ML25269A130

Safety Evaluation Regarding Blue Energy Topical Report BE-QAPD-001 Quality Assurance Program Description, Revision 2

ML25269A130
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Site:	99902137
Issue date:	12/01/2025
From:	Office of Nuclear Reactor Regulation
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ML25234A175	List: ML25234A176 ML25269A130
References
LTR-BE-QAPD-001, Rev 1
Download: ML25269A130 (0)

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1 SAFETY EVALUATION BY THE OFFICE OF NUCLEAR REACTOR REGULATION REGARDING BLUE ENERGY GLOBAL INC. QAPD LTR - BE-QAPD-001, QUALITY ASSURANCE PROGRAM DESCRIPTION, REVISION 2

==1.0 INTRODUCTION

==

By \

letter dated March 28, 2025 (Reference 1), Blue Energy Global Inc. (Blue Energy),

submitted for U.S. Nuclear Regulatory Commission (NRC) staff review Topical Report (TR)

BE-QAPD-001, Quality Assurance Program Description, Revision 0.

The NRC staff held a teleconference with Blue Energy on April 29, 2025, to ask clarifying questions as part of the acceptance review. Following the teleconference, Blue Energy submitted Revision 1 of the Quality Assurance Program Description (QAPD) by \

letter dated May 8, 2025 (Reference 2). The NRC staff held a public meeting with Blue Energy on July 29, 2025 (Reference 3) to discuss a number of information needs items. By \

letter dated August 27, 2025, Blue Energy submitted Revision 2 of the QAPD (Reference 4). This safety evaluation (SE) is based on the staffs review of the Blue Energy QAPD Revision 2.

Blue Energys QAPD addresses design and pre-construction activities affecting the quality and performance of safety-related structures, systems, and components (SSCs) in support of a construction permit (CP) under Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities. The QAPD is based on the applicable portions of Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to 10 CFR Part 50. Additionally, Blue Energys QAPD commits to the applicable requirements of the American Society of Mechanical Engineers (ASME) NQA 2022, Quality Assurance Program Requirements for Nuclear Facilities, (Reference 5) edition, as endorsed by NRC Regulatory Guide (RG) 1.28, Revision 6, Quality Assurance Program Criteria (Design and Construction) (Reference 6).

2.0 REGULATORY EVALUATION

10 CFR 50.34(a)(7) requires an application for a CP to include a description of the quality assurance program (QAP) to be applied to the design, fabrication, construction, and testing of SSCs of the facility. The description of the QAP for a nuclear power plant or a fuel reprocessing plant shall include a discussion of how the applicable requirements of Appendix B to 10 CFR Part 50 will be satisfied.

Appendix B to 10 CFR Part 50 sets forth the requirements for QAPs for nuclear power plants and establishes quality assurance (QA) requirements for the design, fabrication, construction, and testing of SSCs for the facility. The pertinent requirements of Appendix B apply to all activities affecting the safety-related functions of those SSCs, including designing, purchasing, fabricating, handling, shipping, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, refueling, and modifying SSCs.

2

3.0 TECHNICAL EVALUATION

In evaluating the compliance of Blue Energys QAPD with applicable requirements, the NRC staff utilized the guidance contained in NUREG-0800, Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition (SRP), Section 17.5, Revision 1, Quality Assurance Program Description - Design Certification, Early Site Permit and New License Applicants (Reference 7). SRP Section 17.5, Revision 1, outlines an acceptable QAP template for design certification, early site permit, combined license, CP, and operating license applicants. SRP Section 17.5, Revision 1, describes regulatory and industry guidance determined to be acceptable methods for satisfying the requirements of Appendix B to 10 CFR Part 50.

3.1 Quality Assurance Program Description Details 3.1.1 Organization The Blue Energy QAPD follows the guidance of SRP Section 17.5, Paragraph II.A, for providing an organizational description that includes the organizational structure, functional responsibilities, levels of authority, and interfaces for establishing, executing, and verifying Blue Energys QAP implementation. Based on its review, the NRC staff finds that Blue Energys QAPD establishes independence between the organization that performs oversight functions related to the QAP and the organization responsible for performing the functions to be evaluated. In addition, the Blue Energy QAPD provides for applicable management to be responsible to size the QA organization commensurate with the duties and responsibilities assigned. The QAPD clearly describes and defines the responsibility and authority for planning, establishing, and implementing an effective overall QAP.

The QAPD provides the authority and responsibility to stop work immediately in response to quality problems.

The Blue Energy QAPD commits to implementing the quality standards described in NQA-1-2022, Part I, Requirement 1, without further clarifications or exceptions.

As stated in RG 1.28, Revision 6, NQA-1-2022 is considered acceptable to the NRC staff and provides an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50. Based upon its review, the NRC staff finds that the description of Blue Energys Organization, as detailed above, complies with the requirements of Criterion I, Organization, of Appendix B to 10 CFR Part 50, and, therefore, is acceptable.

3.1.2 Quality Assurance Program The Blue Energy QAPD follows the guidance of SRP Section 17.5, Paragraph II.B, for establishing the necessary measures to implement a QAP to assure and achieve quality as it pertains to design and pre-construction activities.

Blue Energy may delegate all or part of the activities for which they are responsible to others but retains overall responsibility for the QAP effectiveness. The Blue Energy QAPD provides for measures to assess the adequacy of the QAP and to ensure its effective implementation, at least once each year or at least once during the life of the activity, whichever is shorter.

3 The administrative control of the Blue Energy QAPD will be in accordance with 10 CFR 50.4(b)(7)(ii).

The Blue Energy QAPD follows the guidance of SRP Section 17.5, Paragraphs II.S and II.T, by providing the necessary measures to establish and maintain formal indoctrination and training programs for personnel performing, verifying, or maintaining activities within the scope of the QAPD to ensure that suitable proficiency is achieved and maintained. The Blue Energy QAPD provides the minimum training qualification for all personnel responsible for implementation of Blue Energys QAP.

The Blue Energy QAPD commits to implementing the quality standards described in NQA-1-2022, Part I, Requirement 2, without further clarifications or exceptions.

As stated in RG 1.28, Revision 6, NQA-1-2022, is considered acceptable to the NRC staff and provides an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50. Based upon its review, the NRC staff finds that the description of Blue Energys QAP, as detailed above, complies with the requirements of Criterion II, Quality Assurance Program, of Appendix B to 10 CFR Part 50, and, therefore, is acceptable.

3.1.3 Design Control The Blue Energy QAPD follows the guidance of SRP Section 17.5, Paragraph II.C, for establishing the necessary measures to control the design of items that are subject to the provisions of the QAPD. The Blue Energy QAPD design process includes provisions to control design inputs, outputs, changes, interfaces, records, and organizational interfaces within Blue Energy. These provisions ensure that the design inputs (such as design bases and the performance, regulatory, quality and quality verification requirements) are correctly translated into design outputs (such as analyses, specifications, drawings, procedures, and instructions) so that the final design output can be related to the design input in sufficient detail to permit verification. In addition, the Blue Energy QAPD provides for design documents to be reviewed by individuals knowledgeable in QA to ensure that the documents contain the necessary QA requirements.

Consistent with SRP Section 17.5, Paragraph II.C, the Blue Energy QAPD design processes provide for design verification to ensure that items and activities subject to the provisions of the QAP are suitable for their intended application and are consistent with their effect on safety.

Design changes are subject to these controls, which include verification measures commensurate with those applied to the original plant design. The extent of the design verification required is a function of the importance to safety of the item under consideration or computer program under consideration, the complexity of the design, the degree of standardization, the state-of-the-art, and the similarity with previously proven designs.

Verification methods may include, but are not limited to, design reviews, alternative calculations, and qualification testing. Design verifications are performed by competent individuals or groups other than those who performed the original design but who may be from the same organization.

4 The Blue Energy QAPD states that computer programs used for design analysis shall be verified for use by applying the applicable requirements of NQA-1-2022, Parts I and II prior to use or the computer programs results shall be independently verified with the design analysis for each application.

The Blue Energy QAPD commits to implementing the quality standards described in NQA-1-2022, Part I, Requirement 3, as well as the standards in NQA-1-2022, Part II, Subpart 2.7 Quality Assurance Requirements for Computer Software for Nuclear Facility Applications, and Subpart 2.20 Quality Assurance Requirements for Subsurface Investigations for Nuclear Facilities without further clarifications or exceptions.

As stated in RG 1.28, Revision 6, NQA-1-2022 is considered acceptable to the NRC staff and provides an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50. Based upon its review, the NRC staff finds that the description of Blue Energys Design Control, as detailed above, complies with the requirements of Criterion III, Design Control, of Appendix B to 10 CFR Part 50, and, therefore, is acceptable.

3.1.4 Procurement Document Control The Blue Energy QAPD follows the guidance of SRP Section 17.5, Paragraph II.D, for establishing the necessary measures and governing procedures for preparing and reviewing procurement documents to ensure that the documents include or reference applicable regulatory, technical, and QAP requirements. The Blue Energy QAPD ensures that relevant personnel develop and review the procurement documents and that changes are subject to the same degree of control as that used in preparing the original documents.

The Blue Energy QAPD requires that applicable technical, regulatory, quality, and reporting requirements (such as those in specifications, codes, standards, tests, inspections, special processes, and 10 CFR Part 21, "Reporting of Defects and Noncompliance,") are invoked for the procurement of items and services.

To the extent necessary, procurement documents shall require suppliers to have a documented QAP consistent with the applicable requirements of the Blue Energy QAPD.

The Blue Energy QAPD commits to implementing the quality standards described in NQA-1-2022, Part I, Requirement 4, without further clarifications or exceptions.

As stated in RG 1.28, Revision 6, NQA-1-2022 is considered acceptable to the NRC staff and provides an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50. Based upon its review, the NRC staff finds that the description of Blue Energys Procurement Document Control, as detailed above, complies with the requirements of Criterion IV, Procurement Document Control, of Appendix B to 10 CFR Part 50, and, therefore, is acceptable.

5 3.1.5 Instructions, Procedures, and Drawings The Blue Energy QAPD follows the guidance of SRP Section 17.5, Paragraph II.E, for establishing the necessary measures and governing procedures to ensure that activities affecting quality are prescribed by, and performed in accordance with, documented instructions, procedures, or drawings of a type appropriate to the circumstances and that, where applicable, include quantitative or qualitative acceptance criteria to implement the Blue Energy QAP.

The Blue Energy QAPD commits to implementing the quality standards described in NQA-1-2022, Part I, Requirement 5, without further clarifications or exceptions.

As stated in RG 1.28, Revision 6, NQA-1-2022 is considered acceptable to the NRC staff and provides an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50. Based upon its review, the NRC staff finds that the description of Blue Energys Instructions, Procedures, and Drawings, as detailed above, complies with the requirements of Criterion V, Instructions, Procedures, and Drawings, of Appendix B to 10 CFR Part 50, and, therefore, is acceptable.

3.1.6 Document Control The Blue Energy QAPD follows the guidance of SRP Section 17.5, Paragraph II.F, for establishing the necessary measures and governing procedures to control the preparation, review, approval, issuance of, and changes to documents that specify quality requirements or prescribe how activities affecting quality are controlled. Measures are provided to ensure that documents, including revisions or changes (other than those defined in implementing procedures as minor changes), are reviewed and approved by the same organization that performed the original review and approval, unless other organizations are specifically designated.

The Blue Energy QAPD commits to implementing the quality standards described in NQA-1-2022, Part I, Requirement 6, without further clarifications or exceptions.

As stated in RG 1.28, Revision 6, NQA-1-2022 is considered acceptable to the NRC staff and provides an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50. Based upon its review, the NRC staff finds that the description of Blue Energys Document Control, as detailed above, complies with the requirements of Criterion VI, Document Control, of Appendix B to 10 CFR Part 50, and, therefore, is acceptable.

3.1.7 Control of Purchased Material, Equipment, and Services The Blue Energy QAPD follows the guidance of SRP Section 17.5, Paragraph II.G, for establishing the necessary measures and governing procedures to control the procurement of items and services to ensure conformance with specified requirements. The Blue Energy QAPD provides measures for source evaluation and selection, evaluation of objective evidence of quality furnished by the supplier, source inspection, audit, and examination of items or services. The Blue Energy QAPD establishes and implements measures to assess the quality of purchased items and services, at intervals and to a depth consistent with the item's or service's importance to safety, complexity, quantity, and frequency of procurement.

6 The Blue Energy QAPD provides measures for evaluating prospective suppliers and selecting only qualified suppliers, as well as auditing and evaluating suppliers to ensure that qualified suppliers continue to provide acceptable products and services. Qualified suppliers are audited on a triennial basis. Blue Energy will also perform and document annual evaluations of qualified suppliers to ensure that these suppliers continue to provide acceptable products and services.

The Blue Energy QAPD also outlines acceptance actions, such as source verification, receipt inspection, certificates of conformance, and review of documentation to ensure that requirements have been satisfied. In addition, the QAPD establishes controls for the dedication and/or acceptance of commercial grade items and services to ensure they will perform satisfactorily in service in safety-related applications. The Blue Energy QAPD states that the requirements of 10 CFR Part 21 will apply, upon completion of dedicated items and services.

In establishing procurement verification controls and commercial grade item requirements, the Blue Energy QAPD commits to implementing the quality standards described in NQA-1-2022, Part I, Requirement 7, and Part II, Subpart 2.14 Quality Assurance Requirements for Commercial Grade Items and Services, with the following clarifications and exceptions:

Blue Energy 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 Blue Energy, as not requiring evaluation or audit.

The NRC staff has documented its current regulatory position regarding this exception in SE Section 3.1.7.1 of the Tennessee Valley Authority (TVA) New Nuclear QAPD, dated December 12, 2023 (Reference 8). The NRC staff verified that the Blue Energy QAPD provided the same commitments associated with supplier oversight activities as those provided in the TVA New Nuclear QAPD. Therefore, the NRC staffs position associated with this exception, as documented in the TVA New Nuclear QAPD SE, would apply to the Blue Energy QAPD. The NRC staff concludes that the requested exception regarding audit and evaluation, as described above, is acceptable subject to the limitations described in the TVA New Nuclear QAPD SE, as identified in Section 5.0 of this SE, for control of purchased material, equipment, and services.

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, Blue Energy will implement the requirements of Revision 1 of NEI 14-05A (Reference 9) as endorsed by NRC Final SE (ML20322A019) (Reference 10).

Section 7.7 of the Blue Energy QAPD includes the actions and steps that are necessary for a licensee and/or a supplier of basic components to accept accreditation of domestic and international calibration and test laboratory services by ILAC MRA signatories in lieu of performing a commercial-grade survey as part of the commercial-grade dedication process.

The NRC staff evaluated this proposed clarification and determined that it is consistent with the NRC staffs current regulatory position, documented in RG 1.28, Revision 6, issued September 2023 (Reference 6). In this RG, the NRC staff concluded that NEI 14-05A, Revision 1, provides an acceptable approach for licensees and suppliers subject to the QA requirements of

7 Appendix B to 10 CFR Part 50. This NEI document relates to using laboratory accreditation by Accreditation Bodies that are signatories to the ILAC MRA in lieu of performing commercial-grade surveys as part of the commercial-grade dedication process for procuring calibration and testing services performed by domestic and international laboratories accredited by signatories to the ILAC MRA. Therefore, the NRC staff concluded that this clarification is acceptable.

As stated in RG 1.28, Revision 6, NQA-1-2022 is considered acceptable to the NRC staff and provides an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50. Based upon its review, the NRC staff finds that the description of Blue Energys controls for purchased material, equipment, and services, as detailed above, complies with the requirements of Criterion VII, Control of Purchased Material, Equipment, and Services, of Appendix B to 10 CFR Part 50, and, therefore, is acceptable.

3.1.8 Identification and Control of Materials, Parts, and Components The Blue Energy QAPD follows the guidance of SRP Section 17.5, Subsection II.H, for establishing the necessary measures and governing procedures to identify and control items and to ensure that only correct and accepted items are used or installed. Identification shall be maintained on the items or in documents traceable to the items, or in a manner that ensures that identification is established and maintained.

The Blue Energy QAPD commits to implementing the quality standards described in NQA-1-2022, Part I, Requirement 8, without further clarifications or exceptions.

As stated in RG 1.28, Revision 6, NQA-1-2022 is considered acceptable to the NRC staff and provides an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50. Based upon its review, the NRC staff finds that Blue Energys description of identification and control of materials, parts, and components, as detailed above, complies with the requirements of Criterion VIII, Identification and Control of Materials, Parts, and Components, of Appendix B to 10 CFR Part 50, and, therefore, is acceptable.

3.1.9 Control of Special Processes The Blue Energy QAPD follows the guidance of SRP Section 17.5, Subsection II.I, for establishing the necessary measures and governing procedures to provide assurance that special processes that control or verify quality, such as welding, heat treating, and non-destructive examination are controlled. Special processes are accomplished by qualified personnel using qualified procedures and equipment, and in accordance with applicable codes, standards, specifications, criteria, or other special requirements. Records are maintained as appropriate for currently qualified personnel, processes and equipment for each special process.

The Blue Energy QAPD commits to implementing the quality standards described in NQA-1-2022, Part I, Requirement 9, without further clarifications or exceptions.

As stated in RG 1.28, Revision 6, NQA-1-2022 is considered to be acceptable to the NRC staff and provides an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50. Based upon its review, the NRC staff finds that the description of Blue Energys control of special processes, as detailed above, complies with the requirements of Criterion IX Control of Special Processes of Appendix B to 10 CFR Part 50, and therefore, is acceptable.

8 3.1.10 Inspection The Blue Energy QAPD follows the guidance of SRP Section 17.5, Subsection II.J, for establishing the necessary measures and governing procedures to implement inspections that provide assurance that items, services, and activities affecting safety meet established requirements and conform to applicable documented specifications, instructions, procedures, and design documents. These types of inspections will be performed by properly qualified personnel independent of those who performed or directly supervised the work, and the inspection results will be documented.

Blue Energys inspection program establishes requirements for planning the inspections.

Inspection plans are based on, as appropriate, (1) characteristics to be inspected, (2) method of inspection, and (3) acceptance criteria. Inspection records identify the item inspected, the date of inspection, the inspectors identity, the type of observation, the inspection results and acceptability, and reference to information on action taken in connection with nonconformances.

Inspection results are reviewed by authorized personnel.

The Blue Energy QAPD commits to implementing the quality standards described in NQA-1-2022, Part I, Requirement 10, and Part II, Subpart 2.5 Quality Assurance Requirements for Installation, Inspection, and Testing of Structural Concrete, Structural Steel, Soils, and Foundations for Nuclear Facilities, without further clarifications or exceptions.

As stated in RG 1.28, Revision 6, NQA-1-2022 is considered to be acceptable to the NRC staff and provides an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50. Based upon its review, the NRC staff finds that Blue Energys description of inspection controls, with the included clarification, as detailed above, complies with the requirements of Criterion X, Inspection of Appendix B to 10 CFR Part 50, and, therefore, is acceptable.

3.1.11 Test Control The Blue Energy QAPD follows the guidance of SRP Section 17.5, Subsection II.K, for establishing the necessary measures and governing procedures to demonstrate that items subject to the provisions of the QAPD will perform satisfactorily in service. Test programs include criteria for determining when testing is required to demonstrate that performance of plant systems is in accordance with design. Test procedures also include provisions for assuring the prerequisites and suitable environmental conditions are met, adequate instrumentation is available and used, appropriate tests and equipment are used, and necessary monitoring is performed. Test results shall be documented and maintained and shall be evaluated by the responsible authority to ensure that test requirements have been satisfied. Test records shall be 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. Personnel who perform or evaluate tests are qualified in accordance with the requirements established in Section 2.3.2 of the QAPD.

For non-computer program testing, Blue Energys QAPD commits to implementing the quality standards described in NQA-1-2022, Part 1, Requirement 11 without further clarifications or exceptions.

9 For computer program testing, Blue Energys QAPD commits to implementing the quality standards described in NQA-1-2022, Part I, Requirement 11 and Part II, Subpart 2.7, without further clarifications or exceptions.

As stated in RG 1.28, Revision 6, NQA-1-2022 is considered to be acceptable to the NRC staff and provides an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50. Based upon its review, the NRC staff finds that Blue Energys description of testing controls, as detailed above, complies with the requirements of Criterion XI, Test Control of Appendix B to 10 CFR Part 50, and therefore, is acceptable.

3.1.12 Control of Measuring and Test Equipment The Blue Energy QAPD follows the guidance of SRP Section 17.5, Subsection II.L, for establishing the necessary measures and governing procedures to control the calibration, maintenance, and use of measuring and test equipment (M&TE) to accomplish the required measurements for determining conformance to specified requirements.

The M&TE is labeled, tagged, or otherwise controlled to indicate its calibration status and to ensure its traceability to calibration test data. The M&TE that is found to be out of calibration is tagged or segregated and not used until it is recalibrated. When M&TE is found to be out of calibration, an evaluation is performed and documented to determine the validity of previous inspection or test results and of the acceptability of items previously inspected or tested with that equipment. If any M&TE is consistently found to be out of calibration, it is repaired or replaced. A calibration is performed when the accuracy of the equipment is suspected.

Blue Energys QAPD commits to implementing the quality standards described in NQA-1-2022, Part I, Requirement 12, without further clarifications or exceptions.

As stated in RG 1.28, Revision 6, NQA-1-2022 is considered to be acceptable to the NRC staff and provides an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50. Based upon its review, the NRC staff finds that Blue Energys description of M&TE controls, as detailed above, complies with the requirements of Criterion XII, of Appendix B to 10 CFR Part 50, and therefore, is acceptable.

3.1.13 Handling, Storage, and Shipping The Blue Energy QAPD follows the guidance of SRP Section 17.5, Subsection II.M, for establishing the necessary measures and governing procedures to control the handling, storage, packaging, shipping, cleaning, and preservation of items to minimize deterioration.

Items are appropriately marked and labeled to adequately maintain and preserve the item and provide indication of the needs for special controls. Any special controls (such as containers, shock absorbers, accelerometers, inert gas atmospheres, specific moisture content levels, and temperature levels) are provided when required. Special handling tools and equipment are controlled to ensure safe and adequate handling. These special tools and handling equipment are inspected and tested in accordance with procedures at specified time intervals or before use. Operators of special handling and lifting equipment are experienced or trained in the use of the equipment.

The Blue Energy QAPD commits to implementing the quality standards described in NQA-1-2022, Part I, Requirement 13 and Part II, Subpart 2.2 Quality Assurance Requirements

10 for Packaging, Shipping, Receiving, Storage, and Handling of Items for Nuclear Facilities, without further clarifications or exceptions.

As stated in RG 1.28, Revision 6, NQA-1-2022 is considered to be acceptable to the NRC staff and provides an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50. Based upon its review, the NRC staff finds that Blue Energys description of handling, storage, and shipping controls, as detailed above, complies with the requirements of Criterion XIII, Handling, Storage and Shipping of Appendix B to 10 CFR Part 50, and, therefore, is acceptable.

3.1.14 Inspection, Test, and Operating Status The Blue Energy QAPD follows the guidance of SRP Section 17.5, Subsection II.N, for establishing the necessary measures and governing procedures to identify the inspection, test, and operating status of items, subject to the provisions of the QAPD, in order to ensure that required inspections and tests are performed and to ensure that items that have not passed the required inspection and tests are not inadvertently installed, used, or operated. The operating status of nuclear facility SSCs shall be identified to prevent inadvertent operation. These measures also establish the necessary authorities and controls for the application and removal of status indicators or labels.

The Blue Energy QAPD commits to implementing the quality standards described in NQA-1-2022, Part I, Requirement 14, without further clarifications or exceptions.

As stated in RG 1.28, Revision 6, NQA-1-2022 is considered to be acceptable to the NRC staff and provides an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50. Based upon its review, the NRC staff finds that Blue Energys description of inspection, test, and operating status controls, as detailed above, complies with the requirements of Criterion XIV, Inspection, Test, and Operating Status of Appendix B to 10 CFR Part 50, and, therefore, is acceptable.

3.1.15 Nonconforming Materials, Parts, or Components The Blue Energy QAPD follows the guidance of SRP Section 17.5, Subsection II.O, for establishing the necessary measures and governing procedures to control items that do not conform to specified requirements in order to prevent inadvertent installation or use. Controls provide for the identification, documentation, evaluation, segregation (when practical), and disposition of nonconforming items, and notification to affected organizations.

Nonconforming items are evaluated and recommended dispositions shall be proposed.

Processing, delivery, installation, or use of the item shall be prevented until an evaluation and approved disposition by authorized personnel has occurred. Nonconformances to design requirements that are dispositioned repair or use-as-is are subject to design control measures commensurate with those applied to the original design.

The Blue Energy QAPD provides for establishing the appropriate interfaces between the QAP for identification and control of nonconforming materials, parts, or components and the non-QA Reporting Program to satisfy the requirements of 10 CFR Part 50 and/or 10 CFR Part 21.

11 The Blue Energy QAPD commits to implementing the quality standards described in NQA-1-2022, Part I, Requirement 15, without further clarifications or exceptions.

As stated in RG 1.28, Revision 6, NQA-1-2022 is considered to be acceptable to the NRC staff and provides an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50. Based upon its review, the NRC staff finds that Blue Energys description of controls for nonconforming materials, parts, or components, as detailed above, complies with the requirements of Criterion XV, Nonconforming Materials, Parts, or Components, of Appendix B to 10 CFR Part 50, and, therefore, is acceptable.

3.1.16 Corrective Action The Blue Energy QAPD follows the guidance of SRP Section 17.5, Paragraph II.P, for establishing the necessary measures and governing procedures to promptly identify, document and correct conditions adverse to quality.

The Blue Energy QAPD requires personnel to identify known conditions adverse to quality.

Significant conditions adverse to quality and significant adverse trends are documented and reported to responsible management. In the case of a significant condition adverse to quality, the cause is determined and actions to preclude recurrence are taken. In the case of suppliers or contractors working on safety-related activities, or other similar situations, Blue Energy may delegate specific responsibilities for corrective actions, but Blue Energy maintains overall responsibility for the corrective action program.

The Blue Energy QAPD provides for establishing the appropriate interfaces between the QAP for corrective actions and the non-QA Reporting Program to satisfy the requirements of 10 CFR Part 50 and/or 10 CFR Part 21.

The Blue Energy QAPD commits to implementing the quality standards described in NQA-1-2022, Part I, Requirement 16, without further clarifications or exceptions.

As stated in RG 1.28, Revision 6, NQA-1-2022 is considered to be acceptable to the NRC staff and provides an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50. Based upon its review, the NRC staff finds that the description of Blue Energys Corrective Action program complies with the requirements of Criterion XVI, Corrective Action of Appendix B to 10 CFR Part 50, and, therefore, is acceptable.

3.1.17 Quality Assurance Records The Blue Energy QAPD follows the guidance of SRP Section 17.5, Paragraph II.Q, for establishing the necessary measures to ensure that records of items and activities affecting quality are identified, generated, authenticated, and maintained and their final disposition specified. The Blue Energy QAPD includes requirements for records administration including receipt, preservation, retention, storage, safekeeping, retrieval, and classification.

For electronic records and retrieval systems, Blue Energy QAPD complies with the NRC guidance contained in NRC Generic Letter (GL) 88-18, Plant Record Storage on Optical Disks dated October 20, 1988 (Reference 11). In addition, Blue Energy will manage the storage of QA Records in electronic media consistent Nuclear Information and Records Management Association, Inc. (NIRMA) Technical Guidelines (TG), including TG 11-2011, Authentication of

12 Records and Media, (Reference 12), TG 15-2011, Management of Electronic Records, (Reference 13), TG 16-2011, Software Configuration Management and Quality Assurance, (Reference 14), and TG 21-2011, Electronic Records Protection and Restoration (Reference 15).

The Blue Energy QAPD commits to implementing the quality standards described in NQA-1-2022, Part I, Requirement 17 and Part II, Subpart 2.17 Quality Assurance Requirements for Electronic Quality assurance Records Systems without further clarifications or exceptions.

As stated in RG 1.28, Revision 6, NQA-1-2022 is considered to be acceptable to the NRC staff and provides an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50. Based upon its review, the NRC staff finds that the description of Blue Energys QA Records complies with the requirements of Criterion XVII, Quality Assurance Records, of Appendix B to 10 CFR Part 50 and, therefore, is acceptable.

3.1.18 Audits The Blue Energy QAPD follows the guidance of SRP Section 17.5, Paragraph II.R, for establishing the necessary measures and governing procedures to implement audits to verify that activities covered by the QAP are performed in conformance with the established requirements and performance criteria are met. Blue Energy also reviews the audit programs for effectiveness as part of the overall audit process. Audits are performed with a frequency commensurate with safety significance.

The Blue Energy QAPD provides for conducting periodic internal and external audits. Internal audits of all applicable QAP elements should be completed at least once each year or at least once during the life of the activity, whichever is shorter.

External audits determine the adequacy of supplier and contractor QAPs, and Blue Energy.

External or supplier audits shall be performed on a triennial basis and supplemented by annual evaluation of the Suppliers performance to determine if the regular schedule audit frequency shall be maintained or decreased of if other corrective action is required. In addition, consistent with SRP Section 17.5, Paragraph II.B.10, the Blue Energy QAPD allows for the application of a grace period of 90 days to activities that must be performed on a periodic basis.

Audits are conducted by trained personnel not having direct responsibilities in the area being audited and in accordance with preplanned and approved audit plans or checklists, under the direction of a qualified lead auditor and the cognizance of Blue Energys management.

The Blue Energy QAPD provides for all audit results to be documented and reviewed by responsible management. Management responds to all audit findings and initiates corrective actions when determined necessary. In addition, if corrective action measures are determined necessary, documented follow-up actions are required to verify the implementation and effectiveness of the assigned corrective actions.

The Blue Energy QAPD commits to implementing the quality standards described in NQA-1-2022, Part I, Requirement 18 with the following exception:

13 Blue Energy QAPD Section 18.9.1 states that, Under exigent conditions, the audit and /

or survey interval may be extended up to 25 percent by the CQAM during periods where performance of such activities is not feasible as a result of extenuating circumstances...

The NRC staff notes that the use of the 25 percent frequency extension for audits and commercial-grade surveys during extenuating circumstances was previously approved in the NRC staffs SE for a change to Callaway Plants Operating Quality Assurance Manual, dated August 6, 2020 (Reference 16). However, the NRC staff also notes that the Coronavirus Disease 2019 (COVID-19) related public health emergency expired on May 11, 2023; therefore, the provisions for audit extension and remote source verification under exigent conditions, as described above, can no longer be used unless new exigent conditions exist.

As stated in RG 1.28, Revision 6, NQA-1-2022 is considered to be acceptable to the NRC staff and provides an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50. Based upon its review, the NRC staff finds that the description of Blue Energys audits complies with the requirements of Criterion XVIII, Audits, of Appendix B to 10 CFR Part 50, and, therefore, is acceptable.

3.2 Nonsafety-Related SSC Quality Control 3.2.1 Nonsafety-Related SSCs - Significant Contributors to Plant Safety The Blue Energy QAPD follows the guidance of SRP Section 17.5, Paragraph II.U.1, for establishing necessary measures and governing procedures to be applied to nonsafety-related SSCs that are significant contributors to plant safety, but for which the requirements of Appendix B to 10 CFR Part 50 are not applicable. The Blue Energy QAPD applies specific controls to such items in a selected manner, targeted toward those characteristics or critical attributes that render the SSC a significant contributor to plant safety, consistent with applicable sections of the Blue Energy QAPD.

Based upon its review, the NRC staff has determined that this approach, as described in the Blue Energy QAPD, is consistent with SRP Section 17.5, Paragraph II.U.1 and is therefore, acceptable.

3.2.2 Nonsafety-Related SSCs Credited for Regulated Events In establishing the quality requirements for non-safety-related SSCs credited for regulatory events, the Blue Energy QAPD follows the guidance of SRP Section 17.5, Paragraph II.U.2, and Blue Energy commits to implement the following regulatory guidance:

The quality requirements for the fire protection system in accordance with Regulatory Position 1.7, Quality Assurance, in RG 1.189, Revision 5 Fire Protection for Operating Nuclear Power Plants, dated October 2023 (Reference 17).

The quality requirements for anticipated transient without scram (ATWS) equipment in accordance with NRC GL 85-06, "Quality Assurance Guidance for ATWS Equipment That Is Not Safety Related," dated January 16, 1985 (Reference 18).

14 The quality requirements for station blackout (SBO) equipment in accordance with accordance with Regulatory Position 3.5 Quality Assurance and Specific Guidance for SBO Equipment that Is Not Safety Related, and Appendix A, Quality Assurance Guidance for Non-Safety Systems and Equipment, in RG 1.155, "Station Blackout,"

dated August 1988 (Reference 19).

Based upon its review, the NRC staff has determined that this approach, as described in the Blue Energy QAPD, is consistent with SRP Section 17.5, Paragraph II.U.2, and is therefore acceptable.

3.3 Regulatory Commitments The Blue Energy QAPD follows the guidance of SRP Section 17.5, Paragraph II.V, for establishing QAP commitments. Furthermore, Blue Energy commits to comply with the following NRC RGs and other QA standards to supplement and support the QAP:

GL 89-02, Actions to Improve the Detection of Counterfeit and Fraudulently Marked Products, dated March 21, 1989 (Reference 20)

GL 91-05, Licensee Commercial-Grade Procurement and Dedication Programs, dated April 9, 1991 (Reference 21)

RG 1.26, Revision 6, December 2021, Quality Group Classifications and Standards for Water, Steam, and Radioactive-Waste Containing Components of Nuclear Power Plants, (Reference 22)

RG 1.29, Revision 6, July 2021, Seismic Design Classification for Nuclear Power Plants, (Reference 23)

RG 1.164, Revision 1, April 2024, Dedication of Commercial-Grade Items for Use in Nuclear Power Plants, (Reference 24)

RG 1.231, Revision 0, January 2017, Acceptance of Commercial-Grade Design and Analysis Computer Programs Used in Safety-Related Applications for Nuclear Power Plants, (Reference 25)

RG 1.234, Revision 1, March 2024, Evaluating Deviations and Reporting Defects and Noncompliance Under 10 CFR Part 21, (Reference 26)

ASME NQA-1-2022, Part I and Part II (as described in as described in Sections 3.1.1-3.1.18 of this SE with specific identification of exceptions or clarifications.) (Reference 5)

NIRMA TGs, as described in Section 3.1.17 of this SE, (References 12-15)

Based upon its review, the NRC staff has determined that this approach, as described in the Blue Energy QAPD, is consistent with SRP Section 17.5, Paragraph II.V, and, therefore, is acceptable.

15

4.0 CONCLUSION

The NRC staff concludes that the Blue Energy QAPD Revision 2 delineates the policies, processes, and controls and the implementing documents associated with Blue Energys activities that affect the quality of safety-related nuclear plant SSCs and include all planned and systematic activities necessary to provide adequate confidence that such SSCs will perform satisfactorily in service.

The Blue Energy QAPD may also be applied to certain equipment and activities that are not safety-related, but are significant contributors to safety, as described in Section 19 of the Blue Energy QAPD.

The NRC staff finds that the Blue Energy QAPD follows the NRC guidance contained within, and conforms to the format of, SRP Section 17.5. The NRC staff used the acceptance criteria of SRP Section 17.5 as the basis for evaluating the acceptability of the Blue Energy QAPD in conformance with the provisions of 10 CFR 50.34(a)(7) and Appendix B to 10 CFR Part 50.

Based on its review of the Blue Energy QAPD, the NRC staff concludes the following:

The Blue Energy QAPD adequately describes the authority and responsibility of management and supervisory personnel, performance and verification personnel, and self-assessment personnel, in relation to activities to which the Blue Energy QAP is applicable.

The Blue Energy QAPD adequately provides for organizations and personnel to perform verification and self-assessment functions related to Blue Energy activities that affect the quality of safety-related nuclear plant SSCs, as well as select non-safety-related SSCs, with these organizations and personnel having the authority and independence to conduct activities without undue influence from those directly responsible for costs and schedules.

The Blue Energy QAPD adequately apply to activities and items that are important to safety.

The Blue Energy QAPD adequately establishes controls that, when properly implemented, and subject to the limitations in Section 5.0 of this SE, comply with the requirements of Appendix B to 10 CFR Part 50, and 10 CFR Part 21, consistent with the criteria contained in SRP Section 17.5, as well as the relevant regulatory guidance.

Based on its review, the NRC staff has determined that the Blue Energy QAPD, Revision 2, adequately describes the Blue Energy QAP. Accordingly, subject to the limitations and conditions described below, the NRC staff concludes that the Blue Energy QAPD complies with applicable NRC regulations and conforms with applicable industry standards and can be used by Blue Energy for activities associated with design and pre-construction, including those in support of a CP under 10 CFR Part 50.

16 5.0 LIMITATIONS AND CONDITIONS This Blue Energy QAPD is specific to design and pre-construction activities affecting the quality and performance of safety-related SSCs in support of a CP under 10 CFR Part 50. Any application referencing the approved revision of the Blue Energy QAPD shall provide a description in the Blue Energy QAPD that meets Appendix B to 10 CFR Part 50 and associated regulatory requirements.

As referenced in Section 3.1.7 of this SE, the following limitations on the use of this QAPD apply:

The exception to not perform audit or evaluation for procurements from other Part 50 and Part 52 licensees only applies when Blue Energy procures from other 10 CFR Part 50 and 52 power reactor licensees.

When Blue Energy procures from manufacturing licensees where inspections during the fabrication or manufacturing process are required to assure quality, Blue Energy must establish measures for source verification for these procurements, as required by Criterion VII of Appendix B to 10 CFR Part 50.

==6.0 REFERENCES

==

1.

Letter from CJ Fong, Blue Energy Global Inc., to the NRC Document Control Desk, Quality Assurance Program Description, BE-QAPD-001, Revision 0, dated March 28, 2025 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML25087A131).

2.

Letter from CJ Fong, Blue Energy Global Inc., to the NRC Document Control Desk, Quality Assurance Program Description, BE-QAPD-001, Revision 1, dated May 8, 2025 (ML25128A357).

3.

NRC Staff Clarification Call Public Meeting with Blue Energy Global Inc. held on July 29, 2025 (ML25234A176).

4.

Letter from CJ Fong, Blue Energy Global Inc., to the NRC Document Control Desk, Quality Assurance Program Description, BE-QAPD-001, Revision 2, dated August 27, 2025 (ML25239A081).

5.

American Society of Mechanical Engineers (ASME) NQA-1-2022 Quality Assurance Program Requirements for Nuclear Facilities Applications, dated June 30, 2022.

6.

RG 1.28, Quality Assurance Program Criteria (Design and Construction),

Revision 6, dated September 2023 (ML23177A002).

7.

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 August 2015 (ML15037A441).

17 8.

SE by the Office of Nuclear Reactor Regulation Regarding the Topical Report on the Quality Assurance Program Description for the Tennessee Valley Authority New Nuclear Program, dated December 12, 2023 (ML23254A050).

9.

Revision 1 of 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 (ML20259B731).

10. SE by the Office of Nuclear Reactor Regulation Regarding NEI 14-05A, Guidelines for the Use of Accreditation in Lieu of Commercial-Grade Surveys for Procurement of Laboratory Calibration and Test Services, dated November 23, 2020 (ML20322A019).

11. NRC GL 88-18, Plant Record Storage on Optical Disks, dated October 20, 1988.

12. Nuclear Information and Records Management Association (NIRMA),

Authentication of Records and Media, TG 11-2011, New York, NY.

13. NIRMA, Management of Electronic Records, TG 15-2011, Windham, NH.

14. NIRMA, Software Configuration Management and Quality Assurance, TG 16-2011, Windham, NH.

15. NIRMA, Electronic Records Protection and Restoration, TG 21-2011, Windham, NH.

16. Letter to Mr. Fadi Diya, Senior Vice President and Chief Nuclear Officer, Ameren Missouri, Callaway Plant, Unit No. 1 - Operating Quality Assurance Manual Change, Revision 34b, dated August 6, 2020 (ML20216A681).

17. RG 1.189, Revision 5, Fire Protection for Nuclear Power Plants, dated October 2023 (ML23214A287).

18. NRC GL 85-06, "Quality Assurance Guidance for ATWS Equipment That Is Not Safety Related," dated April 16, 1985 (ML031140390).

19. RG 1.155, "Station Blackout, Revision 0, dated August 1988 (ML003740034).

20. NRC, GL 89-02, Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products, dated March 21, 1989 (ML031140060).

21. NRC, GL 91-05, Licensee Commercial-Grade Procurement and Dedication Programs, dated April 9, 1991 (ML031140508).

22. RG 1.26, Revision 6, "Quality Group Classification and Standards for Water, Steam-, and Radioactive-Waste-Containing Components of Nuclear Power Plants, dated December 2021 (ML21232A142).

18

23. RG 1.29, Revision 6, "Seismic Design Classification," dated July 2021 (ML21155A003).

24. RG 1.164, Revision 1, Dedication of Commercial-Grade Items for Use in Nuclear Power Plants, April 2024 (ML24038A310).

25. RG 1.231, Revision 0, Acceptance of Commercial-Grade Design and Analysis Computer Programs used in Safety-Related Applications for Nuclear Power Plants, dated January 2017 (ML16126A183).

26. RG 1.234, Revision 1, Evaluating Deviations and Reporting Defects and Noncompliance Under 10 CFR Part 21, dated March 2024 (ML240038A311).