Text

LLC, Submittal of Topical Report Quality Assurance Program Description, MN-122626, Revision 1
	ML23192A280
Person / Time
Site:	99902078, 05200050
Issue date:	07/11/2023
From:	Shaver M; NuScale
To:	; Office of Nuclear Reactor Regulation, Document Control Desk
References
	LO-145889
	Download: ML23192A280 (1)
	v • d • e

LO-145889 NuScale Power, LLC 1100 NE Circle Blvd., Suite 200 Corvallis, Oregon 97330 Office 541.360.0500 Fax 541.207.3928 www.nuscalepower.com Docket No. 052-050 July 11, 2023 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk One White Flint North 11555 Rockville Pike Rockville, MD 20852-2738

SUBJECT:

NuScale Power, LLC Submittal of Topical Report NuScale Power, LLC Quality Assurance Program Description, MN-122626, Revision 1 NuScale Power, LLC (NuScale) hereby submits Revision 1 of the NuScale Power, LLC Quality Assurance Program Description, MN-122626. The purpose of this submittal is to request that the NRC review and approve the subject report, which supports the NuScale US460 Power Plant Standard Design Approval application. NuScale respectfully requests that the NRC issue a final safety evaluation report in 30 days from the date of transmittal documenting the NRC Staff conclusion that the NuScale topical report NuScale Power, LLC Quality Assurance Program Description, MN-122626, Revision 1 (Enclosure 1), is acceptable for referencing in NuScale licensing applications.

The enclosure to this letter contains the nonproprietary version of the report entitled NuScale Power, LLC Quality Assurance Program Description, MN-122626, Revision 1.

This letter makes no regulatory commitments and no revisions to any existing regulatory commitments.

If you have any questions, please contact Elisa Fairbanks at 541-452-7872 or at efairbanks@nuscalepower.com.

Sincerely, Mark Shaver Director, Licensing NuScale Power, LLC Distribution:

Michael Dudek, NRC Getachew Tesfaye, NRC Bruce Bavol, NRC : NuScale Power, LLC Quality Assurance Program Description, MN-122626, Revision 1

LO-145889 NuScale Power, LLC 1100 NE Circle Blvd., Suite 200 Corvallis, Oregon 97330 Office 541.360.0500 Fax 541.207.3928 www.nuscalepower.com :

NuScale Power, LLC Quality Assurance Program Description, MN-122626, Revision 1

MN-122626 Revision 1 Page 1 of 47 CP-0603-8892-F01-R12 NuScale Nonproprietary NUSCALE POWER, LLC QUALITY ASSURANCE PROGRAM DESCRIPTION Functional Area:

Quality Assurance Organizational Area: Operations Job Title/Role/Name Signature Date QA Specialist/Preparer Kathy Warnock Senior Director, Quality Assurance/Quality Reviewer Carolyn Monaco Job Title/Quality Approver Printed Name N/A Chief Operating Officer/Chief Nuclear Officer / Approver Karin Feldman Approval of final documents signifies the document review was performed, all review comments were resolved, and the document is released for use.

Revision Description x

Updated revision number in header on all pages and copyright date in footer on all pages but approval page.

x Approver updated on approval page x

Updated document date and revision number on cover/title page; template revision for approval page updated x

Table of contents updated x

Policy statement updated to incorporate NuScale Power, LLC affiliates in the first sentence (DA-0223-6209) and to correct grammar in the last sentence of the second paragraph for clarity.

x Section 1.1: Paragraph 1 updated for clarity, and to add NuScale affiliates (DA-0223-6209). Paragraph 2 reworded to clarify applicability of NQA-1 parts.

x Section 1.1.1: Paragraph 1 modified to add clarity with respect to scope. Paragraph 2 reworded to clarify applicability of NQA-1 parts.

x Section 2.1: Paragraph 6 updated to add clarity.

x Figure 2-1: Updated for clarity.

x Section 2.1.4.2: Updated to remove and Operations from title and text.

x Section 2.1.4.4: Former Paragraph 3 rewritten as paragraphs 3 & 4 to add clarity.

x Section 2.1.6 updated for clarity (DA-0323-6296).

x Sections 2.1.8, 2.5.3, 2.6.3, 2.8.1, 2.9.1, 2.13.2, 2.14.1, 2.15.2, 2.16.2, 2.17.3, and 2.18.3 added to restate commitment to compliance with NQA-1 requirements.

x Section 2.2.4: Paragraph 2 added to address QAPD submittals.

x Section 2.2.5: Added sentence on qualification of personnel.

x Section 2.2.6: Paragraph 1 reworded.

x Section 2.7.1: Added clarifying language to bullet 3 of the second paragraph.

x Section 2.7.2.b.3: removed ASME from list of audits from other sources (DA-0123-6183) x Section 2.7.3.1: Paragraph 3 - updated revision of NEI-14-05-A to Rev. 1-A (DA-0123-6182). Edition number added where ISO/IEC-17025 is referenced in this section.

Digitally signed by Kathy Warnock Date: 2023.06.29 13:22:21 -07'00' Carolyn Monaco Digitally signed by Carolyn Monaco Date: 2023.07.03 08:51:33 -07'00' Karin Feldman Digitally signed by Karin Feldman Date: 2023.07.07 14:34:50 -07'00'

MN-122626 Revision 1 Page 2 of 47 CP-0603-8892-F01-R12 NuScale Nonproprietary Revision Description x

Section 2.7.3.2: Corrected EPRI TR document number (DA-1222-6075).

x Section 2.10.3: Removed commitment to NQA-1-2008, Subpart 2.4. NuScale uses guidance from several RGs for work involving digital computer software.

x Section 2.17.2: Text regarding management of QA Records moved from this section to new 2.17.3.

x Section 4.1: Added references to RG 1.164, Revision 0 (4.1.1), RG 1.1231, Revision 0 (4.1.2), and RG 1.234, Revision 0, 4.1.3.

x Section 4.1.4: Removed reference to hydrogen recombiners and reworded sentence (DA-1222-6103).

x Section 4.2: Added references to GL 89-02 (4.2.5) and GL 91-05 (4.2.6)

THIS REVISION ONLY: Optional Review Job Title/Role/Name Signature Date Program Manager, Licensing

/Reviewer Stephanie Terwilliger Note:

Refer to Approval Document Form Instructions, DI-8892-10261 for instructions to complete this form.

Stephanie Terwilliger 2023.06.29 13:25:48 -07'00'

NuScale Power, LLC Quality Assurance Program Description MN-122626 Rev. 1 NuScale Nonproprietary

NuScale Power, LLC Quality Assurance Program Description June, 2023 Revision 1 Docket: 99902078 NuScale Nonproprietary NuScale Power, LLC 1100 NE Circle Blvd Corvallis, Oregon 97330 www.nuscalepower.com

NuScale Power, LLC Quality Assurance Program Description MN-122626 Rev. 1 NuScale Nonproprietary

© Copyright 2023 or later by NuScale Power, LLC ii COPYRIGHT NOTICE This report has been prepared by NuScale Power, LLC who owns the copyright thereto. No right to disclose, use, or copy any of the information in this report, other than by the U.S. Nuclear Regulatory Commission (NRC) or similar international or domestic nuclear regulatory government agency, is authorized without the express, written permission of NuScale Power, LLC. The government agency is permitted to make non-proprietary copies only as necessary for public viewing in the appropriate forums as may be required by government regulations. All copies, regardless of proprietary status, must include this copyright notice.

NuScale Power, LLC Quality Assurance Program Description MN-122626 Rev. 1 NuScale Nonproprietary

© Copyright 2023 or later by NuScale Power, LLC iii Department of Energy Acknowledgement and Disclaimer This material is based upon work supported by the Department of Energy under Award Number DE-NE0008928.

This report was prepared as an account of work sponsored by an agency of the United States Government. Neither the United States Government nor any agency thereof, nor any of their employees, makes any warranty, express or implied, or assumes any legal liability or responsibility for the accuracy, completeness, or usefulness of any information, apparatus, product, or process disclosed, or represents that its use would not infringe privately owned rights. Reference herein to any specific commercial product, process, or service by trade name, trademark, manufacturer, or otherwise does not necessarily constitute or imply its endorsement, recommendation, or favoring by the United States Government or any agency thereof. The views and opinions of authors expressed herein do not necessarily state or reflect those of the United States Government or any agency thereof.

NuScale Power, LLC Quality Assurance Program Description MN-122626 Rev. 1 NuScale Nonproprietary

Part IIntroduction......................................................................................................... 2

1.1

General.................................................................................................................. 2

1.1.1

Scope/Applicability................................................................................................ 3

1.2

Abbreviations / Definitions..................................................................................... 4

2.0

Part IIQuality Assurance Program Description Details............................................ 6

2.1

Organization.......................................................................................................... 6

2.1.1

President and Chief Executive Officer................................................................... 8

2.1.2

Services and Delivery............................................................................................ 8

2.1.3

Technology............................................................................................................ 8

2.1.4

Operations............................................................................................................. 8

2.1.5

Authority to Stop Work......................................................................................... 10

2.1.6

Human Resources............................................................................................... 10

2.1.7

Support Functions............................................................................................... 11

2.1.8

Commitment........................................................................................................ 11

2.2

Quality Assurance Program................................................................................. 11

2.2.1

Responsibilities................................................................................................... 12

2.2.2

Delegation of Work.............................................................................................. 12

2.2.3

Periodic Review of the Quality Assurance Program............................................ 12

2.2.4

Issuance and Revision to Quality Assurance Program........................................ 13

2.2.5

Personnel Training and Qualifications................................................................. 13

2.2.6

Commitment/Exception....................................................................................... 14

2.3

Design Control..................................................................................................... 14

2.3.1

Design Verification............................................................................................... 15

2.3.2

Design Records................................................................................................... 15

2.3.3

Computer Application and Digital Equipment Software....................................... 16

2.3.4

Commitment........................................................................................................ 16

2.4

Procurement Document Control.......................................................................... 16

2.4.1

Commitment/Exceptions..................................................................................... 17

2.5

Instructions, Procedures, and Drawings.............................................................. 17

2.5.1

Procedure Adherence.......................................................................................... 17

2.5.2

Procedure Content.............................................................................................. 18

2.5.3

Commitment........................................................................................................ 18

2.6

Document Control............................................................................................... 18

NuScale Power, LLC Quality Assurance Program Description MN-122626 Rev. 1 NuScale Nonproprietary

2.6.1

Review and Approval of Documents.................................................................... 19

2.6.2

Changes to Documents....................................................................................... 19

2.6.3

Commitment........................................................................................................ 19

2.7

Control of Purchased Material, Equipment, and Services................................... 19

2.7.1

Acceptance of Items or Services......................................................................... 19

2.7.2

Supplier Audits During Exigent Conditions.......................................................... 21

2.7.3

Commitment/Exceptions..................................................................................... 21

2.8

Identification and Control of Materials, Parts, and Components......................... 23

2.8.1

Commitment........................................................................................................ 23

2.9

Control of Special Processes.............................................................................. 24

2.9.1

Commitment........................................................................................................ 24

2.10

Inspection............................................................................................................ 24

2.10.1 Inspection Program............................................................................................. 24

2.10.2 Inspector Qualification......................................................................................... 25

2.10.3 Commitment/Exceptions..................................................................................... 25

2.11

Test Control......................................................................................................... 25

2.11.1 Commitment for non-Computer Program Testing................................................ 26

2.11.2 Commitment for Computer Program Testing....................................................... 26

2.12

Control of Measuring and Test Equipment.......................................................... 26

2.12.1 Commitment/Exceptions..................................................................................... 26

2.13

Handling, Storage, and Shipping......................................................................... 26

2.13.1 Housekeeping..................................................................................................... 27

2.13.2 Commitment........................................................................................................ 27

2.14

Inspection, Test, and Operating Status................................................................ 27

2.14.1 Commitment........................................................................................................ 28

2.15

Nonconforming Materials, Parts, or Components................................................ 28

2.15.1 Interface with the Reporting Program.................................................................. 28

2.15.2 Commitment........................................................................................................ 28

2.16

Corrective Action................................................................................................. 29

2.16.1 Interface with the Reporting Program.................................................................. 29

2.16.2 Commitment........................................................................................................ 29

2.17

Quality Assurance Records................................................................................. 29

2.17.1 Record Retention................................................................................................ 29

2.17.2 Electronic Records.............................................................................................. 30

NuScale Power, LLC Quality Assurance Program Description MN-122626 Rev. 1 NuScale Nonproprietary

2.18

Audits.................................................................................................................. 30

2.18.1 Performance of Audits......................................................................................... 30

2.18.2 Internal Audits...................................................................................................... 31

2.18.3 Commitment........................................................................................................ 31

3.0

Part III - Quality Assurance Program Controls for Nonsafety-Related Structures, Systems, and Components...................................................................... 32

3.1

Nonsafety-Related Structures, Systems, and, ComponentsSignificant Contributors to Plant Safety................................................................................ 32

3.1.1

Organization........................................................................................................ 32

3.1.2

Quality Assurance Program................................................................................. 32

3.1.3

Design Control..................................................................................................... 32

3.1.4

Procurement Document Control.......................................................................... 32

3.1.5

Instructions, Procedures, and Drawings.............................................................. 32

3.1.6

Document Control............................................................................................... 33

3.1.7

Control of Purchased Items and Services........................................................... 33

3.1.8

Identification and Control of Purchased Items..................................................... 33

3.1.9

Control of Special Processes.............................................................................. 33

3.1.10 Inspection............................................................................................................ 33

3.1.11 Test Control......................................................................................................... 33

3.1.12 Control of Measuring and Test Equipment.......................................................... 33

3.1.13 Handling, Storage, and Shipping......................................................................... 33

3.1.14 Inspection, Test, and Operating Status................................................................ 34

3.1.15 Control of Nonconforming Items.......................................................................... 34

3.1.16 Corrective Action................................................................................................. 34

3.1.17 Records............................................................................................................... 34

3.1.18 Audits.................................................................................................................. 34

3.2

Nonsafety-Related Structures, Systems, and Components Credited for Regulatory Events............................................................................................... 34

4.0

Part IV - Regulatory and Other Commitments............................................................ 36

4.1

US Nuclear Regulatory Commission (US NRC) Regulatory Guides and Quality Assurance Standards.............................................................................. 36

4.1.1

US NRC Regulatory Guide 1.164, Revision 0, Dedication of Commercial Grade Items for Use in Nuclear Power Plants.................................................... 36

NuScale Power, LLC Quality Assurance Program Description MN-122626 Rev. 1 NuScale Nonproprietary

US NRC Regulatory Guide 1.231, Revision 0, Acceptance of Commercial Grade Design and Analysis Computer Programs Used in Safety-Related Applications for Nuclear Power Plants....................................... 36

4.1.3

US NRC Regulatory Guide 1.234, Revision 0, Evaluating Deviations and Reporting Defects and Noncompliance Under 10 CFR Part 21......................... 36

4.1.4

US NRC Regulatory Guide 1.26, Revision 6, Quality Group Classifications and Standards for Water-, Steam-, and Radioactive-Waste-Containing Components of Nuclear Power Plants.................................. 36

4.1.5

US NRC Regulatory Guide 1.28, Revision 4, Quality Assurance Program Requirements (Design and Construction).......................................................... 37

4.1.6

US NRC Regulatory Guide 1.29, Revision 6, Seismic Design Classification...................................................................................................... 37

Quality Assurance Standards.......................................................................................... 37

4.1.7

American Society of Mechanical Engineers (ASME) NQA-1-2008 and NQA-1a-2009 addenda editions, New York, NY, Quality Assurance Requirements for Nuclear Facility Applications.................................................. 37

4.2

Other Reference Documents............................................................................... 37

4.2.1

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

Technical Guides (TGs) as endorsed by Regulatory Guide 1.28, Revision

5.......................................................................................................................... 37

4.2.2

ISO/IEC 17025, 2017 Edition, General requirements for the competence of testing and calibration laboratories................................................................ 37

4.2.3

EPRI Technical Report TR 3002019436-A, Remote Source Verification During a Pandemic or Similar State of Emergency - Screening Criteria and Process Guidance....................................................................................... 37

4.2.4

EPRI Technical Report TR 3002020796, Remote Assessment Techniques: Planning and Conducting Audits and Surveys Using Remote Techniques During Exigent Conditions............................................................... 37

4.2.5

GL 89-02, Actions to Improve the Detection of Counterfeit and Fraudulently Marked Products........................................................................... 38

4.2.6

GL 91-05, Licensee Commercial Grade Dedication Programs......................... 38

TABLES Table 1-1.

Abbreviations............................................................................................................ 4

Table 1-2.

Definitions................................................................................................................. 4

FIGURES Figure 2-1. NuScale Organization............................................................................................... 7

NuScale Power, LLC Quality Assurance Program Description MN-122626 Rev. 1 NuScale Nonproprietary

Policy Statement NuScale Power, LLC and its affiliates (NuScale) are committed to improving the quality of life for humankind by continuously improving nuclear power. With a focus on safety and quality, and a commitment to improvement, NuScale will provide innovative, reliable products and services to fulfill customer and regulatory requirements.

NuScale shall design nuclear power plants in a manner that meets customer contract requirements and is in full accord with applicable standards and regulations in a manner that will assure the health and safety of the public and workers. NuScale complies with the regulatory and quality requirements applicable to the items and services it provides for use in nuclear power plants, as imposed by the governing regulatory agency. For nuclear power plants subject to U. S. Nuclear Regulatory Commission (NRC) regulations, these activities shall be performed in compliance with the requirements of the Code of Federal Regulations (CFR), the applicable Nuclear Regulatory Commission (NRC) licensing requirements, and the applicable laws and regulations of state and local governments.

NuScale has developed and implemented a Quality Assurance Program (QAP) which is described in this document, the Quality Assurance Program Description (QAPD) and associated implementing documents. Together, they provide for control of NuScale activities that affect the quality of safety-related nuclear plant structures, systems, and components (SSCs) and include all planned and systematic activities necessary to provide adequate confidence that such SSCs will perform satisfactorily in service. The QAPD may also be applied to certain equipment and activities that are not safety-related, but support safe plant operations, or where other NRC guidance or other governing regulatory body establishes program requirements.

The QAPD is the top-level policy document that establishes the manner in which quality is to be achieved and presents NuScales overall philosophy regarding achievement and assurance of quality. Implementing documents assign more detailed responsibilities and requirements and define the organizational interfaces involved in conducting activities within the scope of the QAP. Senior management establishes overall expectations for obtaining the desired end result and retains accountability for the effectiveness of the QAP.

Compliance with the QAPD and its implementing documents is mandatory for NuScale personnel directly or indirectly associated with the implementation of the QAPD.

John Hopkins President and Chief Executive Officer NuScale Power, LLC

NuScale Power, LLC Quality Assurance Program Description MN-122626 Rev. 1 NuScale Nonproprietary

1.0 Part IIntroduction 1.1 General This Quality Assurance Program Description (QAPD) provides a description of the NuScale Power, LLC Quality Assurance Program (QAP). The QAPD is the top-level document that establishes the quality assurance policy and assigns major functional responsibilities for nuclear power plant activities, including licensing activities, conducted by or for NuScale Power, LLC and its affiliates (NuScale). It has been developed to comply with statutory, regulatory, industry, and customer quality requirements that are applicable to items (i.e., structures, systems, or components) and services provided by NuScale. The QAPD describes NuScales commitment to quality assurance requirements that ensure the highest levels of customer satisfaction.

The QAPD was prepared using guidance provided in NUREG 0800, Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants and Nuclear Energy Institute (NEI)11-04A, Revision 0, Quality Assurance Program Description (QAPD) template. It describes the methods and establishes quality assurance and administrative control requirements that meet 10 CFR 50, Appendix B, 10 CFR 52, and 10 CFR 21. The QAPD is based on the requirements and recommendations of ASME NQA-1-2008 and NQA-1a-2009 addenda, Quality Assurance Requirements for Nuclear Facility Applications, Parts I and II, as endorsed by Regulatory Guide 1.28, Revision 4. Unless stated elsewhere in this document, NuScale commits to compliance with these requirements.

For projects not governed by the requirements of 10 CFR 50, Appendix B, NuScale may utilize other requirements as identified by other regulatory bodies as detailed in customer contracts. This QAPD generally implements a quality management system (QMS) as identified in ISO 9001.

NuScale policy is to assure a high degree of availability and reliability of the nuclear plant(s) while ensuring the health and safety of its workers and the public. To this end, selected elements of the QAPD are also applied to certain equipment and activities that support safe, economic, and reliable plant operations, as imposed by the governing regulatory agency. Implementing documents establish program element applicability to ensure that nuclear safety is not compromised.

The QAP is defined by the required Quality Assurance (QA) elements identified in this QAPD along with associated implementing documents. Procedures and instructions that control activities will be developed prior to commencement of those activities. Policies establish high-level responsibilities and authority for carrying out important administrative functions that may be outside the scope of the QAPD. Procedures establish practices for certain activities that are common to all NuScale organizations performing those activities so that the activity is controlled and carried out in a manner that meets QAPD requirements. Procedures specific to an organization or group establish detailed implementation requirements and methods and may be used to implement policies or be unique to particular functions or work activities.

NuScale Power, LLC Quality Assurance Program Description MN-122626 Rev. 1 NuScale Nonproprietary

1.1.1 Scope/Applicability The QAPD and implementing procedures apply to the following activities affecting the quality and performance of items and services provided by NuScale. It defines the activities, processes, and commitments applicable to standard design application activities and customer contracts including but not limited to:

x designing x

handling x

procuring x

shipping x

fabricating x

storing x

cleaning x

testing x

inspecting x

training x

receiving NuScale complies with the regulatory requirements applicable to items and services it provides for use in nuclear power plants in accordance with the governing regulatory agency. For nuclear power plants subject to U.S. Nuclear Regulatory Commission (NRC) regulations, NuScale complies with the requirements of Title 10, Part 50 of the Code of Federal Regulations (10 CFR 50), Domestic Licensing of Production and Utilization Facilities, Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, and ASME NQA-1-2008 and NQA-1a-2009 addenda, Quality Assurance Program Requirements for Nuclear Facilities, Parts I and II, as endorsed by Regulatory Guide 1.28, Revision 4, Quality Assurance Program Criteria (Design and Construction), unless otherwise identified in this document.

Quality requirements contained in the QAPD may not explicitly address all quality system requirements invoked by customer contracts or required by a governing regulatory agency for each NuScale project. To define and implement an alternate quality system for specific projects, NuScale may utilize a Project Quality Plan (PQP) process to specify supplemental quality requirements, identify supplemental/revised procedures, or provide recognition of and compliance with alternative quality standards such as ISO 9001. For the project to which it is applicable, a PQP provides the quality system description and applies to activities that affect the quality of items and services supplied by NuScale.

Safety-related SSCs subject to the requirements of the QAPD, are identified in design documents. The technical aspects of these items are considered when determining program applicability, including, as appropriate, the item's design safety function. The QAPD may be applied to certain activities where regulations other than 10 CFR 50 and 10 CFR 52 establish QA requirements for activities within their scope.

The QAPD is divided into four parts:

o Part I Introduction o Part II Quality Assurance Program Description (QAPD) Details o Part III Nonsafety-Related Structures, Systems, and Components (SSC) Quality Control o Part IV Regulatory Commitments.

The definitions provided in NQA-1a-2009 addenda, Part I, Section 400 apply to select terms as used in this document.

NuScale Power, LLC Quality Assurance Program Description MN-122626 Rev. 1 NuScale Nonproprietary

1.2 Abbreviations / Definitions Table 1-1.

Abbreviations Term Definition ATWS anticipated transient without scram CEO Chief Executive Officer CFR Code of Federal Regulations DC design certification EPRI Electric Power Research Institute FSAR final safety analysis report ILAC International Laboratory Accreditation Cooperation ISO International Organization for Standardization M&TE Measuring and Test equipment MRA Mutual Recognition Arrangement NRC Nuclear Regulatory Commission NEI Nuclear Energy Institute NIRMA Nuclear Information and Records Management Association QA Quality Assurance QAP Quality Assurance Program QAPD Quality Assurance Program Description RG (NRC) Regulatory Guide SBO station blackout SDA Standard Design Approval SDAA Standard Design Approval Application SMR Small modular reactor SSCs structures, systems, and components TG technical guide Table 1-2.

Definitions Term Definition Applied research Research intended to solve a specific problem or meet a practical need.

Basic research Research conducted to acquire new knowledge of a theoretical or experimental nature.

Design certification (DC)

The process of research and design activities that develop and support an application to the NRC for certification of a standard design nuclear power plant.

Design process Technical and management processes that commence with identification of design input and that lead to and include the issuance of design output documents.

Developmental research Activities associated with the application of proven theory and experimental results and their extension to its end use, e.g., use in a design environment.

NuScale Power Plant A modular, scalable nuclear power plant developed and designed by NuScale Power, LLC.

NuScale Power, LLC Quality Assurance Program Description MN-122626 Rev. 1 NuScale Nonproprietary

Term Definition Quality Assurance Program (QAP)

The QA Program (QAP) described in this report consists of the QAPD and associated implementing documents, which include policies, plans, and procedures.

Quality Assurance Program Description (QAPD)

The document that describes the policies, scope, organizations, objectives, processes, and methods that constitutes the NuScale Power, LLC (NuScale) QAP. Developed to comply with statutory, regulatory, industry and customer quality requirements, the QAPD is the top-level document establishing the quality assurance policy and methods of NuScale Power, LLC and assigns major functional responsibilities for nuclear power plant activities conducted by or for NuScale Power, LLC.

Quality Management System (QMS)

Set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve quality objectives Research and Development support activities Activities that are conventional in nature to the advancement of knowledge and development of technology but allow the primary purpose of the work to be accomplished in a credible manner (e.g.,

calibration of measuring and test equipment).

Standard Design Approval (SDA)

An NRC staff approval, issued under subpart E of 10 CFR 52, of a final standard design for a nuclear power reactor. An applicant for a construction permit or combined license may reference an SDA.

Standard Design Approval Application (SDAA)

An application for a standard design approval by the NRC in accordance with 10 CFR Part 52 Subpart E. An applicant for a construction permit or combined license may reference an SDA.

Sub-tier implementing documents Procedures, instructions, drawings, forms, and other forms of communicating prescribed methods, processes, sequences, authorization/authentication, quantitative /qualitative acceptance criteria, and required documentation necessary to assure and provide documented evidence of the quality of NuScale end products and services.

NuScale Power, LLC Quality Assurance Program Description MN-122626 Rev. 1 NuScale Nonproprietary

2.0 Part IIQuality Assurance Program Description Details 2.1 Organization This section describes the NuScale organizational structure, functional responsibilities, levels of authority, and interfaces for establishing, executing, and verifying QAPD implementation. The organizational structure includes corporate and support functions, including interface responsibilities for multiple organizations that perform quality-related functions. Implementing documents assign more specific organizational details, including authority, responsibilities and duties, and organizational interfaces involved in conducting activities within the scope of the QAPD. Management gives careful consideration to the timing, extent, and effects of organizational structure changes.

Executive management from each organization is responsible for effective implementation of quality program activities described throughout this document and ensuring that appropriate systems, processes, and procedures are implemented. Executive management is also responsible for ensuring through respective leaders that all functional groups understand applicable implementing procedures and that personnel are indoctrinated and trained in the applicable quality system requirements prior to performing tasks, and that instances of noncompliance and opportunities for improvement are addressed in a timely manner.

Each Executive is responsible for ensuring that all personnel are aware of the company-wide Safety Culture / Safety Conscious Work Environment (SCWE) Program and encouraging a questioning attitude.

Achievement of quality is the responsibility of each individual performing work.

Verification of the achievement of quality is accomplished by individuals or groups not directly responsible for performing the work.

Management of the NuScale quality assurance function is responsible to size the quality assurance staff commensurate with the duties and responsibilities assigned.

Services, such as design, engineering, and testing services, are provided to NuScale by qualified contractors in accordance with their QA programs or by contractors working under the NuScale QA program. These contractors are evaluated and approved prior to performing safety-related work. For the purpose of managing the NuScale QAP, the corporate organizational structure is shown in Figure 2-1.

NuScale Power, LLC Quality Assurance Program Description MN-122626 Rev. 1 NuScale Nonproprietary

President and CEO*

Operations Technology Services and Delivery Support Functions Quality Assurance Supply Chain Engineering Program Management Regulatory Affairs Human Resources

Quality has direct access for quality-related issues Figure 2-1.

NuScale Organization

NuScale Power, LLC Quality Assurance Program Description MN-122626 Rev. 1 NuScale Nonproprietary

2.1.1 President and Chief Executive Officer The President and Chief Executive Officer (CEO) is responsible for management of overall activities including design, and delivery of products and services, as well as all technical, human resources, and administrative support activities provided by NuScale and its contractors. The President and CEO directs the various functions in the fulfillment of their responsibilities. The President and CEO has the responsibility and authority for the conduct of NuScale Quality Assurance Program activities and definition of the scope of the QAP. The President and CEO is responsible for establishing overall expectations for effective implementation of the QAP through the Policy Statement.

2.1.2 Services and Delivery The Services and Delivery organization reports to the President and CEO. Comprised of services, supply chain, and client management functions, this organization is responsible for the delivery of services and equipment associated with the sale, development, delivery, and commercial operation of NuScale power plants. This includes functions necessary to inform the NuScale design from an operations and maintenance perspective.

Management of these functions will interface with Operations, Technology and Support Functions to ensure robust implementation of customer, regulatory, and quality requirements.

2.1.2.1 Supply Chain Supply Chain, including procurement, reports to Services and Delivery and is responsible for the development, evaluation, and administration of the NuScale supply chain.

Responsibilities include interfacing with other functional organizations, such as Engineering and Quality, to ensure that suppliers of safety-related items and services are evaluated prior to award and that all applicable technical and quality requirements are effectively communicated through procurement documents.

2.1.3 Technology Technology reports to the President and CEO and responsibilities include development and research collaboration as well as the independent verification and validation of digital instrumentation and control (I&C) software function.

2.1.4 Operations Operations reports to the President and CEO and has overall responsibility for ensuring the effective functioning of all areas of the operations organization including such functions as: quality, engineering, regulatory affairs, information technology, corrective action, document control, corporate services, and project management. Management of the Operations organization is responsible for ensuring effective functioning of all areas and that the performance of each function is consistent with applicable nuclear quality requirements, regulatory requirements, customer requirements, and procedural guidance.

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The Operations Executive is accountable for the effectiveness of the QAP, ensuring that sufficient resources are available, and that the quality policy and quality objectives are established and demonstrate compatibility with NuScale strategies.

The Operations Executive is also responsible for leading the development of an effective company-wide Safety Culture/Safety Conscious Work Environment (SCWE) Program.

The SCWE Program shall ensure awareness of the program by all personnel and encourage a questioning attitude.

2.1.4.1 Engineering Engineering reports to the Operations Executive and is responsible for design, design testing and code development, safety analysis, testing activities, and engineering services. Testing responsibilities include ensuring that test personnel are qualified and that test service providers develop facilities and test programs capable of providing accurate data defining the operating characteristics of the NuScale design. Code development responsibilities include the development of thermal hydraulic software code and the qualification and modification of existing analytical software codes.

2.1.4.2 Program Management Program Management reports to the Operations Executive and maintains responsibility and authority to evaluate new projects and to approve initiation of projects as needed to meet the requirements of NuScale strategic objectives. Program Management has the responsibility to develop and deploy integrated project schedules, with associated budget and project management controls, and to develop a system to address risks and opportunities. Program Management is also responsible for the following enterprise-wide business systems: corrective action program, document control and records management, and other corporate services.

2.1.4.3 Regulatory Affairs Regulatory Affairs reports to the Operations Executive and is responsible for licensing and licensing application activities. Regulatory Affairs is the single point of contact with regulatory agencies for effective communications and is responsible for 1) administration of the 10 CFR 21 evaluation (or other international equivalent) and reporting program and

2) ensuring that licensing-related requirements and commitments are addressed and controlled in an effective manner.

2.1.4.4 Quality Assurance Quality Assurance is responsible for independently planning and performing activities to verify the development and effective implementation of the NuScale QAPD, including, but not limited to, engineering, document control, corrective action program, and procurement processes.

The manager of Quality Assurance is appointed by and reports to the Operations Executive and has the authority to manage quality issues. Quality Assurance is responsible for development, implementation, and maintenance of the QAPD and is responsible for verifying that activities are in compliance with applicable regulatory, code,

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© Copyright 2023 or later by NuScale Power, LLC 10 and industry standard requirements. If Quality Assurance disagrees with actions taken by the NuScale organization and is unable to obtain resolution, Quality Assurance shall inform the Operations Executive and has the authority to directly bring the matter to the attention of the President and CEO for final disposition.

Quality Assurance is responsible for assuring compliance with regulatory requirements, codes, and standards through audits, surveillance activities, technical reviews, and other oversight when appropriate.

Quality Assurance is responsible for ensuring that suppliers providing quality services, parts, components, and materials to NuScale are meeting applicable requirements of 10 CFR 50, Appendix B or other applicable regulatory and contractual requirements through NuScale supplier evaluations, surveillances, and audits. Monitoring of manufacturing activities may be led by Supply Chain, however, Quality Assurance shall review plans for these activities.

Quality Assurance has sufficient independence from other priorities to bring forward issues affecting safety and quality and to make judgments regarding quality in all areas necessary regarding NuScale activities. Management responsible for QA is at the same or higher organizational level as the highest line manager directly responsible for performing the activities affecting quality (i.e., engineering, procurement) and is sufficiently independent from cost and schedule for the conduct of Quality Assurance activities. The Manager responsible for QA is the designated Management Representative when specifically cited by other codes and standards.

2.1.4.5 Quality Assurance Organizational Independence Independence shall be maintained between the organizations performing the checking (quality assurance and control) functions and the organizations performing the functions.

Independence for design reviews and verifications is described in Section 2.3.1.

2.1.5 Authority to Stop Work Each person working for NuScale has the authority and responsibility to stop work immediately when it is believed that current conditions pose an imminent danger to worker or public health or safety.

Quality personnel have the authority, and the responsibility, to stop work in progress that is not being performed in accordance with approved procedures where safety or SSC integrity may be jeopardized. This extends to off-site work performed by suppliers that furnish safety-related items and services to NuScale.

2.1.6 Human Resources Human Resources reports to the President and CEO and is responsible for all personnel decisions regarding recruitment and retention, and the administration of the NuScale training and development program.

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© Copyright 2023 or later by NuScale Power, LLC 11 2.1.7 Support Functions Other support functions reporting to the President and CEO (e.g., finance, legal, business development) are key in supporting the overall operation of the company.

2.1.8 Commitment In establishing its organizational structure, NuScale commits to compliance with NQA 2008, Requirement 1, Sections 100 through 300.

2.2 Quality Assurance Program NuScale has established the necessary measures and governing procedures to implement the QAP as described in this QAPD. NuScale is committed to implementing the QAP in all aspects of work that are important to the safety of the nuclear plant(s) as described and to the extent delineated in this QAPD. The QAP shall include monitoring activities against acceptance criteria in a manner sufficient to provide assurance that the activities important to safety are performed satisfactorily. Further, NuScale ensures through the systematic process described herein that its suppliers of safety-related equipment, items, or services meet the applicable requirements of 10 CFR 50, Appendix B, customer requirements and other governing regulatory and quality requirements as applicable. Senior management is regularly apprised of the adequacy of implementation of the QAP through the audit functions described in Section 2.18 in this document.

The objective of the QAP is to assure that NuScale power plants are designed in accordance with governing regulations and requirements. The program is based on the requirements of ASME NQA-1-2008 and NQA-1a-2009 addenda, Quality Assurance Requirements for Nuclear Facility Applications, as further described in this document. The QAP applies to those quality-related activities that involve the functions of safety-related SSCs associated with the design, fabrication, and testing of the NuScale Power Plant and to the managerial and administrative controls to be used to assure the NuScale Power Plant design complies with applicable regulatory requirements. Examples of safety-related activities include, but are not limited to, basic, applied, and developmental research; determination of SSC safety class; design configuration management; and document control. A list or system that identifies SSC and activities to which this program applies is maintained at NuScale. Cost and scheduling challenges must be addressed; however, they do not prevent proper implementation of the QAP.

As described in Section 3.0 of this document, specific program controls are applied to nonsafety-related SSCs that are significant contributors to plant safety, for which 10 CFR 50, Appendix B is not applicable, or for which other regulations or requirements apply. The specific program controls consistent with applicable sections of the QAPD are applied to those items in a selected manner and targeted at those characteristics or critical attributes that render the SSC a significant contributor to plant safety.

Delegated responsibilities may be performed under a supplier's or principal contractor's QAP, provided the supplier or principal contractor has been approved as a supplier in accordance with the NuScale QAP. Periodic audits and assessments of supplier QA programs are performed to assure compliance with the supplier's or principal contractor's

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© Copyright 2023 or later by NuScale Power, LLC 12 QAPD and implementing procedures. In addition, routine interfaces with the suppliers personnel provide added assurance that quality expectations are met.

Program requirements specified herein are detailed in implementing procedures that are either NuScale implementing procedures or supplier implementing procedures governed by a supplier quality assurance program.

A grace period of 90 days may be applied to scheduled audits and annual evaluations of supplier performance. When the grace period is used, the next scheduled date for the activity shall be based on the activity schedule date and not on the date the activity was actually performed. If the activity is performed early, the next schedule date shall be based on the date the activity was actually performed. Audit schedules are based on the month in which the audit starts. Section 2.7.2 addresses audit or survey interval extensions in the event of exigent conditions.

2.2.1 Responsibilities Personnel who work directly or indirectly for NuScale are responsible for achieving acceptable quality in the work covered by this QAPD. This includes the activities delineated in Section 1.1. NuScale personnel performing verification activities are responsible for verifying the achievement of acceptable quality. Activities governed by this QAPD are performed as directed by documented instructions, procedures, and drawings that are of a detail appropriate to the activity's complexity and effect on safety. Instructions, procedures, and drawings specify quantitative or qualitative acceptance criteria as applicable or appropriate to the activity, and verification is against these criteria. Provisions are established to designate or identify the proper documents to be used in an activity and to ascertain that such documents are being used. The NuScale quality assurance function is responsible to verify that processes and procedures comply with the QAPD and other applicable requirements, that such processes or procedures are implemented, and that management appropriately ensures compliance.

2.2.2 Delegation of Work NuScale retains and exercises the responsibility for the scope and implementation of an effective QAP. Positions identified in Section 2.1 may delegate all or part of the activities of planning, establishing, and implementing the program for which they are responsible to others, but they retain the responsibility for the program's effectiveness. Decisions affecting safety are made at the level appropriate for its nature and effect and with any necessary technical advice or review.

Within the NuScale organization, each Manager or Supervisor may assign performance of their duties to their direct reports who are qualified to perform such duties. The responsibility for those duties, however, cannot be assigned or delegated. Managers or Supervisors, if qualified, may perform the work of their subordinates.

2.2.3 Periodic Review of the Quality Assurance Program Management of those organizations implementing the QA program, or portions thereof, assess the adequacy of that part of the program for which they are responsible to assure

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2.2.4 Issuance and Revision to Quality Assurance Program Changes to this QAPD are evaluated by the NuScale quality assurance organization to ensure that such changes do not degrade previously approved quality assurance controls specified in the QAPD. This document shall be revised, as appropriate, to incorporate additional QA commitments that may be established over time. New revisions to the document will be reviewed, at a minimum, by the NuScale quality assurance organization and approved by the Operations Executive.

Changes to this QAPD are submitted to the US NRC in accordance with 10 CFR 50.4(b)(7)(ii). When required by other regulation(s), changes to this QAPD are submitted to the governing jurisdictional authority.

2.2.5 Personnel Training and Qualifications Personnel assigned to implement elements of this QAPD shall be capable of performing their assigned tasks. To this end, NuScale establishes and maintains formal indoctrination and training programs for personnel performing, verifying, or managing activities within the scope of this QAPD to assure that suitable proficiency is achieved and maintained.

The indoctrination, training, and qualification programs are commensurate with scope, complexity, and importance of the activities; and include or address the following, as appropriate:

x Education, experience, and proficiency of the personnel receiving training x

General criteria, technical objectives, requirements of applicable codes and standards, regulatory commitments, company procedures, and quality assurance program requirements x

On-the-job training, if direct hands-on applications or experience is needed to achieve and maintain proficiency Qualification of inspection, test, special process, auditor and lead auditor personnel shall be certified in writing, including documentation of capability through either written tests or physical demonstration of required skills. Sufficient managerial depth is provided to cover absences of incumbents. When required by code, regulation, or standard, specific qualification and selection of personnel is conducted in accordance with those requirements as established in the applicable NuScale procedures. Indoctrination includes administrative and technical objectives, requirements of the applicable codes and standards, and the QAPD elements to be employed. Records of personnel training and qualification are maintained.

The minimum qualifications of the individual in charge of quality assurance are that he or she holds an engineering or related science degree and a minimum of four years of related experience, including two years of nuclear power plant experience, and one year of supervisory or management experience, with one year of that experience performing quality verification activities. Special requirements shall include management and supervisory skills and experience or training in leadership, interpersonal communication,

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© Copyright 2023 or later by NuScale Power, LLC 14 management responsibilities, motivation of personnel, problem analysis and decision making, and administrative policies and procedures. Individuals who do not possess these formal education and minimum experience requirements are not eliminated automatically when other factors provide sufficient demonstration of their abilities. These other factors are evaluated on a case-by-case basis and approved and documented by senior management.

The minimum qualifications of the individuals responsible for planning, implementing, and maintaining the programs of the QAPD are that each has a high school diploma, or equivalent, and has a minimum of one year of related experience. Individuals who do not possess these formal education and minimum experience requirements should not be eliminated automatically when other factors provide sufficient demonstration of their abilities. These other factors are evaluated on a case-by-case basis and approved and documented by senior management.

2.2.6 Commitment/Exception In establishing qualifications, NuScale commits to compliance with NQA-1-2008 and NQA-1a-2009 addenda, Requirement 2, Sections 100 through 500 with the following clarifications and exceptions for Lead Auditors:

x NQA-1-2008, Section 303.3, Audit Participation NuScale considers that prospective Lead Auditors, with comparable industry experience, may satisfy the Lead Auditor qualification requirement of participating in a minimum of five QA audits within a period of 3 years prior to the date of qualification by alternatively demonstrating the ability to properly implement the audit process, effectively organize and report results, and participate in at least one nuclear audit within the year preceding the date of qualification, subject to review and acceptance by the responsible QA organization.

2.3 Design Control NuScale has established and implements a process to control the design and design changes of items that are subject to the provisions of this QAPD. The design process includes provisions to control design inputs, outputs, changes, interfaces, records, and organizational interfaces within NuScale and with suppliers. These 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 can be related to the design input in sufficient detail to permit verification. Design change processes and the division of responsibilities for design-related activities are detailed in NuScale and supplier procedures. The design control program includes interface controls necessary to control the development, verification, approval, release, status, distribution, and revision of design inputs and outputs. Design changes and disposition of nonconforming items as use as is or repair are reviewed and approved by the NuScale design organization or by other organizations so authorized by NuScale.

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© Copyright 2023 or later by NuScale Power, LLC 15 Design documents are reviewed by individuals knowledgeable and qualified in QA through education, experience, and training to ensure the documents contain the necessary QA requirements.

2.3.1 Design Verification NuScale design processes provide for design verification to ensure that items, computer programs, and activities subject to the provisions of this QAPD are suitable for their intended application and consistent with their effect on safety. Design changes are subjected to these controls, which include verification measures commensurate with those applied to original plant design.

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. The verifier shall not have taken part in the selection of design inputs, the selection of design considerations, or the selection of a singular design approach, as applicable. This verification may be performed by the originator's supervisor provided the supervisor did not specify a singular design approach, rule out certain design considerations, and did not establish the design inputs used in the design, or if the supervisor is the only individual in the organization competent to perform the verification. If the verification is performed by the originator's supervisor, the justification of the need is documented and approved in advance by management.

The extent of the design verification required is a function of the importance to safety of the item under consideration, the complexity of the design, the degree of standardization, the state of the art, and the similarity with previously proven designs. This includes design inputs, design outputs, and design changes. 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 documented. Verification methods may include, but are not limited to, design reviews, alternative calculations, and qualification testing. Testing used to verify the acceptability of a specific design feature demonstrates acceptable performance under conditions that simulate the most adverse design conditions expected for the item's intended use.

NuScale 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 testing. Procedures are established that require identification and control of any portion of the design where verification has not been completed. When such timing cannot be achieved, the design verification is completed before relying on the item to perform its intended design or safety function.

2.3.2 Design Records NuScale maintains records sufficient to provide evidence that the design was properly accomplished. These records include the final design output and any revisions thereto, as well as records of the important design steps (e.g., calculations, analyses, and computer programs) and the sources of input that support the final output.

Plant design drawings reflect the properly reviewed and approved configuration of the plant.

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© Copyright 2023 or later by NuScale Power, LLC 16 2.3.3 Computer Application and Digital Equipment Software This QAPD governs the development, procurement, testing, maintenance, and use of computer application and digital equipment software when used in safety-related applications and designated nonsafety-related applications. Computer program acceptability is pre-verified or the results verified with the design analysis for each application. Pre-verified computer programs are controlled using a software configuration management process. NuScale and suppliers are responsible for developing, approving, and issuing procedures, as necessary, to control the use of such computer application and digital equipment software. The procedures require that the application software be assigned a proper quality classification and that the associated quality requirements be consistent with this classification. Each application software and revision thereto is documented and approved by authorized personnel. The QAP is also applicable to the administrative functions associated with the maintenance and security of computer hardware where such functions are considered essential in order to comply with other QAP requirements such as QA records.

2.3.4 Commitment In establishing its program for design control and verification, NuScale commits to compliance with NQA-1-2008 and NQA-1a-2009 addenda, Requirement 3, Sections 100 through 900, and the standards for computer software in NQA-1-2008 and NQA-1a-2009 addenda, Part II, Subpart 2.7 Quality Assurance Requirements for Computer Software for Nuclear Facility Applications and Subpart 2.14 Quality Assurance Requirements for Commercial Grade Items and Services.

2.4 Procurement Document Control NuScale has established the necessary measures and governing procedures to assure that purchased items, computer programs, and services are subject to appropriate quality and technical requirements. Procurement documents and any changes affecting the technical or quality requirements shall be subject to the same degree of control as utilized in the preparation of the original documents. These controls include the following provisions:

x If original technical or quality assurance requirements cannot be determined, an engineering evaluation is conducted and documented by qualified staff to establish appropriate requirements and controls to assure that interfaces, interchangeability, safety, fit, and function, as applicable, are not adversely affected or contrary to applicable regulatory requirements.

x Applicable technical, regulatory, administrative, quality, and reporting requirements (such as specifications, codes, standards, tests, inspections, special processes, and 10 CFR 21) are invoked for procurement of items and services. 10 CFR 21 (or other applicable international equivalent) requirements for posting, evaluating, and reporting shall be followed and imposed on suppliers when applicable. Applicable design bases and other requirements necessary to assure adequate quality shall be included or referenced in documents for procurement of items and services. To the extent necessary, procurement documents shall require suppliers to have a documented QA program that is determined to meet the applicable requirements of 10 CFR 50,

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© Copyright 2023 or later by NuScale Power, LLC 17 Appendix B. For projects governed by requirements other than 10 CFR 50 Appendix B, NuScale may utilize other controls to satisfy the governing regulatory agency or customer contract as appropriate to the circumstances of procurements. Alternatively, the supplier may work under NuScales approved QA program.

Reviews of the technical and quality requirements for inclusion in procurement documents shall be performed by personnel who have access to pertinent information and who have an adequate understanding of those requirements and their intent.

2.4.1 Commitment/Exceptions In establishing controls for procurement, NuScale commits to compliance with NQA 2008, Requirement 4, Sections 100 through 400, with the following clarifications and exceptions:

x With regard to service performed by a supplier, NuScale procurement documents may allow the supplier to work under the NuScale QAP, including implementing procedures, in lieu of the supplier having its own QAP.

x Sections 300 and 400 of Requirement 4 require the review of technical and Quality Assurance Program requirements of procurement documents prior to award of a contract and for procurement document changes (respectively). NuScale may satisfy this requirement through the review of procurement specifications when the specification contains the technical and quality assurance requirements of the procurement.

x Procurement documents for Commercial Grade Items that will be procured by NuScale for use as safety-related items shall contain technical and quality requirements such that the procured item can be appropriately dedicated in accordance with Section 2.7 of this document.

2.5 Instructions, Procedures, and Drawings NuScale has established the necessary measures and governing procedures to ensure that activities affecting quality are prescribed by, and performed in accordance with, instructions, procedures, or drawings of a type appropriate to the circumstances and which, where applicable, include quantitative or qualitative acceptance criteria to implement the QAP as described in this document. Such documents are prepared and controlled according to Section 2.6 in this document. In addition, means are provided to disseminate to the staff instructions of both general and continuing applicability, as well as those of short-term applicability. Provisions are included for reviewing, updating, and canceling such procedures.

2.5.1 Procedure Adherence NuScales policy is that procedures are followed, and the requirements for use of procedures have been established in administrative procedures. Where procedures cannot be followed as written, provisions are established for making changes in accordance with Section 2.6 in this document. Requirements are established to identify the manner in which procedures are to be implemented.

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© Copyright 2023 or later by NuScale Power, LLC 18 2.5.2 Procedure Content The established measures address the applicable content of procedures as described in Part II, Introduction, Section 402 of NQA-1-2008. Procedures governing tests, inspections, operational activities, and maintenance will include, as applicable, initial conditions and prerequisites for the performance of the activity.

2.5.3 Commitment In establishing procedural controls, NuScale commits to compliance with NQA-1-2008, Requirement 5, Section 100.

2.6 Document Control NuScale has established the necessary measures and governing procedures to control the preparation of, issuance of, and changes to documents that specify quality requirements or prescribe how activities affecting quality, including organizational interfaces, are controlled to assure that correct documents are being employed. The control systems (including electronic systems used to make documents available) are documented and provide for the following:

x identification of documents to be controlled and their specified distribution x

a method to identify the correct document (including revision) to be used and control of superseded documents x

identification of assignment of responsibility for preparing, reviewing, approving, and issuing documents x

review of documents for adequacy, completeness, and correctness prior to approval and issuance x

a method for providing feedback from users to continually improve procedures and work instructions x

coordinating and controlling interface documents and procedures The types of documents to be controlled include x

drawings x

engineering calculations x

design specifications x

purchase orders and related documents x

vendor-supplied documents x

audit, surveillance, and quality verification/inspection procedures x

inspection and test reports x

instructions and procedures for activities covered by the QAP x

technical specifications

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nonconformance reports and corrective action reports 2.6.1 Review and Approval of Documents Documents are reviewed for adequacy by qualified persons other than the preparer.

Procedures for design and installation are also reviewed by the quality group to ensure quality assurance measures have been appropriately applied. The documented review signifies concurrence. Prior to issuance or use, documents including revisions thereto, are approved by the designated authority. A listing of all controlled documents identifying the current approved revision or date is maintained so personnel can readily determine the appropriate document for use.

2.6.2 Changes to Documents Changes to documents, other than those defined in implementing procedures as minor changes, are reviewed and approved by the same organizations that performed the original review and approval, unless other organizations are specifically designated. The reviewing organization has access to pertinent background data or information upon which to base their approval. Minor changes to documents, such as inconsequential editorial corrections, do not require that the revised documents receive the same review and approval as the original documents. To avoid a possible omission of a required review, the type of minor changes that do not require such a review and approval, and the persons who can authorize such a classification shall be clearly delineated in implementing procedures.

2.6.3 Commitment In establishing provisions for document control, NuScale commits to compliance with NQA-1-2008, Requirement 6, Sections 100 through 300.

2.7 Control of Purchased Material, Equipment, and Services NuScale has established the necessary measures and governing procedures to control the procurement of items and services to assure conformance with specified requirements. Such control provides for the following, as appropriate: source evaluation and selection; evaluation of objective evidence of quality furnished by the supplier; source inspection, audit, and examination of items or services.

2.7.1 Acceptance of Items or Services NuScale establishes and implements measures to assess the quality of purchased items and services, whether purchased directly or through contractors, at intervals and to a depth consistent with the item's or service's importance to safety, complexity, quantity, and frequency of procurement. Verification actions include testing, as appropriate. Verifications occur at the appropriate phases of the procurement process, including, as necessary, verification of activities of suppliers below the first tier.

Measures to assure the quality of purchased items and services include the following, as applicable:

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Items are inspected, identified, and stored to protect against damage, deterioration, or misuse.

x Prospective suppliers of safety-related items and services are evaluated to assure that only qualified suppliers are used. Qualified suppliers are audited on a triennial basis.

The triennial period begins when an initial qualification audit is performed. If there is insufficient evidence of implementation of a QA program, the initial evaluation is of the existence of a QA program addressing the scope of services to be provided. The initial audit is performed after the supplier has completed sufficient work to demonstrate that its organization is implementing a QA program. Refer to Section 2.2 if use of a grace period is required and Section 2.7.2 for supplier audits conducted during exigent conditions. In addition, if a subsequent contract or a contract modification significantly enlarges the scope of, or changes the methods or controls for activities performed by the same supplier, an audit of the modified requirements is conducted, thus starting a new triennial period. NuScale may utilize audits conducted by outside organizations for supplier qualification provided that the scope and adequacy of the audits meet NuScale requirements. Documented annual evaluations are performed for qualified suppliers to assure they continue to provide acceptable products and services.

Industry programs such as those applied by ASME may be used as input for the basis for supplier qualification whenever appropriate. The results of the reviews are promptly considered for effect on a supplier's continued qualification and adjustments made as necessary (including corrective actions, adjustments of supplier audit plans, and input to third-party auditing entities, as warranted). In addition, results are reviewed periodically to determine if, as a whole, they constitute a significant condition adverse to quality requiring additional action.

x NuScale recognizes that the ASME Accreditation Program and associated certificates of authorization establish that the holder of the certificate of authorization has a documented QA program that meets the requirements of Appendix B to 10 CFR 50, however, NuScale requires that either audits are performed or periodic product verification testing is conducted to ensure that suppliers are effectively implementing their approved QA program.

x Provisions are made for accepting purchased items and services, such as source verification, receipt inspection, certificates of conformance, and document reviews (including Certified Material Test Report/Certificate). Acceptance actions and documents are established by the purchaser with appropriate input from the supplier and are completed to ensure that procurement, inspection, and test requirements, as applicable, have been satisfied before relying on the item to perform its intended safety function.

x Fully remote source verification may be conducted during exigent conditions due to restricted access or travel to a supplier providing the source verification is conducted in accordance with EPRI Technical Report (TR) 30020219436-A. See Section 2.7.3.2.

x Controls are imposed for the selection, determination of suitability for intended use (critical characteristics), evaluation, receipt, and acceptance of commercial grade services or items to assure they will perform satisfactorily in service in safety-related applications.

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© Copyright 2023 or later by NuScale Power, LLC 21 2.7.2 Supplier Audits During Exigent Conditions Under exigent conditions, the audit or survey interval may be extended up to 25% of the periodicity of the audit or survey when performance of such activities is not feasible.

This unique grace period can be applied if exigent conditions exist including, but not limited to:

a. a severe local or national public health concern,

b. natural disaster, severe localized or national weather conditions, or

c. a declaration of a national emergency.

Under these exigent conditions, the grace period clock reset as described in Section 2.2 of this QAPD does not apply; the audit performed within this extension period resets the triennial clock. The 25% grace period extension is applicable to domestic and international suppliers.

During the use of the 25% extension, an evaluation of the suppliers program shall be performed and the documented results used to determine any necessary adjustments to their qualification status. Suppliers on the NuScale Evaluated Supplier List (ESL) may be maintained during the 25% extension period provided the following actions (a - c) are taken and the results satisfactory:

a. Verification that:

1. the supplier is still implementing a quality assurance program that meets 10 CFR 50 Appendix B or

2. commercial suppliers surveyed are still maintaining adequate controls for activities affecting quality.

b. Monitor on-going and previous supplier performance promptly considering the impact of the following types of information:

1. Results of receipt inspection activities or other operating experience.

2. Review of supplier-furnished documents and records such as certificates of conformance, nonconformance notices, and corrective actions.

3. Results of audits and inspections from other sources (e.g., customer, NIAC audits or NRC inspections).

c. In the event of a new procurement activity or change to existing procurements that significantly extends the scope or changes the method / controls for activities performed by the supplier, the evaluation shall document the justification that the change(s) are adequately addressed by the suppliers quality assurance program or mitigating actions taken by NuScale.

2.7.3 Commitment/Exceptions 2.7.3.1 NQA-1-2008 and NQA-1a-2009 In establishing procurement verification controls, NuScale commits to compliance with NQA-1-2008 and NQA-1a-2009 addenda, Requirement 7, Sections 100 through 800, with the following clarifications and exceptions:

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NQA-1-2008, Sections 200 & 503(f)

NuScale considers that other 10 CFR 50 licensees, authorized nuclear inspection agencies, National Institute of Standards and Technology, or other state and federal agencies that may provide items or services to NuScale are not required to be evaluated or audited.

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 (MRA), commercial grade surveys need not be performed provided each of the following conditions are met, as detailed in Nuclear Energy Institute (NEI) 14-05-A, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Testing Services, Revision 1-A:

x A documented review of the suppliers accreditation is performed and includes a verification of the following:

The calibration or test laboratory holds accreditation by an accrediting body recognized by the ILAC MRA. The accreditation encompasses ISO/IEC-17025:2017, General Requirements for the Competence of Testing and Calibration Laboratories.

For procurement of calibration services, the published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.

For procurement of testing services, the published scope of accreditation for the test laboratory covers the needed testing services, including test methodology and tolerances/uncertainty.

The laboratory has achieved accreditation based on an on-site accreditation assessment by the selected Accreditation Body (AB) within the past 48 months. The laboratorys accreditation cannot be based on two consecutive remote accreditation assessments.

x The purchase documents require that

The service be provided in accordance with the suppliers accredited ISO/IEC-17025:2017 program and scope of accreditation.

As-found calibration data must be reported in the certificate of calibration when calibrated items are found to be out-of-tolerance (for calibration services only).

The equipment/standards used to perform the calibration must be identified in the certificate of calibration (for calibration services only).

Subcontracting of these accredited services is prohibited.

The customer must be notified of any condition that adversely impacts the laboratorys ability to maintain the scope of accreditation.

Additional technical and quality requirements, as necessary, based upon a review of the procured scope of services, which may include, but are not

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Performance of services is contingent on the laboratory's accreditation having been achieved through an on-site accreditation assessment by the accreditation body (AB) within the past 48 months.

x It is validated, at receipt inspection, that the laboratorys documentation certifies that

The contracted calibration or test service has been performed in accordance with their ISO/IEC-17025:2017 program and has been performed within their scope of accreditation.

The purchase order requirements are met.

In establishing commercial grade item requirements, NuScale commits to compliance with NQA-1a-2009, Requirement 7, Section 700, and Subpart 2.14.

NuScale will assume 10 CFR Part 21 reporting responsibility for commercial items and services that NuScale dedicates for use in safety-related applications.

2.7.3.2 EPRI Technical Report TR 3002019436-A In establishing a program for remote source verification during exigent conditions, NuScale commits to compliance with the screening process described in EPRI TR 3002019436-A (ML20300A386), Section 4 to determine if remote source verification is appropriate prior to conducting the activity remotely.

2.7.3.3 EPRI Technical Report TR 3002020796 In establishing a program for remote audits or surveys during exigent conditions, NuScale commits to only utilize these provisions for previously qualified suppliers to renew their qualifications, and to the EPRI TR 3002020796 screening process (ML21161A201) to determine if remote audits or surveys are appropriate and can be effectively applied to the activities, and the applicable quality and technical requirements of interest can be reviewed and or verified.

2.8 Identification and Control of Materials, Parts, and Components Prior to initiating the activities defined in this section, necessary measures and governing procedures will be established to identify and control items to prevent the use of incorrect or nonconforming items. This includes controls for consumable materials and items with limited shelf life. The identification of items is maintained throughout fabrication, erection, installation and use so that the item can be traced to its documentation, consistent with the item's effect on safety. Identification locations and methods are selected so as not to affect the function or quality of the item.

2.8.1 Commitment In establishing provisions for identification and control of items, NuScale commits to compliance with NQA-1-2008, Requirement 8, Sections 100 through 300.

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© Copyright 2023 or later by NuScale Power, LLC 24 2.9 Control of Special Processes Prior to initiating the activities defined in this section, necessary measures and governing procedures will be established to assure that special processes that require interim process controls to assure quality, such as welding, heat treating, and nondestructive examination, are controlled. These provisions include assuring that special processes are accomplished by qualified personnel using qualified procedures and equipment.

Personnel are qualified and special processes are performed in accordance with applicable codes, standards, specifications, criteria, or other specially established requirements. Special processes are those where the results are highly dependent on the control of the process or the skill of the operator, or both, and for which the specified quality cannot be fully and readily determined by inspection or test of the final product.

2.9.1 Commitment In establishing provisions for control of special processes, NuScale commits to compliance with NQA-1-2008, Requirement 9, Sections 100 through 400.

2.10 Inspection Prior to initiating the activities defined in this section, necessary measures and governing procedures will be established to implement inspections that assure items, services, and activities affecting safety meet established requirements and conform to applicable documented specifications, instructions, procedures, and design documents. Inspection may also be applied to items, services, and activities affecting plant reliability and integrity.

Types of inspections may include those verifications related to procurement, such as source, in-process, final, and receipt inspection activities. Inspections for acceptance are carried out by properly qualified persons independent of those who performed or directly supervised the work. Inspection results are documented.

2.10.1 Inspection Program When implemented, the inspection program establishes inspections (including surveillance of processes), as necessary, to verify quality x

at the source of supplied items or services x

in-process during fabrication at a supplier's facility or at a NuScale facility x

for final acceptance of fabricated and/or installed items x

upon receipt of items The inspection program establishes requirements for planning inspections, including the identification of the group or discipline responsible for performing the inspection, establishing inspection hold points, determining applicable acceptance criteria, determining the frequency of inspection to be applied, and identifying any special tools needed to perform the inspection. Inspection planning is performed by personnel qualified in the discipline related to the inspection and may include qualified inspectors or engineers. Inspection plans are based on, as a minimum, the importance of the item to the safety of the facility, the complexity of the item, technical requirements to be met, and

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© Copyright 2023 or later by NuScale Power, LLC 25 design specifications. Where significant changes in inspection activities are to occur, management responsible for the inspection programs evaluate the resource and planning requirements to ensure effective implementation of the inspection program.

Inspection program documents establish requirements for performing the planned inspections and documenting required inspection information such as rejection, acceptance, 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.

2.10.2 Inspector Qualification NuScale, suppliers and subcontractors shall, where applicable, establish a qualification program for personnel performing quality inspections. The qualification program requirements are described in Section 2.2 in this document. These qualification programs are applied to individuals performing quality inspections regardless of the functional group where they are assigned.

2.10.3 Commitment/Exceptions In establishing inspection requirements, NuScale commits to compliance with NQA 2008, Requirement 10, Sections 100 through 800 and Part II, Subparts 2.5, and 2.8 for establishing appropriate inspection requirements.

2.11 Test Control NuScale has established the necessary measures and governing procedures to demonstrate that items subject to the provisions of the QAPD will perform satisfactorily in service. These measures and governing procedures include criteria for determining when testing is required to demonstrate that performance of plant systems is in accordance with design. Tests are performed in accordance with applicable procedures that include, consistent with the effect on safety, x

instructions and prerequisites to perform the test x

use of proper test equipment x

acceptance criteria x

mandatory verification points as necessary to confirm satisfactory test completion Test results are documented and evaluated by the organization performing the test and reviewed by a responsible authority to assure that the test requirements have been satisfied. If acceptance criteria are not met, retesting is performed as needed to confirm acceptability following correction of the system or equipment deficiencies that caused the failure.

Tests are performed and results documented in accordance with applicable technical and regulatory requirements, including ensuring appropriate retention of test data in

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© Copyright 2023 or later by NuScale Power, LLC 26 accordance with the records requirements of the QAPD. Personnel who perform or evaluate tests are qualified in accordance with the requirements established in Section 2.2 in this document.

2.11.1 Commitment for non-Computer Program Testing In establishing provisions for testing, NuScale commits to compliance with NQA-1a-2009 addenda, Requirement 11, Sections 100 through 300, 500, 600 and 601.

2.11.2 Commitment for Computer Program Testing NuScale establishes and implements provisions to assure that computer software used in applications affecting safety is prepared, documented, verified, tested, and used such that the expected output is obtained and configuration control maintained. To this end, NuScale commits to compliance with the requirements of NQA-1a-2009 addenda, Requirement 11, Sections 100, 200, 400, 600 and 602, and Subpart 2.7 to establish the appropriate provisions in addition to the commitment to NQA-1-2008, Requirement 3.

2.12 Control of Measuring and Test Equipment NuScale has established the necessary measures and governing procedures to control the calibration, maintenance, and use of Measuring and Test equipment (M&TE) that provide data to verify acceptance criteria are met or information important to safe plant operation. The provisions of such procedures cover equipment such as indicating and actuating instruments and gauges, tools, reference and transfer standards, and nondestructive examination equipment. The suppliers of commercial grade calibration services are controlled as described in Section 2.7 in this document.

2.12.1 Commitment/Exceptions In establishing provisions for control of M&TE, NuScale commits to compliance with NQA-1-2008, Requirement 12, Sections 100 through 400, with the following clarification and exception:

x The out of calibration conditions described in Section 303.2 refers to when the M&TE is found to be out of the required accuracy limits (i.e., out of tolerance) during calibration and not overdue for calibration.

x Measuring and test equipment are not required to be marked with the calibration status, as described in Section 303.6, where it is impossible or impractical due to equipment size or configuration (such as the label will interfere with operation of the device) provided the required information is maintained in suitable documentation traceable to the device. This exception also applies to the calibration labeling requirement stated in NQA-1-2008, Subpart 2.4 (See Section 7.2.1 of ANSI/IEEE Std. 336-1985).

2.13 Handling, Storage, and Shipping Prior to initiating the activities defined in this section, necessary measures and governing procedures will be established to control the handling, storage, packaging, shipping, cleaning, and preservation of items to prevent inadvertent damage or loss, and to minimize

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© Copyright 2023 or later by NuScale Power, LLC 27 deterioration. These provisions include specific procedures, when required to maintain acceptable quality of the items important to the safe operations of the plant. Items are appropriately marked and labeled during packaging, shipping, handling and storage to identify, maintain, and preserve the item's integrity and indicate the need for special controls. Special controls (such as containers, shock absorbers, accelerometers, inert gas atmospheres, specific moisture content levels, and temperature levels) are provided when required to maintain acceptable quality.

Special or additional handling, storage, shipping, cleaning and preservation requirements are identified and implemented as specified in procurement documents and applicable procedures. Where special requirements are specified, the items and containers (where used) are suitably marked.

Special handling tools and equipment are used and controlled as necessary to ensure safe and adequate handling. Special handling tools and equipment are inspected and tested in accordance with procedure at specified time intervals, or prior to use.

Operators of special handling and lifting equipment are experienced or trained in the use of the equipment. Where required, NuScale complies with applicable hoisting, rigging, and transportation regulations and codes.

2.13.1 Housekeeping Housekeeping practices are established to account for conditions or environments that could affect the quality of structures, systems, and components. This includes control of cleanliness of facilities and materials, fire prevention and protection, disposal of combustible material and debris, control of access to work areas, and protection of equipment. Housekeeping practices help assure that only proper materials, equipment, processes, and procedures are used and that the quality of items is not degraded.

Necessary procedures or work instructions are developed and used.

2.13.2 Commitment In establishing provisions for handling, storage, and shipping, NuScale commits to compliance with NQA-1-2008, Requirement 13, Sections 100 through 600.

2.14 Inspection, Test, and Operating Status Prior to initiating the activities defined in this section, necessary measures and governing procedures will be established to identify the inspection, test, and operating status of items and components subject to the provisions of the QAPD in order to maintain personnel and reactor safety and avoid inadvertent operation of equipment. Where necessary to preclude inadvertent bypassing of inspections or tests, or to preclude inadvertent operation, these measures require the inspection, test, or operating status be verified before release, fabrication, receipt, installation, test, or use. These measures also establish the necessary authorities and controls for the application and removal of status indicators or labels.

In addition, temporary design changes (temporary modifications), such as temporary bypass lines, electrical jumpers and lifted wires, and temporary trip-point settings, will be

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© Copyright 2023 or later by NuScale Power, LLC 28 controlled by procedures that include requirements for appropriate installation and removal, independent/concurrent verifications, and status tracking.

Administrative procedures will also describe the measures taken to control altering the sequence of required tests, inspections, and other operations. Review and approval for these actions is subject to the same control as taken during the original review and approval of tests, inspections, and other operations.

2.14.1 Commitment In establishing measures for control of inspection, test, and operating status, NuScale commits to compliance with NQA-1-2008, Requirement 14, Section 100.

2.15 Nonconforming Materials, Parts, or Components NuScale has established the necessary measures and governing procedures to control items, including services, that do not conform to specified requirements to prevent inadvertent use. Instructions require that the individual discovering a nonconformance identify, describe, and document the nonconformance, including use of the corrective action program. Controls provide for identification, documentation, evaluation, segregation (when practical), disposition of nonconforming items, and notification to affected organizations. Controls are provided to address conditional release of nonconforming items for use on an at-risk basis prior to resolution and disposition of the nonconformance, including maintaining identification of the item and documenting the basis for such release.

Conditional release of nonconforming items requires the approval of management.

Nonconformances are corrected or resolved before relying on the item to perform its intended safety function. Nonconformances are evaluated for impact on operability of safety-related structures, systems, and components to assure that the final condition does not adversely affect safety, operation, or maintenance of the item or service.

Nonconformances to design requirements, dispositioned repair, or use-as-is are subject to design control measures commensurate with those applied to the original design.

Nonconformance dispositions are reviewed for adequacy, analysis of quality trends, and reports provided to the designated management. Significant trends are reported to management in accordance with NuScale procedures, regulatory requirements, and industry standards.

2.15.1 Interface with the Reporting Program NuScale has appropriate interfaces between the QAP for identification and control of nonconforming items, including services, and the reporting programs to satisfy the requirements of 10 CFR 50, 10 CFR 52, and 10 CFR 21. NuScale will develop appropriate reporting mechanisms when different regional, national, or international reporting requirements apply.

2.15.2 Commitment In establishing measures for nonconforming items, including services, NuScale commits to compliance with NQA-1-2008, requirement 15, Sections 100 through 400.

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© Copyright 2023 or later by NuScale Power, LLC 29 2.16 Corrective Action NuScale has established the necessary measures and governing procedures to promptly identify, control, document, classify, correct and verify conditions adverse to quality.

NuScale procedures assure that corrective actions are documented and initiated following the determination of conditions adverse to quality in accordance with regulatory requirements and applicable quality standards. NuScale procedures require personnel to identify known conditions adverse to quality. When complex issues arise where it cannot be readily determined if a condition adverse to quality exists, NuScale documents establish the requirements for documentation and timely evaluation of the issue. Reports of conditions adverse to quality are analyzed to identify trends. Significant conditions adverse to quality and significant adverse trends are documented and reported to 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 working on safety-related activities, or other similar situations, NuScale may delegate specific responsibilities for corrective actions, but NuScale maintains responsibility for the effectiveness of corrective action measures.

2.16.1 Interface with the Reporting Program NuScale has appropriate links between the implementing procedures of the QAP for corrective actions and the reporting procedures to satisfy the requirements of 10 CFR 50, 10 CFR 52, and 10 CFR 21. NuScale will develop appropriate reporting mechanisms when different regional, national, or international reporting requirements apply.

2.16.2 Commitment In establishing provisions for corrective action, NuScale commits to compliance with NQA-1-2008, Requirement 16, Section 100.

2.17 Quality Assurance Records NuScale 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. The provisions of such procedures establish the scope of the records retention program for NuScale and include requirements for records administration including receipt, preservation, retention, storage, safekeeping, retrieval, access controls, user privileges, and final disposition.

2.17.1 Record Retention Measures are established that ensure that sufficient records of completed items and activities affecting quality are appropriately stored. Records of activities for design, engineering, procurement, inspection, test, and audits and their retention times are defined in appropriate procedures. The records and retention times are based on Regulatory Position C.1 of Regulatory Guide 1.28, Revision 4, and NQA-1a-2009 addenda, Part III, Subpart 3.1 for Nonmandatory Appendix 17A-1, Section 200 as applicable. In all cases where state, local, or other regulatory agencies have more restrictive requirements for record retention, those requirements will be met.

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© Copyright 2023 or later by NuScale Power, LLC 30 2.17.2 Electronic Records When using optical disks for electronic records storage and retrieval systems, NuScale complies with the NRC guidance in Generic Letter 88-18, Plant Record Storage on Optical Disks.

For the management of electronic records, appropriate controls on quality assurance include the following:

(a) No deletion or modification of records unless authorized pursuant to the record retention rule (b) Redundancy (system backup, dual storage, etc.) is provided (c) Legibility is required of each record (d) Records media are properly maintained (e) Inspections to ensure no degradation of records (f) Records are acceptably converted into any new system before the old system is taken out of service 2.17.3 Commitment In establishing provisions for records, NuScale commits to compliance with NQA-1-2008, Requirement 17, Sections 100 through 800 with the following clarifications:

NuScale manages the storage of QA Records in electronic media consistent with the intent of RIS 2000-18 and associated Nuclear Information and Records Management Association (NIRMA) technical guides TG 11-2011, TG 15-2011, TG 16-2011, and TG 21-2011.

2.18 Audits NuScale has established the necessary measures and governing procedures to implement audits to verify that activities covered by the QAPD are performed in conformance with the requirements established. The audit programs are reviewed for effectiveness as a part of the overall audit process.

2.18.1 Performance of Audits Audits are conducted according to a formal, preplanned audit schedule. The audit system is reviewed periodically and revised as necessary to assure coverage commensurate with current and planned activities. Additional audits may be performed as deemed necessary by management. The scope of an audit is determined by the quality status and safety importance of the activities being performed. These audits are conducted by trained personnel not having direct responsibilities in the area being audited and in accordance

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© Copyright 2023 or later by NuScale Power, LLC 31 with preplanned and approved audit plans or checklists, under the direction of a qualified lead auditor and the cognizance of NuScale Quality Assurance management.

Quality Assurance management is responsible for conducting periodic internal and external audits. Internal audits are conducted to determine the adequacy of programs and procedures (by representative sampling), and to determine if they are meaningful and comply with the overall QAP. External audits determine the adequacy of supplier and contractor quality assurance programs. Audit reports are issued to the management of the audited organization and applicable NuScale management.

Audits of suppliers of safety-related components and/or services are conducted as described in Section 2.7.1 in this document. In the event of exigent conditions, Section 2.7.2 may also apply.

2.18.2 Internal Audits Internal audits should be performed in such a manner as to assure that an audit of all applicable QA program elements is completed for each functional area at least once each year or at least once during the life of the activity, whichever is shorter. In determining the scope of an audit, an evaluation of the activity being audited may be useful. The evaluation may include results of previous QA program audits and the results of audits from other sources, including the nature and frequency of identified deficiencies and any significant changes in personnel, the organization, or the QA program.

Internal audits include verification of compliance and effectiveness of the administrative controls established for implementing the requirements of the QAPD. These include regulations; provisions for training, retraining, qualification, and performance of personnel performing activities covered by the QAP; and observation of the performance of activities including associated recordkeeping.

Results of internal audits are reported to applicable Executive and responsible function management, as appropriate.

Management responds to all audit findings and initiates corrective action when determined necessary. When corrective action measures are determined to be necessary, documented follow-up of applicable areas through inspections, reviews, re-audits, or other appropriate means is conducted to verify implementation and effectiveness of corrective actions.

2.18.3 Commitment In establishing the independent audit program, NuScale commits to compliance with NQA-1-2008, Requirement 18, Sections 100 through 800.

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© Copyright 2023 or later by NuScale Power, LLC 32 3.0 Part III - Quality Assurance Program Controls for Nonsafety-Related Structures, Systems, and Components 3.1 Nonsafety-Related Structures, Systems, and, ComponentsSignificant Contributors to Plant Safety Specific QA program controls are applied to nonsafety-related SSCs that are significant contributors to plant safety, but are not subject to 10 CFR 50, Appendix B. The specific program controls consistent with applicable sections of this QAPD are applied to those items in a selected manner and targeted at those characteristics or critical attributes that render the SSC a significant contributor to plant safety.

The following clarify the applicability of the QA Program to the nonsafety-related SSC and related activities, including the identification of exceptions to the QA Program for nonsafety-related SSC that are described in Sections 2.1 through 2.18 of this document.

3.1.1 Organization The verification activities described in this section may be performed by the NuScale line organization. The QA organization described in Section 2.1 is not required to perform these functions.

3.1.2 Quality Assurance Program NuScale QA requirements for nonsafety-related SSCs are established in this QAPD and appropriate procedures. Suppliers of these SSCs or related services describe the quality controls applied in appropriate procedures. A new or separate QA program is not required.

3.1.3 Design Control NuScale has design control measures to ensure that the established design requirements are included in the design. These measures ensure that applicable design inputs are included or correctly translated into the design documents and deviations from those requirements are controlled. Design verification is provided through the normal supervisory review of the designer's work.

3.1.4 Procurement Document Control Procurement documents for items and services obtained by or for NuScale include or reference documents describing applicable design bases, design requirements, and other requirements necessary to ensure component performance. The procurement documents are controlled to address deviations from the specified requirements.

3.1.5 Instructions, Procedures, and Drawings NuScale provides documents such as, but not limited to, written instructions, plant procedures, drawings, vendor technical manuals, and special instructions in work orders to direct the performance of activities affecting quality. The method of instruction employed provides an appropriate degree of guidance to the personnel performing the activity to achieve acceptable functional performance of the SSC.

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© Copyright 2023 or later by NuScale Power, LLC 33 3.1.6 Document Control NuScale controls the issuance and change of documents that specify quality requirements or prescribe activities affecting quality to ensure that correct documents are used. These controls include review and approval of documents, identification of the appropriate revision for use, and measures to preclude the use of superseded or obsolete documents.

3.1.7 Control of Purchased Items and Services NuScale employs measures, such as inspection of items or documents upon receipt or acceptance testing, to ensure that all purchased items and services conform to appropriate procurement documents.

3.1.8 Identification and Control of Purchased Items NuScale will employ measures where necessary, to identify purchased items and preserve their functional performance capability. Storage controls take into account appropriate environmental, maintenance, or shelf-life restrictions for the items.

3.1.9 Control of Special Processes NuScale will employ process and procedure controls for special processes, including welding, heat treating, and nondestructive testing. These controls are based on applicable codes, standards, specifications, criteria, or other special requirements for the special process.

3.1.10 Inspection NuScale requires use of documented instructions to ensure necessary inspections are performed to verify conformance of an item or activity to specified requirements or to verify that activities are satisfactorily accomplished. These inspections may be performed by knowledgeable personnel in the line organization. Knowledgeable personnel can be from the same discipline and have experience related to the work being inspected.

3.1.11 Test Control NuScale employs measures to identify required testing that demonstrates that equipment conforms to design requirements. These tests are performed in accordance with test instructions or procedures. The test results are recorded, and authorized individuals evaluate the results to ensure that test requirements are met.

3.1.12 Control of Measuring and Test Equipment NuScale employs measures to control M&TE use, calibration, and adjustment at specific intervals or prior to use.

3.1.13 Handling, Storage, and Shipping NuScale will employ measures to control the handling, storage, cleaning, packaging, shipping, and preservation of items to prevent damage or loss and to minimize

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3.1.14 Inspection, Test, and Operating Status NuScale employs measures to identify items that have satisfactorily passed required tests and inspections and to indicate the status of inspection, test, and operability as appropriate.

3.1.15 Control of Nonconforming Items NuScale employs measures to identify and control items that do not conform to specified requirements to prevent their inadvertent installation or use.

3.1.16 Corrective Action NuScale employs measures to ensure that failures, malfunctions, deficiencies, deviations, and nonconformances are properly identified, reported, and corrected.

3.1.17 Records NuScale employs measures to ensure records are prepared and maintained to furnish evidence that the above requirements for design, procurement, document control, inspection, and test activities have been met.

3.1.18 Audits NuScale employs measures for line management to periodically review and document the adequacy of processes, including taking any necessary corrective action. Audits independent of line management are not required. Line management is responsible for determining whether reviews conducted by line management or audits conducted by any organization independent of line management are appropriate. If performed, audits are conducted and documented to verify compliance with design and procurement documents, instructions, procedures, drawings, and inspection and test activities. Where the measures of this section (Section 3.0) are implemented by the same programs, processes, or procedures as the comparable activities of Section 2.0, the audits performed under the provisions of Section 2.0 may be used to satisfy the review requirements of this section (Section 3.1.18).

3.2 Nonsafety-Related Structures, Systems, and Components Credited for Regulatory Events The following criteria apply to fire protection (10 CFR 50.48), anticipated transients without scram (ATWS) (10 CFR 50.62), and the station blackout (SBO) (10 CFR 50.63) SSCs that are not safety-related:

x NuScale implements quality requirements for the fire protection system in accordance with Regulatory Position 1.7, Quality Assurance, in Regulatory Guide 1.189, Revision 4, Fire Protection for Operating Nuclear Power Plants.

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NuScale implements the quality requirements for ATWS equipment in accordance with Generic Letter 85-06, Quality Assurance Guidance for ATWS Equipment That Is Not Safety Related.

x NuScale implements quality requirements for SBO equipment in 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 Nonsafety Systems and Equipment, in Regulatory Guide 1.155, Revision 0, August 1988, Station Blackout.

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© Copyright 2023 or later by NuScale Power, LLC 36 4.0 Part IV - Regulatory and Other Commitments 4.1 US Nuclear Regulatory Commission (US NRC) Regulatory Guides and Quality Assurance Standards This section identifies the US NRC Regulatory Guides (RG) and the other quality assurance standards that have been selected to supplement and support the NuScale QAP. NuScale complies with these standards to the extent described or referenced in the Scope/Applicability Section 1.1.1. Full evaluation of conformance with the guidance in NRC RGs in effect six months prior to the submittal date of an application is described within Chapter 1 of the NuScale Final Safety Analysis Report (FSAR) associated with that application.

Commitment to a particular RG or standard does not constitute a commitment to other RGs or standards that may be referenced therein. Additional standards may be referenced, or commitments specified in project specific quality plans and implementing procedures.

Regulatory Guides 4.1.1 US NRC Regulatory Guide 1.164, Revision 0, Dedication of Commercial Grade Items for Use in Nuclear Power Plants 4.1.2 US NRC Regulatory Guide 1.231, Revision 0, Acceptance of Commercial Grade Design and Analysis Computer Programs Used in Safety-Related Applications for Nuclear Power Plants 4.1.3 US NRC Regulatory Guide 1.234, Revision 0, Evaluating Deviations and Reporting Defects and Noncompliance Under 10 CFR Part 21 4.1.4 US NRC Regulatory Guide 1.26, Revision 6, Quality Group Classifications and Standards for Water-, Steam-, and Radioactive-Waste-Containing Components of Nuclear Power Plants Regulatory Guide 1.26, Revision 6 defines classification of systems and components.

The NuScale power plant design is unique in configuration and safety feature functions.

The design includes components not found in existing standard design reactors (e.g.,

containment pressure vessel) and does not include some components found in existing standard designs. Examples of features not found in the NuScale design include, but are not limited to, reactor coolant pumps, cold legs, hot legs, pressurizer surge line, core make-up tanks and piping, direct vessel injection lines, passive residual heat removal heat exchangers, and in-containment storage tanks. These unique design features and the equivalence of their design safety functions, including application to committed regulatory guidance, will be detailed in Chapter 3 of the FSAR.

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Regulatory Guide 1.28, Revision 4 describes a method acceptable to the NRC staff for complying with the provisions of 10 CFR 50, Appendix B with regard to establishing and implementing the requisite quality assurance program for the design of nuclear power plants.

4.1.6 US NRC Regulatory Guide 1.29, Revision 6, Seismic Design Classification Regulatory Guide 1.29, Revision 6 defines systems required to withstand a safe shutdown earthquake.

Quality Assurance Standards 4.1.7 American Society of Mechanical Engineers (ASME) NQA-1-2008 and NQA-1a-2009 addenda editions, New York, NY, Quality Assurance Requirements for Nuclear Facility Applications NuScale commits to NQA-1-2008 and NQA-1a-2009 addenda, Parts I and II as described in Section 2.0 in this document with specific identification of exceptions or clarification. NuScale commits to NQA-1-2008 with NQA-1a-2009 addenda, Part III only as specifically noted in Section 2.0 of this document.

4.2 Other Reference Documents 4.2.1 Nuclear Information and Records Management Association, Inc. (NIRMA) Technical Guides (TGs) as endorsed by Regulatory Guide 1.28, Revision 5.

4.2.1.1 TG-11, 2011 Edition, Authentication of Records and Media 4.2.1.2 TG-15, 2011 Edition, Management of Electronic Records 4.2.1.3 TG-16, 2011 Edition, Software Configuration Management and Quality Assurance 4.2.1.4 TG-21, 2011 Edition, Electronic Records Protection and Restoration 4.2.2 ISO/IEC 17025, 2017 Edition, General requirements for the competence of testing and calibration laboratories 4.2.3 EPRI Technical Report TR 3002019436-A, Remote Source Verification During a Pandemic or Similar State of Emergency - Screening Criteria and Process Guidance 4.2.4 EPRI Technical Report TR 3002020796, Remote Assessment Techniques: Planning and Conducting Audits and Surveys Using Remote Techniques During Exigent Conditions EPRI Technical Report TR 3002020796 was approved for use by the US NRC via Safety Evaluation Report (SER) (Accession No. ML21161A201).

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© Copyright 2023 or later by NuScale Power, LLC 38 4.2.5 GL 89-02, Actions to Improve the Detection of Counterfeit and Fraudulently Marked Products 4.2.6 GL 91-05, Licensee Commercial Grade Dedication Programs NOTE: Additional standards may be referenced, or commitments specified in customer or project specific project quality plans and implementing procedures.

ML23192A280

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SUBJECT:

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