ML20138M299

Requests Addl Info Re Quality Assurance Program Amend 21 for Further Clarification

ML20138M299
Person / Time
Site:	McGuire, Mcguire
Issue date:	02/21/1997
From:	Berkow H NRC (Affiliation Not Assigned)
To:	Tuckman M DUKE POWER CO.
References
TAC-M96624, TAC-M96625, TAC-M96626, TAC-M96627, TAC-M96628, TAC-M96629, TAC-M96630, NUDOCS 9702250322
Download: ML20138M299 (6)

Text

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February-21, 1997.

Mr. M. S. Tuckman Senior Vice President Nuclear Generation Duke Power Company P. O. Box 1006 Charlotte, NC 28201

SUBJECT:

DUKE POWER COMPANY QUALITY ASSURANCE PROGRAM - AMENDMENT 21 -

REQUEST FOR ADDITIONAL INFORMATION (TAC NOS. M96624 THROUGH M96630)

Dear Mr. Tuckman:

By letter dated July 11, 1996, as supplemented by letters dated November 19, and December 3,1996, you provided your Quality Assurance Program, Amendment 21, for staff review. Based on our review, the enclosed request for additional information is required for further clarification. If you have any questions, please contact Mr. Victor Nerses at 301-415-1484.

Sincerely, Original signed by P. Tam for:

Herbert N. Berkow, Director Project Directorate 11-2 Division of Reactor Projects - I/II Office of Nuclear Reactor Regulation Docket Nos. 50-369 and 50-370

Enclosure:

As stated cc w/ encl: See next page Distribution:

Docket File HBerkow JJohnson, RII PUBLIC LBerry RCrlenjak, RII PD 11-2 Rdg. VNerses PTam SVarga JZwolinski 0GC ACRS DLabarge b(4\

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To receive a copy of this document, indicate in the box: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N" - No copy 0FFICE PM:PQII-2 k9 LA:PDIIS2// D:PDII-2 l l l NAME W(ERSES:cn LBERRY1//P HBERK0W DATE &/ 4/ /97 cQ/N t/97 2 /2.( /97 / /97 / /97 / /97 J0CUMENT NAME: G:\MCGUIRE\ DUKE 21.RAI 0FFICIAL RECORD COPY 9702250322 970221 PDR ADOCK 05000369 gg Fil.E CENTER COPY

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NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20066 4001 l

,,,,, February 21, 1997 Mr. M. S. Tuckman Senior Vice President Nuclear Generation Duke Power Company i P. O. Box 1006 Charlotte, NC 28201 SUSJECT: DUKE POWER COMPANY QUALITY ASSURANCE PROGRAM - AMENDMENT 21 -

REQUEST FOR ADDITIONAL INFORMATION (TAC NOS. M96624 THROUGH M9663

Dear Mr. Tuckman:

By letter dated July 11, 1996, as supplemented by letters dated November 19, and December 3, 1996, you provided your Quality Assurance l Program, Amendment 21, for staff review. Based on our review, the enclosed

l. request for additional information is required for further clarification. If i'

you have any ye stions, please contact Mr. Victor Nerses at 301-415-1484.

Sincerely, t

1 e  ;

l

\ -

W {

Herbert N. Berkow, Director Project Directorate II-2 Division of Reactor Projects - I/II Office of Nuclear Reactor Regulation Docket Nos. 50-369 and 50-370

Enclosure:

As stated cc w/ enc 1: See next page i

A 1

Duke Power Ccmpany McGuire Nuclear Station cc:

Mr. Paul R. Newton Mr. Dayne H. Brown, Director  !

Duke Power Company, PB05E Department of Environmental, '

422 South Church Street Health and Natural Resources l Charlotte, North Carolina 28242-0001 Division of Radiation Protection  !

! P. O. Box 27687

County Manager of Mecklenberg County Raleigh, North Carolina 27611-7687 l 720 East Fourth Street l Charlotte, North Carolina 28202 Ms. Karen E. Long

. Assistant Attorney General

Mr. J. E. Snyder North Carolina Department of

! Regulatory Compliance Manager Justice ,

Duke Power Company P. O. Box 629 McGuire Nuclear Site Raleigh, North Carolina 27602 l 12700 Hagers Ferry Road Huntersville, North Carolina 28078- Mr. G. A. Copp 8985 Licensing - EC050 l Duke Power Company J. Michael McGarry, III, Esquire 526 South Church Street Winston and Strawn Charlotte, North Carolina 28242-1400 L Street, NW. 0001 Washington, DC 20005 Regional Administrator, Region II Senior Resident Inspector U.S. Nuclear Regulatory Commission c/o U. S. Nuclear Regulatory 101 Marietta Street, NW. Suite 2900 Commissiw Atlanta, Georgia 30323 12700 haw M Ferry Road ,

Huntersville, North Carolina 28078 Elaine Wathen, Lead REP Planner '

Division of Emergency Management Mr. T. Richard Puryear 116 West Jones Street Owner's Group (NCEMC) Raleigh, North Carolina 27603-1335 Duke Power Company 4800 Concord Road Mr. H. B. Barron York, South Carolina 29745 Vice President, McGuire Site Duke Power Company Dr. John M. Barry 12700 Hagers Ferry Road Mecklenberg County Huntersville, North Carolina 28078 j Department of Environmental '

Protection 700 N. Tryon Street Charlotte, North Carolina 28202 l

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Request for Additional Information f

1. Item 5 - Page 17-9. ANSI /ASME N45.2.23-1978 equires that the i

prospective Lead Auditor shall have participated in a minimum of five (5) quality assurance audits within a period of time not to exceed three (3) years prior to the date of qualification, one audit ,

of which shall be a nuclear quality assurance audit within the year i prior to the individual's qualification, The proposed alternative  ;

qualifications are the prospective Lead Auditor shall demonstrate  ;

! their ability to effectively implement the audit process and l

effectively lead an audit team. Upon successful demonstration of the ability to effectively lead audits, licensee management may certify the individual as a lead auditor. The NRC does not consider '

this to be an :eptable alternative. The NRC considers the following to L an acceptable alternative to ANSI N45.2.23-1978:

Prospective lead auditors shall demonstrate their ability  !

to effectively implement the audit process and effectively '

lead an audit team. The employer shall describe this l demonstration process in written procedures or instructions and shall evaluate and document the results of the demonstration. Regardless of th methods used for ,

the demonstration,.the prospective lead auditor shall have participated in at least one nuclear quality assurance audit within two years preceding the individual's effective date of qualification. Upon successful demonstration of the ability to effectively implement the audit process and effectively lead audits, and having met l

the other provisions of ANSI N45.2.23-1978, the individual may be certified as being qualified to lead audits.

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Explain and discuss how Duke's alternative will be revised to be consistent with NRC's October 24, 1996 letter to NEI entitled

" Review of Nuclear Energy Institute (NEI) Proposed Improvements to Quality Assurance Programs."

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2. Item 12 - Pages 17-26 through 17-30. The basis / reason and discussion in this section does not provide enough information to adequately review this section.

a. Provide the basis / reason why the last sentence in the last paragraph was changed / deleted on page 17-26 (Bid evaluation includes evaluation of the technical, quality and commercial qualifications of the prospective suppliers).

b. NRC positions on the use of the ASME Accreditation Process is provided in Information Notice 86-21 and its supplements. The i proposed, revised QA Program description needs to address Information Notice 86-21 (see last sentence in the first paragraph on page 17-27). . For example, the extent of the surveillance, test,

or inspection activities shall, in any combination, confirm / verify 1 that the applicable portions of the supplier's QA program are being j' effectively implemented, i

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. c. The last sentence of first full paragraph on page 17-27 of the proposed QA Program needs to reflect the NRC's position on third l

l party audits. "hird party audits shall be reviewed in detail to 1 l determine the scope of the audit and to ensure that items to be l

purchased are within the audit scope, and to ensure that any unique plant quality and technical requirements are within the scope of such audit. Provide the justification for not conforming to the l above statement,

d. Changing the audit frequency from 36 to 42 months appears to be unacceptable and no reasonable justification is provided. Why can't l

supplier audits be planned 3 years in advance? Also with l organizations like NUPIC performing third party audits, this should

! not be a problem. Discuss and explain changing the audit frequency

! in more detail.

e. For paragraph 4 on page 17-27 of the proposed QA Program change, provide justification and discussion why' reference to specifications and Codes was deleted. No justification is provided to evaluate

this change.

l l f. The last sentence in paragraph 4 page 17-27 of the proposed QA Program needs to reflect Criterion VIII of Appendix B to 10 CFR Part 50 which requires in part that the effectiveness'of suppliers be assessed. Proposed page 17-27 states " Supplier evaluation and re- i evaluation are done in accordance with procedures to assure their '

documentation is valid." Section 50.34(b)(6)(ii) requires that_the QA Program describe how the requirements of Appendix B will be satisfied. The proposed QA Program would only reference ' procedures '

and does not describe how supplier evaluations / assessments are 1 performed, therefore it appears that 50.34(b)(6)(ii) is not being met. Discuss and provide some additional detail for inclusion in the QA Program to explain how you are tonforming with the regulations,

g. The last sentence on page 17-27 needs to be modified to comply with 10 CFR 21.3 " Dedication" definition. Section 21.3 recognizes historical analysis only as a sunnlementary dedication method which i should not be used as the sole method. i i h. The second to last paragraph in section 17.3.2.4 used to state "the

certificate specifies," now states "the documentation specifies."

i Only a certificate, signed by the vendor can certify that the

! purchase order requirements have been met. Please discuss and

provide justification for deletion of the term " certificate". Also f

see Section 10.2 of ANSI .445.2.12 and its discussion on the use of j' certification during the receiving process.

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1. Section 17.3.2.6c used to state " traceable to original material,"

now states " traceable at receipt." This may be somewhat true for basic components that are procured commercially and dedicated, but may not be true for items / materials purchased from approved suppliers. Provide basis / reasons for this change. What is the meaning of " traceable to receipt?"

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3. Item 16 - Page 17-37. In what manuals are the governing procedures for the Nuclear Assessment and Issues Division? What is the Assessment 4

Organization? Discuss and explain.

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4. Item 17 - Page 17-37. Approval of the procedures for the Nuclear Safety Review Board (Nuclear System Directive) by the Senior Vice President, Nuclear Generation, has been deleted. Discuss and explain the  ;

justification for this removal. 1

5. Item 18 - Page 17-38. How does one know that the maintenance and testing of electrical equipment procedures is contained in the Nuclear Policy  !

Manual or the ESS functional manuals? Where in the QA Program is this i stated? What are the ESS functional manuals? Discuss and explain.

6. Item 24 - Page 17-37. Where is it stated that Department Heads and the Senior Vice President, Nuclear Generation, will receive the results of the audit? Who does " senior management" include? Are the audit results reported to all of the senior management? Who is coordinating these assessments? Discuss and explain.

7. Item 26 - Page 17-45. Wiy were there originally commitments to perform Integrated Safety Assessinents? How has the original reason changed? How does the monthly trend tracking report maintain independence from the station operation management? Discuss and explain.