ML15138A347

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Request for Change to Quality Assurance Topical Report (TAC Nos. MF5055 - MF5061)
ML15138A347
Person / Time
Site: Oconee, Catawba, McGuire  Duke Energy icon.png
Issue date: 05/26/2015
From: Robert Pascarelli
Plant Licensing Branch II
To: Zaremba A
Duke Energy Carolinas
Miller G
References
TAC MF5055, TAC MF5056, TAC MF5057, TAC MF5058, TAC MF5059, TAC MF5060, TAC MF5061
Download: ML15138A347 (7)


Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 Mr. Arthur Zaremba

  • Nuclear CFAM - Regulatory Affairs
  • Duke Energy Carolinas Mail Code EC2ZF/P.O. Box 1006 Charlotte, NC 28201-1006 May 26, 2015

SUBJECT:

CATAWBA NUCLEAR STATION, UNITS 1AND2; MCGUIRE NUCLEAR STATION, UNITS 1 AND 2; AND OCONEE NUCLEAR STATION UNITS 1, 2, AND 3: REQUEST FOR CHANGE TO QUALITY ASSURANCE TOPICAL REPORT (TAC NOS_. MF5055, MF5056, MF5057, MF5058, MF5059, MF5060 ANDMF5061)

Dear Mr. Zaremba:

By letter dated October 23, 2014 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML14300A011 ), as supplemented by letter dated March 12, 2015 (ADAMS Accession No. ML15092A098). Duke Energy Carolinas (Duke) submitted a request for the U.S. Nuclear Regulatory Commission (NRC) approval of a change to the Quality Assurance Topical Report (QATR) for the subject sites. The proposed change would revise the QATR to reference the 2011 Nuclear Information and Records Management Association standard for the management of electronic records.

The NRC staff has completed its review of your request and determined that the requested change will continue to satisfy the requirements of Appendix B to Title 10 of the Code of Federal Regulations Part 50, and is therefore acceptable. A copy of the related Safety Evaluation is enclosed.

If you have any questions, please contact G. Edward Miller at (301) 415-2481.

Sincerely, Robert J. Pascarelli, Chief Plant Licensing Branch 11-1 Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation Docket Nos.: 50-413, 50-414, 50-369, 50-370,

. 50-269, 50-270, and 50-287

Enclosure:

Safety Evaluation cc w/encl: Distribution via Listserv

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 SAFETY EVALUATION BY THE OFFICE OF NUCLEAR REACTOR REGULATION QUALITY ASSURANCE TOPICAL REPORT CHANGE DUKE ENERGY CAROLINAS, LLC CATAWBA NUCLEAR STATION, UNIT NOS: 1AND2 MCGUIRE NUCLEAR STATION, UNIT NOS. 1AND2 OCONEE NUCLEAR STATION, UNIT NOS 1, 2 AND 3 DOCKET NOS. 50-413, 50-414, 50-369, 50-370, 50-269, 50-270 AND 50-287

1.0 INTRODUCTION

By letter dated October 23, 2014, as supplemented by letter dated March 12, 2015, (References 1 and 2), Duke Energy Carolinas (DEC) submitted a change, Amendment 40 to the Quality Assurance Topical Report (QATR), pertaining to the Catawba Nuclear Station Unit Nos. 1 and 2, McGuire Nuclear Station, Unit Nos. 1 and 2, and Oconee Nuclear Station, Unit Nos. 1, 2, and 3. The purpose of this proposed change is to use the latest guides for electronic records, storage *and management. Specifically, the following Nuclear Information and Records Management Association (NIRMA) Technical Guides (TGs) are being requested for use:

TG 11-2011, "Authentication of Records and Media,"

TG 15-2011, "Management of Electronic Records,"

TG 16-2011, "Software Quality Assurance Documentation and Records,"

TG 21-2011, "Required Records Protection, Disaster Recovery and Business Continuation" This proposed change allows use of the 2011 NIRMA TGs instead of the older 1998 version, which are listed in Attachment 1 of Regulatory Issue Summary 2000-018, "Guidance on Managing Quality Assurance Records in Electronic Media."

2.0 REGULATORY EVALUATION

The proposed change is for the electronic records, storage, and management program. The current regulatory bases for the quality assurance record program are described below.

Enclosure The Commission's [U.S. Nuclear Regulatory Commission (NRC)] regulatory requirements related to quality assurance (QA) programs are set forth in Appendix B, "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," to Title 10 of the Code of Federal Regulations (10 CFR) Part 50 and 10 CFR 50.54(a).

Appendix B of 10 CFR Part 50 establishes QA requirements for the design, construction, and operation of structures, systems, and components of the facility. The pertinent requirements for QA records are contained in Criterion XVII which states that "Sufficient records shall be maintained to furnish evidence of activities affecting quality. The records shall include at least the following: operating logs and the results of reviews, inspections, tests, audits, monitoring of work performance, and materials analyses. The records shall also include closely-related data such as qualifications of personnel, procedures, and equipment. Inspection and test records shall, as a minimum, identify the inspector or data recorder, the type of observation, the results, the acceptability, and the action taken in connection with any deficiencies noted.

Records shall be identifiable and retrievable. Consistent with applicable regulatory requirements, the applicant shall establish requirements concerning record retention, such as duration, location, and assigned responsibility."

Section 50.54(a)(4) of 10 CFR Part 50, states that "changes made to the quality assurance program description that do reduce the commitments must be submitted to the NRC and receive NRC approval prior to implementation."

The NRC accepted practices for the collection, storage, and maintenance of QA records for nuclear power plants are described in the following documents:

American National Standards lnstitute(ANSI) N45.2.9-1974, "Requirements for Collection, Storage and Maintenance of Quality Assurance Records for Nuclear Power Plants," as endorsed by Regulatory Guide 1.88, "Collection, Storage and Maintenance of Nuclear Power Plant Quality Assurance Records," Revision 2, and ANSI/American Society of Mechanical Engineers, (ANSl/ASME) NQA-1-2008 and the NQA-1a-2009 addenda, "Quality Assurance Program Requirements For Nuclear Facilities," as endorsed by Regulatory Guide 1.28, "Quality Assurance Program Requirements (Design and Construction)," Revision 4.

Regulatory Issue Summary (RIS) 2000-018, "Guides on Managing Quality Assurance Records,"

and Generic letter 88-18, "Plant Record Storage on Optical Discs," provide guidance forthe maintenance of QA records in electronic media. RIS 2000-018 states that four NIRMA guides (TG 11-1998, TG 15-1998, TG 16-1998, and TG 21-1998) provide an acceptable basis for complying with the recordkeeping requirements of 10 CFR Part 31, Part 32, Part 34, Part 40, and Appendix B to 10 CFR Part 50, Part 60, Part 70, Part 71, Part 72, or Part 76.

3.0 TECHNIAL EVALUATION The NRC staff reviewed the DEC request by comparing the difference between the newer 2011 NIRMA TGs to the 1998 NIRMA TGs. The staff reviewed Attachment1 of the submittal which discussed the differences between the newer 201_1 NIRMA guides and the 1998 version.

In RIS 2000-018, the NRC staff determined that NIRMA TG 11-1998, "Authentication of Records and Media," TG 15-1998, "Management of Electronic Records," TG 16-1998, "Software Configuration Management and Quality Assurance," and TG 21-1998, "Electronic Records Protection and Restoration," provided acceptable methods for managing QA records in electronic media. NIRMA updated these four TGs in 2011 to reflect the best practices for managing electronic records.

The newer 2011 NIRMA TGs provide supplemental guidance for electronic records to ensure the records are identifiable and retrievable for their required retention period. The updated NIRMA TGs provide detailed guidance in the areas of records authentication, software QA, and disaster recovery. These changes are based on the development and implementation of enterprise content management systems, web-based technologies, and higher capacity LAN/WAN networks. The key difference between the 1998 and 2011 NIRMA TGs is that the newer guides provide better understanding and controls for an integrated approach to the creation, capture, and maintenance of records using electronic tools.

The QATR change affects Table 17-1, "Conformance of DEC's Program to Quality Assurance Standards, Requirements, and Guides," as an alternative to Regulatory Guide 1.88, Revision 2.

For the management of electronic records, the appropriate controls on quality include the following:

(a) No deletion or modification of records unless authorized pursuant to the record retention rule (b) Redundancy (system backup, dual storage, etc.) is met (c) Legibility is required of each record (d) Records media is properly maintained (e) Random inspections to ensure no degradation of records (f) Records are acceptably converted into any new system before the old system is taken out of $ervice.

The NRC staff has reviewed the licensee analysis provided in Attachment 1 of the submittal, dated March 12, 2015, and find that the four 2011 NIRMA TGs referenced above in Section 1.0 provide adequate guidance for electronic records, storage, and management. Based on these findings, the NRC staff concludes that there is reasonable assurance that the requirements of Criterion XVII of Appendix B continue to be met. Therefore, the staff finds the proposal acceptable.

4.0 CONCLUSION

As described above, the NRC staff evaluated the licensees' QATR (Reference 1) submittal and the supplement (Reference 2) and concludes that the licensees' QA program continues to satisfy the requirements of Appendix B to 10 CFR Part 50. Specifically, the newer 2011 version of the NIRMA TGs provide additional implementing details that continue to meet the QA record requirements contained in Appendix B, Criterion XVII. The proposed change is acceptable.

5.0 REFERENCES

1.

Duke Energy Carolinas to the NRC, Catawba Nuclear Station, Units Nos. 1 and 2, McGuire Nuclear Station Unit, Nos. 1 and 2, and Oconee Nuclear Station, Unit Nos. 1, 2, and 3, Submission of "Change to Quality Assurance Topical Report, Amendment 40,"

Dated October 23, 2014, (Agencywide Documents Access and Management System (ADAMS) Accession No. ML14300A011).

2.

Duke Energy Carolinas to the NRC, Response to Request for Additional Information Regarding Change to Quality Assurance Topical Report, Dated March 12, 2015, (ADAMS Accession No. ML15092A098).

3, NRC Regulatory Issue Summary 2000-018, "Guidance on Managing Quality Assurance Records In Electronic Media," dated October 23, 2000.

4.

NIRMA TG 11-2011, "Authentication of Records and Media"

5.

NIRMA TG 15-2011, "Management of Electronic Records"

6.

NIRMA TG 16-2011, "Software Quality Assurance Documentation and Records"

7.

NIRMA TG 21-2011, "Required Records Protection, Disaster Recovery and Business Continuation" Principal Contributors: R. Laura Date: May 26, 2015

A Zaremba If you have any questions, please contact G. Edward Miller at (301) 415-2481.

Sincerely,

/RA/

Robert J. Pascarelli, Chief Plant Licensing Branch 11-1 Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation Docket Nos.: 50-413, 50-414, 50-369, 50-370, 50-269, 50-270, and 50-287

Enclosure:

Safety Evaluation cc w/encl: Distribution via Listserv DISTRIBUTION:

PUBLIC LPL2-1 Reading RidsAcrsAcnw_MailCTR Resource RidsNroDcipQvib Resource RidsNrrDorllpl2-1 Resource RidsNrrPMCatawba Resource RidsNrrPMMcGuire Resource RidsNrrLASFigueora Resource RidsNrrPMOconee Resource RidsRgn2MailCenter Resource RidsOgcRp Resource KKavanagh, NRO/DCIP/QVIB Rlaura, NRO/DCIP/QVIB ADAMS Accession No. ML15138A347

  • via safety evaluation input OFFICE DORL/LPL2-1 /PM DORL/LPL2-1/LA NRO/DCIP/QVIB/BC*

NAME GEMiller SFigueora (SRohrer for)

KKavanagh

  • DATE 05/20/15 05/20/15 05/11/15 OFFICE DORL/LPL2-1 /BC DORL/LPL2-1 /BC NAME RPascarelli GEMiller DATE 05/22/15 05/26/15 OFFICIAL AGENCY RECORD