guides may be issued or this regulatory guide may be revised, if necessary, to amplify the general requirernents contained in this standard.

Appendix A to this guide has been further revised as a result of additional comments received on the guide and additional staff review.

C. Regulatory Position

The overall quality assurance program requirements (or the operation phase that are included in ANSI NIS .7-I 976/ANS-3.2 are acceptable to the NRC staff and provide an adequate basis (or complying with the quality assurance program requirements or Appendix B to 10 CFR Part 50, subject to the following:

1. ANSI N18.7-l976/ANS-3.2 requires the preparation of many procedures to carry out an effective quality assurance program. Appendix A, "Typical Procedures for Pressurized Water Reactors and Boiling Water Reactors," to this regulatory guide should be used as guidance to ensure minimum procedural coverage for plant operating activities, including related maintenance activities. Appendix A lists typical safety-related activities that should be covered by written procedures but does not provide a complete listing of needed procedures. Many other activities carried out during the operation phase of a nuclear power plant require written procedures not included in Appendix A. Appendix A may also contain procedures that are not applicable to an applicant because or the configuration of the nuclear power plant. The procedures listed in Appendix A may be combined, separated, or deleted to conform to the applicant's procedures plan.

2. Throughout ANSI N1S.7-1976/ANS-3.2, other documents required to be included as a part of this standard are identified at the point of reference. The specific acceptability of these standards listed in ANSI N1S.7-I976/ANS-3.2 has been addressed in the latest revision of the following regulatory guides:

ANSI Standard	Regulatory Guide
N45.2	1.28
NN45.2.1	1.37
N45.2.2	1.38
N45.2.3	1.39
N45.2.4	1.30
N45.2.5	1.94
N45.2.6	1.58
N45.2.8	1.116
N45.2.9	1.88
N45.2.10	1.74
N45.2.11	1.64
N45.2.l3	1.123
N1S.1	1.8
N1S.17	1.17
N101.4	1.54

Note: N45.2, 12 is discussed in NRC documents WASH-1283, "Guidance on Quality Assurance Requirements During Design and Procurement Phase of Nuclear Power Plants," (Grey Book) and WASH-1309, "Guidance on Quality Assurance Requirements During the Construction Phase of Nuclear Power Plants," (Green Book) and will be endorsed by a regulatory guide upon its approval as an ANSI standard.

3.  Section 4,3.4, "Subjects Requiring Independent Review," Item (3) states, in part, that changes to the technical specifications or license amendments related to nuclear safety are required to be reviewed by the independent review body prior to implementation. It should be noted that proposed changes to technical specifications or license amendments should be reviewed by the independent review body prior to their submittal to the Commission for approval.

4. Section 4.5, "Audit Program," of ANSI N 18.7- 1976/ANS-3.2 states that audits of selected aspects of operational phase activities shall be per formed with a frequency commensurate with their safety significance and in such a manner as to ensure that an audit of all safety-related functions is completed within a period of 2 years. In amplification of this requirement, the following program elements should be audited at the indicated frequencies:

1. The results of actions taken to connect deficiencies that affect nuclear safety and occur in facility equipment, structures, systems, or method of operation-at least once per 6 months,

2. The conformance of facility operation to provisions contained within the technical specifications and applicable license conditions-at least once per 12 months.

3. The performance, training, and qualifications of the facility staff-at least once per 12 months.

5. The guidelines (indicated by the verb "should") of ANSI N18.7-1976/ANS-3.2 contained in the following sections have sufficient safety importance to be treated the same as the requirements (indicated by the verb "shall") of the standard:

1. Section 4.4-The guidelines concerning review activities of the onsite operating organization, except the guideline that refers to screening subjects of potential concern.

2. Section 5.2.3-The guideline concerning review and updating of standing orders.

3. Section 5.2.4-The guideline concerning review, updating, and cancellation of special orders.

4. Section 5.2.7. I-The guidelines that address adequate design and testing of replacement parts

5. Section 5.2.13.14-The guideline concerning special handling tools and equipment.

6. Section 5.2. 19(2) The guideline for checking plant operating procedures during the testing program,

7. Section 5.2.19.l- The guidelines for preoperational tests, except the guideline that refers to a run-in period for equipment. In addition to these guidelines, the prerequisite steps for each equipment lest should be completed prior to the commencement of the preoperational test.

8. Section 5.3.2-The guidelines that describe the content (excluding format) of procedures, except for the guidelines that address (1) a separate statement of applicability in Section 5.3.2(2), (2) inclusion of references in procedures, as applicable, in Section 5.3.2(3), and (3) inclusion of quantitative control guides in Section 5.3.2(6).

9. Section 5.3.9-The guideline concerning emergency procedures requiring prompt implementation of immediate operator actions when required to prevent or mitigate the consequences of a serious condition.

10. Section 5.3.9.1-The guidelines that describe the content (excluding formal) for: the title in Section 5.3.9.1(1); the inclusion of symptoms to aid in identification in Section 5.3.9.1(2); automatic actions in Section 5.3.9.1(3); immediate operator action, excluding those guidelines contained in the examples, in Section 5.3.9.1(4); and subsequent operator actions in Section 5.3.9.1(5).

D. Implementation

The purpose of this section is to provide information to applicants and licensees regarding the NRC staff's plans for using this regulatory guide.

This guide reflects current NRC practice. Therefore, except in those cases in which the applicant proposes an acceptable alternative method for complying with the specified portions of the Commission's regulations, the method described herein is being and will continue to be used in the evaluation of submittals for operating license applications until this guide is revised as a result of suggestions from the public or additional staff review.

Appendix A

Typical Procedures For Pressurized Water Reactors And Boiling Water Reactors

The following are typical safety-related activities that should be covered by written procedures. This appendix is not intended as an inclusive listing of all needed procedures since many other activities carried out during the operation phase of nuclear power plants should be covered by procedures not included in this list.

Footnotes

1. Copies may be obtained from American Nuclear Society, 555 North Kensington Avenue, La Grange Park, Illinois 60525.

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