ML22279A104
| ML22279A104 | |
| Person / Time | |
|---|---|
| Site: | 99900003 |
| Issue date: | 10/26/2022 |
| From: | Ekaterina Lenning Licensing Processes Branch |
| To: | GE-Hitachi Nuclear Energy Americas |
| Shared Package | |
| ML22278A214 | List: |
| References | |
| EPID L-2021-TOP-0036, NEDO-11209-A, Rev 17 | |
| Download: ML22279A104 (1) | |
Text
Enclosure U. S. NUCLEAR REGULATORY COMMISSION FINAL SAFETY EVALUATION BY THE OFFICE OF NUCLEAR REACTOR REGULATION FOR THE GE-HITACHI NUCLEAR ENERGY AMERICAS PROPOSED REVISION 17 TO NEDO-11209-A REVISION 16, GE HITACHI NUCLEAR ENERGY QUALITY ASSURANCE PROGRAM DESCRIPTION DOCKET NO. 99900003 EPID L-2021-TOP-0036
- 1.
INTRODUCTION By letter dated December 14, 2021 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML21348A339), GE Hitachi Nuclear Energy (GEH) submitted to the U.S. Nuclear Regulatory Commission (NRC) the proposed Revision 17 to NEDO-11209A Revision 16, GE Hitachi Nuclear Energy Quality Assurance Program Description, Topical Report (TR) in accordance with Title 10 of the Code of Federal Regulations (10 CFR) paragraph 50.4(b)(7)(ii). The GEH quality assurance (QA) program description (QAPD) applies to work involving activities affecting structures, systems, and components (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.
GEH is also a 10 CFR Part 71, Packaging and Transportation of Radioactive Material, license holder and utilizes the same QAPD to meet the requirements of 10 CFR Part 71. GEH QAPD provides an overview of the program controls applied to quality related items and activities at GEH. The changes included in Revision 17 include a complete rewrite to the Policy Statement and commitment to the Electric Power Research Institute (EPRI) documents 3002019436-A and 3002020796 (Refs. 8 and 9) regarding remote audits, as well as other editorial and clarification changes.
- 2.
REGULATORY EVALUATION The Commissions regulatory requirements in 10 CFR 50.4(b)(7)(ii) state that a change to an NRC-accepted QAPD 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 QAPD for acceptability to ensure the applicable requirements of Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to 10 CFR Part 50 will be satisfied. Appendix B to 10 CFR Part 50 establishes QA requirements for the design, fabrication, construction, and testing of 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.
TECHNICAL EVALUATION NUREG-0800, Standard Review Plan (SRP) 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, Revision 1, dated August 2015 (ADAMS Accession No. ML15037A441) provides acceptance criteria for QAPDs. SRP Section 17.5 is based on the 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. The NRC staff used SRP Section 17.5 acceptance criteria as the basis for evaluating the acceptability of the changes to the GEH QAPD, Revision 17 under Appendix B to 10 CFR Part 50.
In addition, the NRC staff used Regulatory Guide (RG) 1.28, Quality Assurance Program Criteria (Design and Construction), Revision 5, dated October 2017, that endorses the use of NQA-1-2015 with exceptions and clarifications. The GEH QAPD, Revision 17, is based on NQA-1-2015 and the exceptions and clarifications noted in RG 1.28, Revision 5. The GEH QAPD provides guidance for establishing a top-level policy document that defines the quality requirements and assigns major functional responsibilities.
3.1.
Scope The GEH Policy Statement was re-written and expanded to include additional detail on the scope of the QAPD. GEH specified that the Quality Senior Vice President will resolve any problems that cannot be resolved through the processes included in the QAPD, and if needed, the GEH President and CEO will make a final determination. The new title is Quality Policy and Statement of Authority.
The NRC staff reviewed the QA measures to be implemented by GEH in QAPD Policy Statement and concluded that the organizational structure in the QAPD continues to meet the guidance in SRP Section 17.5 and Appendix B to 10 CFR Part 50, Criterion I, Organization.
3.2.
Introduction In Part I, Introduction, GEH Nuclear Energy SMR Technologies Canada LLC was added to the list of companies affiliated and applicable to the GEH QAPD and Ontario, Canada was added to the list of business locations.
The NRC staff reviewed the QA measures to be implemented by GEH in the QAPDs Introduction and concluded that the organizational structure in the QAPD continues to meet the guidance in SRP Section 17.5 and Appendix B to 10 CFR Part 50, Criterion I, Organization.
3.3.
Control of Purchased Material, Equipment, and Services In Part II, QAPD Details, Section 7.0, Control of Purchased Material, Equipment, and Services, GEH added Section 7.6.3.2.5 to include fully remote source verification during exigent conditions and added a commitment to conduct those remote source verifications in accordance with EPRI Report 3002019436-A. This is consistent with the NRC safety evaluation for EPRI TR 3002019436, Remote Source Verification During a Pandemic or Similar State of Emergency (Ref. 9) that previously approved this alternative.
In Section 7.10, Commitment, GEH made minor editorial changes and updated the reference to the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) to the 2017 Edition. The 2017 Edition of ISO/IEC, General Requirements for the Competence of Testing and Calibration Laboratories, was approved by the NRC staff (Ref. 2).
GEH added Nuclear Energy Institute (NEI)14-05A, Revision 1, dated September 2020 (Ref. 10)
(ADAMS Accession No. ML21069A347),1 requirements for supplier accreditation review and the content of purchase documentation. In Section 7.10.1.2.1, GEH added a statement that a laboratory performing calibration or testing services cannot be accredited based upon two consecutive remote accreditation assessments. In Section 7.10.3, GEH committed to establishing a program for the detection of counterfeit, fraudulent, and suspect items in accordance with NRC Generic Letter 89-02. GEH clarified that the commitment reference to NQA-1-2015 excludes Subpart 2.14 pertaining to calibration and testing services.
GEH has committed to NEI 14-05A, Revision 1, dated September 2020, for those services.
NRC Generic Letter 89-02 and EPRI TR 3002019436-A were added to the reference list.
The NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 7.0 and concluded that the changes in the QAPD continue to meet the guidance in SRP Section 17.5 and Appendix B to 10 CFR Part 50, Criterion VII, Control of Purchased Material, Equipment, and Services.
3.4.
Control of Measuring and Test Equipment In Part II, QAPD Details, Section 12.0, Control of Measuring and Test Equipment, GEH updated the details for reference standard accuracy to read that reference standards shall have a minimum accuracy that is four times greater than that of the measuring and test equipment being calibrated.
The NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 12.0 and concluded that the changes in the QAPD continue to meet the guidance in SRP Section 17.5 and Appendix B to 10 CFR Part 50, Criterion XII, Control of Measuring and Test Equipment.
3.5.
Audits In Part II, QAPD Details, Section 18.0, Audits, GEH added a section for Fully Remote and Provisional Remote assessments and added a commitment reference to EPRI report 3002020796 (Ref. 8).
The NRC staff reviewed the changes related to internal audits. The NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 18.0 and concluded that the changes in the QAPD continue to meet the guidance in SRP Section 17.5 and Appendix B to 10 CFR Part 50, Criterion XVIII, Audits.
1 The NRC staff recognizes that the SE for Revision 16 of the GEH QAPD (ADAMS Accession No. ML20350B363) states that GEH has previously been approved to use Revision 1 of NEI 14-05A. This is a typographical error and refers to the August 2014 version of NEI 14-05 (ADAMS Accession Package No. ML14245A389), approved by the NRC in February 2015 (ADAMS Accession No. ML15075A434), and submitted to the staff as NEI 14-05A Revision 0 in March 2015 (ADAMS Accession Package No. ML15075A433). The staff reviewed Revision 1 of NEI 14-05 dated August 2014 and found it acceptable for meeting the requirements of Appendix B to 10 CFR Part 50 (ADAMS Accession No. ML14322A535). In 2020, NEI submitted NEI 14-05A Revision 1, which the NRC reviewed and approved for use (ADAMS Accession No. ML20322A019).
3.6.
Regulations and Standards References In Part IV, Regulatory Commitments, Section 2.0, QAPD Part II Regulations and Standards References, GEH added NRC-approved EPRI Reports 3002019436-A and 3002020796 (Refs. 8 and 9). GEH also specified the version of NEI 14-05A GEH committed to: Revision 1, September 2020. GEH removed a commitment to the NRC letter endorsing ISO/IEC 17-25:2005 and ISC/IEC:2017.
The NRC staff reviewed the changes related to regulations and standards references. The NRC staff concluded that the changes to commitments by GEH continue to meet the guidance in SRP Section 17.5 and Appendix B to 10 CFR Part 50.
- 4.
CONCLUSION The NRC staff used SRP Section 17.5 acceptance criteria as the basis for evaluating the acceptability of the changes to the GEH QAPD, Revision 17, under Appendix B to 10 CFR Part 50. Based on its review, the NRC staff concludes that GEH proposed Revision 17 to NEDO-11209A Revision 16, GE Hitachi Nuclear Energy Quality Assurance Program Description, is acceptable because the QAPD changes continue to follow the NRC guidance contained within Regulatory Guide 1.28 and NUREG-0800, Section 17.5, and comply with the Appendix B to 10 CFR Part 50 requirements for the QA program.
- 5.
REFERENCES
- 1. NRC SE for GEH Quality Assurance TR, NEDO-11209, Revision 16, Quality Assurance Program Description, dated December 17, 2020 (ADAMS Accession No. ML20350B363).
- 2. NRC Final SE for the NEI Technical Report 14-05A, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, Revision 1, dated February 19, 2021 (ADAMS Accession No. ML20322A019).
- 3. NEI Submittal of Revision 1 to Technical Report NEI 14-05A, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, dated February 20, 2020 (ADAMS Accession No. ML20054C066).
- 4. NRC Final SE for the GEH Quality Assurance TR, NEDO-11209, Revision 15, Quality Assurance Program Description, dated May 20, 2020 (ADAMS Accession No. ML20140A322).
- 5. RG 1.28, Quality Assurance Program Criteria (Design and Construction), dated October 2017 (ADAMS Accession No. ML17207A293).
- 6. 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, dated August 2015 (ADAMS Accession No. ML15037A441).
7.
ASME NQA-1-2015, Quality Assurance Requirements for Nuclear Facility Applications, dated February 20, 2015.
- 8. SE for Request of Changes to the Southern Nuclear Operating Company Edwin I. Hatch Nuclear Plant, Units 1 and 2, Joseph M. Farley Nuclear Plant, Units 1 and 2, Vogtle Electric Generating Plant, Units 1 and 2, Quality Assurance TR, dated June 22, 2021 (ADAMS Accession No. ML21161A201).
9.
SE for Request of Changes to the Southern Nuclear Operating Company Edwin I. Hatch Nuclear Plant, Units 1 and 2, Joseph M. Farley Nuclear Plant, Units 1 and 2, Vogtle Electric Generating Plant, Units 1 and 2, Quality Assurance TR, dated June 22, 2021 (ADAMS Accession No. ML21161A201).
- 10. NRC SE for EPRI TR 3002019436, Remote Source Verification During a Pandemic or Similar State of Emergency, dated September 16, 2020 (ADAMS Accession No. ML20244A017).
- 11. NEI Revision 1 of Technical Report, NEI 14-05A, Guidelines for The Use of Accreditation In Lieu Of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, dated September 2020 (ADAMS Accession No. ML21069A347).
- 12. NRC Verification of NEI 14-05-A Rev. 1, dated April 2021 (ADAMS Package Accession No. ML21116A575).
Principal Contributor: L. Smith, NRR Date: October 26, 2022