ML23027A132

Clinch River CP Saf RAIs - RAI (Final) on Topical Report, Quality Assurance Program Description (QAPD) for TVA New Nuclear Program

ML23027A132
Person / Time
Site:	99902056
Issue date:	01/27/2023
From:	NRC
To:	NRC/NRR/DNRL
References
Download: ML23027A132 (16)

Text

From:

Allen Fetter Sent:

Friday, January 27, 2023 1:48 PM To:

ClinchRiver-CPSafRAIsPEm Resource; Schiele, Raymond Joseph Cc:

Deanna Zhang; Kerri Kavanagh; Jordan Glisan

Subject:

RAI (Final) on Topical Report, Quality Assurance Program Description (QAPD) for TVA New Nuclear Program Attachments:

Final RAI for TVA New Nuclear Program QAPD TR.pdf Good Afternoon, Attached is the final version of the RAI on the Tennessee Valley Authority (TVA) Topical Report (TR) NNP-TR-001-NP, Revision 0, Quality Assurance Program Description [(QAPD)] for TVA New Nuclear Program. NRC shared a draft version of RAI with TVA on December 12, 2022 and TVA requested clarification calls with NRC on the draft RAI questions. NRC and TVA engaged two separate clarification calls on December 19, 2022 and January 17, 2023, and the no changes were made to the RAI based on the clarification calls. The e-RAI identifying number is eRAI-386.

TVA has 30 calendar days to respond to this RAI, and changes to the overall review schedule could result if more time is needed by TVA to provide responses to all of the questions in the RAI.

Please let me know if you have any questions.

Allen H. Fetter, Senior Project Manager U.S. Nuclear Regulatory Commission Office of Nuclear Reactor Regulation Division of New and Renewed Licenses New Reactor Licensing Branch Washington, D.C.

301-415-8556 (Office) 301-385-5342 (Mobile)

Hearing Identifier:

ClinchRiver_CPSafRAIs_Public Email Number:

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Subject:

RAI (Final) on Topical Report, Quality Assurance Program Description (QAPD) for TVA New Nuclear Program Sent Date:

1/27/2023 1:48:15 PM Received Date:

1/27/2023 1:48:21 PM From:

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January 27, 2023 Request for Additional Information (RAI) on Tennessee Valley Authority Topical Report (TR) NNP-TR-001-NP, Revision 0, Quality Assurance Program Description [(QAPD)] for TVA New Nuclear Program eRAI-386 By letter dated August 25, 2022 (Agencywide Document Access and Management System (ADAMS) Accession No. ML22238A101), the Tennessee Valley Authority (TVA) submitted Topical Report (TR) NNP-TR-001-NP, Revision 0, Quality Assurance Program Description

[(QAPD)] for TVA New Nuclear Program, (hereafter referred to as TVA New Nuclear Program QAPD TR) to the U.S. Nuclear Regulatory Commission (NRC). In this letter, TVA requested the NRC staffs review and approval of this TR to be used to satisfy the quality assurance requirements for use by nuclear power plant applications submitted in accordance with Title 10 of the Code of Federal Regulations, (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities, and 10 CFR Part 52, Licenses, Certifications, and Approvals for Nuclear Power Plants, for:

Limited Work Authorizations (LWA) pursuant to 10 CFR 50.10(d)(3)(i)

Construction Permit (CP) Applications pursuant to 10 CFR 50.34(a)(7)

Operating License (OL) Applications pursuant to 10 CFR 50.34(b)(6)(ii)

Early Site Permit (ESP) Applications pursuant to 10 CFR 52.17(a)(1)(xi)

Design Certification (DC) Applications pursuant to 10 CFR 52.47(a)(19)

Combined Operating License (COL) Applications pursuant to 10 CFR 52.79(a)(25)

Standard Design Approval (SDA)) Applications pursuant to 10 CFR 52.137(a)(19)

The applicant specified that the TVA New Nuclear Program QAPD TR is based on the applicable portions of both Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to 10 CFR Part 50 and American Society of Mechanical Engineers (ASME) NQA-1-2015, Quality Assurance Program Requirements for Nuclear Facilities, as endorsed by NRC Regulatory Guide (RG) 1.28, Quality Assurance Program Criteria (Design and Construction), Revision 5.

The NRC staff reviewed the information presented in the TVA New Nuclear Program QAPD TR, Revision 0 against the quality assurance (QA) requirements in Appendix B to 10 CFR Part 50, in accordance with the review guidance in NUREG-0800, Standard Review Plan (SRP), Section 17.5, Quality Assurance Program Description - Design Certification, Early Site Permit and New License Applicants, Revision 1. Based on this review, the NRC staff requests additional information, as documented in the questions below, to complete its review.

Question 1 Criterion I, Organization, of Appendix B to 10 CFR Part 50 requires, in part, that the applicant shall be responsible for the establishment and execution of the Quality Assurance Program (QAP). The authority and duties of person and organizations performing activities affecting the safety-related functions of SSCs shall be clearly established and delineated in writing. The persons and organizations performing QA functions shall have sufficient authority and organizational freedom to identify quality problems; to initiate, recommend, or provide solutions; and to verify implementation of solutions. The persons organizations performing quality assurance functions shall report to a management level so that the required authority and

organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations, are provided. SRP Section 17.5, Subsection II, SRP Acceptance Criteria, Item A specifies acceptance criteria to meet the requirements of Criterion I of Appendix B to 10 CFR Part 50. Item A.13 within this SRP section, states, The person responsible for directing and managing the onsite QA program is identified and has appropriate organizational position, responsibility, and authority to exercise proper control over the QA program. This individual is free from non-QA duties and can thus give full attention to ensuring that the QA program at the plant site is being effectively implemented.

Part II.Section I, Organization of the TVA New Nuclear Program QAPD TR describes the TVA New Nuclear Program organizational structure, functional responsibilities, levels of authority and interfaces for establishing, executing, and verifying QAPD implementation. This section states that the TVA New Nuclear organization is responsible for all aspects of design, construction, and operation of TVAs New Nuclear plants. In addition, this section specifies that several organizations within the TVA New Nuclear Program implement and support the QAPD, which include engineering, operations support, and quality assurance. This section also states that the TVA New Nuclear Program oversees multiple sites and projects and Figure II.1-1 is provided to illustrate the TVA New Nuclear Program organization.

Part II, Section 1.5.1 of the TVA New Nuclear Program QAPD TR, Revision 0, states, in part, that The Senior Vice President, New Nuclear Projects is responsible for all aspects of design, construction, and operations for Site ProjectsTransition from design phase to construction and operations phases occurs such that those positions required to support quality-related activities will retain their applicable responsibilities until it is deemed that they are no longer necessary.

During all phases, QA management has access to the Senior Vice President, New Nuclear Projects as the executive with overall responsibilities for QA. Part II, Section 1.5.2, General Manager New Nuclear Quality Assurance, of the QAPD TR, states, in part, that The General Manager, New Nuclear Quality Assurance reports to the TVA Senior Vice President, New Nuclear Projects with direct access to Chief Operating Officer [(COO)]. The General Manager is responsible for planning and performing activities to verify the development and effective implementation of the QAPDThe QA function has sufficient independence from other TVA New Nuclear Program priorities to bring forward issues affecting safety and quality and makes judgments regarding quality in all areas regarding TVA New Nuclear Program design activities as appropriate. In Part II, Section 1.10, NQA-1 Commitment, of the QAPD TR, in establishing its organizational structure, the applicant commits to compliance with NQA-1-2015, Requirement 1.

The NRC staff finds that the descriptions of the TVA New Nuclear Program Organization, including the responsibilities for aspects of the design, construction, and operation phase, in Part 2, Section 1 of the TVA New Nuclear Program QAPD TR, is not sufficient to clearly delineate the roles and responsibilities of personnel for onsite and offsite activities affecting quality to meet the requirements of Criterion I to Appendix B. Specifically, the NRC staff did not find a clear mapping of the responsibilities for quality related activities during each of the phases, as identified in the table provided in Part 2, Section 1 of the TVA New Nuclear Program QAPD TR, to the descriptions of positions within Part 1, Sections 1.1 thru 1.7 of the QAPD TR or the organizational structure depicted in Figure II.1-1. The NRC staff requests the applicant to provide a mapping of the responsibilities identified in the table to the descriptions in Sections 1.1 thru 1.7 and verify alignment with Figure II.1-1. In addition, the NRC staff requests the applicant to clarify whether the role of President/Chief Executive Officer (CEO), Executive Vice President (EVP)/Chief Nuclear Officer (CNO), and EVP/COO will oversee the design, construction, and operation phase for all new nuclear projects.

The NRC staff also reviewed the role of the Senior Vice President, New Nuclear Projects and the General Manager New Nuclear Quality Assurance, as described in Sections 1.5.1 and 1.5.2 of the TVA New Nuclear Program QAPD TR, Revision 0 and requests the applicant to clarify whether there is a specific QA person assigned to each new nuclear plant site during the operational phase who will be responsible for directing and managing the onsite QA program, to address the acceptance criteria in in Section 17.5, Subsection II, Item A.13.

Question 2 Criterion I of Appendix B to 10 CFR Part 50 requires, in part, that the applicant shall be responsible for the establishment and execution of the QAP. The applicant may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or any part thereof, but shall retain responsibility for the quality assurance program.

Part II.Section I, Organization, states Design, engineering, environmental, and construction services may be provided to the TVA New Nuclear Program organization by contractors in accordance with their QAPDs. Section 1.4, New Nuclear Program within Part II.Section I, states, TVA New Nuclear Program is responsible for all aspects of licensing, nuclear site development, and advanced design engineering. Section 1.5, New Nuclear Projects, states New Nuclear Projects is responsible for the site preparation and infrastructure, developing the standard plant design, establishing the construction plan applying innovation in engineering design and construction activities, and executing the projects.

Based on the description of Part I,Section I regarding use of contractors and the role of the TVA New Nuclear Program, the NRC staff requests the following clarifications:

1) Clarify whether design, engineering, environmental, and construction services associated with safety-related activities performed by contractors in accordance with their QAPDs is limited to those contractors that perform these services through a QAPD that is compliant with Appendix B to 10 CFR Part 50.

2) Clarify the relationship between TVA New Nuclear Program and New Nuclear Projects.

3) Clarify the role of TVA New Nuclear Program in terms of licensing activities. Specifically, will this program be responsible for design certification/standard design approval related activities and any site specific licensing activities (e.g., COL, ESP, CP, etc.). If this program is responsible for all these activities, will there be any separation of roles and responsibilities within the organization for each type of application to resolve any interface issues between these types of applications.

Question 3 Criterion I of Appendix B to 10 CFR Part 50 requires, in part, that The persons and organizations performing QA functions shall have sufficient authority and organizational freedom to identify quality problems; to initiate, recommend, or provide solutions; and to verify implementation of solutions. The persons organizations performing quality assurance functions shall report to a management level so that the required authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations, are provided.

Part II, Section 1.5.2, General Manager, New Nuclear Quality Assurance, of the TVA New Nuclear Program QAPD TR, Revision 0, states, in part, The General Manager, New Nuclear Quality Assurance reports to the TVA Senior Vice President, New Nuclear Projects with direct access to Chief Operating Officer. The General Manager is responsible for planning and performing activities to verify the development and effective implementation of the QAPD. The QA function has sufficient independence from other TVA New Nuclear Program priorities to bring forward issues affecting safety and quality and makes judgments regarding quality in all areas regarding TVA New Nuclear Program design activities as appropriate. QA may make recommendations to management regarding improving the quality of work processes. If QA disagrees with any actions taken by the organization and is unable to obtain resolution, QA shall inform quality assurance management and bring the matter to the attention of the COO, who will determine the final disposition. Figure II.1 depicts the organizational relationship of the General Manager New Nuclear Quality Assurance under the EVP/COO and separately, the VP New Nuclear Programs falls under EVP/CNO. Part II, Section 2.1, Responsibilities, of the QAPD states that personnel who work directly or indirectly for TVA New Nuclear Program are responsible for achieving acceptable quality in the work covered by the QAPD. This includes the activities delineated in Part I, Section 1.1.

The NRC staff reviewed Part II, Sections 1.5.2 and 2.1 of the TVA New Nuclear Program QAPD TR and finds that this section does not clearly describe the personnel and organization that will be performing QA function as required by Criterion I of Appendix B to 10 CFR Part 50. The NRC staff requests the applicant to specify whether a QA organization will be established for design, construction, and operations phases, to which the General Manger, New Nuclear Quality Assurance, will oversee. In addition, given that the EVP/CNO and EVP/COO both reporting to the President/CEO, the NRC staff requests the applicant to explain the authority of EVP/COO to make appropriate QA decisions for the TVA New Nuclear Program.

Question 4 Criterion II, Quality Assurance Program, of Appendix to 10 CFR Part 50 requires the applicant to establish at the earliest practicable time, consistent with the schedule for accomplishing the activities, a quality assurance program which complies with the requirements of this appendix.

This program shall be documented by written policies, procedures, or instructions and shall be carried out throughout plant life in accordance with those policies, procedures, or instructions.

The applicant shall identify the structures, systems, and components to be covered by the quality assurance program and the major organizations participating in the program, together with the designated functions of these organizations. SRP Section 17.5, Subsection II, Item B specifies acceptance criteria to meet the requirements of Criterion II of Appendix B to 10 CFR Part 50. Item B.5 within this SRP section specifies that, The QAPD includes the criteria used to identify the items and activities to which the QA program applies. A list of the SSCs and/or activities under the control of the QA program is required to be established and maintained at the applicants or holders facility. This does not apply to ESP applicant QA programs. In addition, Item B.6 within this SRP section states, The QA program ensures that activities affecting quality will be accomplished under suitable controlled conditions, including (1) the use of appropriate equipment, (2) a suitable environment for accomplishing the activity, e.g.,

adequate cleanliness, and (3) compliance with necessary prerequisites for the given activity.

Part II, Section 2, Quality Assurance Program, of the TVA New Nuclear Program QAPD TR, Revision 0, states, in part, that The objective of the QAP is to assure that TVA New Nuclear Programs nuclear generating plants are designed, constructed, and operated in accordance with governing regulations and license requirements. The QAP applies to those quality-related

activities that involve the functions of safety-related structures, systems, and components (SSCs) associated with the design, fabrication, construction, and testing of the SSCs of the facility and to the managerial and administrative controls to be used to assure safe operations.

Examples of ESP, CP/OL, or COL program safety-related activities include, but are not limited to, site-specific engineering related to safety-related SSCs, site geotechnical investigations, site engineering analysis, seismic analysis, and meteorological analysis. A list or system that identifies SSCs and activities to which this program applies is maintained at the appropriate facility.

Part II, Section 2 also states New nuclear plant construction will be the responsibility of TVA New Nuclear Program 's construction organization. Detailed engineering specifications and construction procedures will be developed to implement the QAPD prior to commencement of pre-construction and/or construction activities. In general, the program requirements specified herein are detailed in implementing procedures that are either TVA New Nuclear Program implementing procedures, or supplier implementing procedures governed by a supplier quality assurance program.

The NRC staff reviewed Part II, Section 2 of the TVA New Nuclear Program QAPD TR, Revision 0, and finds that additional information is required to demonstrate compliance with the requirements of Criterion II of Appendix B to 10 CFR Part 50. Specifically, the NRC staff requests the applicant to:

1) Clarify the applicability of this QAPD to quality related activities that involve the functions of safety-related activities for DC and SDA applications;

2) Demonstrate how the acceptance criteria within SRP Section 17.5, Subsection II, Item B.5 for criteria that will be used to identify SSCs and/or activities to which the QAP applies and Item B.6 for the QAP to ensure that activities affecting quality will be accomplished under suitable controlled conditions, have been addressed in the QAPD TR; and

3) Clarify whether New Nuclear Projects will be using the TVA New Nuclear Program implementing procedures or will separate implementing procedures be developed and used by New Nuclear Projects.

Question 5 Criterion II of Appendix to 10 CFR Part 50 states, in part, that The program shall provide for indoctrination and training of personnel performing activities affecting quality as necessary to assure that suitable proficiency is achieved and maintained. RG 1.28, Revision 5, endorses NQA-1-2015 with specific clarifications, as one method for meeting the requirements of Appendix B to 10 CFR Part 50. NQA-1-2015, Part 1, Requirement 2, provides specific training and qualification requirements for personnel performing nondestructive examination, inspection and test, and audits. RG 1.28, Section C.1.a provides clarifications on audit participation requirements in NQA-1-2015, Part 1, Requirement 2.

Part II, Section 2.6, Personnel Training and Qualification of the TVA New Nuclear Program QAPD TR, Revision 0, states, in part, TVA New Nuclear Program establishes and maintains formal indoctrination, training, and qualification as necessary for personnel performing, verifying, or managing activities within the scope of the QAPD to achieve initial proficiency, maintain

proficiency, and adapt to technology changes, method, or job responsibilities. The NRC staff reviewed this section and found that no specific training or qualification requirements were provided for personnel performing nondestructive examination, inspection and test, and audits, as specified in NQA-1-2015, Part 1, Requirement 2 and clarified in RG 1.28, Section C.1.a. As such, the NRC staff requests the applicant to provide additional information in TVA New Nuclear Program QAPD TR to address training and qualification requirements for these positions.

Question 6 Criterion III, Design Control, of Appendix B to 10 CFR Part 50 requires, in part, that measures to be established to assure that applicable regulatory requirements and the design basis, as defined in § 50.2 and as specified in the license application, for those structures, systems, and components to which this appendix applies are correctly translated into specifications, drawings, procedures, and instructions. These measures shall include provisions to assure that appropriate quality standards are specified and included in design documents and that deviations from such standards are controlled. Measures shall also be established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems and components.

NQA-1-2015, Part I, Requirement 3, as endorsed in RG 1.28, Revision 5, provides criteria on establishing design control measures. Section 200 within Requirement 3 states, Applicable design inputs shall be identified and documented, and their selection reviewed and approved.

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

Section 300 within Requirement 3 specifies criteria for the design process.

Part II, Section 3, Design Control of the TVA New Nuclear Program QAPD TR, Revision 0 states, in part, that TVA New Nuclear Program has established and implements a process to control the design, design changes, and temporary modifications (e.g., temporary bypass lines, electrical jumpers, and lifted wires, and temporary setpoints) of items that are subject to the provisions of the QAPD. The design process includes provisions to control design inputs, outputs, changes, interfaces, records, and organizational interfaces within TVA New Nuclear Program and with suppliersThese provisions assure that 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 contains or references appropriate acceptance criteria that can be related to the design input in sufficient detail to permit verification by inspection and test, as required.

Part II, Section 3.5, NQA-1 Commitment, of the TVA New Nuclear Program QAPD TR, Revision 0, states that In establishing its program for design control and verification, TVA New Nuclear Program commits to compliance with NQA-1-2015 Part II, Subpart 2.7 Quality Assurance Requirements for Computer Software for nuclear facilities applications, NQA-1-2015, Part II, Subpart 2.14 for Quality Assurance Requirements for Commercial Grade Items and Services, and Part II, Subpart 2.20 for Quality Assurance Requirements for Subsurface Investigations for Nuclear Facilities (Subpart 2.20 does not apply to Operations activities).

The NRC staff reviewed Part II, Section 3.1 of the TVA New Nuclear Program QAPD TR, Revision 0, and finds that this section does not specify that design inputs will be identified and documented, and the selection of these design inputs are reviewed and approved, to address

the guidance in Section 200 within Requirement 3 of NQA-1-2015. In addition, the NRC staff finds this section of the QAPD does not address the guidance in Section 300 within Requirement 3 of NQA-1-2015 for the design process. Further, Part II, Section 3.5 of the QAPD TR only commits to NQA-2015, Part II, Subparts 2.7, 2.14, and 2.20, and does not commit to compliance with NQA-1-2015, Part I, Requirement 3. The staff requests the applicant to clarify whether it commitments to compliance NQA-1-2015, Part I, Requirement 3, and if so, how the guidance in Section 200 and 300 of the NQA-1-2015, Part I, Section 3 are addressed in the TVA New Nuclear Program QAPD, TR, in order to meet the requirements in Criterion III of Appendix B to 10 CFR Part 50.

Question 7 Criterion III of Appendix B to 10 CFR Part 50 requires, in part, that design changes, including field changes, shall be subject to design control measures commensurate with those applied to the original design and be approved by the organization that performed the original design unless the applicant designates another responsible organization.

Part II, Section 3 of the TVA New Nuclear Program QAPD TR, Revision 0 states, in part, that Design change processes and the division of responsibilities for design-related activities are detailed in TVA New Nuclear Program and supplier procedures. Changes to design inputs, final designs, and field changes, and temporary and permanent modifications to operating facilities are justified and subject to design control measures commensurate with those applied to the original design Design changes and disposition of nonconforming items as "use as is" or "repair" are reviewed and approved by the New Nuclear Program, Project Engineering or by other organizations so authorized by TVA New Nuclear Program.

The NRC staff reviewed this section and requests the applicant to clarify:

1) whether the design change processes and the division of responsibilities for design-related activities will remain with the TVA New Nuclear Program procedures during the operation phase of a site; and

2) whether the statement: Changes to design inputs, final designs, and field changes, and temporary and permanent modifications to operating facilities are justified and subject to design control measures commensurate with those applied to the original design, applies only to the facilities in operation or would this statement also apply to changes during the design and construction phase.

Question 8 Criterion III of Appendix B to 10 CFR Part 50 requires, in part, that design control measures shall provide for verifying or checking the adequacy of design, such as by the performance of design reviews, by the use of alternate or simplified calculational methods, or by the performance of a suitable testing program. The verifying or checking process shall be performed by individuals or groups other than those who performed the original design, but who may be from the same organization. SRP Section 17.5, Subsection II, Item C specifies acceptance criteria to meet the requirements of Criterion III of Appendix B to 10 CFR Part 50. Item C.19.b within this SRP section states, in part, that Construction site activities associated with a design or design change should not proceed without verification past the point where the installation would become irreversible (i.e., require extensive demolition and rework). In all cases, the design verification should be complete prior to fuel load for a plant under construction, or in the case of an operating plant, prior to relying upon the component, system, or structure to perform

its function. In addition, Item C.19.c within this SRP section states, in part, that Procedural control is established for design documents; this control differentiates between documents that receive formal design verification by interdisciplinary or multi-organizational teams and those which can be reviewed by a single individual (a signature and date is acceptable documentation for personnel certification).

Part II, Section 3.1, Design Verification, of the TVA New Nuclear Program QAPD TR, Revision 0 states, in part, that, TVA New Nuclear Program design processes provide for design verification to ensure that items, computer programs, and activities subject to the provisions of the QAPD are suitable for their intended application, consistent with their effect on safety Design verification procedures are established and implemented to assure that an appropriate verification method is used, the appropriate design parameters to be verified are chosen, the acceptance criteria are identified, and the verification is satisfactorily accomplished and documentedTVA New Nuclear Program normally completes design verification activities before the design outputs are used by other organizations for design work, and before they are used to support other activities such as procurement, or construction. When such timing cannot be achieved, the design verification is completed before relying on the item to perform its intended design or safety function.

Based on the review Part II, Section 3.1 of the QAPD TR, the NRC staff requests the applicant to demonstrate how the guidance within SRP, Section 17.5, Subsection II, Item C.19.b related to construction activities design change verification and completion of design verification prior to fuel load for a plant under construction, are addressed in the TVA New Nuclear Program QAPD TR. In addition, the NRC staff requests the applicant to demonstrate how the guidance SRP, Section 17.5, Subsection II, Item C.19.c related to establishing controls to differentiates between documents that receive formal design verification by interdisciplinary or multi-organizational teams and those which can be reviewed by a single individual, are addressed in in the TVA New Nuclear Program QAPD TR.

Question 9 Criterion III of Appendix B to 10 CFR Part 50 states, in part, that Measures shall be established to assure that applicable regulatory requirements and the design basis, as defined in § 50.2 and as specified in the license application, for those structures, systems, and components to which this appendix applies are correctly translated into specifications, drawings, procedures, and instructions.

Part II, Section 3.4, Setpoint Control, of the TVA New Nuclear Program QAPD TR, Revision 0, states that instrument and equipment setpoints that could affect nuclear safety shall be controlled in accordance with written instructions. This section provides criteria that should be included, as a minimum, in these written instructions. The NRC staff requests the applicant to clarify whether the criteria written instructions used for setpoint control apply to only the operational phase or to the design and construction phases as well.

Question 10 Criterion IX, Control of Special Processes, of Appendix B to 10 CFR Part 50, states, Measures shall be established to assure that special processes, including welding, heat treating, and nondestructive testing, are controlled and accomplished by qualified personnel using qualified procedures in accordance with applicable codes, standards, specifications, criteria, and other special requirements. SRP Section 17.5, Subsection II, Item I specifies

acceptance criteria to meet the requirements of Criterion IX of Appendix B to 10 CFR Part 50.

Items I.3 and I.4 within this SRP section state, Each special process instruction includes or references procedure(s), personnel, and equipment qualification requirements, and Records are maintained as appropriate for the currently qualified personnel, processes, and equipment for each special process, respectively.

The NRC staff reviewed Part II, Section 9, Control of Special Processes, and Section 17, Quality Assurance Record, of the TVA New Nuclear Program QAPD TR, Revision 0, and did not identify how the applicant has addressed the guidance in SRP, Section 17.5, Subsection II, Item I.3 and I.4 states. As such the NRC staff requests the applicant to address the guidance in SRP, Section 17.5, Subsection II, Item I.3 and I.4.

Question 11 Criterion X, Inspection, of Appendix B to 10 CFR Part 50, states, in part, that A program for inspection of activities affecting quality shall be established and executed by or for the organization performing the activity to verify conformance with the documented instructions, procedures, and drawings for accomplishing the activity. SRP Section 17.5, Subsection II, Item J specifies acceptance criteria to meet the requirements of Criterion X of Appendix B to 10 CFR Part 50. Item J.9 within this SRP section, states Inspection records identify item inspected, date of inspection, the inspectors identity, type of observation, results, or acceptability, and reference to information on action taken in connection with nonconformances.

Part II, Section 10, Inspection, of the TVA New Nuclear Program QAPD TR, Revision 0, states, in part, that Inspection results are documented. Part II. Section 10.1, Inspection Program, of the QAPD TR states, in part, that, Inspection program documents establish requirements for performing the planned inspections, and documenting required inspection information such as rejection, acceptance, and re-inspection results, and the person(s) performing the inspection. Inspection results are documented by the inspector, reviewed by authorized personnel qualified to evaluate the technical adequacy of the inspection results, and controlled by instructions, procedures, and drawings.

The NRC staff reviewed Part II, Sections 10 and 10.1 of the TVA New Nuclear Program QAPD TR, Revision 0, and finds that these sections did not address the guidance in SRP Section 17.5, Subsection II, Item J.9 for the type of observation and references to information on action taken in connection with nonconformances. As such, the NRC staff requests the applicant to address this portion of the guidance in SRP Section 17.5, Subsection II, Item J.9.

Question 12 Criterion XI, Test Control of Appendix B to 10 CFR Part 50, states, in part, that A test program shall be established to assure that all testing required to demonstrate that structures, systems, and components will perform satisfactorily in service is identified and performed in accordance with written test procedures which incorporate the requirements and acceptance limits contained in applicable design documentsTest results shall be documented and evaluated to assure that test requirements have been satisfied. SRP Section 17.5, Subsection II, Item K specifies acceptance criteria to meet the requirements of Criterion XI of Appendix B to 10 CFR Part 50. Item K.6 within this SRP section states, Test records, at a minimum, identify the item tested, date of test, tester or data recorder, type of observation, results and acceptability, action taken in connection with any deviations noted, and the person evaluating test results.

Part II, Section 11, Test Control, of the TVA New Nuclear Program QAPD TR, Revision 0, states, in part, that Test programs ensure appropriate retention of test data in accordance with the records requirements of the QAPD.

The NRC staff reviewed Part II, Section 17 of the TVA New Nuclear Program QAPD TR, Revision 0, and did not identify specific records requirements for retention of test data. In addition, the NRC staff finds that the guidance in SRP Section17.5, Subsection II, Item K.6, specific to test records requirements, has not been addressed by the applicant. As such, the NRC staff requests the applicant to address the guidance in SRP Section 17.5, Subsection II, Item K.6.

Question 13 Criterion XII, Control of Measuring and Test Equipment, of Appendix B to 10 CFR Part 50, states Measures shall be established to assure that tools, gages, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specified periods to maintain accuracy within necessary limits. SRP Section 17.5, Subsection II, Item L specifies acceptance criteria to meet the requirements of Criterion XII of Appendix B to 10 CFR Part 50. Item L.4 within this SRP section states that maintenance and test equipment (M&TE) should be calibrated, adjusted, and maintained at prescribed intervals or, prior to use, against certified equipment having known valid relationships to nationally recognized standards. If no nationally recognized standards exist, the bases for calibration should be documented. Item L.5 within this SRP section states that M&TE that are found to be out of calibration should be tagged or segregated and not used until it is recalibrated. When M&TE is found out of calibration, an evaluation should be made and the validity of previous inspection or test results and of the acceptability of items previously inspected or tested should be documented. If any measuring or test equipment is consistently found out of calibration, it should be repaired or replaced. A calibration should be performed when the accuracy of the equipment is suspect.

Part II, Section 12, Control of Measuring and Test Equipment, of the TVA New Nuclear Program QAPD TR, Revision 0, states, in part, that the TVA New Nuclear Program has established the necessary measures and governing procedures to control the calibration, maintenance, and use of M&TE that provides data to verify acceptance criteria are met or information important to safe plant operation. Section 12.1 of the QAPD TR describes the controls for calibration and adjustment of instrument and control devices installed in the facility during the operational phase of the facility.

The NRC staff reviewed Part II, Sections 12 and 12.1 of the TVA New Nuclear Program QAPD TR, Revision 0, and finds that these sections did not contain information to address the guidance in SRP Section 17.5, Subsection II, Items L.4 and L.5. As such, the NRC staff requests the applicant to demonstrate how the guidance in Items L.4 and L.5 of this SRP section has been addressed in the QAPD TR.

Question 14 Criterion XV, Nonconforming Materials, Parts, or Components, of Appendix B to 10 CFR Part 50, states Measures shall be established to control materials, parts, or components which do not conform to requirements in order to prevent their inadvertent use or installation.

Nonconforming items shall be reviewed and accepted, rejected, repaired or reworked in accordance with documented procedures. SRP Section 17.5, Subsection II, Item O specifies

acceptance criteria to meet the requirements of Criterion XV of Appendix B to 10 CFR Part 50.

Item O.5 within this SRP section states that the disposition, such as use as-is, reject, repair, or rework, of nonconforming items should be identified and documented. Technical justification for the acceptability of a nonconforming item, dispositioned repair, or use as-is should be documented. Item O.6 within this SRP section states that reworked, repaired, and replacement items should be inspected and tested in accordance with the original inspection and test requirements or specified alternatives.

Part II, Section 15, Control of Nonconforming Items, of the TVA New Nuclear Program QAPD TR, Revision 0, states, in part, that TVA New Nuclear Program has established the necessary measures and governing procedures to control items, including services that do not conform to specified requirements to prevent inadvertent installation or use.

The NRC staff reviewed Part II, Section 15, of the TVA New Nuclear Program QAPD TR, Revision 0 and finds that these sections did not contain information to address the guidance SRP Section 17.5, Subsection II, Items O.5 and O.6. As such, the NRC staff requests the applicant the applicant to demonstrate how the guidance in Items O.5 and O.6 of this SRP section has been addressed in the QAPD TR.

Question 15 Criterion XV of Appendix B to 10 CFR Part 50, states, in part, Measures shall be established to control materials, parts, or components which do not conform to requirements in order to prevent their inadvertent use or installation. 10 CFR Part 21.2(a)(3) and (a)(4) identify applicability of 10 CFR Part 21 for each individual, corporation, partnership, or other entity doing business within the United States, and each director and responsible officer of such an organization, applying for a design certification rule 10 CFR Part 52, and applying for or holding a standard design approval under 10 CFR Part 52, respectively.

Part II, Section 15.1, Interface with the Reporting Program, of the QAPD TR, Revision 0, describes the 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 52, 10 CFR 50.55, and 10 CFR 21 during ESP/CP/COL design and construction, and 10 CFR 21 during operations.

The NRC staff requests the applicant to clarify whether there will be appropriate interfaces between the QAP for identification and control of non-conforming materials, parts or components and the non-QA Reporting Program to satisfy the requirements of interface requirements of 10 CFR Part 52 and 10 CFR Part 21 for design certification and standard design approval applicants and holders.

Question 16 Criterion XVI, Corrective Action of Appendix B to 10 CFR Part 50, states, in part, Criterion XV of Appendix B to 10 CFR Part 50, states, in part, Measures shall be established to control materials, parts, or components which do not conform to requirements in order to prevent their inadvertent use or installation. 10 CFR Part 21.2(a)(3) and (a)(4) identify applicability of 10 CFR Part 21 for each individual, corporation, partnership, or other entity doing business within the United States, and each director and responsible officer of such an organization, applying for a design certification rule 10 CFR Part 52, and applying for or holding a standard design approval under 10 CFR Part 52, respectively.

Part II, Section 16.1, Interface with the Reporting Program, of the QAPD TR, Revision 0, describes the interfaces between the QAP for corrective actions and the non-QA Reporting Program to satisfy the requirements of 10 CFR 52, 10 CFR 50.55, and 10 CFR 21 during ESP/CP/COL design and construction, and 10 CFR 21 during operations.

The NRC staff requests the applicant to clarify whether there will be appropriate interfaces between the QAP for corrective action and the non-QA Reporting Program to satisfy the requirements of interface requirements of 10 CFR Part 52 and 10 CFR Part 21 for design certification and standard design approval applicants and holders.

Question 17 Criterion XVII, Quality Assurance Records of Appendix B to 10 CFR Part 50, states, in part, that Sufficient records shall be maintained to furnish evidence of activities affecting quality. The records shall include at least the following: Operating logs and the results of reviews, inspections, tests, audits, monitoring of work performance, and materials analyses. The records shall also include closely-related data such as qualifications of personnel, procedures, and equipment. Inspection and test records shall, as a minimum, identify the inspector or data recorder, the type of observation, the results, the acceptability, and the action taken in connection with any deficiencies noted.

SRP Section 17.5, Subsection II, Item Q specifies acceptance criteria to meet the requirements of Criterion XVII of Appendix B to 10 CFR Part 50. Item Q.8 within this SRP section states that all records should be retrievable, maintained in a readable format, and safeguarded against equipment malfunction or human error. Document access controls, user privileges, and other appropriate security controls should be established. RG 1.28, Revision 5, Section C.3 provides the staffs position on QA records in addition to NQA-1-2015, Requirement 17.

Part II, Section 17 of the TVA New Nuclear Program QAPD TR, Revision 0, states, in part, that TVA New Nuclear Program has the necessary measures and governing procedures to ensure that sufficient records of items and activities affecting quality are developed, reviewed, approved, issued, used, and revised to reflect completed work. Section 17.1, Record Retention, of QAPD TR, states, in part, that Records of activities for design, engineering, procurement, construction, inspection and test, installation, pre-operation, startup, operations, maintenance, modification, and audits and their retention times are defined in appropriate procedures. The records and retention times are based on Regulatory Position C.3.a.(1) and C.3.a.(2) of Regulatory Guide 1.28, Revision 5 for design, construction, and initial start-up.

Retention times for operational phase records are based on construction records that are similar in nature.

The NRC staff reviewed Part II, Sections 17 and 17.1 of the TVA New Nuclear Program QAPD TR, Revision 0 and finds that information was not included to demonstrate how the requirement for inclusion of operating logs and the results of reviews, monitoring of work performance, and materials analyses in records in Criterion XVII of Appendix B to 10 CFR Part 50 are met. In addition, the NRC staff did not identify how the guidance in SRP 17.5, Subsection II, Item Q.8 with respect to ensuring records are safeguarded against equipment malfunction or human error, and establishing access controls, user privileges, and other appropriate security controls, has been addressed in the QAPD TR, Revision 0. As such, the NRC staff requests the applicant to demonstrate how the requirements in Criterion XVII of Appendix B to 10 CFR Part 50 for the types of records that must be maintained are met. In addition, the NRC staff requests that the

applicant address the guidance in Section 17.5, Subsection II, Items Q.8. Further, NRC staff requests the applicant to clarify whether RG 1.28, Revision 5, Regulatory Position C.3.a.(1),

with respect to maintaining a lifetime record for the life of the particular item for the life while it is installed in the plant or stored for future use, and Regulatory Position C.3.a(2) with respect to documenting nonpermanent record retention periods and maintaining of these records for their retention period, are applied to permanent and nonpermanent records, respectively, during plant operational phase.

Question 18 Part III, Section 2, NonSafety-Related Structures, Systems, and Components Credited for Regulatory Events, of the TVA New Nuclear Program QAPD TR, Revision 0, states that for fire protection (10 CFR 50.48), anticipated transients without scram (ATWS) (10 CFR 50.62), the station blackout (SBO) (10 CFR 50.63) SSCs that are not safety-related, TVA New Nuclear program implements quality requirements for:

Fire protection systems in accordance with Regulatory Position 1.7, Quality Assurance, in RG 1.189, Fire Protection for Nuclear Power Plants, Revision 3; Safety Significant, but not safety-related, ATWS equipment in accordance with Part III, Section 1 of the TVA New Nuclear Program QAPD TR, Revision 0; Safety Significant, but not safety-related, SBO equipment in accordance with Part III, Section 1 of the TVA New Nuclear Program QAPD TR, Revision 0.

The NRC staff reviewed the criteria that are applied to SSCs that are not safety-related but are credited for regulatory events in Part III, Section 2 of the TVA New Nuclear Program QAPD TR, Revision 0, and has the following questions regarding the quality requirements that are applied to fire protection systems. Specifically, the TVA New Nuclear Program QAPD TR, Revision 0, references RG 1.189, Revision 3. However, RG 1.189, Revision 4 is the most up-to-date version of this RG. The staff requests the applicant to clarify why Revision 3 was referenced in the QAPD TR instead of Revision 4. In addition, in Part IV, Regulatory Commitments, of the QAPD TR, the applicant did not specify it conform to the guidance in RG 1.189. Therefore, the staff requests the applicant to clarify whether it commitments to conformance with RG 1.189, Revision 4.

In addition, the NRC staff requests the applicant to clarify whether applicability of Part III, Section 1 to ATWS and SBO equipment is consistent with the applicants planned applications with respect to different reactor technologies.

Question 19 Criterion III, Criterion IV, Procurement Document Control, and Criterion VII, Control of Purchased Material, Equipment, and Services, of Appendix B to 10 CFR Part 50 establish the underlying regulatory requirements for dedication of commercial grade items for use as basic components at nuclear power plants. 10 CFR Part 21, Reporting of Defects and Noncompliance, establish regulatory requirements to determine whether a basic component contains a defect or whether there is a failure to comply with Atomic Energy Act of 1954, as amended, or any applicable rule, regulation, order, or license of the Commission relating to substantial safety hazards.

RG 1.164, Dedication of Commercial-Grade Items for Use in Nuclear Power Plant, Revision 0, describes methods acceptable to the NRC staff for complying with the regulatory requirements

for dedication of commercial-grade items and services used in nuclear power plants. RG 1.231, Acceptance of CommercialGrade Design and Analysis Computer Programs Used in Safety Related Applications for Nuclear Power Plants, Revision 0, describes methods acceptable to the NRC staff for complying with the regulatory requirements for acceptance and dedication of commercial-grade design and analysis computer programs used in safety-related applications for nuclear power plants. RG 1.234, Evaluating Deviations and Reporting Defects and Noncompliance Under 10 CFR Part 21, Revision 0, describes methods acceptable to the NRC staff for complying with the provisions of 10 CFR Part 21.

Part IV of the TVA New Nuclear Program QAPD TR, Revision 0, identifies the NRC RGs and other QA standards which have been selected to supplement and support the QAPD. This section identifies the extent of conformance to these RGs and QA standards, including cases when conformance to these documents will be addressed within applicable license application documents submitted in accordance with 10 CFR Part 50 and 10 CFR Part 52. A list of RGs and standards is included in this section with descriptions of the applicants commitment to conforming with the guidance.

The NRC staff reviewed the information on commitments to RGs and QA standards in this section and finds that Part IV of the TVA New Nuclear Program QAPD TR, Revision 0, did not include commitments to RG 1.164, Revision 0, RG 1.231, Revision 0, and RG 1.234, Revision

0. Given that these RGs provide guidance on acceptable methods to comply with regulatory requirements for commercial-grade dedication, and evaluation and reporting requirements in 10 CFR Part 21, the NRC staff requests the applicant to clarify whether it intends to conform to the guidance in these RGs or whether alternative methods will be used to comply with the applicable regulatory requirements.

Question 20 10 CFR 50.34(b)(6)(ii) requires that each application for an operating license includes a final safety analysis report (FSAR) that contain information on managerial and administrative controls to be used to assure safe operation. 10 CFR 52.79(a)(27) requires that an application for a COL includes a that contain information on managerial and administrative controls to be used to assure safe operation. Both these 10 CFR sections requires that the information on the controls to be used for a nuclear power plant must include a discussion of how the applicable requirements of Appendix B to 10 CFR Part 50 is satisfied.

RG 1.33, Quality Assurance Program Requirements (Operation), Revision 3, describes methods that the NRC staff considers actable for complying with the provisions of regulations in 10 CFR 50.34(b)(6)(ii) and 10 CFR 52.79(a)(27). RG 1.33 endorses ANSI/ANS 3.2-2012, Managerial, Administrative, and Quality Assurance Controls for Operational Phase of Nuclear Power Plants.

Part IV of the TVA New Nuclear Program QAPD TR, Revision 0, provides a list and descriptions of RGs and quality assurance standards that the applicant commitments to conformance with.

The NRC staff reviewed this list and finds that the list does not include commitment to ANSI/ANS 3.2-2012. The NRC staff requests the applicant to clarify whether it will conform to the guidance in ANSI/ANS 3.2-2012, as endorsed by RG 1.33, Revision 3.