ML23123A140
| ML23123A140 | |
| Person / Time | |
|---|---|
| Site: | 99901469 |
| Issue date: | 05/03/2023 |
| From: | Michael Orenak NRC/NRR/DANU |
| To: | Statile D BWXT |
| References | |
| Download: ML23123A140 (5) | |
Text
From:
Michael Orenak Sent:
Wednesday, May 3, 2023 9:37 AM To:
Statile, Don J Cc:
Schilthelm, Steve W; Dong Park
Subject:
Transmittal of Requests for Additional Information - BWXT Topical Report:
Quality Assurance Program Description Attachments:
BANR QAPD RAIs.pdf Good morning:
By letter dated November 30, 2022 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML22335A417), BWX Technologies, LLC (BWXT) submitted topical report BANR QAPD-001, BWXT Advanced Nuclear Reactor Quality Assurance Program Description, Revision 000, for U.S. Nuclear Regulatory Commission (NRC) staff review.
The NRC staff viewed the report and concluded that additional information is needed to complete the review. A RAI clarification call was held on May 3, 2023.
The final RAIs are enclosed. Please provide the RAIs response by June 2, 2023.
If you would like to discuss or need additional time to provide the responses to the RAIs, please do not hesitate to contact me.
This email will be placed in ADAMS and will be declared public.
- Regards, Michael D. Orenak, Project Manager Advanced Reactor Licensing Branch 1 (UAL1)
NRR - Division of Advanced Reactors and Non-Power Production and Utilization Facilities (DANU) 301-415-3229 Michael.Orenak@nrc.gov
Hearing Identifier:
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Subject:
Transmittal of Requests for Additional Information - BWXT Topical Report Quality Assurance Program Description Sent Date:
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5/3/2023 9:36:00 AM From:
Michael Orenak Created By:
Michael.Orenak@nrc.gov Recipients:
"Schilthelm, Steve W" <swschilthelm@bwxt.com>
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Tracking Status: None "Statile, Don J" <djstatile@bwxt.com>
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1 REQUEST FOR ADDITIONAL INFORMATION BY THE OFFICE OF NUCLEAR REACTOR REGULATION BWXT BANR QUALITY ASSURANCE PROGRAM DESCRIPTION (QAPD)
BWX TECHNOLOGIES, INC.
DOCKET NO. 99901469 ISSUE DATE: 5/3/2023
=
Background===
By letter dated November 30, 2022 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML22335A417), BWXT Advanced Technologies LLCs (hereafter referred to as BWXT AT), submitted for U.S. Nuclear Regulatory Commission (NRC) staff review Topical Report, BWXT-QAPD-001, BWXT Advanced Nuclear Reactor Quality Program Description, Revision 000.
The BWXT Advanced Nuclear Reactor (BANR) Quality Assurance Program Description (QAPD) topical report addresses the activities associated with BWXT technology development and design activities conducted by or for BWXT AT. The QAPD is based on the applicable portions of both Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to Title 10 of the Code of Federal Regulations, (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities, and American Society of Mechanical Engineers (ASME) NQA-1-2015, Quality Assurance Program Requirements for Nuclear Facility Applications, as endorsed by NRC Regulatory Guide (RG) 1.28, Quality Assurance Program Criteria (Design and Construction) Revision 5.
Regulatory Basis The NRCs regulatory requirements related to quality assurance (QA) programs are set forth in forth in Appendix B to 10 CFR Part 50. Appendix B to 10 CFR Part 50 establishes QA requirements for the design, fabrication, construction, and testing of structures, systems, and components (SSCs) for the facility. The pertinent requirements of Appendix B to 10 CFR Part 50 apply to all activities affecting the safety-related functions of those SSCs and include designing, purchasing, fabricating, handling, shipping, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, refueling, and modifying SSCs.
Question 1 The BANR QAPD addresses the activities associated with the technology development and design activities conducted by or for BWXT AT. However, since BWXT AT is not presently an applicant for a construction permit, operating license (OL), design certification, early site permit, combined license (COL), standard design approval, or manufacturing license activities as described in 10 CFR Part 50 and 10 CFR Part 52, the NRC staff will limit its review to the QA activities associated only with technology development and high-level design activities.
2 For example, the BANR QAPD did not establish quality requirements for nonsafety-related SSCs that are credited for regulated events, which the NRC staff reviews for OLs and COLs per the guidance in NUREG-0800, Section 17.5, Paragraph II.U.2. The NRC staff will not review the QAPD for this topic. Any BWXT AT activities outside of technology development and high-level design activities will not be covered by NRC approval of the BANR QAPD without additional supplements or submittals.
Please confirm BWXT ATs desired scope of review and if it aligns with the NRC staff's proposed scope of review.
Question 2 Section 7.2 of the BANR QAPD states, BWXT AT will implement the NRC endorsed guidance from NEI 14-05A, Rev. 1-A, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys in Procurement of Laboratory Calibration and Test Services [ADAMS Accession No. ML21069A347] when procuring commercial grade calibration and testing services. In addition, Section 12 of the BANR QAPD states, The suppliers of commercial-grade calibration services are controlled as described in Part II, Section 7, The NRC safety evaluation for NEI 14-05A, Revision 1, (ML20322A019) contains the following conditions in Section 3.4,
- 2) The method the licensee and/or supplier of basic components needs to follow, and document in their QA program, consists of:
- 1. A documented review of the laboratorys accreditation is performed and includes a verification of the following:
The calibration or test laboratory holds accreditation by an accrediting body recognized by the ILAC MRA. The accreditation encompasses ISO/IEC-17025:2017, General Requirements for the Competence of Testing and Calibration Laboratories.
For procurement of calibration services, the published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.
For procurement of testing services, the published scope of accreditation for the test laboratory covers the needed testing services including test methodology and tolerances/uncertainty.
The laboratory has achieved accreditation based on an on-site accreditation assessment by the selected AB within the past 48 months. The laboratory's accreditation cannot be based on two consecutive remote accreditation assessments."
Please confirm if these conditions are applicable to BWXT AT's proposed scope of review for the QAPD and/or applicable to the approach to supplier accreditation within the BANR QAPD. If they are applicable, discuss where these conditions will be listed to demonstrate how commercial-grade calibration services are controlled.
3 Question 3 Section 10.2 of the BANR QAPD states that, [inspection] qualification program requirements are described in [QAPD] Part II, Section 2," and Section 18.1 of the BANR QAPD references a qualified lead auditor.
Part II, Section 2.6, of the BANR QAPD commits to implement the quality standards described in NQA12015, Quality Assurance Requirements for Nuclear Facility Applications, Requirement 2, however, the BANR QAPD does not specifically address the qualification program requirements for Inspection and Test, Lead Auditor, Auditors, and Technical Specialists. NQA-1-2015, Requirement 2, Section 302 through 305, provides Qualification Requirements (Section 300) for Inspection and Test (Section 302), Lead Auditor (Section 303),
Auditors (Section 304), and Technical Specialists (Section 305). Additionally, RG. 1.28, Quality Assurance Program Criteria (Design and Construction), Revision 5, (ML17207A293)
Regulatory Position C.1.a, contains a clarification regarding the qualifications of lead auditors.
Please provide additional information regarding the qualification program requirements for Inspection and Test, Lead Auditor, Auditors, and Technical Specialists.
Question 4 The NRC staff observed a possible typographical error in the third bullet in Section 7.2, NQA-1 Commitment / Exceptions, of the BANR QAPD. The NRC staff assumes that 2015 refers to NQA-1-2015.
Please confirm if this assumption is correct.
Question 5 Section 7.1 of the BANR QAPD states, BWXT AT may utilize audits conducted by outside organizations for supplier qualification provided that the scope and adequacy of the audits meet BWXT AT requirements. Documented annual evaluations are performed for qualified suppliers to assure they continue to provide acceptable products and services. Industry programs, such as those applied by the American Society of Mechanical Engineers (ASME), Nuclear Procurement Issues Committee (NUPIC), or other established utility groups, are used as input or the basis for supplier qualification whenever appropriate. The results of the reviews are promptly considered for effect on a supplier's continued qualification and adjustments made as necessary (including corrective actions, adjustments of supplier audit plans, and input to third party auditing entities, as warranted). In addition, results are reviewed periodically to determine if, as a whole, they constitute a significant condition adverse to quality requiring additional action.
The NRC staff understands that BWXT AT does not currently have access to supplier information from ASME (non-public), NUPIC (not a member), or other established utility groups.
Please describe how BWXT AT intends to obtain input for the basis for supplier qualification or edit Section 7.1 to remove reference to such industry programs.