RA-15-0007, Units 1 & 2 and Oconee, Units 1, 2 & 3 - Response to Request for Additional Information Regarding Change to Quality Assurance Topical Report

Units 1 & 2 and Oconee, Units 1, 2 & 3 - Response to Request for Additional Information Regarding Change to Quality Assurance Topical Report

ML15092A098
Person / Time
Site:	Oconee, Mcguire, Catawba, McGuire
Issue date:	03/12/2015
From:	Repko R Duke Energy Corp
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
RA-15-0007, TAC MF5055, TAC MF5056, TAC MF5057, TAC MF5058, TAC MF5059, TAC MF5060, TAC MF5061
Download: ML15092A098 (18)

Text

(ro*DUKE ENERGY.

Regis T. Repko 526 South Church Street Charlotte, NC 28202 Mailing Address:

Mail Code EC07H,/P.O. Box 1006 Charlotte, NC 28201-1006 704-382-4126 704-382-4541 fax March 12, 2015 10 CFR 50.54(a)(4)

RA-15-0007 U. S. Nuclear Regulatory Commission Attn: Document Control Desk Washington, DC 20555-0001 Catawba Nuclear Station, Unit Nos. I and 2 Docket Nos. 50-413 and 50-414 / Renewed License Nos. NPF-35 and NPF-52 McGuire Nuclear Station, Unit Nos. 1 and 2 Docket Nos. 50-369 and 50-370 / Renewed License Nos. NPF-9 and NPF-17 Oconee Nuclear Station, Unit Nos. 1, 2 and 3 Docket Nos. 50-269, 50-270, 50-287 / Renewed License Nos. DPR-38, DPR-47, and DPR-55 Subet Response to Request For Additional Information Regarding Change To Quality Assurance Topical Report (TAC Nos. MF5055, MF5056, MF5057, MF5058, MF5059, MFS060 And MF5061)

References:

1.

Letter from Duke Energy (Ernest J. Kapopoulos, Jr.) to USNRC (Document Control Desk), "Change to Quality Assurance Topical Report, Amendment 40," dated October 23,2014 (ML14300A011)

2.

Letter from USNRC (Ed Miller) to Duke Energy (Art Zaremba), "Catawba Nuclear Station, Units I and 2; McGuire Nuclear Station, Units 1 and 2; and Oconee Nuclear Station Units 1, 2, and 3; Request For Additional Information Regarding Change To Quality Assurance Topical Report (TAC Nos. MF5055, MF5056, MF5057, MF5058, MF5059, MF5060 And MF5061)," dated February 12,2015 (M115041A544)

In Reference 1, Duke Energy Carolinas, LLC (Duke Energy) submitted a request for approval of a change to the*r Ouality Assurance Topical Report (QATFI). The requested change was to be allowed to use the latest Nuclear Information and Records Management Association (NIRMA) standards for records storage and management. These changes were submitted for approval to the Nuclear Regulatory Commission (NRC) in accordance with 10 CFR 50.54(a)(4).

Reference 2 transmitted Requests for Additional Information (RAls) regarding the Reference 1 submittal. The responses to these requests are provided in Attachment 1. Attachment 2 provides a revised markup of Table 17-1. Clean typed pages are provided as Attachment 3.

These pages supersede those of Reference 1.

Should you have any questions regarding this request, please contact Thomas R. Byme at (980) 373-3249.

0004-

U.S. Nuclear Regulatory Commission March 12, 2015 Page 2 Sincerely, Regis T. Repko Senior Vkce President Governance, Proje*t, and Engineeing Aitachmnents:,

1)

Response to Request for Additional Information Regarding the Change to Quality Assurance Topical Report, Amendment 40

2)

Quality Assurance Topical Report Pages 17-8 and 17-9 with Requested ChA*

3 Clean Typed Quality Assurance Topical Report Pages 17-8 and 17-9

U.S. Nuclear Regulatory Commission March 12, 2015 Page 3 xc:

V. M. McCree, Region II Admiitrator U.S. Nudew Regulaory Cwwomsion Mquis Ons Toer 245 Peats Cener Avenue E, Suite 1200 Aftf Gwogin 30303-1257 Randy HW, Pe M Wage (ONS)

U.S. uclew Regul-y Commission 1160 Fckvife Pike Rockyile, MID 20852-2738 G. E. M

, Projec Manaer (C*N and MINIS)

U.S. Nuckea Regiulaoy Cnile 1155 Rockvilie Pike PRWIPMe, MID 20S52-2M~

USNRC Resknt Inspedw - CNS USNAC RAdent apecdw -

-MMNS USA Resident I-pectoir - ONS

RA-15-0007 Page 1 of 8 Response to Request for Additional Information Regarding the Change to Quality Assurance Topical Report, Amendment 40

RA-15-0007 Page 2 of 8 Response to Request for Additional Information Regarding the Change to Quality Assurance Topical Report, Amendment 40 NRC &Z"m #1 Criterion XVII, "Quality Assurance Records" of Appendix B to Title 10 of the Code of Federal Regulations (10 CFR) Part 50 states In part 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 qualificatlons of personnel, procedures, and equipment. Inspection and test records shall, as a minimum, identify the inspector or data recorder, the type of operation the acceptability, and 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 Clarify the key differences between the latest 2011 NIRMA records standards (TG-1 1, TG-5, TG-16, and TG-21) and the 1998 version. Include a discussion of how these changes ensure the requirements of Criterion XVII will continue to be met.

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, Rev. 2, "Collection, Stage, and Maintenance of Nuclear Power Plant Quality Assurance Records,"

contains adequate requiements to assure satisfaction of the Appendix B Criterion XVII requirement.

Regardless of records media, ANSI N45.2.9-1974 contains adequate requirements to assre satisfaction of the Appendix B Criterion XVII requirements for "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, monitorn of work peifo

, and materials analyses. The records shaI also include closely-related data such a qualatons of personnel, procedures, and epment.' The ANSI Standards also contain adequate requirements to assure satisfaction of the Appendix B Criterion XVII requirements for Inspection and test records shall, as a minimum, identify the Inspector or data recorder, the type of operation the acceptabity, and action taken I 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."

The requested use of the 2011 NIRMA standards, consistent with the guidance in RIS 2000-018 and Generic Letter (GL) 88-18, is to provide supplemental guidance for the maintenance of Quality Assurance (QA) records in electronic media. In particular, the NIRMA Standards provide supplemental guidance specific to electronic records to ensure the records are identifiable and retrievable for their required retention period.

RA-15-0007 Page 3 of 8 The context for the 1998 versions of the NIRMA standards was the nuclear records management approaches and information technologies present in the mid-i 990s, consisting primarily of conversion of hardcopy records to electronic form using image-capture based systems (scanned documents resulting in single-or multi-page images). These images were typically captured to optical disks, which were managed in multi-platter jukeboxes", and accessed through client-server, LAN-based networks. The 1998 versions recognized the need to expand beyond optical disk storage systems into magnetic disk storage, and address electronic record formats that can be viewed over time. The 1998 versions also brought to light the need to formally address software configuration management and quality assurance, since it was recognized that licensees would become dependent on the electronic record - only viewable, not as paper, but through the means of information technology (hardware and software). This dependency also dictated the need to address electronic records protection, backups, and disaster recovery, to be compliant with regulatory requirements.

The 2011 versions retained the fundamental philosophies of the 1998 versions and maintained the relationship among the four stated TGs, that is: TG-15 presents the overall program for managing electronic records, with TG's 11, 16, and 21 providing more detailed information into specific areas of records auOteticaki, software quality assurance, and disaster recovery. The key changes are based on development and implementation of enterprise content management systems, web-based technologies, and higher capacity LAN/WAN networks. Leveraging those technologies enabled the development of more efficient and effective best practices for managing electronic records, with authentication and records turnover occurring more frequently in "e-space. The key differences between each 2011 NIRMA Standard and each 1998 version are identified below. In short, the 2011 NIRMA standards provide better understanding and controls for an integrated approach to the creation, capture, and maintenance of records using electronic tools.

Management of Ellec Rswrds T16-2011 - This guideline addresses the complete life cycle of electronic records and their information processing environmernt. Electronic records may exist in any electronic format, and on various media (e.g. optical disk, magnetic tape, magnetic disk), capable of being read by computer system application software and peripheral subsmystems.

Overview of Changes from 1998 Version: The content has been rearranged and expanded to provide performance based criteria for sustainable electronic records. No content significant to the management of electronic records was deleted from this TG. TO15 provides a comprehensive approach that can be used to design an electronic records management program. TGI5 is current with existing codes and standards and addresses the issue of sustainability by various file types. TG IS also addresses digital and information rights management. TG15 has undergon significant format revisions from the 1998 version. The revised structure promotes better understanding of the electronic records management process addressing the significant phases in separate sections. The following table provides a comparison of the differences between the two versions:

RA-15-0007 Page 4 of 8 Differences between TG15-2011 and TG15-1998 TG15-2011 Document TG15-1998 sections Comments tucture addressed Section 4. CREATING Section 5.1 Section 5.1.1, which ELECTRONIC RECORDS addressed electronic file The 2011 version focuses types, is replaced with on the management of performance requirements Records, not the work for ensuring the file is in a processes for creating, sustainable format. This is reviewing, and approving addressed in Section 8.3 a document that will and APPENDIX B of the become a record.

2011 version.

Section 5.

Topic not addressed New content included for AUTHENTICATING understanding of the ELECTRONIC RECORDS process Section 6. TRANSFERRING Topic not addressed New content included for AND RECEIVING understanding of the ELECTRONIC RECORDS process.

Section 7. INDEXING Section 52 Content of Section 5.2 is ELECTRONIC RECORDS now addressed in Sections 7 and 8.

Section 8. STORING AND Section 5.2 Content of Section 5.2 is MAINTAINING ELECTRONIC now addressed in Sections RECORDS 7 and 8.

Subsection 8.3 Section 5.1.1 Addresses electronic file types from paragraph 5.1.1.

Subsection 8.4 Section 6.2.

Section number change Section 9. RETRIEVING Topic not addressed New content Included for ELECTRONIC RECORDS understanding of the process.

Section 10. RECORDS Sections 7.1, 7.2, and Section number change RETENTION 7.3 Section 11. DESTROYING Section 7.5 Section number change ELECTRONIC RECORDS Section 12. SECURING Section 5.3 Section number change ELECTRONIC RECORDS Section 13. PLANNING FOR Topic not addressed New content included for DISASTERS AND understanding of the RECOVERING process. See TG21 for ELECTRONIC RECORDS more information.

Section 14. DEFINING Sections 3 and 7.4 Section number change SYSTEM AND SOFTWARE QUAUTY ASSURANCE REQUIREMENTS APPENDIX A -

Section 4 Section number change ESTABLISHING AN ELECTRONIC RECORDS MANAGEMENT PROGRAM Subsection A6.5 Section 6.1 Section number change

RA-1 5-0007 Page 5 of 8 TG15-2011 Document TG15-1998 sections Comments structure addressed APPENDIX B - FORMAT Topic not addressed Supplements Section 8.3 in SUSTAINABILITY (SORT BY addressing electronic file ACRONYM) types from paragraph 5.1.1 of 1998 version.

APPENDIX C - FORMAT Topic not addressed New content included for TRANSFORMATION understanding of the process.

APPENDIX D - CONTENT Topic not addressed New content included for RIGHTS MANAGEMENT understanding of the

_process.

Aattwintlctilon of Reords and Med1 a TG11-2011 - This document provides guidance to assist in establishing authentication requirements for records and records media submitted for control, storage, and retrieval.

Overview of Changes from 1998 Version: Additions have been made to better define capture of e

onic records such as Record and Media Certificaton definitiot, destruction of hard copy upon completion of electronic scan, media certification. This aligns authentication aspects with other TGs cleanly without duplication. This also limits the content to the authentication, record creation processing. The definition of authentication is reduced to a simple format that matches the ANSI N45 and ASME NQA-1, allowing destruction of the hard copy record once properly transformed to a new final media type.

Removed content is addressed in the following:

The records media table previously in Section 3.5 was deleted. Content addressed non-electronic media and was not pertinent to the scope of this TG. TG15 addresses consideration for the use of electronic media.

Specific user identrficatiopassword guidance in authentication methods (former section 4.1.3) has been removed. This is addressed in the controls for creation of the electronic docmentsr as referenced In TG15 Section 5.2.

The section addressing 'Sc System is replaced by the more generically applicable Section 5.5 Conversion Systems, which retains the requirement to verify record legibility following conversion.

Section 6 has bee retitled 'Record Series Processing" from the previous -Media Certification." In conjunction with this change, the content of Sections 6.4.1, 6.4.2, and 6.4.3 was removed. This content Is addressed in TG15 Sections 4 and 8, which address perfomance requirements for ensuring a sustainable format.

Sections 7.3 for corrections to records on microfilm and 7.4 corrections to hardcopy records were removed as these are not in the scope of electronic records.

Softwa Quality Asou r e Docunentation and Recorfs T016-2011 - This TG, like the 1998 version, contains no requirements specific to the Electronic Records Management System. The technical guideline addresses documentation and records requirements for Configuration Management and Software Quality Assurance (SOA) to furnish documentary evidence of the quality and configuration control from inception to the end of life cycle. This

RA-15-0007 Page 6 of 8 documentation is typical for SQA and not specific to the Electronic records Management System.

Overview of Changes from 1998 Version: The revision removed content specifying generic requirements of a SQA Program. The current structure addresses documents and records necessary to develop, verify and validate, and maintain the Electronic Records Management System. The focus of the 1998 Edition was on providing a detailed Software Quality Assurance (SQA) definition. The 2011 edition focus is on the support role of Information Rights Management (IRM) in SQA activities.

Required Records Probation, Disater Recoery ond Businea Continuation, TG21-2011-This TG provide guidance concerning the protection, disaster recovery and business continuation efforts associated with a Records Management Program. This guidelin, originally titled "Electronic Records Protection and Restoration, has been renamed to more accurately reflect its scope. This guideline was developed recognizing the constant state of technology change evident in a Records Management Program. Therefore, efforts have been made to ensure its applicability regardless of media type, technology platform, or system hardware/

software configuration. Companies should be expected to customize their own program based upon their needs end aftlie resources. The rrmost effective Records Disaster Plan is comprOwn,*nWsey wvIntewan with nd an Itegral. part of the Company's overall Business Continuation Plan. As such, the user should find references to both the Company's plan and the Reod Prorm Plan. Unless stated otherwise, all references found wihin should be assumed to be related to the Recards Program.

Overview of Chw gsmm 196 Veslon: The ducument was vised to clearly address planning for oW respwone to dsatmes Dtai wm added for all formats and media; spofft &Ausin ooitlemon. The decmeit no addesses the need to have in place a plan an town, b*We r secuwry s

e Q rules, ead backup programs created by Informltion Technolog personmi.

Part of the proposed revision includes deleting the statement that the program for storage of records on optical disks wi# meet the quality controls contaied in NRC Generic Letter 88-

18. Pro'wkle a justiIn for deleting #1. statement or exlain how the use of the 2011 NIRMA standards will provide an equKIvaent Imewl of quality control.

The 2I1 NJIRMA standards address use of eaermnic records on optical disks as well as on other ecronic media. The markup was intended to convey the requirements for newly created electronic recrds; Duke would use the 2011 Standards. No key content was deleted.

In terms. of Elecpnic Reoom the necessary quality controls, consistent with GL 88-18, can be summarized as follows:

a)

The Electronic Records Managemert (qRM) system does not allow deletion or modification of records. (NOTE: Authorized deletion of records per the Record Retention Rules is controlled.)

b)

The eRM system provides redundancy (i.e., system backup, dual storage, etc.).

RA-15-0007 Page 7 of 8 c)

The legibility of each record is verified prior to acceptance into the eRM system.

d)

The media used by the eRM system is maintained to ensure the records are acceptably copied onto a new media before the manufacturer's certified useful life of *the media isexceeded. This icludes verification of the records so copied.

e)

Pekroi random *iqnpctlons of records are performed to verify that there has been no degradation of record quality.

f) fthe eRM system ln use is to be replaced by new system, the records stored on the old system are acceptably converted into the new system before the old system is taken out of service. This includes verification of the records so copied.

To improve the description of the quality ontrol for electronic records, Duke Energy proposes to update the request of Reference 1. Duke Energy proposes to change the following portions of Table 17-1, "Conformance of DEC's Program to Quality Assurance Standards, Requirements, and Guides," under the description of Regulatory Guide 1.88 Rev 2 - Collection, Storage, and Maintenance of Nuclear Power Plant Quality Assurance Records (pages 17-8 and 17-9):

Delete the folowing portion:

IC **

nee~s [Nuclear Information and Records Management Association)

And replace with the following:

The DEC parnra for skap ci recordse on microfilm, dual on quality em. Summarized as follows:

a) The Electroni Records Management (eRM) sysm does nct allow dsletcn or xmoication of records. (NOTE:

Authorized deletio of records per the Record Retention Rules is controlld) b) The eRM system pr*-,,de redundancy (i.e., system

, dual storm, etc.).

c) The legiblIty ds ot record is verified prior to a into the eRM sysem.

d) The media used by the eFM system is maintained to ensure the records are copied onto a new media before the manufacturers certified useful life of the

RA-15-0007 Page 8 of 8 media Is exceeded. This includes verification of the records so copied.

e) Periodic random inspections of records are performed to verify OWt there has been no degradation of record quality.

f) If the eRM system in use is to be replaced by new system, the records stored on the old system are acceptaly converted into the new system before the old system Is taken out of service. This Includes verfication of the records so copied.

To irsoimert t#ose conrols, DEC use the folow*ng:

- NIAM TG 11-2011 "Auntdiation of Records and Meda"

- NIRMA TO 15-2011, Mawnaement of Electronic Re"ords*

- NIORA TO 16-2011, Software Quality Asswwce, DocuR v!91mentfton Oand Records

- N~

TG 21-2011, 'Required Records Protection, DisastW Re-Vew and uSies Connuatio provides a revised markup of Table 17-1. Clean typed pages are provided as. These pages supersede those of Reference 1.

1.

Letter from Duke Energy (Ernest J. Kapopoulos, Jr.) to USNRC (Document Control Desk), "Change to Quality Assurance Topical Report, Amendment 40,"

dated October 23, 2014 (MLI 4300A01 1)

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RA-15-0007 Pege3of3 QATR Insert A:

The C roa f e of r microfm d or in electronic format ets the seto requ n f e

n QA Recrords.

For~~~~~~~~~~~~~

mangeen of ecrncrcrs h aecnrl nqaitare summarized

~ntin Rles IsoN uprul Gtor Uj The eRM systen, pro~ldes redundancy Theiegbilty f ech ecod ~ velfla por o acepAnc noteaMsse d~l The (~d~J used by the eRM s~ps~

)(~ept~bly copied onto a new ~'n Je of i~n~ ~e4la ~s e~ceedeo Th rmanslnd s esue he reors r ed by ne* sy~iem, the records stored on v o en ws~stembefore Th Ic Ionoftherecords tplen~

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RA-1 5-0007 Clean Typed Quafty Anmunce Topical RepoW Pages 17-8 anld 17-9 2 Pages Follow

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eqUb ald Giais Assurance Rsqumens -- for 000ig of Ciedloio the rilgineto,' bwimdift supervisor for design verifcaion sOW Nuclear P~e Wsbe rm eskoe lasupcial sibodions whos the inwwdiae supervisor is the oa* inidividual cqmtil of peuf irmn tdo writication.

Pah m csuci on fo such we slmil be docuanted and sierd by gow upwvI Ws

ýVmmpmnwml And So fequency and eftONer"ml of the *Wviesoft uwe -

design verifier we indpedey ~uW~s to ualmd "a" Aft"ue The, supervisor wil not fte f design 1 lera on wo*afor which he is the actu pemil lntloiinimor.

Regulatoy Guide 1.74 Re* (0) - Qually Confon RO 1.74 Rev (0) U os ANP81 N45.2.10-1973. Some Assurance Terms and De6nions debitions, used by*DEC wre rd dlhrey than those in this

-ldd* hover, the generalenings ar the same.

Rogltdosy Guide 1.88 Rev (2) - ColsetioWn AMoema RO 1.81 Rev (2) tbi porst 81 A

4M 2.9-1274. The EC Storage, anmid maitencel of f a

G coQVso to M 1.88

~iept a ros m m orage faciates Power Plant Quaiy ANuranc Feords m

a mirnfim 3hour rating. A qlifd Fie Pmtetion E.,-e u-r-d eba..t. record storape armas (including sallief Nes) to mmm mrcordd me adequat*l poiscd frm damage.

Tte t pr4beion senoginee shallbe a gaduat of an engineering 1nu10dum of scopd stending mid sha hae compbled not as tn 6 years aeen ment inlicav*e of growth in enieering compamncy and achievement, 3 years of which shall hwe been in sponef cag of tire poe n meWe, work. ThM OEC program for storage of rmcords on i*rln, dual storage or in eietu c bW meets the prervation reqrment or the retentn A Re s.

For meagement ofelectronic m

reorsth ppropriatecontrols bn quary we sunmmmnd as folows:

a) TheEleonicRecordsi I,-a,,--,-gement(R)system does not allow deleibon or modiicaton of records. (NOTE:

AuOth ed deletion of records per the Record Rete n

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d) The awu wsd by O aeRMA system is maintained to woew. the reo ds a aspta r opie d onto a new media bsfon he mamt**

oed use*l ie of the medlv is smined. This kiKnc s vermcon of oe goowdm so -.4 *f e) Perodkc random inspeclom of r acds are pefonned to very t*

huw has ben no degradation ofrod quaky.

t) N theoeRM sysSm in un ist o be m ed by new vwsm,

• h,e mc stored on the old system ae acceptat cowiad into the new ytwm befke the old Wsyswe is tIden ou f asvice. This inckudes veriicalon of the rem ors so cpi0d To inpiment tosm cnhoos, DEC uss following:

NVOK TG I 1-2011 "Authenlicaion of Records and Media" NlWATG 15-2011, ¶hnagsnnt lofEletronicRecords,"

URMA TG 16-2011, "So~wae Qua~ly Asurance

-Ocumentan Cand Rector" NOIRM TG 21-2011, "Required Records Proatection, Disaster Regul" ~y Guide 1.94 Rev (1) - QOuaty for Aternuiv RG 1.94 Rev (1) Irnrporates, ANSI program for McGuire and Installaion, Inspection, and Testing of Catat cmfms to ANSI 45.2.5-1974 except the length of Structural Concrete and S.uctural St bolts sh be lush wih the outsi taco of the nut Durin t

nxon Phas of Nucler Pa*grph 5.5 requires inspection of trucr stel welding to be performed in accordno wih the provisions of Section 6 of the

,WS DI.1. V a Weld Acceptanc teria (VWAC) for Structural Wldftn at Nuclea Powe Plants, NCIG-01, Revision 2, endT~me7t 174 17.9