ML20329A003
| ML20329A003 | |
| Person / Time | |
|---|---|
| Site: | 99901376, PROJ0712 |
| Issue date: | 12/01/2020 |
| From: | Ngola Otto Licensing Processes Branch |
| To: | GE-Hitachi Nuclear Energy Americas |
| Otto N | |
| Shared Package | |
| ML20329A006 | List: |
| References | |
| EPID L-2020-TOP-0042 | |
| Download: ML20329A003 (8) | |
Text
Enclosure OFFICE OF NUCLEAR REACTOR REGULATION 1
DRAFT SAFETY EVALUATION FOR GE HITACHI NUCLEAR ENERGY 2
PROPOSED REVISION 16 TO TOPICAL REPORT, NEDO-11209A, REVISION 15 3
GE HITACHI NUCLEAR ENERGY QUALITY ASSURANCE PROGRAM DESCRIPTION 4
(EPID: L-2020-TOP-0042) 5 6
1.0 INTRODUCTION
7 8
By letter dated July 29, 2020 (Agencywide Documents Access and Management System 9
(ADAMS) Accession No. ML20211L779), GE Hitachi Nuclear Energy (GEH) submitted for the 10 U.S. Nuclear Regulatory Commission (NRC) staffs review and approval the proposed 11 Revision 16 to NEDO-11209A Revision 15, GE Hitachi Nuclear Energy Quality Assurance 12 Program Description, in accordance with Title 10 of the Code of Federal Regulations (10 CFR) 13 paragraph 50.4(b)(7)(ii). GEH is also a 10 CFR Part 71, Packaging and Transportation of 14 Radioactive Material, licensee holder and utilizes the same quality assurance (QA) program 15 description (QAPD) to meet the requirements of 10 CFR Part 71. The GEH QAPD provides an 16 overview of the program controls applied to quality related items and activities at GEH. GEH 17 proposed that Revision 16 would replace the current Revision 15 QAPD, in its entirety. The 18 changes included in Revision 16 include updating the QAPD to be based on American Society 19 of Mechanical Engineers (ASME) Nuclear Quality Assurance (NQA)-1-2015, Quality Assurance 20 Requirements for Nuclear Facility Application, dated February 20, 2015, updated to reflect new 21 organization structure, updates to more recent documents, and editorial and clarification 22 changes.
23 24
2.0 REGULATORY EVALUATION
25 26 The Commissions regulatory requirements related to QA programs for non-licensees are set 27 forth in 10 CFR 50.4(b)(7)(ii). This regulation requires that a change to an NRC-accepted 28 QAPD from non-licensees (i.e., architect/engineers, nuclear steam system suppliers, fuel 29 suppliers, constructors, etc.) must be submitted to the NRC. The NRC will review the proposed 30 QAPD for acceptability to ensure the applicable requirements of Appendix B to 10 CFR Part 50 31 will be satisfied.
32 33 Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing 34 Plants, to 10 CFR Part 50 establishes QA requirements for the design, fabrication, 35 construction, and testing of structures, systems, and components (SSCs) of the facility. The 36 pertinent requirements of Appendix B to 10 CFR Part 50 apply to all activities affecting the 37 safety-related functions of SSCs and include designing, purchasing, fabricating, handling, 38 shipping, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, 39 repairing, refueling, and modifying.
40 41
3.0 TECHNICAL EVALUATION
42 43 NUREG-0800, Standard Review Plan for the Review of Safety Analysis Reports for Nuclear 44 Power Plants, Section 17.5, Quality Assurance Program Description - Design Certification, 45 Early Site Permit and New License Applicants, Revision 1, dated August 2015 (ADAMS 46
Accession No. ML15037A441), which provides acceptance criteria for QAPDs. SRP 1
Section 17.5 is based on ASME Standard NQA-1-2008 Edition and the NQA-1a-2009 Addenda, 2
as supplemented by additional regulatory and industry guidance for nuclear operating facilities.
3 In addition, the NRC staff used Regulatory Guide (RG) 1.28, Quality Assurance Program 4
Criteria (Design and Construction), Revision 5, dated October 2017, endorses the use of 5
NQA-1-2015 with exceptions and clarifications, within. The GEH QAPD, Revision 16, is based 6
on NQA-1-2015 and the exceptions and clarifications noted in RG 1.28, Revision 5.
7 8
The format used for the NRC staffs evaluation followed the sequence of the 18 criteria of 9
Appendix B and corresponding provisions of NQA-1-2015. The QAPD provides guidance for 10 establishing a top-level policy document that defines the quality requirements and assigns major 11 functional responsibilities. The GEH QAPD applies to work involving SSCs for nuclear power 12 plants and fuel reprocessing plants that prevent or mitigate the consequences of postulated 13 accidents that could cause undue risk to the health and safety of the public. In Part I, 14 Introduction, GE Reuter Stokes was removed from the list of companies affiliated and 15 applicable to the GEH QAPD.
16 17 3.1 Organization 18 19 In Part II, QAPD Details, Section 1.0, Organization, GEH made changes to personnel and 20 organizational titles and reporting structure. In Section 1.10, Commitment, GEH commits to 21 compliance with Appendix B to 10 CFR Part 50, Criterion I, Organization, and NQA-1-2015 22 Edition, Requirement 1.
23 24 The NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 1.0 and 25 concluded that the organizational changes in the QAPD continue to meet the guidance in SRP 26 Section 17.5, and Appendix B to 10 CFR Part 50, Criterion I, Organization.
27 28 3.2 Quality Assurance Program 29 30 In Part II, Section 2.0, Quality Assurance Program, GEH made minor changes to the 31 discussion on review and approval of subsequent issues. In Section 2.9, Commitment, GEH 32 commits to compliance with Appendix B to 10 CFR Part 50, Criterion II, Quality Assurance 33 Program, and NQA-1-2015 Edition, Requirement 2.
34 35 The NRC staff reviewed Section 2.0 of the GEH QAPD, and the measures documented and its 36 commitment. The NRC staff finds the changes to the QAPD continue to meet the guidance in 37 SRP Section 17.5 and the requirements in Appendix B to 10 CFR Part 50, Criterion II, Quality 38 Assurance Program.
39 40 3.3 Design Control 41 42 In Part II, Section 3.0, Design Control, GEH made changes to add clarity and remove 43 duplication of information. In Section 3.10, Commitment, GEH commits to compliance with 44 Appendix B to 10 CFR Part 50, Criterion III, Design Control, and NQA-1-2015 Edition, 45 Requirement 3. In addition, GEH commits to compliance with NQA-1-2015, Subpart 2.7 for 46 establishing requirements for computer program design control.
47 48
The NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 3.0 and 1
concluded that the changes in the QAPD continue to meet the guidance in SRP Section 17.5, 2
and Appendix B to 10 CFR Part 50, Criterion III, Design Control.
3 4
3.4 Procurement Document Control 5
6 In Part II, Section 4.0, Procurement Document Control, GEH added controls for software 7
errors in procurement documents. In Section 4.5, Commitment, GEH commits to compliance 8
with Appendix B to 10 CFR Part 50, Criterion IV, Procurement Document Control, and 9
NQA-1-2015 Edition, Requirement 4.
10 11 The NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 4.0 and 12 concluded that the changes in the QAPD continue to meet the guidance in SRP Section 17.5, 13 and Appendix B to 10 CFR Part 50, Criterion IV, Procurement Document Control.
14 15 3.5 Instructions, Procedures, and Drawings 16 17 In Part II, Section 5.0, Instructions, Procedures, and Drawings, GEH made no modifications to 18 this section except to update its commitment. In Section 5.4, Commitment, GEH commits to 19 compliance with Appendix B to 10 CFR Part 50, Criterion V, Instructions, Procedures, and 20 Drawings, and NQA-1-2015 Edition, Requirement 5.
21 22 The NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 5.0 and 23 concluded that the changes in the QAPD continue to meet the guidance in SRP Section 17.5, 24 and Appendix B to 10 CFR Part 50, Criterion V, Instructions, Procedures, and Drawings.
25 26 3.6 Document Control 27 28 In Part II, Section 6.0, Document Control, GEH made no modifications to this section except to 29 update its commitment to reflect the use of NQA-1-2015 Edition. In Section 6.5, Commitment, 30 GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion IV, Document 31 Control, and NQA-1-2015 Edition, Requirement 6.
32 33 The NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 6.0 and 34 concluded that the changes in the QAPD continue to meet the guidance in SRP Section 17.5, 35 and Appendix B to 10 CFR Part 50, Criterion VI, Document Control.
36 37 3.7 Control of Purchased Material, Equipment, and Services 38 39 In Part II, Section 7.0, Control of Purchased Material, Equipment, and Services, GEH changed 40 the title of Source Acceptance to Source Verification. In Section 4.5, Commitment, GEH 41 commits to compliance with Appendix B to 10 CFR Part 50, Criterion VII, Control of Purchase 42 Material, Equipment, and Services, and NQA-1-2015 Edition, Requirement 7. In addition, 43 GEH added requirement for the calibration or a test laboratory to be accredited to 44 ISO/IEC 17025:2017 or 2005.
45 46 The NRC staff notes that the proposed GEH QAPD has already been approved to use the 47 Nuclear Energy Institute (NEI) Technical Report NEI 14-05A, Revision 1, Guidelines for the 48 Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory 49 Calibration and Test Services, dated August 2014 (ADAMS Accession No. ML14245A391), in 50
NRC staff safety evaluation for GEH QAPD, Revision 12, dated June 6, 2016 (ADAMS 1
Accession No. ML161138A359).
2 3
The NRC staff is currently completing its review of Revision 1 to NEI 14-05A submitted to the 4
NRC by NEI on February 20, 2020 (ADAMS Accession No. ML20054C066). The revision 5
provides clarification guidance for the use of the International Laboratory Accreditation 6
Cooperation (ILAC) process and the use of the 2017 edition of ISO/IEC 17025.
7 8
It is expected that when the NRC approval is completed, GEH will incorporate all limitations and 9
conditions documented in the revision to NEI-14-05 and the associated NRC staffs safety 10 evaluation.
11 12 The NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 7.0 and 13 concluded that the changes in the QAPD continue to meet the guidance in SRP Section 17.5, 14 and Appendix B to 10 CFR Part 50, Criterion VII, Control of Purchased Material, Equipment, 15 and Services.
16 17 3.8 Identification and Control of Materials, Parts, and Components 18 19 In Part II, Section 8.0, Identification and Control of Materials, Parts, and Components, GEH 20 made no modifications to this section except to update its commitment. In Section 8.6, 21 Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion VIII, 22 and NQA-1-2015 Edition, Requirement 8.
23 24 The NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 8.0 and 25 concluded that the changes in the QAPD continue to meet the guidance in SRP Section 17.5, 26 and Appendix B to 10 CFR Part 50, Criterion VIII, Identification and Control of Materials, Parts, 27 and Components.
28 29 3.9 Control of Special Processes 30 31 In Part II, Section 9.0, Control of Special Processes, GEH made no modifications to this 32 section except to update its commitment to reflect the use of NQA-1-2015 Edition. In 33 Section 9.6, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, 34 Criterion IX, and NQA-1-2015 Edition, Requirement 9.
35 36 The NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 9.0 and 37 concluded that the changes in the QAPD continue to meet the guidance in SRP Section 17.5, 38 and Appendix B to 10 CFR Part 50, Criterion IX, Control of Special Processes.
39 40 3.10 Inspection 41 42 In Part II, Section 10.0, Inspection GEH made no modifications to this section except to update 43 its commitment to reflect the use of NQA-1-2015 Edition. In Section 10.6, Commitment, GEH 44 commits to compliance with Appendix B to 10 CFR Part 50, Criterion X, Inspection, and 45 NQA-1-2015 Edition, Requirement 10.
46 47 The NRC staff reviewed the changes to the QA measures to be implemented by GEH in QAPD 48 Section 10.0 and concluded that the changes in the QAPD continue to meet the guidance in 49 SRP Section 17.5, and Appendix B to 10 CFR Part 50, Criterion X, Inspection.
50
3.11 Test Control 1
2 In Part II, Section 11.0, Test Control, GEH made modifications and reorganized statements 3
related to software testing based on the commitment to NQA-1-2015 Subpart 2.7. In 4
Section 11.6, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, 5
Criterion XI, Test Control, and NQA-1-2015 Edition, Requirement 11. In addition, GEH added 6
In establishing requirements for computer program test procedures and test records, GEH 7
commits to compliance with NQA-1-2015, Subpart 2.7.
8 9
The NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 11.0 10 and concluded that the changes in the QAPD continue to meet the guidance in SRP 11 Section 17.5, and Appendix B to 10 CFR Part 50, Criterion XI, Test Control.
12 13 3.12 Control of Measuring and Test Equipment 14 15 In Part II, Section 12.0, Control of Measuring and Test Equipment, GEH made no 16 modifications to this section except to update its commitment to reflect the use of NQA-1-2015 17 Edition. In Section 12.6, Commitment, GEH commits to compliance with Appendix B to 18 10 CFR Part 50, Criterion XII, Control of Measuring and Test Equipment, and NQA-1-2015 19 Edition, Requirement 12.
20 21 The NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 12.0 22 and concluded that the changes in the QAPD continue to meet the guidance in SRP 23 Section 17.5, and Appendix B to 10 CFR Part 50, Criterion XII, Control of Measuring and Test 24 Equipment.
25 26 3.13 Handling, Storage, and Shipping 27 28 In Part II, Section 13.0, Handling, Storage, and Shipping, GEH made no modifications to this 29 section except to update its commitment to reflect the use of NQA-1-2015 Edition. In 30 Section 13.6, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, 31 Criterion XIII, Handling, Storage, and Shipping, and NQA-1-2015 Edition, Requirement 13.
32 33 The NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 13.0 34 and concluded that the changes in the QAPD continue to meet the guidance in SRP 35 Section 17.5, and Appendix B to 10 CFR Part 50, Criterion XIII, Handling Storage, and 36 Shipping.
37 38 3.14 Inspection, Test, and Operating Status 39 40 In Part II, Section 14.0, Inspection, Test, and Operating Status, GEH made no modifications to 41 this section except to update its commitment to reflect the use of NQA-1-2015 Edition. In 42 Section 14.3, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, 43 Criterion XIV, Inspection, Test and Operating Status, and NQA-1-2015 Edition, 44 Requirement 14.
45 46 The NRC staff reviewed the changes to the QA measures to be implemented by GEH in QAPD 47 Section 14.0 and concluded that the changes in the QAPD continue to meet the guidance in 48 SRP Section 17.5, and Appendix B to 10 CFR Part 50, Criterion XIV, Inspection, Test, and 49 Operating Status.
50
3.15 Nonconforming Material or Components 1
2 In Part II, Section 15.0, Nonconforming Material or Components, GEH made no modifications 3
to this section except to update its commitment to reflect the use of NQA-1-2015 Edition. In 4
Section 15.5, Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, 5
Criterion XV, Nonconforming, Material or Components, and NQA-1-2015 Edition, 6
Requirement 15.
7 8
The NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 15.0 9
and concluded that the changes in the QAPD continue to meet the guidance in SRP 10 Section 17.5, and Appendix B to 10 CFR Part 50, Criterion XV, Nonconforming Material or 11 Components.
12 13 3.16 Corrective Action Program 14 15 In Part II, Section 16.0, Corrective Action, GEH made a minor grammatical change to this 16 section and updated its commitment to reflect the use of NQA-1-2015 Edition. In Section 16.5, 17 Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion XVI, 18 Corrective Action, and NQA-1-2015 Edition, Requirement 16.
19 20 The NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 16.0 21 and concluded that the changes in the QAPD continue to meet the guidance in SRP 22 Section 17.5, and Appendix B to 10 CFR Part 50, Criterion XVI, Corrective Action.
23 24 3.17 Quality Assurance Records 25 26 In Part II, Section 17.0, Quality Assurance Records, GEH made modifications to 27 Section 17.7.4 related to indexing information necessary to retrieve the record to this section 28 and updated its commitment to reflect the use of NQA-1-2015 Edition. In Section 17.8, 29 Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion XVII, 30 Quality Assurance Records, and NQA-1-2015 Edition, Requirement 17, and RG 1.28, 31 Revision 5.
32 33 The NRC staff reviewed the changes to the QA measures to be implemented by GEH in QAPD 34 Section 17.0 and concluded that the changes in the QAPD continue to meet the guidance in 35 SRP Section 17.5, and Appendix B to 10 CFR Part 50, Criterion XVII, Quality Assurance 36 Records.
37 38 3.18 Audits 39 40 In Part II, Section 18.0, Audits, GEH made modifications to this section to reflect the changes 41 in NQA-1-2015 and the regulatory positions in RG 1.28, Revision 5. In addition, GEH made 42 changes to update its commitment to reflect the use of NQA-1-2015 Edition. In Section 18.7, 43 Commitment, GEH commits to compliance with Appendix B to 10 CFR Part 50, Criterion XVIII, 44 and NQA-1-2015 Edition, Requirement 18 and RG 1.28, Revision 5.
45 46 The current revision QAPD, Revision 15 requires the following for internal audits:
47 48 Internal audits of organizations and activities are conducted prior to placing a 49 facility in operation and at least once a year subsequently. Once Activities have 50
been established, internal audits are conducted to ensure all GEH Quality 1
Assurance (QA) program elements are evaluated for each functional area within 2
a period of two years. Activities with durations of less than one year are audited 3
at least once during the life of the activity.
4 5
The proposed change in GEH QAPD, Revision 16 requires the following for internal audits:
6 7
Prior to placing a licensed facility into operation - All applicable QA program 8
elements are audited at least once each year or at least once during the life of 9
the activity, whichever is shorter.
10 11 After placing a licensed facility into operation - All applicable QA program 12 elements for each functional area shall be audited within a period of two years.
13 For well-established activities, the period may be extended one year at a time 14 beyond the two-year interval based on the results of an annual evaluation of the 15 applicable functional area and objective evidence that the functional area 16 activities are being satisfactorily accomplished. However, the internal audit 17 interval shall not exceed a maximum of four years.
18 19 Activities not related to a licensed facility or other support activities - All 20 applicable QA program elements shall be audited at least once each year or at 21 least once during the life of the activity, whichever is shorter. This interval may 22 be extended up to two years based on the results of an annual evaluation and 23 objective evidence that the activities are being satisfactorily accomplished in 24 accordance with the applicable QA program elements.
25 26 The NRC staff reviewed the changes related to internal audits. Based on GEHs experience in 27 the nuclear industry, the NRC staff finds GEH has a well-established audit program. The NRC 28 staff determined the GEHs proposed changes in internal audit frequency for internal audits is in 29 alignment with current NRC staff guidance and is therefore acceptable.
30 31 The NRC staff reviewed the QA measures to be implemented by GEH in QAPD Section 18.0 32 and concluded that the changes in the QAPD continue to meet the guidance in SRP 33 Section 17.5, and Appendix B to 10 CFR Part 50, Criterion XVIII, Audits.
34 35
4.0 CONCLUSION
36 37 The NRC staff used the acceptance criteria in NUREG-0800, Section 17.5, as the basis for 38 evaluating the acceptability of the changes to the GEH QAPD, Revision 16, in conformance with 39 the applicable portions of 10 CFR Part 71, and Appendix B to 10 CFR Part 50. The NRC staff 40 concludes that GEH QAPD, NEDO-11209, Revision 16, follows the NRC guidance contained 41 within and conforms to the format of NUREG-0800, Section 17.5, complies with Appendix B to 42 10 CFR Part 50 requirements for the QA program and, therefore, is acceptable.
43 44
5.0 REFERENCES
45 46
- 1. Safety Evaluation of GEH Quality Assurance Topical Report, NEDO-11209, Revision 12, 47 Quality Assurance Program Description, dated June 6, 2016 (ADAMS Accession 48 No. ML16138A359).
49 50
- 2. Final Safety Evaluation of NEI 14-05, Guidelines for the Use of Accreditation in Lieu of 1
Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, 2
Revision 1, dated February 9, 2015 (ADAMS Accession No. ML14322A535).
3 4
- 3. NEI submittal Revision 1 to Technical Report NEI 14-05A, Guidelines for the Use of 5
Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory 6
Calibration and Test Services, dated February 20, 2020 (ADAMS Accession 7
No. ML20054C066).
8 9
- 4. Safety Evaluation of GEH Quality Assurance Topical Report, NEDO-11209, Revision 15, 10 Quality Assurance Program Description, dated May 20, 2020 (ADAMS Accession 11 No. ML20140A322).
12 13
- 5. Regulatory Guide 1.28, Quality Assurance Program Criteria (Design and Construction),
14 dated October 27, 2020 (ADAMS Accession No. ML17207A293).
15 16
- 6. NUREG-0800, Standard Review Plan for the Review of Safety Analysis Reports for Nuclear 17 Power Plants: LWR Edition, Section 17.5 Revision 1, Quality Assurance Program 18 Description - Design Certification, Early Site Permit and New License Applicants, 19 August 2015 (ADAMS Accession No. ML15037A441).
20 21
- 7. American Society of Mechanical Engineers (ASME) NQA-1-2015, Quality Assurance 22 Requirements for Nuclear Facility Applications, dated February 20, 2015.
23 24 Principal Contributor: A. Keim 25 26 Date: December 1, 2020 27