Text

Pre-application Presentation Slides for Amendment to NEDO-11209-A Revision 15, GE Hitachi Nuclear Energy Quality Assurance Program Description
	ML20197A269
Person / Time
Site:	PROJ0710, 99902024, 07100254
Issue date:	07/15/2020
From:	Michelle Catts; GE Hitachi Nuclear Energy
To:	; Document Control Desk, Office of Nuclear Material Safety and Safeguards, Office of Nuclear Reactor Regulation
References
	M200084
	Download: ML20197A269 (155)
	v • d • e

GE Hitachi Nuclear Energy Michelle P. Catts Senior Vice President Nuclear Programs 3901 Castle Hayne Road P.O. Box 780 M/C A-18 Wilmington, NC 28402 USA T 910 200-9836 Michelle.Catts@ge.com M200084 Docket Number: 71-0254 Project Number: 710 July 15, 2020 ATTN: Document Control Desk Director, Division of Reactor Oversight Office of Nuclear Reactor Regulation Director, Division of Fuel Management Office of Nuclear Material Safety and Safeguards US Nuclear Regulatory Commission Washington, DC 20555-0001

Subject:

Pre-application Presentation Slides for Amendment to NEDO-11209-A Revision 15, GE Hitachi Nuclear Energy Quality Assurance Program Description Enclosed are the presentation slides for the pre-application meeting to be held on Monday, July 20, 2020.

If there are any questions, please contact me or Mark Gerdes (mark.gerdes@ge.com; 910-232-1409).

Sincerely, Michelle P. Catts Senior Vice President Nuclear Programs GE-Hitachi Nuclear Energy Americas, LLC

M200084 Page 2 of 2

Enclosures:

1. GEH QAPD NEDO-11209 Revision 16, Pre-Application Meeting Presentation Slides

2. NEDO-11209-A, Revision 15 markup for Revision 16 cc:

N. Otto, NRC, NRR/DORL/LLPB D. Morey, NRC, Chief NRR/DORL/LLPB K. Kavanagh, NRC, Chief NRR/DRO/IQVB C. Miller, NRC, Director NRR/DRO A. Kock, NRC, Director NMSS/DFM J. McKirgan, NRC, Chief NMSS/DFM/STLB M. Catts, GEH Wilmington C. Alonso, GEH Wilmington S. Griffin, GEH Wilmington M. Gerdes, GEH Wilmington

ENCLOSURE 1 M200084 GEH QAPD NEDO-11209 Revision 16, Pre-Application Meeting Slides Non-Proprietary Information - Public

GEH QAPD NEDO-11209 Revision 16

- Pre-Application Meeting July 20, 2020

Pre-Application Meeting Agenda/Purpose Present the GEH QAPD - NEDO-11209 Revision 16 (DRAFT)

Review the details of the changes Discuss the desired schedule of reviews and issuance processes Address questions regarding changes prior to formal submittal The below table lists Acronyms used in this presentation:

Acronym Term Acronym Term EPRI Electrical Power Research Institute NIRMA Nuclear Industry Records Management Association GEH GE Hitachi Nuclear Energy NQA Nuclear Quality Assurance GL Generic Letter QAPD Quality Assurance Program Description IEC International Electrotechnical Commission RG Regulatory Guide ISO International Standards Organization RIS Regulatory Information Standard NEDO Nuclear Energy Document (GEH classified as Public) TG Technical Guide QAPD -NEDO-11209 R16 l 20 July 2020 Non-Proprietary Information - Public

GEH QAPD NEDO-11209 - Structure PART I - Introduction

Defines the Scope and Applicability of the QAPD PART II - QAPD Details

Defines the Quality Program aligned to the 18 Criteria of 10 CFR 50 App. B PART III - Supplemental Details (Not reviewed for approval by the NRC)

Defines the Quality Program aligned to ISO 9001 PART IV - Regulatory Commitments

Defines the Regulatory Commitments and Standards committed to in Part I, II, and III of the QAPD

Provides Position statements clarify commitments, as applicable QAPD -NEDO-11209 R16 l 20 July 2020 Non-Proprietary Information - Public

GEH QAPD - NEDO-11209 Revision 16 - Details This revision incorporates the following:

Update to QAPD Part II Section 1 to reflect current GEH organizational structure Incorporation of RG 1.28 Rev. 5 and RG 1.164 Rev. 0 Update to all Sections reflecting NQA-1-2015 commitment General editorial and content changes to add clarification and grammar/ punctuation updates QAPD -NEDO-11209 R16 l 20 July 2020 Non-Proprietary Information - Public

GEH QAPD - NEDO-11209 Revision 16 - Details PART I -

Introduction:

Updated to reflect changes to NQA-1-2015 commitment in QAPD Part II Removed GE Reuter Stokes LLC PART II - QAPD Details Section 1 - Organization:

Re-written to align with 2020 GEH organizational structure including title update Section 3 - Design:

Updated language for closer alignment and terminology to NQA-1-2015 Subpart 2.7 for Software Design Control

Updated with editorial changes to clarify engineering processes Section 4 - Procurement Document Control:

Added requirement to include Software Errors as part of Procurement Documentation QAPD QAPD-NEDO-11209

-NEDO-11209R15 R16ll27 20April July 2020 Non-Proprietary Information - Public

GEH QAPD - NEDO-11209 Revision 16 - Details PART II - QAPD Details (Cont):

Section 7 - Control of Purchased Material, Equipment, and Services:

Included ISO/IEC 17025 2017 Edition reference Section 11 - Test Control:

Added sections for Acceptance Testing of Computer Programs and Changes to Computer Programs for closer alignment and terminology to NQA-1-2015 Subpart 2.7 Section 17 - Quality Assurance Records:

Updated to clarify indexing requirements for electronic documents

Updated commitment to align to NQA standards and to add reference to RG 1.28 Rev. 5 with clarification of position on NIRMA TG-21 Section 18 - Audits:

Included NQA-1-2015 Section 201 specific requirements for scheduling audits of internal activities. This includes the allowance of an option to extend audit frequency to four years for well-established activities.

QAPD -NEDO-11209 R16 l 20 July 2020 Non-Proprietary Information - Public

GEH QAPD - NEDO-11209 Revision 16 - Details PART II - QAPD Details (Cont):

The following Sections incorporate only editorial and content changes to add clarification, grammar/ punctuation updates, and update reference to NQA-1-2015 Section 2 - Quality Assurance Program Section 5 - Instructions, Procedures and Drawings Section 6 - Document Control Section 8 - Identification and Control of Materials, Parts and Components Section 9 - Control of Special Processes Section 10 - Inspection Section 12 - Control of Measuring and Test Equipment Section 13 - Handling, Storage, and Shipping Section 14 - Inspection, Test, and Operating Status Section 15 - Nonconforming Material or Components Section 16 - Corrective Action Program QAPD -NEDO-11209 R16 l 20 July 2020 Non-Proprietary Information - Public

GEH QAPD - NEDO-11209 Revision 16 - Details PART IV:

All Sections:

Editorial changes to titles for listed Regulations and Standards

Grammatical changes to facilitate readability Section 1.0 - QAPD Part I and Part II Commitments:

Added Position statement to clarify NQA-1-2015 applicability to QAPD Part I and Part II Section 2.0 - QAPD Part II Regulations and Standards

References:

Updated reference to RG 1.28 Rev. 5 as endorsed by the NRC and removed RIS 2000-18 and GL 88-18

Added Position statement related to GEH commitment of NQA-1-2015 Section 201 for internal audit frequency allowance to four years

Updated to include RG 1.164 as endorsed by the NRC and removed EPRI 5652, GL 89-02 and GL 91-05

Added Position statement related to company commitment of NIRMA TG-21, 1998 Version

Added statement specifying other commitments/references in quality plans or procedures Section 3.0 - QAPD Part I and Part III Standards:

Updated ISO 45001 reference QAPD -NEDO-11209 R16 l 20 July 2020 Non-Proprietary Information - Public

GEH QAPD - NEDO-11209 Revision 16 - Schedule TOPIC DATE Pre-Application Meeting July 20, 2020 Submittal of QAPD NEDO-11209 Rev. 16 (DRAFT) to NRC July 27, 2020 Anticipated QAPD Approval November 20, 2020 QAPD -NEDO-11209 R16 l 20 July 2020 Non-Proprietary Information - Public

Q&A QAPD -NEDO-11209 R16 l 20 July 2020 Non-Proprietary Information - Public

ENCLOSURE 2 M200084 GEH QAPD NEDO-11209-A, Revision 15 markup for Revision 16 Non-Proprietary Information - Public

GE Hitachi Nuclear Energy GE -Hitachi Nuclear Energy Americas LLC NEDO-11209-A 3901 Castle Hayne Road DRAFT CHANGES TO REVISION 15 Wilmington, North Carolina 28401 May 2020 Non-Proprietary Information - Public Quality Assurance Topical Report GE Hitachi Nuclear Energy Quality Assurance Program Description Title PREPARED BY:

CARMEN ALONSO, QUALITY PROGRAMS LEADER REVIEWED BY:

NEDO-11209-A Draft Changes to Revision 15 Disclaimer GEH Quality Assurance Program Description Page 2 of 103 DISCLAIMER This document was prepared by GE Hitachi Nuclear Energy Americas LLC (GEH) and is furnished solely for the purpose or purposes stated in the transmittal letter. No other use, direct or indirect, of the document or the information it contains is authorized. Neither GEH nor any of the contributors to this document:

Makes any representation or warranty (express or implied) as to the completeness, accuracy or usefulness of the information contained in this document or that such use of any information may not infringe privately owned rights; or Assumes any responsibility for liability or damage of any kind that may result from any use of such information.

UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Disclaimer GEH Quality Assurance Program Description Page 3 of 103 Insert Revision 16 Safety Evaluation here.

UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Revision History GEH Quality Assurance Program Description Page 4 of 103 REVISION HISTORY Revision Description Date Author E.L.

9 Complete re-write 06/28/10 Jordan Incorporation 12/09/10 E.L.

Page Section Change of NRC RAI Jordan responses i Title Page Reformatted and editorial 1-8 1 re-written (RAI 1 to 4) changes 9 2.1 Spelling 14 3.4 reworded (RAI 7) 18 3.6 Detail added (RAI 8) 29 7.8 Spelling 43 13.3 Detail added (RAI 9) 53 18.3.1 Detail added (RAI 11) 54 18.4 Reworded (RAI 11) 56 Appx. A Detail added (RAI 6)

Created Page Section Change 08/08/11 E.L.

Approved All All Jordan Added -A; August 2011 Final Version Mult. All NQA-1-2008 added to commitment statements of each sec.

iv - vii TOC Updated NA Inserted NRC Letter NA Added SE and RAIs Page Section Change 10 12/20/12 M. Gerdes All All General format changes to acronym references and text per writers guide and bulleted lists iv, v, TOC Updated vi, vii viii All Updated acronyms and abbreviations 1 1.1 Clarified QAPD adherents and removed org.

elements table 1 1.2.1, 1.2.1.1, Updated to reflect current organizational 1.2.1.2, 1.2.1.3 structure 3&4 1.2.2.3 Removed NQA & Support Services titles, which are now included in Quality Programs, combined P&L and Support Quality Leaders to Org. Specific Quality Leaders, added Continuous Improvement 4 1.4 Removed NQA title and added QA organization 6 Fig. 1 Replaced figure with new reflecting current organizational structure 7 Fig. 2 Replaced table with new reflecting current organizational structure 22 6.4 Clarified to current process for all temporary changes.

24 7.5 Clarified to remove conditionality of nonconformance reporting 28 7.10 Eliminated 1st bullet exception to Requirement 7

UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Revision History GEH Quality Assurance Program Description Page 5 of 103 Revision Description Date Author 33 10.2 Clarified to include how activities are defined 42 & 15.3 Eliminated 2nd sentence in Rework and Repair 43 definition to align with current procedure requirements 50 18.4 Updated to reflect current organization responsible for Internal Audits Page Section Change 10 All All Admin change to include -A on all page 1/21/2013 M. Gerdes headers 7 Fig. 2 Admin change to correct spelling of New Plant Projects Page Section Change 11 All All Reformatted text and sections 3/13/2014 R. Augi Multiple All Updated for organization changes Multiple Multiple Incorporated portions of NEDO-32280, GEH ISO-9001 Quality Management System into NEDO-11209 Multiple Multiple Clarified NQA-1 commitments All All Formatted overall structure of the QAPD to align with NEI-06-14 6 Policy Statement Added Policy Statement 9 Scope Moved Introduction to this section, Scope

/Applicability rewritten 16 1.7.1 Added Delegation Inside the GEH Organization 18 Figure 2 Deleted 21 2.8 Added Quality Assurance Program Description Management section 39 7.10 Added Perry Johnson to list of accredited calibration bodies 51 12.5.3 Added Out of Calibration section 57 16.1, 16.3, 16.4 Added Corrective Action Program details 65 18.3.3 Added Audit Performance section 67 Part III Added Supplemental Details 74 Part IV Moved Regulatory Commitments from Appendix A Page Section Change 12 21 2.8 Revised Quality Assurance Program Description 2/11/2015 R. Augi Management Section 2.8 29 3.10 Added Subpart 2.7 to Section 3.10 & 11.6 49 11.6 Commitments 77 Appendix A Added a new Appendix A for GEH Responses to NRC RAIs All All Added -A to NEDO-11209 13 Amendment 1 to Revision 12:

Submittal: MFN 15-091, Amendment to NEDO-11209-A Revision 12, GE Hitachi Nuclear Energy Quality Assurance Program Description, October 14, 2015.

Approval: MFN 16-040, Final Safety Evaluation for General Electric Hitachi Nuclear Energy Americas, LLC Amendment to NEDO-11209-A Revision 12, GE Hitachi Nuclear Energy Quality Assurance Program Description, June 6, 2016.

UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Revision History GEH Quality Assurance Program Description Page 6 of 103 Revision Description Date Author Page Section Change 8 Policy Statement Added the safety of its employees and the public 8/04/2016 R. Augi above all other demands to the first sentence and changed the GEH President and CEO from Caroline Reda to Jay Wileman.

10 Acronyms & Removed A2LA, ANS, GSC, IAS, LAS, MRA, Abbreviations NVLAP, PJLA 11 1.0 Added 10 CFR Part 71 (Subpart H) to sixth paragraph 15 1.3.3 Added Quality Control to Nuclear Oversight support 17 1.4.3 Removed Item 3: Deleted Profit & Loss Quality Leaders.

17 1.4.4 Item 1: Added option to report to Nuclear Oversight Senior Vice President.

18 1.5 Converted to numbered items, added 2. All personnel performing Quality Control activities shall be under the direction of the Quality organization and have access to the P&L Quality Leader.

19 Figure 1 Revised Organizational Structure, P&L Specific Quality Leaders solid line to Nuclear Oversight, dotted line to P&L Page Section Change 32 4.2 Added Quality Requirements Flow Down - The Supplier is to flow down appropriate quality assurance requirements in subtier procurement documents.

41, 42 7.10 Item 1: Changed calibration laboratory accreditation to reference NEI 14-05A in place of individual accreditation bodies.

Item 1: Removed ANS from ISO/IEC 17025 Item 2: Removed EPRI NP-5652 (including 89-02 and 91-05) from the commitment statement.

Updated consistent with the RAI response in MFN 16-026 dated April 15, 2016.

65 17.7.6 Item 2: Clarified wording for media environmental controls.

66 18.2 Added a new Item 4: Audit personnel shall not assess their own work.

70 1.3 Item 1: Changed Quality Council to Integrated Management Review.

70 1.3 Made the subject matter a separately numbered item (Item 2), and added Safety, health, environmental items; Security topics; Business Goals to subject matter.

71 2.1 Added Item 2: GEH manages information and knowledge as a resource and Item 3: Change is managed to assure each change is planned, controlled, communicated, monitored and tracked.

73 4.4 Added a new section entitled Graded Approach to Quality.

UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Revision History GEH Quality Assurance Program Description Page 7 of 103 Revision Description Date Author 76 Part IV Added Subpart H to 10 CFR Part 71, added regulations and to the first sentence and added NEI 14-05A to guidance documents.

Page Section Change 77 Appendix A Added GEH RAI responses from MFN 16-017 dated March 2, 2016 and MFN 16-026 dated April 15, 2016.

All All Changed the revision number in the header from 12 to 13 and changed the corporate entity from GE Power and Water to GE Power.

14 Amendment 1 to Revision 13:

Submittal: M170236, Amendment to NEDO-11209-A Revision 13, GE Hitachi Nuclear Energy Quality Assurance Program Description, October 6, 2017.

Approval: M180019, Final Safety Evaluation for GE Hitachi Nuclear Energy Amendment to NEDO 11209-A Revision 13, GE Hitachi Nuclear Energy Quality Assurance Program Description, January 10, 2018.

Page Section Change 01/19/2018 A. Peklaris 11 Acronyms and Added definitions for NOS and NPP; moved US Abbreviations NRC for alphabetical order.

PART I INTRODUCTION 12 1.0 Reuter Stokes to Reuter Stokes LLC Scope/Applicability 13 1.0 GS-R-3 to GSR Part 2 Scope/Applicability 13 1.0 Added LLC after Reuter Stokes Scope/Applicability PART II QAPD DETAILS 15 1.3.1 Profit and At end of first sentence, deleted including Loss Nuclear Fuels & Services and Nuclear Plant Organizations Projects.

15 1.3.1 Profit and Moved content previously in Sections Loss 1.3.1.1, 1.3.1.2 and 1.4.3 and modified it to Organizations reflect current organization structure and responsibilities.

15 1.3.1.1 Nuclear Section 1.3.1.1 has been deleted, its content is Fuels & Services included in paragraph 1.3.1 15 1.3.1.2 Nuclear Section 1.3.1.2 has been deleted, its content is Plant Projects included in paragraph 1.3.1 16 1.3.2 Support Updated this section to reflect new organization Organizations as shown on revised Figure 1 UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Revision History GEH Quality Assurance Program Description Page 8 of 103 Revision Description Date Author 18 1.4.3 Business Section 1.4.3 has been deleted; its content is Leaders for Profit now included in Section 1.3.1 and Loss Organizations (P&L) and Global Supply Chain Organizations 18 1.4.3 Business Paragraph has been deleted. Its content has Leaders for Profit been transferred into paragraph 1.3.1 and Loss Organizations (P&L) and Global Supply Chain Organizations 18, 19 Paragraph Paragraph numbers have changed to 1.4.3, numbers 1.4.4, 1.4.4, 1.4.5 respectively. Note that due to 1.4.5, 1.4.6, 1.4.7 functioning of track changes, previous sections are shown as 1.4.3.1, 1.4.4, 1.4.5, and 1.4.6 respectively.

21 Figure 1: Organization Structure has been changed to Organizational reflect current organization.

Structure PART III SUPLEMENTAL DETAILS 72 1.1 General In item2, added list of items GEH has Requirements accomplished to implement QMS.

72 1.2.1 Quality In item 1, added additional implementation goals Objectives for quality objectives.

72 1.2.2 Quality In item 2, described additional potential changes Management to the QMS.

System Planning 74 3.1 Planning of In item 5, first bullet, added risk and Product opportunities to the parenthetical phrase.

Realization 78 6.0 Safety Culture Added 5th item.

& Safety Conscious Work Environment 80 PART IV REGULATORY COMMITMENTS GS-R-3 changed to GSR Part 2 UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Revision History GEH Quality Assurance Program Description Page 9 of 103 Revision Description Date Author 15 Amendment 1 to Revision 14:

Submittal: M200066, Amendment to NEDO-11209-A Revision 14, GE Hitachi Nuclear Energy Quality Assurance Program Description, October 14, 2015.

Approval: M200077, Final Safety Evaluation for General Electric Hitachi Nuclear Energy Americas, LLC Amendment to NEDO-11209-A Revision 15, GE Hitachi Nuclear Energy Quality Assurance Program Description, May 26, 2020.

70, 71, & 72 18.5 5/22/2020 M. Gerdes Added External/Supplier Audit scheduling to address exigent conditions.

Added one RAI to Appendix A.

Added Appendix B for Historical SEs.

16 Amendment 1 to Revision 15:

Submittal: Mxxxxx, Amendment to NEDO-11209-A Revision 15, GE Hitachi Nuclear Energy Quality Assurance Program Description, xxx xx, 2020.

Approval: Mxxxxx, Final Safety Evaluation for General Electric Hitachi Nuclear Energy Americas, LLC Amendment to NEDO-11209-A Revision 16, GE Hitachi Nuclear Energy Quality Assurance Program Description, xxx xx, 2020.

1 Title Page Updated Quality SVP and Quality Programs TBD M. Gerdes titles Updated copyright date from 2017 to 2020 14 Acronyms Removed P&L - Profit and Loss and Added GL - Generic Letter Abbreviations Added RG - Regulatory Guide Added SVP - Senior Vice President All PART II and Updated overall formatting and section PART III numbering All PART II Changed commitments and references from NQA-1-2008 with 2009 Addenda to NQA 2015 PART I 15 & 16 1.0 Scope Removed GE Reuter Stokes LLC and Applicability Added services, related fuel services and decommissioning to statement for responsible activities PART II 17 1.2 Updated terminology for clarity 18 1.3.2 Updated to clarify Org Chart control in project plans and procedures 18 1.3.3 Rewritten to reflect new organization structure definitions and responsibilities.

Aligned section order and added details to clarify Operational and Functional Orgs Removed previous organizational details of Services, Fuels, NPP and Support Orgs 19 1.4.1 Removed reference to President of GE Power UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Revision History GEH Quality Assurance Program Description Page 10 of 103 Revision Description Date Author 19 & 20 1.4.2 Updated organizational titles to Quality from Nuclear Oversight, Quality Programs from Quality Oversight Removed Quality Oversight Leader Removed Performance Improvement Leader Updated Quality Leader reporting structure and responsibility details Removed Sourcing General Manager 20 1.5 Updated for Operational and Function Organization per 1.3.3 20 1.7.2 Updated to clarify Quality Control activities and Quality organization 21 1.8.2 Updated organizational titles to Quality from Nuclear Oversight, Quality Programs from Quality Oversight 21 1.9.1.3 Updated organizational titles to Quality from NOS 22 1.0 - Updated Figure 1 to reflect new Figure 1 organization/reporting structure 23 2.1.4 Updated Quality title from Nuclear Oversight 26 2.8.1, 2.8.2 Updated to add details related to management of the QAPD 27-33 3.1, 3.2, 3.3, Updated to reflect requirements and 3.4, 3.5, 3.6, terminology to NQA-1-2015 and alignment to 3.7 design processes 33 3.8 Added clarification to NQA-1-2015 Subpart 2.7 33 3.10 Added commitment to NQA-1-2015 Subpart 2.7 34 4.2 Added Software Errors as item covered in procurement documentation 41 7.6.3.2 Updated section title to Source Verification from Source Acceptance 44 7.10.1 Updated to reflect ISO/IEC 17025 2017 Edition from 2005 Edition 45 7.10.2 Updated commitment statement to NQA 2015 Subpart 2.14 52 11.2 Added 11.2.6 and 11.2.7 related to Acceptance Testing of computer programs 52 11.3.1 Updated title to Test Procedures from Test Procedures for Other than Computer Programs 52 11.3.2 Removed 11.3.2 with commitment to NQA 2015 Subpart 2.7 UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Revision History GEH Quality Assurance Program Description Page 11 of 103 Revision Description Date Author 53 11.5.3 to Removed 11.5.3 to 11.5.8 with addition of 11.5.8 11.2.6 and 11.2.7 and commitment to NQA 2015 Subpart 2.7 54 11.6 Updated commitment statement to NQA 2015 Subpart 2.7 66 1.7.4 Updated to clarify indexing of electronic documents 67 17.8 Removed GL 88-18 and RIS 2000-18 and added RG 1.28 Rev. 5 68 18.3 Updated title to Audit Planning and Performance from Audit Documentation 68 & 69 18.3.1 Updated to reflect requirements and terminology to NQA-1-2015 and alignment to processes 72 18.7 Added RG 1.28 Rev. 5 and removed RIS 2000-18 PART III 73 1.0 Updated title to Quality Management System and Processes from Management Responsibility Updated to reflect QMS acronym 74 & 75 2.2 & 2.3 Moved Sections 1.3 and 1.4 to section 2.0 as Added Section 2.2 Communication and 2.3 Management Review 74 2.0 Updated title to Support Management from Resource Management 74 2.1 Updated title to Resources from Provision of Resources 75 3.0 Updated title to Operations from Product Realization 75 3.1 Updated title to Operational Planning and Control from Planning of Product Realization 76 3.2 Updated title to Requirements for Product and Services from Customer Related Processes 77 3.3 Moved Graded Approach to Quality to 3.3 from 4.4 78 5.0 Updated title to Monitoring, Measurement, Analysis and Evaluation from Measurement, Analysis and Improvement PART IV 81 & 82 All Updated Part IV format to include section numbering and titles for:

Sec 1.0 QAPD Part I and Part II Commitments Sec 2.0 QAPD Part II Regulations and Standards References UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Revision History GEH Quality Assurance Program Description Page 12 of 103 Revision Description Date Author Sec 3.0 QAPD Part I and Part III Standards 81 1.0 Updated commitments to include titles Updated to NQA-1-2015 from NQA-1-2008 with 2009 Addenda and added position statement to clarify NQA-1-2015 Part I and Part II commitments 81 & 82 2.0 Updated standards applicable to GEH QAPD and GEH Quality Assurance Programs Updated reference to RG 1.28 to Revision 5 and added position statement for audit frequencies Added reference to RG 1.164 Revision 0 and removed reference to EPRI NP-5652, GL 02, and GL 91-05 Removed reference to GL 88-18 per NRC endorsement of RG 1.28 Updated reference to NIRMA Technical Guides TG-11, TG-15, TG-16 and TG-21, 2011 Editions, per NRC endorsement of RG 1.28, removed reference to RIS 2000-18, and added position statement for NIRMA TG-21 Added ML19056A451 (Provisional Recognition to ISO/IEC 17025, 2017 Edition)

Added statement clarifying use of additional standards 82 3.0 Added ISO 45001 removing OHSAS 18001:2007 Updated commitment statement clarifying use of addition standards APPENDIXES 83 Appendix A Moved GEH Responses to NRC RAIs to Appendix A TBD Appendix B Added Appendix B Historical NRC Safety Evaluations UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Revision History GEH Quality Assurance Program Description Page 13 of 103 POLICY STATEMENT GE Hitachi Nuclear Energy (GEH) is committed to the safety of its employees and the public above all other demands. GEH is committed to achieving the highest quality products and services through the disciplined application of the GEH Quality Management System (QMS).

GEH shall provide the required designs, components, materials, parts, and services in response to customer contract requirements and in full accord with applicable standards and regulations in a manner that will ensure the health and safety of the public and workers. These activities shall be performed in compliance with the requirements of the Code of Federal Regulations (CFR), the applicable Nuclear Regulatory Commission (NRC) Facility Operating Licenses, regulatory guidance documents, applicable laws and regulations of the state and local governments, and ISO 9001 (most recent edition).

GEH has developed and implemented a QMS in order to document the companys best business practices, better satisfy the requirements and expectations of its customers, and improve the overall management of the company. The GEH QMS is comprised of this Quality Assurance Program Description (QAPD) and the implementing procedures. Together they provide for control of GEH activities that affect the quality of safety-related nuclear plant structures, system, and components (SSCs) and include all planned and systematic activities necessary to provide adequate confidence that such SSCs will perform satisfactorily in service.

This QAPD may also be applied to certain equipment and activities that are not safety-related, but support safe plant operations, or where other NRC guidance establishes program requirements. GEH strives to continually improve the overall effectiveness of the Quality Management System.

The QAPD is the top-level policy document that establishes the manner in which quality is to be achieved and presents GEHs overall philosophy regarding achievement and assurance of quality. Implementing procedures assign more detailed responsibilities and requirements, and define the organizational interfaces involved in conducting activities within the scope of the QMS. Compliance with the QAPD and implementing procedures is mandatory for personnel directly or indirectly associated with implementation of the GEH QMS.

Jay Wileman President and CEO Date GE Hitachi Nuclear Energy UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Table of Contents GEH Quality Assurance Program Description Page 14 of 103 TABLE OF CONTENTS DISCLAIMER ................................................................................................................................................ 2 REVISION HISTORY .................................................................................................................................. 43 POLICY STATEMENT ............................................................................................................................ 1312 TABLE OF CONTENTS .......................................................................................................................... 1413 ACRONYMS AND ABBREVIATIONS ..................................................................................................... 1514 PART I INTRODUCTION ........................................................................................................................ 1615 1.0 SCOPE/APPLICABILITY ........................................................................................................ 1615 PART II QAPD DETAILS ........................................................................................................................ 1817 1.0 ORGANIZATION..................................................................................................................... 1817 2.0 QUALITY ASSURANCE PROGRAM ..................................................................................... 2623 3.0 DESIGN CONTROL................................................................................................................ 3027 4.0 PROCUREMENT DOCUMENT CONTROL ........................................................................... 3934 5.0 INSTRUCTIONS, PROCEDURES, AND DRAWINGS ........................................................... 4136 6.0 DOCUMENT CONTROL ........................................................................................................ 4237 7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES ......................... 4439 8.0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS.......... 5146 9.0 CONTROL OF SPECIAL PROCESSES ................................................................................ 5348 10.0 INSPECTION .......................................................................................................................... 5449 11.0 TEST CONTROL .................................................................................................................... 5752 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT ........................................................ 6155 13.0 HANDLING, STORAGE, AND SHIPPING .............................................................................. 6357 14.0 INSPECTION, TEST, AND OPERATING STATUS ............................................................... 6458 15.0 NONCONFORMING MATERIAL OR COMPONENTS .......................................................... 6559 16.0 CORRECTIVE ACTION PROGRAM ...................................................................................... 6761 17.0 QUALITY ASSURANCE RECORDS ...................................................................................... 6963 18.0 AUDITS .............................................................................................................................. 7468 PART III SUPPLEMENTAL DETAILS..................................................................................................... 7973 1.0 QUALITY MANAGEMENT SYSTEM AND PROCESSES...................................................... 7973 2.0 SUPPORT MANAGEMENT.................................................................................................... 8174 3.0 OPERATIONS ........................................................................................................................ 8275 4.0 PRODUCTION AND SERVICE PROVISION ......................................................................... 8477 5.0 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION ...................................... 8578 6.0 SAFETY CULTURE & SAFETY CONSCIOUS WORK ENVIRONMENT .............................. 8780 PART IV REGULATORY COMMITMENTS ............................................................................................ 8881 APPENDIX A: GEH RESPONSES TO NRC RAI ................................................................................... 9083 APPENDIX B: HISTORICAL NRC SAFETY EVALUATIONS (SE) ...................................................... 10396 UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Acronyms and Abbreviations GEH Quality Assurance Program Description Page 15 of 103 ACRONYMS AND ABBREVIATIONS Acronym Definition ASME American Society of Mechanical Engineers CAQ Condition Adverse to Quality CFR Code of Federal Regulations EHS Environmental Health and Safety EPRI Electric Power Research Institute GEH GE Hitachi Nuclear Energy GL Generic Letter GNF Global Nuclear Fuel IEC International Electrotechnical Commission ILAC International Laboratory Accreditation Cooperation ISO International Standards Organization M&TE Measuring and Test Equipment QA Quality Assurance QAP Quality Assurance Program QAPD Quality Assurance Program Description QMS Quality Management System P&L Profit and Loss Center RG Regulatory Guide RIS Regulatory Issue Summary SCAQ Significant Condition Adverse to Quality SSC Structures, systems and components SVP Senior Vice-President US NRC United States Nuclear Regulatory Commission UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part I GEH Quality Assurance Program Description Page 16 of 103 PART I INTRODUCTION 1.0 SCOPE/APPLICABILITY This Quality Assurance Program Description (QAPD) implements the GE Hitachi Nuclear Energy (GEH) Quality Management System and has been adopted by the following companies affiliated with the General Electric Company (GE) and the GE Power business unit that are engaged in providing products and services to the nuclear power industry and which have agreed to be bound by the provisions of this QAPD, including the assignment of authority and responsibility set forth herein:

GE -Hitachi Nuclear Energy LLC GE -Hitachi Nuclear Energy Americas LLC GE -Hitachi Nuclear Energy International LLC Global Nuclear Fuel Americas LLC Global Nuclear Fuel Japan Ltd.

GE Reuter-Stokes LLC The companies that have adopted this QAPD have authorized the President and Chief Executive Officer (hereinafter the President) of GE -Hitachi Nuclear Energy LLC to establish the quality program as described in this document and have committed each of the companies to implement the quality program.

Additional companies affiliated with GE may adopt this QAPD in the future by agreeing to be bound by its provisions. For ease of reference this QAPD is identified as a topical report issued by GE -Hitachi Nuclear Energy (GEH) notwithstanding that it has been adopted by the companies identified above. References to GEH in this QAPD shall be interpreted to refer to and apply to each of the companies that have adopted this QAPD with compliance verified by periodic audits and self-assessment activities.

The companies that have adopted this QAPD are comprised of both operating components and business-specific organizations. These organizations are responsible for activities including, but not limited to, marketing, design, procurement, manufacture, installation, inspection, testing, servicing, project management, and operation of certain nuclear power plant products, services, fuel and fuel related services, and radioactive material packaging and transportation, and decommissioning. GEH also offers new plant designs and engineering services such as system studies, diagnostics, fuel and service analyses, and product and service testing.

This QAPD is divided into the following parts:

Part I: Introduction Part II: QAPD Details (per 10 CFR 50 Appendix B)

Part III: Supplemental Details Part IV: Regulatory Commitments Part II of this QAPD describes the portion of the QMS required to meet the requirements of the United States of America contained in 10 CFR Part 50 Appendix B, 10 CFR Part 71 (Subpart UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part I GEH Quality Assurance Program Description Page 17 of 103 H), 10 CFR Part 21, and ASME NQA-1-20152008 Edition with the NQA-1a-2009 Addenda.

Specifically, it applies to work involving structures, systems and components (SSC) for nuclear power plants and fuel reprocessing plants that prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public. GEH may extend this program to other areas that do not meet these criteria.

Part III addresses the supplemental portions of the QMS that are not specifically addressed by 10 CFR 50 Appendix B or NQA-1 to create an integrated quality program for projects that may refer to ISO 9001, GSR Part 2 , KTA-1401 and other standardss as applicable. Part III is not reviewed or approved by the NRC.

In some cases, Part II and Part III of this QAPD are supplemented by quality plans at specific locations or functional areas of GEH to assist in the implementation of the specific requirements for those activities. In all cases, this QAPD will be a referenced document. Regardless, this QAPD document is the overall description of the GEH Nuclear Energy Quality Assurance Program that implements the GEH Quality Management System. When there are conflicts between the requirements of any of these documents, the QAPD shall be followed, and the conflict shall be reported in accordance with Part II, Section 16 of this document.

This QAPD is applicable at the following GEH facilities and other locations performing contracted services:

Wilmington, NC San Jose, CA Pleasanton, CA (Vallecitos Site)

Twinsburg, OH (Reuter Stokes LLC)

Philadelphia, PA (Service Shop)

Kurihama, Japan (NOTE: GNF-J utilizes Part I and II of this QAPD for 10 CFR 50, Appendix B activities. GNF-J maintains a separate ISO quality program that is not covered under the scope of this QAPD)

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 18 of 103 PART II QAPD DETAILS 1.0 ORGANIZATION General This Section describes the GE Hitachi Nuclear Energy (GEH) organizational structure, functional responsibilities, levels of authority and interfaces for establishing, executing, and verifying the Quality Assurance Program Description (QAPD).

The GEH organizational structure encompasses those positions responsible for establishing, managing, implementing, verifying, interpreting, and continually improving the GEH Quality Management System (QMS).

This QAPD describes the relationships of organizations within GEH, and between GEH and principal contractors, in regard to responsibilities and authority for performing activities within the scope of the QAPD.

Adherence to this QAPD includes the organizational elements located at the GEH headquarters facility in Wilmington, NC and all satellite facilities of GEH.

Additionally, adherence to this QAPD may be applied to work performed at customer or supplier locations where required by either regulations or contract requirements.

Management Commitment The GEH businesses shall implement this quality program and demonstrate, by performance inside outside and outside ofinside the Company, total dedication to the attainment of quality leadership.

GEH management is committed to implement and maintain the QMSa Quality Management System and continually improve its effectiveness by:

Communicating to the organization the importance of meeting customer, statutory and regulatory requirements Establishing the quality policy Ensuring that quality objectives are established Conducting management reviews Ensuring the availability of resources GEHTop management ensures that allthe quality programs are communicated to all employees. To achieve this, any or all of the following may be used:

Company communications All employee meetings Staff meetings Internal correspondences and memos Training Organizational Structure For the purposes of managing the GEH QMSQuality Management System, the organizational structure is shown in Figure 1.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 19 of 103 Organizational Charts that depict typical organizational structure and functional descriptions are controlled and included in applicable plans, procedures and instructions and, as necessary, in project plans and /procedures for specific work/project related work to be performed.

1.3.3.1 The GEH business includes Operational Organizations that are comprised of operational segments responsible for project management, product and services management and delivery, continued plant operations support, and development of new plants, technologies and related offerings to the industry. These organizations are established to comply with regulatory requirements.

1.3.3.2 The GEH business includes Functional Support Organizations that are responsible for facilitating and supporting the activities of the Operational Organizations. These Functional Support Organizations include key functions such as Quality, Engineering, Manufacturing Operations and Sourcing. Additional groups include but are not limited to Sales, Commercial Operations, Finance, Human Resources, Legal/Compliance, and Government Affairs.

1.3.3.3 The Quality Organization is responsible for managing and supporting implementation of the QMS and the QAPD with responsibility for Quality Programs and Quality Oversight.

1.3.3.1 The GEH business is comprised of distinct areas with financial responsibility for delivery of products and services called Profit and Loss Organizations (P&Ls)

Activities performed by the Operational or Functional Support organizations that affecting quality are performed under the direction of Executive management, normally Senior Vice Presidents (SVPs),Business Leaders who report to the Ppresident for purpose of the responsibilities of this QAPD.

1.3.3.21.3.3.4 Business Leaders ensure that personnel working under their management are trained in accordance with written procedures; and that only trained personnel are permitted to perform activities affecting quality.

1.3.3.31.3.3.5 Reporting to the SVPs are Business Leaders may be Managers or Technical Leaders, who have been trained in accordance with the QAPD and in accordance with implementing the written procedures.

1.3.3.6 The SVPs, Managers, and Leaders ensure that personnel working under their direction are trained in accordance with written procedures and ensure that only trained personnel are permitted to perform activities affecting quality.

1.3.3.4 These individuals managers and leaders are tasked with assuring that only trained personnel are permitted to perform those activities for which they are qualified.

1.3.3.5 The Services organization includes multiple business segments responsible for the marketing and/or delivery of all non-fuel parts and services to GEH nuclear power plant customers worldwide including: design and engineering, UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 20 of 103 manufacturing, replacements, inspections, and modified/repaired products provided to comply with regulatory requirements, support continued plant operation, or to improve plant performance.

1.3.3.6 The Fuels organization includes multiple business segments responsible for marketing and/or delivery of all fuel related parts and services to nuclear power plant customers worldwide including: design and engineering, manufacturing of replacement parts, inspections, and modified/repaired products provided to comply with regulatory requirements, support continued plant operation, or to improve plant performance. Fuel may provide field services at the clients site or at a GEH authorized service facility.

Activities performed at the customer site locations or GEHs authorized service facilities are controlled by quality plans, procedures and instructions, as applicable.

1.3.3.7 Nuclear Plant Projects (NPP) has the primary responsibility to manage development, design, analysis, procurement, and construction of nuclear power plants.

1.3.3.8 Support Organizations 1.3.3.9 Support Organizations facilitate the activities of the P&Ls and include:

1.3.3.10 Engineering 1.3.3.11 Sourcing 1.3.3.12 Nuclear Oversight 1.3.3.13 Quality 1.3.3.14 Regulatory Affairs 1.3.3.15 Environmental Health and Safety 1.3.3.16 Other organizations include but not limited to, Finance, Commercial (Sales and Marketing), Communications, Legal, Human Resources and Digital Technology.

1.3.3.17 Nuclear Oversight 1.3.3.18 The Nuclear Oversight organization supports the business by providing:

1.3.3.19 Quality Control 1.3.3.20 Quality Oversight 1.3.3.211.3.3.7 Performance Improvement, including the Corrective Action Program Management Positions Key organizational management positions are described below. The specific organizational titles for the quality assurance functions are identified in procedures.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 21 of 103 The authority to accomplish the quality assurance functions described is delegated to the incumbents staff as necessary to fulfill the identified responsibility. Any internal disagreements that cannot be resolved through the system described in this QAPD are to be submitted to the Presidents office for resolution.

1.4.1.1 The President reports to the President of GE Power and the Governing Board of GE-Hitachi Nuclear Energy LLC.

1.4.1.21.4.1.1 The President has executive responsibility and sets appropriate directives, policiesy, goals and objectives to ensure the total quality of all GEH products and services.

1.4.1.31.4.1.2 The President retains specific duties and responsibilities that cannot be delegated. These include but are not limited to:

Approving this QAPD through the Statement of Policy Establishing the GEH organizational structure, including the organizational roles, responsibilities, authority and accountability Integrating quality assurance program activities into overall business activities Monitoring key performance indicators as part of a management review 1.4.1.41.4.1.3 The GEH President has established forums for communication and periodic reviews of quality objectives and business commitments with the business segments and quality management, including but not limited to:

Periodic reviews of business and quality objectives (customer scorecards, delivered product defects, corrective actions, trends, and process improvements)

Management reviews of the status and adequacy of the GEH Quality Management System 1.4.2.1 The GEH Nuclear Oversight (NOS) Quality Senior Vice President (SVP) reports to the President and Chief Executive Officer.

1.4.2.2 The GEH Nuclear Oversight (NOS) Quality SVP is responsible for governance and implementation of the QAPD in accordance with regulatory requirements and GEH company requirements/commitments.

1.4.2.3 The Quality NOS SVP reports to top management on the performance of the quality program and any need for improvement.

1.4.2.4 The Quality NOS SVP is responsible for maintaining this QAPD and an organization that is appropriately staffed to effectively manage its duties and responsibilities, including but not limited to, performance of audits and oversight activities to ensure adherence to and effectiveness of the overall quality assurance program.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 22 of 103 1.4.2.5 The Quality NOS SVP assigns the responsibility to appropriate quality groups leaders in the business the authority and organizational freedom to carry out the following:

a) Iidentifyication of quality assurance issues; b) Iinitiateion of corrective action; c) Verifyverification that required action has been properly implemented; d) Llimitation to or control of further processing, delivery or installation of a nonconforming item, or an unsatisfactory condition until proper disposition has occurred; e) performance of audits for the adherence to and effectiveness of the overall quality assurance program; and f)e) Ffreedom to oversee and verify compliance with the regulatory requirements and industry and international standards.

1.4.2.6 Quality Oversight Leader 1.4.2.6.1 The Quality Oversight Leader reports to Nuclear Oversight (NOS) Senior Vice President (SVP) 1.4.2.6.2 The Quality Oversight Leader is assigned the responsibility for the activities of quality program audits to assess the effectiveness of implementation of the requirements set forth in this QAPD.

1.4.2.6.3 Additional responsibilities include the implementation of cross-functional and cross-organizational activities as assigned by the GEH NOS SVP.

1.4.2.6.41.4.2.5.1 This structure is designed to provide sufficient independence from cost and schedule when opposed to quality and safety considerations, provides the required independence between the performers and the verifiers, and enables a direct line of communication to the Quality SVP and PresidentNOS SVP.

1.4.2.7 Performance Improvement Leader 1.4.2.7.1 A representative from the NOS Organization who reports to the GEH NOS SVP and is assigned the responsibility for ensuring business results are achieved through effectively monitoring performance, identifying specific actions to improve less-than-expected performance, and implementing change to improve performance.

1.4.2.7.2 The Performance Improvement Leader has the responsibility to implement the GEH Corrective Action Program.

1.4.2.81.4.2.6 Profit & Loss Quality Leaders 1.4.2.8.11.4.2.6.1 The Quality Leaders are assigned the responsibility to support the implementation of the quality requirements set forth in this QAPD within their assigned organizations.Representatives from the P&L Organization who report directly to the GEH NOS SVP and dotted line to the P&L Business Leader or who report directly to the P&L Business Leader and dotted line to the GEH NOS SVP and are assigned the responsibility to support the implementation of the quality requirements set forth in this QAPD for the organization they are assigned.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 23 of 103 1.4.2.8.21.4.2.6.2 These Quality Leaders are responsible for verification that administrative controls are implemented or assuring that an activity has been correctly performed within their assigned organizations.

1.4.2.8.31.4.2.6.3 This verification includes leadership of quality engineers, inspection personnel, and performance of independent inspectionsassessment or verification activities.

1.4.2.6.4 The Quality Leaders report to the Quality Organization and indirectly to the Operational or Functional Organizations or may report to the Operational or Functional Organizations and indirectly to the Quality Organization.

1.4.2.8.41.4.2.6.5 This structure is designed to provide sufficient independence from cost and schedule when opposed to quality and safety considerations, provides the required independence between the performers and the verifiers, and enables a direct line of communication to the Operational or Functional Leaders Business Leader and the Quality NOS SVP.

1.4.2.9 Sourcing General Manager 1.4.2.9.1 The Sourcing General Manager is responsible for the quality management of the GEH supplier base.

1.4.2.9.2 The Sourcing General Manager is responsible for providing a process for receiving inspection activities.

Organizational and Functional Responsibilities The functional responsibilities of the Operational and Functional OrganizationsP&L Organizations, Support Organizations, and the NOS Organization are detailed in implementing procedures.

Interface Responsibilities Interfaces are defined in one of two methods: either through policy in the case of defining interfaces between legal entities, or by procedures.

Responsibilities of all Employees and Contractors All employees and contractors are responsible for the following:

Ensuring strict compliance with laws and regulations pertaining to the quality, safety, and performance requirements in every country where GEH products and services are offered.

Incorporating quality during in their routineall work activities such as, but not limited to: qualifying suppliers; preparing, reviewing, verifying, and approving designs; purchasing; preparing procurement documents; manufacturing; installation; assessing; and controlling records.

Reporting conditions that are not consistent with the requirements of the QAPD through the Corrective Action Program.

All personnel performing Quality Control activities shall be under the direction of the Quality organization for implementation of the quality requirements set forth in this QAPD and have access to the Quality SVPP&L Quality Leader.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 24 of 103 Authority to Stop Work All employees and contractors have the authority and responsibility to stop work if continuing the work is or could be detrimental to the final product or would be masked by successive manufacturing activities or if the activity is not compliant with the procedural guidance or would create an unsafe condition.

The GEH NOS Quality SVP, Nuclear OversightQuality Programs organization and the P&L Quality Leaders have the authority and the responsibility to issue a stop work notice and control further processing, delivery, installation, or use of nonconforming products or services.

This authority is to ensure that cost and schedule considerations do not override quality or safety considerations.

Delegation 1.9.1.1 Each Manager, Supervisor or Leader may assign the performance of their duties to their direct reports who are qualified to perform such duties. However, the responsibility for those duties cannot be assigned or delegated.

1.9.1.2 Managers, Supervisors or Leaders, if qualified, may perform the work for their subordinates.

1.9.1.3 Sufficient authority to accomplish the assigned tasks is also delegated, although Tthe President, Quality NOS SVP and other positions identified herein retain overall responsibility for the program although authority to accomplish assigned tasks may also be delegated.

Major dDelegation of work to participants outside of the GEH Quality Assurance Program, such as subcontractors or suppliers, will be identified and described as follows:

The organizational elements responsible for the delegated work are identified and documented.

Management controls and lines of communication between the GEH designated person and the delegated organization are identified and documented.

Responsibility for the Quality Assurance Program and the extent of management oversight is established.

The performance of delegated work is formally evaluated.

Commitment In establishing its organizational structure, GEH commits to compliance with 10 CFR Part 50 Appendix B, Criteria I, and NQA-1-20152008 Edition, with the NQA-1a-2009 Addenda, Requirement 1.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 25 of 103 FIGURE 1: ORGANIZATIONAL STRUCTURE UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 26 of 103 2.0 QUALITY ASSURANCE PROGRAM General This section describes the GE Hitachi Nuclear Energy (GEH) quality assurance program, as documented through this Quality Assurance Program Description (QAPD) and its implementing policies, procedures and instructions, and identifies the associated requirements for planning, implementing, monitoring, and maintaining the program. This program was documented, approved, and implemented prior to the commencement of the activities within its scope.

The quality assurance program is maintained and continually improved through the use of quality policies, quality objectives, periodic audit and assessment results, analysis of data, corrective and preventive action, and periodic management review.

The quality program is binding on all companies that have adopted this QAPD, including participating organizations from the President to all employees and contractors whose activities may influence quality.

Controls are provided over activities affecting quality to an extent consistent with the importance of those activities.

The President, Nuclear Oversight Quality SVPSenior Vice President and other positions identified herein retain and exercise the responsibility for the scope and implementation of an overall QAPD.

Activities performed at GEH that are included in the scope of this QAPD include but are not limited to: training, indoctrination and certification of personnel; design activities; procurement; instructions, procedures and drawings; document control; control and identification of purchased material parts and components; special processes; test and inspection; control of Measuring and Test Equipment (M&TE);

handling, storage and shipping; maintenance of test, inspection and operating status of items; control of nonconforming material,; corrective action;, records, and audits.

Project, product, or service specific Quality Plans may be developed to supplement the requirements of this QAPD and provide for specific contractual requirements and alternate quality assurance standards when necessary.

Controlled Conditions Planning and performance of activities affecting quality are accomplished under suitably controlled conditions as delineated in appropriate implementing procedures and instructions.

Controlled conditions include:

The use of appropriate equipment (hardware and software)

Suitable workspace and utilities Suitable environmental conditions for accomplishing the activity, such as adequate cleanliness Supporting services to achieve conformity to product and service requirements UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 27 of 103 Assurance that all prerequisites for the given activity have been satisfied.

Special controls, processes, test equipment, tools, and skills to attain the required quality of activities or items and verification are provided.

Work environment in the manufacturing, assembly, inspection, test, and material storage areas is maintained as required to achieve conformity to product specifications, applicable standards, and regulations.

GEH policies, procedures and instructions related to Quality and Environmental Health and Safety, define the implementation of requirements for adequate and safe facilities and plant activities.

Indoctrination and Training GEH personnel indoctrination and training is commensurate with the scope, complexity, and importance of the activities; and with the education, experience, and proficiency of the personnel performing the activity.

Training shall be provided to achieve initial proficiency, maintain proficiency, and adapt to changes in technology, methods, or job responsibilities.

On-the-job training shall be used if direct hands-on applications or experience is needed to achieve and maintain proficiency.

Personnel performing or managing activities affecting quality receive indoctrination and training in their job responsibilities and authority, that includes general criteria, technical objectives, requirements of applicable codes and standards, regulatory commitments, company procedures, and quality requirements.

Records of indoctrination and training include the employees name, topic covered and date of completion.

Qualification Requirements Quality-related activities that require qualification of personnel are listed in this section.

Qualification is controlled by written procedures and only those personnel who have met the requirements are permitted to perform these activities.

The qualification of inspection, test, auditor, lead auditor and special process personnel shall be certified in writing and records thereof maintained.

The need for initial and periodic special physical characteristics and physical examination of personnel shall be identified, and copies of appropriate objective evidence shall be retained.

The companies that have adopted this QAPD shall have a written practice for qualification of nondestructive examination personnel who perform processes such as ultrasonic, radiographic, magnetic particle, liquid penetrant, electromagnetic, leak, or visual examination in accordance with applicable industry codes and standards.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 28 of 103 Procedures specify minimum initial capabilities, education, experience, and training, as well as, examination, performance, re-evaluation periods, and permissible gaps in activity, for inspection and test personnel.

2.4.7.1 Requirements for a lead auditors qualification are defined in written procedures.

2.4.7.2 The evaluation criteria include education, experience, communication skills, training, audit participation, examination as well as maintenance of proficiency and requalification.

2.4.7.3 Audit team members, including technical specialists, shall have, or be given, appropriate training (including orientation) to develop their competence for performing audits.

Detection and Correction of Quality Problems A corrective action program has been established to document quality problems, assign actions to correct the problem, take preventative steps to prevent reoccurrence, and to verify effective remediation.

The corrective action program is described in Section 16 of this QAPD.

Assessment of Effectiveness Quality personnel monitor activities affecting quality against acceptance criteria to ensure satisfactory performance. These criteria are outlined in implementing procedures.

GEH management reviews the GEH Quality Management System to ensure its continuing suitability and effectiveness. The review is performed to integrate and communicate quality-related matters, problems, corrective actions, status and effectiveness of assigned projects for continuous improvement, and annual reports on the status and adequacy of the quality management system to the top level management. These reviews identify opportunities for improvement and needed changes. Records are maintained of the management review meetings.

2.6.2.1 During management reviews, typical input includes the following:

Results of audits and assessments Customer feedback Customer and regulatory requirements Process performance and product conformity Status of corrective and preventive actions Follow-up actions from previous management reviews Planned changes that could affect the Quality Management System Recommendations for improvement 2.6.2.2 Output from the management review shall include decisions and actions related to the following:

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 29 of 103 Improvement of the effectiveness of the Quality Management System and its processes Improvement of product related to customer requirements Resource needs to ensure proper implementation of the Quality Management System, and assignment of responsibilities for completing actions Managers review those portions of the program under their area of responsibility.

To ensure effective implementation, these reviews take place at least once each fiscal year.

Grace Period A grace period of 90 days may be applied to provisions that are required to be performed on a periodic basis unless otherwise noted. The grace period does not allow the clock for a particular activity to be reset forward. The clock is reset backwards by performing the activity early.

Quality Assurance Program Description Management Proposed changes to this QAPD are submitted to the NRC for review and approval per 10 CFR 50.4(b)(7)(ii). The proposed changes will be termed amendments to the QAPD and will be presented as markups of the then current approved accepted version along with a basis discussion for each change.

Upon receipt of the NRC approval Safety Evaluation (SE) and acceptance of each amendment, the QAPD revision shall be revised finalized and issued as NEDO-11209-A and with the revision Draft designation removed and the revision number incremented. The SEs forE each previous NRC approved accepted amendment, with the associated changes, is illustrated in the Revision History located are provided in Appendix Bthe front of this document. The SE for the current revision is placed after the Disclaimer page in the front of the document.

Commitment In establishing its Quality Assurance Program, GEH commits to compliance with 10 CFR Part 50 Appendix B, Criteria II and NQA-1-20152008 Edition with the NQA-1a-2009 Addenda, Requirement 2.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 30 of 103 3.0 DESIGN CONTROL GENERAL This section describes the GE Hitachi Nuclear Energy (GEH) program that ensures allThe engineering organizations of the companies that have adopted this Quality Assurance Program Description (QAPD) have overall responsibility for the control of the design process from its inception to the final result.

In controlling the design process the goal is to ensure that a design and its associated design documentation meet all applicable technical requirements, regulatory requirements, codes and standards, and contractual requirements.

The GE Hitachi Nuclear Energy (GEH) design program extends to the control of the design, the control of design changes, and to temporary modifications to structures, systems, components, and software (including design reports) subject to the provisions of this QAPD.

This section describes control of the design inputs, design processes, design analyses, design verification, change control, interface control, Quality Assurance (QA) responsibilities, and documentation and records.

Design control ensures that design inputs are correctly translated into design outputs (such as specifications, drawings, procedures, reports, and instructions) so that the final design output can be related to the design input in sufficient detail to permit verification.

Design Inputs Engineering is responsible for identifying and documenting design inputs for each design project.

Sources of design input may include: customer specifications, design bases, previous similar designs, regulatory requirements, functional requirements, and industry standards as well as other technical, commercial, and performance requirements.

The design inputs are specified to the level of detail necessary to permit the design activities to be carried out in a correct manner and to provide a consistent basis for completing design activities, making design decisions, accomplishing design verification, and evaluating design changes.

Each design requires that the design inputs be verified. The purpose of this verification is to determine whether the design inputs were correctly selected and whether the assumptions made to perform the design activity were adequately identified and reasonable.

Applicable information derived from plant operating and construction experience is made available to the responsible organization as appropriate.

When structures, systems, and components (SSC) necessary for safety are selected for a design, the selection and review criteria are conducted according to implementing procedures.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 31 of 103 When GEH performs design activities for nuclear licensees, GEH records may not contain all necessary design information. In such cases, GEH will need to obtain and documentverified design inputs from the licensee for use in the design and document them in the GEH records storage system.

Design Process 3.3.1.1 The Engineering organization develops and maintains procedures that comply with the requirements of this QAPD and that specify the activities that are to be performed in each design project. The procedures related to design and development processes describe the details of the design and development stages with responsibilities and authorities; and appropriate review, verification, and validation activities.

3.3.1.2 For each specific design project, the GEH design organization documents and organizes the design information in sufficient detail to permit the design process to be performed in a correct manner, and to permit verification that the design meets requirements.

3.3.1.3 Appropriate quality standards are also identified and their selection reviewed and approved.

3.3.2.1 The design methods, materials, parts, equipment, and processes that are essential to the function of the structures, systems, and components (SSC) or to the completion of a design report are selected and independently reviewed for suitability for their intended application.

3.3.2.2 Design methods are documented, controlled, reviewed, and approved as applicable. Where design activities are repeated, documented design methods are reviewed on a periodic basis to confirm continued applicability and updated as necessary.

3.3.2.3 The design organization may also maintain applicable lessons learned information derived from experience for use by responsible design personnel.

3.3.3.1 The engineering organizations are responsible for delivering design output that meets design process requirements to ensure that the design result:

Is based upon and accurately incorporates verified design inputs Is documented in sufficient detail to permit the design to be recreated independently in the absence of the original designer Is relatable to the design input by documentation in sufficient detail to support design verification Defines criteria for inspections and tests when they are required Includes or references to appropriate acceptance criteria UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 32 of 103 Identifies assemblies and/or components that are part of the item being designed For commercial grade items refer to Section 7.8 of this QAPD 3.3.3.2 To ensure that design inputs are properly related to the design results by design documentation, design results are subjected to a design verification process that requires an independent reviewer to verify that the design complies with the customer requirements, technical requirements, regulatory requirements, and codes and standards.

3.3.3.3 The verifier ensures that appropriate design methods are used, that design inputs are correctly incorporated into the design and that the design output is reasonable when compared with the design input.

3.3.3.2 Applicable information derived from plant operating and construction experience is made available to the responsible organization as appropriate.

3.3.3.43.3.3.3 Characteristics critical to the safe and proper functioning of the product are classified and designated on the appropriate drawings and specifications according to implementing procedures or appropriate international practices specified by the customer.

3.3.3.53.3.3.4 The design and development outputs provide information for purchasing, production, and product acceptance criteria.

3.3.3.63.3.3.5 Requirements for special processes such as welding, heat-treating, and nondestructive examination are specified on design documentation by the GEH engineer responsible for the design.

Design Analyses Design analyses are sufficiently detailed such that a person technically qualified in the subject can review and understand the analyses and verify the adequacy of the results without recourse to the originator.

3.4.1.1 Each computer program used for design analysis is accepted for use and controlled by applying the applicable requirements of this section prior to use (i.e.,

pre-verified or controlled computer programs), or the computer programs results are independently verified with the design analysis for each applicationComputer programs used for design analyses include commercially purchased software and software developed for specific applications.

3.4.1.2 The acceptance of controlled computer programs used for design analysis, and verification methods applied to the results of unproven programs, meet the following requirementsThe results of computer programs used for design analysis are verified with each use or pre-verified to show the following:

The computer program, or the verification method applied to the computer program results, produces correct solutions for the appliedencoded mathematical model within defined limits for each parameter employed.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 33 of 103 The appliedencoded mathematical model produces a valid solution to the physical problem associated with the particular application.

3.4.1.3 Pre-verified computer programs are controlled to ensure that changes are documented and approved by authorized personnel.

3.4.1.4 When pre-verified computer programs are used, the encoded mathematical model does not need to be verified.

3.4.2.1 Documentation of design analyses is legible, reproducible, and includes the following:

Identification of the person responsible for the design The scope and/or objective of the analyses Design inputs and their sources Results of literature searches or other background data if applicable Assumptions and indication of those assumptions that must be verified as the design proceeds Methods and equations that are implemented in computer programs, or if a pre-verified computer program is used, the computer type, program name and revision, and confirmation that the computer program is used within its approved application Design results, conclusions, and output Review and/or verification and approval A record of comments made or issues raised during review and/or verification, and the resolution of those comments and issues Identification of the persons originating and performing the review, verification and approval Identification of the system or component for which the calculation applies Design calculations are identified by subject including the system or component to which the calculation applies, the preparer, the verifier, and date generated, or other pertinent information so that calculations are retrievable.

Design and Development Review 3.4.4.13.4.3.1 The design and development activities are reviewed according to the requirements of the related design review procedures. The review process evaluates design outputs against input requirements; and provides an opportunity to take actions on any problems identified.

3.4.4.23.4.3.2 The review team consists of representatives of functions concerned with the activity.

3.4.4.33.4.3.3 Records of the results of the reviews and any necessary actions are maintained.

Design Verification UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 34 of 103 The companies that have adopted this QAPD have a design verification program that ensures that design inputs, calculations, changes, and results are independently reviewed and approved by personnel other than the preparer of the design or design document.

3.5.1.1 The responsible design organization identifies and documents the design verification scope and method(s) used.

3.5.1.2 The results of design verification are documented with the identification of the verifier clearly indicated.

3.5.1.3 Design verification is performed by one or more competent individuals or groups other than those who performed the design but who may be from the same organization.

3.5.1.4 This verification may be performed by the originators manager, provided:

a) the manager did not specify a singular design approach or rule out certain design considerations and did not establish the design inputs used in the design; and b) the manager is the only individual in the organization competent to perform the verification 3.5.2.1 Design verification is performed prior to releasing the design for procurement, manufacture, construction, licensing applicationsubmittal or use by another design organization, except where this timing cannot be met, such as when insufficient data exist. In those cases, the unverified portion of the design is identified and controlled as unverified or conditional.

3.5.2.2 In all cases the design verification is completed prior to relying upon the component, system, structure, or computer program to perform its intended function.

If the design is modified to resolve verification findings, the modified design is verified prior to release or use.

3.5.4.1 The extent of the design verification is a function of the importance to safety, the complexity of the design, the degree of standardization, the state of the art and the similarity with previously proven designs.

3.5.4.2 The extent is defined by the originator in the verification scope, agreed to by the verifier, and approved by the managersupervisor.

3.5.4.3 Where the design has been previously verified, the verification extent or scope may be reduced; verification need not be duplicated for identical designs.

However, the applicability of previously verified designs, with respect to meeting pertinent design inputs, is verified for each application.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 35 of 103 3.5.4.4 Known problems affecting previously verified designs and their effects on other features are considered.

3.5.4.5 The original design and associated verification documentation are referenced in records of subsequent application of the verified design.

Acceptable verification methods include, but are not limited to, any one or a combination of the following:

3.5.5.1 Design Reviews 3.5.5.1.1 Design reviews for verification may be performed by an individual or by a team.

3.5.5.1.2 A design review provides assurance that the final design is correct and satisfactory by addressing the following, where applicable:

The design inputs were correctly selected.

Assumptions necessary to perform the design activity are adequately described and reasonable. Where necessary, assumptions are identified for subsequent verifications when the detailed design activities are completed.

Appropriate design methods and computer programs were used and design calculations were performed correctly.

Design inputs were correctly incorporated into the design.

Design output is reasonable compared to design inputs.

Design inputs necessary for interfacing organizations are specified in the design documents or in supporting procedures or instructions.

Suitable materials, parts, processes, and inspection and testing criteria are specified.

3.5.5.2 Alternate Calculations 3.5.5.2.1 Alternate calculations useby alternative methods are required to for verifyication correctness of calculations unless pre-verified computer programs are used within their applicable defined limits.

3.5.5.2.2 The appropriateness of assumptions, input data, and calculation method used are considered.

3.5.5.2.3 When calculations are performed by computers, the review also considers the computer program; its associated computer hardware, and system software.

3.5.5.3 Qualification Tests UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 36 of 103 3.5.5.3.1 Testing demonstrates adequacy of performance under conditions that simulate the most adverse design conditions. Operating modes and environmental conditions are considered in determining the most adverse conditions.

3.5.5.3.2 Where the test is intended to verify only specific design features, the other features of the design are verified by other approved verification methods.

3.5.5.3.3 When tests are being performed on models or mockups, scaling laws are established and verified. The results of model test work are documented, subjected to error analysis, where applicable, and evaluated prior to use in the final design.

3.5.5.3.4 If qualification testing indicates that modifications to the item are necessary to obtain acceptable performance, the modification is documented and the item modified and retested or otherwise verified to ensure satisfactory performance.

3.5.5.4 Design and Development Validation 3.5.5.4.1 Design validation is performed to ensure that a design meets a customers requirements. Validation is normally performed for the final product under controlled conditions by testing, lead use assemblies, following the performance of a lead unit(s), environmental testing, system and plant pre-operational and startup testing, mock-up testing, etc., preferably prior to delivery to customer.

3.5.5.4.2 Requirements for Engineering tests/inspections and tests/inspections at Operating Plants are specified in implementing procedures.

Change Control Changes to design inputs, final designs, field changes, temporary and permanent modifications, and system application and previously verified designs to GEH products are justified and subject to design control measures commensurate with those applied to the original design.

These measures include evaluation of effects of those changes on the overall design and on any analysis upon which the design is based.

The evaluations include facility configurations that affect operation or performance of a GEH product such as conditions that occur during operation, maintenance, test, surveillance, and inspection activities.

The same affected groups or organizations that reviewed and approved the original design documents shall approve design changes.

When organizational responsibilities change, the owner or designee is responsible to designate a new responsible organization that has demonstrated competence in the specific design area and has an adequate understanding of the requirements and intent of the original design.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 37 of 103 Where a significant design change is necessary due to a design error, the design and verification procedures are reviewed for adequacy and modified as necessary.

Design change requests from the field are processed in accordance with procedures relating to field deviation disposition requests and field disposition instructions for the communication of instructions to the field to implement approved changes.

Records of the changes, reviews, and any necessary actions are maintained in accordance with applicable procedures for processing design records.

Interface Control The companies that have adopted this QAPD are responsible to control interfaces among themselves and between their organizations and their subcontractors and suppliers.

Interface control is specified in implementing procedures that assign responsibility to the participating design organizations for review, approval, release, distribution, and revision of documents across design interfaces.

Design information transmitted across interfaces identifies the status of the design information, as verified or unverified, for the document provided and identifies incomplete items that require further evaluation, review, or approval.

Where it is necessary to initially transmit design information by other informal means, the transmittal is confirmed promptly by a controlled document.

Software Design Control The design process for development of software that falls under the requirements of 10 CFR Part 50 Appendix B is documented, approved by the responsible organization, and controlled per QAPD Section 3.0 except for Sections 3.2 - Design Input, 3.3 - Design Process, 3.5 - Design Verification, and 3.6 - Change Control, which are performed in accordance with NQA-1-2015 Subpart 2.7.

The GEH software design process ensures the following is documented:

3.8.1.1 Software Design Requirements such as operating system, function, interfaces, performance requirements, installation considerations, design inputs and design constraints.

3.8.1.2 Software Design details such as numerical methods, mathematical models, physical models, control flow, control logic, and data flow (may be combined with the software design requirements documentation).

3.8.1.3 Implementation of Software Design - translation of the software design into computer program(s).

3.8.1.4 Software Design Verification performed by an individual, other than the developer, who is competent in both the verification process and the implementing procedures, programming standards, and conventions.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 38 of 103 3.8.1.5 Computer Program Testing performed in accordance with the requirements of the computer test control procedures discussed in Section 11, Test Control.

The GEH software configuration management program includes, but is not limited to, the following activities until such computer software is retired (i.e. removed from use).

3.8.2.1 Configuration Identification - The GEH software responsible organization establishes a baseline as each activity of the software design program is completed.

3.8.2.2 Configuration Change Control - Changes to software are formally documented and are subject to the software design verification process.

3.8.2.3 Configuration Status Control - Controls include a process for maintaining the status of changes that are proposed and approved, but not implemented, and provide for notification to affected organizations.

Documentation and Records Design documentation and records, that provide evidence that the design and design verification processes were properly performed are collected, stored, and maintained in accordance with Section 17, Quality Assurance Records, of this QAPD.

Design documentation and records include not only final design documents, such as drawings and specifications, and revisions to those documents, but also documentation that identifies the important steps in the design process, including sources of design inputs, that support the final design.

Commitment In establishing provisions for design control, GEH commits to compliance with 10 CFR Part 50 Appendix B, Criteria III and NQA-1-20152008 Edition with the NQA-1a-2009 Addenda, Requirement 3. In establishing requirements for computer program design control, GEH commits to compliance with NQA-1-2015 Subpart 2.7. and Subpart 2.7 for computer software.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 39 of 103 4.0 PROCUREMENT DOCUMENT CONTROL General This section describes the GE Hitachi Nuclear Energy (GEH) program that ensures sufficient technical, quality, and regulatory requirements to ensure the requisite level of quality are included or referenced in the documents for procurement of items and services.

The program is applied to all phases of procurement and may require verification of activities of suppliers below the first tier.

Procurement Document Contents The following requirements and information are included in procurement documents, as applicable:

Scope of Work Statement - A statement of the scope of work to be performed by the Supplier Technical Requirements - Drawings, specifications, codes, standards, regulations, and procedures or instructions including revisions that describe the items or services to be furnished Appropriate customer unique requirements, including customer specified surveillance or inspection at the suppliers facility The procurement documents also identify appropriate test, inspection and acceptance criteria for evaluating the suppliers performance Requirements for qualification of personnel Quality Assurance Program Requirements - A reference to the suppliers documented Quality Assurance Program that has been reviewed and determined to meet the applicable requirements of 10 CFR Part 50 Appendix B consistent with the circumstances of the procurement. Alternately, Suppliers may work to the GEH Quality Assurance Program and implementing procedures.

Quality Requirements Flow Down - The Supplier is to flow down appropriate quality assurance requirements in subtier procurement documents.

Right of Access - Provisions for access to the Suppliers and subtier Suppliers facilities and records for surveillance or audit by GEH, their designated representative and others authorized by GEH.

Documentation Requirements - Identification of supplier documentation to be submitted to GEH for information, review, or approval. The time of submittal will also be specified. GEH will specify retention times and disposition requirements for records to be kept by the Supplier.

Nonconformances - The procurement documents specify the GEH requirements for the Suppliers reporting of nonconformances, including invoking the requirements of 10 CFR Part 21 if applicable.

Software Errors - The procurement documents specify the GEH requirements for the Suppliers reporting of software errors, including invoking the requirements of 10 CFR Part 21 if applicable.

Spare and Replacement Parts - The procurement documents specify the applicable requirements to identify spare and replacement parts or assemblies and the related data required for ordering these parts or assemblies.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 40 of 103 Commercial Grade Items - Procurement documents for Commercial Grade Items that will be procured by GEH for use as Safety-Related items contain technical and quality requirements such that the procured item can be appropriately dedicated per Section 7.8 of this QAPD.

Review of Procurement Documents Technical or quality changes made as a result of bid evaluations or negotiations are incorporated in the procurement documents prior to issuance.

Personnel performing reviews have access to pertinent information and an adequate understanding of the requirements and intent of the procurement documents.

Procurement Document Changes Changes to procurement documents are subject to the same level of control as was exercised in the preparation of the original procurement documents.

Commitment In establishing controls for procurement documents, GEH commits to compliance with 10 CFR Part 50 Appendix B, Criteria IV and NQA-1-20152008 Edition with the NQA-1a-2009 Addenda, Requirement 4.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 41 of 103 5.0 INSTRUCTIONS, PROCEDURES, AND DRAWINGS General This section establishes the requirements to ensure that activities affecting quality are prescribed by and performed in accordance with implementing procedures or work instructions (i.e., approved procedures, instructions, and drawings).

Requirements Activities affecting quality are prescribed by controlled implementing procedures of a type appropriate to the circumstance and will be accomplished in accordance with these implementing procedures or work instructions. These procedures shall be readily available at their point of use.

Activities affecting quality are suspended if they cannot be accomplished as described in controlled implementing procedures.

Engineering drawings and specifications are also controlled to ensure that products are identified during all stages of production, delivery, and installation; and that the products are traceable.

Content of Procedures The activity is described to a level of detail that is based on one or more of the following: the complexity of the task, the need to ensure consistent and acceptable results, the significance of the item, the work environment, or worker proficiency and ability.

Quantitative and/or qualitative acceptance criteria are included for determining that prescribed activities have been satisfactorily accomplished and that prescribed results have been satisfactorily attained.

Commitment In establishing procedural controls, GEH commits to compliance with 10 CFR Part 50 Appendix B, Criteria V and NQA-1-20152008 Edition with the NQA-1a-2009 Addenda, Requirement 5.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 42 of 103 6.0 DOCUMENT CONTROL General GE Hitachi Nuclear Energy (GEH) has established the necessary measures and governing procedures to control the preparation of, issuance of, and changes to documents that specify quality requirements or prescribe how activities affecting quality, including organizational interfaces, are controlled to ensure that correct documents are being employed.

The operation and use of the document control system (including electronic systems used to make documents available at points of use) is documented and provides for the following:

Identification of internal and external documents to be controlled Identification of the correct document (including revision) to be used and control of superseded documents Distribution for use at the appropriate location Identification of assignment of responsibility for preparing, reviewing, approving, and issuing documents Review of documents for adequacy, completeness, legibility and correctness prior to approval and issuance A method for providing feedback from users to continually improve procedures and work instructions Coordinating and controlling interface documents and procedures The types of documents to be controlled include, but are not limited to:

a) Drawings such as design, construction, installation, and as-built drawings b) Engineering calculations c) Design specifications d) Purchase orders and related documents e) Vendor-supplied documents f) Audit, surveillance, and quality verification/inspection procedures g) Inspection and test reports h) Instructions and procedures for activities covered by this Quality Assurance Program Description (QAPD) i) Technical requirements j) Nonconformance reports Review and Approval of Documents Individuals other than the preparer review documents for adequacy, accuracy, and completeness.

Prior to issuance or use, the reviewed documents are approved. This review process is applied to all subsequent revisions.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 43 of 103 A listing of all controlled documents identifying the current approved revision, or date of approval, is maintained so personnel can readily determine the appropriate document for use.

Changes to Documents Changes to documents, other than those defined in implementing procedures as minor changes, are reviewed and approved by the same organizations that performed the original review and approval unless other organizations are specifically designated.

The reviewing organization is given access to pertinent background data or information upon which to base their approval.

Minor changes to documents, such as inconsequential editorial corrections, do not require that the revised documents receive the same review and approval as the original documents.

To avoid a possible omission of a required review, the type of minor changes that do not require such a review and approval and the persons who can authorize such a classification will be clearly delineated in implementing procedures.

Temporary Documents Temporary procedures include designation of the period of time during which it is valid to use them.

Temporary procedure changes are approved by two members of the staff knowledgeable in the areas affected by the procedures.

Commitment In establishing procedural controls, GEH commits to compliance with 10 CFR Part 50 Appendix B, Criteria VI, and NQA-1-20152008 Edition with the NQA-1a-2009 Addenda, Requirement 6.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 44 of 103 7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES General This section describes the GE Hitachi Nuclear Energy (GEH) program for ensuring that purchased items and services meet specified requirements. The programs systematic activities are performed to written procedures and include the following:

Procurement document preparation, review, and change control according to the requirements of Section 4.0 of this QAPD Selection of procurement sources Proposal/bid evaluation and award Evaluation of GEH contractor/supplier performance Oversight including any hold and witness point notifications Control of nonconformances Corrective action Acceptance of an item or service Identification of Quality Assurance Records GEH retains the responsibility for any outsourced processes that affect product or service conformity with requirements.

Supplier Evaluation and Selection A supplier is selected based on a pre-qualification process performed by GEH before a contract or purchase order is awarded.

During the pre-qualification review, the suppliers capability to provide items or services in accordance with GEH Sourcing requirements is determined.

Measures for evaluating and selecting procurement sources are documented and include one or more of the following elements:

An evaluation of the suppliers history for providing an identical or similar product that performs satisfactorily in actual use. This evaluation is required to reflect the suppliers current capability.

An evaluation of the suppliers current quality assurance records. This evaluation must be supported by documented qualitative and quantitative information that can be objectively evaluated.

An evaluation of the suppliers technical and quality capabilities, based upon a direct review and inspection of suppliers facilities and personnel, and the suppliers implementation of its quality assurance program.

Suppliers that meet the requirements are placed on the GEH Approved Supplier List (ASL) and are subject to periodic re-evaluation and assessments based on the established guidelines and requirements.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 45 of 103 Proposal/Bid Evaluation The proposal/bid evaluation process is required to include a determination of the suppliers capability to conform to technical and quality assurance requirements.

Before the contract is awarded, GEH must resolve, or obtain commitments to resolve, unacceptable quality conditions identified during the proposal/bid evaluation.

Control of Supplier Generated Documents Supplier generated documents are controlled, processed, and accepted in accordance with established methods.

These measures must provide for the acquisition (per procurement document requirements; reference Section 4 of this QAPD), processing, and recorded evaluation of technical, inspection, and test data compared against the acceptance criteria.

If GEH approval of supplier procedures is required, this approval is accomplished prior to the suppliers use.

Instructions are provided for the retention and disposition of quality assurance records that are to be retained by the supplier.

Control of Supplier Nonconformances GEH and its suppliers establish and document methods for disposition of nonconforming items and services in their purchase agreements.

Suppliers are instructed to send GEH all nonconformance reports from procurement documentation requirements generated during the manufacturing process.

As a minimum, nonconformance reports are obligated to contain the following:

A description of the nonconforming item An evaluation of the nonconforming item At least one recommended corrective action A technical justification for each corrective action identified Nonconformances to the contractual procurement requirements or GEH approved documents are required to be submitted to GEH for approval of the recommended disposition prior to shipment when the nonconformance consists of one or more of the following:

A violation of technical or material requirements A violation of a GEH-approved requirement in supplier documents A nonconformance that cannot be corrected by continuation of the original manufacturing process or by rework (i.e., use-as-is)

An item that does not conform to the original requirement even though the item can be restored to a condition such that the capability of the item to function is unimpaired (i.e., repair)

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 46 of 103 Acceptance of Items or Services.

Suppliers are required to verify that furnished items or services comply with GEH procurement document requirements before offering the items or services for acceptance.

The extent of verification activities performed by GEH is a function of the relative importance, complexity and quantity of the items or services procured; and the suppliers past performance relative to quality.

Methods of Acceptance GEH methods for accepting supplier-furnished items or services ensure that items or services comply with GEH procurement document requirements and include one or more of the following, as appropriate to the items or services being procured:

7.6.3.1 Certificate of Conformance When a certificate of conformance is used to accept an item or related service the following are considered minimum requirements:

The certificate identifies the purchased item or service to the specific procurement document.

The certificate identifies the specific procurement document requirements met by the purchased item or service, such as codes, standards, and other specifications. The procurement document requirements identified include any approved changes, waivers, or deviations applicable to the item or service.

The certificate identifies any procurement document requirements that have not been met, together with an explanation and the means for resolving the nonconformances.

A person who is responsible for this quality function and whose responsibilities and position are described in the suppliers quality assurance program attests to the certificate.

The certification process, including the implementing documents to be followed in filling out a certificate and the administrative implementing documents for review and approval of the certificates, are described in the GEH or suppliers implementing procedure.

Measures are identified to verify the validity of certificates and the effectiveness of the certification process (i.e., by audit of the supplier or by an independent inspection or test of the item). GEH will conduct verifications at intervals commensurate with the past quality performance of the supplier.

7.6.3.2 Source VerificationAcceptance 7.6.3.2.1 GEH may accept an item or service by source verification such as monitoring, witnessing, or observing activities performed by the supplier.

7.6.3.2.2 Source verification is implemented at intervals consistent with the importance and complexity of the item or service.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 47 of 103 7.6.3.2.3 Source verification is planned and performed so that observations of specific activities at predetermined points can be accomplished and may include customer required involvement.

7.6.3.2.4 Documented evidence of acceptance of source verified items or services are retained by GEH and furnished to the receiving destination of the item and the supplier.

7.6.3.3 Receiving Inspection 7.6.3.3.1 When receiving inspection is used, items are verified by objective evidence, which includes such features as:

a) Item configuration b) Item identification c) Item dimensional, physical or other characteristics d) Whether or not the item is free from shipping damage e) Item cleanliness 7.6.3.3.2 Receiving inspection is coordinated with a review of supplier documentation.

7.6.3.4 Post-installation Testing When post-installation testing is used, test requirements and acceptance criteria are mutually established by GEH and the customer.

7.6.3.5 Acceptance of Services In cases involving procurement of services only, such as third-party inspection, engineering and consulting services, auditing, installation, repair, overhaul, or maintenance work, GEH accepts the service by any or all of the following methods:

a) A technical review of the data produced b) A surveillance and/or audit of the activity c) A review of any objective evidence for conformance to the procurement document requirements Supplier Performance Evaluation GEH, as a purchaser of items and services, establishes measures to interface with its suppliers to verify their performance.

These measures include any of the following:

Establishing an understanding between GEH and the supplier regarding the requirements and specifications identified in the procurement documents Requiring the supplier to identify planning techniques and processes to be used in fulfilling procurement document requirements Reviewing supplier documents that are prepared or processed during work performed to fulfill procurement document requirements Identifying and processing necessary change information Establishing the method to be used to document information exchanges between GEH and the particular supplier UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 48 of 103 Establishing the extent of source surveillance and inspection Determining any additional or modified design criteria Analyzing exceptions or changes requested or specified by the supplier and determining the effects that such changes may have on the intent of the procurement documents or quality of the item or service furnished Ensuring that GEH verification activities do not relieve the supplier of its responsibilities for verification of quality achievement If there is no ongoing receipt inspection or operating experience with which to analyze the supplier for a period of twelve months, an annual evaluation is performed as follows:

Review of supplier-furnished documents and records such as certificates of conformance, nonconforming notices, and corrective actions Results of previous source verifications, audits, and receiving inspections Operating experience of identical or similar products furnished by the same supplier Results of audits from other sources (e.g., customer, ASME, or NRC audits)

Commercial Grade Items and Services - Dedication Utilization of commercial grade items or services is permitted if controls are in place to provide reasonable assurance that the item or service will perform its intended safety function.

Such controls include, but are not limited to the following:

a) A determination that the item or service performs a safety function b) Confirmation that the item or service meets the applicable commercial grade item definitions c) Identification and documentation of the critical characteristics, including acceptance criteria d) Selection, performance (inspection/test/survey/surveillance), acceptance, and documentation of the dedication methods for determining compliance with the critical characteristic acceptance criteria The commercial grade item or service dedication process will be controlled via documented procedures and retention of objective evidence.

Records Records are maintained to indicate the performance of the following functions:

Supplier evaluation and selection Acceptance of the items or services procured Supplier nonconformances to procurement document requirements, including a description of their evaluation and disposition UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 49 of 103 Commitment In establishing a program for the control of items and services, GEH commits to compliance with 10 CFR Part 50 Appendix B, Criteria VII and NQA-1-20152008 Edition with the NQA-1a-2009 Addenda, Requirement 7 with the following exceptions:

GEH considers 10 CFR Part 50 licensees, Authorized Nuclear Inspection Agencies, National Institute of Standards and Technology, or other State and Federal agencies, which may provide items or services to GEH, as not requiring evaluation or audit.

When purchasing commercial grade calibration or testing services from a laboratory holding accreditation by an accrediting body recognized by the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement, commercial grade surveys and source verifications need not be performed provided each of the following conditions are met:

A documented review of the supplier's accreditation will be performed and will include a verification of each of the following:

o The calibration or test laboratory is accredited to ISO/IEC 17025:2017 or 2005 General Requirements for the Competence of Testing and Calibration Laboratories by an accreditation body that is a signatory to the ILAC Mutual Recognition Arrangement per NEI 14-05A as endorsed by the US NRC.

o For procurement of calibration services, the published scope of accreditation for the calibration laboratory covers the necessary measurement parameters, ranges, and uncertainties.

o For procurement of testing services, the published scope of accreditation for the test laboratory covers the necessary testing services including test methodology and tolerances/uncertainty.

The purchase documents require the following:

o The service must be provided in accordance with the suppliers accredited ISO/IEC-17025:2017 or 2005 program and scope of accreditation.

o The reporting of as-found calibration data in the certificate of calibration when calibrated items are found to be out-of-tolerance.

o The certificate of calibration includes identification of the laboratory equipment and standards used to perform the calibration.

o The supplier is to notify GEH of any condition that adversely impacts the laboratorys ability to maintain the scope of accreditation.

o Impose any additional technical and administrative requirements, as necessary, to comply with the GEH QA program and technical provisions, which may include but are not necessarily limited to, tolerances, accuracies, ranges, and industry standards.

At receipt inspection, GEH shall validate the following:

o The contracted calibration or testing service has been performed in accordance with the suppliers ISO/IEC-17025:2017 or 2005 program, and has been performed within the laboratorys scope of accreditation, and o The purchase orders requirements are met.

UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 50 of 103 In establishing a programThe GEH program for dedication of commercial-grade items GEH commits to compliancebe consistent with NQA-1-2015NQA 1a 2009, Subpart 2.14.

UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 51 of 103 8.0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS General GE Hitachi Nuclear Energy (GEH) has established a program to provide for the identification and control of materials, parts, and components (partially fabricated assemblies, consumables, and limited shelf life items).

Integral to the program are measures for preventing the use, shipment, or installation of incorrect or unacceptable items.

The program provides for the identification of each item that is established and maintained throughout fabrication, erection, installation, and use so the item can be traced to its documentation.

The identification and control measures provide for relating an item or product (batch, lot, part, or assembly) at any stage, from material receipt through fabrication and shipment to an applicable design drawing, specification, or other pertinent control document.

When required by codes, standards, contract or specifications, traceability will be maintained to specific material certifications, test reports, heat numbers, heat treatment lot numbers, or other attributes.

Identification Methods Procedures related to material and equipment traceability requirements are used to assure product identification and traceability.

Item identification is maintained through the life of the product, component, part, or item so marked.

This identification is accomplished using heat numbers, part numbers, serial numbers, or other appropriate means; and is located either on the item or on records traceable to the item.

Items in the production stream, whether they are batch, lot, component, or part items, are identified from initial receipt from the supplier through fabrication, delivery, installation, and use.

The identification corresponds to a listing or other specifying process that relates the product, component, or part to the product delivered.

Preference for Physical Marking Where practical, physical identification is given preference to other forms of identification.

When physical identification is neither practical nor sufficient, physical separation, procedural control, or other appropriate means will be used.

Maintenance of Marking Markings will be transferred to each part of an item when subdivided and will not be obliterated or hidden by surface treatment or coatings unless other means of maintaining identification are utilized.

UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 52 of 103 Where identification marking of an item is employed, the marking will be clear, unambiguous and indelible, and will be applied in such a manner as not to affect the function or quality of the item.

Measures to maintain or replace identification markings will be based on the expected length of time in storage and environmental conditions so that they are not obliterated due to handling, aging, or deterioration.

Limited Life Items Measures are established to track the age of limited shelf life items so that they cannot be used after the established lifetime has expired. Provisions are made for updating inventory records.

Commitment In establishing provisions for identification and control of items, GEH commits to compliance with 10 CFR Part 50 Appendix B Criteria VIII and NQA-1-20152008 Edition with the NQA-1a-2009 Addenda, Requirement 8.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 53 of 103 9.0 CONTROL OF SPECIAL PROCESSES General The GE Hitachi Nuclear Energy (GEH) program ensures that special processes such as welding, heat treating, and nondestructive examination are properly controlled.

Special processes are accomplished by personnel qualified under associated codes, standards, regulations, specifications, design criteria and other special requirements.

Special processes are conducted in accordance with the applicable codes, standards, regulations, specifications, design criteria and other special requirements, procedures, and equipment.

Control is accomplished through the use of instructions, procedures, drawings, checklists, or other appropriate means within established parameters and is maintained under specified environmental conditions.

Each special process work instruction will include, or reference, procedures, personnel, and equipment qualification and calibration requirements appropriate to that particular process.

Criteria A process is designated special if the success of the process is highly dependent on the control of the process or the skill of the operators, or both, and if the specified quality cannot be readily determined by inspection or test of the product.

Non-Standard Processes For special processes not covered by existing codes or standards, or where product requirements exceed those of established codes or standards, the necessary requirements for the qualification of personnel, procedures, or equipment are defined or referenced in procedures or work instructions.

Responsibility The organization performing the special process is responsible for adherence to the approved procedures and processes.

Records Records are maintained, as appropriate for the qualified personnel, processes, and equipment, and their revalidation, for each special process.

Commitment In establishing measures for the control of special processes, GEH commits to compliance with 10 CFR Part 50 Appendix B, Criteria IX and NQA-1-20152008 Edition with the NQA-1a-2009 Addenda, Requirement 9.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 54 of 103 10.0 INSPECTION General This section describes the GE Hitachi Nuclear Energy (GEH) program for inspection of items and activities to verify conformance to requirements and adherence to documented instructions, procedures, and drawings.

Inspection types include, but are not limited to:

source, in process, final, receipt, maintenance, modification, in-service, and operations Inspection results are documented by the inspector, reviewed by authorized personnel qualified to evaluate the technical adequacy of the inspection results, and controlled by instructions, procedures, and drawings.

Appropriately controlled measuring and test equipment (reference Section 12.0 of this QAPD) shall be used in the performance of the inspections.

Inspection Personnel Inspections are performed by independent personnel who have not performed the work and do not report to the supervisors responsible for the work being inspected.

Those activities that require qualified inspection personnel are defined per implementing procedures or instructions.

Planning Provisions are incorporated into inspection work instructions to ensure inspection planning is properly accomplished to assure quality of product or service.

Planning activities identify the characteristics and activities inspected, sample size, inspection methods, acceptance criteria, and organization responsible for performing the inspection.

Inspection requirements and acceptance criteria include requirements specified in the applicable design documents or in other pertinent technical documents approved by the responsible design organization.

Examinations, measurements, or tests of material or products processed are performed for each work operation where necessary to ensure quality.

Inspections and tests are utilized to ensure control of special processes as designated in applicable test and inspection procedures.

UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 55 of 103 If sampling procedures are used, they are based on standard statistical methods or industry practices with either engineering or quality approval.

10.3.7.1 Mandatory inspection hold points that require documented consent of the designated representative prior to the work proceeding are specified in appropriate documents.

10.3.7.2 Consent to waive specified hold points is recorded prior to continuation of work beyond the designated hold point.

10.3.8.1 If inspection of processed material or products is impossible or disadvantageous, indirect control by monitoring process methods, equipment, and personnel are provided.

10.3.8.2 Both inspection and process monitoring are provided when control is inadequate without both.

10.3.8.3 When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed. This is completed prior to initial use and reconfirmed as necessary.

Modifications, repairs, or replacements of items performed after final inspection require re-inspection or retest, as appropriate, to verify acceptability.

Final Inspection A records review of the results and resolution of nonconformances identified by prior inspections will be included as part of the final inspection.

The GEH final inspection requirements include verification of the following:

completeness of the product or service, markings, calibration, adjustments, protection from damage, or other characteristics, as required, to verify the quality and conformance of the item to the specified requirements.

10.4.3.1 Only authorized personnel are permitted to accept the work being inspected.

10.4.3.2 Release of product to ship is authorized by issuing a Product Quality Certificate.

Records Appropriate records are established, maintained, and include the following as a minimum:

Item inspected The date of the inspection UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 56 of 103 The name of the inspector The type of observation The acceptability of the result One or more references to information on any action taken in connection with nonconformances Commitment In establishing inspection requirements, GEH commits to compliance with 10 CFR Part 50 Appendix B, Criteria X and NQA-1-20152008 Edition with the NQA-1a-2009 Addenda, Requirement10.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 57 of 103 11.0 TEST CONTROL General This section establishes the GE Hitachi Nuclear Energy (GEH) program to control testing, to collect data such as for design input or to verify conformance of an item to specified requirements, or to demonstrate satisfactory performance for service.

Characteristics to be tested and test methods to be employed are specified.

The test program includes proof tests before installation, preoperational tests, post maintenance tests, post modification tests, and operational tests as appropriate.

Test results are documented and their conformance with the test requirements and the acceptance criteria are evaluated.

Test Requirements Test requirements and acceptance criteria are provided in an applicable design, or other pertinent technical document, and are approved by the responsible design organization.

Criteria are defined that specify when testing is required and activities that require qualified test personnel.

Required tests are controlled under appropriate environmental conditions using the tools and equipment, including appropriately controlled measuring and test equipment (reference Section 12.0 of this QAPD), necessary to conduct the test in a manner to fulfill test requirements and acceptance criteria.

The tests performed obtain the necessary data with sufficient accuracy for evaluation and acceptance.

If temporary changes to the approved configuration of a facility are required for testing purposes, approval by the responsible design organization is required prior to performing the test.

Acceptance testing of computer programs demonstrates, as appropriate, that the computer program properly handles abnormal conditions and events as well as credible failures; does not perform adverse unintended functions; and does not degrade the system either by itself or in combination with other functions or configuration items Acceptance testing of changes to computer programs is subjected to selective retesting to detect unintended adverse effects introduce during the change and to verify that a modified system(s) or system component(s) still meets specified software design requirements.

Test Procedures UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 58 of 103 11.3.1.1 Test procedures include or reference the test configuration and test objectives.

11.3.1.2 Test procedures also include provisions for assuring that prerequisites and suitable environmental conditions are met, adequate instrumentation is available and used, appropriate tests and equipment are used, and necessary monitoring is performed.

11.3.1.3 Prerequisites include the following, as applicable:

a) The test instrumentation must be properly calibrated b) The appropriate equipment must be used c) The test must be conducted by personnel who are trained in the procedures d) The condition of the test equipment and the item to be tested must meet test specifications e) Suitable environmental conditions must exist in the test location f) The provisions for data acquisition must be working and in good order 11.3.1.4 Alternately, appropriate sections of related documents, such as ASTM methods, Supplier manuals, equipment maintenance instructions, or approved drawings or travelers with acceptance criteria, may be used. Such documents include or are supplemented with appropriate criteria listed above to ensure adequate procedures for the test..

This section applies to the testing of computer programs and, as appropriate, to the computer hardware and operating system.

11.3.2.1 Computer program test procedures provide for demonstrating the adherence of the computer program to documented requirements.

11.3.2.2 For those computer programs used in design activities, computer program test procedures provide for assuring that the computer program produces correct results.

11.3.2.3 The procedures also provide for evaluating technical adequacy through comparison of test results from alternative methods such as hand calculations, calculations using comparable proven programs, or empirical data and information from technical literature.

11.3.2.4 For those computer programs used for operational control, computer program test procedures provide for demonstrating required performance over the range of operation of the controlled function or process.

11.3.2.5 In-use test procedures are developed and documented to permit confirmation of acceptable performance of the computer program in the operating system.

11.3.2.6 In-use test procedures are performed after the computer program is installed on a different computer or when there are significant changes in the operating system.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 59 of 103 11.3.2.7 Periodic in-use manual or automatic self-check in-use tests are performed for those computer programs in which program errors, data errors, computer hardware failures, or instrument drift can affect the required performance of the program.

11.3.2.8 Test procedures or plans are required to specify the following, as applicable to the test parameters:

a) The required tests and test sequence b) The required ranges of input parameters c) The stages at which testing is required d) The criteria for establishing test cases e) The requirements for testing logic branches f) The criteria for hardware integration g) Anticipated output values h) The acceptance criteria to be used to evaluate whether a test is successful i) The reports, records, standard formatting, and conventions in which the results must be reported Test Results Test results are documented and evaluated by a responsible authority to ensure that test requirements have been satisfied.

Test results for design qualification tests are evaluated by the responsible design organization.

Test Records Test records are established and maintained to indicate the ability of the item or computer program to satisfactorily perform its intended function or to meet its documented requirements.

Test records vary depending on the test type, purpose, and application, but contain the following information, as a minimum:

a) The item tested b) The date of the test c) The name of the tester or data recorder d) The type of observation required e) The results and acceptability of those results f) Any action taken in connection with deviations from the original testing specification or procedure g) The name of the person evaluating test results In addition to the above, test records for computer programs also contain the following information:

UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 60 of 103 The name of the computer program tested including the system software used The computer hardware used The type of test equipment and, if applicable, calibrations used Any simulation models used, where applicable Any test problems encountered Commitment In establishing test control requirements, GEH commits to compliance with 10 CFR Part 50 Appendix B, Criteria XI and NQA-1-20152008 Edition with the NQA-1a-2009 Addenda, Requirement11. In establishing and Subpart 2.7 for requirements for computer programsoftware test procedures and test records, GEH commits to compliance with NQA-1-2015 Subpart 2.7.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 61 of 103 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT General GE Hitachi Nuclear Energy (GEH) has established a program, including governing procedures, to control the calibration, maintenance, storage, and use of Measuring and Test Equipment (M&TE).

The procedures cover equipment such as indicating and actuating instruments and gages, tools, reference and transfer standards, and nondestructive examination equipment.

The suppliers of commercial-grade calibration services are evaluated for compliance with the control measures as described in Section 7 of this QAPD.

Calibration and control measures are not required for commercial equipment such as rulers, tape measures, levels, etc., if such equipment provides the required accuracy.

M&TE is properly handled and stored to maintain accuracy.

Selection of Equipment for Use Selection of M&TE is based on the type, range, accuracy, and tolerance needed to accomplish the required measurements for determining conformance to specified requirements.

The utilization of M&TE is traceable to their application and use.

Calibration Process M&TE are calibrated at prescribed intervals, or whenever the accuracy of the M&TE is suspect, or prior to use.

Calibration is conducted against certified equipment or reference standards having known valid relationships to nationally recognized standards, or to international standards which are known to be equivalent to and verified against corresponding nationally recognized standards. The program requires that traceability to the reference standards be maintained. Where no such standards exist, the basis for calibration or verification is documented.

M&TE is safeguarded from adjustments that would invalidate the measurement result.

M&TE is protected from damage and deterioration during handling, maintenance and storage.

Calibration tolerance relative to the accuracy of reference standards used and the M&TE calibrated shall be addressed in calibration documentation. When tolerance ratios become close, the basis for the selection of the specific reference standard shall be technically justified.

Control of Calibration Status M&TE are suitably marked, tagged, labeled, or otherwise identified to indicate calibration status and establish traceability to calibration records.

M&TE that is overdue for calibration or found to be out-of-calibration is tagged and/or segregated, removed from service, and not used until it has been recalibrated.

M&TE consistently found to be out-of- calibration will be repaired or replaced.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 62 of 103 Records Records are established and maintained to indicate calibration status and the capability of M&TE to satisfactorily perform its intended function.

Reports and Certificates Calibration reports and certificates reporting the results of calibrations include the information and data necessary for interpretation of the calibration results and verification of conformance to applicable requirements.

12.5.3.1 When M&TE is lost, damaged or found out-of-calibration, the validity of previous measurements, inspections, or test results, and the acceptability of items previously inspected or tested from the last acceptable calibration shall be evaluated.

12.5.3.2 The responsible quality organization assesses and records the validity of the previous measuring results.

12.5.3.3 Appropriate action is taken on the equipment and any product affected.

Commitment In establishing a M&TE calibration program, GEH commits to compliance with 10 CFR Part 50 Appendix B, Criteria XII and NQA-1-20152008 Edition with the NQA-1a-2009 Addenda, Requirement12.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 63 of 103 13.0 HANDLING, STORAGE, AND SHIPPING General GE Hitachi Nuclear Energy (GEH) has established a program to control the handling, storage, packaging, cleaning, shipping, and preservation of items to prevent inadvertent damage or loss, and to minimize deterioration.

Customer supplied material is controlled to ensure that the material is received, inspected, stored, and maintained in a controlled environment; and that any customer supplied material that is lost, damaged, or is otherwise unsuitable for use be reported to the customer.

The design of packaging and shipping containers is procedurally controlled by packaging related procedures for GEH Procured or Manufactured Items.

Instructions Cleaning, handling, storing, packaging, shipping, and preservation of items are controlled by written instructions, drawings, specifications or other pertinent documents. Sufficient labeling is provided to identify the items and to indicate any special conditions needed to prevent degradation.

Special Controls Special controls (such as containers, shock absorbers, and accelerometers) and environments (such as inert gas atmospheres, specific moisture content levels, and temperature levels) are provided and verified when required to maintain acceptable quality.

The presence of these special environments is indicated by marking the exterior of the container to prevent premature penetration of the sealing boundary.

The need for special controls or specific procedures is established on a case by case basis according to the items complexity, use, and sensitivity to damage. Consideration for critical, sensitive, perishable or high-value items should be incorporated in controls and procedures.

Special Tools and Equipment Special handling tools and equipment will be used and controlled as necessary to ensure safe and adequate handling.

Special handling tools and equipment will be inspected and tested at specified time intervals, or prior to use, and in accordance with procedures to verify that the tools and equipment are adequately maintained.

Operators Operators of special handling and lifting equipment will be experienced or trained in the use of the equipment.

Commitment In establishing provisions for handling, storage, and shipping, GEH commits to compliance with 10 CFR Part 50 Appendix B, Criteria XIII and NQA-1-20152008 Edition with the NQA-1a-2009 Addenda, Requirement 13.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 64 of 103 14.0 INSPECTION, TEST, AND OPERATING STATUS General GE Hitachi Nuclear Energy (GEH) has established a program to identify the inspection and test status of individual items and for indicating the operating status of equipment, such as valves and switches. Implementing procedures specify the authority for the application and removal of these status indicators.

Inspection and Test Status Inspection and test status indicators provide assurance that items that have not successfully passed required inspections and/or tests are not inadvertently installed, used, operated, or released for subsequent operations or shipment.

The inspection and test status is maintained through the use of physical location, status indicators (such as tags, markings, shop travelers, stamps, or inspection records), or other suitable means.

Commitment In establishing measures for control of inspection, test, and operating status, GEH commits to compliance with 10 CFR Part 50 Appendix B, Criteria XIV and NQA 20152008 Edition with the NQA-1a-2009 Addenda, Requirement 14.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 65 of 103 15.0 NONCONFORMING MATERIAL OR COMPONENTS General GE Hitachi Nuclear Energy (GEH) has established a program to control nonconforming items and to prevent inadvertent installation or use.

Nonconforming items have a deficiency in characteristic, documentation, or procedure that makes the quality of the item or activity unacceptable or indeterminate.

Controls provide for identification, documentation, evaluation, segregation (when practical), disposition of nonconforming items, and for notification to affected organizations.

Identification and Control Nonconforming items are identified by legible marking, tagging, or other methods not detrimental to the item, on the item, the container, or the package containing the item.

Nonconforming items that are segregated are placed in a clearly identified and designated hold area until they can be properly dispositioned.

When segregation is impractical or impossible due to physical conditions, such as size, weight, or access limitations, other administrative measures are employed to preclude inadvertent use of a nonconforming item.

Further processing, delivery, installation, or use of a nonconforming item is administratively controlled until an evaluation of the item is completed by authorized personnel and the appropriate disposition for that item is determined.

Disposition The responsibility and authority for the evaluation and disposition of nonconforming items is defined in implementing procedures.

Responsibility for the control of further processing, delivery, installation, or use of nonconforming items is designated in writing.

Personnel performing evaluations to determine a disposition must have the following qualifications:

a) Demonstrated competence in the specific area they are evaluating b) Possess an adequate understanding of the requirements c) Access to pertinent background information Dispositions can include:

Rework - the process by which an item is made to conform to original requirements by completion or correction.

Repair - the process of restoring a nonconforming characteristic to a condition such that the capability of an item to function reliably and safely is unimpaired, even though that item still does not conform to the original requirement.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 66 of 103 Use-as-is - a disposition permitted for a nonconforming item when it has been established that the item is satisfactory for its intended use.

Reject - the item is unsuitable for use and is to be designated as scrap or returned to the vendor.

Technical justification for the acceptability of a nonconforming item dispositioned in either the repair or use-as-is categories must be documented.

Nonconformances to design requirements dispositioned use-as-is or repair are subject to design control measures commensurate with those applied to the original design.

Required as-built records reflect the use-as-is or repair condition.

When required by contract, the proposed disposition is submitted to the Customer for approval prior to acceptance for delivery.

Each nonconformance is reviewed to determine if such nonconformity may exist in the delivered products. If there is a concern that a nonconformance could lead to creation of a substantial safety hazard, a request to initiate an evaluation is made in accordance with the Corrective Action Program for Reporting of Defects and Noncompliance Under 10 CFR Part 21.

Re-examination Reworked, repaired, or replacement items are re-examined in accordance with applicable procedures and with the original acceptance criteria, unless otherwise stipulated.

Repaired items may use alternate acceptance criteria if the need is established during the repair plan design review.

Commitment GEH commits to compliance with 10 CFR Part 50 Appendix B, Criteria XV and NQA 20152008 Edition with the NQA-1a-2009 Addenda, Requirement 15.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 67 of 103 16.0 CORRECTIVE ACTION PROGRAM General The GEH Corrective Action Program utilizes a system of implementing procedures to establish the necessary measures to promptly identify, control, document, classify, and correct Conditions Adverse to Quality (CAQs).

The GEH implementing procedures ensure that appropriate actions are initiated following the determination of CAQs in accordance with regulatory requirements and applicable quality standards.

These measures ensure that corrective actions are adequately documented and not inadvertently nullified by subsequent actions. Completion of corrective actions shall be confirmed.

GEH implementing procedures require personnel to identify known CAQs.

When complex issues arise, such that an immediate determination of whether a CAQ exists cannot be made, the GEH Corrective Action Program identifies a process for the documentation and timely evaluation of the issue.

If there is a concern that a CAQ that could result in a substantial safety hazard, a safety evaluation is requested in accordance with the Corrective Action Program for Reporting of Defects and Noncompliance Under 10 CFR Part 21.

A Ssignificant Ccondition Aadverse to Qquality (SCAQ) is a failure, malfunction, deficiency, defective item, or nonconformance that, if uncorrected, could have a serious effect on safety or operability. SCAQs are documented and reported to responsible management. Their cause is determined and actions to preclude their recurrence are taken.

Implementing procedures for the Corrective Action Program are used to ensure that:

All corrective actions from audits and self-assessments, all nonconformances, and customer complaints are analyzed to detect conditions or potential CAQs.

Changes in processes or procedures resulting from corrective and preventive actions are implemented and recorded.

The Corrective Action Program and related tools are utilized to document, track status, and maintain records of corrective and preventive action activities and results.

Warranty service and customer complaint related procedures are used to ensure that customer complaints are documented, dispositioned and resolved.

Identification of Trends Reports of conditions that are adverse to quality are analyzed to identify trends in quality performance.

Significant conditions and trends adverse to quality are reported to the appropriate level of management.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 68 of 103 Corrective Action Appropriate corrective actions are taken to resolve CAQs observed during internal or external audits.

Implementing procedures define the requirements for:

Reviewing CAQs and determining their severity level Determining the root causes and their effects and extents Evaluating the need for action to avoid recurrence Determining and implementing corrective action needed Reviewing corrective actions taken Preventive Action GEH identifies actions to eliminate the causes of SCAQs in order to prevent their reoccurrence. Preventive actions are taken as appropriate to address the causes of the problems.

Commitment In establishing corrective action requirements, GEH commits to compliance with 10 CFR Part 50 Appendix B, Criteria XVI and NQA-1-20152008 Edition with the NQA-1a-2009 Addenda, Requirement 16.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 69 of 103 17.0 QUALITY ASSURANCE RECORDS General GE Hitachi Nuclear Energy (GEH) has established measures to provide provisions for the identification, administration, receipt, storage, preservation, safekeeping, retrieval, and disposition of all records such that damage or loss does not occur.

Quality records are established to provide objective evidence of conformance to requirements and effective implementation of the GEH quality management system.

The records system is defined, implemented, and enforced in accordance with written procedures, instructions, or other documentation.

The applicable design specifications, procurement documents, test procedures, operational procedures, or other documents specify the records generated, supplied, and maintained. Records shall be traceable to associated items and activities, and accurately reflect the work accomplished or information required.

Records may be hard copy, electronic, or both.

Records shall be examined for adequacy, legibility, and completeness.

Safekeeping of records includes access control and protection from equipment malfunction.

Records shall remain legible, readily identifiable and retrievable, even after hardware, software or technology changes.

Administration 17.2.1.1 Requirements and responsibilities for record transmittal, receipt, location, distribution, retention, maintenance, and disposition are described in implementing procedures.

17.2.1.2 Training is provided for individuals or organizations in charge of the generation of electronic records, data and media storage, the implementation of security measures, the migration of data, the regeneration of data, and the recovery of data.

An indexing system provides sufficient information to permit identification between the record and the item, or activity, to which it applies. Record controls shall provide for retrievability within planned retrieval times based on the record classification, type or content.

17.2.3.1 Records are corrected or changed in accordance with procedures that provide for appropriate review or approval by the originating organization.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 70 of 103 17.2.3.2 The correction or change includes the date and the identification of the person authorized to issue such correction or change.

Classification Records are classified as Lifetime or Nonpermanent.

17.3.1.1 Lifetime records are those that meet one or more of the following criteria:

a) Significant value in demonstrating capability for safe operation b) Significant value in maintaining, reworking, repairing, replacing, or modifying an item c) Significant value in determining the cause of an accident or malfunction of an item d) Provision of required baseline data for in-service inspections and in-service tests.

17.3.1.2 Lifetime records are maintained for the life of the particular item while it is installed in the plant or stored for future use.

17.3.2.1 Nonpermanent records are those required to show evidence that an activity was performed in accordance with the applicable requirements but need not be retained for the life of the item because they do not meet the criteria for lifetime records.

17.3.2.2 The retention period for nonpermanent records is established in implementing procedures.

Receipt Control The person or organization responsible for receiving the records is designated.

This designee is responsible for organizing and implementing a system of receipt control of records for permanent and temporary storage, and for providing protection from damage or loss during the time that the records are in their possession.

At a minimum, a receipt control system includes the following:

a) a method for designating the required records; b) a method for identifying records received; c) procedures for receipt and inspection of incoming records; and d) a method for submittal of completed records to the storage facility without unnecessary delay.

Each receipt control system is structured to permit a current and accurate assessment of the status of records during the receiving process.

Authentication Documents are considered valid records only if stamped, initialed, authenticated, or signed and dated by authorized personnel.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 71 of 103 This authentication may take the form of a statement by the responsible individual or organization.

Handwritten signatures are not required if the document is clearly identified as a statement by the reporting individual or organization. These records may be originals or reproduced copies.

Storage 17.6.1.1 Records will be stored at a predetermined location in facilities, containers, or a combination thereof, constructed and maintained in a manner that minimizes the risk of loss, damage, or destruction from:

Natural disasters such as winds, floods, or fires Environmental conditions such as high and low temperatures and humidity Infestation of insects, mold, or rodents Dust or airborne particles 17.6.1.2 Activities that may be detrimental to the records are prohibited in the designated storage area.

17.6.1.3 Access to the processing, storage, and retrieval of records is limited to authorized personnel.

17.6.1.4 Provisions have been made to prevent damage from harmful conditions (such as excessive light, stacking, electromagnetic fields, temperature, and humidity), as applicable to the specific media utilized for record storage.

GEH uses two methods of providing storage - single and dual.

17.6.2.1 Single storage consists of a storage facility, vault, room, or containers with a minimum two-hour fire rating.

17.6.2.2 The design and construction of a single storage facility, vault, room, or container will be reviewed for adequacy by a person competent in fire protection or contain a certification or rating from an accredited organization.

17.6.2.3 Dual facilities, containers, or a combination thereof are located at facilities that are sufficiently remote from each other to eliminate the chance exposure to a simultaneous hazard. The requirements of Section 17.6.1 shall apply to both facilities.

When temporary storage of reviewed and approved records (such as for processing, review, or use) is required, the storage facility or container will provide a one-hour fire rating, unless dual storage requirements are met.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 72 of 103 17.6.4.1 Integral to the GEH records storage program is an implementing procedure that records retention periods.

17.6.4.2 This procedure notifies personnel of record retention requirements and helps to ensure that records are maintained for their retention periods.

Provisions are established to ensure that when records are duplicated or transferred to the same media or different media for the purpose of maintenance or storage, that the duplication or transfer is appropriately authorized, and that record content, legibility and retrievability are maintained.

Electronic Records For Quality Assurance Records in electronic media, the GEH program includes controlling procedures with provisions for the generation, distribution, use, maintenance, storage, and disposition of electronic records.

The procedures identify the acceptable media on which electronic records may be created and stored. Also, the procedures include provisions to verify that the media is appropriate, suitable for the capture or storage of records, and error/defect free.

Electronic documents shall be authenticated with appropriate information on the media or with the information contained within or linked to the document itself.

Electronic documents shall be indexed with appropriate information including necessary fields (metadata) as necessary to retrieve the recordThe software name, version, and equipment (hardware) used to produce and maintain the electronic media are identified on the record.

A new record is to be generated when substantial corrections or changes to previous electronic records are required.

17.7.6.1 Electronic records are subject to the same retention requirements as paper records.

17.7.6.2 Retention requirements for electronic records also identify and maintain the information system (software/hardware), the documentation that describes the information system operation and use, and the record standard it produces.

The person or organization responsible for receiving the records is also responsible for organizing and implementing an inventory of system applications, record formats, and programs required to process and retrieve electronic records.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 73 of 103 17.7.8.1 For electronic records, authentication is accomplished by manually affixing a seal, signature, an electronic representation (user ID/password combination and digital signature) or other acceptable process control that ensures genuineness, validity, or reliability.

17.7.8.2 Authorized personnel with access to electronic records and information systems should have a unique user ID/password for access.

17.7.8.3 The system should provide controls for users who enter or alter information in electronic records to ensure its data integrity and prevent unauthorized alteration or erasure.

17.7.8.4 Transfer of authentication authority is documented and controlled in accordance with written procedures.

17.7.9.1 Electronic media should be stored in a dust-free environment and away from electronic devices and demagnetizing equipment such that no unacceptable degradation of the media occurs during the established retention period.

17.7.9.2 Media should be maintained at a constant temperature between 40 to 80 degrees Fahrenheit (4.4 to 26.7 degrees Celsius), and a relative humidity between 30 to 50 percent.

17.7.9.3 Magnetic and optical media should be tested periodically to identify any loss of data, to ensure that they are free of permanent errors, and that the record system hardware/software still supports the retrieval of the records.

17.7.10.1 An electronic record migration/regeneration program is implemented for electronic records stored in media with a standard life expectancy that fails to meet the specific retention period.

17.7.10.2 This program is implemented in accordance with documented procedures that provide for appropriate record authentication, quality verification of the completion, and accuracy of the data transferred.

Commitment In establishing a quality assurance records program, GEH commits to compliance with 10 CFR Part 50 Appendix B, Criteria XVII, NQA-1-20152008 Edition with the NQA-1a-2009 Addenda, Requirement 17, US NRC Regulatory Guide (RG) 1.28, Revision 5, October 2017Generic Letter 88-18, and RIS 2000-18.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 74 of 103 18.0 AUDITS General The GE Hitachi Nuclear Energy (GEH) audit program is designed to verify compliance to quality assurance program requirements, to verify that performance criteria are met, to determine the effectiveness of the program, and to provide a comprehensive independent evaluation of activities and procedures.

Audits are performed in accordance with written procedures or checklists by qualified personnel who do not have direct responsibility for performing the activities being audited.

Audit results are documented and reviewed by responsible management.

Follow-up action is taken where indicated.

If work under this QAPD is delegated to others, then the work is to be audited by GEH in accordance with this QAPD.

Personnel An audit team is identified prior to the beginning of each audit. This team contains one or more auditors; and is led by a lead auditor.

The lead auditor organizes and directs the audit and verifies that the audit team has the necessary experience or training commensurate with the scope, complexity, or special nature of the activities to be audited.

Audit personnel are given sufficient authority and organizational freedom to make the audit process meaningful and effective.

Audit personnel shall not assess their own work.

Audit Scheduling, Planning and PerformanceDocumentation 18.3.1.1 An audit schedule is documented at the beginning of each year to document the planned, periodic coverage of internal functions performing quality related activities, commensurate with the status and importance of the activity, and the performance of suppliers.

18.3.1.2 Audits are scheduled for internal activities at the following intervals: Internal audits of organizations and activities are conducted prior to placing a facility in operation and at least once a year subsequently a) Prior to placing a licensed facility into operation - All applicable quality assurance program elements are audited at least once each year or at least once during the life of the activity, whichever is shorter.

b) After placing a licensed facility into operation - All applicable quality assurance program elements for each functional area shall be audited within a period of two years. For well-established activities, the period may be extended one year at a time beyond the two-year interval based on the results of an annual evaluation of the applicable functional area and objective evidence that the functional area UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 75 of 103 activities are being satisfactorily accomplished. However, the internal audit interval shall not exceed a maximum of four years.

c) Activities not related to a licensed facility or other support activities - All applicable quality assurance program elements shall be audited at least once each year or at least once during the life of the activity, whichever is shorter. This interval may be extended up to two years based on the results of an annual evaluation and objective evidence that the activities are being satisfactorily accomplished in accordance with the applicable quality assurance program elements.

18.3.1.2 Once Activities have been established, internal audits are conducted to ensure all GEH Quality Assurance Program elements are evaluated for each functional area within a period of two years.

18.3.1.3 Activities with durations of less than on year are audited at least once during the life of the activity.

18.3.1.418.3.1.3 The audit schedule is reviewed periodically and revised, as necessary, to ensure that coverage is current.

18.3.1.518.3.1.4 When necessary to ensure adequate coverage, the scheduled audits may be supplemented by focused, in-depth audits or self-assessments covering specific subjects.

18.3.2.1 The auditing organization develops and documents an audit plan specific to each audit.

18.3.2.2 This plan identifies the audit scope, requirements, personnel assigned to the audit, the activities to be audited, any organizations to be notified; and the applicable documents, schedules, and written procedures or checklists to be used.

Audit Performance 18.3.3.1 Elements selected for audit shall be evaluated against specified requirements.

18.3.3.2 Objective evidence shall be examined to the depth necessary to determine if the elements are effectively implemented.

18.3.3.3 Conditions requiring prompt corrective action shall be reported immediately to management of the audited organization.

Following the audit, a report is generated and signed by the audit team leader. The report includes the following information, as appropriate:

a) A description of the audit scope b) Identification of the auditors by name and organization c) Identification of persons contacted during audit activities d) A summary of the audit results, including a statement on the effectiveness of the quality assurance program elements that were audited UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 76 of 103 e) A description of each adverse audit finding in sufficient detail to enable an effective corrective action to be taken by the audited organization Audit records are required to include audit plans, audit reports, written replies, and the record of the completion of any corrective actions resulting from the audit.

Internal Audits The Quality Oversight organization is responsible for internal audits of the implementation of the requirements stated in this QAPD to accomplish the following:

to ensure compliance with the overall Quality Assurance Program, to ensure compliance with the applicable codes, standards, and regulations, to ensure the QAPD is effectively implemented, to ensure the QAPD is adequate and maintained.

Supplier Audits Supplier quality assurance programs are audited on a triennial basis starting with the year that the first audit occurs, and if the procurement scope significantly changes from the originally audited scope.

Exigent Conditions:

18.5.2.1 During periods of exigent conditions affecting GEH facilities or its suppliers, and where performance of audit or survey activities for domestic and international suppliers is not feasible, a 25% extension of the triennial audit period may be exercised. The total allowable extension for exigent conditions is 275 days.

Examples of exigent conditions include, but are not limited to the following:

a. declaration of a national emergency or state of emergency impacting GEH facilities or supplier infrastructure,

b. natural disaster, weather emergency or other severe localized or national weather event or resulting damage to or impacting GEH facilities or supplier infrastructure, or

c. localized outbreak of a severe health concern to the public impacting GEH facilities or supplier infrastructure.

18.5.2.2 Continued use of suppliers that have exceeded the time period for audits or surveys due to exigent conditions is allowed, if the following conditions are met:

a. Priority should be given to completing audits and surveys of affected suppliers in order of the expiration of the triennial audit period. Such audits or surveys should be completed as soon as practical and shall also include a review of supplier activities performed since the triennial audit expiration date.

b. GEH shall verify that the supplier is still implementing a quality assurance program that meets Appendix B to 10 CFR Part 50.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 77 of 103 GEH shall verify that the suppliers have maintained adequate documented programmatic controls in place for the activity affecting quality.

c. A documented evaluation shall be performed identifying the conditions inhibiting performance of the audit or survey and providing a basis for maintaining the supplier as an approved supplier during the exigent condition 25% extension period. The evaluation should consider the following, as applicable:

1) Any significant open issues with the NRC, any open Part 21 notifications, and any open findings since the previous triennial audit.

2) The relative importance, complexity and quantity of the items/services procured,

3) Suppliers quality performance

4) Consideration of additional procurement or inspection requirements, such as:

Supplier document submittals for review Supplier inspection/testing requirements or sampling plans Receipt inspection or sampling plans

d. If there is no ongoing receipt inspection or operating experience with which to analyze the supplier for a period of 12 months since the last audit or survey, an annual documented evaluation shall be performed and include the following:

1) Review of supplier-furnished documents and records such as certificates of conformance, nonconformance notices, and corrective actions.

2) Results of previous source verifications, audits, survey and receiving inspection activities.

3) Operating experience of identical or similar products furnished by the same supplier.

4) Results of audits from other sources (e.g., customer, American Society of Mechanical Engineers (ASME), or NRC audits).

e. If the contract or a contract modification significantly enlarges the scope of, or changes the methods or controls for, activities performed by the same supplier, the supplier will provide documented justification that the change(s) are adequately addressed by its quality assurance program controls.

18.5.2.3 For audits performed during the 25% extension period for exigent conditions, the audit clock does not reset backwards to the original date the audit or survey should have been performed. Rather, the date that the audit or survey is actually performed would be the start of the new triennial audit or survey frequency.

In addition to triennial audits, annual evaluations of suppliers are conducted as described in Section 7 of this QAPD.

If more than one purchaser buys from a single supplier, a purchaser may either perform or arrange for an audit of the supplier on behalf of itself and other purchasers to reduce the number of external audits of the supplier.

The scope of this audit should satisfy the needs of all of the purchasers, and the audit report should be distributed to all the purchasers for whom the audit was conducted.

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NEDO-11209-A Draft Changes to Revision 15 Part II GEH Quality Assurance Program Description Page 78 of 103 Each of the purchasers relying on the results of an audit performed on behalf of several purchasers remains individually responsible for the adequacy of the audit.

Audit Response and Follow-up Management of the audited organization or activity performs the following activities:

Investigates adverse audit findings Schedules corrective action, including measures to prevent recurrence of significant conditions adverse to quality Notifies the auditing organization in writing of action taken or planned Responses to audit findings are evaluated by the auditing organization.

Follow-up action is taken to verify that any corrective action required is accomplished as scheduled.

Commitment In establishing an audit program, GEH commits to compliance with 10 CFR Part 50 Appendix B, Criteria XVIII, NQA-1-20152008 Edition with the NQA-1a-2009 Addenda, Requirement 18 and US NRC Regulatory Guide (RG) 1.28, Revision 5, October 2017RIS 2000-18.

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NEDO-11209-A Draft Changes to Revision 15 Part III GEH Quality Assurance Program Description Page 79 of 103 PART III SUPPLEMENTAL DETAILS 1.0 QUALITY MANAGEMENT SYSTEM AND PROCESSESMANAGEMENT RESPONSIBILITY General Requirements The Quality Management System (QMS) as delineated in this Quality Assurance Program Description (QAPD) is implemented, maintained and continually improved through the use of implementing procedures, quality objectives, audit results, analysis of data, corrective and preventive action, and management review.

To establish and implement this Quality Management System (QMS), GEH has:

Identified and documented the processes needed, and their application throughout the organization.

Determined the sequence and interaction of these processes.

Determined criteria and methods needed to ensure that the operation and control of the processes are effective and are documented in quality plans and implementing procedures.

Ensured the continuing availability of resources and information necessary to achieve planned results and continual improvement of these processes.

Established a system for addressing risks and opportunities.

Determined external and internal issues to achieve planned results.

Established systems to monitor, measure, review and analyze these processes.

Established processes to identify and implement actions necessary to achieve planned results and continual improvement of these processes.

Provided products and services that meet customer and applicable statutory and regulatory requirements by determining the interested parties relevant to the quality management system and assuring that the interested parties requirements accomplished by monitoring and reviewing information about their relevant requirements.

Planning 1.2.1.1 Quality objectives are established throughout the organization to implement the quality policy, to meet process and product requirements, to include risk and opportunities, including internal and external issues, to promote the use of risk basedrisk-based thinking and to facilitate continual improvement.

1.2.1.2 During management review meetings, quality objectives are reviewed against set goals and past performance.

1.2.2.1 Quality system processes are planned to ensure that the system is appropriate for its intended purpose, and that it is effective.

1.2.2.2 Various quality objectives and documents comprising the QMS are periodically reviewed and appropriate changes are made. These changes may be in response to UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part III GEH Quality Assurance Program Description Page 80 of 103 changing circumstances, such as process or organizational change, external or internal factors evaluation, risk and opportunities analysis change or to improve the effectiveness of the quality system.

1.2.2.3 Before implementing, each quality assurance programmatic change is reviewed to ensure that it does not conflict with the integrity of the QMS.

Internal Communication To achieve the effectiveness of the QMS, the following internal communication channels are established within GEH:

Broadcast communications Indoctrination sessions or staff meetings Integrated Management Review (to review, integrate and communicate quality-related matters, problems, corrective actions, status and effectiveness of assigned projects for continuous improvement, and annual reports on the status and adequacy of the quality management system to the top level management)

The subject matter discussed may include:

Performance and/or improvements upon quality objectives Customer feedback Customer/regulatory requirements Adequacy of quality system, processes, and procedures Safety, health, environmental items Security topics Business goals The distribution of results from management reviews, internal audit results, etc. are also used as communication tools regarding the effectiveness of the QMS.

Management Review Top management of GEH reviews the GEH QMS to ensure its continuing suitability and effectiveness. These reviews identify opportunities for improvement and needed changes.

During management reviews, typical input includes the following:

Quality objectives Results of audits Customer feedback Process performance and product conformity Status of corrective and preventive actions Follow-up actions from previous management reviews Planned changes that could affect the Quality Management System Recommendations for improvement UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part III GEH Quality Assurance Program Description Page 81 of 103 Review output from the management review shall include decisions and actions related to the following:

Improvement of the effectiveness of the QMS and its processes Improvement of product related to customer requirements Resource needs to ensure proper implementation of the QMS, and assignment of responsibilities for completing actions 2.0 SUPPORTRESOURCE MANAGEMENT Provision of Resources The GEH business segments have the responsibility of planning and implementing the quality assurance functions performed within their area of responsibility. The quality assurance activities related to design, procurement, production, installation, inspection, and test of the product and services are performed by the business segments and supporting organizations.

GEH manages information and knowledge as a resource.

Change is managed to assure each change is planned, controlled, communicated, monitored and tracked.

The business segments are responsible for identifying quality requirements, quality related activities to be performed, and for providing adequate resources to:

Plan, develop processes, implement requirements, and deliver products and services to customer satisfaction Maintain and continually improve the QMS Enhance delivered quality and customer satisfaction Perform audit and oversight activities Communication To achieve the effectiveness of the QMS, the following internal communication channels are established within GEH:

Broadcast communications Indoctrination sessions or staff meetings Integrated Management Review (to review, integrate and communicate quality-related matters, problems, corrective actions, status and effectiveness of assigned projects for continuous improvement, and annual reports on the status and adequacy of the quality management system to the top-level management)

The subject matter discussed may include:

Performance and/or improvements upon quality objectives Customer feedback Customer/regulatory requirements Adequacy of quality system, processes, and procedures Safety, health, environmental items UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part III GEH Quality Assurance Program Description Page 82 of 103 Security topics Business goals The distribution of results from management reviews, internal audit results, etc. are also used as communication tools regarding the effectiveness of the QMS.

Management Review Top management of GEH reviews the GEH QMS to ensure its continuing suitability and effectiveness. These reviews identify opportunities for improvement and needed changes.

During management reviews, typical input includes the following:

Quality objectives Results of audits Customer feedback Process performance and product conformity Status of corrective and preventive actions Follow-up actions from previous management reviews Planned changes that could affect the Quality Management System Recommendations for improvement Review output from the management review shall include decisions and actions related to the following:

Improvement of the effectiveness of the QMS and its processes Improvement of product related to customer requirements Resource needs to ensure proper implementation of the QMS, and assignment of responsibilities for completing actions 3.0 OPERATIONSPRODUCT REALIZATION Operational Planning of Product and Control Realization The processes needed for product realization have been developed and are consistent with the requirements of the other processes of the QMS.

All products and services shall meet the applicable quality requirements addressed in Part II of this QAPD and the following:

Customer procurement requirements specified in contracts, purchase orders, procurement documents, work authorizations, specifications, or equivalent controlled documents Industrial, regulatory, environmental, and safety standards and controls as specified by controlled work authorization, specification, customer procurement requirements, or equivalent controlled documents, as applicable to the business UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part III GEH Quality Assurance Program Description Page 83 of 103 Implementing procedures related to work planning and scheduling require the responsible manager to develop and document the work plan for the overall job, including appropriate consideration of purchase order requirements, quality requirements, organizational interfaces, verification, and job closure.

Implementing procedures related to new product introduction describe the detailed process for the development and introduction of new products.

Other considerations during product realization planning include product specific:

Quality objectives and requirements (customer wants, regulatory, risk and opportunities, technical and quality)

Processes (design engineering, procurement, supplier evaluation)

Documentation (drawings, specifications, procedures, plans, instructions)

Resources (personnel with appropriate skills and qualifications, facilities, equipment)

Verification, validation, monitoring, inspection and test requirements (evidence of results, certifications and Quality Assurance Records)

Acceptance criteria Product realization planning and requirements for customer site work are addressed in applicable project and quality plans.

Requirements for Products and ServicesCustomer-related Processes Proposals and contracts are reviewed to determine customer requirements in accordance with implementing procedures for commercial risk and approval, work planning and scheduling, design inputs and customer technical requirements, and spare and renewal parts. This includes customers stated requirements or intended expectations, regulatory requirements, product specification, and any other GEH identified requirements.

3.2.2.1 Prior to contract acceptance, various product and service related requirements are reviewed in accordance with the commercial risk and approval process to ensure that:

Product and service requirements are defined Contract requirements differing from those previously stated are resolved GEH has the ability to meet the defined requirements Where a customer does not provide a documented statement of requirement, the customer requirements are confirmed before acceptance 3.2.2.2 Implementing procedures define processes and requirements for review and acceptance of customer technical requirements and design inputs for design and engineering services, and requirements for review and acceptance of requirements for spare and renewal parts.

3.2.3.1 Customer Account Leaders/Project Managers are responsible for fulfilling customer requirements for product information, inquiries, and orders including amendments.

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NEDO-11209-A Draft Changes to Revision 15 Part III GEH Quality Assurance Program Description Page 84 of 103 Responsible Customer Account Leaders/Project Managers monitor customer satisfaction with products through customer feedback methods and direct communication with the goal of improving customer satisfaction.

3.2.3.2 Direct customer communications areis accomplished utilizing media, such as:

Product Services Information Letters (SIL)

Internet website for engineering services Request for quote inquiries Customer feedback and/or complaints Graded Approach to Quality The safety related classification of products and services is documented and approved by the appropriate management.

The safety related classification of products and services is based upon:

Significance and complexity Hazards and magnitude of the potential impact including the possible consequences of failure.

The process, control and methodology to ensure accurate classification of items is documented in procedures.

4.0 PRODUCTION AND SERVICE PROVISION Control of Production and Service Provision GEH will plan and implement production and service activities (including field services) under controlled conditions, which include:

The availability of information that describes the characteristics of the product/service The availability of work instructions The use of suitable equipment and trained/qualified personnel The availability and use of monitoring and measurement equipment The implementation of monitoring and measurement activities The implementation of product/service release, delivery and post-delivery activities Manufacturing suppliers are evaluated to ensure their capability to produce under controlled conditions including suitable equipment, processes, personnel skills, procedures, and work instructions, and utilization of calibrated measuring and test equipment for product acceptance.

Servicing of material/equipment is performed by the applicable business in accordance with the customers contract.

Field services are provided under individual project or quality plans, as applicable to the contract.

Identification and Traceability UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part III GEH Quality Assurance Program Description Page 85 of 103 Unique identification and traceability of materials, parts and components, is addressed in Part II, Section 8.0 of this QAPD.

The status of materials, parts and components is addressed in Part II, Section 14.0 of this QAPD.

All GEH engineering drawings and specifications are controlled according to implementing procedures to ensure that products are identified during all stages of production, delivery, and installation; and that they are traceable.

Product definition documentation is controlled as Quality Assurance Records per implementing procedures.

Procedures related to material and equipment traceability requirements are used to assure product identification and traceability.

Procedures related to material inspection and release ensure that inspected and tested products are identified appropriately to indicate monitoring and measurement status.

Inspection and test status at customer sites is controlled in accordance with applicable project and quality plans.

Customer Property Procedures pertaining to customer supplied material ensure that customer supplied material is received, inspected, stored, maintained in a controlled environment, and that any customer supplied material that is lost, damaged, or is otherwise unsuitable for use be reported to the customer.

Implementing procedures that define control of proprietary information ensure that customer supplied documents are protected and handled in a controlled manner.

5.0 GRADED APPROACH TO QUALITY 6.0 THE SAFETY RELATED CLASSIFICATION OF PRODUCTS AND SERVICES IS DOCUMENTED AND APPROVED BY THE APPROPRIATE MANAGEMENT.

7.0 THE SAFETY RELATED CLASSIFICATION OF PRODUCTS AND SERVICES IS BASED UPON:

8.0 SIGNIFICANCE AND COMPLEXITY 9.0 HAZARDS AND MAGNITUDE OF THE POTENTIAL IMPACT INCLUDING THE POSSIBLE CONSEQUENCES OF FAILURE.

10.0 THE PROCESS, CONTROL AND METHODOLOGY TO ENSURE ACCURATE CLASSIFICATION OF ITEMS IS DOCUMENTED IN PROCEDURES.

11.05.0 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATIONIMPROVEMENT General UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part III GEH Quality Assurance Program Description Page 86 of 103 GEH plans and implements periodic self-assessments and audits, performs measurement and analysis, and determines improvements as needed to:

Demonstrate conformity of the product and services Ensure conformity of the QMS Continually improve the effectiveness of the QMS These requirements and methods are identified in the procedures for audits, self-assessments and the Corrective Action Program.

Procedures are established for assessing statistical trends and include determination of applicable methods, including statistical techniques, and the extent of their use.

Monitoring and Measurement 11.2.1.15.2.1.1 GEH's commitment to customer satisfaction includes serving customer needs with reliable, consistent, and superior products and service, while maintaining the highest standards of integrity.

11.2.1.25.2.1.2 Customer Feedback and related information is used to gauge company performance against customer requirements.

11.2.1.35.2.1.3 Direct communications are established with customers by the GEH Customer Service representatives, Account Leaders and Project Managers to inquire, monitor, and ensure that customer requirements are fulfilled.

11.2.1.45.2.1.4 General Expectations for customer satisfaction are to:

Drive customer satisfaction and loyalty.

Deliver results with a sustained compliance culture.

Continually improve everything we do, leveraging Lean and Six Sigma methodologies.

Achieve operational excellence that our employees and customers feel.

Provide and understand customer needs and make every reasonable effort satisfy them before, during, and after every transaction.

Make every effort to honor commitments to customers that reflect our expertise and capabilities while providing clear and timely communications.

11.2.2.15.2.2.1 Self-assessments, in addition to audits and measurement methods, where applicable, are applied to demonstrate the ability of the processes of the QMS to achieve planned results. This QAPD and implementing procedures for the Corrective Action Program define activities such as:

Setting quality objectives Performing self-assessments Initiating actions to correct identified deficiencies Conducting management reviews UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part III GEH Quality Assurance Program Description Page 87 of 103 11.2.2.25.2.2.2 Control of nonconforming material related procedures detail the process of documenting and controlling nonconforming products and services.

Analysis of Data Data is collected and analyzed to demonstrate effectiveness of the QMS and to evaluate the following:

Customer satisfaction (complaints, feedback, scorecards)

Conformity to product and services requirements (nonconformances, analyses, and trends)

Corrective Action Program Suppliers (performance trend)

Data collected at various sources is analyzed to assess and improve customer satisfaction, product quality, process trends, and supplier performance.

In addition to standard data analysis tools, Six-Sigma continuous process improvement techniques may be incorporated.

Procedures related to statistical techniques list various techniques for use by GEH personnel.

12.06.0 SAFETY CULTURE & SAFETY CONSCIOUS WORK ENVIRONMENT GEH management performs the following actions to establish the appropriate safety conscious work environment within GEH operations:

Ensures common understanding of the key aspects of safety culture within the organization.

Provides the means by which the organization supports individuals and teams in carrying out their tasks safely and successfully, taking into account the interaction between individuals, technology and the organization.

Reinforces a learning and questioning attitude at all levels of the organization.

Provides the means by which the organization continually seeks to develop and improve its safety culture.

Provides the means by which the organization assess the performance of its safety culture.

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NEDO-11209-A Draft Changes to Revision 15 Part IV GEH Quality Assurance Program Description Page 88 of 103 PART IV REGULATORY COMMITMENTS 1.0 QAPD Part I and Part II Commitments Within Part I and Part II of this QAPD, The companyGEH commits to compliance with the following regulations and standards:

10CFR Part 50 Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants ASME NQA-1-20152008 Edition with the NQA-1a-2009, Quality Assurance Requirements for Nuclear Facility Applications Position: The company commits to NQA-1-2015 Part I in its entirety and and Part II for those activities within GEHs scope as an NSSS supplier. as described in The commitment are further described in the commitment sections of this QAPD and contract specific quality plans.

10 CFR Part 21, Reporting of Defects and Noncompliance 10 CFR Part 70, Domestic Licensing of Special Nuclear Material; Subpart D (70.22(f))

for licensing of special nuclear material 10 CFR Part 71, Packaging and Transportation of Radioactive Material; Subpart H 10 CFR Part 72, Licensing Requirements for Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste and Reactor-Related Greater than Class C Waste; Subpart G for storage of radioactive material and waste 2.0 QAPD Part II Regulations and Standards References The companyGEH also commits to the following guidance documents to develop the GEH Quality Assurance Program:

Nuclear Information and Records Management Association, Inc. (NIRMA) Technical Guides (TG) as endorsed by US NRC RIS 2000-18 EPRI NP-5652, Guideline for the Utilization of Commercial-Grade Items in Nuclear Safety Related Applications (6/88 as endorsed and modified by US NRC Generic Letter 89-02, Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products)

ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories US NRC Regulatory Guide (RG) 1.28, Revision 54, October 2017,2010 - Quality Assurance Program CriteriaRequirements (Design and Construction)

Position: The company commits to the audit frequency requirements as defined in NQA-1-2015, Section 201.

US NRC Regulatory Guide (RG) 1.164, Revision 0, June 2017, Dedication of Commercial-Grade Items for use in Nuclear Power Plants US NRC Generic Letter 88-18, Plant Record Storage on Optical Disks UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Part IV GEH Quality Assurance Program Description Page 89 of 103 US NRC Generic Letter 89-02, Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products US NRC Generic Letter 91-05, Licensee Commercial-Grade Procurement and Dedication Programs US NRC RIS 2000-18, Guidance on Managing Quality Assurance Records in Electronic Media ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories, 2017 Edition ML19056A451 (April 16, 2019), Provisional Recognition of the International Standard Organization (ISO)/International Electromechanical Commission (IEC) standard No.

17025, General Requirements for the Competence of Testing and Calibration Laboratories, 2017 Edition NEI 14-05A, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services NIRMA (Nuclear Information and Records Management Association, Inc.) Technical Guides (TG); NIRMA TG-11, NIRMA TG-15, and NIRMA TG-16; as endorsed by US NRC Regulatory Guide (RG) 1.28, Revision 5 Position: The company commits to NIRMA TG-21 1998 Edition as endorsed by US NRC RIS 2000-18.

Additional standards may be referenced, or commitments specified in project specific or work specific quality plans and implementing procedures as required.

3.0 QAPD Part I and Part III Standards Within Part I and Part III of this QAPD, The companyGEH commits to compliance with the following standards:

ISO 9001, Quality Management Systems IAEA GSR Part 2, Leadership and Management for Safety KTA 1401, General Quality Requirements JEAC 4111, Quality Assurance Code for Safety in Nuclear Power Plants ISO 14001:2004, Environmental Management Systems ISO 45001, Occupational Health and Safety Management Systems Requirements with Guidance for UseOHSAS 18001:2007, Health and Safety Management Systems Commitments to aAdditional standards may be specifiedcommitted to in project specific or work specific quality plans and implementing procedures as required.

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NEDO-11209-A Draft Changes to Revision 15 Appendix A GEH Quality Assurance Program Description Page 90 of 103 APPENDIX A: GEH RESPONSES TO NRC RAI This appendix includes the GEH responses to the following RAIs:

Responses to RAIs on NEDO-11209 Revision 11:

Three RAIs from MFN 14-057, dated August 29, 2014 A supplemental response to RAI 2, from MFN 14-057 Supplement 1, dated September 23, 2014.

Responses to RAIs on the amendment to NEDO-11209 Revision 12:

One RAI from MFN 16-017, dated March 2, 2016 One RAI from MFN 16-026 dated April 15, 2016 Response to the one RAI on NEDO-11209 Revision 15:

One RAI from M200075, dated May 13, 2020 UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Appendix A GEH Quality Assurance Program Description Page 91 of 103 RAI 1: (MFN 14-057, dated August 29, 2014)

In January 2011, the U.S. Nuclear Regulatory Commission (NRC) staff approved NEDO-11029, GE Hitachi Quality Assurance Program Description, Revision 9. In March 2014, General Electric Hitachi (GEH) submitted Revision 11 to the NRC, but did not submit Revision 10. GEH provided Enclosure 2, Roadmap for NEDO-11209, Revision 11, which covered NEDO-11209, Revision 9 mapping to Revision 10 and 11.

In the Table, the NRC staff identified five changes made in NEDO-11209, Revision 10, Section 1.1, Section 1.4.2.2, Section 1.4.3.1, and Section 18.4. The NRC staff requests that GEH verify that these are all the changes made to the NRC approved NEDO-11209, Revision 9, that were incorporated into NEDO-11209, Revision 10. The staffs purpose is to verify that GEHs Revision 10 of the Quality Assurance Program Description (QAPD) remained acceptable in accordance with Title 10 of the Code of Federal Regulation (10 CFR) 50.4(b)(7)(ii).

GEH Response:

GEH has provided Attachment 1 to this document which lists all the changes from Revision 9 to Revision 10.

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NEDO-11209-A Draft Changes to Revision 15 Appendix A GEH Quality Assurance Program Description Page 92 of 103

RAI 2

In the GEH QAPD, Part II, QAPD Details, changes were made to Section 2.0, QUALITY ASSURANCE PROGRAM, Subsection 2.8, Quality Assurance Program Description Management, Item 1, to read as follows:

Changes that are made to the QAPD that are a reduction in commitment are submitted to the US NRC for review and approval per 10 CFR 50.4(b)(7)(ii).

The requirements of 10 CFR 50.4(b)(7)(ii) for changes to a vendors QA program do not permit vendors to evaluate whether or not changes to an NRC approved QAPD are reductions in commitment. The NRC staff requests that GEH clarify its process of evaluating potential reductions in commitment.

GEH Response:

The basis for the GEH request for this process option originates in our understanding of the NRCs approach in dealing with non-licensee Quality Assurance (QA) programs. It is clear in 10 CFR 50.4(b)(7)(ii) that a change to an approved program has to be submitted, but it isnt clear that NRC review and approval is always required. Two examples, in particular, led to the requested item being added to our revision request.

First, in the approval letter for another vendors Quality Management System (QMS) (ML12338A515), it is clear that the NRC review utilizes, in part, 10 CFR 50.54(a)(4) to determine the acceptability of changes to a non-licensee QMS program. Second, the Safety Evaluation Report provided by the NRC for Revision 9 of NEDO-11209 (ML112140602) contained the following paragraph in the Regulatory Evaluation section (bold text added for emphasis):

The NRC regulatory requirements related to quality assurance (QA) programs for non-licensees are set forth in 10 CFR 50.4(b)(7)(ii). This regulation requires that a change to an NRC accepted QATR from non-licensees (i.e., architect/engineers, nuclear steam supply system (NSSS) suppliers, fuel suppliers, constructors, etc.) must be submitted to the NRC. When requested, the NRC will review the proposed QATR for acceptability to ensure the applicable requirements of Appendix B to 10 CFR Part 50 will be satisfied.

The phrase When requested implied that further review and approval by the NRC staff was contingent upon a specific request. GEH interpreted these two examples to mean that we should submit all changes but only request NRC review and approval of those that failed a detailed screening criteria as discussed below.

GEH has drafted Section 2.8 based upon 10 CFR 50.54 (3) and will use a screening process to evaluate potential reductions in commitment that are in line with 10 CFR 50.54 (3).

1. The first category of changes is administrative in nature: improvement and clarifications, spelling corrections, punctuation, or editorial items.

2. The second category of changes are based upon NRC acceptance of other standards:

o The use of a QA standard approved by the NRC which is more recent than the QA standard in the QAPD at the time of the change; o The use of a QA alternative or exception approved by an NRC safety evaluation (SE),

provided that the bases of the NRC approval are applicable to GEH; and o The elimination of QA program information that duplicates language in QA regulatory guides and QA standards to which GEH is committed.

3. The third category is focused on organizational changes:

o The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles; o The use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or, alternately, the use of descriptive text; and o Organizational revisions that ensure that persons and organizations performing QA functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations.

4. The fourth category is intended to cover changes in the QAPD in Part III that are made to address international standards changes. NEDO-11029 Revision 11 Section 2.8(g) currently states:

Any change to Part III, Supplemental Details or Part IV, References that do not entail NRC related standards (i.e. ISO 9001, KTA-1401, GS-R-3).

GEH proposes to make the following changes in the -A version of NEDO-11209 Revision 11:

Move the international standards from Part IV, Regulatory Commitments to Part III; UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Appendix A GEH Quality Assurance Program Description Page 93 of 103 Create a new section in Part III Supplemental Details: Section 7.0 References; and NEDO-11209 Part II Section 2.8 (g) would be changed to read:

Any change to Part III, Supplemental Details that do not entail NRC related standards (i.e. ISO 9001, KTA-1401, GS-R-3).

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NEDO-11209-A Draft Changes to Revision 15 Appendix A GEH Quality Assurance Program Description Page 94 of 103

RAI 3

The NRC staff determined that GEH did not make a commitment to the American Society of Mechanical Engineers NQA-1-2008/2009a, Subpart 2.7, Quality Assurance Requirements of Computer Software for Nuclear Facility Applications. The staff requests clarification on the applicability of Subpart 2.7 to GEHs quality activities.

GEH Response:

GEH will include a commitment to NQA-1-2008/2009a, Subpart 2.7, Quality Assurance Requirements of Computer Software for Nuclear Facility Applications in Sections 3.10 and 11.6 of the -A version of NEDO-11209 based on the NRC SE.

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NEDO-11209-A Draft Changes to Revision 15 Appendix A GEH Quality Assurance Program Description Page 95 of 103 Attachment 1: GEH Quality Assurance Program Description NEDO-11209 Revision 9 Mapping to Revision 10 Revision 9 Revision 9 Section Description Revision 10 Summary of Change Section Disclaimer No change Revision History Updated Table of Contents Updated Acronyms & Abbreviations Added EHS, GSC, SCAQ in Revision 10 In Revision 10, Removed NQA from Acronyms &

Abbreviations.

Introduction No change Scope No change SECTION 1 Organization No change 1.1 General Clarified QAPD adherents Removed organizational elements table 1.2 Organizational Description No change 1.2.1 Organizational Structure Updated to reflect 2012 organizational structure 1.2.1.1 P&Ls Updated to reflect 2012 organizational structure 1.2.1.2 Support Organizations Updated to reflect 2012 organizational structure 1.2.1.3 Quality Updated to reflect 2012 organizational structure 1.2.2 Management Positions No change 1.2.2.1 President and Chief Executive Wording change in first paragraph, removed Officer duplicate text on establishment of GEH QA policy.

Added that the President additionally reports to GE Power and Water.

1.2.2.2 Business Leaders for P&Ls and No change Support Organizations 1.2.2.3 Quality Leader Removed NQA & Support Services title, combined them into Quality Programs Combined P&L and Support Quality Leaders into Organization Specific Quality Leaders Added Continuous Improvement 1.2.3 Functional Responsibilities No change 1.2.4 Interface responsibilities No change 1.3 All Employees and contractors No change 1.4 Authority to Stop Work Removed NQA title and added Quality Assurance Organization 1.5 Delegation Outside the GEH No change Organization 1.6 Commitment No change Figure 1 Organizational Structure Updated figure for 2012 organization Figure 2 Functional Responsibilities Replaced table with new table reflecting 2012 organization SECTION 2 QUALITY ASSURANCE No change PROGRAM SECTION 3 DESIGN CONTROL No change SECTION 4 PROCUREMENT DOCUMENT No change CONTROL SECTION 5 PROCEDURES, INSTRUCTIONS, No change AND DRAWINGS SECTION 6 DOCUMENT CONTROL No change 6.1 General No change UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Appendix A GEH Quality Assurance Program Description Page 96 of 103 Revision 9 Revision 9 Section Description Revision 10 Summary of Change Section 6.2 Review and Approval of No change Documents 6.3 Changes to Documents No change 6.4 Temporary Documents Clarified to current process for all temporary changes 6.5 Commitment No change SECTION 7 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES 7.1 General No change 7.2 Supplier Evaluation and Selection No change 7.3 Proposal/Bid Evaluation No change 7.4 Control of Supplier Generated No change Documents 7.5 Control of Supplier Removed conditionality of nonconformance reporting Nonconformances from #4 7.6 Acceptance of Items or Service No change 7.7 Supplier Performance Evaluation No change 7.8 Commercial Grade Items and No change Services - Dedication 7.9 Records No change 7.10 Commitment Eliminated 1st bullet exception to Requirement 7 Editorial changes SECTION 8 IDENTIFICATION AND CONTROL No change OF MATERIALS, PARTS AND COMPONENTS SECTION 9 CONTROL OF SPECIAL No change PROCESSES SECTION 10 INSPECTION 10.1 General No change 10.2 Inspection Personnel Clarified to include how activities are defined 10.3 Planning No change 10.4 Final Inspection No change 10.5 Records Editorial/layout changes 10.6 Commitment No change SECTION 11 TEST CONTROL Some editorial changes throughout section SECTION 12 CONTROL OF MEASURING AND No change TEST EQUIPMENT SECTION 13 HANDLING, STORAGE, AND No change SHIPPING SECTION 14 INSPECTION, TEST, AND No change OPERATING STATUS SECTION 15 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS 15.1 General No change 15.2 Identification and Control No change 15.3 Disposition Eliminated 2nd sentence in Rework and Repair definition to align with current procedure requirements Editorial changes 15.4 Re-examination No change 15.5 Commitment No change SECTION 16 CORRECTIVE ACTION No change UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Appendix A GEH Quality Assurance Program Description Page 97 of 103 Revision 9 Revision 9 Section Description Revision 10 Summary of Change Section SECTION 17 QUALITY ASSURANCE Editorial changes RECORDS SECTION 18 AUDITS 18.1 General No change 18.2 Personnel No change 18.3 Audit Documentation Editorial changes 18.4 Internal Audits Updated to reflect 2012 organization change responsibility for Internal Audits 18.5 Supplier Audits No change 18.6 Audit Response and Follow-up No change 18.7 Commitment No change APPENDIX A REGULATORY COMMITMENTS No change UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Appendix A GEH Quality Assurance Program Description Page 98 of 103 RAI 2: (MFN 14-057 Supplement 1, dated September 23, 2014)

In the GEH QAPD, Part II, QAPD Details, changes were made to Section 2.0, QUALITY ASSURANCE PROGRAM, Subsection 2.8, Quality Assurance Program Description Management, Item 1, to read as follows:

Changes that are made to the QAPD that are a reduction in commitment are submitted to the US NRC for review and approval per 10 CFR 50.4(b)(7)(ii).

The requirements of 10 CFR 50.4(b)(7)(ii) for changes to a vendors QA program do not permit vendors to evaluate whether or not changes to an NRC approved QAPD are reductions in commitment. The NRC staff requests that GEH clarify its process of evaluating potential reductions in commitment.

GEH Response:

GEH will replace the three numbered sections in Subsection 2.8 Quality Assurance Program Description Management with the following two numbered sections in the -A version of NEDO-11209 based on the NRC SE:

1. Proposed changes to this QAPD are submitted to the NRC for review and approval per 10 CFR 50.4(b)(7)(ii). The proposed changes will be termed amendments to the QAPD and will be presented as markups of the then approved version along with a basis discussion for each change.

2. Upon receipt of the NRC approval of each amendment, the QAPD shall be revised and issued as NEDO-11209-A and the revision number incremented. Each NRC approved amendment, with the associated changes, is illustrated in the Revision History located in the front of this document.

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NEDO-11209-A Draft Changes to Revision 15 Appendix A GEH Quality Assurance Program Description Page 99 of 103 RAI 1.0: (MFN 16-017, dated March 2, 2016)

General Electric Hitachi Nuclear Energy QAPD, draft changes to Revision 12, Part III, Supplemental Details, Section 4.4, Graded Approach to Quality, provides a brief description and the safety classification basis.

Provide additional details to clarify which systems, structures, and components (SSCs) would be subject to the graded approach to quality. Explain what specific criteria will be used to identify which SSCs can use graded quality assurance, and explain how that meets the requirements of Title 10 of the Code of Federal Regulations Part 50, Appendix B.

GEH Response:

GEH applies the graded approach to quality for all items that do not meet the definition of a basic component as defined by 10 CFR Part 21.

A graded approach to quality only applies to non-basic components. For example, it applies to SSCs with a Safety-Related Classification of S (Special) in Tier 2 Table 3.2-1 of the ESBWR Design Control Document, Revision 10, dated April 2014 (i.e., the ESBWR DCD), as certified by the US NRC effective 11/14/2014. The ESBWR DCD elevates many SSCs that would have been classified as Non-Safety Related under 10 CFR 50, Appendix B in order to apply more rigorous quality requirements (see Note 5 of Tier 2 Table 3.2-1 of the ESBWR DCD).

In addition, GEH may apply the classification of Special to products and services provided to international nuclear power plants not covered by 10 CFR 50 Appendix B or 10 CFR Part 21 to ensure that applicable international regulations, codes, and standards are met.

GEHs use of a graded approach to quality meets the requirements of Title 10 of the Code of Federal Regulations Part 50, Appendix B in that GEH applies all applicable 10 CFR 50 Appendix B requirements, as described and endorsed by ASME NQA-1, to all basic components as defined by 10 CFR Part 21.

Effect on QAPD Topical Report:

This RAI response has no effect on the QAPD Topical Report.

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NEDO-11209-A Draft Changes to Revision 15 Appendix A GEH Quality Assurance Program Description Page 100 of 103 RAI: (MFN 16-026, dated April 15, 2016)

General Electric Hitachi Nuclear Energy QAPD, draft changes to Revision 12, Part II, QAPD Details, Section 7.10, Commitment, provides a brief description of the requirements to be followed when procuring commercial-grade calibration services from a calibration laboratory.

Section 4 of NEI 14-05, Guidelines for the Use of Accreditation in Lieu of Commercial-Grade Surveys for Procurement of Laboratory Calibration and Test Services, Revision 1, states, in part, Purchasers that rely on the accreditation by ILAC signatories in lieu of commercial-grade surveys are required by 10 CFR Part 50, Appendix B to document this alternative method in their QA Program. A Template for describing the use of the ILAC process in lieu of a commercial-grade survey in a Purchasers QA Program is provided in Appendix A. Although a Purchaser is not required to use the Template in Appendix A, all of the actions and steps described in Appendix A need to be included in the Purchasers QA Program. The staffs evaluation and endorsement of NEI 14-05, is documented in the Final Safety Evaluation for Technical Report NEI 14-05, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, Revision 1, (ADAMS No.

ML14322A535), dated February 9, 2015. Additionally, the staff recently issued Regulatory Issue Summary (RIS) 2016-01, Nuclear Energy Institute Guidance for The Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, (ADAMS No.

ML15323A346), dated March 16, 2016. The RIS also reiterated the requirement to include all of the actions and steps in the QA Program.

The proposed change to NEDO-11209-A, Revision 12, does not address the requirements of Appendix A of NEI 14-05 as approved by the staff. Provide clarification on how General Electric Hitachi Nuclear Energy incorporates these requirements of Appendix A in its QAPD.

GEH Response:

GEH will revise its QAPD, NEDO-11209-A, to add all requirements in Appendix A of NEI 14-05A as applicable to procurement of commercial-grade calibration and testing services from a laboratory. These changes can specifically be seen in the attached markup (Enclosure 2) of Section 7.10 of the QAPD and will be incorporated into the final, approved Revision 13 of the QAPD.

Effect on QAPD Topical Report:

The QAPD is modified as described in the GEH response. Enclosure 2 provides a revised Section 7.10 that will be incorporated into the final, approved Revision 13 of the QAPD. Because of the extensive changes, a revision bar version of Section 7.10 is provided in lieu of a redline-strikethrough version.

Other administrative changes to the QAPD from the draft version submitted via GEH letter MFN 15-091, dated October 14, 2015, are associated with organizational changes within General Electric and GEH.

Namely, GE Power and Water will be changed to GE Power throughout, and Jay Wileman has replaced Caroline Reda as President and CEO of GE Hitachi Nuclear Energy. Finally, the copyright year on the cover page will be changed from 2015 to 2016. These administrative changes are not shown in this response, but will be incorporated in the final, approved Revision 13 of the QAPD.

QAPD Modifications from MFN 16-026 Enclosure 2 7.8 Commercial Grade Items and Services - Dedication

1. Utilization of commercial grade items or services is permitted if controls are in place to provide reasonable assurance that the item or service will perform its intended safety function.

2. Such controls include, but are not limited to the following:

(a) A determination that the item or service performs a safety function (b) Confirmation that the item or service meets the applicable commercial grade item definitions (c) Identification and documentation of the critical characteristics, including acceptance criteria (d) Selection, performance (inspection/test/survey/surveillance), acceptance, and documentation of the dedication methods for determining compliance with the critical characteristic acceptance criteria UNCONTROLLED WHEN PRINTED OR TRANSMITTED ELECTRONICALLY

NEDO-11209-A Draft Changes to Revision 15 Appendix A GEH Quality Assurance Program Description Page 101 of 103

3. The commercial grade item or service dedication process will be controlled via documented procedures and retention of objective evidence.

7.9 Records Records are maintained to indicate the performance of the following functions:

(e) Supplier evaluation and selection (f) Acceptance of the items or services procured (g) Supplier nonconformances to procurement document requirements, including a description of their evaluation and disposition 7.10 Commitment

1. In establishing a program for the control of items and services, GEH commits to compliance with 10 CFR Part 50 Appendix B, Criteria VII and NQA-1-2008 Edition with the NQA-1a-2009 Addenda, Requirement 7 with the following exceptions:

GEH considers 10 CFR Part 50 licensees, Authorized Nuclear Inspection Agencies, National Institute of Standards and Technology, or other State and Federal agencies, which may provide items or services to GEH, as not requiring evaluation or audit.

When purchasing commercial grade calibration or testing services from a laboratory holding accreditation by an accrediting body recognized by the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement, commercial grade surveys and source verifications need not be performed provided each of the following conditions are met:

A documented review of the supplier's accreditation will be performed and will include a verification of each of the following:

o The calibration or test laboratory is accredited to ISO/IEC 17025:2005 General Requirements for the Competence of Testing and Calibration Laboratories by an accreditation body that is a signatory to the ILAC Mutual Recognition Arrangement per NEI 14-05A as endorsed by the US NRC.

o For procurement of calibration services, the published scope of accreditation for the calibration laboratory covers the necessary measurement parameters, ranges, and uncertainties.

o For procurement of testing services, the published scope of accreditation for the test laboratory covers the necessary testing services including test methodology and tolerances/uncertainty.

- The purchase documents require the following:

o The service must be provided in accordance with the supplier's accredited ISO/IEC-17025:2005 program and scope of accreditation.

o The reporting of as-found calibration data in the certificate of calibration when calibrated items are found to be out-of-tolerance.

o The certificate of calibration includes identification of the laboratory equipment and standards used to perform the calibration.

o The supplier is to notify GEH of any condition that adversely impacts the laboratory's ability to maintain the scope of accreditation.

o Impose any additional technical and administrative requirements, as necessary, to comply with the GEH QA program and technical provisions, which may include but are not necessarily limited to, tolerances, accuracies, ranges, and industry standards.

At receipt inspection, GEH shall validate the following:

o The contracted calibration or testing service has been performed in accordance with the suppliers ISO/IEC-17025:2005 program, and has been performed within the laboratorys scope of accreditation, and o The purchase orders requirements are met.

2. The GEH program for dedication of commercial-grade items commits to be consistent with NQA-1a-2009, Subpart 2.14.

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NEDO-11209-A Draft Changes to Revision 15 Appendix A GEH Quality Assurance Program Description Page 102 of 103 RAI: (M200075, dated May 13, 2020)

By letter dated April 29, 2020 (Agencywide Documents Access and Management System Package Accession No. ML20120A553), GE Hitachi Nuclear Energy (GEH) submitted to the U.S. Nuclear Regulatory Commission (NRC) proposed Topical Report, NEDO-11209A, Quality Assurance Program Description (QAPD), Revision 15. Below is the NRC staff request for additional information:

1) In Section 18.5, Supplier Audits, of the GEH Quality Assurance Program Description (QAPD),

GEH proposes an overall 25% extension of the triennial audit period for audits or surveys of domestic and international suppliers to be exercised during periods of exigent conditions affecting GEH facilities or its suppliers, and where performance of such activities is not feasible. GEH also notes that the 25% extension of the triennial audit period is inclusive of the 90-day grace period.

Please describe how GEH ensures that this wording is clear in its use and applicability in that the 25% extension is only for exigent conditions and does not create confusion regarding the existing 36 months audit frequency and associated 90-day grace period afforded for emergent administrative issues as discussed in GEH QAPD, Section 2.7, Grace Period.

GEH Response:

GEH will update the Proposed Revision 15 to NEDO-11209A Revision 14, GE Hitachi Nuclear Energy Quality Assurance Program Description, Section 18.5 first paragraph of sub-section 2.1 which states, An overall 25% extension of the triennial audit period for audits or surveys of domestic and international suppliers may be exercised during periods of exigent conditions affecting GEH facilities or its suppliers, and where performance of such activities is not feasible. Note: The 25% extension of the triennial audit period is inclusive of the 90-day grace period.

QAPD Modifications from M200075 Enclosure 1 The updated text will state:

During periods of exigent conditions affecting GEH facilities or its suppliers, and where performance of audit or survey activities for domestic and international suppliers is not feasible, a 25% extension of the triennial audit period may be exercised. The total allowable extension for exigent conditions is 275 days.

Additionally, QAPD Section 18.5 Sub-part 2.2 will state Continued use of suppliers that have exceeded the time period for audits or surveys due to exigent conditions is allowed, if the following conditions are met: and Sub Part 2.2 c will state A documented evaluation shall be performed identifying the conditions inhibiting performance of the audit or survey and providing a basis for maintaining the supplier as an approved supplier during the exigent condition 25% extension period. The evaluation should consider the following, as applicable:

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NEDO-11209-A Draft Changes to Revision 15 Appendix D GEH Quality Assurance Program Description Page 103 of 103 APPENDIX B: HISTORICAL NRC SAFETY EVALUATIONS (SE)

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NEDO-11209-A Revision 15 Non-Proprietary Information - Public Office of Nuclear Reactor Regulation Minimal Revisions Review Topical Report Final Safety Evaluation for GE Hitachi Nuclear Energy Topical Report NEDO-11209A, Quality Assurance Program Description (QAPD)

Topical Report Information Review Information Report Number: Topical Report NEDO-11209A Division/ Branch: DRO/IQVB

Title:

Proposed Revision 15 to GE Hitachi Project Manager: Ngola Otto Nuclear Energy (GEH) Topical Report NEDO-11209A, Quality Assurance Program Description (QAPD)

EPID: L-2020-TOP-0023 Reviewers: Carla Roque-Cruz Docket No.: 99902024 Determination of Minimal Revisions Is this the review of very limited scope? Yes X No Does the TR change maintain the original SE Yes X No conclusions?

Do the staff methods for establishing the original Yes X No conclusions remain unaffected?

If any of the above questions are answered no, a simplified safety evaluation cannot be used.

1. Introduction By letter dated April 29, 2020 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML20120A553), GE Hitachi Nuclear Energy (GEH), requested approval of a proposed change to its quality assurance (QA) program description (QAPD). In response to the United States Nuclear Regulatory Commission (NRC) staffs request for additional information (ADAMS Accession No. ML20125A033) to clarify the proposed changes, GEH provided a supplemental submittal (ADAMS Accession No. ML20134J088) to include additional information to its QAPD. The proposed change was considered a change to an NRC-accepted QAPD from nonlicensees (i.e., architect/engineers, nuclear steam system suppliers (NSSS)), in accordance with Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities, 50.4(b)(7)(ii). GEH is also a 10 CFR Part 71, Packaging and Transportation of Radioactive Material, licensee holder and utilizes the same QAPD to meet the requirements of 10 CFR Part 71. The proposed change extends the supplier audit frequency from once every three years (i.e., triennial) for supplier audits and surveys affected by exigent conditions. The increased period between supplier audits and surveys will be supplemented by analysis or evaluations of supplier performance as prescribed in this safety evaluation. The change is applicable to supplier audits performed to meet the requirements of Appendix B, "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," to 10 CFR Part 50 and Subpart H, Quality Assurance, of 10 CFR Part 71 for supplier audit frequency for exigent conditions, as described in GEHs QAPD.

Currently, GEHs QAPD Chapter 18, "Audits," requires supplier QA programs to be audited on a triennial basis starting with the year that the first audit occurs, and if the procurement scope significantly changes from the originally audited scope. In addition to triennial audits, annual evaluations of suppliers are conducted as described in Section 7 of the QAPD.

GEH proposed change to its QAPD is a new section to Chapter 18, Section 18.5.2, to incorporate Exigent Condition requirements. This section includes an overall 25 percent extension of the triennial audit period for audits or surveys of domestic and international suppliers that may be exercised during periods of exigent conditions affecting GEH facilities or NEDO-11209-A Revision 15 Non-Proprietary Information - Public Office of Nuclear Reactor Regulation Minimal Revisions Review Topical Report Final Safety Evaluation for GE Hitachi Nuclear Energy Topical Report NEDO-11209A, Quality Assurance Program Description (QAPD)

Topical Report Information Review Information Report Number: Topical Report NEDO-11209A Division/ Branch: DRO/IQVB

Title:

Proposed Revision 15 to GE Hitachi Project Manager: Ngola Otto Nuclear Energy (GEH) Topical Report NEDO-11209A, Quality Assurance Program Description (QAPD)

EPID: L-2020-TOP-0023 Reviewers: Carla Roque-Cruz Docket No.: 99902024 its suppliers, and where performance of such activities is not feasible. Subsection 18.5.2, Exigent Conditions to this QAPD states that:

During periods of exigent conditions affecting GEH facilities or its suppliers, and where performance of audit or survey activities for domestic and international suppliers is not feasible, a 25 percent extension of the triennial audit period may be exercised. The total allowable extension for exigent conditions is 275 days.

Exigent conditions, such as the state of emergency caused by COVID-19, impacts GEHs ability to complete external supplier audits and surveys within the frequency specified in their NRC-approved QA program. Exigent conditions have restricted both domestic and international travel and restricted access to supplier facilities. The proposed change to GEHs QAPD would provide an extension to the external supplier audit and survey frequency that need to be completed during exigent conditions.

The NRC staff has reviewed the proposed change to GEHs QAPD that would be implemented in the event of exigent conditions for QA programs submitted under 10 CFR 50.4(b)(7)(ii).

Details of the NRC staffs evaluation are summarized below.

2. Regulatory Basis The regulations at 10 CFR 50.4(b)(7)(ii), set forth the NRCs regulatory requirements regarding changes to an NRC-accepted QA TR from non-licensees (i.e., architect/engineers, NSSS, fuel suppliers, constructors, etc.) that must be submitted to the NRC's Document Control Desk.

Similarly, 10 CFR 71.106 sets forth the NRCs regulatory requirements regarding changes to NRC-approved QA programs that will reduce commitments in the program description as approved by the NRC.

The regulatory requirements for QA program audits of suppliers is set forth in Criterion VII, Control of Purchased Material, Equipment, and Services and Criterion XVIII, Audits, of Appendix B to 10 CFR Part 50, and in 10 CFR Part 71.115, Control of Purchase Material, Equipment, and Services and 10 CFR 71.137, Audits. Licensees contractually impose these requirements upon their suppliers. Criterion VII of Appendix B to 10 CFR Part 50 and 10 CFR 71.115 require establishing measures for assuring that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents. These measures shall include provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of NEDO-11209-A Revision 15 Non-Proprietary Information - Public Office of Nuclear Reactor Regulation Minimal Revisions Review Topical Report Final Safety Evaluation for GE Hitachi Nuclear Energy Topical Report NEDO-11209A, Quality Assurance Program Description (QAPD)

Topical Report Information Review Information Report Number: Topical Report NEDO-11209A Division/ Branch: DRO/IQVB

Title:

Proposed Revision 15 to GE Hitachi Project Manager: Ngola Otto Nuclear Energy (GEH) Topical Report NEDO-11209A, Quality Assurance Program Description (QAPD)

EPID: L-2020-TOP-0023 Reviewers: Carla Roque-Cruz Docket No.: 99902024 products upon delivery. Documentary evidence that material and equipment conform to the procurement requirements shall be available at the nuclear power plant or fuel reprocessing plant site prior to installation or use of such material and equipment. Criterion XVIII of Appendix B to 10 CFR Part 50 and 10 CFR 71.137 require a comprehensive system of planned and periodic audits shall be carried out to verify compliance with all aspects of the QA program and to determine the effectiveness of the program.

Regulatory Guide (RG) 1.28, "Quality Assurance Program Criteria (Design and Construction),"

Revision 4 (ADAMS Accession No. ML100160003) and RG 7.10, Establishing Quality Assurance Programs for Packaging Used in Transport of Radioactive Material, Revision 3 (ADAMS Accession No. ML14064A505), identify the ASMEs Standard, NQA-1, Quality Assurance Requirements for Nuclear Facility Applications, as an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50 and 10 CFR Part 71 Subpart H.

RG 1.28 identifies some exceptions which are discussed in the Regulatory Position section of RG 1.28, Revision 4. Both RGs state that the audits and surveys are to be conducted on a triennial basis. RG 1.28, Revision 4, Section C.2.b.5 allows a general grace period to be taken for a supplier audit that must be performed on a triennial basis. Further, the grace period does not allow the supplier audit clock to be reset forward. However, the clock can be reset backwards by the supplier audit activity being performed early.

3. Technical Evaluation In evaluating the adequacy of the proposed change, the NRC staff considered the guidance of NUREG-0800, Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition, Chapter 17.5, Quality Assurance Program Description - Design Certification, Early Site Permit and New License Applicants; RG 1.28, Revision 4; and ASME NQA-1. The guidance in RG 1.28, Regulatory Position 2.b, External Audits, states in part, that audits of suppliers QA program should be performed on a triennial basis.

The extension of the audit frequency during exigent conditions as proposed by GEH will provide for greater flexibility in its consideration of other similar events, such as the ongoing COVID-19 pandemic. The current national emergency limiting domestic and international travel, is resulting in GEH not meeting its contractual commitment imposed by licensees associated with the external audit frequency. As the duration of the current national emergency is unknown, the NRC agrees an overall extension of 25 percent to the triennial audit frequency for impacted supplier audits and surveys may be implemented for exigent conditions.

During the exigent conditions, GEH may continue to use suppliers that have exceeded the maximum allowed audit or survey time based on the conditions set forth in the new subsection, NEDO-11209-A Revision 15 Non-Proprietary Information - Public Office of Nuclear Reactor Regulation Minimal Revisions Review Topical Report Final Safety Evaluation for GE Hitachi Nuclear Energy Topical Report NEDO-11209A, Quality Assurance Program Description (QAPD)

Topical Report Information Review Information Report Number: Topical Report NEDO-11209A Division/ Branch: DRO/IQVB

Title:

Proposed Revision 15 to GE Hitachi Project Manager: Ngola Otto Nuclear Energy (GEH) Topical Report NEDO-11209A, Quality Assurance Program Description (QAPD)

EPID: L-2020-TOP-0023 Reviewers: Carla Roque-Cruz Docket No.: 99902024 Exigent Conditions, within the GEH QAPD, Revision 15. The NRC staff found that the descriptions provided in Subsection 18.5.2 are consistent with the following NRC staffs considerations for allowing extensions to the periodicity of audits and surveys for suppliers during exigent conditions:

a. GEH should prioritize completing audits or surveys of affected suppliers based on safety significance and any issues with the supplier. However, the audit or survey shall be completed within the 25 percent grace period.

b. There is verification that the supplier is still implementing a quality assurance program that meets Appendix B to 10 CFR Part 50.

i. For suppliers with delinquent surveys, the entity shall ensure that the suppliers have maintained adequate documented programmatic controls in place for the activity affecting quality.

c. The alternative method of the 25 percent extension discussed above is applicable to domestic and international suppliers.

d. Receipt inspection and industry operating experience are reviewed on an ongoing basis as the information becomes available and documented. The results of the review are promptly considered for the effects on a suppliers continued qualification and adjustments made as necessary, including corrective actions.

e. If there is no ongoing receipt inspection or operating experience with which to analyze the supplier for a period of 12 months since the last audit or survey, an annual documented evaluation shall be performed and include, as appropriate, the following:

i. Review of supplier-furnished documents and records such as certificates of conformance, nonconformance notices, and corrective actions.

ii. Results of previous source verifications, audits, survey and receiving inspection activities.

iii. Operating experience of identical or similar products furnished by the same supplier.

iv. Results of audits from other sources (e.g., customer, American Society of Mechanical Engineers (ASME), or NRC inspection).

NEDO-11209-A Revision 15 Non-Proprietary Information - Public Office of Nuclear Reactor Regulation Minimal Revisions Review Topical Report Final Safety Evaluation for GE Hitachi Nuclear Energy Topical Report NEDO-11209A, Quality Assurance Program Description (QAPD)

Topical Report Information Review Information Report Number: Topical Report NEDO-11209A Division/ Branch: DRO/IQVB

Title:

Proposed Revision 15 to GE Hitachi Project Manager: Ngola Otto Nuclear Energy (GEH) Topical Report NEDO-11209A, Quality Assurance Program Description (QAPD)

EPID: L-2020-TOP-0023 Reviewers: Carla Roque-Cruz Docket No.: 99902024

f. If the contract or a contract modification significantly enlarges the scope or changes the methods or controls for activities performed by the same supplier, the supplier will provide documented justification the change(s) are adequately addressed by its quality assurance program controls.

The overall 25 percent extension for audits or surveys would only be applicable to exigent conditions. A determination of exigent conditions would be based on GEHs prudent judgement.

The above frequency extension for supplier audits or surveys during exigent conditions is a different alternative to the 90-day grace period allowed under RG 1.28, Revision 4, Section C.2.b.5. The general 90-day grace period alternative will remain unchanged for conditions of a minor nature. Examples of conditions of a minor nature would include, but not limited to: 1) staffing limitations preventing a timely audit to be completed and 2) scheduling conflicts by either the vendor, supplier or sub-tier supplier.

As previously stated, the expectation for the use of the 25 percent frequency extension would be limited to implementation for exigent conditions. The expectation would be that GEH attempts to maintain the current triennial audit or survey period. Unlike the existing alternative on the use of a grace period, GEH would not have to reset the clock backwards when the audit or survey is finally performed to the original date the audit or survey should have been performed. The date that the audit or survey is finally performed would be the start of the new triennial audit or survey frequency. The NRC staff considered that should events of a severe nature occur closely together, the requirement for not allowing the clock to be reset forward would result in an additional potential scheduling constraint on completing audits or surveys in a timely manner.

The NRC considered the maturity of the GEH QA program and its supply chain oversight in determining this allowance of a 25 percent extension for audits and surveys to be completed from the date of the expiration of the triennial audit or survey frequency. The NRC also considered the potential risk significance of extending the audit and survey frequency by 25 percent. Based on the reliability of GEHs QA program, the expected short duration that GEH will be under an exigent condition, and GEHs continuous monitoring of ongoing and previous supplier performance, the NRC staff determined that there is minimal risk associated with implementing the extended audit and survey frequencies during exigent conditions.

Therefore, the NRC concluded that the conditions stated above ensure that reasonable assurance of the quality of items and services will continue to be maintained during this extension period.

NEDO-11209-A Revision 15 Non-Proprietary Information - Public Office of Nuclear Reactor Regulation Minimal Revisions Review Topical Report Final Safety Evaluation for GE Hitachi Nuclear Energy Topical Report NEDO-11209A, Quality Assurance Program Description (QAPD)

Topical Report Information Review Information Report Number: Topical Report NEDO-11209A Division/ Branch: DRO/IQVB

Title:

Proposed Revision 15 to GE Hitachi Project Manager: Ngola Otto Nuclear Energy (GEH) Topical Report NEDO-11209A, Quality Assurance Program Description (QAPD)

EPID: L-2020-TOP-0023 Reviewers: Carla Roque-Cruz Docket No.: 99902024

4. Conclusion The NRC staff has reviewed GEHs QAPD, Revision 15 submittal. As stated above, the NRC staff concluded that there is reasonable assurance that GEHs QA program will continue to meet the requirements of Appendix B to 10 CFR Part 50, and 10 CFR Part 71 Subpart H while implementing the 25 percent extension of audit and survey frequencies during exigent conditions. Therefore, the NRC staff found GEHs proposed changes to its QAPD, Revision 15 to be an acceptable method for extending audit frequencies during exigent conditions.

Principal Contributor: Carla P. Roque-Cruz Date: May 21, 2020 ADAMS Accession Nos: Package: ML20141K704; Transmittal Email: ML20140A332 SE: ML20140A322 Approval Printed Name Signature Date Kerri Kavanagh /RA/ 5/20/2020 Technical Branch Chief Projects Branch Dennis Morey /RA/ 5/20/2020 Chief NEDO-11209-A Revision 15 Non-Proprietary Information - Public January 10, 2018 Mr. Jerald G. Head Senior Vice President, Regulatory Affairs General Electric-Hitachi Nuclear Energy Americas, LLC P.O. Box 780, M/C A-18 Wilmington, NC 28401-0780

SUBJECT:

FINAL SAFETY EVALUATION FOR GE HITACHI NUCLEAR ENERGY AMENDMENT TO NEDO-11209 REVISION 13, GE HITACHI NUCLEAR ENERGY QUALITY ASSURANCE PROGRAM DESCRIPTION (EPID L-2017-TOP-0058)

Dear Mr. Head:

By letter dated October 6, 2017 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML17279A629), GE Hitachi Nuclear Energy Americas LLC (GEH) submitted the proposed amendment to Topical Report (TR) NEDO-11209, Revision 13, GE Hitachi Nuclear Energy Quality Assurance Program Description, to the U.S. Nuclear Regulatory Commission (NRC) staff for review.

By letter dated December 8, 2017, an NRC draft safety evaluation (SE) regarding our approval of TR NEDO-11209 Revision 13, GE Hitachi Nuclear Energy Quality Assurance Program Description, was provided for your review and comment (ADAMS Accession No. ML17334A074). By letter dated December 15, 2017, you stated that GEH did not identify any factual errors or clarity concerns in the draft SE (ADAMS Accession No. ML17349A537).

The NRC staff has found that TR NEDO-11209, Revision 13, is acceptable for referencing in licensing applications for nuclear power plants to the extent specified and under the limitations delineated in the TR and in the enclosed final SE. The final SE defines the basis for our acceptance of the TR.

Our acceptance applies only to material provided in the subject TR. We do not intend to repeat our review of the acceptable material described in the TR. When the TR appears as a reference in licensing applications, our review will ensure that the material presented applies to the specific plant involved. License amendment requests that deviate from this TR will be subject to a plant-specific review in accordance with applicable review standards.

NEDO-11209-A Revision 15 Non-Proprietary Information - Public J. Head In accordance with the guidance provided on the NRC website, we request that GNF publish an approved version of TR NEDO-11209 Revision 13, within three months of receipt of this letter.

The approved version shall incorporate this letter and the enclosed final SE after the title page.

The approved version shall include a "-A" (designating approved) following the TR identification symbol.

If future changes to the NRCs regulatory requirements affect the acceptability of this TR, GNF will be expected to revise the TR appropriately or justify its continued applicability for subsequent referencing. Licensees referencing this TR would be expected to justify its continued applicability or evaluate their plant using the revised TR.

Sincerely,

/RA/

Dennis C. Morey, Chief Licensing Processes Branch Division of Policy and Rulemaking Office of Nuclear Reactor Regulation Docket No. 99902024

Enclosure:

Final SE (Non-Proprietary)

ML18002A432; *concurrence via e-mail NRR-106 OFFICE NRR/DLP/PLPB/PM NRR/DLP/PLPB/LA* NRO/DCIP/QVIB-3/BC NRR/DLP/PLPB/BC NAME JGolla DHarrison KKavanagh DMorey DATE 1/9/2018 1/9/2018 1/9/2018 1/10/2018 NEDO-11209-A Revision 15 Non-Proprietary Information - Public GE-Hitachi Nuclear Energy Americas Docket No. 99902024 cc:

Mr. James F. Harrison GE-Hitachi Nuclear Energy Americas LLC Vice President - Fuel Licensing P.O. Box 780, M/C A-55 Wilmington, NC 28401-0780 james.harrison@ge.com Ms. Patricia L. Campbell Vice President, Washington Regulatory Affairs GE-Hitachi Nuclear Energy Americas LLC 1299 Pennsylvania Avenue, NW 9th Floor Washington, DC 20004 patriciaL.campbell@ge.com Dr. Brian R. Moore General Manager, Core & Fuel Engineering Global Nuclear Fuel-Americas, LLC P.O. Box 780, M/C A-75 Wilmington, NC 28401-0780 Brian.Moore@gnf.com

NEDO-11209-A Revision 15 Non-Proprietary Information - Public FINAL SAFETY EVALUATION OF GENERAL ELECTRIC HITACHI NUCLEAR ENERGY, QUALITY ASSURANCE TOPICAL REPORT NEDO-11209-A, REVISION 13, GE HITACHI NUCLEAR ENERGY QUALITY ASSURANCE PROGRAM DESCRIPTION (EPID L-2017-TOP-0058)

DOCKET NO. 99902024

1.0 INTRODUCTION

By letter dated October 6, 2017 (Ref. 1), General Electric Hitachi Nuclear Energy (GEH) submitted an amendment to Quality Assurance Topical Report (QATR) NEDO 11209-A, Revision 13, GE Hitachi Nuclear Energy Quality Assurance Program Description, to the U.S. Nuclear Regulatory Commission (NRC) for review and approval in accordance with the provisions of Title 10 of the Code of Federal Regulations (10 CFR), Section 50.4(b)(7)(ii). GEH proposed that this updated QATR would replace the current QATR for GEH, which was approved by NRC as documented in a safety evaluation (SE) dated June 6, 2016 (Ref. 2).

2.0 REGULATORY BASIS The Commissions regulatory requirements related to Quality Assurance (QA) programs for non-licensees are set forth in Title 10 of the Code of Federal Regulations (10 CFR) 50.4(b)(7)(ii).

This regulation requires that a change to a NRC-accepted QA program description from non-licensees (i.e., architect/engineers, nuclear steam system suppliers, fuel suppliers, constructors, etc.) must be submitted to the NRC. The NRC will review the proposed QATR for acceptability to ensure the applicable requirements of Appendix B to 10 CFR Part 50 will be satisfied.

Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to 10 CFR Part 50 establishes QA requirements for the design, fabrication, construction, and testing of structures, systems, and components (SSCs) of the facility. The pertinent requirements of Appendix B to 10 CFR Part 50 apply to all activities affecting the safety-related functions of SSCs and include designing, purchasing, fabricating, handling, shipping, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, refueling, and modifying.

3.0 EVALUATION In evaluating the adequacy of the GEH QATR, the NRC staff used the guidance contained in NUREG-0800, "Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants," SRP Section 17.5, Quality Assurance Program Description - Design Certification, Early Site Permit and New License Applicants," Revision 1, dated August 2015 (Ref. 3) hereafter referred to as standard review plan (SRP) Section 17.5, which provides acceptance criteria for design certification, early site permit, combined operating license, construction permit, and operating license applicants. SRP Section 17.5 is based on American Society of Mechanical Engineers (ASME) Standard NQA-1-2008 Edition and the NQA-1a-2009 Addenda, as supplemented by additional regulatory and industry guidance for nuclear operating facilities. ASME Standard NQA-1-2008 Edition and the NQA-1a-2009 Addenda, upon which the Enclosure

NEDO-11209-A Revision 15 Non-Proprietary Information - Public 2-GEH QATR is based, incorporated the supplemental guidance into a single document, and is, therefore, in alignment with SRP Section 17.5. In addition, NQA-1-2008 Edition and the NQA-1a-2009 Addenda, is endorsed by NRC Regulatory Guide 1.28, Quality Assurance Program Requirements (Design and Construction), Revision 4.

The proposed changes made to GEHs QATR, Revision 13, include minor editorial changes and changes to the organizational structure within GEH. In a conference call held on November 9, 2017, GEH staff provided clarification for organizational changes regarding the reporting structure of the Profit and Loss (P&L) Business Leaders, Nuclear Oversight Quality, and P&L Quality Leaders. GEH clarified that the dotted lines between P&L Business leaders and P&L Quality leaders and the dotted lines between Nuclear Oversight Quality and P&L Quality leaders, as shown in Figure 1 of Revision 13 to the QATR, provide flexibility for the management of resources in implementing the quality requirements set forth in the QATR; however, Nuclear Oversight Quality maintains responsibility for the final release of products to the customer.

The NRC staff verified that the revised GEH QATR continues to ensure that persons and organizations performing quality assurance functions have the required authority and organizational freedom, and remain sufficiently independent from cost and schedule when opposed to safety considerations.

4.0 CONCLUSION

The NRC staff used the acceptance criteria of NUREG-0800, Section 17.5 as the basis for evaluating the acceptability of the GEH QATR, NEDO-11209-A, Revision 13 for conformance with the applicable requirements of Appendix B to 10 CFR Part 50. The NRC staff concludes that GEHs QATR, NEDO-11209-A, Revision 13, follows the NRC guidance contained within and conforms to the format of NUREG-0800, Section 17.5, complies with Appendix B to 10 CFR Part 50 requirements for the QA program and, therefore, is acceptable.

5.0 REFERENCES

1. GE Hitachi Nuclear Energy Amendment to NEDO-11209-A, Revision 13, October 6, 2017, GE Hitachi Nuclear Energy Quality Assurance Program Description (Agencywide Documents Access and Management System (ADAMS) Accession No. ML17279A629).

2. Safety Evaluation of General Electric Hitachi GE Hitachi Nuclear Energy, Quality Management System, Quality Assurance Topical Report, NEDO-11209, Revision 12, Quality Assurance Program Description (CAC NO. MF7028), June 6, 2016 (ADAMS Accession No. ML16138A359).

3. NUREG-0800, Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition, Section 17.5 Revision 1, Quality Assurance Program Description - Design Certification, Early Site Permit and New License Applicants, August 2015 (ADAMS Accession No. ML15037A441).

Principal Contributor: Ashley Ferguson, NRO Date: January 10, 2018

NEDO-11209-A Revision 15 Non-Proprietary Information - Public June 6, 2016 Mr. Jerald G. Head Senior Vice President, Regulatory Affairs General Electric-Hitachi Nuclear Energy Americas, LLC P.O. Box 780, M/C A-18 Wilmington, NC 28401-0780

SUBJECT:

FINAL SAFETY EVALUATION FOR GENERAL ELECTRIC HITACHI NUCLEAR ENERGY AMERICAS, LLC AMENDMENT TO NEDO-11209-A REVISION 12, GE HITACHI NUCLEAR ENERGY QUALITY ASSURANCE PROGRAM DESCRIPTION, (CAC NO. MF7028)

Dear Mr. Head:

By letter dated October 14, 2015 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML15287A009), GE Hitachi Nuclear Energy Americas, LLC (GEH) submitted Amendment to NEDO-11209-A Revision 12, GE Hitachi Nuclear Energy Quality Assurance Program Description, to the U.S. Nuclear Regulatory Commission (NRC) staff for review.

By letter dated May 6, 2016, an NRC draft safety evaluation (SE) regarding our approval of NEDO-11209-A, Revision 12, was provided for your review and comment (ADAMS Accession No. ML16110A324). By letter dated May 16, 2016, (ADAMS Accession No. ML16137A542) you replied that you had no comments.

The NRC staff has found that Amendment to NEDO-11209-A, Revision 12, is acceptable for referencing in licensing applications for nuclear power plants to the extent specified and under the limitations delineated in the Amendment and in the enclosed final SE. The final SE defines the basis for our acceptance of the Amendment.

Our acceptance applies only to material provided in the subject Amendment. We do not intend to repeat our review of the acceptable material described in the Amendment. When the Amended Topical Report (TR) appears as a reference in license applications, our review will ensure that the material presented applies to the specific plant involved. License amendment requests that deviate from this Amended TR will be subject to a plant-specific review in accordance with applicable review standards.

In accordance with the guidance provided on the NRC website, we request that GEH publish the approved Amendment to TR NEDO-11209-A, Revision 12, within three months of receipt of this letter. The approved version shall incorporate this letter and the enclosed final SE Supplement after the title page. Also, it must contain historical review information, including NRC requests for additional information and your responses. The approved version shall include an "-A" (designating approved) following the TR identification symbol.

NEDO-11209-A Revision 15 Non-Proprietary Information - Public J. Head If future changes to the NRC's regulatory requirements affect the acceptability of this TR, GEH will be expected to revise the TR appropriately. Licensees referencing this TR would be expected to justify its continued applicability or evaluate their plant using the revised TR.

Sincerely,

/RA/

Kevin Hsueh, Chief Licensing Processes Branch Division of Policy and Rulemaking Office of Nuclear Reactor Regulation Project No. 710

Enclosure:

Final SE cc w/encl: See next page

ML16138A359; *concurred via e-mail NRR-106 OFFICE NRR/DPR/PLPB NRR/DPR/PLPB* NRO/QVIB NRR/DPR/PLPB NAME JGolla DHarrison KKavanagh KHsueh DATE 5/26/2016 05/24/2016 5/31/2016 6/6/2016 NEDO-11209-A Revision 15 Non-Proprietary Information - Public GE-Hitachi Nuclear Energy Americas Project No. 710 cc:

Mr. James F. Harrison GE-Hitachi Nuclear Energy Americas LLC Vice President - Fuel Licensing P.O. Box 780, M/C A-55 Wilmington, NC 28401-0780 james.harrison@ge.com Ms. Patricia L. Campbell Vice President, Washington Regulatory Affairs GE-Hitachi Nuclear Energy Americas LLC 1299 Pennsylvania Avenue, NW 9th Floor Washington, DC 20004 patriciaL.campbell@ge.com Dr. Brian R. Moore Core & Fuel Engineering Manager Global Nuclear Fuel-Americas, LLC P.O. Box 780, M/C A-55 Wilmington, NC 28401-0780 Brian.Moore@gnf.com

NEDO-11209-A Revision 15 Non-Proprietary Information - Public FINAL SAFETY EVALUATION BY THE OFFICE OF NEW REACTORS OF GENERAL ELECTRIC HITACHI NUCLEAR ELECTRIC, QUALITY ASSURANCE TOPICAL REPORT NEDO-11209-A, REVISION 12, GE HITACHI NUCLEAR ENERGY QUALITY ASSURANCE PROGRAM DESCRIPTION (CAC NO. MF7028)

1.0 INTRODUCTION

By letter dated October 14, 2015 (Reference 1), General Electric Hitachi Nuclear Energy (GEH) submitted an amendment to Quality Assurance Topical Report (QATR)

NEDO 11209-A, Revision 12, GE Hitachi Nuclear Energy Quality Assurance Program Description, to the U.S. Nuclear Regulatory Commission (NRC) for review and approval in accordance with the provisions of Title 10 of the Code of Federal Regulations (10 CFR), Section 50.4(b)(7)(ii). GEH proposed that this updated QATR would replace the current QATR for GEH, which was approved by NRC as documented in a safety evaluation report (SER) dated October 20, 2014 (Reference 6).

During its review, the NRC staff determined that additional information was required to complete its review. On February 8, 2016 (Reference 2) and April 11, 2016 (Reference 3), the NRC transmitted two requests for additional information (RAIs) that were necessary complete the staffs review of QATR Revision 12. By letter dated March 2, 2016, and electronic correspondence dated April 15, 2016, GEH responded to the staffs RAIs (Reference 4 and Reference 5).

2.0 REGULATORY BASIS The Commissions regulatory requirements related to Quality Assurance (QA) programs for non-licensees are set forth in 10 CFR 50.4(b)(7)(ii). This regulation requires that a change to a NRC-accepted QA program description from non-licensees (i.e., architect/engineers, nuclear steam system suppliers, fuel suppliers, constructors, etc.) must be submitted to the NRC. The NRC will review the proposed QATR for acceptability to ensure the applicable requirements of Appendix B to 10 CFR Part 50 will be satisfied.

Enclosure

NEDO-11209-A Revision 15 Non-Proprietary Information - Public Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to 10 CFR Part 50 establishes QA requirements for the design, fabrication, construction, and testing of structures, systems, and components (SSCs) of the facility. The pertinent requirements of Appendix B to 10 CFR Part 50 apply to all activities affecting the safety-related functions of SSCs and include designing, purchasing, fabricating, handling, shipping, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, refueling, and modifying.

3.0 EVALUATION In evaluating the adequacy of the GEH QATR, the NRC staff used the guidance contained in NUREG-0800, "Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants," SRP Section 17.5, Quality Assurance Program Description - Design Certification, Early Site Permit and New License Applicants,"

Revision 1, dated August 2015 (Reference 7) hereafter referred to as standard review plan (SRP) Section 17.5, which provides acceptance criteria for design certification, early site permit, combined operating license, construction permit, and operating license applicants. SRP Section 17.5 is based on American Society of Mechanical Engineers (ASME) Standard NQA-1-2008 Edition and the NQA-1a-2009 Addenda, as supplemented by additional regulatory and industry guidance for nuclear operating facilities. ASME Standard NQA-1-2008 Edition and the NQA-1a-2009 Addenda, upon which the GEH QATR is based, incorporated the supplemental guidance into a single document, and is therefore in alignment with SRP Section 17.5. In addition, NQA-1-2008 Edition and the NQA-1a-2009 Addenda, is endorsed by NRC Regulatory Guide (RG) 1.28, Quality Assurance Program Requirements (Design and Construction), Revision 4.

The proposed changes made to QATR Revision 12, include the following:

Minor editorial changes spelling corrections, punctuation, administrative improvements, and clarifications to reflect the current organization within General Electric and GEH. The staff verified that the revised GEH QATR continues to ensure that persons and organizations performing quality assurance functions have the required authority and organizational freedom, and remain sufficiently independent from cost and schedule when opposed to safety considerations.

In addition to the minor editorial changes, GEH added Section 4.4,Graded Approach to Quality, to PART III, Supplemental Details, of the QATR. The NRC staff submitted RAI 1 (Reference 2) requesting additional details how GEH planned to implement Section 4.4. GEHs response to RAI 1 (Reference 4) described that the graded approach to quality only applies to non-basic components. For example, it applies to SSCs with a Safety-Related Classification of S (Special) in Tier 2 Table 3.2-1 of the Economic Simplified Boiling Water Reactor Design Control Document (ESBWR DCD), Revision 10 dated April 2014, as certified by the US NRC (Reference 8). The ESBWR DCD

NEDO-11209-A Revision 15 Non-Proprietary Information - Public elevates many SSCs that would have been classified as Non-Safety Related under Appendix B to 10 CFR Part 50, in order to apply more rigorous quality requirements (see Note 5 of Tier 2 Table 3.2-1 of the ESBWR DCD). In addition, GEH in their response described that they may apply the classification of Special to products and services provided to international nuclear power plants not covered by Appendix B to 10 CFR Part 50 or 10 CFR Part 21 to ensure that applicable international regulations, codes, and standards are met. GEHs use of a graded approach to quality meets the requirements of Appendix B to 10 CFR Part 50 in that GEH applies all applicable Appendix B to 10 CFR Part 50 requirements, as described by ASME in NQA-1-2008 Edition and supplemented by NQA-1a-2009 Addenda, to all basic components as defined by 10 CFR Part 21. The NRC staff found this approach to be acceptable.

The proposed amendment to QATR Revision 12 also included a commitment to implement the quality assurance program alternative of the Nuclear Energy Institute (NEI) Technical Report NEI 14-05, Revision 1, "Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services," dated August 2014 (Reference 9).

The NRC staff concluded, in an SER dated February 9, 2015 (Reference 10),

that NEI 14-05, Revision 1, provided an acceptable approach for licensees and suppliers subject to the QA requirements of Appendix B to 10 CFR Part 50, for using laboratory accreditation by Accreditation Bodies that are signatories to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) in lieu of performing commercial-grade surveys as part of the commercial-grade dedication process for procurement of calibration and testing services performed by domestic and international laboratories accredited by signatories to the ILAC MRA.

The proposed change was deemed to constitute a reduction in commitment. The NRC staff's review verified that GEH correctly implemented the requirements of NEI 14-05, Revision 1. NEI 14-05, Revision 1, Section 4, Purchasers Quality Assurance Program, states, in part, that "Purchasers that rely on the accreditation by ILAC signatories in lieu of commercial-grade surveys are required by 10 CFR Part 50, Appendix B to document this alternative method in their QA Program. A Template for describing the use of the ILAC process in lieu of a commercial-grade survey in a Purchasers QA Program is provided in Appendix A. Although a Purchaser is not required to use the Template in Appendix A, all of the actions and steps described in Appendix A need to be included in the Purchasers QA Program.

Section 7.10, Commitment, of PART II, QAPD Details, was revised to include guidance proposed by GEH to implement the requirements of NEI 14-05, Revision 1.

The proposed change to this section, as described, did not address the requirements of this alternative as outlined in NEI 14-05, Revision 1. The NRC staff electronically transmitted RAI 2 (Reference 3) requesting clarification on how GEH planned to meet the requirements of NEI 14-05, Revision 1 in its QATR. In response (Reference 5), GEH revised Section 7.10 to include all the requirements listed in Appendix A of NEI 14-05, Revision 1. The NRC staff found this approach to be acceptable.

NEDO-11209-A Revision 15 Non-Proprietary Information - Public

3.0 CONCLUSION

The NRC staff used the acceptance criteria of NUREG-0800, Section 17.5 as the basis for evaluating the acceptability of the GEH QATR, NEDO-11209-A, Revision 12 for conformance with the applicable requirements of Appendix B to 10 CFR Part 50. The NRC staff concludes that GEHs Quality Assurance Topical Report NEDO-11209-A Revision 12, follows the NRC guidance contained within and conforms to the format of NUREG-0800, Section 17.5, complies with Appendix B to 10 CFR Part 50 requirements for the QA program, and is therefore, acceptable.

4.0 REFERENCES

1. GE Hitachi Nuclear Energy Amendment to NEDO-11209-A, Revision 12, dated October 14, 2015, GE Hitachi Nuclear Energy Quality Assurance Program Description (Agencywide Documents Access and Management System (ADAMS)

Accession No. ML15287A009).

2. NRC letter to GE Hitachi Nuclear Energy, Request for Additional Information Regarding Review of Amendment to NEDO-11209-A Revision 12, GE Hitachi Nuclear Energy Quality Assurance Program Description, dated February 8, 2016 (ADAMS Accession No. ML16005A572).

3. NRC electronic correspondence to GE Hitachi Nuclear, Request for Additional Information Regarding Review of Amendment to NEDO-11209-A Revision 12, GE Hitachi Nuclear Energy Quality Assurance Program Description, dated April 11, 2016 (ADAMS Accession No. ML16102A443)

4. GE Hitachi Nuclear Energy letter to NRC, NRC Request for Additional Information Regarding Review of Amendment to NEDO-11209-A Revision 12, GE Hitachi Nuclear Energy Quality Assurance Program Description, dated March 2, 2016 (ADAMS Accession No. ML16063A013)

5. GE Hitachi Nuclear Energy electronic correspondence to NRC, NRC Request for Additional Information Regarding Review of Amendment to NEDO-11209-A Revision 12, GE Hitachi Nuclear Energy Quality Assurance Program Description, dated April 15, 2016 (ADAMS Accession Nos. ML16106A161).

6. Safety Evaluation of General Electric Hitachi GE Hitachi Nuclear Energy, Quality Management System, Quality Assurance Topical Report, NEDO-11209, Revision 11, Quality Assurance Program Description (TAC NO. MF3792), dated October 20, 2014 (ADAMS Accession No. ML14267A483)

7. NUREG-0800, Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition, Section 17.5 Revision 1, Quality Assurance

NEDO-11209-A Revision 15 Non-Proprietary Information - Public Program Description - Design Certification, Early Site Permit and New License Applicants, dated August 2015, (ADAMS Accession No. ML15037A441).

8. NUREG-1966 "Final Safety Evaluation Report Related to the Certification of the Economic Simplified Boiling-Water Reactor Standard Design" (ADAMS Accession No. ML14100A304)

9. Submittal of NEI 14-05, Revision 1, "Guidelines for the Use of Accreditation in Lieu of Commercial-Grade Surveys for Procurement of Laboratory Calibration and Test Services," dated August 31, 2014 (ADAMS Accession No. ML14245A392).

10. Final Safety Evaluation for Technical Report NEI 14-05, Guidelines for the use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, Revision 1 dated February 9, 2015 (ADAMS Accession No. ML14322A535)

Principal Contributor: Jonathan Ortega-Luciano, NRO Date:

NEDO-11209-A Revision 15 Non-Proprietary Information - Public January 16, 2015 Mr. Jerald G. Head Senior Vice President, Regulatory Affairs General Electric-Hitachi Nuclear Energy Americas, LLC P.O. Box 780, M/C A-18 Wilmington, NC 28401-0780

SUBJECT:

FINAL SAFETY EVALUATION FOR GENERAL ELECTRIC HITACHI NUCLEAR ENERGY AMERICAS, LLC TOPICAL REPORT NEDO-11209, GE HITACHI NUCLEAR ENERGY QUALITY ASSURANCE PROGRAM DESCRIPTION, REVISION 11 (TAC NO. MF3792)

Dear Mr. Head:

By letter dated March 31, 2014 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML14090A330), GE Hitachi Nuclear Energy Americas, LLC (GEH) submitted Topical Report (TR) NEDO-11209, GE Hitachi Nuclear Energy Quality Assurance Program Description Revision 11, to the U.S. Nuclear Regulatory Commission (NRC) staff for review.

By letter dated November 14, 2014, an NRC draft safety evaluation (SE) regarding our approval of NEDO-11209, Revision 11, was provided for your review and comment (ADAMS Accession No. ML14316A349). The NRC staff's disposition of the GEH comments on the draft SE are presented in the attachment to the final SE enclosed with this letter.

The NRC staff has found that NEDO-11209, Revision 11, is acceptable for referencing in licensing applications for nuclear power plants to the extent specified and under the limitations delineated in the TR and in the enclosed final SE. The final SE defines the basis for our acceptance of the TR.

Our acceptance applies only to material provided in the subject TR. We do not intend to repeat our review of the acceptable material described in the TR. When the TR appears as a reference in license applications, our review will ensure that the material presented applies to the specific plant involved. License amendment requests that deviate from this TR will be subject to a plant-specific review in accordance with applicable review standards.

In accordance with the guidance provided on the NRC website, we request that GEH publish the approved TR NEDO-11209, Revision 11, within three months of receipt of this letter. The approved version shall incorporate this letter and the enclosed final SE Supplement after the title page. Also, it must contain historical review information, including NRC requests for additional information and your responses. The approved version shall include an "-A" (designating approved) following the TR identification symbol.

NEDO-11209-A Revision 15 Non-Proprietary Information - Public If future changes to the NRC's regulatory requirements affect the acceptability of this TR, GEH and/or licensees referencing it will be expected to revise the TR appropriately, or justify its continued applicability for subsequent referencing.

Sincerely,

/RA/

Aby S. Mohseni, Deputy Director Division of Policy and Rulemaking Office of Nuclear Reactor Regulation Project No. 710

Enclosure:

Final Safety Evaluation cc w/encl: See next page

ML14349A682 NRR-106 OFFICE NRR/DPR/PLPB NRR/DPR/PLPB NRO/QVIB NRR/DPR/PLPB NRR/DPR NAME JGolla DHarrison KKavanagh AMendiola AMohseni DATE 1 / 5 /2014 12/19/2014 1 / 7 /2014 1 / 14 /2014 1/16/2014 NEDO-11209-A Revision 15 Non-Proprietary Information - Public GE-Hitachi Nuclear Energy Americas Project No. 710 cc:

Mr. James F. Harrison GE-Hitachi Nuclear Energy Americas LLC Vice President - Fuel Licensing P.O. Box 780, M/C A-55 Wilmington, NC 28401-0780 james.harrison@ge.com Ms. Patricia L. Campbell Vice President, Washington Regulatory Affairs GE-Hitachi Nuclear Energy Americas LLC 1299 Pennsylvania Avenue, NW 9th Floor Washington, DC 20004 patriciaL.campbell@ge.com

NEDO-11209-A Revision 15 Non-Proprietary Information - Public SAFETY EVALUATION BY THE OFFICE OF NEW REACTORS GENERAL ELECTRIC (GE) HITACHI NUCLEAR ENERGY AMERICAS, LLC.

QUALITY MANAGEMENT SYSTEM, QUALITY ASSURANCE TOPICAL REPORT NEDO-11209, REVISION 11 "GE HITACHI NUCLEAR ENERGY QUALITY ASSURANCE PROGRAM DESCRIPTION PROJECT NO. 710

1.0 INTRODUCTION

By letter dated March 31, 2014 (Reference 1), GEH submitted quality management system (QMS) quality assurance (QA) topical report (QATR) NEDO-11209, Revision 11, GE Hitachi Nuclear Energy Quality Assurance Program Description [QAPD], to the U.S. Nuclear Regulatory Commission (NRC) for review and approval in accordance with the provisions of Title 10 of the Code of Federal Regulations (10 CFR), Section 50.4(b)(7)(ii). GEH proposed that this updated QATR would replace the current QATR for GEH, which was approved by the NRC as documented by letter dated January 11, 2011 (Reference 5).

2.0 REGULATORY BASIS The NRC regulatory requirements related to QA programs for non-licensees are set forth in 10 CFR 50.4(b)(7)(ii). This regulation requires that a change to an NRC accepted QATR from non-licensees (i.e., architect/engineers, nuclear steam supply system (NSSS) suppliers, fuel suppliers, constructors, etc.) must be submitted to the NRC.

When requested, the NRC will review the proposed QATR for acceptability to ensure the applicable requirements of Appendix B to 10 CFR Part 50 will be satisfied.

Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to 10 CFR Part 50 establishes QA requirements for the design, construction, and operation of structures, systems, and components (SSCs) of nuclear facilities. The relevant requirements of Appendix B to 10 CFR Part 50 apply to all activities affecting the safety-related functions of those SSCs including their design, purchase, fabrication, handling, shipping, storage, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, refueling, and modification.

3.0 TECHNICAL EVALUATION

In evaluating the adequacy of the GEH QMS QATR, the NRC staff used the guidance contained in NUREG-0800, "Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants," SRP Section 17.5, Quality Assurance Program Description - Design Certification, Early Site Permit and New License Applicants," dated March 2007 (Reference 4) hereafter referred to as standard review plan (SRP)

Section 17.5, which provides acceptance criteria for design certification, early site permit, combined operating license, construction permit, and operating license applicants. SRP Section 17.5 is based on American Society of Mechanical Engineers

NEDO-11209-A Revision 15 Non-Proprietary Information - Public (ASME) Standard NQA-1-1994 Edition, as supplemented by additional regulatory and industry guidance for nuclear operating facilities. ASME Standard NQA-1-2008 and the NQA-1a-2009 Addenda, upon which the GEH QATR is based, incorporated the supplemental guidance into a single document, and is therefore in alignment with SRP Section 17.5. In addition, NQA-1-2008 and the NQA-1a-2009 Addenda, hereafter referred to as NQA-1-2008, is endorsed by NRC Regulatory Guide (RG) 1.28, Quality Assurance Program Requirements (Design and Construction), Revision 4.

3.1 BACKGROUND

The proposed GEH QMS QATR is similar in many respects to previous submittals approved for licensees in accordance with NUREG-0800, Section 17.5. The original QAPD was based largely on commitments to the following: (1) Appendix B of 10 CFR Part 50, (2) RG 1.28, Quality Assurance Program Requirements (Design and Construction), (3) ANSI N45.2-1971, "Quality Assurance Program Requirements for Nuclear Power Plants," and (4) applicable sections of the ASME Boiler and Pressure Vessel Code.

This QATR is based on GEH commitment to 10 CFR Part 50, Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, and ASME Nuclear Quality Assurance (NQA) Standard NQA-1-2008, Quality Assurance Requirements for Nuclear Facility Applications and NQA-1a-2009 Addenda. The QATR is organized into eighteen basic sections corresponding to the quality requirements delineated in Appendix B to 10 CFR Part 50 and is responsive to both Appendix B, as applicable, and the regulatory guidance set forth in RG 1.28, Revision 4. GEH considers the collective requirements of the QATR and NQA-1-2008 and NQA-1a-2009 Addenda equivalent to the NRC staff guidance in SRP Section 17.5.

NUREG-0800, SRP Section 17.5 outlines the NRC staff review of a standardized QA program and is based on the following documents: (1) ASME Standard NQA-1 (1994 Edition); (2) RG 1.8, Qualification and Training of Personnel for Nuclear Power Plants; (3) RG 1.28, Quality Assurance Program Requirements (Design and Construction);

(4) RG 1.33, Quality Assurance Program Requirements (Operation); and (5) NRC Review Standard 002, Processing Applications for Early Site Permits. The review approach of SRP Section 17.5 has previously been used by the NRC staff for evaluating the NQA-1-1994 standard as the basis for a QA Program.

3.2 EVALUATION The NRC staff evaluated the adequacy of the GEH QMS QATR in describing how the requirements of Appendix B to 10 CFR Part 50 will be satisfied. The format and content of the QATR were evaluated in accordance with the guidance of Section 17.5, which provides a basis for the NRC staffs review of QA programs based on the NQA-1-2008 Standard. The acceptability of the level of detail provided by the QATR is in part determined by its adequacy in addressing the acceptance criteria of SRP Section 17.5.

In January 2011, the U.S. NRC staff approved NEDO-11029, GE Hitachi Quality Assurance Program Description, Revision 9. In March 2014, GEH submitted

NEDO-11209-A Revision 15 Non-Proprietary Information - Public Revision 11 to the NRC, but did not submit Revision 10. GEH provided Enclosure 2, Roadmap for NEDO-11209, Revision 11, which covered NEDO-11209, Revision 9 mapping to Revision 10 and 11. In the Table, the NRC staff identified five changes made in NEDO-11209, Revision 10, to Section 1.1, Section 1.4.2.2, Section 1.4.3.1, and Section 18.4.

On August 18, 2014, the NRC staff requested that GEH (Reference 6) verify that these were all the QA changes made to NRC approved NEDO-11209, Revision 9, that were incorporated into NEDO-11209, Revision 10. The NRC staffs purpose was to verify that GEHs Revision 10 of the QAPD remained acceptable in accordance with 10 CFR 50.4(b)(7)(ii). This was Request for Additional Information (RAI) 1. On August 29, 2014, GEH responded to RAI 1 (Reference 7). The NRC staff confirmed that all of the QA changes made in GEH NEDO-11209, Revision 10, were acceptable and incorporated into GEH NEDO-11209, Revision 11. This resolved RAI 1.

3.2.1 Format and Content of the QATR The format used for the NRC staffs evaluation followed the sequence of the 18 criteria of Appendix B and corresponding provisions of NQA-1. The QATR provides guidance for establishing a top-level policy document that defines the quality requirements and assigns major functional responsibilities. The GEH QATR applies to work involving SSCs for nuclear power plants and fuel reprocessing plants that prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public. It is incumbent upon the client to identify the specific QA requirements that must be met for the scope of vendor QA scope of work activities.

3.2.1.1 ORGANIZATION In Part II, QAPD Details, Section 1.0, ORGANIZATION, GEH made the following organizational changes: (1) added ISO9001 and GS-R-1 industry guidance; (2) added Nuclear Fuels & Services subsection 1.3.1.1; (3) added Nuclear Plant Projects subsection 1.3.1.2; (4) modified Nuclear Oversight Organization in subsection 1.3.2 to add support organizations; (5) renamed Nuclear Oversight in subsection 1.3.3 with added support organizations; (6) removed duplicate items in subsection 1.4.1 for the President and Chief Executive Officer, and moved duplicate items to the GEH QAPD Statement of Policy and added responsibility items 2 and 4; (7) renamed the Quality Leader, as the Nuclear Oversight Senior Vice President, and added responsibility items 2, 3, and 5; (8) renamed the Nuclear Quality Assurance Leader, as the Quality Oversight Leader in subsection 1.4.2.1 with clarified responsibilities for this position; (9) modified the responsibilities to remove audit functions for Profit and Loss Quality Leaders in subsection 1.4.3.1; (10) added the Sourcing General Manager in subsection 1.4.4; (11) added the responsibilities of employees and contractors in Section 1.5; (12) updated organizational structures and clarified conditions for issuing a stop work; in Section 1.6; and (13) added section with delegation authority inside the GEH Organization in Section 1.7.

In Section 1.8, Commitments, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion I, and NQA-1-2008 and NQA-1a-2009, Addenda, Requirement 1. As set forth above, the NRC staff reviewed the QA measures to be implemented by GEH in

NEDO-11209-A Revision 15 Non-Proprietary Information - Public QAPD Section 1.0 and concluded that the controls for the organizational structure meet the guidance in SRP Section 17.5, Section A, ORGANIZATION (Criteria I).

3.2.1.2 QUALITY ASSURANCE PROGRAM (QAP)

In Part II, QAPD Details, GEH made changes to QAPD Section 2.0, QUALITY ASSURANCE PROGRAM. The NRC staff reviewed and found acceptable the minor editorial changes to QAPD Sections 2.1, General, through 2.7, Grace Period.

However, GEH made significant QAP management changes to QAPD Section 2.8, Quality Assurance Program Description Management. Specifically, changes to QAPD Section 2.8 included:

1. Changes that are made to the QAPD are submitted to the NRC for review and approval per 10 CFR 50.4(b)(7)(ii).

2. In addition to QAP changes involving administrative improvements and clarifications, spelling corrections, punctuation, or editorial items, the following changes are not considered to be reductions in commitment:

(a) The use of a QA standard approved by the NRC which is more recent than the QA standard in the QAPD at the time of the change; (b) The use of a QA alternative or exception approved by an NRC safety evaluation, provided that the bases of the NRC approval are applicable to GEH; (c) The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles; (d) The use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or, alternately, the use of descriptive text; (e) The elimination of QAP information that duplicates language in quality assurance RGs and QA standards to which GEH is committed; (f) Organizational revisions that ensure that persons and organizations performing QA functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations; and (g) Any change to Part III, Supplemental Details, or Part IV, References, that do not entail NRC related standards (i.e., ISO 9001, KTA-1401, GS-R-3).

The NRC staff reviewed the regulations in 10 CFR 50.54(a)(3)(i) through 10 CFR 50.54(a)(3)(vi) and determined that GEH QAPD Section 2.8, Items (a) through (f) noted above, are not applicable to GEH since GEH is an NSSS vendor, not a licensee. The

NEDO-11209-A Revision 15 Non-Proprietary Information - Public requirements of 10 CFR 50.4(b)(7)(ii) for changes to a vendors QA program do not permit vendors to evaluate whether or not changes to an NRC accepted vendor QAPD are reductions in commitment. The NRC staff requested that GEH clarify its process for evaluating potential reductions in commitment. On August 18, 2014, the NRC staff sent GEH NRC RAI 2 on this issue (Reference 6).

On August 29, 2014, GEH responded to RAI 2 (Reference 7). On September 11, 2014, the NRC staff conducted a conference call with GEH to clarify GEHs use of 10 CFR 50.54(a)(3) and 10 CFR 50.54(a)(4). The NRC staff reiterated an Office of General Counsel interpretation on the applicability of this regulation. On September 23, 2014, GEH again responded to RAI 2 by removing use of the regulations in 10 CFR 50.54(a)(3) and 10 CFR 50.54(a)(4) for QA reductions in commitments (Reference 8).

GEH submitted changes to the GEH QAPD, Revision 11, appropriately applying the regulation in 10 CFR 50.4(b)(7)(ii). This resolved RAI 2.

With respect to Part III, Supplemental Details, and Part IV, References, that do not involve NRC regulations or related standards (i.e., ISO 9001, GS-R-3, KTA-1401, and GS-R-3), the NRC staff determined that GEH may use these industry standards at their own discretion without prior NRC review and approval as long as these industry standards do not conflict with 10 CFR Part 50, Appendix B, for safety related components.

In GEH QATR QAPD Section 2.9, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion II, NQA-1-2008 and the NQA-1a-2009 Addenda, Requirement 2. As set forth above, the NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 2.0 and concluded that the controls for the QAP meet the guidance in SRP Section 17.5, Section B, QUALITY ASSURANCE PROGRAM (Criteria II).

3.2.1.3 DESIGN CONTROL In Part II, QAPD Details, GEH made changes to Section 3.0, DESIGN CONTROL.

The NRC staff reviewed and found acceptable editorial changes to the QAPD which added: (1) Sections 3.2, Design Inputs, (2) Subsection 3.3.3, Design Results; bullet items 4, 5, and 6; (3) Subsection 3.4.3, Design and Development Review; (4) Subsection 3.5.4, Extent of Design Verification; added item 1 with the words state of the art; (5) Subsection 3.5.6, Design and Development Validation, and (6)

Section 3.6, Change Control, added items 7 and 8.

In GEH QATR QAPD Section 3.10, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion III, NQA-1-2008 and the NQA-1a-2009 Addenda, Requirement 3. As set forth above, the NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 3.0 and concluded that the controls for design meet the guidance in SRP Section 17.5, Section C, DESIGN CONTROL AND VERIFICATION (Criteria III).

NEDO-11209-A Revision 15 Non-Proprietary Information - Public 3.2.1.4 PROCUREMENT DOCUMENT CONTROL In Part II, QAPD Details, GEH made minor editorial changes to Section 4.0, PROCUREMENT DOCUMENT CONTROL. In Section 4.5, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion IV, NQA-1-2008 and NQA-1a-2009 Addenda, Requirement 4. As set forth above, the NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 4.0 and concluded that the controls for procurement documents meet the guidance in SRP Section 17.5, Section D, PROCUREMENT DOCUMENT CONTROL (Criteria IV).

3.2.1.5 INSTRUCTIONS, PROCEDURES, AND DRAWINGS In Part II, QAPD Details, GEH made minor editorial changes to GEH QAPD Section 5.0, INSTRUCTIONS, PROCEDURES AND DRAWINGS. In Section 5.4, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion V, NQA-1-2008 and NQA-1a-2009 Addenda, Requirement 5. As set forth above, the NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 5.0 and concluded that the controls for instructions, procedures, and drawings meet the guidance in SRP Section 17.5, Section E, INSTRUCTIONS, PROCEDURES, AND DRAWINGS (Criteria V).

3.2.1.6 DOCUMENT CONTROL In Part II, QAPD Details, GEH made minor editorial changes to GEH QAPD Section 6.0, DOCUMENT CONTROL. In Section 6.5, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion VI and NQA-1-2008 Edition with the NQA-1a-2009 Addenda, Requirement 6. As set forth above, the NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 6.0 and concluded that the controls for documents meet the guidance in SRP Section 17.5, Section F, DOCMENT CONTROL (Criteria VI).

3.2.1.7 CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES In Part II, QAPD Details, GEH made changes to Section 7.0, CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES.

1. In GEH QATR QAPD Section 7.10, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion VII, NQA-1-2008 and the NQA-1a-2009 Addenda, Requirement 7, with the following exceptions:

GEH considers 10 CFR Part 50 licensees, Authorized Nuclear Inspection Agencies, National Institute of Standards and Technology, or other State and Federal agencies, which may provide items or services to GEH, as not requiring evaluation or audit.

When purchasing commercial grade calibration services from a calibration laboratory, procurement source evaluation and selection measures need not be performed provided each of the following conditions are met:

NEDO-11209-A Revision 15 Non-Proprietary Information - Public The purchase documents impose any additional technical and administrative requirements, as necessary, to comply with the GEH QAP and technical provisions. At a minimum, the purchase document will require that the calibration certificate/report include identification of the laboratory equipment/standard used.

The purchase documents require reporting as-found calibration data when calibrated items are found to be out-of-tolerance.

A documented review of the supplier's accreditation will be performed and will include a verification of each of the following:

The calibration laboratory holds a domestic accreditation by the National Voluntary Laboratory Accreditation Program (NVLAP), the American Association for Laboratory Accreditation (A2LA), ACLASS Accreditation Services, Laboratory Accreditation Bureau (LAB), International Accreditation Services (IAS) or Perry Johnson Laboratory Accreditation, Inc. (PJLA) as recognized through the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA).

The accreditation is based on ANS/ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories.

The published scope of accreditation for the calibration laboratory covers the necessary measurement parameters, ranges, and uncertainties.

2. The GEH program for dedication of commercial-grade items commits to be consistent with the following:

NQA-1a-2009, Subpart 2.14, EPRI NP-5652, Guideline for the Utilization of Commercial-Grade Items in Nuclear Safety Related Applications, 6/88 as endorsed and modified by the following NRC Generic Letters (GLs):

GL 89-02, Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products (3/89)

GL 91-05, Licensee Commercial-Grade Procurement and Dedication Programs (4/91)

As set forth above, the NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 7.0 and concluded that the controls for purchased material, equipment, and services, including controls for commercial-grade calibration services and commercial-grade dedication, meet the guidance in Section 17.5. Section G, CONTROL OF PURCHASED MATERAIL, EQUIPMENT AND SERVICES (Criteria VII), Item 12b,

NEDO-11209-A Revision 15 Non-Proprietary Information - Public Accreditation to ANSI/ISO/IEC 17025, and Section V, QA Program Commitments, to GL 89-02 and GL 91-05.

3.2.1.8 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMPONENTS In Part II, QAPD Details, GEH made minor editorial changes to Section 8.0, IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS.

In Section 8.6, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion VIII, NQA-1-2008 and the NQA-1a-2009 Addenda, Requirement 8. As set forth above, the NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 8.0 and concluded that the controls for purchased material, parts, and components meet the guidance in SRP Section 17.5, Section H, IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMPONENTS (Criteria VIII).

3.2.1.9 CONTROL OF SPECIAL PROCESSES In Part II, QAPD Details, GEH made minor editorial changes to Section 9.0, CONTROL OF SPECIAL PROCESSES. In GEH QATR QAPD Section 9.6, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion IX, NQA-1-2008 and the NQA-1a-2009 Addenda, Requirement 9. As set forth above, the NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 9.0 and concluded that the control of special processes meets the guidance in SRP Section 17.5, Section I, CONTROL OF SPECIAL PROCESSES.

3.2.1.10 INSPECTION In Part II, QAPD Details, GEH made minor editorial changes to GEH QAPD Section 10.0, INSPECTION. In Section 10.6, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion X, NQA-1-2008 and the NQA-1a-2009 Addenda, Requirement 10. As set forth above, the NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 10.0 and concluded that the controls for inspections meet the guidance in SRP Section 17.5, Section J, INSPECTION.

3.2.1.11 TEST CONTROL In Part II, QAPD Details, GEH made minor editorial changes to Section 11.0, TEST CONTROL. In Section 11.6, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion XI and NQA-1-2008 Edition with the NQA-1a-2009 Addenda, Requirement 11. As set forth above, the NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 11.0 and concluded that controls for tests meet the guidance in SRP Section 17.5, Section K, TEST CONTROL.

NEDO-11209-A Revision 15 Non-Proprietary Information - Public 3.2.1.12 CONTROL OF MEASURING AND TEST EQUIPMENT In Part II, QAPD Details, GEH made minor editorial changes to GEH QAPD Section 12.0, CONTROL OF MEASURING AND TEST EQUIPMENT. In Section 12.6, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion XII, NQA-1-2008 and the NQA-1a-2009 Addenda, Requirement 12. As set forth above, the NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 12.0 and concluded that the control of measuring and test equipment meets the guidance in SRP Section 17.5, Section L, CONTROL OF MEASURING AND TEST EQUIPMENT.

3.2.1.13 HANDLING, SHIPPING, AND STORAGE In Part II, QAPD Details, GEH made no changes to GEH QAPD Section 13.0, HANDLING, SHIPPING, AND STORAGE. In Section 13.6, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion XIII, NQA-1-2008 and the NQA-1a-2009 Addenda, Requirement 13. As set forth above, the NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 13.0 and concluded that the controls for handling, shipping and storage meet the guidance in SRP Section 17.5, Section M, HANDLING, STORAGE, AND SHIPPING.

3.2.1.14 INSPECTION, TEST, AND OPERATING STATUS In Part II, QAPD Details, GEH made no changes to Section 14.0, INSPECTION, TEST, AND OPERATING STATUS. In Section 14.3, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion XIV, NQA-1-2008 and the NQA-1a-2009 Addenda, Requirement 14. As set forth above, the NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 14.0 and concluded that the controls for inspections, tests, and operating status meet the guidance in SRP Section 17.5, Section N, INSPECTION, TEST, AND OPERATING STATUS.

3.2.1.15 NONCONFORMING MATERIAL AND COMPONENTS In Part II, QAPD Details, GEH made minor editorial changes to Section 15.0, NONCONFORMING MATERIAL AND COMPONENTS. In Section 15.5, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion XV, NQA-1-2008 and the NQA-1a-2009 Addenda, Requirement 15. As set forth above, the NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 15.0 and concluded that the controls for nonconforming material and components meet the guidance in SRP Section 17.5, Section O, NONCONFORMING MATERIAL AND COMPONENTS.

3.2.1.16 CORRECTIVE ACTION In Part II, QAPD Details, GEH made minor editorial changes to Section 16.0, CORRECTIVE ACTION. In Section 16.5, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion XVI, NQA-1-2008 and the NQA-1a-2009 Addenda, Requirement 16. As set forth above, the NRC staff reviewed the QA

NEDO-11209-A Revision 15 Non-Proprietary Information - Public measures to be implemented by GEH in QAPD Section 16.0 and concluded that the controls for corrective action meet the guidance in SRP Section 17.5, Section P, CORRECTIVE ACTION.

3.2.1.17 QUALITY ASSURANCE RECORDS In Part II, QAPD Details, GEH made minor editorial changes to Section 17.0, QUALITY ASSURANCE RECORDS. In GEH QATR QAPD Section 17.8, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion XVII, NQA-1-2008 and the NQA-1a-2009 Addenda, Requirement 17, GL 88-18, Plant Records and Storage on Optical Disk, and Regulatory Information Summary (RIS) 2008-18, Guidance on Managing Quality Assurance Records in Electronic Media.

As set forth above, the NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 17.0 and concluded that the controls for QA records meet the guidance in SRP Section 17.5, Section Q, QUALITY ASSURANCE RECORDS.

3.2.1.18 AUDITS In Part II, QAPD Details, GEH made minor editorial changes to Section 18.0, AUDITS. In GEH QATR QAPD Section 18.7, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion XVIII, NQA-1-2008 and the NQA-1a-2009 Addenda, Requirement 18. As set forth above, the NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 18.0 and concluded that the controls for audits meet the guidance in SRP Section 17.5, Section R, AUDITS.

3.2.1.19 GEH QATR QAPD, Part IV, REGULATORY COMMITMENTS In Part IV, REGULATORY COMMITMENTS, GEH commits to the following regulations and guidance documents in Part I and II:

10 CFR Part 50, Appendix B

ASME NQA-1-2008 and the NQA-1a-2009, Part I in its entirety and Part II for those activities within GEHs scope as an NSSS supplier as described in contract specific quality plans.

10 CFR Part 21

10 CFR Part 70, Subpart D (70.22(f)) for licensing of special nuclear material

10 CFR Part 71

10 CFR Part 72, Subpart G for storage of radioactive material and waste

Nuclear Information and Records Management Association, Inc. (NIRMA)

Technical Guides (TGs) as endorsed by US NRC RIS 2000-18

EPRI NP-5652, Guideline for the Utilization of Commercial-Grade Items in Nuclear Safety Related Applications (as endorsed and modified by US NRC GL 89-02, Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products)

ANS/ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories

NEDO-11209-A Revision 15 Non-Proprietary Information - Public

RG 1.28, Revision 4, 2010 - Quality Assurance Program Requirements (Design and Construction)

GL 88-18, Plant Record Storage on Optical Disks

GL 89-02, Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products

GL 91-05, Licensee Commercial-Grade Procurement and Dedication Programs

RIS 2000-18, Guidance on Managing Quality Assurance Records in Electronic Media The NRC staff found that GEH did not commit to ASME NQA-1-2008 and NQA-1-2009a Addenda, Subpart 2.7, Quality Assurance Requirements of Computer Software for Nuclear Facility Applications. On August 18, 2014, the NRC staff requested additional information from GEH (Reference 6) to verify if GEH quality activities should include ASME NQA-1-2008/2009a Edition, Subpart 2.7. This was RAI 3.

On August 29, 2014, in GEHs response to RAI 3 (Reference 7), GEH stated that GEH will include a commitment to NQA-1-2008/2009a, Subpart 2.7, Quality Assurance Requirements of Computer Software for Nuclear Facility Applications, in Section 3.10 and 11.6 of the A (Approved Version) of NEDO-12209. Based on this GEH response, the NRC staff determined that RAI 3 is resolved.

4.0 CONCLUSONS The NRC staff evaluated GEHs QATR QAPD, Revision 11 (Reference 1), reviewed the previous GEH submittal letter (Reference 2) on GEH QATR QAPD, Revision 9 (Reference 3) and the NRC approval letter and safety evaluation for GEH QATR QAPD, Revision 9 (Reference 5). The NRC staff concludes that GEH provided adequate responses (Reference 7 and 8) to resolve three NRC staff RAIs (Reference 6) in Sections 3.2.1.2 and 3.2.1.19 of this safety evaluation. The NRC staff also concludes that GEHs QATR QAPD, Revision 11, including QA alternatives, adequately addresses the requirements of Appendix B to 10 CFR Part 50 and is acceptable.

5.0 REFERENCES

1. Letter from GE Hitachi Nuclear Energy (GEH) to NRC, MFN 14-108, Quality Assurance Topical Report (QATR) NEDO-11209, GE Hitachi Nuclear Energy Quality Assurance Program Description, Revision 11, dated March 31, 2014 (ADAMS Accession No. ML14090A330).

2. Letter from GE Hitachi Nuclear Energy (GEH) to NRC, MFN 10-354, Response to NRC RAIs on GE Hitachi Nuclear Energy QATR NEDO-11209, Revision 9, GE Hitachi Nuclear Energy Quality Assurance Program Description, dated December 10, 2010 (ADAMS Accession No. ML103480313).

NEDO-11209-A Revision 15 Non-Proprietary Information - Public

3. GEH QATR NEDO-11209, GE Hitachi Nuclear Energy Quality Assurance Program Description, Revision 9, dated December 9, 2010 (ADAMS Accession No. ML103480314).

4. NRC NUREG-0800, "Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants," Section 17.5, Quality Assurance Program Description - Design Certification, Early Site Permit and New License Applicants,"

dated March 2007 (ADAMS Accession No. ML06319009)

5. NRC Approval Letter for GEH QATR QAPD, Revision 9, dated January 11, 2011 (ADAMS Accession No. ML110110473)

6. NRC Letter to GEH, Request for Additional information RE: General Electric Hitachi (GEH) Quality Assurance Topical Report NEDO-11209, GE Hitachi Nuclear Energy Quality Assurance Program Description, Revision 11, August 18, 2014 (TAC No. MF3792) (ADAMS Accession No. ML14217A387)

7. Letter from GEH to NRC, MFN 14-057, GEH Response to NRC Request for Additional Information 2, dated August 29, 2014 Re: GE Hitachi (GEH) Quality Assurance Topical Report (QATR) NEDO-11209, GE Hitachi Nuclear Energy Quality Assurance Program Description, Revision 11, March 2014 (TAC No. MF3792)

(ADAMS Accession No. ML14241A433)

8. Letter from GEH to NRC, MFN 14-057, Supplement 1, GEH Response to RAI No. 2, dated September 23, 2014, RE: GEH QATR NEDO-11209, GEH Nuclear Energy QAPD, Revision 11, March 2014 (TAC No. MF3792) (ADAMS Accession No. ML14266A382).

Attachment:

Resolution of Comment Principal Contributor: Francis X. Talbot Date:

NEDO-11209-A Revision 15 Non-Proprietary Information - Public RESOLUTION OF COMMENTS BY THE OFFICE OF NUCLEAR REACTOR REGULATION ON DRAFT SAFETY EVALUATION FOR TOPICAL REPORT NEDO-11209, REVISION 11, GE HITACHI NUCLEAR ENERGY QUALITY ASSURANCE PROGRAM DESCRIPTION (TAC NO. MF3792)

Location Comment NRC Disposition Page 6, Item (3) Subsection 3.4.2, Design and Comment accepted.

Section Development Review; should be Subsection Change made in final 3.2.1.3 3.4.3. SE.

Design Control

ML20197A269

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Subject:

Enclosures:

Introduction:

References:

RAI 2

RAI 3

Title:

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Dear Mr. Head:

Enclosure:

1.0 INTRODUCTION

4.0 CONCLUSION

5.0 REFERENCES

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Dear Mr. Head:

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1.0 INTRODUCTION

3.0 CONCLUSION

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Dear Mr. Head:

Enclosure:

1.0 INTRODUCTION

3.0 TECHNICAL EVALUATION

3.1 BACKGROUND

5.0 REFERENCES

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