ML050450589

E-mail RAI for Proposed QAPM, Rev. 9

ML050450589
Person / Time
Site:	Indian Point, Grand Gulf, Pilgrim, Arkansas Nuclear, River Bend, Vermont Yankee, Waterford, FitzPatrick
Issue date:	05/06/2004
From:	Alexion T NRC/NRR/DLPM/LPD4
To:	Millar D Entergy Nuclear Operations
Alexion T W, NRR/DLPM, 415-1326
References
Download: ML050450589 (4)

Text

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Subject:

RAI FOR PROPOSED QAPM, REV. 9 Dana, See the attached.

Tom

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Subject:

RAI FOR PROPOSED QAPM, REV. 9 Creation Date: 5/6/04 10:35AM From: Thomas Alexion Created By: TWA@nrc.gov Recipients Action Date & Time entergy.com Transferred 05/06/04 10:35AM DMILLAR (MILLAR, DANA)

Post Office Delivered Route entergy.com Files Size Date & Time QAPM.RAI 8625 05/06/04 10:17AM MESSAGE 698 05/06/04 10:35AM Options Auto Delete: No Expiration Date: None Notify Recipients: Yes Priority: Standard Reply Requested: No Return Notification: None Concealed

Subject:

No Security: Standard To Be Delivered: Immediate Status Tracking: Delivered & Opened

REQUEST FOR ADDITIONAL INFORMATION PROPOSED CHANGE TO QUALITY ASSURANCE PROGRAM MANUAL, REVISION 9 ENTERGY NORTH AND SOUTH PLANTS

Background

10 CFR, Part 50, Appendix B, Criterion II - Quality Assurance Program, states in part, the following:

The applicant shall regularly review the status and adequacy of the quality assurance program. Management of other organizations participating in the quality assurance program shall regularly review the status and adequacy of that part of the quality assurance program which they are executing.

NUREG-0800, Standard Review Plan (SRP), Chapter 17.1, provides the following acceptance criteria for evaluating the adequacy of this management review requirement as:

A description is provided of how management (above or outside the QA organization) regularly assesses the scope, status, adequacy, and compliance of the QA program to 10 CFR Part 50, Appendix B. These measures should include:

a. Frequent contact with program status through reports, meetings, and/or audits.

b. Performance of an annual assessment preplanned and documented. Corrective action is identified and tracked.

In addition, SRP Chapter 17.3 states the following:

Senior level management is to assess annually the adequacy of the QA program's implementation.

The staff has found the following methods for implementing this requirement to be acceptable in Regulatory Guide 1.28, Revision 3, which endorses N45.2-1977 and NQA-1 -1983:

"The program shall provide for the regular review, by management of organizations participating in the program, of the status and adequacy of that part of the Quality Assurance Program for which they have designated responsibility."

(ANSI/ASME N45.2-1977, Section 2, Paragraph 7)

"Management of those organizations implementing the quality assurance program, or portions thereof, shall regularly assess the adequacy of that part of the program for which they are responsible and shall assure its effective implementation."

(ANSI/ASME NQA-1 -1983, Basic Requirement 2, Paragraph 4)

Licensee's Proposal By letter November 17, 2003, the licensee proposed a change to the Entergy Quality Assurance Program Manual (QAPM), Revision 9 (Accession No. ML033290602).- The revision would eliminate Section A.3.c from their QAPM. Section A.3.c currently states:

"The adequacy of the QAPM's implementation is assessed annually by the manager(s) responsible for quality assurance and reported to the chief executive officer and the associated executive for overall plant nuclear safety."

The licensee's justification provided for deleting management review of their QA program is that this function is duplicated by the independent review function described by Section 4.3 of ANSI N1 8.7-1976, "Administrative Controls and Quality Assurance for the Operational Phase of Nuclear Power Plants." (The licensee does not specifically mention Section 4.3; however, the staff believes that this is the applicable section). This implies that the management review function is redundant to that provided by the independent review program.

Based on its initial review of the licensee's submittal, the staff does not understand how the independent review function, as described in ANSI N1 8.7, satisfies the management review requirement of Criterion II of Appendix B. The independent review function is a safety assessment function, while Appendix B, Criterion II places responsibility for implementation for the QA program with management.

NRC Questions

1. The NRC staff does not understand how the independent review function, which provides independent oversight for the operational program, satisfies the Appendix B, Criterion II, requirement for management review of the status and adequacy of that part of the QA program which they are implementing. Please clarify.

2. The submittal refers to ANSI N18.7, Section 3.4.2, 'Requirements for the Onsite Operating Organization.' This section states that 'An individual or organization unit knowledgeable and experienced in nuclear power plant operational phase activities and quality assurance practices shall be designated and assigned the responsibility to verify that the program is being effectively implemented,' and 'The individual or organizational unit shall report on the effectiveness of the program to the Plant Manager and to other cognizant management as may be designated."

Question - The application doesn't say who the individual is or what organizational unit does this. Is it referring to the independent review function (offsite review committee),

which you refer to in the second to the last paragraph on page 2 of 2? Please clarify who the individual is or what organizational unit does this and how this satisfies the Appendix B, Criterion II, requirement for management review.

3. The submittal also refers to ANSI N1 8.7, Section 4.5, 'Audit Program.' In this context, the submittal states that this section 'addresses audit reports and provides for independent oversight of the audit program."

Question - The audit program satisfies Appendix B, Criterion XVIII, "Audits," but the proposed deletion is a Criterion II, quality assurance requirement. You do not identify what organizational unit provides the "independent oversight of the audit program.'

Please clarify what organizational unit does this and how this satisfies the Appendix B, Criterion II, requirement for management review.