ML25308A252

Quality Assurance Program Manual

ML25308A252
Person / Time
Site:	07000754, Vallecitos Nuclear Center
Issue date:	10/31/2025
From:	Self L NorthStar Vallecitos
To:	Office of Nuclear Material Safety and Safeguards, Office of Nuclear Reactor Regulation, Document Control Desk
References
NSV 25-022
Download: ML25308A252 (1)

Text

Luke M. Self Vice President, NorthStar Vallecitos 10 CFR 71.106(b) 10 CFR 50.54(a)(3)

NSV 25-022 October 31, 2025 ATTN: Document Control Desk U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

SUBJECT:

Quality Assurance Program Manual Vallecitos Nuclear Center Docket Nos.70-754 and 50-73 License No. SNM-960 and R-33

REFERENCES:

1. Letter, NRC to NorthStar Vallecitos, LLC, Issuance of Amendment No. 25 to Indemnity Agreement No. B-11, dated September 26, 2024 (ML24266A219(P)).

2. Letter, NorthStar Vallecitos, LLC, Vallecitos Boiling Water Reactor Request for Exemption from License Termination Requirements in 10 CFR part 20 and Request for License Termination - Approval (L-2025-LLE-0009 and L-2025-LLA-0031) (License No. DPR-1, Docket No. 50-18), dated August 27, 2025 (ML25199A097, ML25199A099).

Dear Sir or Madam:

In accordance with 10 CFR 71.106(b) and 10 CFR 50.54(a)(3) Vallecitos Nuclear Center (VNC) hereby submits (Enclosure) Revision 0 to the NorthStar VNC Quality Assurance Program Manual (QAPM).

This change to the VNC QAPM reflects recent changes due to the transfer of the VNC licenses from General Electric Hitachi to NorthStar Vallecitos, LLC. Specifically, by order dated April 25, 2024 (Agencywide Documents Access and Management System Package Accession No. ML24039A011), the U.S. Nuclear Regulatory Commission (NRC) staff approved the license transfer application dated September 1, 2023 (ML23244A247), submitted by GE-Hitachi Nuclear Energy Americas, LLC and NorthStar Vallecitos, LLC. The Issuance of the conforming license amendments related to the order approving the transfer of the VNC licenses was issued on March 14, 2025 (ML24053A122, ML24053A121 and ML24046A092). At the time of the license transfer, the GEH Quality Assurance Program Description was in effect (ML24115A078).

Changes made throughout the VNC QAPM include the following: references of General Electric Hitachi (GEH) have been changed to NorthStar Vallecitos, LLC (NSV); and changed titles of positions to reflect the NSV naming conventions.

NorthStar Vallecitos, LLC 6705 Vallecitos Rd.

Sunol, Ca 94586 www.northstar.com

NSV 25-022 / Page 2 of 2 The following additional changes were made during this QAPM revision:

Section 1, Organization - Updated the titles of the organizations positions to reflect the NorthStar naming conventions.

Section 2, Quality Assurance Program - GE Section 2.2.2; removed the parenthetical referencing hardware and software.

Section 3, Design Control - GE Section 3.1.3 & 3.8, References to software quality assurance (QA) have been removed. NSV does not intend to use quality-related software for safety-significant analysis or design activities. This change does not represent a reduction in commitment; rather, it reflects the decision to eliminate the use of QA-related software entirely, thereby making such references unnecessary.

Section 4, Procurement Document Control - GE Section 4.2, References to software quality assurance (QA) have been removed. NSV does not intend to use quality-related software for safety-significant analysis or design activities. This change does not represent a reduction in commitment; rather, it reflects the decision to eliminate the use of QA-related software entirely, thereby making such references unnecessary.

Section 5, Instructions, Procedures and Drawings - No changes.

Section 6, Document Control - No changes.

Section 7, Control of Purchased Material, Equipment and Services - No change of intent.

Section 8, Identification and Control of Material, Parts and Components - No change of intent.

Section 9, Control of Special Processes - No change of intent.

Section 10, Inspection - GE Section 10.3.8.3, References to computer software have been removed. NSV does not intend to use quality-related software for safety-significant analysis or design activities. This change does not represent a reduction in commitment; rather, it reflects the decision to eliminate the use of QA-related software entirely, thereby making such references unnecessary.

Section 11, Test and Control - No change of intent.

Section 12, Control of Measuring and Test Equipment - No change of intent.

Section 13, Handling, Storage and Shipping - No change of intent.

Section 14, Inspection, Test and Operating Status - No change of intent.

Section 15, Nonconforming Materials, Parts and Components - No change of intent.

Section 16, Corrective Action - No change of intent.

Section 17, Quality Assurance Records - No change of intent.

Section 18, Audits - No change of intent.

An evaluation of this QAPM revision in accordance with 10 CFR 71.106 has determined that the proposed changes do not constitute a reduction in commitment of the plan and that the plan continues to meet the standards of 10 CFR 50 Appendix B as applicable.

The 10 CFR 71 Quality Assurance Program Approval, No. 0254, which applies to radioactive material packages applied to GEH facilities, which included the VNC facility. Accordingly, NSV hereby requests that a facility specific Form 311 be issued for the VNC.

This letter contains no new regulatory commitments.

NSV 25-022 / Page 3 of 2 Should you have any questions concerning this letter, please contact Mr. Thomas B. Silko at (802) 451-5354, Ext 2506.

I declare under penalty of perjury that the foregoing is true and correct to the best of my knowledge.

Sincerely, Signature Executed On (Date)

Luke M. Self, Vice President, NorthStar Vallecitos LMS/tbs

Enclosure:

Quality Assurance Program Manual.

cc: Director, Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, DC 20555 Regional Administrator, Region 4 U.S. Nuclear Regulatory Commission 1600 East Lamar Boulevard Arlington, Texas 76011-4511 Signature 10/31/25

NSV 25-022 Docket Nos.70-754, 50-73 Enclosure Vallecitos Nuclear Center Quality Assurance Program Manual (19 pages excluding this cover page)

Effective: October 2025 Revision 0 Vallecitos Nuclear Center Docket 50-183, License DR-10, EVESR Docket 50-70, License TR-1, GETR Docket 50-73, License R-33, NTR Docket 70-754, License SNM-960 Quality Assurance Program Manual NSV 25-022 / Enclosure / Page 1 of 19

VNC QUALITY ASSURANCE PROGRAM MANUAL Revision 0 POLICY STATEMENT NorthStar Vallecitos, LLC (NorthStar) shall maintain and operate Vallecitos Nuclear Center (VNC) in a manner that will ensure the health and safety of the public and workers. The facility shall be maintained in compliance with the requirements of the Code of Federal Regulations, the applicable Nuclear Regulatory Commission (NRC) Facility Licenses, and applicable laws and regulations of the state and local governments.

The Quality Assurance Program (QAP) described herein and associated implementing documents provide for control of activities that affect the quality of structures, systems, and components (SSCs) classified as important-to-safety (ITS) to satisfy the requirements of 10 CFR 71 and Items Relied on for Safety (IROFS) to satisfy the requirements for Special Nuclear Material (SNM) managed under 10 CFR 70. There are no safety-related SSCs or activities remaining at VNC controlled under 10 CFR 50, nor any Items Relied on For Safety (IROFS) for SNM managed under 10 CFR 70.

This Quality Assurance Program Manual (QAPM) is the top-level policy document that establishes the manner in which quality is to be achieved and presents our 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 QAPM. Compliance with the QAPM and implementing documents is mandatory for personnel directly or indirectly associated with implementation of the QAP.

NSV 25-022 / Enclosure / Page 2 of 19

VNC QUALITY ASSURANCE PROGRAM MANUAL Revision 0 TABLE OF CONTENTS SECTION PAGE Policy Statement 1.0 Organization 5 2.0 Quality Assurance Program 7 3.0 Design Control 8

4.0 Procurement Document Control 10 5.0 Instructions, Procedures and Drawings 10 6.0 Document Control 11 7.0 Control of Purchased Material, Equipment and Services 11 8.0 Identification and Control of Material, Parts and Components 11 9.0 Control of Special Processes 12 10.0 Inspection 12 11.0 Test Control 12 12.0 Control of Measuring and Test Equipment 13 13.0 Handling, Storage and Shipping 13 14.0 Inspection, Test and Operating Status 13 15.0 Nonconforming Materials, Parts and Components 14 16.0 Corrective Action 15 17.0 Quality Assurance Records 15 18.0 Audits 15 Appendix A - Important-to-Safety Structures, Systems and Components 14 Appendix B - Regulatory Commitments 15 Appendix C - Administrative Controls 16 NSV 25-022 / Enclosure / Page 3 of 19

VNC QUALITY ASSURANCE PROGRAM MANUAL 1

1.0 Organization The organizational structure responsible for implementation of the QAPM is described below. The organizational structure consists of corporate and VNC functions. The specific organization titles for the quality assurance functions described are identified in procedures.

The authority to accomplish the quality assurance functions described is delegated to staff as necessary to fulfill the identified responsibility.

a. Corporate Organization The NorthStar president is responsible for overall corporate policy and provides executive direction and guidance for the corporation as well as promulgates corporate policy through the Companys senior management staff. Responsibility for developing, implementing, and verifying execution of the Quality Assurance Program is delegated to the nuclear executive. The authority for developing and verifying execution of the program is delegated to the management position responsible for nuclear oversight.

The nuclear executive is responsible for providing top-level direction for the safe management of VNC's nuclear site. This executive provides guidance with regard to the company quality assurance policy. The results of Independent Management Assessments are reported to this executive. The nuclear executive establishes the policies, goals, and objectives of the quality assurance policy and ensures guidance and interpretation for implementing the company quality assurance policy are provided. The management position responsible for nuclear oversight is the individual responsible for ensuring the implementation of the quality assurance program is in accordance with regulatory requirements.

b. VNC Site Organization The following site management positions describe the typical site QAPM functional responsibilities, which may be delegated to others as established in this document.

These functions may be performed by the same individuals and may report through an additional layer of management but shall maintain sufficient authority and organizational freedom to implement the assigned responsibilities.

1. The VNC top level management position reports to the nuclear executive and is responsible for VNC site activities and implementing quality assurance policies, goals and objectives. These responsibilities also include, but are not limited to functional areas, such as engineering, procurement, security, information technology, project management, emergency planning, and technical services.

2. A management position that is responsible for overall SNM operational activities is accountable for maintaining the facility within the constraints of applicable regulatory requirements and the operating license, including training. Different aspects of these responsibilities may be fulfilled by separate management positions.

3. A management position that is responsible for engineering and technical services is responsible for the development and maintenance of engineering programs, facility design bases, policies, and procedures and for providing engineering services.

Other responsibilities include licensing, corrective action program, records NSV 25-022 / Enclosure / Page 4 of 19

VNC QUALITY ASSURANCE PROGRAM MANUAL 2

management, document control and information technology. Different aspects of these responsibilities may be fulfilled by separate managers.

4.

The management position that is responsible for quality assurance has overall authority and responsibility for establishing, controlling, and verifying the implementation and adequacy of the quality assurance program as described in this QAPM. This position has the authority and responsibility to escalate matters directly to the nuclear executive, if necessary.

5.

A management position that is responsible for materials, purchasing, and contracts is responsible for procurement, services, receipt, storage, and issue of materials, parts, and components. Different aspects of these responsibilities may be fulfilled by separate site managers.

6.

A management position that is responsible for radiation protection activities. This management position is responsible for the implementation of the Radiation Protection Program, Radiological Environmental Monitoring Program, Radiological Effluent Controls Program, and Radioactive Waste Shipping.

c.

Independent Review The Independent Safety Review function and Independent Management Assessments independently review activities to provide additional assurance that VNC is maintained in accordance with the Possession Only and Materials Licenses and applicable regulations that address nuclear safety. The independent safety review function is described in Appendix C.

d. Responsibility 1.

VNC management has the responsibility for the scope and implementation of an effective quality assurance program.

2.

VNC management may delegate all or part of the activities of planning, establishing, and implementing the quality assurance program to others, but retains the responsibility for the program's effectiveness.

3.

VNC management is responsible for ensuring that the applicable portion(s) of the quality assurance program is properly documented, approved, and implemented (people are trained and resources are available) before an activity within the scope of the QAPM is undertaken.

4.

Individual management positions are to ensure that personnel working under their management cognizance are provided the necessary training and resources to accomplish their assigned tasks within the scope of the QAPM.

5.

Procedures that implement the QAPM are approved by the management position responsible for the applicable quality function. These procedures are to reflect the QAPM and work is to be accomplished in accordance with them.

6.

The Independent Management Assessments are periodically performed to monitor overall performance and confirm that activities affecting quality comply with the QAPM and that the QAPM is effectively implemented. The Independent Management NSV 25-022 / Enclosure / Page 5 of 19

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Assessment is performed by individual(s) designated by the nuclear executive, independent of activities assessed and who provide the appropriate level of expertise in the activities assessed. The Independent Management Assessment results are communicated in an understandable form and in a timely fashion to a level of management having the authority to effect corrective action. In addition, these results are reported in a timely fashion to the nuclear executive.

e. Authority

1. When VNC management delegates responsibility for planning, establishing, or implementing any part of the overall QA program, sufficient authority to accomplish the assigned responsibilities is delegated.

2. The management position responsible for quality assurance has the responsibility and the authority to stop unsatisfactory work and control further processing, delivery, installation, or use of non-conforming items or services. Cost and schedule considerations will not override safety considerations.

2.0 Quality Assurance Program The Quality Assurance Program (QAP) for VNC is described in this QAPM. This QAPM provides control over important to safety and selected decommissioning related activities to an extent consistent with their importance to ensure safety and compliance as defined in procedures. The QAPM includes specific monitoring activities which are measured against acceptance criteria in a manner sufficient to provide VNC management assurance that the important to safety activities are performed in an acceptable manner. The VNC QAPM requirements apply to SSCs designated as important to safety defined in Appendix B and those administrative requirements associated the regulatory programs defined in Appendix C.

The QAPM satisfies the requirements of 10 CFR 50 Appendix B Quality Assurance Criteria for Nuclear Power Plants and Fuel Processing Plants, 10 CFR 71, Subpart H, Quality Assurance for Packaging and Transportation of Radioactive Material, and 10 CFR 70, Domestic Licensing of Special Nuclear Material. Additional regulatory commitments are listed within Appendix B of the QAPM. Implementation of the VNC QAPM is controlled through separately issued procedures, instructions and drawings. Each organization is responsible for the establishment and implementation of procedures and instructions prescribing the important to safety activities for which they are responsible.

Important to safety activities shall be accomplished under suitably controlled conditions.

Controlled conditions include the use of appropriate equipment; suitable environmental conditions for accomplishing the activity, such as adequate cleanliness; and assurance that all prerequisites for the given activity have been satisfied. The QAP takes into account the need for special controls, processes, test equipment, tools, and skills to attain the required quality, and the need for verification of quality by inspection and test.

Changes to the QAPM will be implemented in accordance with 10 CFR 50.54(a) and 10 CFR 71.106.

NSV 25-022 / Enclosure / Page 6 of 19

VNC QUALITY ASSURANCE PROGRAM MANUAL 4

Program Control and Authority The manager responsible for quality assurance is responsible for ensuring that the applicable portions of the QAPM are properly documented, approved and implemented (with trained staff, necessary materials and approved procedures) before an activity within the scope of the QAPM is executed. Disputes arising between departments or organizations on any QA matter that cannot be resolved at a lower level of management will be referred to the nuclear executive.

Additional requirements for specific programs are described in Appendix C, Administrative Controls.

Personnel Training and Qualifications Individual managers are responsible for ensuring that personnel working under their cognizance are provided with the necessary training and resources to accomplish assigned activities which fall under the scope of the QAPM.

Members of the VNC staff (including audit and inspection personnel) shall have the appropriate qualifications necessary to perform their assigned duties defined in implementing procedures.

These implementing procedures provide the criteria utilized for determining and assessing appropriate staff qualification. Additionally, Appendix C cites references that stipulate the use of specific industry standards addressing qualifications. Training programs are established and implemented to ensure that personnel achieve and maintain suitable proficiency. Personnel training and qualification records are maintained in accordance with approved procedures.

QA Lead Auditors are qualified and certified by the manager responsible for quality assurance in accordance with approved procedures. Training methods, minimum experience requirements, and certification practices are in accordance with established procedures and based on criteria set forth in QA implementing procedures. Proficiency evaluations are performed and documented as defined in approved procedures.

Records of the implementation for staff training, as well as records for audit and inspection personnel qualification shall be maintained in accordance with approved procedures and show the appropriate documentary evidence of training completion.

Performance/Verification

a.

Personnel performing work activities such as design, engineering, procurement, installation, maintenance, modification, operation, and decommissioning are responsible for achieving acceptable quality.

b.

Personnel performing independent verification activities are responsible for verifying the achievement of acceptable quality and are different personnel than those who performed the work.

c.

Work is accomplished and verified using instructions, procedures, or other appropriate means that are of a detail commensurate with the activitys complexity and importance to safety.

d.

Criteria that define acceptable quality are specified, and quality is verified against these criteria.

NSV 25-022 / Enclosure / Page 7 of 19

VNC QUALITY ASSURANCE PROGRAM MANUAL 5

3.0 Design Control The program will ensure that activities associated with the design of important to safety structures, systems and components and modifications thereto, are executed in a planned, controlled, and orderly manner.

The program utilizes the guidance of NUREG/CR-6407 to classify structures, systems and components such that appropriate quality requirements are identified and documented on drawings, component lists, or procurement documents, as applicable.

The program includes provisions to control design inputs, processes, outputs, changes, interfaces, records, and organizational interfaces.

Design inputs (e.g., performance, conditions of the facility license, quality, and quality verification requirements) shall be correctly translated into design outputs (e.g., specifications, drawings, procedures, and instructions).

The final design output shall relate to the design input in sufficient detail to permit verification.

The design process shall ensure that materials, parts, equipment and processes are selected and independently verified consistent with their importance to safety to ensure they are suitable for their intended application.

Changes to final designs (including field changes and modifications) and dispositions of non-conforming items to either use-as-is or repair shall be subjected to design control measures commensurate with those applied to the original design and approved by the organization that performed the original design or a qualified designee. The current design requirements for VNC are identified in Appendix A. Subsequent changes to the original design can be made by VNC as defined in the design control process.

Interface controls (internal and external between participating design organizations and across technical disciplines) for the purpose of developing, reviewing, approving, releasing, distributing, and revising design inputs and outputs shall be defined in procedures.

Design documentation and records, which provide evidence that the design and design verification process was performed in accordance with the QAP, shall be collected, stored, and maintained in accordance with documented procedures. This documentation includes final design documents, such as drawings, and specifications, and revisions thereto and documentation which identifies the important steps, including sources of design inputs that support the final design.

Design Verification The program will verify the acceptability of design activities and documents for the design of items.

The selection and incorporation of design inputs and processes, outputs and changes are verified.

Verification methods include, but are not limited to, design reviews, alternative calculations, and qualification testing. The extent of this verification will be a function of the importance to safety of the item, the complexity of the design, the degree of standardization, the state of the art, and the similarity with previously proven designs.

When a test program is used to verify the acceptability of a specific design feature, the test NSV 25-022 / Enclosure / Page 8 of 19

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program will demonstrate acceptable performance under conditions that simulate the most adverse design conditions that are expected to be encountered.

Independent design verification is to be completed before 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 this timing cannot be achieved, the unverified portion of the design is to be identified and controlled. In all cases, the design verification is to be completed before relying on the item to perform its Important to safety function.

Individuals or groups responsible for design reviews or other verification activities shall be identified in procedures and their authority and responsibility shall be defined and controlled. Design verification shall be performed by any competent individuals or groups other than those who performed the original design but who may be from the same organization. The designers immediate supervisor or manager may perform the design verification and controls for this are defined in approved procedures.

Design verification procedures are to be established and implemented to ensure that an appropriate verification method is used, the appropriate design parameters to be verified are chosen, the acceptance criteria is identified, the verification is satisfactorily accomplished, and the results are properly recorded.

4.0 Procurement Document Control The program will ensure that purchased items and services are of acceptable quality.

The program includes provisions for evaluating prospective suppliers and ensuring that selected suppliers continue to provide acceptable products and services.

The program includes provisions for taking corrective action with suppliers (qualified or otherwise) whose products and services are not considered acceptable.

The program includes provisions for source verification (inspection, audit, etc.) for accepting purchased items and services identified as important to safety when determined necessary.

The program includes provisions for invoking applicable technical, regulatory, administrative, and reporting requirements (e.g., specification, codes, standards, tests, inspections, special processes, records, certifications, 10 CFR 21) applicable to the procurement to be specified in procurements documents.

The program includes provisions for ensuring that documented evidence of an items conformance to procurement requirements is available at the site before the item is placed in service or used unless otherwise specified in procedures.

The program includes provisions for ensuring that procurement, inspection, and test requirements have been satisfied before an item is placed in service or used unless otherwise specified in procedures.

The procurement of components, including spare and replacement parts, is subject to quality and technical requirements suitable for their intended service.

NSV 25-022 / Enclosure / Page 9 of 19

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The program includes provisions for the identification of critical characteristics and methods of acceptance for the dedication of a commercial grade item or service for its use in an important to safety function(s).

5.0 Instructions, Procedures and Drawings Measures are established to assure that quality activities are prescribed by and performed in accordance with documented instructions, procedures, or drawings. These instructions, procedures, and drawings include as appropriate, quantitative or qualitative acceptance criteria for determining that activities have been satisfactorily accomplished. Controls are established which ensure that instructions, procedures, and drawings are current and accurately reflect the facility design and regulatory requirements.

Changes or deviations from established instructions, procedures or drawings for SSCs and other quality activities that have current important to safety functions, require the same review and approval as the original document. Instructions, procedures and drawings, including changes and deviations subject to the VNC QAPM, shall be maintained as required by administrative procedures.

Administrative controls may be established that provide the methods by which temporary changes can be made to procedures which are approved, including the designation of persons authorized to approve such changes.

6.0 Document Control The program will control the development, review, approval, issue, use, and revision of documents.

The scope of the document control program includes, but is not limited to:

a. NRC License Documents, including Technical Specifications;

b. Design Documents and Drawings;

c. Procurement Documents;

d. Procedures, Manuals, Plans, Directives, Policies, Instructions, etc.;

e. Corrective Action Documents; and

f.

Other documents as defined in procedures.

Revisions of controlled documents are reviewed for adequacy and approved for release by the same organization that originally reviewed and approved the documents or by a designated organization that is qualified and knowledgeable.

Copies of controlled documents are distributed to and used by the person performing the activity.

The distribution of new and revised controlled documents is in accordance with procedures.

Superseded documents are controlled to prevent inadvertent use.

NSV 25-022 / Enclosure / Page 10 of 19

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7.0 Control of Purchased Materials, Equipment and Services The program will verify the quality of purchased items and services at intervals and to a depth consistent with the items or services importance to safety, complexity and quality of the item or service. Control of items and services for important to safety applications are clearly and adequately specified in procurement documents.

The program is executed in all phases of procurement. As necessary, this may require verification of activities of suppliers below the primary supplier of the item or service.

Procedures shall describe each organizations responsibilities for the control of purchased material, equipment and services including the interfaces between all affected organizations.

Controls for the audits or surveys of suppliers providing important to safety items and services are provided for in Section 18.

Controls for the inspection (source verification / surveillance / inspection) of suppliers providing important to safety items and services are provided for in Section 10.

8.0 Identification and Control of Materials, Parts and Components The program will identify and control important to safety items to prevent the use of incorrect or defective items. Identification of each item is maintained throughout fabrication, erection, installation, and use so that the item can be traced to its documentation. Traceability is maintained to an extent consistent with the items importance to safety.

9.0 Control of Special Processes This program will ensure that special processes identified as important to safety are properly controlled. The criteria that establish which processes are special are described in procedures.

The following are examples of special processes:

a. Welding;

b. Heat treating;

c. NDE (Non-Destructive Examination);

d. Chemical cleaning; and

e. Unique fabricating or test processes which require in-process controls.

Special processes are accomplished by qualified personnel, using appropriate equipment, and procedures in accordance with applicable codes, standards, specifications, criteria, and other special requirements.

10.0 Inspection The program will ensure inspections of important to safety activities are planned, executed and documented in order to verify conformance with instructions, procedures and drawings for accomplishing the activity.

NSV 25-022 / Enclosure / Page 11 of 19

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Provisions to ensure inspection planning is properly accomplished are to be established. Planning activities shall identify the characteristics and activities to be inspected, the inspection techniques, the acceptance criteria, and the organization responsible for performing the inspections.

Provisions to identify any required inspection hold points, beyond which work is not to proceed without the consent of the inspection organizations are to be defined.

Inspection results are to be documented by the inspector and reviewed by qualified personnel.

Unacceptable inspection results shall be evaluated and resolved in accordance with procedures.

Inspections are performed by qualified personnel other than those who performed or directly supervised the work being inspected. While performing the inspection activity, inspectors functionally report to the nuclear safety manager.

11.0 Test Control The program will demonstrate that items will perform satisfactorily in service using approved test procedures. The test control program includes, as appropriate, proof tests before installation, pre-operational tests, post-maintenance tests, post-modification tests, and operational tests. Test procedures shall be developed which include:

a. Instructions and prerequisites to perform the test.

b. Use of proper test equipment.

c. Acceptance criteria; and

d. Mandatory inspections, as required.

Test results are evaluated and documented to assure that test objectives and inspection requirements have been satisfied. Unacceptable test results shall be evaluated and documented for impact on safety and reportability.

12.0 Control of Measuring and Test Equipment The program will control the calibration, maintenance and use of measuring and test equipment consistent with activities important to safety to ensure accuracy.

Calibration reference standards shall be based on traceability to nationally recognized standards. Where national standards do not exist, M&TE is calibrated against standards that have an accuracy of at least four (4) times the required accuracy of the equipment being calibrated, or when this is not possible have an accuracy that ensures the equipment being calibrated will be within the required tolerance. Special calibration and control measures are not required when normal commercial practices provide adequate accuracy (e.g. rulers, tape measures, level, and other such devices).

The types of equipment covered by the program (e.g., instruments, tools, gages, and reference and transfer standards) are defined in procedures.

Measuring and test equipment is calibrated at specified intervals or immediately before use on the basis of the items required accuracy, intended use, frequency of use, stability characteristics and other conditions affecting its performance.

NSV 25-022 / Enclosure / Page 12 of 19

VNC QUALITY ASSURANCE PROGRAM MANUAL 10 Measuring and test equipment is labeled, tagged, or otherwise controlled to indicate its traceability to calibration test data.

Measuring and test equipment found damaged or out of calibration is tagged or segregated. The acceptability shall be determined of items measured, inspected, or tested with a damaged or out-of-calibration device.

13.0 Handling, Storage and Shipping The program will control the handling, storage, shipping, cleaning, and preserving of items important to safety to ensure the items maintain acceptable quality.

Special protective measures (e.g., containers, shock absorbers, accelerometers, inert gas atmospheres, specific moisture content levels and temperature levels, etc.) are specified and provided when required to maintain acceptable quality.

Specific procedures shall be developed and used for cleaning, handling, storage, packaging, shipping and preserving items when required to maintain acceptable quality.

Items are marked and labeled during packaging, shipping, handling, and storage to identify, maintain, and preserve the items integrity and identify the need for any special controls.

14.0 Inspection, Test and Operating Status The program will ensure that required inspections and tests and the operating status of items important to safety is verified before release, fabrication, receipt, installation, test, and use, as applicable. This verification is to preclude inadvertent bypassing of inspections and tests and to prevent inadvertent operation of controlled equipment. Operating status is identified by the use of tags, markings, stamps, or other suitable means.

Items whose required inspections and tests are incomplete or inconclusive may be released for further processing. Controls are provided in procedures for establishing limitations on the release, applying status indications and documenting the basis for the conditional release of the item and any limitations.

The application and removal of inspection, test, and operating status indicators are controlled in accordance with procedures.

15.0 Nonconforming Materials, Parts or Components VNC establishes measures to control important to safety materials, parts and components which do not conform to requirements. The measures used to control nonconforming materials, parts and components are described by approved procedures.

Management at all levels and each individual working at the facility is responsible for promptly identifying and reporting the identification of nonconforming materials, parts and components.

The corrective action program will be used to ensure the prompt identification, documentation, and correction of nonconforming materials, parts and components as described in Section 16.0.

NSV 25-022 / Enclosure / Page 13 of 19

VNC QUALITY ASSURANCE PROGRAM MANUAL 11 Nonconforming items are properly controlled by approved procedures describing the identification, documentation, segregation requirements disposition and notification to the affected organizations to prevent their inadvertent installation or use. Nonconforming items are reviewed and either accepted, rejected, repaired, or reworked in accordance with approved procedures.

16.0 Corrective Action Each individual working at the facility is responsible for promptly identifying and reporting conditions adverse to quality. Management at all levels encourages the identification of conditions that are adverse to quality.

Significant conditions adverse to quality shall require cause determination, a corrective action that should prevent recurrence, and be documented and reported to appropriate levels of management. Follow-up action shall be taken to verify effective implementation of the required corrective actions to prevent recurrence and to verify that they are effectively implemented.

Specific responsibilities within the corrective action program may be delegated, but the VNC nuclear executive maintains responsibility for the programs effectiveness.

Reports of conditions that are adverse to quality are analyzed to identify negative performance trends. Significant conditions adverse to quality and significant trends are reported to the appropriate levels of management.

17.0 Quality Assurance Records The program will ensure that sufficient records of important to safety items and activities affecting quality (e.g. design, engineering, procurement, manufacturing, construction, inspection and test, installation, pre-operation, startup, operations, maintenance, modification, decommissioning, and audits) are generated and maintained to reflect the completed work.

Controls for the administration, identification, receipt, storage, preservation, safekeeping, retrieval, and disposition of records are provided in procedures.

Management of the electronic storage of records will utilize the guidance provided in the following industry standards as described in approved procedures:

NIRMA TG 11-2011, Authentication of Records and Media NIRMA TG 15-2011, Management of Electronic Records NIRMA TG 16-2011, Software Quality Assurance Documentation and Records NIRMA TG 21-2011, Required Records Protection, Disaster Recovery and Business Continuation

• NIRMA - Nuclear Information and Records Management Association Records generated for SSCs that were once classified as safety-related or quality-related but no longer have a safety function do not need to be retained for purposes of the QAPM (but may need to be retained for other purposes, such as compliance with 10 CFR 50.75(g), other regulations, or for business reasons).

NSV 25-022 / Enclosure / Page 14 of 19

VNC QUALITY ASSURANCE PROGRAM MANUAL 12 18.0 Audits VNC establishes measures for a system of planned and documented audits in order to verify compliance with all aspects of the QAPM and determines the effective implementation of programs covered by the QAPM. QA internal and supplier audits are planned and performed by qualified auditors utilizing approved written procedures and/or checklists. External audits by licensees / utilities, Contractors, or Consultants acting for VNC to satisfy VNC audit requirements shall have the results evaluated by VNC to ensure acceptability.

Lead Auditors shall have experience, training or qualifications commensurate with the scope and complexity of their audit responsibility. Individuals performing audits shall not have direct responsibilities in the areas being audited.

Scheduling, preparation, personnel selection, performance, reporting, response, follow-up, and records management for audits are performed in accordance with written procedures. Audit scopes and schedules are based upon the status of work progress, important to safety activities being performed, and regulatory requirements. Internal audits for the VNC QAPM shall continue on a 24-month cycle with a 90-day grace period. Grace periods are not intended to be used repetitively, merely as an administrative convenience to extend audit intervals. Therefore, the next performance due date is based on the originally scheduled date.

When specific audits are identified as requiring a more frequent periodicity, the shortest periodicity will be adhered to for activities covered by those specific regulatory requirements.

The frequency of internal audits will be prescribed by the site implementing procedures which govern the conduct of QA audits.

External audits of suppliers providing important to safety materials, parts, equipment or services are scheduled and performed based on the importance of the activity and to confirm implementation of the suppliers QAP at a frequency of not less than three (3) years with a 90-day grace period. The supplier audit requirement shall not apply to standard off-the-shelf items and bulk commodities where required quality can adequately be determined by receipt inspection or post-installation test.

Audit reports shall be prepared, reviewed, approved and distributed in accordance with approved procedures.

Results of audits are reviewed with the management of the organization audited. Responsible management in the areas audited shall implement the necessary corrective actions required to address deficiencies. These actions are documented and reviewed periodically and, if needed, re-examined during re-audits of the subject area to verify deficient areas have completed corrective actions.

Audit records shall be retained in accordance with approved implementing procedures.

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VNC QUALITY ASSURANCE PROGRAM MANUAL 13 Appendix A IMPORTANT-TO-SAFETY STRUCTURES, SYSTEMS AND COMPONENTS The pertinent quality assurance requirements of 10 CFR 50 Appendix B and 10 CFR 71 Subpart H will be applied, as a minimum, to all quality activities affecting safety related and Important-to-Safety SSCs.

NOTE The safety classification of systems, structures, and components (SSCs) at the VNC facility may be revised based on engineering evaluations and a revision to the VNC safety basis documents. These modifications are controlled in accordance with the design control process and are not considered a reduction in the commitments to the QAPM.

The quality classification of NRC Licensed Transportation Packages may not be revised using the VNC Design Control Process. These modifications must be made by the NRC Certificate Holder. The Certificate Holder is responsible for design and licensing controls for these components under their NRC approved Quality Assurance Program. VNC utilizes these types of packages under the provisions of an NRC General License for Radioactive Material Transportation Packages (10 CFR 71).

Safety related SSCs are controlled through engineering processes. There are no safety related SSCs at the VNC facility for the 3 shutdown reactors. As stated in the SNM-960 application, VNC activities licensed under SNM-960 are excluded from the requirements of a 10 CFR 70 Integrated Safety Analysis and Items Relied on for Safety (IROFS). Nevertheless, applicable safety programs and management controls are effectively implemented.

Items and services associated with Radioactive Material Transport Packages subject to the provisions of 10 CFR 71, Subpart C, General Licenses are Important-to-Safety and subject to the applicable requirements of the QAP.

NOTES:

1.

No safety related SSCs remain at the VNC facility.

2.

For the definition of Quality Categories, A, B, and C refer to NUREG/CR-6407.

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VNC QUALITY ASSURANCE PROGRAM MANUAL 14 Appendix B Regulatory Commitments A.

Regulatory Guide 1.8 Revision 1, dated September 1975 Clarification/Exception

1. General VNC is committed to Sections 1 - 4 of ANSI/ANS 3.1-1978 with following clarifications and exceptions.

Qualification requirements for personnel shall meet ANSI/ANS 3.1-1978 except the following:

a.

The radiation protection manager shall meet or exceed the qualifications of ANSI/ANS 3.1-2014 (Section 4.3.3, Radiation Protection).

2. General The following qualifications may be considered equivalent to a bachelors degree:

a. 4 years of post-secondary schooling in science or engineering,

b. 4 years of applied experience at a nuclear facility in the area for which qualification is sought,

c. 4 years of operational or technical experience/training in nuclear power, or

d. any combination of the above totaling 4 years.

Years of experience used to meet the education requirements as allowed by this exception shall not be used to also meet the experience requirements.

3. ANSI/ANS 3.1 Section 4 Individuals assigned to professional-technical comparable positions shall have the authority and specified qualifications to accomplish the functional responsibilities of the position.

4. ANSI/ANS 3.1 Section 4.4.5 Individuals who do not possess the formal education and minimum experience requirements for the manager responsible for quality assurance 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. As a minimum, the Special Requirements of ANSI/ANS 3.1-1993 Section 4.3.7 must be met if the manager responsible for Quality Assurance does not meet the requirements of section 4.4.5 of ANSI/ANS 3.1-1978.

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VNC QUALITY ASSURANCE PROGRAM MANUAL 15

5. ANSI/ANS 3.1 Section 5 VNC will maintain a training program for the associated unit staff as defined in Appendix C, Section 2.2.B, that meets the applicable regulations and meets the standards of section 5 of ANSI/ANS 3.1-1978.

B. Regulatory Guide 7.10, Revision 3 (6/15), Establishing Quality Assurance Programs for Packaging Used in the Transportation of Radioactive Material is used as a guidance document.

C. NUREG/CR-6407 (2/96), Classification of Transportation Packaging and Dry Fuel Storage System Components According to Importance to Safety is used as a guidance document.

Alternatives Suppliers providing commercial grade calibration and testing services, who are accredited by a nationally recognized accrediting body, as described in Nuclear Energy Institute (NEI) 14-05 guidelines, may be used without additional qualification, provided the conditions of the associated NRC Safety Evaluation are met. Controls shall be established in applicable procedures to ensure the requirements of the NRC Safety Evaluation are satisfied prior to acceptance.

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VNC QUALITY ASSURANCE PROGRAM MANUAL 16 Appendix C Administrative Controls 1.0 INDEPENDENT SAFETY REVIEW An Independent Safety Review shall be a thorough review conducted by one or more qualified Independent Safety Reviewers. Persons performing these reviews shall be knowledgeable in the subject area being reviewed. Independent Safety Reviews must be completed prior to implementation of proposed activities.

1. Independent Safety Reviewers shall be individuals without direct responsibility for the performance of these activities under review. These reviews may be from the same functionally cognizant organization as the individual or group performing the original work.

2. Independent Safety Reviewers shall have at least 5 years of professional experience and either a Bachelors Degree in Engineering or the Physical Sciences or shall have equivalent qualifications in accordance with ANSI/ANS 3.1-1978. The manager responsible for the overall operational activities (or designee) shall document the appointment of Independent Safety Reviewers.

3. The following subjects shall be independently reviewed by a qualified Independent Safety Reviewer:

a) Evaluations for changes to the facility as described in the licensing basis documents (LBDs). Changes to procedures as described in the LBDs and tests or equipment not described in the LBDs to verify that such actions do not involve a change to the Technical Specifications or will not require prior NRC approval as defined in 10 CFR 50.59 or 10 CFR 70.72, and b) Proposed changes to the programs required by the QAPM Appendix B to verify that such changes do not involve a change to the Technical Specifications or will not require prior NRC approval as defined in 10 CFR 50.59 or 10 CFR 70.72.

2.0 ADMINISTRATIVE CONTROLS RELOCATED FROM VNC LICENSES The following administrative controls are from the current VNC NRC Licenses.

NorthStar shall conduct activities at VNC in accordance with statements, representations, and conditions as described in License Renewal Applications and licenses.

Sealed Plutonium sources shall be subject to leak testing and actions specified in License Condition for Leak Testing Sealed Plutonium Sources.

Release of equipment or materials for unrestricted use shall be in accordance with Guidelines for Decontamination of Facilities and Equipment Prior to Release for Unrestricted Use or Termination of Licenses for Byproduct, Source, or Special Nuclear Material, April 1993.

NorthStar shall provide to the Commission copies of the annual report summarizing the effluent monitoring and environmental surveillance programs at VNC.

Exemptions to the requirements of 10 CFR 70.24 Criticality Accident Requirements are granted according to license SNM-960.

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