ML26048A290
| ML26048A290 | |
| Person / Time | |
|---|---|
| Site: | Kewaunee, 99902159  |
| Issue date: | 02/17/2026 |
| From: | Hazelhoff A EnergySolutions |
| To: | Office of Nuclear Reactor Regulation, Document Control Desk |
| References | |
| ES-RA-2026-011 | |
| Download: ML26048A290 (0) | |
Text
February 17, 2026 ES-RA-2026-011 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555-0001
Subject:
Topical Report Quality Assurance Program Description for the EnergySolutions Kewaunee New Nuclear Initiative - Project No. 99902159 This letter transmits the subject topical report which provides the Quality Assurance Program Description (QAPD) being applied to the EnergySolutions Kewaunee New Nuclear Initiative (KNNI). This topical report provides a description of the EnergySolutions 10 CFR 50, Appendix B, QAPD for the site-selection, design, construction, and decommissioning of nuclear plant(s) at multiple sites and projects.
EnergySolutions developed this QAPD consistent with the Nuclear Energy Institute (NEI)11-04A, Nuclear Generation Quality Assurance Program Description, template.
EnergySolutions made departures from the NEI template as necessary to conform with the Nuclear Regulatory Commission (NRC) Regulatory Guide 1.28, Revision 6, endorsement of NQA-1-2022. Excluded from the QAPD scope is nuclear power plant operation.
EnergySolutions does not plan to be the Operator for nuclear power plants and as such would require an Operational Phase partner to provide the Operational Phase Quality Assurance Program as part of an application which is outside the scope of this QAPD.
EnergySolutions does not intend to replace its existing NRC-approved QA Program for 10 CFR 71 Licensed activities, or the NRC-approved Decommissioning Quality Assurance Plans (DQAP) at either the Kewaunee Power Station or Three Mile Island Unit 2 with this QAPD as part of this submittal.
This topical report is provided for NRC review and approval and will be referenced in future license applications by EnergySolutions. The scope and schedule for submitting this report was discussed in a public pre-submittal meeting with the NRC staff on February 9, 2026.
EnergySolutions is actively developing a significant licensing action application for the Kewaunee Power Station site in the Town of Carlton, Kewaunee County, Wisconsin. In support of the application submittal, EnergySolutions requests the Staff's review be complete by December 31, 2026, so that the Quality Assurance Program Description can be included by reference.
There are no regulatory commitments associated with this submittal.
Page 2 ES-RA-2026-011 Please feel free to contact Mr. Joe Lynch, Regulatory Affairs/Licensing Director (D&D),
should you require any additional information or if you have any questions concerning this submittal, at jrlynch@energysolutions.com or (508) 728-1421.
Respectfully, Amy C. Hazelhoff Senior Vice President (SVP) Regulatory Affairs EnergySolutions
- EnergySolutions 10 CFR 50, Appendix B, Quality Assurance Program Description cc:
NRC Regional Administrator - Region III Chief, Licensing and Regulatory Infrastructure Branch - Michelle Hayes Chief, Quality Assurance and Vendor Inspection Branch - Doug Bollock NRC Project Manager - KNNI - Carolyn Lauron Amy C Hazelhoff Digitally signed by Amy C Hazelhoff Date: 2026.02.17 12:59:37
-05'00'
58 Pages Follow EnergySolutions 10 CFR 50, Appendix B Quality Assurance Program Description
Electronic documents, once printed, are uncontrolled and may become outdated.
Refer to the Intranet or the Document Control authority for the correct revision.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Title Signature and Date Authored By:
EnergySolutions Quality Assurance Manager Reviewed By:
EnergySolutions Group Director Quality Assurance Approved By:
EnergySolutions President D&D and Chief Projects Officer Approved By:
EnergySolutions Chief Operating Officer Approved By:
EnergySolutions Senior Vice President Regulatory Affairs Approved By:
EnergySolutions President and Chief Executive Officer Effective Date:
l T
Digitally signed by Michael T. Janus DN: OU=Quality Assurance, O=Quality Assurance, CN=
Michael T. Janus, E=mtjanus@energysolutions.com Reason: I am the author of this document Location:
Date: 2025.08.25 16:23:15-04'00' Foxit PDF Editor Version: 12.0.1 Michael T.
Janus Christopher A. Boschetti Digitally signed by Christopher A. Boschetti DN: dc=com, dc=energysolutions, ou=North America, ou=Users, ou=CHNC, cn=Christopher A. Boschetti, email=caboschetti@energysolutions.com Date: 2025.08.25 16:42:13 -04'00' Digitally signed by Charles Jeff Richardson Date: 2025.10.20 15:55:09 -04'00' Amy C. Hazelhoff Digitally signed by Amy C. Hazelhoff Date: 2025.10.22 13:05:06 -04'00' 10/30/25 10/30/25 11/4/2025
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 ii REVISION HISTORY REVISION NUMBER CHANGES IMPLEMENTED 0
Initial Revision
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 iii EXECUTIVE
SUMMARY
This topical report provides a description of the EnergySolutions (ES) 10 CFR 50 Appendix B Quality Assurance Program Document (QAPD) for the site-selection, design, construction, and decommissioning of nuclear plant(s) at multiple sites and projects. Excluded from this QAPD scope is nuclear plant operation.
This QAPD applies to ES and any wholly or partially-owned subsidiary, affiliate, or partnership engaged in activities requiring compliance with the requirements of 10 CFR 50 Appendix B.
The QAPD has been prepared in accordance 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-1-2022, Quality Assurance Requirements for Nuclear Facility Applications as endorsed by Regulatory Guide (RG) 1.28, Revision 6, Quality Assurance Program Criteria (Design and Construction).
Additionally, this topical report considered the guidance in NUREG-0800, Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition, Section 17.5; NUREG 1757, Consolidated Decommissioning Guidance, NUREG-2215, Standard Review Plan for Spent Fuel Dry Storage Systems and Facilities, Chapter 15; and NUREG 2216, Standard Review Plan for Transportation Packages for Spent Fuel and Radioactive Material, Chapter 10.
This topical report is based on the Nuclear Energy Institute (NEI)11-04A, Nuclear Generation Quality Assurance Program Description template. This template is based upon RG 1.28 Revision 4 and ASME NQA-1-2008/2009a. Departures from the NEI 11-04A template were necessary in some instances to conform to the Nuclear Regulatory Commission endorsement of NQA-1-2022 in RG 1.28, Revision 6, and the addressing of other quality standards (e.g., 10 CFR 830 Subpart A & DOE O 414.1D).
Consistent with common licensing practice, text is written in the present tense, active voice, including discussions of activities and processes associated with a phased implementation of design, and construction.
In accordance with the NEI 11-04A template, this topical report is divided into four parts:
I. Introduction and Scope II. Quality Assurance Program Description (QAPD) Details III. Non-safety-Related Structures, Systems, and Components (SSC) Quality Control IV. Regulatory Commitments The fifth part in the template, Additional QA and Administrative Controls for the Plant Operational Phase, was excluded since the Operational Phase for a nuclear plant us not included in the scope of this QAPD.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 iv This topical report will be used to satisfy quality assurance requirements for use by ES nuclear power plant applications submitted in accordance with 10 CFR 50 and 10 CFR 52 as follows:
Limited Work Authorizations (LWA) pursuant to 10 CFR 50.10(d)(3)(i)
Construction Permit (CP) Applications pursuant to 10 CFR 50.34(a)(7)
Early Site Permit (ESP) Applications pursuant to 10 CFR 52.17(a)(1)(xi)
Combined Operating License Applications (COLAs)* pursuant to 10 CFR 52.79(a)(25)
- ES does not plan to be the Operator for nuclear plants and as such would require an Operational Phase partner to provide the Operational Phase Quality Assurance Program as part of the application which is outside the scope of this QAPD.
In addition, this topical report may be used by ES as allowed by regulations to satisfy the quality assurance requirements for the Packaging and Transportation of Radioactive Material in accordance with 10 CFR 71 (§ 71.101(f)), the Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reactor-Related Greater than Class C Waste in accordance with 10 CFR 72 (§ 72.140(d)), Licensing Requirements for Land Disposal of Radioactive Waste in accordance with 10 CFR 61
(§61.12(j)), the quality assurance requirements for the Transfer of Low Level Radioactive Waste Intended for Disposal at Licensed Land Disposal Facilities and Manifests in accordance with 10 CFR 20 Appendix G, and providing items and services to DOE nuclear facilities in accordance with 10 CFR 830 Subpart A, and DOE Order 414.1D requirements.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 v
ACRONYMS AND ABBREVIATIONS Acronym Definition AE Architect/Engineer ANS American Nuclear Society ASL Approved Suppliers List ASME The American Society of Mechanical Engineers ATWS Anticipated Transient Without Scram CFR Code of Federal Regulations COL Combined Operating License COLA Combined Operating License Application CP Construction Permit ES EnergySolutions ESP Early Site Permit FSAR Final Safety Analysis Report ILAC International Laboratory Accreditation Cooperation ISO International Organization for Standardization ITAAC Inspection, Tests, Analysis, Acceptance Criteria ITS Important to Safety LWA Limited Work Authorization M&TE Measuring and Test Equipment MRA Mutual Recognition Agreement NEI Nuclear Energy Institute NIAC Nuclear Industry Assessment Corporation NIRMA Nuclear Information and Records Management Association NITS Not Important to Safety NRC Nuclear Regulatory Commission NSSS Nuclear Steam Supply System NUPIC Nuclear Procurement Issues Corporation OL Operating License QA Quality Assurance QAP Quality Assurance Program QAPD Quality Assurance Program Description QAPIP Quality Assurance Program Implementation Plan QC Quality Control RG Regulatory Guide RIS Regulatory Issues Summary SBO Station Blackout SDA Standard Design Approval SMR Small Modular Reactor SSC Structures, Systems, and Components
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 vi POLICY STATEMENT EnergySolutions (ES) shall license, design, procure, construct, and decommission nuclear plants in a manner that will ensure the health and safety of the public and workers. These activities shall be performed in compliance with the requirements of the Code of Federal Regulations (CFR), the applicable Nuclear Regulatory Commission (NRC) Facility Operating License[s] and applicable laws and regulations of the state and local governments. This policy statement is consistent with the overall ES quality policy signed by ES top management.
The ES 10 CFR 50 Appendix B Quality Assurance Program (QAP) is comprised of the Quality Assurance Program Description (QAPD) provided in this document and the associated implementing documents. Together they provide for control of ES 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 where other NRC regulations or guidance establish quality assurance program requirements.
The QAPD is the top-level policy document that establishes the manner in which quality is to be achieved and presents ESs 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 effective implementation of the quality assurance program and is responsible for obtaining the desired outcomes. Compliance with the QAPD and implementing documents is mandatory for personnel directly or indirectly associated with implementation of the ES QAP.
Signed Ken Robuck President and Chief Executive Officer EnergySolutions Date: 10/30/2025
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 1 of 52 TABLE OF CONTENTS EXECUTIVE
SUMMARY
....................................................................................................................... iii ACRONYMS AND ABBREVIATIONS................................................................................................... v POLICY STATEMENT............................................................................................................................ vi PART I INTRODUCTION................................................................................................................... 4 SECTION 1 GENERAL.................................................................................................................... 4 1.1 Scope/Applicability................................................................................................................... 4 PART II QAPD DETAILS..................................................................................................................... 6 SECTION 1 ORGANIZATION......................................................................................................... 6 1.1 EnergySolutions President and Chief Executive Officer (CEO)........................................... 6 1.2 EnergySolutions Chief Operating Officer (COO).................................................................. 6 1.2.1 EnergySolutions President Decommissioning & Decontamination (D&D) and Chief Projects Officer (CPO).............................................................................................................. 6 1.2.1.1 EnergySolutions Executive for Nuclear Development.......................................................... 7 1.2.2 EnergySolutions President Waste Management................................................................... 7 1.2.3 EnergySolutions President Nuclear Services......................................................................... 7 1.3 EnergySolutions Chief Financial Officer (CFO)..................................................................... 7 1.4 EnergySolutions Chief Administrative Officer....................................................................... 7 1.5 Quality Assurance Organization............................................................................................. 7 1.5.1 EnergySolutions Senior Vice President Regulatory Affairs.................................................. 8 1.5.2 Group Director Quality Assurance......................................................................................... 8 1.5.3 Quality Assurance Manager.................................................................................................... 8 1.6 General Counsel....................................................................................................................... 8 1.7 Corporate Director Health and Safety.................................................................................... 8 1.8 Nuclear Steam Supply System (NSSS) Supplier....................................................................... 8 1.9 Architect/Engineering (A/E) Supplier................................................................................... 9 1.10 Authority to Stop Work............................................................................................................ 9 1.11 QA Organizational Independence........................................................................................... 9 1.12 NQA-1 Commitment................................................................................................................. 9 Figure II.1-1........................................................................................................................................ 10 SECTION 2 QUALITY ASSURANCE PROGRAM...................................................................... 11 2.1 Responsibilities....................................................................................................................... 13 2.2 Delegation of Work................................................................................................................. 13 2.3 Site-specific Safety-Related Design Basis Activities........................................................... 13 2.4 Periodic Review of the Quality Assurance Program............................................................ 13 2.5 Issuance and Revision to Quality Assurance Program....................................................... 14 2.6 Personnel Training and Qualifications................................................................................. 14 2.7 NQA-1 Commitment / Exceptions......................................................................................... 15 SECTION 3 DESIGN CONTROL.................................................................................................. 16 3.1 Design Verification................................................................................................................. 16 3.2 Design Records........................................................................................................................ 17 3.3 Computer Application and Digital Equipment Software.................................................... 18
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 2 of 52 3.4 Setpoint Control...................................................................................................................... 18 3.5 Interface Control.................................................................................................................... 18 3.6 NQA-1 Commitment............................................................................................................... 19 SECTION 4 PROCUREMENT DOCUMENT CONTROL........................................................... 20 4.1 NQA-1 Commitment / Exceptions......................................................................................... 20 SECTION 5 INSTRUCTIONS, PROCEDURES, AND DRAWINGS.......................................... 22 5.1 Procedure Adherence............................................................................................................. 22 5.2 Procedure Content.................................................................................................................. 22 5.3 NQA-1 Commitment............................................................................................................... 22 SECTION 6 DOCUMENT CONTROL.......................................................................................... 23 6.1 Review and Approval of Documents..................................................................................... 24 6.2 Changes to Documents........................................................................................................... 24 6.3 NQA-1 Commitment............................................................................................................... 24 SECTION 7 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES..... 25 7.1 Acceptance of Item or Service............................................................................................... 25 7.2 NQA-1 Commitment / Exceptions......................................................................................... 26 SECTION 8 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS......................................................................................................... 28 8.1 NQA-1 Commitment.............................................................................................................. 28 SECTION 9 CONTROL OF SPECIAL PROCESSES.................................................................. 29 9.1 NQA-1 Commitment.............................................................................................................. 29 SECTION 10 INSPECTION............................................................................................................ 30 10.1 Inspection Program................................................................................................................ 30 10.2 Inspector Qualification.......................................................................................................... 30 10.3 NQA-1 Commitment / Exceptions......................................................................................... 31 SECTION 11 TEST CONTROL....................................................................................................... 32 11.1 NQA-1 Commitment for Computer Program Testing........................................................... 32 11.2 NQA-1 Commitment............................................................................................................... 32 SECTION 12 CONTROL OF MEASURING AND TEST EQUIPMENT...................................... 33 12.1 Installed Instrument and Control Devices........................................................................... 33 12.2 NQA-1 Commitment / Exceptions......................................................................................... 33 SECTION 13 HANDLING, STORAGE, AND SHIPPING............................................................. 34 13.1 Housekeeping.......................................................................................................................... 34 13.2 NQA-1 Commitment / Exceptions......................................................................................... 34 SECTION 14 INSPECTION, TEST, AND OPERATING STATUS.............................................. 36 14.1 NQA-1 Commitment.............................................................................................................. 36 SECTION 15 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS....................... 37 15.1 Interface with the Reporting Program.................................................................................. 37 15.2 NQA-1 Commitment............................................................................................................... 37 SECTION 16 CORRECTIVE ACTION........................................................................................... 38 16.1 Interface with the Reporting Program.................................................................................. 38 16.2 NQA-1 Commitment............................................................................................................... 38
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 3 of 52 SECTION 17 QUALITY ASSURANCE RECORDS....................................................................... 39 17.1 Record Retention.................................................................................................................... 39 17.2 Electronic Records.................................................................................................................. 39 17.3 NQA-1 Commitment / Exceptions......................................................................................... 39 SECTION 18 AUDITS...................................................................................................................... 40 18.1 Performance of Audits........................................................................................................... 40 18.2 Internal Audits....................................................................................................................... 41 18.3 NQA-1 Commitment.............................................................................................................. 41 PART III NON-SAFETY-RELATED SSC QUALITY CONTROL................................................. 44 SECTION 1 NON-SAFETY-RELATED SSCs / SIGNIFICANT CONTRIBUTORS TO PLANT SAFETY..................................................................................................................... 44 SECTION 2 NON-SAFETY-RELATED SSCs CREDITED FOR REGULATORY EVENTS.... 48 PART IV REGULATORY COMMITMENTS.................................................................................... 49 NRC Regulatory Guides and Quality Assurance Standards............................................................... 49 Section 1 Regulatory Guides..................................................................................................... 49 Section 2 Standards................................................................................................................... 52
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 4 of 52 PART I INTRODUCTION SECTION 1 GENERAL ES 10 CFR 50 Appendix B Quality Assurance Program Description (QAPD) is the top-level policy document that establishes the quality assurance policy and assigns major functional responsibilities for activities conducted by or for ES in compliance with 10 CFR 50 Appendix B.
The QAPD describes the methods and establishes quality assurance and administrative control requirements that meet 10 CFR 50, Appendix B. This QAPD may be used by ES to satisfy the quality assurance requirements of 10 CFR 20 Appendix G, 10 CFR 52, 10 CFR 61, 10 CFR 71 Subpart H, 10 CFR 72 Subpart G, and the Quality Assurance Requirements for Decommissioning as addressed in NUREG 1757, 10 CFR 830 Subpart A, and DOE Order 414.1D. The QAPD is based on the requirements and guidance of ASME NQA-1-2022, "Quality Assurance Requirements for Nuclear Facility Applications," Parts I and II with specific reference to selected Part IV sections as identified in this document.
Implementation of this 10 CFR 50 Appendix B QAPD across ESs activities will be controlled by a QAPD implementation document that will define the scopes of application and the necessary implementing procedures.
The QA Program (QAP) is defined by the NRC-approved regulatory document that describes the QA elements (i.e., the QAPD), along with the associated implementing documents. Procedures and instructions that control ES activities will be developed prior to commencement of those activities. Policies establish high-level responsibilities and authority for carrying out important administrative functions which are outside the scope of the QAPD. Procedures establish practices for certain activities which are common to all ES organizations performing those activities so that the activity is controlled and carried out in a manner that meets QAPD requirements. Procedures specific to a site, 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.
1.1 Scope/Applicability The QAPD applies to ES activities affecting the quality and performance of safety-related structures, systems, and components, including, but not limited to:
Designing Receiving Startup Siting Storing Repairing Procuring Constructing Maintaining Fabricating Erecting Modifying Cleaning Installing Training Handling Inspecting Decommissioning Shipping Testing Pre-operational activities (including ITAAC)
ITAAC are those Inspections, Tests, Analyses, and Acceptance Criteria the applicant must satisfy as determined by the commission in accordance with 10 CFR Part 52.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 5 of 52 Safety-related SSCs, under the control of the QAPD, are identified by 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 policy of ES is to assure a high degree of availability and reliability for the SSCs, 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 are not safety-related, but support safe, economic, and reliable operations, or where other NRC guidance establishes quality assurance requirements. QAPD implementing documents establish QA program element applicability to specific ES 10 CFR 50 Appendix B activities The definitions provided in ASME NQA-1-2022 Part I, Section 400, apply to select terms as used in this document.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 6 of 52 PART II QAPD DETAILS SECTION 1 ORGANIZATION This section describes the ES organizational structure, functional responsibilities, levels of authority and interfaces for establishing, executing, and verifying QAPD implementation.
The organizational structure includes corporate support, off-site and on-site functions for ES activities including interface responsibilities for multiple organizations that perform quality-related functions. Implementing documents assign more specific responsibilities and duties, and define the organizational interfaces involved in conducting activities and duties within the scope of the QAPD. Management gives careful consideration to the timing, extent, and effects of organizational structure changes.
The Senior Vice President Regulatory Affairs is responsible to size the QA staff commensurate with the duties and responsibilities assigned.
The following sections describe the reporting relationships, functional responsibilities, and authorities for the ES organizations implementing this QAPD and supporting the QA Program. The ES organization that implements this QAPD is shown in Figure II.1-1.
1.1 EnergySolutions President and Chief Executive Officer (CEO)
The ES President and CEO is responsible for all aspects of ESs activities. The ES President and CEO is also responsible for all technical and administrative support activities provided by ES and its contractors. The ES President and CEO directs the Chief Operating Officer, the Chief Financial Officer, the Chief Administrative Officer, the Senior Vice President Regulatory Affairs, the General Counsel, and the Corporate Director Health and Safety in fulfillment of their responsibilities. The ES President and CEO reports to the ES Board of Directors with respect to all matters.
1.2 EnergySolutions Chief Operating Officer (COO)
The ES COO reports to the ES President and CEO and is responsible for supporting company activities in accordance with this QAPD through managing the corporate organizations that perform Nuclear Development, Design/Engineering, Construction, Fabrication, Installation, Decommissioning and Decontamination, Waste Management, and Nuclear Services activities as applicable.
1.2.1 EnergySolutions President Decommissioning & Decontamination (D&D) and Chief Projects Officer (CPO)
The ES President D&D and CPO reports to the ES COO and is responsible for supporting company activities in accordance with this QAPD through managing corporate organizations that perform Nuclear Development, Decommissioning and Decontamination, Project Management/Controls and Design/Engineering activities as applicable.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 7 of 52 1.2.1.1 EnergySolutions Executive for Nuclear Development The ES Executive for Nuclear Development reports through the ES President D&D and CPO to the ES COO and is responsible for the establishment and implementation of the ES Nuclear Development activities in accordance with this QAPD with support from the other corporate entities.. This executive directs the planning and development of the Nuclear Development staff, and organization resources. This executive is also responsible for establishing and managing contracts supporting Nuclear Development activities.
1.2.2 EnergySolutions President Waste Management The ES President Waste Management reports to the ES COO and is responsible for the establishment and implementation of ES Waste Management activities in accordance with this QAPD as applicable.
1.2.3 EnergySolutions President Nuclear Services The ES President Nuclear Services reports to the ES COO and is responsible for the establishment and implementation of ES Nuclear Services activities in accordance with this QAPD as applicable.
1.3 EnergySolutions Chief Financial Officer (CFO)
The ES CFO reports to the ES President and CEO and is responsible for supporting the company activities in accordance with this QAPD through managing the corporate Financial Services and Procurement organizations as applicable.
1.4 EnergySolutions Chief Administrative Officer The ES Chief Administrative Officer reports to the ES President and CEO and is responsible for supporting the company activities in accordance with this QAPD through managing the Human Resources, Document Control, Records, Information Technology, and Training programs as applicable.
1.5 Quality Assurance Organization The ES QA Organization is responsible for independently planning and performing activities to verify the development and effective implementation of the ES QAPDs.
The QA organization has sufficient independence from other ES Nuclear activities to identify issues affecting safety and quality and makes judgments regarding quality in all areas regarding ES Nuclear activities as appropriate. QA may make recommendations to management regarding improving the quality of work processes. If QA disagrees with actions taken and is unable to obtain resolution, QA shall bring the matter to the attention of the President and CEO, who will determine the final disposition. QA personnel are sufficiently free from direct pressures of cost and schedule, and have the responsibility and authority delineated in writing to stop unsatisfactory work and control further processing, delivery, or installation of nonconforming material.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 8 of 52 1.5.1 EnergySolutions Senior Vice President Regulatory Affairs The ES Senior Vice President Regulatory Affairs reports directly to the ES President and CEO and is responsible for supporting the company activities in accordance with this QAPD through managing for the implementation of the QA, Licensing, Regulatory Affairs, and Environmental Programs for ES. This position administers the quality assurance responsibilities through the management positions responsible for Corporate QA, Facility/Site QA, and QC Services. This position is the highest-level management position responsible for the QA Organization company wide.
1.5.2 Group Director Quality Assurance The Group Director QA reports to the Senior Vice President Regulatory Affairs and is responsible for developing and maintaining the ES QAPDs, evaluating compliance to QA Program requirements, and managing QA Organization resources.
1.5.3 Quality Assurance Manager The QA Manager (QAM) reports to the Group Director QA and is responsible for the development and verification of implementation of the QAPD described in this document.
The QAM is responsible for assuring compliance with regulatory requirements and procedures through audits, surveillances, and in field observations as applicable, technical reviews; monitoring organizational processes to ensure conformance to commitments and licensing document requirements; and ensuring that vendors providing quality services, parts, and materials to ES are meeting the requirements of 10 CFR 50, Appendix B.
1.6 General Counsel The Corporate General Counsel reports to the ES President and CEO and is responsible for supporting the company activities through managing the Legal, Contracts organizations and the implementation of the Employee Concerns Program.
1.7 Corporate Director Health and Safety The Corporate Director Health and Safey report to the ES President and CEO and is responsible for supporting the company activities through managing the implementation of companywide industrial / occupational health and safety programs.
1.8 Nuclear Steam Supply System (NSSS) Supplier An NSSS Supplier provides engineering services for plant design and licensing of specific plant types. These engineering services for nuclear generation include site-specific engineering and design necessary to support development of licensing applications and preconstruction and construction activities.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 9 of 52 1.9 Architect/Engineering (A/E) Supplier An A/E Supplier provides engineering services for the development of the licensing applications and permits. These engineering services include site-specific licensing, engineering, and design activities; including planning and support for preconstruction and construction of new nuclear generation facilities.]
1.10 Authority to Stop Work QA and Quality Control Inspection personnel have the authority, and the responsibility, to stop work in progress which is not being done in accordance with approved procedures or where safety or SSC integrity may be jeopardized. This authority extends to off-site work performed by suppliers that furnish safety-related materials and services to ES.
1.11 QA Organizational Independence QA Organizational Independence shall be maintained between the organization(s) performing the checking (quality assurance and control) functions and the organizations performing the functions. This provision is not applicable to design review/verification.
1.12 NQA-1 Commitment In establishing its organizational structure, ES commits to compliance with NQA-1-2022, Requirement 1.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 10 of 52 Figure II.1-1 EnergySolutions Organization
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 11 of 52 SECTION 2 QUALITY ASSURANCE PROGRAM ES has established the necessary measures and governing procedures to implement the QAP as described in the QAPD. ES is committed to implementing the QAP in all aspects of work that are important to the safety of the SSCs as described and to the extent delineated in the 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, ES ensures through the systematic process described herein that its suppliers of safety-related equipment or services meet the applicable requirements of 10 CFR 50, Appendix B. Senior management is regularly apprised of the adequacy of implementation of the QAP through the audit functions described in Part II, Section 18.
The objective of the QAP is to ensure that ESs activities associated with SSC design, construction, fabrication and decommissioning are performed in accordance with governing regulations and license requirements. The program is based on the requirements of ASME NQA-1-2022 "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 structures, systems, and components (SSCs) associated with the design, fabrication, construction, and testing of the SSCs of the facility.
Examples of safety-related activities include, but are not limited to, site-specific engineering related to safety-related SSCs, site geotechnical investigations, site engineering analysis, seismic analysis, and meteorological analysis. A list or system that identifies SSCs and activities to which this program applies is maintained at the appropriate facility. Design documents are used as the basis for this list. Cost and scheduling challenges must be addressed; however, they do not prevent proper implementation of the QAP.
As described in Part III of this QAPD, specific program controls are applied to non-safety-related SSCs for which 10 CFR 50, Appendix B, is not applicable. The specific program controls, consistent with applicable sections of the QAPD, are applied to those items in a select manner, targeted at those characteristics or critical attributes of the SSC. This includes those items identified as Important to Safety from 10 CFR 50 Appendix A, Regulatory Guide 1.26, Quality Group Classifications and Standards for Water-, Steam-,
and Radioactive-Waste-Containing Components of Nuclear Power Plants, and NUREG/CR-6407, Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety..
Delegated responsibilities may be performed under a supplier's or principal contractor's QAP, provided that the supplier or principal contractor has been approved as a supplier in accordance with the ES QAP. Periodic audits and assessments/evaluations of supplier QA programs are performed to assure compliance with the supplier's or principal contractor's QAPD and implementing procedures. In addition, routine interfaces with the suppliers personnel provide added assurance that quality expectations are met.
The QAPD applies to those ES activities that can affect either directly or indirectly the safety-related site characteristics or analysis of those characteristics. In addition, the QAPD applies to engineering activities that are used to characterize the site or analyze that
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 12 of 52 characterization.
When new nuclear plant construction is the responsibility of ESs Nuclear Development organization, detailed engineering specifications and construction procedures will be developed to implement the QAPD and NSSS QA programs prior to commencement of preconstruction (ESP) and/or construction (COL) activities. Examples of Limited Work Authorization (LWA) activities that could impact safety-related SSCs include impacts of construction to existing facilities and, for construction of a new plants, the interface between non-safety-related and safety-related SSCs and the placement of seismically designed backfill.
In general, the program requirements specified herein are detailed in implementing procedures that are either ES implementing procedures, or supplier implementing procedures governed by a supplier quality assurance program.
This QAPD is the top-level 10 CFR 50 Appendix B document that describes the practices for a planned and disciplined approach to achieving quality. The QAPD is reviewed and approved by the ES President and Chief Executive Officer and represents ES overall approach to quality. QAPD implementation documents are written for the control of project/facility activities describing criteria unique to the scope of work. These QAPD implementation documents are developed and maintained consistent with this QAPD, and additional regulatory or contractual requirements. Implementing procedures describe how ES implements the requirements of the QAPD with these specific implementing procedures listed in the QAPD implementation document as a method to demonstrate conformance.
These procedures document methods for planning, reviewing, implementing, controlling, and verifying activities affecting quality under suitably controlled conditions. Controlled conditions include the use of appropriate equipment, suitable environmental conditions for accomplishing the activity, and assurance that prerequisites for the given activity have been satisfied.
A grace period of 90 days may be applied to provisions that are required to be performed on a periodic basis, unless otherwise noted. Annual evaluations and audits that must be performed on a triennial basis are examples where the 90-day general period could be applied. The grace period does not allow the "clock" for a particular activity to be reset forward. The "clock" for an activity is reset backwards by performing the activity early.
Audit schedules are based on the month in which the audit starts.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 13 of 52 2.1 Responsibilities Personnel who work directly or indirectly for ES are responsible for achieving acceptable quality in the work covered by the QAPD. This includes the activities delineated in Part I, Section 1.1. ES personnel performing verification activities are responsible for verifying the achievement of acceptable quality. Activities governed by the QAPD are performed as directed by documented instructions, procedures, and drawings that are of a detail appropriate for the activity's complexity and effect on safety. Instructions, procedures, and drawings specify quantitative or qualitative acceptance criteria as applicable or appropriate for 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 QA Manager is responsible to verify that processes and procedures comply with QAPD and other applicable requirements, that such processes or procedures are implemented, and that management appropriately ensures compliance.
2.2 Delegation of Work ES retains and exercises the responsibility for the scope and implementation of an effective QAP. Positions identified in Part II, Section 1, may delegate all or part of the activities of planning, establishing, and implementing the program for which they are responsible to others, but retain the responsibility for the program's effectiveness. Decisions affecting safety are made at the appropriate level based upon their nature and effect, with technical advice or review as appropriate.
2.3 Site-specific Safety-Related Design Basis Activities Site-specific safety-related design basis activities are defined as those activities, including sampling, testing, data collection, and supporting engineering calculations and reports, that will be used to determine the bounding physical parameters of the site. Appropriate quality assurance measures are applied.
2.4 Periodic Review of the Quality Assurance Program Management of those organizations implementing the QA program, or portions thereof, shall assess the adequacy of that part of the program for which they are responsible to assure its effective implementation at least once each year or at least once during the life of the activity, whichever is shorter.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 14 of 52 2.5 Issuance and Revision to Quality Assurance Program Administrative control of the QAPD will be in accordance with 10 CFR 50.55(f) and 10 CFR 50.54(a). Changes to the QAPD are evaluated by the Group Director QA to ensure that such changes do not degrade safety for 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 during the licensing application development process. New revisions to the document will be reviewed, at a minimum, by the ES QA Group Director and approved by the President and CEO of ES.
2.6 Personnel Training and Qualifications Personnel assigned to implement elements of the QAPD shall be capable of performing their assigned tasks. To this end, ES establishes and maintains formal indoctrination, training, and qualification as necessary for personnel performing, verifying, or managing activities within the scope of the QAPD to achieve initial proficiency, maintain proficiency, and adapt to technology changes, method, or job responsibilities. The indoctrination, training, and qualification programs are commensurate with scope, complexity, and importance of the activities; and include or address the following, as appropriate:
Education, experience, and proficiency of the personnel receiving training.
General criteria, technical objectives, requirements of applicable codes and standards, regulatory commitments, company procedures, and quality assurance program requirements.
On-the-job training if direct hands-on applications or experience is needed to achieve and maintain proficiency.
Sufficient managerial depth is provided to cover the 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 ES procedures. Indoctrination includes the 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 QA Manager are that the position holds an engineering or related science degree and a minimum of four years of related experience including two years of nuclear power plant experience, one year of supervisory or management experience, and one year of the experience is in performing quality verification activities.
Special requirements shall include management and supervisory skills and experience or training in leadership, interpersonal communication, 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 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.
The minimum qualifications for the individuals responsible for supervising QA or QC
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 15 of 52 personnel is that each has a high school diploma or equivalent and has a minimum of one year of experience performing quality verification activities. Individuals who do not possess these formal education and 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.
The minimum qualifications of individuals that are part of the QA Organization responsible for planning, implementing, and maintaining the programs for 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.
2.7 NQA-1 Commitment / Exceptions In establishing qualification and training programs, ES commits to compliance with NQA-1-2022, Requirement 2 and Regulatory Position C.1.a(1) as stated in Regulatory Guide 1.28, Revision 6, September 2023 with the following clarifications and exceptions:
ES follows NQA-1-2022, Requirement 2, Section 301 for qualification of nondestructive examination personnel, except that ES will follow the applicable standard cited in the version(s) of Section III and Section XI of the ASME Boiler and Pressure Vessel Code approved by the NRC for use where ES performs activities for the scope of activities governed by these cited standards.
NQA-1-2022, Requirement 2, Section 303.3 Audit Participation, Prospective Lead Auditors shall participate in a minimum of five quality assurance audits within a period of time not to exceed 3 years prior to the date of qualification. ES considers that Lead Auditor candidates with comparable industry experience may satisfy the lead auditor participation requirement by alternatively demonstrating the ability to properly implement the audit process, effectively organize and report results and participate in at least one nuclear quality assurance audit in the year preceding the date of qualification, subject to review and acceptance by the responsible Group Director QA.
NQA-1-2022, Requirement 2, Section 401 (g) requires the date of certification expiration be included on the qualification record. ES considers the certification expiration date to be the date from the certification or recertification date plus the certification interval time and its inclusion on the qualification record is optional.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 16 of 52 SECTION 3 DESIGN CONTROL ES has established and implements a process to control the design, design changes, and temporary modifications (e.g., temporary bypass lines, electrical jumpers, and lifted wires, and temporary setpoints) of items that are subject to the provisions of the QAPD. The design process includes provisions to control design inputs, outputs, changes, interfaces, records, and organizational interfaces within ES 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 contains or references appropriate acceptance criteria that can be related to the design input in sufficient detail to permit verification by inspection and test, as required.
Design change processes and the division of responsibilities for design-related activities are detailed in ES and supplier procedures. Changes to design inputs, final designs, and field changes are justified and subject to design control measures commensurate with those applied to the original design. 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 ES design organization or by other organizations so authorized by ES.
Design documents are reviewed by individuals knowledgeable in QA to ensure the documents contain the necessary QA requirements.
Use of existing data for new nuclear development activities may be performed in accordance with NQA-1-2022, Part IV, Subpart 4.2.3, Guidance on Qualification of Existing Data, or other methodologies that assure that design inputs (such as design bases and the performance, regulatory, quality, and quality verification requirements) are correctly translated into design outputs (such as analyses, specifications, drawings, procedures, and instructions) so that the final design output contains or references appropriate acceptance criteria that can be related to the design input in sufficient detail to permit verification by inspection and test, as required.
Design control measures are applied to specific areas when required by regulations such as 10 CFR 71.107(b)&(c) and 10 CFR 72.146(b)&(c).
3.1 Design Verification ES design processes provide for design verification to ensure that items, computer programs, and activities subject to the provisions of the QAPD are suitable for their intended application, consistent with their effect on safety. Design changes are subjected to these controls, which include verification measures commensurate with those applied to original design.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 17 of 52 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 or computer program under consideration, the complexity of the design, the degree of standardization, the state-of-the-art, and the similarity with previously proven designs. This includes design inputs, design outputs, and design changes. Design verification procedures are established and implemented to ensure 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.
ES 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, manufacture, or construction. When such timing cannot be achieved, the design verification is completed before relying on the item to perform its intended design or safety function.
3.2 Design Records ES 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 record of the important design steps (e.g., calculations, analyses, and computer programs) and the sources of input that support the final output.
Design drawings reflect the properly reviewed and approved configuration of the plant and SSCs as applicable.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 18 of 52 3.3 Computer Application and Digital Equipment Software This QAPD governs the development, procurement, testing, maintenance, control, and use of computer applications and digital equipment software when used in safety-related applications and designated non-safety-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. ES and suppliers are responsible for developing, approving, and issuing procedures, as necessary, to control the use of such computer applications 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 QAPD 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 QAPD requirements such as QA records.
3.4 Setpoint Control Instrument and equipment setpoints that could affect nuclear safety shall be controlled in accordance with written instructions. As a minimum, these written instructions shall:
Identify responsibilities and processes for reviewing, approving, and revising setpoints and setpoint changes originally supplied by the NSSS supplier, DC holder, the A/E, and the technical staff.
Ensure that setpoints and setpoint changes are consistent with design and accident analysis requirements and assumptions.
Provide for documentation of setpoints, including those determined operationally.
Provide for access to necessary set-point information for personnel who write or revise procedures, operate or maintain equipment, develop or revise design documents, or develop or revise accident analyses.
3.5 Interface Control Formal design interfaces are established when multiple organizations (internal or external) participate in the design process. Procedures are written that establish and document responsibility and authority for transmittal, review, approval, release, distribution, and revision of design inputs and design output documents. Transmittals indicate the status of design information or of documentation submitted, including any incomplete items that require further actions. When it is necessary to initially transmit design information orally or by other means, the transmittal is confirmed promptly by a controlled document.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 19 of 52 3.6 NQA-1 Commitment In establishing its program for design control and verification, ES commits to compliance with:
NQA-1-2022 Requirement 3.
NQA-1-2022 Part II Subpart 2.7 Quality Assurance Requirements for Computer Software for Nuclear Facility Applications.
NQA-1-2022 Part II Subpart 2.14 for Quality Assurance Requirements for Commercial Grade Items and Services.
NQA-1-2022 Part II Subpart 2.20 Quality Assurance Requirements for Subsurface Investigations for Nuclear Facilities, (Subpart 2.20 does not apply to Operational Phase activities).
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 20 of 52 SECTION 4 PROCUREMENT DOCUMENT CONTROL ES has established the necessary measures and governing procedures to ensure that purchased items, computer programs, and services are subject to appropriate quality and technical requirements. Procurement document changes shall be subject to the same degree of control as utilized in the preparation of the original documents. These controls include provisions such that:
Where 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, fit, and function, as applicable, are not adversely affected or contrary to applicable regulatory requirements.
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 requirements for posting, evaluating, and reporting will be followed and imposed on suppliers when applicable.
Applicable design bases and other requirements necessary to ensure 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, Appendix B, as appropriate to the circumstances of procurements (or the supplier may work under ESs approved QA program).
Reviews of procurement documents shall be performed by personnel who have access to pertinent information and who have an adequate understanding of the requirements and intent of the procurement documents.
4.1 NQA-1 Commitment / Exceptions In establishing controls for procurement, ES commits to compliance with NQA-1-2022, Requirement 4, with the following clarifications and exceptions:
Section 203 requires the purchaser to specify requirements in the procurement documents. To meet this requirement, ES may require suppliers to have a documented QAP that meets the applicable requirements of 10 CFR 50 Appendix B or other regulations as appropriate to the circumstances of the procurement.
Regarding services performed by a supplier, ES procurement documents may allow the supplier to work under the ES QAP, including implementing procedures, in lieu of the supplier having its own QAP.
Section 300 and 400 of Requirement 4 require the review of technical and QA Program requirements of procurement documents prior to award of a contract and for procurement document changes. ES may satisfy this requirement through the review of the procurement specification when the specification contains the technical and quality assurance requirements of the procurement.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 21 of 52 Section 202, Technical Requirements, and Section 203, Quality Assurance Program Requirements, of Requirement 4, require that the technical and quality requirements be specified in procurement documents. As a clarification, procurement documents for Commercial Grade Items that will be procured by ES for use as safety-related items shall contain technical and quality requirements such that the procured item can be appropriately dedicated in accordance with the ES QAPD, Section 7, Control of Purchased Material, Equipment and Services.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 22 of 52 SECTION 5 INSTRUCTIONS, PROCEDURES, AND DRAWINGS ES 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 the QAPD. Such documents are prepared and controlled according to Part II, Section 6. 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.
5.1 Procedure Adherence ESs 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 Part II, Section 6.
Requirements are established to identify the manner in which procedures are to be implemented, including identification of those tasks that require: (1) the written procedure to be present and followed step-by-step while the task is being performed, (2) the user to have committed the procedure steps to memory, (3) verification of completion of significant steps, by initials or signatures or use of check-off lists. Procedures that are required to be present and referred to directly are those developed for extensive or complex jobs where reliance on memory cannot be trusted, tasks that are infrequently performed, and tasks where steps must be performed in a specified sequence.
In cases of emergency, personnel are authorized to depart from approved procedures when necessary to prevent injury to personnel or damage to SSCs. Such departures are recorded describing the prevailing conditions and reasons for the action taken.
5.2 Procedure Content The established measures address the applicable content of procedures as described in the Introduction to Part II of NQA-1-2022 (Sections 402, 601, and 602). In addition, procedures governing tests, inspections, operational activities, and maintenance will include as applicable, initial conditions and prerequisites for the performance of the activity.
5.3 NQA-1 Commitment In establishing procedural controls, ES commits to compliance with NQA-1-2022, Requirement 5.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 23 of 52 SECTION 6 DOCUMENT CONTROL ES has established the necessary measures and governing procedures to control the preparation, issuance, and revision of documents that specify quality requirements or prescribe how activities affecting quality, including organizational interfaces, to ensure that correct documents are employed. The following controls, including electronic systems used to make documents available, are applied to documents and changes thereto:
Identification of controlled documents Specified distribution of controlled documents for use at the appropriate location A method to identify the correct document (including revision) to be used and control of superseded documents Identification of individuals responsible for controlled document preparation, review, approval, and distribution Review of controlled documents for adequacy, completeness, and approval prior to distribution A method to ensure the correct documents are being used A method to provide feedback from users to improve procedures and work instructions Coordinating and controlling interface documents and procedures The types of documents to be controlled include but are not limited to:
Drawings such as design, construction, installation, and as-built drawings Engineering calculations Design specifications Purchase orders and related documents Vendor-supplied documents Audit, surveillance, and quality verification/inspection procedures Inspection and test reports Instructions and procedures for activities covered by the QAPD including but not limited to design, construction, installation, operating, maintenance, calibration, and routine testing Technical specifications Nonconformance reports and corrective action reports
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 24 of 52 6.1 Review and Approval of Documents Documents are reviewed for adequacy by qualified persons other than the preparer. During the ESP or construction phase for new nuclear plants, procedures for design, construction, and installation are also reviewed by the QA Organization 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.
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 review and approval and the persons who can authorize such a classification shall be clearly delineated in implementing procedures.
6.3 NQA-1 Commitment In establishing provisions for document control, ES commits to compliance with NQA 2022, Requirement 6.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 25 of 52 SECTION 7 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES ES has established the necessary measures and governing procedures to control purchased 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.
7.1 Acceptance of Item or Service ES 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 or service importance to safety, complexity, quantity, and the frequency of procurement. Verification actions include testing, as appropriate, during design, fabrication, construction, and decommissioning activities. 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:
Items are inspected, identified, and stored to protect against damage, deterioration, or misuse.
Prospective safety-related items and service suppliers are evaluated by qualified personnel to ensure only qualified suppliers are used. Qualified suppliers are audited on a triennial basis. In addition, if a subsequent contract or a contract modification significantly changes the scope, methods, or controls performed by a supplier, an audit of the changes is performed, thus starting a new triennial period.
ES may utilize audits conducted by outside organizations for supplier qualification provided that the scope and adequacy of the audits meet ES requirements.
Documented annual evaluations are performed for qualified suppliers to ensure they continue to provide acceptable products and services. Industry programs, such as those applied by ASME, Nuclear Industry Assessment Corporation (NIAC), Nuclear Procurement Issues Corporation (NUPIC), or other established utility groups, are used as applicable as input or the basis for supplier qualification whenever appropriate. The results of the reviews are promptly considered for effect on a supplier's continued qualification and adjustments made as necessary (including corrective actions, adjustments of supplier audit plans, and input to third party auditing entities, as warranted). In addition, results are reviewed periodically to determine if, as a whole, they constitute a significant condition adverse to quality requiring additional action.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 26 of 52 Provisions are made for accepting purchased items and services, such as source verification, receipt inspection, pre-and post-installation tests, certificates of conformance, and document reviews (including Certified Material Test Report/Certificate). Acceptance actions/documents should are established by the Purchaser with appropriate input from the Supplier and be 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.
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.
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.
7.2 NQA-1 Commitment / Exceptions In establishing controls for purchased items and services, ES commits to compliance with NQA-1-2022 Requirement 7, and the Regulatory Positions C.2.a(1) and C.4.a(1), C.4.b(1),
C.4.b(2), C.4.b(3), C.4.b(4) as stated in Regulatory Guide 1.28, Revision 6, September 2023 with the following clarifications and exceptions:
ES considers that other 10 CFR Parts 50 and 52 licensees, Authorized Nuclear Inspection Agencies, National Institute of Standards and Technology, or other State and Federal agencies which may provide items or services to ES are not required to be evaluated or audited.
ES commits to develop procedures to implement the NRC endorsed guidance from NEI 14-05A, Revision 1A, September 2020, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys in Procurement of Laboratory Calibration and Test Services.
For Section 501, ES considers documents that may be stored in approved electronic media under ES or vendor control, not physically located on the plant site, but accessible from the respective nuclear facility site as meeting the NQA-1 requirement for documents to be available at the site. Following completion of the construction period, sufficient as-built documentation will be turned over to ES to support operations. The ES records management system will provide for timely retrieval of necessary records.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 27 of 52 In establishing commercial grade item requirements, ES commits to compliance with NQA-1-2022, Requirement 7, Section 700, and Subpart 2.14, with the following clarification:
For commercial grade items, quality verification requirements are established and described in ES documents to provide the necessary assurance that an item will perform satisfactorily in service. The ES documents address determining the critical characteristics that ensure an item is suitable for its intended use, technical evaluation of the item, receipt requirements, and quality evaluation of the item.
ES will assume 10 CFR 21 reporting responsibility for all items that ES dedicates as safety related.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 28 of 52 SECTION 8 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS ES has established the necessary measures and governing procedures to identify and control items to prevent the use of incorrect or defective 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.
8.1 NQA-1 Commitment In establishing provisions for identification and control of items, ES commits to compliance with NQA-1-2022, Requirement 8.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 29 of 52 SECTION 9 CONTROL OF SPECIAL PROCESSES ES has established the necessary measures and governing procedures to assure that special processes that require interim process controls to assure quality, such as coatings, 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.
9.1 NQA-1 Commitment In establishing measures for the control of special processes, ES commits to compliance with NQA-1-2022, Requirement 9.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 30 of 52 SECTION 10 INSPECTION ES has established the necessary measures and governing procedures 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 verifications related to procurement, such as source, in-process, final, and receipt inspection, as well as construction, installation, maintenance, modification, and in-service, activities. Inspections are carried out by properly qualified persons independent of those who performed or directly supervised the work. Inspection results are documented.
10.1 Inspection Program The inspection program establishes inspections (including surveillance of processes), as necessary to verify quality: (1) at the source of supplied items or services, (2) in-process during fabrication at a supplier's facility or at a ES facility, (3) for final acceptance of fabricated and/or installed items during construction, and (4) upon receipt of items for a facility.
The inspection program establishes requirements for planning inspections, such as the group or discipline responsible for performing the inspection, where inspection hold points are to be applied, determining applicable acceptance criteria, the frequency of inspection to be applied, and identification of special tools needed to perform the inspection. Inspection planning is performed by personnel qualified in the discipline related to the inspection and includes 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 design specifications. Where significant changes in inspection activities for the facilities 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, and re-inspection results, and the person(s) performing the inspection.
Inspection results are documented by the inspector, reviewed by authorized personnel qualified to evaluate the technical adequacy of the inspection results, and controlled by instructions, procedures, and drawings.
10.2 Inspector Qualification ES has established qualification programs for personnel performing quality inspections. The qualification program requirements are described in Part II, Section 2. These qualification programs are applied to individuals performing quality inspections regardless of the functional group where they are assigned.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 31 of 52 10.3 NQA-1 Commitment / Exceptions In establishing inspection requirements, ES commits to compliance with NQA-1-2022, Requirement 10, NQA-1-2022, and Subparts, 2.5 and 2.8, Regulatory Position C.6 as stated in Regulatory Guide 1.28, Revision 6, September 2023 for establishing appropriate inspection requirements.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 32 of 52 SECTION 11 TEST CONTROL ES has established the necessary measures and governing procedures to demonstrate that items subject to the provisions of the QAPD will perform satisfactorily in service, can be operated safely and as designed, and that the coordinated operation of the SSCs as a whole is satisfactory. These programs include criteria for determining when testing is required, such as proof tests before installation, pre-operational tests, post-maintenance tests, post-modification tests, in-service tests, and operational tests (such as surveillance tests required by Plant Technical Specifications), to demonstrate that performance of SSCs are in accordance with design. Programs also include provisions to establish and adjust test schedules, and to maintain status for periodic or recurring tests. Tests are performed according to applicable procedures that include, consistent with the effect on safety: (1) instructions and prerequisites to perform the tests, (2) use of proper test equipment, (3) acceptance criteria, and (4) 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, re-testing is performed as needed to confirm acceptability following correction of the system or equipment deficiencies that caused the failure. Test records at a minimum, shall identify the item tested, date of test, tester or data recorder, type of observation, results and acceptability, action taken in connection with any deviations noted, and the person evaluating test results.
Except for computer program testing, which is addressed in Section 11.1, tests are performed and results documented in accordance with applicable technical and regulatory requirements., Test programs ensure appropriate retention of test data in accordance with the records requirements of this QAPD. Personnel that perform or evaluate tests are qualified in accordance with the requirements established in Part II, Section 2.
11.1 NQA-1 Commitment for Computer Program Testing ES establishes and implements provisions to ensure that computer software used in applications affecting safety is prepared, documented, verified and tested, and used such that the expected output is obtained and configuration control maintained. To this end ES commits to compliance with the requirements of NQA-1-2022, Requirement 11 and Subpart 2.7 to establish the appropriate provisions in addition to the commitment to NQA-1-2022, Requirement 3.
11.2 NQA-1 Commitment In establishing provisions for testing, ES commits to compliance with NQA-1-2022, Requirement 11.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 33 of 52 SECTION 12 CONTROL OF MEASURING AND TEST EQUIPMENT ES has established the necessary measures and governing procedures to control the calibration, maintenance, and use of measuring and test equipment (M&TE) that provides 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 gages, tools, reference and transfer standards, and nondestructive examination equipment. The suppliers of commercial-grade calibration services are controlled as described in Part II, Section 7.
12.1 Installed Instrument and Control Devices ES establishes and implements procedures for the calibration and adjustment of instrument and control devices installed in the facility. The calibration and adjustment of these devices is accomplished through the facility maintenance programs to ensure the facility is operated within design and technical requirements. Appropriate documentation will be maintained for these devices to indicate the control status, when the next calibration is due, and identify any limitations on use of the device.
12.2 NQA-1 Commitment / Exceptions In establishing provisions for control of measuring and test equipment, ES commits to compliance with NQA-1-2022, Requirement 12 with the following clarification and exception:
The out of calibration conditions described in Section 303.2 refers to when the M&TE is found out of the required accuracy limits (i.e., out of tolerance) during calibration and not overdue for calibration.
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 the operation of the device) provided the required information is maintained in suitable documentation traceable to the device.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 34 of 52 SECTION 13 HANDLING, STORAGE, AND SHIPPING ES has established the necessary measures and governing procedures to control the handling, storage, packaging, shipping, cleaning, and preservation of items to prevent inadvertent damage or loss, and to minimize deterioration. These provisions include specific procedures, when required to maintain acceptable quality of the items important to the safe operations of the SSCs. 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 procedures 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, ES complies with applicable hoisting, rigging and transportation regulations and codes.
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, as well as, radioactive contamination control, and storage of solid radioactive waste. Housekeeping practices help ensure that only proper materials, equipment, processes, and procedures are used and that the quality of items is not degraded. Necessary procedures or work instructions, such as for electrical bus and control center cleaning, cleaning of control consoles, and radioactive decontamination are developed and used.
13.2 NQA-1 Commitment / Exceptions In establishing provisions for handling, storage, and shipping, ES commits to compliance with NQA-1-2022, Requirement 13. ES also commits, during the construction of new nuclear plants, to compliance with the requirements of NQA-1-2022, Subpart 2.1, Subpart 2.2, Subpart 2.3, Subpart 2.15 and Regulatory Position C.5 as stated in Regulatory Guide 1.28 Revision 6, September 2023, with the following clarifications and exceptions:
NQA-1-2022, Subpart 2.1 Subpart 2.1, Section 301 and 302 establish criteria for classifying items into
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 35 of 52 cleanness classes and requirements for each class. Instead of using the cleanness level system of Subpart 2.1, ES may establish cleanness requirements on a case-by-case basis, consistent with the other provisions of Subpart 2.1.
ES establishes appropriate cleanliness controls for work on safety-related equipment to minimize the introduction of foreign material and maintain system/component cleanliness throughout maintenance or modification activities, including documented verification of absence of foreign material prior to system closure.
NQA-1-2022, Subpart 2.2 Subpart 2.2, Section 201 establishes criteria for classifying items into protection levels. Instead of classifying items into protection levels during the operational phase, ES may establish controls for the packaging, shipping, handling, and storage of such items on a case-by-case basis with due regard for the items complexity, use, and sensitivity to damage. Prior to installation or use, the items are inspected and serviced as necessary to assure that no damage or deterioration exists which could affect their function.
Subpart 2.2, Section 606, "Storage Records" This section requires written records be prepared containing information on personnel access. As an alternative to this requirement, ES documents the establishment of controls for storage areas that describe those authorized to access areas and the requirements for recording access of personnel. However, these records of access are not considered quality records and will be retained in accordance with applicable administrative controls.
Subpart 2.2, Section 700 Handling refers to Subpart 2.15 for requirements related to handling of items. The scope of Subpart 2.15 includes hoisting, rigging, and transporting of items.
NQA-1-2022, Subpart 2.3 Subpart 2.3, Section 202 requires the establishment of five zone designations for housekeeping cleanliness controls. Instead of the five-level zone designation, ES bases its control over housekeeping activities on a consideration of what is necessary and appropriate for the activity involved. The controls are implemented through procedures or instructions which, in the case of maintenance or modification work, are developed on a case-by-case basis. Factors considered in developing the procedures and instructions include cleanliness control, personnel safety, fire prevention and protection, radiation control, and security. The procedures and instructions make use of standard janitorial and work practices to the extent possible.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 36 of 52 SECTION 14 INSPECTION, TEST, AND OPERATING STATUS ES has established the necessary measures and governing procedures 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, are controlled by procedures that include requirements for appropriate installation and removal, independent/concurrent verifications, and status tracking.
Administrative procedures 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.
14.1 NQA-1 Commitment In establishing measures for control of inspection, test, and operating status, ES commits to compliance with NQA-1-2022, Requirement 14.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 37 of 52 SECTION 15 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS ES has established the necessary measures and governing procedures to control items, including services that do not conform to specified requirements to prevent inadvertent installation or use. Instructions require that the individual discovering a nonconformance identify, describe, and document the nonconformance in accordance with the requirements of Part II, Section 16. Controls provide for identification, documentation, evaluation, segregation when practical, and disposition of nonconforming items, and for 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 for installation requires the approval of the designated management. Nonconformances are corrected or resolved prior to depending on the item to perform its intended safety function. Nonconformances are evaluated for impact on operability of quality 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 ES procedures, regulatory requirements, and industry standards.
15.1 Interface with the Reporting Program ES has appropriate interfaces between the QAPD for identification and control of nonconforming materials, parts, or components and the non-QA Reporting Program to satisfy the requirements of 10 CFR 52, 10 CFR 50.55 and/or 10 CFR 21 during design and construction, and 10 CFR 21 during operations.
15.2 NQA-1 Commitment In establishing measures for nonconforming materials, parts, or components, ES commits to compliance with NQA-1-2022, Requirement 15.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 38 of 52 SECTION 16 CORRECTIVE ACTION ES has established the necessary measures and governing procedures to promptly identify, control, document, classify, and correct conditions adverse to quality. ES procedures ensure that corrective actions are documented and initiated following the determination of conditions adverse to quality in accordance with regulatory requirements and applicable quality standards. ES 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, ES 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 responsible management. In the case of a significant condition adverse to quality, the cause is determined and actions to preclude recurrence are taken.
In the case of suppliers working on safety-related activities, or other similar situations, ES may delegate specific responsibilities for corrective actions but ES maintains responsibility for the effectiveness of corrective action measures.
16.1 Interface with the Reporting Program ES has appropriate interfaces between the QAP for corrective actions and the non-QA Reporting Program to satisfy the requirements of 10 CFR 52, 10 CFR 50.55 and/or 10 CFR 21 during design and construction, and 10 CFR 21 when performing work in support of operating nuclear plants.
16.2 NQA-1 Commitment In establishing provisions for corrective action, ES commits to compliance with NQA-1-2022, Requirement 16.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 39 of 52 SECTION 17 QUALITY ASSURANCE RECORDS ES 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 ES and include requirements for records administration, including receipt, preservation, retention, storage, safekeeping, retrieval, access controls, user privileges, and final disposition.
In addition, instructions, procedures, and drawings produced in accordance with the requirements of Part II Section 5 are considered to be QA Records.
The results of material analysis when implementing the requirements of 10 CFR 72 are also considered to be QA Records.
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, manufacturing, construction, inspection and test, installation, pre-operation, startup, modification, decommissioning, and audits and their retention times are defined in appropriate procedures. The records and retention times are based on Regulatory Position C.3.a.(1) and C.3.a.(2) of Regulatory Guide 1.28, Revision 6, September 2023 for design, construction, and initial start-up. In all cases where state, local, or other agencies have more restrictive requirements for record retention, those requirements will be met.
For activities governed by 10 CFR 72, ES will retain quality assurance records in accordance with the requirements of 10 CFR 72.174.
17.2 Electronic Records When using optical disks for electronic records storage and retrieval systems, ES complies with the NRC guidance in Generic Letter 88-18, "Plant Record Storage on Optical Disks."
ES will manage the storage of QA Records in electronic media consistent with the intent of RIS 2000-18, Guidance on Managing Quality Assurance Records in Electronic Media, and associated Nuclear Information and Records Management Association (NIRMA) Guidelines TG 11-2011, TG15-2011, TG16-2011, and TG21-2011.
17.3 NQA-1 Commitment / Exceptions In establishing provisions for records, ES commits to compliance with NQA-1-2022, Requirement 17, and Regulatory Positions C.3.a(1), C.3.a(2), C.3.b(1) and C.3.b(2) as stated in Regulatory Guide 1.28, Rev 6, September 2023.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 40 of 52 SECTION 18 AUDITS ES 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 established requirements and performance criteria are met. The audit programs are themselves reviewed for effectiveness as a part of the overall audit process.
18.1 Performance of Audits Internal audits of selected aspects of licensing, design, construction, and decommissioning phase activities are performed with a frequency commensurate with safety significance and in a manner which ensures that audits of safety-related activities are completed. During the early portions of ES Nuclear Development activities, audits will focus on areas including, but not limited to, site investigation, procurement, and corrective action.
Functional areas of an organization's QA program for auditing include, at a minimum, verification of compliance and effectiveness of implementation of internal rules, procedures (e.g., design, procurement, maintenance, modification, surveillance, test, security, radiation control procedures, and the emergency plan), Technical Specifications, regulations and license conditions, programs for training, retraining, qualification and performance of staff, corrective actions, and observation of performance of modification activities, including associated record keeping.
The audits are scheduled on a formal preplanned audit schedule and in a manner to provide coverage and coordination with ongoing activities, based on the status and importance of the activity. Additional audits may be performed as deemed necessary by management. The scope of the 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 with preplanned and approved audit plans or checklists, under the direction of a qualified lead auditor and the cognizance of the QA Manager responsible for the day to day program as documented in Part II Section 1.
ES 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 QAPD.
External audits determine the adequacy of a supplier or contractor quality assurance program and are issued to the management of the audited organization and applicable ES management.
The results of each audit are reported in writing to the ES President and CEO and Senior Vice President Regulatory Affairs or designee(s), as appropriate. Additional internal distribution is made to other concerned management levels and to management of the internal audited organizations or activities in accordance with approved procedures.
Management responds to all audit findings and initiates corrective action where indicated.
Where corrective action measures are indicated, documented follow-up of applicable areas through inspections, review, re-audits, or other appropriate means is conducted to verify implementation of assigned corrective action.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 41 of 52 Audits of suppliers of safety-related components and/or services are conducted as described in Section 7.1.
18.2 Internal Audits Internal audits of activities associated with the design and construction of nuclear power plants or facilities (e.g., LWA, CP, ESP, or COLA), conducted prior to placing the facility in operation, 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.
Internal audits of ES 10 CFR 50 Appendix B activities outside of nuclear power plant design and construction noted above, 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 within a period of two years. Internal audit frequencies of well established activities, conducted after placing the facility in operation, may be extended one year at a time beyond the above two-year interval based on the results of an annual evaluation of the applicable functional area and objective evidence that the functional area activities are being satisfactorily accomplished. The evaluation should include a detailed performance analysis of the functional area based upon applicable internal and external source data and due consideration of the impact of any functional area changes in responsibility, resources, or management. However, the internal audit frequency interval should not exceed a maximum of four years. If an adverse trend is identified in the applicable functional area, the extension of the internal audit frequency interval should be rescinded and an audit scheduled as soon as practicable.
Internal audits as described in this section may be used to meet the periodic review requirements of the code for the Security, Emergency Preparedness, Fire Protection, Independent Spent Fuel Storage Installations (10 CFR 72 Subpart G), Packaging and Transportation of Radioactive Material (10 CFR 71 Subpart H), and Radiological Protection programs within the provisions of and at the frequencies required by the applicable code committed to by ES in licensing basis documents. Fire Protection equipment and program implementation inspections and audits are conducted utilizing either a qualified off-site licensed fire protection engineer or an outside qualified fire protection consultant.
Internal audits include verification of compliance and effectiveness of the administrative controls established for implementing the requirements of the QAPD; regulations and license provisions; provisions for training, retraining, qualification, and performance of personnel performing activities covered by the QAPD; corrective actions taken following abnormal occurrences; and, observation of the performance of construction, fabrication, maintenance, modification, and decommissioning activities including associated record keeping.
18.3 NQA-1 Commitment In establishing the independent audit program, ES commits to compliance with NQA 2022, Requirement 18 with the clarifications and exceptions noted below. ES commits to the regulatory positions C.4.b(1), C.4.b(2), C.4.b(3), C.4.b(4) stated in Regulatory Guide 1.28,
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 42 of 52 Rev 6, September 2023 with no exceptions. ES commits to implement internal audits per regulatory position C.4.a(1) as stated Regulatory Guide 1.28, Rev 6, September 2023 only for nuclear development activities as described above.
Section 201, Internal Audits - ES may apply an extension, not to exceed 25 percent of the audit interval as follows:
Audits shall be performed at the intervals designated for each audit area. Schedules shall be based on the month in which the audit starts.
No extensions are allowed for scheduled audits of Emergency Preparedness, Security, Cyber Security, or Access Authorization.
When an audit interval extension greater than one month is used, the next audit for that particular audit area will be scheduled from the original anniversary month rather than from the month of the extended audit.
Section 202, External Audits - ES may apply an extension, not to exceed 25 percent of the audit interval, to contractor/supplier audits or surveys that are normally of triennial frequency where performance of the audit or survey is not feasible. The end of the audit or survey will determine the date of the next triennial audit or survey. Application of the 25 percent extension is limited to extenuating circumstances, which include, but are not limited to:
Declaration of a national emergency.
Severe localized or national weather conditions or damage to ES or the suppliers infrastructure, or Localized outbreak of a severe health concern to the public and ES Continued use of ES suppliers that have exceeded the maximum allowed audit or survey time due to extenuating circumstances is allowed if the following conditions are met:
- 1. A documented evaluation must be performed to summarize why the audit or survey could not be performed prior to the end of the 90-day grace period and to provide the basis for maintaining the supplier as an approved supplier during the 25% (9-month) grace period. While implementing procedures must describe elements to be included in the documented evaluation, the following items should be considered as applicable:
a) For 10 CFR 50, Appendix B suppliers, verification that the suppliers quality assurance program is still committed to meeting the requirements of 10 CFR 50, Appendix B.
b) For commercial suppliers who are approved based on commercial grade survey, verification the supplier has maintained adequate documented programmatic controls in place for the activities affecting the critical characteristics of the items/
services being procured.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 43 of 52 c) Evaluation of any significant open issues with the NRC, 10 CFR Part 21 Notifications, and any open findings since the previous triennial audits describing impact on the items/services being procured from that supplier.
d) Review of procurement history since last triennial audit/survey including receipt inspection results to identify any potential issues. The results of the performance history must be included in the evaluation.
e) The degree of standardization of the items being procured. For instance, suppliers of catalog items which are used across multiple industries with widely accepted good performance histories would be considered good candidates for a 25% (9-month) grace period.
- 2. If concerns are identified based on the above evaluation, the following mitigating actions may be considered:
a) Enhanced receiving inspections beyond visual inspections and quality checks.
b) Identification of any additional requirements/restrictions to be placed on the supplier.
- 3. For audits/surveys performed during the 25% grace period, the audit/survey shall include a review of activities performed by the supplier since the 36-month audit/survey expiration date.
- 4. The allowance would only apply to existing suppliers on ES Approved Supplier List.
- 5. The 25% grace period discussed above is applicable to domestic and international suppliers.
- 6. For audits/surveys performed during the 25% grace period, the audit/survey clock does not have to reset backwards to the original expiration date for which the audit/survey should have been performed. The end of the audit or survey would determine the date of the next triennial audit/survey.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 44 of 52 PART III NON-SAFETY-RELATED SSC QUALITY CONTROL SECTION 1 NON-SAFETY-RELATED SSCs / SIGNIFICANT CONTRIBUTORS TO PLANT SAFETY Specific program controls are applied to non-safety-related SSCs, for which 10 CFR 50, Appendix B is not applicable, that are significant contributors to nuclear plant safety. The specific program controls consistent with applicable sections of the QAPD are applied to those items in a selected manner, targeted at those characteristics or critical attributes that render the SSC a significant contributor to nuclear plant safety or as important to safety as determined by applicable regulation(s).
For non-safety-related SSCs and associated activities, implementation of NQA-1-2022, Parts I, II and Part IV is not required, but may be invoked when required by regulation or at the discretion of ES. Similarly, the commitments made in Part II of the document regarding the applicability of Regulatory Guide 1.28, Revision 6, do not apply to non-safety related SSCs and associated activities, but may be invoked when required by regulation or at the discretion of ES.
The following clarify the applicability of the QA Program to the non-safety-related SSCs and related activities, including the identification of exceptions to the QA Program described in Part II, Sections 1 through 18 taken for non-safety-related SSCs.
1.1 Organization The verification activities described in this part may be performed by the ES line organization. The QA organization described in Part II is not required to perform these functions.
1.2 QA Program ES QA requirements for non-safety-related SSCs (i.e., Important To Safety (ITS) are established in the 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. SSCs that have been categorized as Not Important to Safety (NITS) are outside the scope of the QAPD.
The following further defines how ES will implement the requirements of this program:
For ITS Category A (as defined in NUREG-CR-6407) SSCs will be treated as Safety Related and the requirements of Part II of the document will apply.
For ITS Category B and C (as defined in NUREG-CR-6407) SSCs will be treated as Non-Safety Related and the requirements of Part III of this document will apply.
SSCs that have been categorized as Not Important to Safety (NITS) (as defined in NUREG-CR-6407) are outside the scope of this QAPD.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 45 of 52 For Decommissioning activities as prescribed in NUREG-1757, QA Program requirements will meet those defined in Section 17.6 of NUREG-1757.
1.3 Design Control ES has design control measures to ensure that the contractually 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.
1.4 Procurement Document Control Procurement documents for items and services obtained by or for ES 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.
1.5 Instructions, Procedures, and Drawings ES 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.
1.6 Document Control ES 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.
1.7 Control of Purchased Items and Services ES 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.
1.8 Identification and Control of Purchased Items ES employs 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.
1.9 Control of Special Processes ES employs process and procedure controls for special processes, including welding, heat
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 46 of 52 treating, and nondestructive testing. These controls are based on applicable codes, standards, specifications, criteria, or other special requirements for the special process.
1.10 Inspection ES uses 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 are from the same discipline and have experience related to the work being inspected.
1.11 Test Control ES 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.
1.12 Control of Measuring and Test Equipment (M&TE)
ES employs measures to control M&TE use, and calibration and adjustment at specific intervals or prior to use.
1.13 Handling, Storage, and Shipping ES employs measures to control the handling, storage, cleaning, packaging, shipping, and preservation of items to prevent damage or loss and to minimize deterioration. These measures include appropriate marking or labels, and identification of any special storage or handling requirements.
1.14 Inspection, Test, and Operating Status ES 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.
1.15 Control of Nonconforming Items ES employs measures to identify and control items that do not conform to specified requirements to prevent their inadvertent installation or use.
1.16 Corrective Action ES employs measures to ensure that failures, malfunctions, deficiencies, deviations, defective components, and nonconformances are properly identified, reported, and corrected.
1.17 Records
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 47 of 52 ES 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.
1.18 Audits ES employs measures for line management to periodically review and document the adequacy of the process, 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 part (Part III) are implemented by the same programs, processes, or procedures as the comparable activities of Part II, the audits performed under the provisions of Part II may be used to satisfy the review requirements of this Section (Part III, Section 1.18).
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 48 of 52 SECTION 2 NON-SAFETY-RELATED SSCs 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; ES implements quality requirements for the fire protection system in accordance with Regulatory Position 1.7, "Quality Assurance," in Regulatory Guide 1.189, Fire Protection for Nuclear Power Plants, Revision 5, October 2023 for Nuclear Development activities.
ES implements the quality requirements for ATWS equipment in accordance with Part III, Section 1.
ES implements quality requirements for SBO equipment in accordance with Part III, Section 1.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 49 of 52 PART IV REGULATORY COMMITMENTS NRC Regulatory Guides and Quality Assurance Standards This section identifies the NRC Regulatory Guides (RG) and the other quality assurance standards which have been selected to supplement and support the ES QAPD. ES complies with these standards to the extent described or referenced. Commitment to a particular RG or standard does not constitute a commitment to other RGs or standards that may be referenced therein.
Section 1 Regulatory Guides Regulatory Guide 1.26, [Revision 6, December 2021] - Quality Group Classifications and Standards for Water-, Steam-, and Radioactive-Waste-Containing Components of Nuclear Power Plants.
Regulatory Guide 1.26 describes a quality classification system used to determine quality standards acceptable to the staff of the U.S. Nuclear Regulatory Commission for satisfying General Design Criteria 1 Quality Standards and Records of 10 CFR 50 Appendix A for components containing water, steam, or radioactive material in light-water-cooled nuclear power plants.
ES identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in applicable license applications and documents.
Regulatory Guide 1.28, [Revision 6, September 2023] - Quality Assurance Program Criteria (Design and Construction).
Regulatory Guide 1.28 describes a methods acceptable to the staff of the U.S. Nuclear Regulatory Commission 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 and construction of nuclear power plants.
ES identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in applicable license applications and documents.
Regulatory Guide 1.29, [Revision 6, July 2021] - Seismic Design Classification for Nuclear Power Plants.
Regulatory Guide 1.29 describes a method acceptable to the staff of the U.S. Nuclear Regulatory Commission for identifying and classifying those features of light-water-reactors designed to withstand the effects of a safe shutdown earthquake (SSE).
ES identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in applicable license applications and documents.
Regulatory Guide 1.54, [Revision 3, April 2017] - Service Level I, II, and III Protective Coatings Applied to Nuclear Power Plants.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 50 of 52 Regulatory Guide 1.54 describes a method acceptable to the staff of the U.S. Nuclear Regulatory Commission for the selection, application, qualification, inspection, and maintenance of protective coatings applied to nuclear power plants.
ES identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in applicable license applications and documents.
Regulatory Guide 1.87, (Draft Regulatory Guide DG-1436, Proposed Revision 3 to Regulatory Guide 1.87, issued December 2024, Acceptability of ASME Code Section III, Division 5, High Temperature Reactors Appendix A, High Temperature Reactor Quality Group Classification.
Regulatory Guide 1.87, Appendix A provides guidance on establishing quality group assignments of mechanical systems and components of non-light-water reactors acceptable to the U.S. Nuclear Regulatory Commission (NRC) staff for all the safety classification methods.
ES identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in applicable license applications and documents.
Regulatory Guide 1.164, [Revision 1, April 2024] - Dedication of Commercial-Grade Items for Use in Nuclear Power Plants.
Regulatory Guide 1.164 describes methods that the staff of the U.S. Nuclear Regulatory Commission (NRC) considers acceptable in meeting regulatory requirements for dedication of commercial-grade items and services used in nuclear power plants.
ES identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in applicable license applications and documents.
Regulatory Guide 1.189, [Revision 5, October 2023] - Fire Protection for Nuclear Power Plants.
Regulatory Guide 1.189 describes an approach that is acceptable to the staff of the U.S.
Nuclear Regulatory Commission (NRC) to meet the regulatory requirements of Title 10 of the Code of Federal Regulations (10 CFR) section 50.48(a) and (b), and 10 CFR Part 50, Appendix R, Fire Protection Program for Nuclear Power Facilities Operating Prior to January 1, 1979. These regulations state the requirements governing a civilian nuclear power generating plants fire protection program (FPP).
ES identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in applicable license applications and documents.
Regulatory Guide 1.191, [Revision 1, January 2021] - Fire Protection for Nuclear Power Plants During Decommissioning and Permanent Shutdown.
Regulatory Guide 1.191 describes methods acceptable to the U.S. Nuclear Regulatory Commission (NRC) staff for complying with the NRCs regulations for fire protection programs for licensees that have certified that their plants have permanently ceased operations and that the fuel has been permanently removed from the reactor vessels. The NRC describes these certifications for decommissioning in 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities, Section 50.82, Termination of license
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 51 of 52 and 10 CFR 52.110, Termination of licenses.
ES identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in applicable license applications and documents.
Regulatory Guide 1.231, [Revision 0, December 2016] - Acceptance of Commercial Grade Design and Analysis Computer Programs Used in Safety Related Applications for Nuclear Power Plants.
Regulatory Guide 1.231 describes methods that the staff of the U.S. Nuclear Regulatory Commission (NRC) considers acceptable in meeting regulatory requirements for acceptance and dedication of commercial-grade design and analysis computer programs used in safety-related applications for nuclear power plants.
ES identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in applicable license applications and documents.
Regulatory Guide 1.232, [Revision 0, April 2018] - Guidance for Developing Principal Design Criteria for Non-Light Water Reactors.
Regulatory Guide 1.232 describes the Nuclear Regulatory Commissions (NRCs) proposed guidance on how the general design criteria (GDC) in Appendix A, General Design Criteria for Nuclear Power Plants, of Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities, (Ref. 1), may be adapted for non-light-water reactor (non-LWR) designs. This guidance may be used by non-LWR reactor designers, applicants, and licensees to develop principal design criteria (PDC) for any non-LWR designs, as required by the applicable NRC regulations, for nuclear power plants. The RG also describes the NRCs proposed guidance for modifying and supplementing the GDC to develop PDC that addresses two specific non-LWR design concepts: sodium cooled fast reactors (SFRs), and modular high temperature gas-cooled reactors (MHTGRs).
ES identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in applicable license applications and documents.
Regulatory Guide 1.233, [Revision 0, June 2020] - Guidance for a Technology-Inclusive, Risk-Informed, and Performance Based Methodology to Inform the Licensing Basis and Content of Applications for Licenses, Certifications, and Approvals for Non-Light Water Reactors.
Regulatory Guide 1.233 provides the U.S. Nuclear Regulatory Commission (NRC) staffs guidance on using a technology-inclusive, risk-informed, and performance-based methodology to inform the licensing basis and content of applications for non-light-water reactors (non-LWRs), including, but not limited to, molten salt reactors, high-temperature gas-cooled reactors, and a variety of fast reactors at different thermal capacities.
ES identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in applicable license applications and documents.
Regulatory Guide 1.234, [Revision 1, March 2024] - Evaluating Deviations and Reporting Defects and Noncompliance Under 10 CFR Part 21.
EnergySolutions 10 CFR 50 Appendix B Quality Assurance Program Description ES-QA-PG-003, Revision 0 Page 52 of 52 Regulatory Guide 1.234 describes methods that the staff of the U.S. Nuclear Regulatory Commission (NRC) considers acceptable for complying with the provisions of Title 10 of the Code of Federal Regulations (10 CFR) Part 21, Reporting of Defects and Noncompliance.
ES identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in applicable license applications and documents.
Section 2 Standards ASME NQA-1-2022-Quality Assurance Requirements for Nuclear Facility Applications ES commits to NQA-1-2022, Parts I and II, as described in Part II of this document with specific identification of exceptions or clarification.
Section 3 Other NEI 14-05A - Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, Revision 1 ES commits follow the guidance in NEI 14-05A, revision 1 as endorsed by Regulatory Guide 1.28, revision 6 and addressed in Part II, Section 7.2.
Nuclear Information and Records Management Association, Inc. (NIRMA)
Technical Guides (TGs)
ES commits to NIRMA TGs as described in Part II, Section 17.