PNP 2024-030, Update Report for Holtec Decommissioning International Fleet Decommissioning Quality Assurance Program Rev. 3 and Palisades Transitioning Quality Assurance Plan, Rev 0

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Update Report for Holtec Decommissioning International Fleet Decommissioning Quality Assurance Program Rev. 3 and Palisades Transitioning Quality Assurance Plan, Rev 0
ML24215A356
Person / Time
Site: Palisades, Indian Point, Oyster Creek, Pilgrim, Big Rock Point
Issue date: 08/02/2024
From: Fleming J
Holtec Decommissioning International
To:
Office of Nuclear Material Safety and Safeguards, Office of Nuclear Reactor Regulation, Document Control Desk
References
HDI PNP 2024-030, HDI BRP 2024-001, HDI-PIL-24-014, HDI-IPEC-24-033, HDI-OC-24-030
Download: ML24215A356 (1)


Text

Krishna P. Singh Technology Campus, 1 Holtec Blvd., Camden, NJ 08104 Telephone (856) 797-0900 Fax (856) 797-0909 1 of 3 HDI PNP 2024-030 HDI BRP 2024-001 HDI-PIL-24-014 HDI-IPEC-24-033 HDI-OC-24-030 10 CFR 50.54(a)(3) 10 CFR 50.71(e)(4) 10 CFR 71.101(f) 10 CFR 71.106(b) 10 CFR 72.140(d)

August 2, 2024 U.S. Nuclear Regulatory Commission Attn: Document Control Desk Washington, DC 20555-0001 Oyster Creek Nuclear Generating Station Renewed Facility Operating License No. DPR-16 NRC Docket Nos. 50-219 and 72-15 Pilgrim Nuclear Power Station Renewed Facility License No. DPR-35 NRC Docket No. 50-293 and 72-1044 Indian Point Nuclear Generating Unit Nos. 1,2, and 3 Provisional Operating License No. DPR-5 Renewed Facility License Nos. DPR-26 and DPR-64 NRC Docket Nos.50-003, 50-247, 50-286 and 72-051 Palisades Nuclear Plant Renewed Facility Operating License No. DPR-20 NRC Docket Nos. 50-255 and 72-007 Big Rock Point Plant Facility Operating License No. DPR-6 NRC Docket Nos. 50-155 and 72-043

Subject:

Update Report for Holtec Decommissioning International (HDI) Fleet Decommissioning Quality Assurance Program (DQAP) Revision 3 and Palisades Transitioning Quality Assurance Plan (TQAP) Rev 0 Holtec Decommissioning International (HDI) is submitting Revision 3 of the Decommissioning Quality Assurance Program, (DQAP) in accordance with Title 10 of the Code of Federal Regulations Part 50, Section 71, Maintenance of records, making of reports, paragraph (e)(4),

(10 CFR 50.71(e)(4)), and 10 CFR 71, Packaging and Transportation of Radioactive Material, Section 106, Changes to quality assurance program, paragraph (b), (10 CFR 71.106(b)).

HOLTEC DECOMMISSIONING INTERNATIONAL

HOLTEC Krishna P. Singh Technology Campus, 1 Holtec Blvd., Camden, NJ 08104 DECOMMISSIONING INTERNATIONAL Telephone (856) 797-0900 Fax (856) 797-0909 Palisades Nuclear Plant has submitted Palisades Energy Quality Assurance Program Manual (QAPM), Revision O (Reference 1) which is under NRC review. With the need for Palisades to increase commitments as the site transitions back to an operating status. The Quality Assurance Plan for Palisades was moved to a standalone Transitioning Quality Assurance Plan (TQAP)

(Enclosure 3). This was needed to address the increase in needed commitments particular to Palisades as site transitions back to an operating status. provides a copy of DQAP Revision 3, which includes a synopsis of the changes associated with Revision 3. provides the Decommissioning Quality Control Program Change Evaluation Forms associated with Revision 3 of DQAP. provides a copy of Palisades' TQAP Revision 0. provides the Transitional Quality Control Program Change Evaluation Forms associated with Revision O of TQAP.

This letter contains no new regulatory commitments.

Should you have any questions or require further information, please contact William Naval, at (856) 797-0900 X 3587.

Respectfully, 9-- (l_,4,.,,,0 Jean A. Fleming Vice President, Licensing and Regulatory Affairs Holtec International

Reference:

[1] HDI letter to NRC, tilted Supplement to Application for Order Consenting to Transfer of Control of License and Approving Conforming License Amendments, Proposed Power Operations Quality Assurance Program Manual, Revision O (ADAMS Accession Number ML24144A106), dated May 23, 2024

Enclosure:

1. Decommissioning Quality Assurance Program (DQAP) Revision 3
2. Decommissioning Quality Control Program Change Evaluation Form for Rev 3
3. Palisades' Transitional Quality Assurance Plan (TQAP) Revision O
4. Transitional Quality Control Program Change Evaluation Forms for Rev 0 H DI PNP 2024-030 H DI BRP 2024-001 H DI-PIL-24-014 HDI-IPEC-24-033 H DI-OC-24-030 2 of 3

Krishna P. Singh Technology Campus, 1 Holtec Blvd., Camden, NJ 08104 Telephone (856) 797-0900 Fax (856) 797-0909 3 of 3 HDI PNP 2024-030 HDI BRP 2024-001 HDI-PIL-24-014 HDI-IPEC-24-033 HDI-OC-24-030 cc:

USNRC Director - Nuclear Reactor Regulation (NRR)

USNRC Director - Nuclear Material Safety and Safeguards (NMSS)

USNRC Region I - Regional Administrator USNRC Region III - Regional Administrator USNRC Inspector(s) - Palisades Nuclear Plant, Big Rock Point, Oyster Creek, Pilgrim and Indian Point.

USNRC Project Manager(s), NMSS - Palisades Nuclear Plant, Big Rock Point, Oyster Creek, Pilgrim and Indian Point.

HOLTEC DECOMMISSIONING INTERNATIONAL

Decommissioning Quality Assurance Program (DQAP) Revision 3

Page 1 of 35 CD-020 Decommissioning Quality Assurance Program (DQAP)

Revision 03 Effective August 2, 2024 HOLTEC DECOMMISSION I NG INTERNATIONAL

Holtec Decommissioning International DQAP Page 2 of 35 Holtec Decommissioning International Site Listing Oyster Creek Nuclear Generating Station Docket No. 50-219 Renewed Facility Operating License No. DPR-16 Docket No. 72-0015 Docket No. 71-0964 Pilgrim Nuclear Power Station Docket No. 50-293 Renewed Facility Operating License No. DPR-35 Docket No. 72-1044 Docket No. 71-0963 Indian Point Energy Center Indian Point 1 Nuclear Power Plant Docket No.50-003 License No. DPR-05 Docket No. 72-51 Docket No.: 71-0240 Indian Point 2 Nuclear Power Plant Docket No. 50-247 License No. DPR-26 Docket No. 72-51 Docket No.: 71-0240 Indian Point 3 Nuclear Power Plant Docket No. 50-286 License No. DPR-64 Docket No. 72-51 Docket No.: 71-0240 Big Rock Point Nuclear Plant - Independent Spent Fuel Storage Installation Docket No. 50-155 License No. DPR-6 Docket No. 72-43 Docket No. 71-0937

Holtec Decommissioning International DQAP Page 3 of 35 Letter #: N/A

Subject:

Removal of Palisades Nuclear Power Plant (PAL) from Holtec Decommissioning International (HDI)

Decommissioning Quality Assurance Plan (DQAP) Revision 03. Palisades was moved to a Transition Quality Assurance Plan for restart activities.

(TQAP) Revision 0 Section I Revision Concurrence and Agreement to Issue DQAP Revision 03 POSITION / NAME Action (concurrence, certification, etc.)

Signature (sign, interoffice memo, e-mail, or telecom)

HDI-Regulatory Assurance Director/ William Noval Preparer HDI - Manager, Quality Assurance/ Kevin Block Preparer Holtec VP Licensing and Regulatory Affairs / Jean Fleming Reviewer Holtec VP Quality Assurance / Mark Soler Approver COMMENTS

  • NOTE: Individuals signing above confirm their review and concurrence with revision of the HDI DQAP and the completeness and accuracy of the information contained within in it.

Holtec Decommissioning International DQAP Page 4 of 35 Revision Summary Revision Number Location Description of Changes 03 Cover Page

a. Updated revision number from 02 to 03.
b. Effective date updated to August 2, 2024.

HDI Site List

a. Removed Palisades facility Docket information.

Signature Page

a. Changed title; Holtec VP Licensing and Regulatory Affairs
b. Added a second preparer and reviewer 1.2.3
a. Updated VP of QA reports to CNO, matrix reporting to Holtec President.

Whole Document

b. Updated Page Numbering
c. Updated title change, HDI President to Holtec President
d. Updated title changes, Holtec President and CEO to Holtec CEO and Executive Chairman Table of Contents
a. Updated Page Numbering

Page 5 of 35 TABLE OF CONTENTS Policy Statement.

6 1.0 Organization...... 7 2.0 Quality Assurance Program...

11 3.0 Design Control.

13 4.0 Procurement Document Control 16 5.0 Instructions, Procedures, and Drawings..

17 6.0 Document Control 18 7.0 Control of Purchased Material, Equipment, and Services.

19 8.0 Identification and Control of Materials, Parts, and Components..

22 9.0 Control of Special Processes.

23 10.0 Inspection..

24 11.0 Test Control..

25 12.0 Control of Measuring and Test Equipment..

26 13.0 Handling, Storage, and Shipping..

27 14.0 Inspection, Test, and Operating Status....

28 15.0 Nonconforming Material, Parts, or Components.....

29 16.0 Corrective Action..

30 17.0 Quality Assurance Records...

31 18.0 Audits.

32 Appendix A General Administrative Requirements..

33 Appendix B Site Specific Administrative Requirements.

35

Page 6 of 35 Policy Statement The Decommissioning Quality Assurance Program (DQAP), is the highest tiered document that assigns major functional responsibilities for decommissioning facilities owned and operated by Holtec International and Holtec Decommissioning International respectively (referred to as HDI in this document). Implementing documents assign more specific responsibilities and define the organizational interfaces involved in conducting safety significant (term used in this DQAP to identify both safety related and important to safety) activities within the scope of this DQAP.

These requirements apply to those organizations and positions, which manage and perform activities within its scope.

The HDI organization is structured on the basis that the attainment of the objectives of this Program relies on those who manage, perform, and support the performance of activities within the scope of the DQAP. Assurance of this attainment relies on those who have no direct responsibility for performing the activity.

HDI will maintain the decommissioning facilities in a manner that will ensure the health and safety of the public and the workers. All facilities shall, at a minimum, be in compliance with the applicable requirements of the Code of Federal Regulations, NRC Licenses, and the laws and regulations of the state and local governments.

Page 7 of 35

1.

ORGANIZATION HDI is responsible for the establishment and execution of the DQAP at the decommissioning facilities owned by Holtec and maintained by HDI. These decommissioning facilities have submitted a Certification of Permanent Cessation of Operations and Certification of Permanent Removal of Fuel to the Nuclear Regulatory Commission (NRC) per 10 CFR 50.82(a)(1)(i) and (ii), respectfully. The titles of managers used in the DQAP are generic, or functional titles and their formal titles may vary. Unless otherwise specifically prohibited, responsibilities of managers described in the DQAP may be delegated to, and be performed by, other qualified individuals.

1.1.

Responsibilities 1.1.1. The authorities and duties of persons and organizations performing activities within the scope of this DQAP are established and delineated in writing.

1.1.2. All personnel who work directly, or indirectly for HDI are responsible for the achievement of quality in their work. Accordingly, all HDI personnel and its contractors engaged in supporting decommissioning activities shall comply with the requirements of this DQAP.

1.1.3. The overall responsibility for operation, maintenance, inspection, test, modification, decommissioning, and storage of spent fuel resides with the Holtec President and is overseen by the Holtec CEO and Executive Chairman. The HDI Site Vice President at each decommissioning facility is responsible for the administration and implementation of the DQAP at the applicable facility.

1.1.4. The DQAP is reviewed and approved by the Holtec Vice President of Quality Assurance. The management position responsible for Quality Assurance/Nuclear Oversight is responsible for periodically reporting to the Chief Nuclear Officer (CNO) and Holtec President on the effectiveness of the DQAP implementation and immediately apprising them of significant problems affecting quality.

1.1.5. Management of line organizations at the decommissioning facilities are responsible to ensure that the quality of work and activities meets the requirements set forth in the NRC licenses including the site technical specifications, this DQAP, and implementing procedures.

1.2.

Corporate Organizations 1.2.1. The Holtec President has the overall responsibility for the safety, operation, and decommissioning of the nuclear sites maintained by HDI including oversight of the decommissioning activities performed by HDI. This is the

Page 8 of 35 senior executive responsible for providing strategic direction to the HDI organization and to the senior leadership of the decommissioning facilities maintained by HDI. This position is responsible for providing management direction, oversight and support to the site organizations and for setting and implementing policies, objectives, expectations, and priorities to ensure activities are performed in accordance with the DQAP and other requirements.

1.2.2. The Holtec CEO and Executive Chairman provides oversight of all HDIs nuclear activities including decommissioning of the nuclear sites maintained by HDI.

1.2.3. The Holtec Vice President of Quality Assurance reports to the CNO and has a matrix reporting structure to Holtec President. The position provides quality assurance oversight for the decommissioning facilities maintained by HDI. In addition, this position is responsible for verifying the DQAP is effectively implemented, that Quality Assurance (QA) personnel have sufficient authority and organizational freedom to identify quality problems and to verify implementation of corrective actions, and that QA personnel have direct access to appropriate levels of management necessary to perform their function and shall be independent from cost and schedule when opposed to quality and safety considerations. Functional responsibilities include:

  • Managing the performance of periodic audits and quality verification inspections to verify that activities within the scope of this DQAP have been correctly performed.
  • Establishing quality assurance practices and policies.
  • Reporting on oversight activities to the Holtec Senior Vice President of Business Development and Holtec President.
  • Authority to stop work when quality is adversely affected.

1.2.4. The following management positions report to and/or receive direction from the Holtec President with respect to their assigned roles and responsibilities associated with the execution of this DQAP:

  • The Vice President of Licensing and Regulatory Affairs is responsible for providing licensing oversight for the decommissioning facilities maintained by HDI. This position is responsible for overseeing and guiding development and submission of licensing, regulatory and environmental actions. This position also conducts routine assessments of the regulatory activities at each of the decommissioning facilities and supports the interface between the site and nuclear regulators while also taking a lead role on generic issues in decommissioning.

Page 9 of 35

  • Additional support organizational activities such as Emergency Preparedness, calibrations, procurement, training, legal, communications, records and document control, information technology, business operations, and human resources may be provided by the decommissioning facility or by the corporate organizations.

1.3.

Decommissioning Facility Management The following are HDI decommissioning facility management positions and associated DQAP functional responsibilities which may be delegated to others as established in this document. These individuals may report through an additional layer of management but shall maintain sufficient authority and organizational freedom to implement assigned responsibilities.

1.3.1. The HDI Site Vice President for each decommissioning facility maintained by HDI is responsible for providing day-to-day on-site leadership and direction to the associated decommissioning facility to assure the safe decommissioning, maintenance, and regulatory compliance of the station including control over those onsite activities necessary for safe storage and maintenance of spent nuclear fuel, including maintaining the facility within the constraints of applicable regulatory requirements, licenses, Technical Specifications dry storage system Certificate of Compliance and training. The HDI Site Vice President, or specified designee, shall approve, prior to implementation, all tests, experiments, and modifications to systems or equipment that affect the safe storage and maintenance of spent nuclear fuel. The following positions report to the HDI Site Vice President:

  • A management position responsible for operational activities necessary for safe storage and maintenance of spent fuel including maintaining the facility within the constraints of applicable regulatory requirements and the decommissioning facility licenses.
  • A management position responsible for radiation protection, ALARA planning, chemistry, and environmental activities.
  • A management position responsible for supporting the VP of Licensing and Regulatory Affairs in maintaining an interface between the station and federal, state, and local regulators. Also, responsible for Emergency Preparedness, the Corrective Action Program, and document control and records management functions.
  • A management position responsible for managing decommissioning projects within the constraints of the decommissioning facility licenses and regulatory requirements.
  • A management position responsible for engineering support activities, development and maintenance of engineering programs, policies, procedures, and providing engineering services in accordance with the

Page 10 of 35 DQAP.

  • A management position responsible for the execution of maintenance and modification activities.
  • A management position responsible for implementation of the decommissioning facility security plan.

This following position may be included in the decommissioning facility management or in the corporate organization.

  • A management position responsible for material management and decommissioning facility supply, which coordinates, evaluates, and procures materials for the decommissioning facility.

Page 11 of 35

2. QUALITY ASSURANCE PROGRAM 2.1.

The Quality Assurance (QA) Program for HDI decommissioning facilities as described in this DQAP provides control over activities affecting quality to an extent consistent with their importance to safety and compliance. The DQAP includes specific monitoring activities which are measured against acceptance criteria in a manner sufficient to provide HDI management assurance that the activities affecting quality are performed in an acceptable manner. The DQAP requirements apply to (i.e. the following are in the scope of the DQAP) structure, system, or components (SSCs) designated as safety significant, applicable regulatory programs, and for other applicable activities and SSCs identified in either the facility-specific Decommissioning Safety Analysis Report (DSAR) or Appendices of this DQAP.

2.2.

The DQAP 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 72 Subpart G, Quality Assurance for Independent Storage of Spent Nuclear Fuel and High-Level Radioactive Waste. HDI also commits to NUREG/CR-6407, Classification of Transportation Packaging and Dry Fuel Storage System Components According to Important to Safety (2/1996).

Implementation of this DQAP is controlled through separately issued procedures, instructions, and drawings. Each organization is responsible for the establishment and implementation of procedures and instructions prescribing the activities within the scope of this DQAP for which they are responsible.

2.3.

Activities affecting quality 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 DQAP 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 where required.

2.4.

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

2.5.

Program Control and Authority 2.5.1. The Holtec VP of Quality Assurance is responsible for ensuring that the applicable portions of the DQAP are properly documented, approved, and implemented before an activity within the scope of the DQAP is executed.

Page 12 of 35 2.5.2. Additional requirements for specific programs are described in the Administrative Controls section of the applicable decommissioning facility Technical Specifications or in the DSAR, with the exception of security requirements which are contained in the applicable facility Physical Security Plan; and Emergency Plan requirements which are contained within the applicable facility Site Emergency Plan. Fire Protection Program requirements are addressed in Appendix A of this DQAP.

2.6.

Program Review 2.6.1. The status and effectiveness of the DQAP and its implementation is periodically reviewed by the management of the organization responsible for its execution.

2.7.

Personnel Training and Qualifications 2.7.1. Formal indoctrination and training programs for personnel performing or verifying activities within the scope of this DQAP are established and maintained. The indoctrination and training programs are established by on-site and/or off-site organizational units responsible for the performance or verification of activities within the scope of this DQAP.

2.7.2. Personnel shall have sufficient qualifications, as applicable, to perform their assigned duties. Implementing procedures provide the criteria utilized for determining and assessing appropriate staff qualifications. Indoctrination, training, and qualification programs are established such that:

  • Personnel performing and/or verifying activities affecting quality are trained and qualified, as applicable, in the principles, techniques, and requirements of the activity being performed.
  • Formal training and qualification program documentation includes the objective, content of the program, attendees, and date of attendance.
  • Proficiency tests are given as applicable to those personnel performing and verifying activities affecting quality.
  • A certificate of qualification, as applicable, clearly delineates the specific quality assurance functions personnel are qualified to perform and the criteria used to qualify personnel in each function.

Page 13 of 35 3.0.

DESIGN CONTROL 3.1.

Measures are established to assure that the designs, including applicable regulatory requirements and design bases, technical and quality requirements are correctly translated to design documents which include specifications, drawings, procedures, and instructions. HDI has overall responsibility for design and design control activities including preparing, reviewing, approving, and verifying design documents related to the facility's structures, systems, and components (SSCs) within the scope of the DQAP.

3.2.

Design changes to SSCs within the scope of this DQAP shall be properly controlled using design control measures commensurate with those applied to the original design as appropriate. Design changes are reviewed and approved by the same design groups cognizant in the discipline affected by the change that reviewed and approved the original documentation unless alternative design groups are designated. Design activities associated with the decommissioning facility changes or modifications may be performed by HDI or qualified contractors. Design groups shall have access to background information, shall be competent in the specific area of design interest, and shall understand the requirements and intent of the original design.

3.3.

Measures shall be established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to SSCs that have current safety significant functions. Design control implementing procedures shall define responsibility for the following:

  • Design Input
  • Design Performance
  • Design Interface Control
  • Design Verification
  • Design Change 3.4.

Design inputs shall be identified, documented, and correctly used to derive design outputs. Design inputs shall be specified to a level of detail necessary to allow the design activities to be carried out in a controlled manner.

Page 14 of 35 3.5.

The design organization shall prescribe and document the design activities to the level of detail necessary to permit the design process to be completed in a correct manner which permits verification that the design meets requirements. Design documents shall support facility design, construction, safe storage and handling of spent fuel, and decommissioning projects.

Appropriate quality standards shall be identified and documented, and their selection reviewed and approved. Deviations from original design standards shall be reviewed to ensure that the designated quality requirements remain in the design of SSCs as applicable.

3.6.

Design control measures shall be applied to those SSCs within the scope of this DQAP. Design analyses shall be sufficiently detailed such that a person technically qualified in the subject can review and understand the analyses and verify the adequacy of the results without additional input.

3.7.

Design interfaces for SSCs within the scope of this DQAP shall be identified and controlled. Interface controls shall include the assignment of responsibility and the establishment of procedures among participating design organizations. Controls shall be established for the review, approval, release, distribution, and revision of documents involving design interfaces.

Design information transmitted across interfaces shall be documented and controlled.

3.8.

Changes or modifications to designated SSCs shall be approved by the Design Authority or designee. Procedures for implementing design changes and field changes shall assure that the impact of the change is considered, required actions documented, and information concerning the change transmitted to affected persons or organizations. Applicable regulatory change process criteria (e.g., 10 CFR 50.59, 10 CFR 50.82(a), or 10 CFR 72.48) shall be used to determine if NRC approval is required prior to implementation of a design change. For SSCs within the scope of this DQAP, these changes shall be subject to design control measures commensurate with those applied to the original design.

3.9.

Design verification for SSCs within the scope of this DQAP shall provide assurance that the final design is correct and has been performed in accordance with approved procedures for the design reviews.

Documentation to be reviewed for this design work includes the necessary calculations and/or analysis, design criteria specifications, drawings, procedures, and instructions as applicable to permit a comprehensive review.

3.10. Design verification may be accomplished through design reviews, alternate calculations, or qualification testing. These methods of design verification are defined in design procedures as applicable. The results of the design verification activities shall be documented with the identification of the verifier clearly documented. Design verification shall be performed by competent individual(s) other than those who performed the original design but may be

Page 15 of 35 from the same organization. This verification may be performed by the originators supervisor, provided the supervisor did not specify a singular design approach, rule out certain design considerations, did not establish the design inputs used in the design, or the supervisor is the only individual in the organization competent to perform the verification. Cursory supervisory reviews do not satisfy the intent of design verification. Design verification shall be completed prior to relying upon the SSC to perform its safety significant function.

3.11. Nonconforming activities such as deviations, errors, or deficiencies in the approved design documents, including design methods (e.g., computer codes), shall be identified, documented, and controlled. Computer programs used to calculate or develop data for safety significant activities shall be subject to validation and verification.

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

Page 16 of 35 4.0.

PROCUREMENT DOCUMENT CONTROL 4.1.

Measures are established for the preparation, review, and approval of procurement documents for those items and activities within the scope of this DQAP. Procurement documents include or reference the appropriate regulatory, technical, and quality requirements necessary to assure adequate quality for those materials, equipment, and services that are within the scope of this DQAP. Measures are established to assure that, to the extent necessary, contractors or subcontractors provide a QA Program consistent with the provisions of 10 CFR 50 Appendix B, 10 CFR 71 Subpart H, or 10 CFR 72 Subpart G, and 10 CFR 21, as applicable.

4.2.

HDI maintains an Approved Vendor List (AVL) for those vendors qualified to perform safety significant work. The qualification requirements for vendors on the AVL are described in controlling procedures except for procurement from other licensees that have an NRC approved quality program. Vendor qualification processes use a graded approach based on the qualification level of the vendor.

4.3.

Procurement document control applies to SSCs within the scope of this DQAP and any spare or replacement parts for those SSCs. Procurement documents shall include those requirements necessary to assure that the items and services to be provided meet the specified technical and quality requirements. Specifically, the procurement system assures that the appropriate technical and quality requirements are specified for procurement of items and services considering the safety significant function, complexity of the design, manufacturing, degree of inspection/testability upon receipt and other factors which affect the quality of products and services. In addition, procurement documents will, as applicable, require vendors to a) invoke applicable requirements on their vendors; b) allow for right of access for further evaluations as needed.

4.4.

Procedures that implement procurement document control shall describe the organizational responsibilities for procurement planning, preparation, review, approval and control of procurement documents, and vendor selection.

4.5.

Procedures shall be established to review the adequacy of the technical and QA requirements specified within procurement documents. Personnel who have access to pertinent information and who have an adequate understanding of the requirements and intent of the procurement documents shall perform reviews required to ensure the adequacy of the technical and QA requirements. Changes to procurement documents shall be subject to the same controls as the original documents.

Page 17 of 35 5.0.

INSTRUCTIONS, PROCEDURES AND DRAWINGS 5.1.

Measures are established to assure that quality activities are prescribed by and performed in accordance with documented instructions, procedures, or drawings. Documented and approved instructions, procedures, and drawings are required to accomplish work on SSCs within the scope of this DQAP.

5.2.

These instructions, procedures, and drawings include, as appropriate, quantitative or qualitative acceptance criteria for determining that activities have been satisfactorily accomplished. The activities shall be described to a level of detail commensurate with the complexity of the activity and the need to assure consistent and acceptable results.

5.3.

Controls are established which ensure that instructions, procedures, and drawings are current and accurately reflect decommissioning facility design and regulatory requirements.

Page 18 of 35 6.0.

DOCUMENT CONTROL 6.1.

Measures are established to control the issuance of documents, such as instructions, procedures, drawings, including changes thereto, which prescribe activities affecting quality and activities within the scope of this DQAP. These measures assure that documents, such as procedures, instructions and drawings, are reviewed for adequacy by qualified personnel other than the personnel that prepared the document, approved for release and use, and available at the location where the activity is performed. Written procedures shall define the type of documents to which the document control system applies. These procedures also define the process for controlling the preparation, review, approval, issuance, and distribution.

6.2.

Documents and changes to documents that prescribe or verify activities within the scope of this DQAP shall be controlled in a manner that precludes the use of inappropriate or outdated documents.

6.3.

Changes to documents shall be reviewed and approved by the same organization that performed the original review and approval unless another qualified organization has been designated. Administrative controls shall 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, and the time period during which they may be used. Minor changes to documents, such as inconsequential editorial corrections, shall not require that the revised documents receive the same review and approval as the original documents. To avoid a possible omission of a required review, the type of minor changes that do not require such a review and approval and the persons who can authorize such a decision shall be clearly delineated.

Page 19 of 35 7.0.

CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES 7.1.

Measures are established for the control of purchased material, equipment (identified as items), and services to assure they conform to the procurement documents as they apply to activities within the scope of this DQAP. These measures provide for the following as appropriate: source evaluation and selection, evaluation of objective evidence of quality furnished by the vendor, source inspection, audit, and examination of items or services. Procedures shall describe each organization's responsibilities for the control of items and services, including the interfaces between all affected organizations.

Documentation of acceptance of items shall be available prior to installation or acceptance for use.

7.2 Verification that a vendor can meet the specified technical and quality requirements shall be documented. HDI maintains an Approved Vendor List (AVL) for those vendors qualified to perform safety significant work. The qualification requirements for vendors on the AVL are described in controlling procedures. Vendor qualification processes use a graded approach based on the qualification level of the vendor.

7.3 This DQAP considers that other 10 CFR Part 50 licensees, Authorized Nuclear Inspection Agencies, National Institute of Standards and Technology, or other State and Federal agencies which may provide items or services to the facility are not required to be evaluated or audited.

7.4 Commercial grade calibration and/or testing services may be procured from domestic and international commercial calibration and/or testing laboratories based on the laboratory's accreditation to ISO/IEC-17025:2017 by an Accreditation Body (AB) which is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) provided all of the following are met:

7.4.1 A documented review of the vendors accreditation is performed and includes a verification of the following:

  • The calibration or test laboratory holds accreditation by an accrediting body recognized by the ILAC MRA. The accreditation encompasses ISO/IEC-17025:2017, "General Requirements for the Competence of Testing and Calibration Laboratories."
  • For procurement of calibration services, the published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.
  • For procurement of testing services, the published scope of accreditation for the test laboratory covers the needed testing services including test methodology and tolerances / uncertainty.

Page 20 of 35 7.4.2. The purchase documents require that:

  • The service must be provided in accordance with their accredited ISO/IEC-17025:2017 program and scope of accreditation.
  • As found calibration data must be reported in the certificate of calibration when calibrated items are found to be out-of-tolerance. (For calibration services only)
  • The equipment /standards used to perform the calibration must be identified in the certificate of calibration. (For calibration services only)
  • The customer must be notified of any condition that adversely impacts the laboratorys ability to maintain the scope of accreditation.
  • Additional technical and quality requirements, as necessary, based upon a review of the procured scope of services, which may include, but are not necessarily limited to, tolerances, accuracies, ranges, and industry standards.
  • Supplier shall not sub-contract the service to any other supplier.

7.4.3. It is validated, at receipt inspection, that the laboratory's documentation certifies that:

  • The contracted calibration or test service has been performed in accordance with their ISO/IEC-17025:2017 program, and has been performed within their scope of accreditation; and
  • The purchase order's requirements are met.

7.5.

The effectiveness of contractors and vendors s QA program shall be assessed at intervals consistent with the importance, complexity, and quantity of the item or service. Vendor performance and compliance with procurement documents are monitored by source verification, receipt inspection, audit, or a combination to ensure continued acceptable vendor performance. Receiving inspection shall verify, by objective evidence, the acceptability of items in accordance with decommissioning facility procedures. Accepted items are appropriately marked and located in a controlled storage area until use. Documentary evidence shall be retained in accordance with decommissioning facility requirements and applicable regulatory requirements and shall be sufficient to identify the specific requirements, such as codes, standards, or specifications, met by the purchased items.

Page 21 of 35 7.6.

For acquiring of services only, such as: third-party inspection, engineering and consulting services; auditing and installation; and repair, overhaul, or maintenance work, from vendors whose QA Program has not been reviewed or accepted, those vendors may be used provided additional controls such as technical verification of data produced, surveillance and/or audit of the activity, or review of objective evidence are employed. Additional controls will be approriately identified and implemented.

7.7.

Spare and replacement parts are procured such that their performance and quality are at least equivalent to those of the parts that will be replaced, as determined by engineering where applicable.

7.8.

Designated quality personnel or other personnel with appropriate qualifications are responsible for assuring source inspections, surveys, or audits of vendors are performed as necessary.

Page 22 of 35 8.0.

IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS 8.1.

Measures are established for the identification and control of material, parts, and components, including partially fabricated assemblies and consumables (identified as items), to assure that only correct and accepted items are used or installed. Identification is maintained on the items or in documents traceable to the items, and physical identification shall be used to the maximum extent possible. If physical identification is either impractical or insufficient for proper control, HDI controls an item by physical separation, procedural control, or other appropriate means.

8.2.

Markings are applied using materials and methods that are clear, legible and do not detrimentally affect the function or service life of the items that are marked. Markings are transferred to each part of an identified item prior to being subdivided. Markings are not obliterated or masked by surface treatments or coatings unless alternative identification methods are established.

8.3.

Provisions are made in procedures for maintenance or replacement of markings or identification due to damage from handling or aging, excessive deterioration due to environmental exposure, and for updating records while in storage.

8.4 Items having limited shelf or operating life are controlled to preclude use after the shelf life or operating life has expired.

Page 23 of 35 9.0.

CONTROL OF SPECIAL PROCESSES 9.1.

Measures are established to assure that special processes that require interim process controls to assure quality, such as welding, heat treating, and nondestructive examination, are controlled. These provisions include assuring, as applicable, that special processes are accomplished by qualified personnel using instructions, procedures, drawings, checklists, or other appropriate means. 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.

Records are maintained, as appropriate, for the qualified personnel, processes, and equipment.

Page 24 of 35

10.

INSPECTION 10.1. Measures are established for inspection of activities within the scope of this DQAP by or for the organization performing the activity, to verify conformance with approved instructions procedures, drawings, and specifications for accomplishing the task.

10.2. A comprehensive program of inspections shall be established and implemented to verify conformance of an item or activity with the specified requirements. Inspections shall be performed by qualified individuals other than those who perform or directly supervise the activity being inspected.

10.3. Where mandatory hold or witness points are required for witness or inspection activities by designated personnel, the designated hold points shall be indicated in appropriate documentation. Work shall not progress beyond the point of an assigned hold point unless the inspection is complete or consent to waive the hold point is given by the designated organization.

10.4. Inspections shall be planned to ensure the characteristic to be inspected and the methods used to perform the inspection and acceptance criteria are documented. If inspection of items is impractical, monitoring of the processing method and equipment shall be utilized. Process monitoring shall be performed by qualified personnel or a qualified automated process.

Inspection and process monitoring shall both be used if quality control is inadequate without both.

10.5. Inspection records shall identify the item inspected, date of inspection, inspectors identity, and results of inspection.

10.6. Unacceptable inspection results shall be evaluated and resolved in accordance with approved procedures. Any modifications, repairs, and replacements are re-inspected to the same standard or method to verify acceptability of the items.

Page 25 of 35

11.

TEST CONTROL 11.1. Measures are established for a documented test program in accordance with applicable Technical Specifications, license conditions, and design documents to assure that all required testing demonstrate that the SSCs within the scope of this DQAP will perform satisfactorily in service. The test program shall ensure that design and performance criteria have been satisfied and that the testing does not adversely affect the safety significant SSCs.

11.2. The test program shall include criteria for determining when testing is required, such as proof tests prior to installation, preoperational tests, and operational tests of SSCs. The procedures that implement testing shall specify the appropriate prerequisites for the test (e.g., personnel qualification requirements, environmental conditions, equipment requirements), sufficient instruction for the performance of the testing, hold or witness points, acceptanceIrejection criteria and limits, and the required test documentation.

11.3 Test results are evaluated by the responsible organization to determine compliance with established acceptance criteria. Test results which do not meet acceptance criteria, shall be documented and evaluated to determine the appropriate corrective actions.

11.4 The test program shall require that modifications, repairs, and replacement of items that have a current safety significant function be tested, utilizing the same criteria as the original items to the extent applicable to the current safety significant function. If alternative tests are required, the alternative tests must be reviewed and approved by the same organization that established the original requirements unless the applicable manager designates another responsible organization. Test records shall be maintained in accordance with approved procedures.

Page 26 of 35

12.

CONTROL OF MEASURING AND TEST EQUIPMENT 12.1. Measures are established to assure those tools, gauges, instruments, and other measuring and test equipment (M&TE), used for activities within the scope of this DQAP, are controlled, calibrated and adjusted in order to maintain accuracy within necessary limits and to ensure M&TE traceability to calibration test data. For the purposes of this section, M&TE is considered to include both portable and permanently installed instrument and control devices.

12.2. Organizational responsibilities are delineated for establishing, implementing, and assuring the effectiveness of the calibration program for M&TE.

Reference standards used to determine the acceptability of items and activities, are of appropriate type, and maintained within prescribed accuracy limits, suitable range and accuracy in order to verify conformance to specified requirements.

12.3. Procedures for the control and calibration of M&TE that are within the scope of this DQAP shall specify identification requirements (labeling, codes, or other documented control system), the recall process and calibration process and frequencies (including documented pre-calibration checks) of the M&TE to nationally recognized standards. Calibration methods are documented and performed by competent personnel in an environment that does not adversely affect the calibration. The calibration procedures shall specify recording of as-found conditions.

12.4. The calibration procedures shall delineate special controls where applicable, for usage, handling, and storage required for environmental conditions such as temperature, humidity, cleanliness, or radiation to maintain accuracy and operating characteristics of the M&TE.

12.5. Calibration reference standards shall be based on nationally recognized standards or accepted values of natural physical constants. Where national standards do not exist, the basis for the calibration shall be documented.

Special calibration and control measures are not required when normal commercial practices provide adequate accuracy (e.g. rulers, tape measures, levels, and other such devices).

12.6. M&TE which is found to be damaged, out-of-calibration or for which accuracy is suspect, shall be tagged and segregated and processed in accordance with approved procedures. When M&TE is found to be out-of-tolerance, an evaluation is made of its previous uses to determine corrective action.

Page 27 of 35

13.

HANDLING, STORAGE, AND SHIPPING 13.1. Measures are established to control the handling, storage, shipping, packaging, cleaning and preservation of items within the scope of this DQAP in order to prevent damage or deterioration.

13.2. Special coverings, equipment and protective environments shall be specified and provided where necessary for the protection of items from damage and deterioration. Special protective measures are specified and provided when required to maintain acceptable quality. When special protective features are required, their existence shall be verified and monitored as necessary to assure that the special protective features continue to serve their intended function. Special handling tools and equipment shall be provided, where necessary, to ensure items can be handled safely and without damage.

13.3. Controls for hoisting, rigging, and transporting shall be established to protect SSCs within the scope of this DQAP as applicable. Markings or labeling shall be used to indicate the presence of special environments, or the need for special controls. Provisions shall be described for the storage of chemicals, reagents (including control of shelf life), lubricants and other combustible materials. Cleanliness controls shall be implemented to protect applicable SSCs from the introduction of foreign material and maintain system cleanliness as applicable throughout maintenance and modification activities.

Page 28 of 35

14.

INSPECTION, TEST, AND OPERATING STATUS 14.1. Measures are established for indicating the status of items within the scope of this DQAP undergoing inspections and tests to prevent the inadvertent bypassing or altering the sequence of such inspections or tests and avoid inadvertent operation. 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.

14.2. 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 where necessary, and status tracking.

14.3. The operating status of nonconforming, inoperable or malfunctioning SSCs shall be identified and documented to prevent inadvertent operation.

Page 29 of 35

15.

NONCONFORMING MATERIAL, PARTS, OR COMPONENTS 15.1. Measures are established for the identification, evaluation, segregation (when practical), disposition of nonconforming items, and for notification to affected organizations. Items (including applicable services) that do not conform to specified requirements shall be controlled to prevent inadvertent installation or use.

15.2. Measures are established to require that the individual (or designee),

discovering a nonconformance, identify, describe, and document the nonconformance in accordance with the requirements of the corrective action program. Actions taken to address nonconforming items shall be documented.

15.3 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 in the decommissioning facility requires the approval of the designated management.

15.4 Nonconformances are corrected or resolved prior to depending on the item to perform its intended safety significant function. Nonconformances to design requirements dispositioned as repair or use-as-is are subject to design control measures commensurate with those applied to the original design.

Significant trends in nonconformances are reported to management in accordance with applicable procedures, regulatory requirements, and industry standards.

15.5. Nonconforming items that are being used for training must be controlled (e.g.,

administratively controlled, permanently identified, marked, obliterate Material ID Tag or Q level indicators) to prevent inadvertent or inappropriate use of the item.

Page 30 of 35

16.

CORRECTIVE ACTION 16.1. Measures are established to promptly identify, control, document, classify, and correct conditions adverse to quality. Procedures assure that corrective actions are documented and initiated following the determination of conditions adverse to quality in accordance with regulatory requirements and applicable quality standards. Procedures require personnel to identify known conditions adverse to quality. When a complex issue arises where it cannot be readily determined if a condition adverse to quality exists, measures shall be established for documentation and timely evaluation of the issue. Significant conditions adverse to quality 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 and followed up on to verify implementation.

16.2. In the case of vendors performing activities within the scope of this DQAP the applicable manager may delegate specific responsibilities for corrective actions but maintains responsibility for the effectiveness of corrective action measures.

Page 31 of 35

17.

QUALITY ASSURANCE RECORDS 17.1. Measures are established which define the requirements and responsibilities for identification, generation, collection, compilation, storage, maintenance, retention, and retrieval of records necessary to provide objective evidence that activities within the scope of this DQAP are in compliance with the regulations and decommissioning facility implementing procedures.

17.2. Distribution of records shall be controlled in accordance with written procedures. Measures are established for replacement, restoration, or substitution of lost or damaged records.

17.3. Records are legible, accurate, complete, identifiable, and retrievable.

Records are considered valid and complete when dated and stamped, initialed, signed, or otherwise authenticated. Corrections, revisions, or supplements to completed records are reviewed and approved by an authorized individual in the originating organization. Such changes are dated and stamped, initialed, signed, or otherwise authenticated including the use of electronic approval and authorization as applicable.

17.4 Record storage facilities are established and maintained in a manner that minimizes the risk of damage or destruction. Records may be kept by vendors and maintained on an available basis for a specified period of time.

Records may be stored in electronic media provided that the process for managing and storing data is documented in procedures that comply with applicable regulations, including NRC guidance in RIS 2000-18 and as recognized in NIRMA (Nuclear Information Records Management Association) technical guides TG-11, TG-15, TG-16, and TG-21.

17.5 The program includes provisions for the use of various record storage media to maintain QA records. Procedures are developed to implement the regulatory guidance associated with the media used. The NRC Generic Letter 88-18 Plant Record Storage on Optical Disk is implemented for optical disk media. The Regulatory Issue Summary 2000-18 Guidance on Managing QA Records in Electronic Media is implemented for electronic media.

17.6. Record retention periods are established to meet regulatory, UFSAR/DSAR, DQAP, and License requirements. The most stringent retention period is implemented when multiple requirements exist. Records are dispositioned at the end of the prescribed retention period.

Page 32 of 35

18.

AUDITS 18.1. Measures are established for a system of planned and documented audits to verify compliance with all aspects of the DQAP and determine the effective implementation of programs covered by the DQAP.

18.2 Internal and vendor audits are conducted in accordance with written procedures or checklists. Audit personnel shall not have direct responsibilities in the areas to be audited.

18.3. The internal audit program is conducted on a performance driven frequency that is commensurate with the status and importance of the activity to be completed but does not exceed 24-months, unless otherwise required by regulation. Audits may be extended beyond their originally scheduled due date based on the following criteria:

A. Audits shall be performed at the intervals designated and the schedules are based on the month in which the audit starts.

B. A maximum extension not to exceed 25 percent of the audit interval is allowed unless restricted by regulation.

18.4 The vendor audit program is conducted on a performance driven frequency that is commensurate with the status and importance of the activity to be completed but does not exceed 36-months, unless otherwise required by regulation.

A. A maximum extension not to exceed 25 percent of the audit interval shall be allowed except that a total combined time interval for any three consecutive audit intervals should not exceed 3.25 times the specified audit interval, unless otherwise required by regulation.

18.5 When an audit interval extension greater than one month is used, the next audit for that particular audit area is scheduled from the original anniversary month rather than from the month of the extended audit.

18.6 Audit scheduling, preparation, personnel selection, personnel qualification, 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, activities being performed, regulatory requirements, and/or experience with the organization being audited. An audit schedule shall be maintained, reviewed, and revised as necessary at least annually, to ensure that programs receive necessary audits to support regulatory compliance.

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

Page 33 of 35 Appendix A Page 1 of 2 GENERAL ADMINISTRATIVE REQUIREMENTS A.1 Fire Protection 10 CFR 50.48(f) requires that licensees that have submitted the certification required under 50.82(a)(1) shall maintain a fire protection program to address the potential for fires that could cause the release or spread of radioactive materials. The quality assurance program established for these fire protection SSCs ensures that design, procurement, instruction, procedures, drawings, inspection, installation, testing, maintenance, operations, nonconforming Items, corrective action, records, audits and administrative controls meet the applicable quality assurance guidelines as described in the applicable edition of Branch Technical Position (BTP) 9.5-1 for each facility during decommissioning and permanent shutdown. Engineering determines what fire protection SSCs are required to prevent fires, rapidly detect, control, and extinguish fires that do occur and could result in a radiological hazard and, minimize the risk the public, environment, and decommissioning facility personnel resulting from fires that could result in a release of radioactive materials.

Engineering also establishes the requirements for the design, procurement, fabrication, installation and/or modification of these fire protection SSCs.

All other fire protection equipment and supplies will be of commercial quality, in accordance with National Fire Protection Association (NFPA) guidelines.

A.2 Transport of Radioactive Waste A.2.1 When HDI contracts with vendors to transport radioactive waste in NRC approved shipping packages, the contract is written such that the requirements of 10 CFR 71, Subpart H and Regulatory Guide 7.10, Revision 3 (6/15), Establishing Quality Assurance Programs for Packaging Used in the Transportation of Radioactive Material are met. HDI assures that this service is procured from an organization with a QA program and if applicable, includes a NRC licensed transport system. Loading, surveying, closure, placarding, and inspections are conducted in accordance with written procedures and instructions. Transport casks and trailers are inspected before release in accordance with Department of Transportation (DOT) 49 CFR. Shipping manifests, including final radiation surveys, are completed and retained. Radioactive waste shipments not meeting the requirements for NRC approved packaging, shall meet the requirements of DOT 49 CFR.

Page 34 of 35 Appendix A Page 2 of 2 GENERAL ADMINISTRATIVE REQUIREMENTS A.3.

Services A.3.1. HDI procures services from qualified vendors. It is not necessary that these vendors have a quality assurance program approved by the licensee, however, vendors should provide a quality assurance program that includes the quality assurance program elements presented in Regulatory Guide 4.15, Quality Assurance for Radiological Monitoring Programs (Normal Operations)

- Effluent Streams and the Environment, and routinely provide program data summaries sufficiently detailed to permit evaluation of the program for the following areas:

  • Meteorology.
  • Radiological environmental monitoring.

A.4.

License Renewal A.4.1. Consistent with the requirements of 10 CFR 54.21(a)(3), HDI implements the requirements of DQAP Section 1 through 18 for aging management activities related to safety significant SSCs as described by licensing documents for those systems that remain active.

A.4.2. Additionally, to manage the aging effects of non-safety significant SSCs that were determined to be within the scope of License Renewal, HDI implements the administrative controls, corrective actions and confirmation processes described in DQAP Sections 6, 16 and the applicable requirements of this appendix.

A.5.

Safety Review Committee A.5.1. The Safety Review Committee (SRC) serves the HDI President as an on-site review body that performs procedure and program reviews for decommissioning activities and ISFSI operation as necessary on matters of Nuclear Safety. Details regarding the membership, quorum, agenda, and meeting schedule are contained in implementing procedures.

Page 35 of 35 Appendix B Page 1 of 1 SITE SPECIFIC ADMINISTRATIVE REQUIREMENTS B.1.

Regulatory Guide 1.33 B.1.1. Written procedures applicable to safe storage of nuclear fuel recommended in Appendix A of Regulatory Guide 1.33, shall be established, implemented, and maintained.

B.2 Regulatory Guide 1.88 B.2.1 Procedures for the collection, storage, and maintenance of decommissioning facility quality assurance records will be consistent with Regulatory Guide 1.88 Revision 2, dated October 1976. (Collection, storage, and maintenance of decommissioning facility quality assurance records).

B.3.

Independent Spent Fuel Storage Installation (ISFSI) SSC B.3.1. ISFSI quality assurance program requirements are performed in accordance with the applicable 10 CFR 72.212 report which invokes the portions of the NRC approved 10 CFR 50 Appendix B quality assurance program as described in this DQAP, commensurate with the safety classification of the component and quality requirements specified in the cask vendor Final Safety Analysis Report (FSAR) or decommissioning facility ISFSI specific license.

B.3.2 Radioactive Material Transport Packages (10 CFR 71)

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 DQAP.

Decommissioning Quality Control Program Change Evaluation Form for Rev 3

DQAP CHANGE EVALUATION FORM Sheet 1 of 5 Holtec Decommissioning Quality Assurance Program Manual (DQAP) Rev~

LBDCR NO:

-Hl,lr-

'L\\.f-00.S-DQAP Change Evaluation NOTE - The basis for the answers should be of sufficient depth and detail to support the conclusions reached and allow for independent review. Simply stating the change does not decrease the effectiveness without stating why is not acceptable.

Editorial corrections (i.e., spelling, punctuation, typographical or grammatical errors, and incorrect cross-references) are not considered changes and therefore, a Quality Assurance Program Regulatory Review is not required. All boxes should be checked "N/A" and proceed to signature page of the evaluation form.

YES, NO, or N/A
1. Is this change an editorial change as defined in 1 0 CFR 50.54(a)(3)

YES and 10 CFR 71.106? (If yes, provide basis, mark remaining questions "N/A" and state "not a reduction in commitment") Proceed to approval page of attachment.

Basis for Answer: The change for the proposed Revision 3 of the DQAP is editorial only. The change is specific to the removal of references to the Palisades Nuclear Power Plant (Docket No. 50-225, License No. DRP-20, Docket No.72-007, and Docket No. 71-0937) from the Licensee listino oaoe.

2. For any YES answer in the 10 CFR 50.54(a) Screening or for the QA-N/A initiated change, does the proposed change represent a reduction in commitment or process(es) described or established in the approved QA Program?

Basis for Answer: N/A

3. If item 2 above is YES, is the proposed change limited to the use of a N/A quality assurance alternative or exception approved by the NRC Safety Evaluation Report (SER}, for which the bases of the NRC approval are applicable to HDI?

If YES, explain how all of the NRC approval bases from the SER are incorporated or covered by the HDI QA Program.

This exemption is not allowed under 10 CFR 71.106 and cannot be used to reduce commitments under part 71.

Basis for Answer: Not a reduction in commitment.

4. Is the proposed change a change to a QA standard approved by the N/A NRC which is more recent than the QA standard currently established in the Program?

Basis for Answer: Not a reduction in commitment.

50.54(a) Evaluation

ATTACHMENT 9.9 DQAP CHANGE EVALUATION FORM Sheet 2 of 5 Holtec Decommissioning Quality Assurance Program Manual (DQAP) Rev 3 LBDCR NO: ~

'Z.14-ooS-

YES, NO, or N/A
5. Is the proposed change a change involving the use of generic N/A organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles?

Basis for Answer: Not a reduction in commitment.

6. Is the proposed change a change involving the use of generic N/A organizational charts to indicate functional relationships, authorities, and responsibilities, or alternately, the use of descriptive text?

Basis for Answer: Not a reduction in commitment.

7. Is the proposed change an elimination of Quality Assurance Program N/A information that duplicates language in Quality Assurance Regulatory Guides and Quality Assurance Standards to which HDI is committed?

Basis for Answer: Not a reduction in commitment.

8. Does the proposed change continue to ensure that persons and N/A organizations performing Quality Assurance functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations?

Basis for Answer: Not a reduction in commitment.

9. Is a change to the DQAP required? If YES, process change per EN-YES Ll-113. If NO, distribute as indicated below.

Basis for Answer: The revision to the HDI DQAP requires the EN-LI-113 to be implemented alonq with the development of an LBDCR.

50.54(a) Evaluation

ATTACHMENT 9.9 DQAP CHANGE EVALUATION FORM Sheet 3 of 5 Holtec Decommissioning Quality Assurance Program Manual (DQAP) Rev 3 LBDCR NO:

..AUA,.

"'Z.C.C*OOS"'

DQAP CHANGE REVIEW RESULTS

[X]

Change is editorial in accordance with 10 CFR 50.54(a)(3) and 10 CFR 71.106 thus, does not represent a reduction in commitment. The change can be implemented upon approval of parent change document. (Question 1 is YES)

[X]

Does not represent a reduction of commitment and can be implemented upon approval of parent change document. (Questions 4, 5, 6, 7, 8 and 9 are YES or N/A)

[ ]

Represents a reduction of commitment with prior NRC approval. The safety evaluation issued by the NRC has been evaluated and it directly applies to the proposed changes. The change can be implemented upon approval of parent change document. (Question 3 is YES)

[ ]

Represents a reduction of commitment; however, the change has sufficient basis to demonstrate continued compliance with Appendix B and USAR commitments.

Therefore, the proposed change should be submitted for NRC review/approval.

(Questions 2 is YES and Question 3 is NO)

[ ]

Represents a reduction of commitment with insufficient basis to demonstrate continued compliance. Therefore, the activity should not be processed.

Ke

___ v--'-'in~B""'"'lo'""'"ck/;.;;......__~

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_____,/ __

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Preparer Date N..,./A __________________,_

...,NI __ A ____ _

Manager, QA Date 50.54(a) Evaluation

ATTACHMENT 9.9 DQAP CHANGE EVALUATION FORM Sheet 4 of 5 Holtec Decommissioning Quality Assurance Program Manual (DQAP) Rev 3 LBDCR NO:

-"'A-

"'2..H-eQS"""

QA Site Supervisor Review:

Applicable Site QA Supervisor Reviews Required (see attached sheets for documentation of reviews)

Indian Point Yes No Oyster Creek Yes No Pilgrim Station Yes No Site Review Due Date:

N/A Site Review Input:

Record references below. If there are none state None.

I Indian Point Energy Center: NIA Site Regulatory Manager acknowledges completion of reviews below Indian Point D I

Oyster Creek: NIA Site Regulatory Manager acknowledges completion of reviews below Oyster Creek D I

Pilgrim Station: NIA Site Regulatory Manager acknowledges completion of reviews below Pilgrim Station D QA Manager acknowledgement (print & sign) /date Yes IZ!No Kevin Block QA Manager I ?{ II / ZD'l'*(

/Date 50.54(a) Evaluation

ATTACHMENT 9.9 DQAP CHANGE EVALUATION FORM Sheet 5 of 5 Holtec Decommissioning Quality Assurance Program Manual (DQAP) Rev 3 CHANGE DISPOSITION

[gl Approved for implementation D Disapproved D Approved for submittal to the NRC LBDCR NO: -NH1r-

'2.'t-OO.S'""

Approved by/Date: ~::::..,.~21-<'-1-.J.U.a.ac.Y!!'.!b------------7-/_1_,_/_,J_z_'-f_

Jea leming - VP of L' Date Aff rs, and PSA Dep Distribution:

Original - Attach to Parent Document.

Copy - Quality Assurance 50.54(a) Evaluation

Attachment A DQAP Change Request UC XXXX-XXXX - 10CFR50.54(a) Evaluation Purpose The purpose of this 1 0CFR50.54( a) Evaluation is to assess the changes being implemented, associated with preparing the Holtec Decommissioning International (HDI)

Fleet Decommissioning Quality Assurance Program (DQAP) for revision. The HDI DQAP will be revised from Revision 2 to Revision 3. This 50.54(a) evaluation is performed for the purposes of explaining that the changes from the DQAP Revision 2 to the DQAP Revision 3 do not require prior NRC approval pursuant to the requirements of 10CFR50.54(a)(3).

Discussion The DQAP Revision 2 was issued on June 28, 2022. The changes in the DQAP (from Revision 2) contained no changes in commitments and, therefore, did not require prior NRC approval.

The primary focus of this change is to transition from Revision 2 to Revision 3. The change for the proposed Revision 3 of the Decommissioning Quality Assurance Program Manual (DQAP) is editorial only. The change for the proposed Revision 3 of the Decommissioning Quality Assurance Program Manual (DQAP) is editorial only. The change is specific to the removal of references to the Palisades Nuclear Power Plant (Docket No. 50-225, License No. DRP-20, Docket No.72-007, and Docket No. 71-0937) from the Licensee listing page. Revision 2 and Revision 3 of the DQAP are provided as Attachment Band Attachment C, respectfully, to this 10CFR50.54(a) Evaluation.

Conclusion The 10CFR50.54(a) evaluation concluded that the change (editorial,) can be made without prior NRC approval, based on the guidance provided within 10CFR50.54(a)(3).

The specific discussion for each of the proposed changes for each of the sections and the associated evaluation is included in the attached table.

6

Attachment A Table of Changes and the Associated Evaluation DQAP Change Request UC XXX-XXX-10CFR50.54(a) Evaluation DQAP Change(s)

Evaluation and Justification Section Licensee Information Listing Page Removed reference to Palisades Nuclear Plant and Removal of a specific licensee from DQAP is considered corresponding License and Docket information specific to editorial and does not constitute a reduction in Palisades commitments to the previously approved DQAP. This change can be implemented without prior NRC approval, based on the guidance provided in 1 0CFR50.54(a)(3).

7 Prior NRC Approval Yes, No or N/A No

HOLTEC DECOMMISSIONING INTERNATIONAL DECOMMISSIONING QUALITY ASSURANCE PROGRAM CHANGE SCREENING FORM Sheet 1 of 3 DQAP Rev 3 Change No. _

LBDCR NO:

24-005 Decommissioning Quality Assurance Program Change Screen Activity/Document Number: Decommissioning Quality Assurance Plan (DQAP) Revision Number:~

Description of Proposed Change: The administrative change to the DQAP is the removal of a Holtec Decommissioning International Site (Palisades Nuclear Power Plant) and the corresponding plant information (names, docket numbers, etc.) to that list. There are no changes to the content, commitments, or program material.

Note: Editorial corrections (i.e., spelling, punctuation, typographical or grammatical errors, and incorrect cross-references) are not considered changes and therefore, a Quality Assurance Program Regulatory Review is not required. If not an editorial correction, proceed with the screening.

A. Screening Criteria Affected DQAP section or reference standard

& section

1. Affect the authority, independence, or management reporting levels previously established for organizations performing quality assurance NIA functions as described in the DQAP?

NO Basis for Answer:

The change for the DQAP from revision 2 to revision 3 is needed due to the removal of Palisades Nuclear Power Plant from the Holtec Decommissioning International Fleet DQAP.

The administrative change to the DQAP removal of the Palisades Nuclear Power Plant and corresponding information (names, docket numbers, etc.) to that list. There are no changes to the content, commitments, or program material.

2. Reduce commitments or the effectiveness of the Quality Assurance functions specifically described in the DQAP?

NIA NO

HOLTEC DECOMMISSIONING INTERNATIONAL DECOMMISSIONING QUALITY ASSURANCE PROGRAM CHANGE SCREENING FORM Sheet 2 of 3 DQAP Rev..A... Change No. _

LBDCR NO:

24-005 Basis for Answer:

The change for the DQAP from revision 2 to revision 3 is needed due to the removal of Palisades Nuclear Power Plant from the Holtec Decommissioning International Fleet DQAP.

The administrative change to the DQAP removal of the Palisades Nuclear Power Plant and corresponding information (names, docket numbers, etc.) to that list. There are no changes to the content, commitments, or program material.

3. Reduce the level of QA activities, controls, or oversight activities as described in the DQAP?

NO Basis for Answer:

NIA The change for the DQAP from revision 2 to revision 3 is needed due to the removal of Palisades Nuclear Power Plant from the Holtec Decommissioning International Fleet DQAP.

The administrative change to the DQAP removal of the Palisades Nuclear Power Plant and corresponding information (names, docket numbers, etc.) to that list. There are no changes to the content, commitments, or program material.

4. Delete or contradict any regulatory requirement listed in the DQAP as modified by Table 1 of the DQAP?

NO Basis for Answer:

NIA The change for the DQAP from revision 2 to revision 3 is needed due to the removal of Palisades Nuclear Power Plant from the Holtec Decommissioning International Fleet DQAP.

The administrative change to the DQAP removal of the Palisades Nuclear Power Plant and corresponding information (names, docket numbers, etc.) to that list. There are no changes to the content, commitments, or program material.

HOLTEC DECOMMISSIONING INTERNATIONAL ATTACHMENT 9.8 DECOMMISSIONING QUALITY ASSURANCE PROGRAM CHANGE SCREENING FORM Sheet 3 of 3 DQAP Rev _L Change No. _

LBDCR NO:

24-005

5. Require a "Quality-Related" procedure revision, which would delete or reduce, a DQAP reference listed in the procedure?

NIA NO Basis for Answer:

The change for the DQAP from revision 2 to revision 3 is needed due to the removal of Palisades Nuclear Power Plant from the Holtec Decommissioning International Fleet DQAP.

The administrative change to the DQAP removal of the Palisades Nuclear Power Plant and corresponding information (names, docket numbers, etc.) to that list. There are no changes to the content, commitments, or program material.

B.

If any of the QA Program Change Screen answers are YES, a change to the DQAP may be required and a commitment reduction assessment performed by Quality Assurance is required prior to proceeding with the change.

C.

If all answers are NO, provide this form to originator of "Process Applicability Determination" form.

NlA Preparer:

Date Kevin Block 1,/1,/zu-z.'-t Quality Assurance Manager - HDI Date

Palisades Transitional Quality Assurance Plan (TQAP) Revision 0

HOL TEC O(C0\\1MIS51U~l~G l~J(I \\ H IO ~,H HDI - PALISADES TQAP HOLTEC DECOMMISSIONING INTERNATIONAL Transition Quality Assurance Plan (TQAP)

Palisades Nuclear Power Plant Effective: August 2, 2024 Palisades Nuclear Power Plant Docket No. 50-255 License No. DPR-20 Docket No.72-007 Docket No.: 71-0937 Page 1 of96 Revision 0

HDI

  • PALISADES TQAP I

Revision Concurrence and Agreement to Issue TQAP Revision O Action Signature POSITION / NAME

( concurrence, (sign, interoffice memo, certification, etc.)

e-mail, or telecoml Holtec Palisades -

t~

Supervisor, Quality Preparer Assurance I William Flick Holtec Palisades -

~l.c*~

Manager, Quality Approver Assurance I Kevin Block Holtec VP Licensing, C)u Rt"t Reg~latory Affairs / Jean Approver Fleming COMMENTS

  • NOTE: Individuals signing above confirm their review and concurrence with revision of the HDI-PALISADES TQAP and the completeness and accuracy of the information contained within in It.

Pagel of96

0((O\\IMISSIO'JI/I.G IN U IH HI O'IIA l Revision Number 0

Location New Procedure HDI - PALISADES TQAP Revision Summary Description of Changes Change the previously authorized Holtec Decommissioning International (HDI) Fleet Decommissioning Quality Assurance Program (DQAP)(Revision2) to a site specific HDI Palisades DQAP renamed the HDI Palisades Transition Quality Assurance Plan (TQAP) (Revision 0). The HDI Palisades TQAP (Revision 0) supports current decommissioning activities as well as those quality related activities necessary to support the reclassification of previously identified safety related Systems, Structures and Components (SSCs) for the future restart of the Palisades Nuclear Power Plant.

Effective date August 2, 2024 Page3 of96

HOLTE(

mcow,USSIOSING INTUSATIO\\:U SECTION HDI - PALISADES TQAP TABLE OF CONTENTS PAGE Preface/Intent.............................................................................................

6 DQAP Policy Statement...............................................................................

8 1.0 Organization.................................................................................

9 2.0 Quality Assurance Program.............................................................

13 3.0 Design Control............................................................................

15 4.0 Procurement Document Control......................................................

18 5.0 Instructions, Procedures, and Drawings............................................

19 6.0 Document Control........................................................................

20 7.0 Control of Purchased Material, Equipment, and Services......................

21 8.0 Identification and Control of Materials, Parts, and Components..............

24 9.0 Control of Special Processes..........................................................

25 10.0 Inspection...................................................................................

26 11.0 Test Control................................................................................

27 12.0 Control of Measuring and Test Equipment.........................................

28 13.0 Handling, Storage, and Shipping.....................................................

29 14.0 Inspection, Test, and Operating Status..............................................

30 15.0 Nonconforming Material, Parts, or Components...................................

31 16.0 Corrective Action..........................................................................

32 17.0 Quality Assurance Records............................................................

33 18.0 Audits........................................................................................

34 Page4 of96

HOLTEC DECOMMISSIONISC l~ TU SATJO...; U SECTION Appendix A Appendix B Appendix C Appendix D HDI - PALISADES TQAP TABLE OF CONTENTS PAGE DQAP General Administrative Requirements.......................

35 DQAP Site Specific Administrative Requirements................

37 Palisades Energy, LLC Quality Assurance Program Manual (QAPM) Rev. 0..............................................................

38 Listing of Safety Related Systems, Structures, and Components applicable to Palisades Restart Activities..........

94 Page 5 of96

HOLTE(

DH:OM\\lli~IO\\I~(;

l\\'TU\\AflO"-U HDI - PALISADES TQAP Preface/Intent of Transition Quality Assurance Plan (TQAP)

To support both the current decommissioning licensing basis as well as the future power operations licensing basis (POLS), a transition strategy is necessary for decommissioning and the restart project. That transition strategy is accomplished through the implementation of a site specific Holtec Decommissioning International (HDI) Palisades Transition Quality Assurance Plan (TQAP) (Revision 0). The HDI Palisades TQAP (Revision 0) will be the overarching document that assigns major functional responsibilities for quality related activities applicable to the current licensing bases, (decommissioning), at Palisades, as well as those restart project quality related activities applicable to the reclassification of the Systems, Structures and Components (SSCs) necessary to support the safe restart of Palisades.

The intent of the site specific HDI Palisades TQAP (Revision 0) is to continue to implement the quality requirements from the most recent HDI DQAP (Revision 2),

adopted at Palisades (June 28, 2022) for those functions/activities specific to decommissioning. For restart project activities, associated with systems, structures, and components (SSCs) that will be reclassified to support a POLS, additional quality requirements will be implemented until the power operations Technical Specifications/Lic~nsing Bases are implemented.

For those quality related activities/functions that are applicable to the reclassification of the SSCs at Palisades (Appendix D), the Palisades Energy, LLC Quality Assurance Program Manual (QAPM) (Revision 0), which was submitted to the Nuclear Regulatory Commission on May 23, 2024 (Adams Accession No. ML24144A106), (Appendix C), and the associated implementing quality related procedures will be utilized to provide the guidance and controls necessary to ensure that the degree of rigor and quality applied to those functions/activities is as previously committed to prior to adopting the HDI DQAP (Revision 2).

Once Palisades transitions from a decommissioning licensing basis to a POLS, quality related activities will be performed in accordance with the guidance contained within the Palisades Energy, LLC QAPM (Revision 0).

The incorporation of the site specific HDI Palisades DQAP and Palisades Energy, LLC QAPM (Revision O) to create the site specific HDI Palisades TQAP (Revision 0) is an enhancement, that implements quality requirements above and beyond those required by the decommissioning license basis, to the previously implemented HDI DQAP (Revision 2) and does not represent a reduction in commitment.

Page 6 of96

D!f.OM\\IISSIOl~l.',C ISTfl ~ HIO~.\\l HDI - PALISADES TQAP HOLTEC DECOMMISSIONING INTERNATIONAL Decommissioning Quality Assurance Program (DQAP)

Palisades Nuclear Power Plant Docket No. 50-255 License No. DPR-20 Docket No.72-007 Docket No.: 71-0937 Page7 of96

HOLTEC Otr0\\1'1,\\ISSIOM:-..G I\\TU!\\U IOSU HDI - PALISADES TQAP Decommissioning Quality Assurance Program (DQAP} Policy Statement The Decommissioning Quality Assurance Program (DQAP} is the highest tiered document that assigns major functional responsibilities for decommissioning facilities owned and operated by Holtec International and Holtec Decommissioning International respectively (HDI}. Implementing documents assign more specific responsibilities and define the organizational interfaces involved in conducting safety significant (term used in this DQAP to identify both safety related and important to safety} activities within the scope of this DQAP. These requirements apply to those organizations and positions, which manage and perform activities within their scope.

The HDI organization is structured on the basis that the attainment of the objectives of this Program relies on those who manage, perform, and support the performance of activities within the scope of the DQAP. Assurance of this attainment relies on those who have no direct responsibility for performing the activity.

HDI will maintain the decommissioning facilities in a manner that will ensure the health and safety of the public and the workers. All facilities shall, at a minimum, be in compliance with the applicable requirements of the Code of Federal Regulations, NRC Licenses, and the laws and regulations of the state and local governments.

Page 8 of96

HOLTEC DECOWMS!IK)!I.IM,;

I\\Tfl'\\llt)~U HDI - PALISADES TQAP

1. ORGANIZATION HDI is responsible for the establishment and execution of the DQAP at the decommissioning facilities owned by Holtec and maintained by HDI. These decommissioning facilities have submitted a Certification of Permanent Cessation of Operations and Certification of Permanent Removal of Fuel to the Nuclear Regulatory Commission (NRC) per 10 CFR 50.82(a)(1 )(i) and (ii), respectfully. The titles of managers used in the DQAP are generic, or functional titles and their formal titles may vary. Unless otherwise specifically prohibited, responsibilities of managers described in the DQAP may be delegated to, and be performed by, other qualified individuals.

1. 1.

Responsibilities 1.1.1. The authorities and duties of persons and organizations performing activities within the scope of this DQAP are established and delineated in writing.

1.1.2. All personnel who work directly, or indirectly for HDI are responsible for the achievement of quality in their work. Accordingly, all HDI personnel and its contractors engaged in supporting decommissioning activities shall comply with the requirements of this DQAP.

1.1.3. The overall responsibility for operation, maintenance, inspection, test, modification, decommissioning, and storage of spent fuel resides with the HDI President and is overseen by the Holtec President and CEO.

The HDI Site Vice President at each decommissioning facility is responsible for the administration and implementation of the DQAP at the applicable facility.

1.1.4. The DQAP is reviewed and approved by the Holtec Vice President of Quality Assurance. The management position responsible for Quality Assurance/Nuclear Oversight is responsible for periodically reporting to the HDI President and Holtec Senior Vice President of Business Development on the effectiveness of the DQAP implementation and immediately apprising them of significant problems affecting quality.

1.1.5. Management of line organizations at the decommissioning facilities are responsible to ensure that the quality of work and activities meets the requirements set forth in the NRC licenses including the site technical specifications, this DQAP, and implementing procedures.

1.2.

Corporate Organizations 1.2.1 The HDI President has the overall responsibility for the safety, operation, and decommissioning of the nuclear sites maintained by HDI including oversight of the decommissioning activities performed by Page 9 of96

HOLTEC Dfr0\\1\\IISSIOW1iG l'Tfl!rt,',JIO\\\\l HDI - PALISADES TQAP HDI. This is the senior executive responsible for providing strategic direction to the HDI organization and to the senior leadership of the decommissioning facilities maintained by HDI. This position is responsible for providing management direction, oversight and support to the site organizations and for setting and implementing policies, objectives, expectations, and priorities to ensure activities are performed in accordance with the DQAP and other requirements.

The Holtec President and CEO provides oversight of all HDl's nuclear activities including decommissioning of the nuclear sites maintained by HDI.

1.2.2 The Holtec Vice President of Quality Assurance reports to the Holtec Senior Vice President of Business Development and the HDI President. The position provides quality assurance oversight for the decommissioning facilities maintained by HDI. In addition, this position is responsible for verifying the DQAP is effectively implemented, that Quality Assurance (QA) personnel have sufficient authority and organizational freedom to identify quality problems and to verify implementation of corrective actions, and that QA personnel have direct access to appropriate levels of management necessary to perform their function and shall be independent from cost and schedule when opposed to quality and safety considerations.

Functional responsibilities include:

Managing the performance of periodic audits and quality verification inspections to verify that activities within the scope of this DQAP have been correctly performed.

Establishing quality assurance practices and policies.

Authority and obligation to raise any conditions adverse to quality to the Holtec Senior Vice President of Business Development and HDI President for resolution, as necessary.

Reporting on oversight activities to the Holtec Senior Vice President of Business Development and HDI President.

Authority to stop work when quality is adversely affected.

1.2.3 The following management positions report to and/or receive direction from the HDI President with respect to their assigned roles and responsibilities associated with the execution of this DQAP:

The CED Vice President of Licensing, Regulatory Affairs, and PSA is responsible for providing licensing oversight for the decommissioning facilities maintained by HDI. This position is responsible for overseeing and guiding development and submission of licensing, regulatory and environmental actions.

Page 10 of96

HOLTEC DEC0,\\1Ml5SIO.\\l~G 1:'I.TU~,\\TI0'4H HDI - PALISADES TQAP This position also conducts routine assessments of the regulatory activities at each of the decommissioning facilities and supports the interface between the site and nuclear regulators while also taking a lead role on generic issues in decommissioning.

Additional support organizational activities such as Emergency Preparedness, calibrations, procurement, training, legal, communications, records and document control, information technology, business operations, and human resources may be provided by the decommissioning facility or by the corporate organizations.

1.3.

Decommissioning Facility Management The following are HDI decommissioning facility management positions and associated DQAP functional responsibilities which may be delegated to others as established in this document. These individuals may report through an additional layer of management but shall maintain sufficient authority and organizational freedom to implement assigned responsibilities.

1.3.1 The HDI Site Vice President for each decommissioning facility maintained by HDI is responsible for providing day-to-day on-site leadership and direction to the associated decommissioning facility to assure the safe decommissioning, maintenance, and regulatory compliance of the station including control over those onsite activities necessary for safe storage and maintenance of spent nuclear fuel, including maintaining the facility within the constraints of applicable regulatory requirements, licenses, Technical Specifications dry storage system Certificate of Compliance and training. The HDI Site Vice President, or specified designee, shall approve, prior to implementation, all tests, experiments, and modifications to systems or equipment that affect the safe storage and maintenance of spent nuclear fuel. The following positions report to the HDI Site Vice President:

A management position responsible for operational activities necessary for safe storage and maintenance of spent fuel including maintaining the facility within the constraints of applicable regulatory requirements and the decommissioning facility licenses.

A management position responsible for radiation protection, ALARA planning, chemistry, and environmental activities.

A management position responsible for supporting the CED VP of Licensing, Regulatory Affairs, and PSA in maintaining an interface between the station and federal, state, and local regulators. Also, Page 11 of96

HOLTEC DE.C0MMl5510:..l~G I\\Tflt~ATIO,Al HDI - PALISADES TQAP responsible for Emergency Preparedness, the Corrective Action Program, and document control and records management functions.

A management position responsible for managing decommissioning projects within the constraints of the decommissioning facility licenses and regulatory requirements.

A management position responsible for engineering support activities, development and maintenance of engineering programs, policies, procedures, and providing engineering services in accordance with the DQAP.

A management position responsible for the execution of maintenance and modification activities.

A management position responsible for implementation of the decommissioning facility security plan.

This following position may be included in the decommissioning facility management or in the corporate organization.

A management position responsible for material management and decommissioning facility supply, which coordinates, evaluates, and procures materials for the decommissioning facility.

Page 12 of96

HOLTE(

DECO\\I\\IIS510Nl~G 1qn~HION"-I HDI - PALISADES TQAP

2. QUALITY ASSURANCE PROGRAM 2.1 The Quality Assurance (QA) Program for HDI decommissioning facilities as described in this DQAP provides control over activities affecting quality to an extent consistent with their importance to safety and compliance. The DQAP includes specific monitoring activities which are measured against acceptance criteria in a manner sufficient to provide HDI management assurance that the activities affecting quality are performed in an acceptable manner. The DQAP requirements apply to (i.e. the following are in the scope of the DQAP) structure, system, or components (SSCs) designated as safety significant, applicable regulatory programs, and for other applicable activities and SSCs identified in either the facility-specific Decommissioning Safety Analysis Report (DSAR) or Appendices of this DQAP.

2.2 The DQAP 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 72 Subpart G, Quality Assurance for Independent Storage of Spent Nuclear Fuel and High-Level Radioactive Waste. HDI also commits to NUREG/CR-6407, Classification of Transportation Packaging and Dry Fuel Storage System Components According to Important to Safety (2/1996).

2.3 Activities affecting quality 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 DQAP 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 where required.

2.4 Changes to the DQAP will be implemented in accordance with 10 CFR 50.54(a).

2.5 Program Control and Authority 2.5.1. The Holtec VP of Quality Assurance is responsible for ensuring that the applicable portions of the DQAP are properly documented, approved, and implemented before an activity within the scope of the DQAP is executed.

Page 13 of96

HOLTEC HDI - PALISADES TQAP DECOM\\IISSIO\\:l:\\G lX:HR:-P,flOV,L 2.5.2. Additional requirements for specific programs are described in the Administrative Controls section of the applicable decommissioning facility Technical Specifications or in the DSAR, with the exception of security requirements which are contained in the applicable facility Physical Security Plan; and Emergency Plan requirements which are contained within the applicable facility Site Emergency Plan. Fire Protection Program requirements are addressed in Appendix A of this DQAP.

2.6.

Program Review 2.6.1. The status and effectiveness of the DQAP and its implementation is periodically reviewed by the management of the organization responsible for its execution.

2. 7.

Personnel Training and Qualifications

2. 7.1. Formal indoctrination and training programs for personnel performing or verifying activities within the scope of this DQAP are established and maintained. The indoctrination and training programs are established by on-site and/or off-site organizational units responsible for the performance or verification of activities within the scope of this DQAP.

2.7.2. Personnel shall have sufficient qualifications, as applicable, to perform their assigned duties. Implementing procedures provide the criteria utilized for determining and assessing appropriate staff qualifications. Indoctrination, training, and qualification programs are established such that:

Personnel performing and/or verifying activities affecting quality are trained and qualified, as applicable, in the principles, techniques, and requirements of the activity being performed.

Formal training and qualification program documentation includes the objective, content of the program, attendees, and date of attendance.

Proficiency tests are given as applicable to those personnel performing and verifying activities affecting quality.

A certificate of qualification, as applicable, clearly delineates the specific quality assurance functions personnel are qualified to perform and the criteria used to qualify personnel in each function.

Page 14 of96

HOLTE(

OEi:G\\l\\115510~1:,.,.G l'ffl\\!*\\TIO\\.U HDI - PALISADES TQAP

3. DESIGN CONTROL 3.1 Measures are established to assure that the designs, including applicable regulatory requirements and design bases, technical and quality requirements are correctly translated to design documents which include specifications, drawings, procedures, and instructions. HDI has overall responsibility for design and design control activities including preparing, reviewing, approving, and verifying design documents related to the facility's structures, systems, and components (SSCs) within the scope of the DQAP.

3.2 Design changes to SSCs within the scope of this DQAP shall be properly controlled using design control measures commensurate with those applied to the original design as appropriate. Design changes are reviewed and approved by the same design groups cognizant in the discipline affected by the change that reviewed and approved the original documentation unless alternative design groups are designated. Design activities associated with the decommissioning facility changes or modifications may be performed by HDI or qualified contractors. Design groups shall have access to background information, shall be competent in the specific area of design interest, and shall understand the requirements and intent of the original design.

3.3 Measures shall be established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to SSCs that have current safety significant functions. Design control implementing procedures shall define responsibility for the following:

Design Input Design Performance Design Interface Control Design Verification Design Change 3.4 Design inputs shall be identified, documented, and correctly used to derive design outputs. Design inputs shall be specified to a level of detail necessary to allow the design activities to be carried out in a controlled manner.

3.5 The design organization shall prescribe and document the design activities to the level of detail necessary to permit the design process to be completed in a correct manner which permits verification that the design meets requirements. Design documents shall support facility design, construction, safe storage and handling of spent fuel, and decommissioning projects.

Appropriate quality standards shall be identified and documented, and their selection reviewed and approved. Deviations from original design standards shall be reviewed to ensure that the designated quality requirements remain in the design of SSCs as applicable.

Page 15 of96

INN HOLTEC DECOM\\11SWO~I\\G I_..TEt!!o,HIOS\\l HDI - PALISADES TQAP 3.6 Design control measures shall be applied to those SSCs within the scope of this DQAP. Design analyses shall be sufficiently detailed such that a person technically qualified in the subject can review and understand the analyses and verify the adequacy of the results without additional input.

3. 7 Design interfaces for SSCs within the scope of this DQAP shall be identified and controlled. Interface controls shall include the assignment of responsibility and the establishment of procedures among participating design organizations. Controls shall be established for the review, approval, release, distribution, and revision of documents involving design interfaces.

Design information transmitted across interfaces shall be documented and controlled.

3.8 Changes or modifications to designated SSCs shall be approved by the Design Authority or designee. Procedures for implementing design changes and field changes shall assure that the impact of the change is considered, required actions documented, and information concerning the change transmitted to affected persons or organizations. Applicable regulatory change process criteria (e.g., 10 CFR 50.59, 10 CFR 50.82(a), or 1 0 CFR 72.48) shall be used to determine if NRC approval is required prior to implementation of a design change. For SSCs within the scope of this DQAP, these changes shall be subject to design control measures commensurate with those applied to the original design.

3.9 Design verification for SSCs within the scope of this DQAP shall provide assurance that the final design is correct and has been performed in accordance with approved procedures for the design reviews.

Documentation to be reviewed for this design work includes the necessary calculations and/or analysis, design criteria specifications, drawings, procedures, and instructions as applicable to permit a comprehensive review.

3.10 Design verification may be accomplished through design reviews, alternate calculations, or qualification testing. These methods of design verification are defined in design procedures as applicable. The results of the design verification activities shall be documented with the identification of the verifier clearly documented. Design verification shall be performed by competent individual(s) other than those who performed the original design but may be from the same organization. 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, did not establish the design inputs used in the design, or the supervisor is the only individual in the organization competent to perform the verification. Cursory supervisory reviews do not satisfy the intent of design verification. Design verification shall be completed prior to relying upon the SSC to perform its safety significant function.

Page 16 of96

HOLTEC DEC011Ml5SIONl",G 11\\.TU""-\\TIONM HDI - PALISADES TQAP 3.11 Nonconforming activities such as deviations, errors, or deficiencies in the approved design documents, including design methods (e.g., computer codes), shall be identified, documented, and controlled. Computer programs used to calculate or develop data for safety significant activities shall be subject to validation and verification.

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

Page 17 of96

w HOLTEC DECOM\\IISSIO~ \\G 1:,, rn :,,u1m, u HDI - PALISADES TQAP

~ PROCUREMENTDOCUMENTCONTROL 4.1.

Measures are ~stablished for the preparation, review, and approval of procurement documents for those items and activities within the scope of this DQAP. Procurement documents include or reference the appropriate regulatory, technical, and quality requirements necessary to assure adequate quality for those materials, equipment, and services that are within the scope of this DQAP. Measures are established to assure that, to the extent necessary, contractors or subcontractors provide a QA Program consistent with the provisions of 10 CFR 50 Appendix B, 10 CFR 71 Subpart H, or 10 CFR 72 Subpart G, and 10 CFR 21, as applicable.

4.2.

HDI maintains an Approved Vendor List (AVL) for those vendors qualified to perform safety significant work. The qualification requirements for vendors on the AVL are described in controlling procedures except for procurement from other licensees that have an NRC approved quality program. Vendor qualification processes use a graded approach based on the qualification level of the vendor.

4.3.

Procurement document control applies to SSCs within the scope of this DQAP and any spare or replacement parts for those SSCs. Procurement documents shall include those requirements necessary to assure that the items and services to be provided meet the specified technical and quality requirements. Specifically, the procurement system assures that the appropriate technical and quality requirements are specified for procurement of items and services considering the safety significant function, complexity of the design, manufacturing, degree of inspection/testability upon receipt and other factors which affect the quality of products and services. In addition, procurement documents will, as applicable, require vendors to a) invoke applicable requirements on their vendors; b) allow for right of access for further evaluations as needed.

4.4.

Procedures that implement procurement document control shall describe the organizational responsibilities for procurement planning, preparation, review, approval and control of procurement documents, and vendor selection.

4.5.

Procedures shall be established to review the adequacy of the technical and QA requirements specified within procurement documents. Personnel who have access to pertinent information and who have an adequate understanding of the requirements and intent of the procurement documents shall perform reviews required to ensure the adequacy of the technical and QA requirements. Changes to procurement documents shall be subject to the same controls as the original documents.

Page 18 of96

HOLTEC DECOM*ll5510NIPl:G IXHR!I..\\TIO\\U HDI - PALISADES TQAP

5. INSTRUCTIONS, PROCEDURES AND DRAWINGS 5.1 Measures are established to assure that quality activities are prescribed by and performed in accordance with documented instructions, procedures, or drawings. Documented and approved instructions, procedures, and drawings are required to accomplish work on SSCs within the scope of this DQAP.

5.2 These instructions, procedures, and drawings include as appropriate, quantitative or qualitative acceptance criteria for determining that activities have been satisfactorily accomplished. The activities shall be described to a level of detail commensurate with the complexity of the activity and the need to assure consistent and acceptable results.

5.3 Controls are established which ensure that instructions, procedures, and drawings are current and accurately reflect decommissioning facility design and regulatory requirements.

Page 19 of96

HO L TEC DECO,\\I\\IISSIONII\\G l'-Tflti\\UI0"-\\1

6. DOCUMENT CONTROL HDI - PALISADES TQAP 6.1.

Measures are established to control the issuance of documents, such as instructions, procedures, drawings, including changes thereto, which prescribe activities affecting quality and activities within the scope of this DQAP. These measures assure that documents, such as procedures, instructions and drawings, are reviewed for adequacy by qualified personnel other than the personnel that prepared the document, approved for release and use, and available at the location where the activity is performed. Written procedures shall define the type of documents to which the document control system applies. These procedures also define the process for controlling the preparation, review, approval, issuance, and distribution.

6.2.

Documents and changes to documents that prescribe or verify activities within the scope of this DQAP shall be controlled in a manner that precludes the use of inappropriate or outdated documents.

6.3.

Changes to documents shall be reviewed and approved by the same organization that performed the original review and approval unless another qualified organization has been designated. Administrative controls shall 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, and the time period during which they may be used. Minor changes to documents, such as inconsequential editorial corrections, shall not require that the revised documents receive the same review and approval as the original documents. To avoid a possible omission of a required review, the type of minor changes that do not require such a review and approval and the persons who can authorize such a decision shall be clearly delineated.

Page 20 of96

HOLTE(

DECOM\\IISSIO",l!\\.G 111-TEI\\\\TIO\\U HDI - PALISADES TQAP

7. CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES 7.1.

Measures are established for the control of purchased material, equipment

{identified as items), and services to assure they conform to the procurement documents as they apply to activities within the scope of this DQAP. These measures provide for the following as appropriate: source evaluation and selection, evaluation of objective evidence of quality furnished by the vendor, source inspection, audit, and examination of items or services. Procedures shall describe each organization's responsibilities for the control of items and services, including the interfaces between all affected organizations.

Documentation of acceptance of items shall be available prior to installation or acceptance for use.

7.2 Verification that a vendor can meet the specified technical and quality requirements shall be documented. HDI maintains an Approved Vendor List (AVL) for those vendors qualified to perform safety significant work. The qualification requirements for vendors on the AVL are described in controlling procedures. Vendor qualification processes use a graded approach based on the qualification level of the vendor.

7.3 This DQAP considers that other 10 CFR Part 50 licensees, Authorized Nuclear Inspection Agencies, National Institute of Standards and Technology, or other State and Federal agencies which may provide items or services to the facility are not required to be evaluated or audited.

7.4 Commercial grade calibration and/or testing services may be procured from domestic and international commercial calibration and/or testing laboratories based on the laboratory's accreditation to ISO/IEC-17025:2017 by an Accreditation Body (AB) which is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) provided all the following are met:

7.4.1 A documented review of the vendor's accreditation is performed and includes a verification of the following:

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

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

Page 21 of96

1r-HOLTEC DEC0.\\l\\1I5SJ0),,,IM,;

1r.:nu.,110,u HDI - PALISADES TQAP For procurement of testing services, the published scope of accreditation for the test laboratory covers the needed testing services including test methodology and tolerances/ uncertainty.

7.4.2 The purchase documents require that:

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

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

(For calibration services only)

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

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

Additional technical and quality requirements, as necessary, based upon a review of the procured scope of services, which may include, but are not necessarily limited to, tolerances, accuracies, ranges, and industry standards.

Supplier shall not sub-contract the service to any other supplier.

7.4.3 It is validated, at receipt inspection, that the laboratory's documentation certifies that:

The contracted calibration or test service has been performed in accordance with their ISO/IEC-17025:2017 program, and has been performed within their scope of accreditation; and The purchase order's requirements are met.

7.5 The effectiveness of contractors and vendor's s QA program shall be assessed at intervals consistent with the importance, complexity, and quantity of the item or service. Vendor performance and compliance with procurement documents are monitored by source verification, receipt inspection, audit, or a combination to ensure continued acceptable vendor performance. Receiving inspection shall verify, by objective evidence, the acceptability of items in accordance with decommissioning facility procedures. Accepted items are appropriately marked and located in a Page 22 of96

HOL TEC DlCOM\\IIS)IOS!)..C isru,-u10,"1 HDI - PALISADES TQAP controlled storage area until use. Documentary evidence shall be retained in accordance with decommissioning facility requirements and applicable regulatory requirements and shall be sufficient to identify the specific requirements, such as codes, standards, or specifications, met by the purchased items.

7.6 For acquiring of services only, such as: third-party inspection, engineering and consulting services; auditing and installation; and repair, overhaul, or maintenance work, from vendors whose QA Program has not been reviewed or accepted, those vendors may be used provided additional controls such as technical verification of data produced, surveillance and/or audit of the activity, or review of objective evidence are employed. Additional controls will be approriately identified and implemented.

7.7 Spare and replacement parts are procured such that their performance and quality are at least equivalent to those of the parts that will be replaced, as determined by engineering where applicable.

7.8 Designated quality personnel or other personnel with appropriate qualifications are responsible for assuring source inspections, surveys, or audits of vendors are performed as necessary.

Page 23 of96

HOLTEC DH OMMISSIQ:--;l!\\G 11\\TfU.ATIIJ~\\l HDI - PALISADES TQAP

8. IDENTIFICATION AND CONTROL OF MATERIALS. PARTS. AND COMPONENTS 8.1.

Measures are established for the identification and control of material, parts, and components, including partially fabricated assemblies and consumables (identified as items), to assure that only correct and accepted items are used or installed. Identification is maintained on the items or in documents traceable to the items, and physical identification shall be used to the maximum extent possible. If physical identification is either impractical or insufficient for proper control, HDI controls an item by physical separation, procedural control, or other appropriate means.

8.2.

Markings are applied using materials and methods that are clear, legible and do not detrimentally affect the function or service life of the items that are marked. Markings are transferred to each part of an identified item prior to being subdivided. Markings are not obliterated or masked by surface treatments or coatings unless alternative identification methods are established.

8.3.

Provisions are made in procedures for maintenance or replacement of markings or identification due to damage from handling or aging, excessive deterioration due to environmental exposure, and for updating records while in storage.

8.4 Items having limited shelf or operating life are controlled to preclude use after the shelf life or operating life has expired.

Page 24 of96

a a HOLTEC OE(0,\\1Ml5510SISCi INT(l~UION-\\L HDI - PALISADES TQAP

9. CONTROL OF SPECIAL PROCESSES 9.1.

Measures are established to assure that special processes that require interim process controls to assure quality, such as welding, heat treating, and nondestructive examination, are controlled. These provisions include assuring, as applicable, that special processes are accomplished by qualified personnel using instructions, procedures, drawings, checklists, or other appropriate means. 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.

Records are maintained, as appropriate, for the qualified personnel, processes, and equipment.

Page 25 of96

HOLTEC Dl(OM\\IISSIO'lll!\\G l:\\TER\\UIOSU

10. INSPECTION HDI - PALISADES TQAP 10.1. Measures are established for inspection of activities within the scope of this DQAP by or for the organization performing the activity, to verify conformance with approved instructions procedures, drawings, and specifications for accomplishing the task.

10.2. A comprehensive program of inspections shall be established and implemented to verify conformance of an item or activity with the specified requirements. Inspections shall be performed by qualified individuals other than those who perform or directly supervise the activity being inspected.

10.3. Where mandatory hold or witness points are required for witness or inspection activities by designated personnel, the designated hold points shall be indicated in appropriate documentation. Work shall not progress beyond the point of an assigned hold point unless the inspection is complete or consent to waive the hold point is given by the designated organization.

10.4. Inspections shall be planned to ensure the characteristics be inspected and the methods used to perform the inspection and acceptance criteria are documented. If inspection of items is impractical, monitoring of the processing method and equipment shall be utilized. Process monitoring shall be performed by qualified personnel or a qualified automated process.

Inspection and process monitoring shall both be used if quality control is inadequate without both.

10.5. Inspection records shall identify the item inspected, date of inspection, inspector's identity, and results of inspection.

10.6. Unacceptable inspection results shall be evaluated and resolved in accordance with approved procedures. Any modifications, repairs, and replacements are re-inspected to the same standard or method to verify acceptability of the items.

Page 26 of96

HOL TEC O(r.D\\l\\ll~SIO~l'iG 1,TER~HIO\\.-\\L

11. TEST CONTROL HDI - PALISADES TQAP 11.1. Measures are established for a documented test program in accordance with applicable Technical Specifications, license conditions, and design documents to assure that all required testing demonstrate that the SSCs within the scope of this DQAP will perform satisfactorily in service. The test program shall ensure that design and performance criteria have been satisfied and that the testing does not adversely affect the safety significant SSCs.

11.2. The test program shall include criteria for determining when testing is required, such as proof tests prior to installation, preoperational tests, and operational tests of SSCs. The procedures that implement testing shall specify the appropriate prerequisites for the test (e.g., personnel qualification requirements, environmental conditions, equipment requirements), sufficient instruction for the performance of the testing, hold or witness points, acceptance/rejection criteria and limits, and the required test documentation.

11.3 Test results are evaluated by the responsible organization to determine compliance with established acceptance criteria. Test results which do not meet acceptance criteria shall be documented and evaluated to determine the appropriate corrective actions.

11.4 The test program shall require that modifications, repairs, and replacement of items that have a current safety significant function be tested, utilizing the same criteria as the original items to the extent applicable to the current safety significant function. If alternative tests are required, the alternative tests must be reviewed and approved by the same organization that established the original requirements unless the applicable manager designates another responsible organization. Test records shall be maintained in accordance with approved procedures.

Page 27 of96

HOLTEC DEC0\\1\\.115~10~ \\C "lEll\\"iTIO\\:-\\L HDI ~ PALISADES TQAP

12. CONTROL OF MEASURING AND TEST EQUIPMENT 12.1. Measures are established to assure those tools, gauges, instruments, and other measuring and test equipment (M& TE), used for activities within the scope of this DQAP, are controlled, calibrated and adjusted in order to maintain accuracy within necessary limits and to ensure M& TE traceability to calibration test data. For the purposes of this section, M& TE is considered to include both portable and permanently installed instrument and control devices.

12.2. Organizational responsibilities are delineated for establishing, implementing, and assuring the effectiveness of the calibration program for M& TE.

Reference standards used to determine the acceptability of items and activities, are of appropriate type, and maintained within prescribed accuracy limits, suitable range and accuracy in order to verify conformance to specified requirements.

12.3. Procedures for the control and calibration of M& TE that are within the scope of this DQAP shall specify identification requirements (labeling, codes, or other documented control system), the recall process and calibration process and frequencies (including documented pre-calibration checks) of the M& TE to nationally recognized standards. Calibration methods are documented and performed by competent personnel in an environment that does not adversely affect the calibration. The calibration procedures shall specify recording of as-found conditions.

12.4. The calibration procedures shall delineate special controls where applicable, for usage, handling, and storage required for environmental conditions such as temperature, humidity, cleanliness, or radiation to maintain accuracy and operating characteristics of the M& TE.

12.5. Calibration reference standards shall be based on nationally recognized standards or accepted values of natural physical constants. Where national standards do not exist, the basis for the calibration shall be documented.

Special calibration and control measures are not required when normal commercial practices provide adequate accuracy (e.g. rulers, tape measures, levels, and other such devices).

12.6. M& TE, which is found to be damaged, out-of-calibration or for which accuracy is suspect, shall be tagged and segregated and processed in accordance with approved procedures. When M& TE is found to be out-of-tolerance, an evaluation is made of its previous uses to determine corrective action.

Page 28 of96

ii HOLTEC DlCOMMISSlONl~G 1'-JEfjS.\\TION.\\L HDI-PALISADES TQAP

13. HANDLING, STORAGE, AND SHIPPING 13.1. Measures are established to control the handling, storage, shipping, packaging, cleaning and preservation of items within the scope of this DQAP in order to prevent damage or deterioration.

13.2. Special coverings, equipment and protective environments shall be specified and provided where necessary for the protection of items from damage and deterioration. Special protective measures are specified and provided when required to maintain acceptable quality. When special protective features are required, their existence shall be verified and monitored as necessary to assure that the special protective features continue to serve their intended function. Special handling tools and equipment shall be provided, where necessary, to ensure items can be handled safely and without damage.

13.3. Controls for hoisting, rigging, and transporting shall be established to protect SSCs within the scope of this DQAP as applicable. Markings or labeling shall be used to indicate the presence of special environments, or the need for special controls. Provisions shall be described for the storage of chemicals, reagents (including control of shelf life), lubricants and other combustible materials. Cleanliness controls shall be implemented to protect applicable SSCs from the introduction of foreign material and maintain system cleanliness as applicable throughout maintenance and modification activities.

Page 29 of96

HOLTEC D(COM\\115510'-l~G l~TEROloHIOSAL HDI - PALISADES TQAP

14. INSPECTION, TEST, AND OPERATING STATUS 14.1. Measures are established for indicating the status of items within the scope of this DQAP undergoing inspections and tests to prevent the inadvertent bypassing or altering the sequence of such inspections or tests and avoid inadvertent operation. 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.

14.2. 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 where necessary, and status tracking.

14.3. The operating status of nonconforming, inoperable or malfunctioning SSCs shall be identified and documented to prevent inadvertent operation.

Page30 of96

HOLTEC DEi 0\\1\\IISSIOSl),,G 1,,u,,rio,"L HDI - PALISADES TQAP

15. NONCONFORMING MATERIAL, PARTS, OR COMPONENTS 15.1. Measures are established for the identification, evaluation, segregation (when practical), disposition of nonconforming items, and for notification to affected organizations. Items (including applicable services) that do not conform to specified requirements shall be controlled to prevent inadvertent installation or use.

15.2. Measures are established to require that the individual (or designee) discovering a nonconformance identifies, describes, and documents the nonconformance in accordance with the requirements of the corrective action program. Actions taken to address nonconforming items shall be documented.

15.3 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 in the decommissioning facility requires the approval of the designated management.

15.4 Nonconformances are corrected or resolved prior to depending on the item to perform its intended safety significant function. Nonconformances to design requirements dispositioned as repair or use-as-is are subject to design control measures commensurate with those applied to the original design.

Significant trends in nonconformances are reported to management in accordance with applicable procedures, regulatory requirements, and industry standards.

15.5. Nonconforming items that are being used for training must be controlled (e.g.,

administratively controlled, permanently identified, marked, obliterate Material ID Tag or Q level indicators) to prevent inadvertent or inappropriate use of the item.

Page 31 of96

HHS HOLTEC DECOM\\IISSIO~,c l~TEU,,HIO'\\iU

16. CORRECTIVE ACTION HDI ~ PALISADES TQAP 16.1. Measures are established to promptly identify, control, document, classify, and correct conditions adverse to quality. Procedures assure that corrective actions are documented and initiated following the determination of conditions adverse to quality in accordance with regulatory requirements and applicable quality standards. Procedures require personnel to identify known conditions adverse to quality. When a complex issue arises where it cannot be readily determined if a condition adverse to quality exists, measures shall be established for documentation and timely evaluation of the issue. Significant conditions adverse to quality 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 and followed up on to verify implementation.

16.2. In the case of vendors performing activities within the scope of this DQAP the applicable manager may delegate specific responsibilities for corrective actions but maintain responsibility for the effectiveness of corrective action measures.

Page32 of96

HOLTE(

OEfO\\I\\IISSIONl'C l°"TER~HION'il HDI - PALISADES TQAP

17. QUALITY ASSURANCE RECORDS 17.1. Measures are established which define the requirements and responsibilities for identification, generation, collection, compilation, storage, maintenance, retention, and retrieval of records necessary to provide objective evidence that activities within the scope of this DQAP are in compliance with the regulations and decommissioning facility implementing procedures.

17.2. Distribution of records shall be controlled in accordance with written procedures. Measures are established for replacement, restoration, or substitution of lost or damaged records.

17.3. Records are legible, accurate, complete, identifiable, and retrievable.

Records are considered valid and complete when dated and stamped, initialed, signed, or otherwise authenticated. Corrections, revisions, or supplements to completed records are reviewed and approved by an authorized individual in the originating organization. Such changes are dated and stamped, initialed, signed, or otherwise authenticated including the use of electronic approval and authorization as applicable.

17.4 Record storage facilities are established and maintained in a manner that minimizes the risk of damage or destruction. Records may be kept by vendors and maintained on an available basis for a specified period of time.

Records may be stored in electronic media provided that the process for managing and storing data is documented in procedures that comply with applicable regulations, including NRC guidance in RIS 2000-18 and as recognized in NIRMA (Nuclear Information Records Management Association) technical guides TG-11, TG-15, TG-16, and TG-21.

17.5 The program includes provisions for the use of various record storage media to maintain QA records. Procedures are developed to implement the regulatory guidance associated with the media used. The NRC Generic Letter 88-18 "Plant Record Storage on Optical Disk" is implemented for optical disk media. The Regulatory Issue Summary 2000-18 "Guidance on Managing QA Records in Electronic Media" is implemented for electronic media.

17.6. Record retention periods are established to meet regulatory, UFSAR/DSAR, DQAP, and License requirements. The most stringent retention period is implemented when multiple requirements exist. Records are dispositioned at the end of the prescribed retention period.

Page 33 of96

HOLTE(

DErOMMISSIOM!\\C 1,TER\\-\\JIO\\-\\L

18. AUDITS HDI - PALISADES TQAP 18.1. Measures are established for a system of planned and documented audits to verify compliance with all aspects of the DQAP and determine the effective implementation of programs covered by the DQAP.

18.2 Internal and vendor audits are conducted in accordance with written procedures or checklists. Audit personnel shall not have direct responsibilities in the areas to be audited.

18.3. The internal audit program is conducted on a performance driven frequency that is commensurate with the status and importance of the activity to be completed but does not exceed 24-months, unless otherwise required by regulation. Audits may be extended beyond their originally scheduled due date based on the following criteria:

Audits shall be performed at the intervals designated and the schedules are based on the month in which the audit starts.

A maximum extension not to exceed 25 percent of the audit interval is allowed unless restricted by regulation.

18.4 The vendor audit program is conducted on a performance driven frequency that is commensurate with the status and importance of the activity to be completed but does not exceed 36-months, unless otherwise required by regulation.

A maximum extension not to exceed 25 percent of the audit interval shall be allowed except that a total combined time interval for any three consecutive audit intervals should not exceed 3.25 times the specified audit interval, unless otherwise required by regulation.

18.5 When an audit interval extension greater than one month is used, the next audit for that particular audit area is scheduled from the original anniversary month rather than from the month of the extended audit.

18.6 Audit scheduling, preparation, personnel selection, personnel qualification, 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, activities being performed, regulatory requirements, and/or experience with the organization being audited. An audit schedule shall be maintained, reviewed, and revised as necessary at least annually, to ensure that programs receive necessary audits to support regulatory compliance.

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

Page34 of96

HDI - PALISADES TQAP Appendix A DQAP GENERAL ADMINISTRATIVE REQUIREMENTS A. 1 Fire Protection 10 CFR 50.48(f) requires that licensees that have submitted the certification required under 50.82(a)(1) shall maintain a fire protection program to address the potential for fires that could cause the release or spread of radioactive materials. The quality assurance program established for these fire protection SSCs ensures that design, procurement, instruction, procedures, drawings, inspection, installation, testing, maintenance, operations, nonconforming Items, corrective action, records, audits and administrative controls meet the applicable quality assurance guidelines as described in the applicable edition of Branch Technical Position (BTP) 9.5-1 for each facility during decommissioning and permanent shutdown. Engineering determines what fire protection SSCs are required to prevent fires, rapidly detect, control.

and extinguish fires that do occur and could result in a radiological hazard and, minimize the risk the public, environment, and decommissioning facility personnel resulting from fires that could result in a release of radioactive materials. Engineering also establishes the requirements for the design, procurement, fabrication, installation and/or modification of these fire protection SSCs. All other fire protection equipment and supplies will be of commercial quality, in accordance with National Fire Protection Association (NFPA) guidelines.

A.2 Transport of Radioactive Waste A.2.1 When HDI contracts with vendors to transport radioactive waste in NRC approved shipping packages, the contract is written such that the requirements of 10 CFR 71, Subpart H and Regulatory Guide 7.10, Revision 3 (6/15), "Establishing Quality Assurance Programs for Packaging Used in the Transportation of Radioactive Material" are met. HDI assures us that this service is procured from an organization with a QA program and, if applicable, includes a NRC licensed transport system. Loading, surveying, closure, placarding, and inspections are conducted in accordance with written procedures and instructions. Transport casks and trailers are inspected before release in accordance with Department of Transportation (DOT) 49 CFR. Shipping manifests, including final radiation surveys, are completed and retained. Radioactive waste shipments not meeting the requirements for NRC approved packaging, shall meet the requirements of DOT 49 CFR.

Page35 of96

i HOLTEC Dff0.\\l\\tl5Sl0MlliG 1,rn,rno~u HDI - PALISADES TQAP A.3.

Services A.3.1. HDI procures services from qualified vendors. It is not necessary that these vendors have a quality assurance program approved by the licensee, however, vendors should provide a quality assurance program that includes the quality assurance program elements presented in Regulatory Guide 4.15, Quality Assurance for Radiological Monitoring Programs (Normal Operations)- Effluent Streams and the Environment, and routinely provide program data summaries sufficiently detailed to permit evaluation of the program for the following areas:

Meteorology.

Offsite Dose Calculation Manual.

Radiological environmental monitoring.

A.4.

License Renewal A.4.1. Consistent with the requirements of 10 CFR 54.21 (a)(3), HDI implements the requirements of DQAP Section 1 through 18 for aging management activities related to safety significant SSCs as described by licensing documents for those systems that remain active.

A.4.2. Additionally, to manage the aging effects of non-safety significant SSCs that were determined to be within the scope of License Renewal, HDI implements the administrative controls, corrective actions and confirmation processes described in DQAP Sections 6, 16, and the applicable requirements of this appendix.

A.5.

Safety Review Committee A.5.1. The Safety Review Committee (SRC) serves the HDI President as an on-site review body that performs procedure and program reviews for decommissioning activities and ISFSI operation as necessary on matters of Nuclear Safety. Details regarding the membership, quorum, agenda, and meeting schedule are contained in implementing procedures.

Page 36 of96

Appendix B DQAP SITE SPECIFIC ADMINISTRATIVE REQUIREMENTS 8.1.

Regulatory Guide 1.33 8.1.1. Written procedures applicable to safe storage of nuclear fuel recommended in Appendix A of Regulatory Guide 1.33, shall be established, implemented, and maintained.

8.2 Regulatory Guide 1.88 8.2.1 Procedures for the collection, storage, and maintenance of decommissioning facility quality assurance records will be consistent with Regulatory Guide 1.88 Revision 2, dated October 1976. (Collection, storage, and maintenance of decommissioning facility quality assurance records).

8.3.

Independent Spent Fuel Storage Installation 0SFSI} SSC 8.3.1. ISFSI quality assurance program requirements are performed in accordance with the applicable 10 CFR 72.212 report which invokes the portions of the NRG approved 10 CFR 50 Appendix 8 quality assurance program as described in this DQAP, commensurate with the safety classification of the component and quality requirements specified in the cask vendor Final Safety Analysis Report (FSAR) or decommissioning facility ISFSI specific license.

8.3.2 Radioactive Material Transport Packages (10 CFR 71). 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 DQAP.

Page37 of96

Appendix C Palisades Energy LLC, Quality Assurance Program Manual (QAPM). Rev.O HOLTEC PALISADES ENERGY Quality Assurance Program Manual Palisades Nuclear Power Plant Palisades Nuclear Power Plant Docket No. 50-255 License No. DPR-20 Docket No.72-007 Docket No.: 71-0937 Page38 of96

HOLTEC PALISADES ENERGY PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL POLICY STATEMENT Palisades Energy, LLC shall maintain and operate the Palisades plant in a manner that will ensure the health and safety of the public and workers. The plant shall be operated in compliance with the requirements of the Code of Federal Regulations, the applicable Nuclear Regulatory Commission (NRC) Facility Operating 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 safety-related nuclear plant structures, systems, and components. The QAP is also applied to certain quality-related equipment and activities that are not safety-related, but support safe plant operations, or where other regulatory or industry guidance establishes program requirements.

The 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.

Responsibility for developing, implementing, and verifying execution of the Quality Assurance Program is delegated to the chief nuclear officer (highest level nuclear executive) and authority for developing and verifying execution of the program to the executive responsible for Quality Assurance.

Page39 of96

HOLTEC PALISADES ENERGY PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL TABLE OF CONTENTS SECTION PAGE A.

MANAGEMENT.................................................................................................. 43

1.

Methodology................................................................. _.......................... 43

2.

Organization............................................. ~******............... il! ************************* 43

3.

Responsibility.......................................................................................... 47

4.

Authority................................................................................................ 47

5.

Personnel Training and Qualification......................................_............. 48

6.

Corrective Action.................................................................................... 48

7.

Regulatory Commitments..................................................................... 49 B.

PERFORMANCENERIFICATION..................................................................... 50

1.

Methodology............................................................................................... 50

2.

Design Control........................................................................................... 50 3..

Design Verification................................................................................................................... 51

4.

Procurement Control............................................................................ 53

5.

Procurement Verification...................................................................... 54

6.

Identification and Control of ltems....................................................... 54

7.

Handling, Storage, and Shipping......................................................... 54

8.

Test Control.......................................................................................... 111........................ 55

9.

Measuring and Test Equipment Control.............................................. 55

10.

Inspection, Test, and Operating Status............................................... 56

11.

Special Process Control....................................................................... 57

12.

Inspection.............................................................................................. 57

13.

Corrective Action ******************-*......................................................................,........ 58 Page40 of96

HOLTEC PALISADES ENERGY PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL TABLE OF CONTENTS SECTION PAGE

14.

Document Control........................................................................................ 58

15.

Records............................................................................................................. 59 C.

AUDIT.................................... *************...................... ******************* ******************* 60

1.

Methodology................................................................................................ 60

2.

Perf'ormance............................................................................................... 60 D.

INDEPENDENT SAFETY REVIEW.................................................................... 63

1.

Description............................................................................................ 63 TABLE 1: REGULATORY COMMITMENTS A.

Regulatory Guide 1.8 Revision 1, dated September 1975, "Personnel Qualification and Training"............................................................................. 64 B.

Regulatory Guide 1.30, dated August 1972, "Quality Assurance Requirements for the Installation, Inspection, and Testing of Instrumentation and Electron Equipment".................................................... 66 C.

Regulatory Guide 1.33 Revision 2, dated February 1978, "Quality Assurance Program Requirements"............................................................... 67 D.

Regulatory Guide 1.37, dated March 1973, "Quality Assurance Requirements for Cleaning of Fluid Systems and Associated Components of Water-Cooled Nuclear Power Plants"................................. 71 E.

Regulatory Guide 1.38 Revision 2, dated May 1977, "Quality Assurance Requirements for Packaging, Shipping, Receiving, Storage and Handling of Items for Water-Cooled Nuclear Power Plants.............................................................................................................. 72 F.

Regulatory Guide 1.39 Revision 2, dated September 1977, "Housekeeping Requirements for Water-Cooled Nuclear Power Plants............................................................................................................... 77 G.

Regulatory Guide 1.58 Revision 1, dated September 1980, "Qualifications of Nuclear Power Plant Inspection, Examination, and Testing Personnel".......................................................................................... 78 H.

Regulatory Guide 1.64 Revision 2, dated June 1976, "Quality Assurance Requirements for the Design of Nuclear Power Plants"........... 79 Page 41 of96

HOLTEC PALISADES ENERGY PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL TABLE OF CONTENTS SECTION PAGE I.

Regulatory Guide 1.74, dated February 1974, "Quality Assurance Terms and Definitions...................................................................................... 80 J.

Regulatory Guide 1.88 Revision 2, dated October 1976, "Collection, Storage and Maintenance of Nuclear Power Plant Quality Assurance Records........................................................................................................... 81 K.

Regulatory Guide 1.94 Revision 1, dated April 1976, "Quality Assurance Requirements for Installation, Inspection and Testing of Structural Steel during the Construction Phase of Nuclear Power Plants............................................................................................................... 83 L.

Regulatory Guide 1.116 Revision 0-R, dated June 1976, "Quality Assurance Requirements for Installation, Inspection and Testing of Mechanical Equipment and Systems"............................................................. 86 M.

Regulatory Guide 1.123 Revision 1, dated July 1977, "Quality Assurance Requirements for control of Procurement of Items and Services for Nu*cIear Power Plants"............................................................... 87 N.

Regulatory Guide 1.144 Revision 1, dated September 1980, "Auditing of Quality Assurance Programs for Nuclear Power Plants"....... 90

0.

Regulatory Guide 1.146 Revision 0, dated August 1980, "Qualification of Quality Assurance Program Audit Personnel for Nuclear Power Plants..................................................................................... 93 Page42 of96

~~"~ PALISADES ENERGY, LLC.QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY A.

MANAGEMENT

1.

Methodology

a.

The Quality Assurance Program Manual (QAPM) provides a consolidated overview of the quality program controls which govern the operation and maintenance of Palisades Energy, LLC quality related items and activities. The Palisades Energy, LLC QAPM describes the Quality Assurance organizational structure, functional responsibilities, levels of authority, and interfaces.

b.

The requirements and commitments contained in the QAPM are mandatory and must be implemented, enforced, and adhered to by all individuals and organizations. Employees are encouraged to actively participate in the continued development of the QAPM as well as its implementation. Changes should be promptly communicated when identified.

c.

The QAPM applies to all activities associated with structures, systems, and components that are safety related or controlled by 10 CFR 72. The QAPM also applies to transportation packages controlled by 10 CFR 71. The methods of implementation of the requirements of the QAPM are commensurate with the items or activity's importance to safety. The applicability of the requirements of the QAPM to other items and activities is determined on a case-by-case basis.

The QAPM implements 10 CFR 50 Appendix B, 10 CFR 71 Subpart H, and 10 CFR 72 Subpart G.

d.

The QAPM is implemented through the use of approved procedures (e.g.,

policies, directives, procedures, instructions, or other documents) which provide written guidance for the control of quality related activities and provide for the development of documentation to provide objective evidence of compliance.

2.

Organization The organizational structure responsible for implementation of the QAPM is described below. The organizational structure consists of corporate and station 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 the incumbent's staff as necessary to fulfill the identified responsibility.

Page43 of96

,~~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY A.2 (continued)

a.

Corporate Organization (1)

The Holtec President is responsible for overall corporate policy and provides executive direction and guidance for the corporation as well as promulgates corporate policy through the Company's senior management staff. Responsibility for developing, implementing, and verifying execution of the Quality Assurance Program is delegated to the chief nuclear officer, the highest-level nuclear executive, and authority for developing and verifying execution of the program to the executive responsible for Quality Assurance.

(2)

The President of Nuclear Generation and Decommissioning is responsible for providing top-level direction for the safe and reliable operation and maintenance of the Palisades site. The President of Nuclear Generation and Decommissioning provides guidance with regards to company Quality Assurance policy. This position is responsible for providing engineering services, nuclear safety, and operations support. Supply chain and information technology are no longer a functional area exclusively within the nuclear organizational structure. However, the oversight and governance of these functional areas remain within the nuclear organization through this executive position that is responsible for nuclear operations.

(3)

The following executives report to the President of Nuclear Generation and Decommissioning and provide governance and oversight in regards to implementing company Quality Assurance policy:

(a) Chief Nuclear Officer (CNO), the highest level nuclear executive officer, is responsible for safe and reliable nuclear operations and operations support. Additionally, this position is responsible for implementing Quality Assurance policies, goals, and objectives and the implementation of all activities associated with the safe and reliable operation of the Palisades site. The following reports to this chief nuclear officer:

Palisades Energy, LLC Site Vice President Nuclear Safety Review Board (NSRB)

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(b) The executive responsible for Licensing/Regulatory Assurance is responsible for Quality Assurance and establishes the policies, goals, and objectives of the Quality Assurance policy; provides guidance and interpretation for implementing the company Quality Assurance policy; and is responsible for governance and implementation of the Quality Assurance program in accordance with regulatory requirements. The following Palisades Energy, LLC Quality Assurance position reports to this executive:

Palisades Energy, LLC Quality Assurance Manager is responsible for Quality Assurance activities and is independent of production. This position provides overall direction for the implementation of the Quality Assurance program and is responsible for Quality Assurance governance. This position has authority and responsibility for establishing, controlling, and verifying implementation and adequacy of the Quality Assurance program as described in this QAPM, including activities related to vendor quality. This position has the authority to Stop Work and responsibility to escalate matters directly to the highest level nuclear executive officer when needed.

b.

Palisades Site Organization The following integrated Palisades Energy, LLC management positions describe the typical site QAPM functional responsibilities, which may be delegated to others as established in this document. These individuals may report through an additional layer of management but shall maintain sufficient authority and organizational freedom to implement the assigned responsibilities.

(1)

The Palisades Energy, LLC Site Vice President position reports through the Chief Nuclear Officer (CNO). This position is responsible for overall plant nuclear safety at Palisades, and is responsible for establishing the policies, goals, and objectives and the implementation of the QAPM at Palisades.

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PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY A.2.b (continued)

(2)

A management position responsible for overall plant operations assures the safe, reliable, and efficient operation of the plant within the constraints of applicable regulatory requirements and the operating license. Different aspects of these responsibilities may be fulfilled by separate managers. The onsite safety review committee reports to the management position responsible for plant operations.

(3)

A management position responsible for emergency planning, training, corrective action program, security, and records management. Different aspects of these responsibilities may be fulfilled by separate managers.

(4)

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

(5)

A management position responsible for engineering, the development and maintenance of engineering programs, plant design bases, policies, and procedures and for providing engineering services. Different aspects of these responsibilities may be fulfilled by separate managers.

(6)

A management position responsible for regulatory assurance.

This position is responsible for maintaining the licensing basis and oversight of licensing and regulatory programs.

(7)

The following site positions report directly to an executive position offsite:

A management position responsible for Quality Assurance who 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 highest level nuclear executive officer when needed. This position reports to the executive responsible for Quality Assurance through the corporate management position responsible for licensing/regulatory assurance ( offsite ).

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c.

The NSRB independently reviews activities to provide additional assurance that the plant is operated and maintained per the Operating License and applicable regulations that address nuclear safety.

3.

Responsibility

a.

Palisades Energy, LLC has the responsibility for the scope and implementation of an effective Quality Assurance program.

b.

Palisades Energy, LLC 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.

c.

Palisades Energy, LLC 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 by Palisades Energy, LLC or by others.

d.

Individual managers 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.

e.

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

4.

Authority

a.

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

b.

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.

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(continued)

5.

Personnel Training and Qualification

a.

Personnel assigned to implement elements of the quality assurance program are capable of performing their assigned tasks.

b.

Training programs are established and implemented to ensure that personnel achieve and maintain suitable proficiency.

c.

Personnel training and qualification records are maintained per procedures.

d.

Additional details concerning Personnel Training and Qualification may be found in the Regulatory Guides and associated Standards as committed to in Section O and Table 1 (eg, Regulatory Guides 1.8, 1.58, and 1.146).

6.

Corrective Action

a.

It is the responsibility of each individual to promptly identify and report conditions adverse to quality. Management at all levels encourages the identification of conditions that are adverse to quality.

b.

A Corrective Action Program (CAP) is established and implemented that includes prompt identification, documentation, and correction of conditions adverse to quality. The corrective action program for significant conditions adverse to quality shall require cause determination and a corrective action plan that precludes repetition.

c.

Specific responsibilities within the corrective action program may be delegated, but Palisades Energy, LLC maintains responsibility for the program's effectiveness.

d.

Non-conforming items are properly controlled to prevent their inadvertent test, installation, or use. They are reviewed and either accepted, rejected, repaired, or reworked.

e.

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

f.

Additional details concerning corrective action activities may be found in the Regulatory Guides and associated Standards as committed to in Section O and Table 1 (eg, Regulatory Guide 1.33).

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PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY A.

(continued)

7.

Regulatory Commitments

a.

Except where alternatives are identified, Palisades Energy, LLC complies with the applicable QA guidance documents listed in Table 1.

If the guidance in one of these documents' conflicts with the QAPM, the guidance provided in the QAPM is the controlling guidance.

Additionally, the following clarifications apply to all guidance documents listed in Table 1:

(1)

For modifications and nonroutine maintenance, guidance applicable to construction-like activities is applicable to comparable plant activities. Except that the inspection of modifications, repairs, rework, and replacements shall be per the original design and inspection requirements or a documented approved alternative.

(2)

The definitions provided by Regulatory Guide 1.74 and associated clarifications as described in Table 1 apply wherever the defined term is used in the QAPM and associated guidance documents.

(3)

Clarification to a guidance document applies wherever the guidance document is invoked.

(4)

In each of the ANSI standards, other documents (eg, other standards, codes, regulations, tables, or appendices) are referenced or described. These other documents are only Quality Assurance program requirements if explicitly committed to in the QAPM. If not explicitly committed to, these documents are not considered as Quality Assurance program requirements, although they may be used as guidance.

(5)

Guidance applicable to safety related items and activities is applicable to comparable items and activities controlled by 10 CFR 72 and transportation packages controlled by 10 CFR 71.

b.

The NRC is to be notified of QAPM changes per 10 CFR 50.54(a)(3) or 10 CFR 50.54(a)(4).

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"~~"~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY B.

PERFORMANCENERIFICATION 1.

Methodology

a.

Personnel performing work activities such as operations, design, engineering, procurement, manufacturing, construction, installation, startup, maintenance, modification are responsible for achieving acceptable quality.

b.

Personnel performing 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 activity's complexity and importance to safety.

d.

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

2.

Design Control

a.

The design control program is established and implemented to assure that the activities associated with the design of systems, components, structures, and equipment and modifications thereto, are executed in a planned, controlled, and orderly manner.

b.

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

c.

Design inputs (eg, performance, regulatory, quality, and quality verification requirements) are to be correctly translated into design outputs (eg, specifications, drawings, procedures, and instructions).

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( continued)

d.

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

e.

The design process is to ensure that items and activities are selected and independently verified consistent with their importance to safety to ensure they are suitable for their intended application.

f.

Changes to final designs (including field changes and modifications) and dispositions of non-conforming items to either use-as-is or repair are to 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.

g.

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 are defined in procedures.

h.

Design documentation and records, which provide evidence that the design and design verification process was performed per this program, shall be collected, stored, and maintained per 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.

i.

Additional details concerning design control activities may be found in the Regulatory Guides and associated Standards as committed to in Section O and Table 1 (eg, Regulatory Guide 1.64).

3.

Design Verification

a.

A program is established and implemented to verify the acceptability of design activities and documents for the design of items. The selection and incorporation of design inputs and design processes, outputs, and changes are verified.

b.

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. Standardized or previously proven designs will be reviewed for applicability prior to use.

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c.

When a test program is used to verify the acceptability of a specific design feature, the test program is to demonstrate acceptable performance under conditions that simulate the most adverse design conditions that are expected to be encountered.

d.

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 function.

e.

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 designer's immediate supervisor may perform the design verification provided:

(1) the supervisor is the only technically qualified individual capable of performing the verification, (2) the need is individually documented and approved in advance by the supervisor's management, and (3) the frequency and effectiveness of the supervisor's use as a design verifier are independently verified to guard against abuse.

f.

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 are identified, the verification is satisfactorily accomplished, and the results are properly recorded.

g.

Additional details concerning design verification activities may be found in the Regulatory Guides and associated Standards as committed to in Section O and Table 1 (eg, Regulatory Guide 1.64).

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(continued)

4.

Procurement Control

a.

A program is established and implemented to ensure that purchased items and services are of acceptable quality.

b.

The program includes provisions for evaluating prospective suppliers and selecting only qualified suppliers.

c.

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

d.

The program includes provisions (eg, source verification, receipt inspection, pre-installation and post-installation tests, and certificates of conformance) for accepting purchased items and services.

e.

Applicable technical, regulatory, administrative, and reporting requirements (eg, specifications, codes, standards, tests, inspections, special processes, and 10 CFR Part 21) are invoked for procurement of items and services.

f.

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

g.

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.

h.

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

i.

Appropriate controls for the selection, determination of suitability for intended use (critical characteristics), evaluation, receipt, and quality evaluation of commercial grade items are to be imposed to ensure that the items will perform satisfactorily in service.

j.

Additional details concerning procurement control may be found in the Regulatory Guides and associated Standards as committed to in Section O and Table 1 (eg, Regulatory Guides 1.33 and 1.123).

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(continued)

5.

Procurement Verification

a.

A program is established and implemented to verify the quality of purchased items and services at intervals and to a depth consistent with the item's or service's importance to safety, complexity, and quantity and the frequency of procurement.

b.

The program is executed in all phases of procurement. As necessary, this may require verification of activities of suppliers below the first tier.

c.

Additional details concerning procurement verification may be found in the Regulatory Guides and associated Standards as committed to in Section O and Table 1 (eg, Regulatory Guides 1.123 and 1.144).

6.

Identification and Control of Items

a.

A program is established and implemented to identify and control items to prevent the use of incorrect or defective items.

b.

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 item's importance to safety.

c.

Additional details concerning identification and control of items may be found in the Regulatory Guides and associated Standards as committed to in Section O and Table 1 (eg, Regulatory Guide 1.33).

7.

Handling, Storage, and Shipping

a.

A program is established and implemented to control the handling, storage, shipping, cleaning, and preserving of items to ensure the items maintain acceptable quality.

b.

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

c.

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

d.

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

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~,~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY B.7 (continued)

e.

Additional details concerning handling, storage, and shipping activities may be found in the Regulatory Guides and associated Standards as committed to in Section O and Table 1 (eg, Regulatory Guide 1.38).

8.

Test Control

a.

A test control program is established and implemented to demonstrate that items will perform satisfactorily in service.

b.

Criteria are defined that specify when testing is required.

c.

The test control program includes, as appropriate, proof tests before installation, pre-operational tests, post-maintenance tests, post-modification tests, and operational tests.

d.

Test procedures are developed that include:

( 1 )

instructions and prerequisites to perform the test, (2) use of proper test equipment, (3) acceptance criteria, and (4) mandatory inspections as required.

e.

Test results are evaluated to assure that test objectives and inspection requirements have been satisfied.

f.

Unacceptable test results shall be evaluated.

g.

Additional details concerning test control may be found in the Regulatory Guides and associated Standards as committed to in Section O and Table 1 (eg, Regulatory Guide 1.33).

9.

Measuring and Test Equipment Control

a.

A program is established and implemented to control the calibration, maintenance, and use of measuring and test equipment. Measuring and test equipment does not include permanently installed operating equipment or test equipment used for preliminary checks where data obtained will not be used to determine acceptability or be the basis for design or engineering evaluation. Additionally, calibration and control measures are not required for rulers, tape measures, levels and other such devices if normal commercial manufacturing practices provide adequate accuracy.

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,~~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY 8.9 (continued)

b.

The types of equipment covered by the program (eg, instruments, tools, gauges, and reference and transfer standards) is defined in procedures.

c.

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

d.

Measuring and test equipment is labeled, tagged, or otherwise controlled to indicate its calibration status and to ensure its traceability to calibration test data.

e.

Measuring and test equipment is calibrated against standards that have an accuracy of at least four 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.

f.

If nationally recognized standards exist, calibration standards are to be traceable to them. Except where calibration standards with the same accuracy as the instruments being calibrated are shown to be adequate for the requirements, calibration standards are to have a greater accuracy than the standards being calibrated.

g.

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

h.

Additional details concerning measuring and test equipment control may be found in the Regulatory Guides and associated Standards as committed to in Section O and Table 1 (eg, Regulatory Guides 1.30, 1.33, 1.94, 1.116, and 1.123).

10.

Inspection, Test, and Operating Status

a.

The status of required inspections and tests and the operating status of items 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.

b.

The application and removal of inspection, test, and operating status indicators are controlled per procedures.

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c.

Additional details concerning inspection, test, and operating status control may be found in the Regulatory Guides and associated Standards as committed to in Section 0 and Table 1 (eg, Regulatory Guide 1.33).

11.

Special Process Control

a.

A program is established and implemented to ensure that special processes are properly controlled.

b.

The criteria that establish which processes are special are described in procedures. The following are special processes:

(1)

welding, (2) heat-treating, (3) non-destructive examination (NOE),

(4) chemical cleaning, and (5) unique fabricating or testing processes that require in-process controls.

c.

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

d.

Additional details concerning special process control may be found in the Regulatory Guides and associated Standards as committed to in Section 0 and Table 1 (eg, Regulatory Guide 1.33).

12.

Inspection

a.

A program is established and implemented for inspections of activities in order to verify conformance to the documented instructions, procedures and drawings for accomplishing the activity. The inspection program may be implemented by or for the organization performing the activity to be inspected.

b.

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

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c.

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

d.

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

e.

1Jnacceptable inspection results shall be evaluated and resolved per procedures.

f.

Inspections are performed by qualified personnel other than those who performed or directly supervised the work being inspected. While performing the inspection activity the inspectors functionally report to the associated management position responsible for Quality Assurance.

g.

Additional details concerning inspections may be found in the Regulatory Guides and associated Standards as committed to in Section O and Table 1 (eg, Regulatory Guides 1.33 and 1.58).

13.

Corrective Action

a.

Procedures shall provide for identification, evaluation, and resolution of conditions adverse to quality.

b.

Reworked, repaired, and replacement items are to be inspected and tested per the original inspection and test requirements or specified alternatives.

c.

Additional details concerning corrective action activities may be found in Section O and the Regulatory Guides and associated Standards as committed to in Section O and Table 1 (eg, Regulatory Guide 1.33).

14.

Document Control

a.

A program is established and implemented to control the development, review, approval, issue, use, and revision of documents.

b.

The scope of the document control program includes:

( 1 )

safety analysis report, (2) design documents, (3) procurement documents, Page 58 of96

,~~, PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY 8.14.b (continued)

(4)

Technical Specifications, (5) procedures, manuals, and plans, (6) corrective action documents, and (7) other documents as defined in procedures.

c.

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.

d.

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

e.

The distribution of new and revised controlled documents is per procedures. Superseded documents are controlled.

f.

Additional details concerning document control may be found in the Regulatory Guides and associated Standards as committed to in Section O and Table 1 (eg, Regulatory Guide 1.33).

15.

Records

a.

A program is established and implemented to ensure that sufficient records of items and activities (eg, design, engineering, procurement, manufacturing, construction, inspection and test, installation, pre-operation, startup, operations, maintenance, modification, decommissioning, and audits) are generated and maintained to reflect completed work.

b.

The program provides provisions for the administration, receipt, storage, preservation, safekeeping, retrieval, and disposition of records.

c.

The program includes provisions for the use of various record storage media to maintain QA records. Procedures are developed to implement the regulatory guidance associated with the media used.

The NRC Generic Letter 88-18 "Plant Record Storage on Optical Disk" is implemented for optical disk media. The Regulatory Issue Summary 2000-18 "Guidance on Managing QA Records in Electronic Media" is implemented for electronic media.

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~~~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY 8.15 (continued)

d.

Additional details concerning record requirements may be found in the Regulatory Guides and associated Standards as committed to in Section O and Table 1 (eg, Regulatory Guide 1.88).

C.

AUDIT 1. Methodology

a.

Personnel responsible for carrying out audits are maintained cognizant of day-to-day activities by the ongoing involvement in the Quality Assurance program requirements so that they can act in a management advisory function.

b.

Organizations performing audits are to be technically and performance oriented commensurate with the activity being reviewed.

c.

Personnel performing audits have no direct responsibilities in the area they are assessing.

d.

Audits are accomplished using instructions, procedures, or other appropriate means that are of a detail commensurate with the activity's complexity and importance to safety.

2. Performance
a.

A program of planned and periodic audits is established and implemented to confirm that activities affecting quality comply with the QAPM and that the QAPM has been implemented effectively. Audit frequencies will be implemented as required by the applicable Code of Federal Regulations, safety analysis report, and commitments by various correspondences to the NRC. Audits will be conducted at a frequency per either Section O or Section 0 below.

(1)

Audit frequencies will be determined per a performance-based audit scheduling program. The scheduling program, through an expert panel, uses assessment indicators to identify and schedule audits based on performance results and importance of the activity relative to safety. Potential audit subject areas are periodically assessed against appropriate performance criteria. From these reviews a determination is made regarding the depth, scope, and scheduling of specific audits.

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~~

PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY C.2.a(1) (continued)

(a)

Functional areas important to safety are assessed annually(+/- 25%) to identify strengths and weaknesses (if applicable) and to determine the level and focus of independent oversight activities for the upcoming year.

(b)

The basis for the assessment shall include the results of audits and surveillance, NRC inspections, Licensee Event Reports (LERs), self-assessments, and applicable Conditions Reports (CRs) (eg, non-conformance and corrective action reports). Personnel changes, change/increase in functional area responsibilities, industry operating experience, and INPO evaluations will also be considered. Each area will be assigned a rating with a comparison to previous years. This assessment will be documented, reviewed, and approved by Quality Assurance management.

(c)

This document is considered a Quality Assurance record and will be available for NRC review. Audit subject areas of Section O shall continue to be audited on the frequencies designated unless expert panel judgment, based on performance results, determines such an audit to be unnecessary. In such cases the expert panel basis shall be documented.

(2)

Audit schedules assure that the following areas are audited at the indicated frequencies, or more frequently as performance dictates.

(a)

Unit operational conformance to provisions contained within the Technical Specifications and applicable license conditions is audited at least once every 24 months.

(b)

The performance, training, and qualifications of the entire staff are audited at least once every 24 months.

(c)

The results of actions taken to correct deficiencies occurring in unit equipment, structure, systems, or method of operation that affect nuclear safety are audited at least once every 24 months.

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(d)

The performance of activities required by the QAPM to meet the criteria of 10 CFR 50 Appendix B are audited at least once every 24 months.

(e)

The Offsite Dose Calculations Manual (ODCM) and Process Control Program and implementing procedures are audited at least once every 24 months.

(f)

The Radiological Environmental Monitoring Program (REMP) and the results thereof is audited at least once every 24 months.

(g)

A fire protection and loss prevention program inspection and audit shall qe performed using either off-site licensee personnel or an outside fire protection firm at least once every 24 months.

(h)

The fire protection program and implementing procedures audit shall be performed at least once every 24 months.

(i)

A fire protection and loss prevention program inspection and audit shall be performed using an outside fire consultant at least once every 36 months.

(3)

A grace period of 90 days may be applied to the 24-month frequency for internal audits. For activities deferred per the 90-day grace period, the next performance due date will be based on their originally scheduled date.

b.

Audits shall provide an objective evaluation of quality related practices, procedures, instructions, activities, and items and a review of documents and records, as applicable.

c.

Audits shall be performed per approved written procedures or checklists. Items from previous audits shall be reviewed and reaudited, as appropriate. The checklists are used as guides to the auditor.

d.

Scheduling and resource allocation are based on the status and safety importance of the activity or process being assessed.

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e.

Scheduling is dynamic, and resources are supplemented when the effectiveness of the Quality Assurance program is in doubt.

f.

Audit reports are written and distributed to the appropriate levels of management for review. Follow-up action, including re-look at deficient areas, is initiated as deemed appropriate.

g.

Implementation of delegated portions of the Quality Assurance program is assessed.

h.

Audits are conducted using predetermined acceptance criteria.

Additional details concerning audits may be found in the Regulatory Guides and associated Standards as committed to in Section O and Table 1 (eg, Regulatory Guides 1.33 and 1.144).

D.

INDEPENDENT SAFETY REVIEW

1.

Description

a.

Independent safety review is performed to meet Palisades Energy, LLC commitment to NUREG-0737, Section 1.8.1.2, "Independent Safety Engineering Group," as described in the unit's safety analysis report.

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,~11~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS Regulatory Guide 1.8 Revision 1, dated September 1975, "Personnel Qualification and Training"

1.

General

2.

General Clarification/Exception Palisades Energy, LLC 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 (RPM) shall meet or exceed the qualifications of Regulatory Guide 1.8, Revision 2, 1987.
b. Managers required to hold a Senior Reactor Operator (SRO) license are specified in the Technical Specifications.
c. Licensed Operators shall be qualified per the requirements of 10 CFR 55.

Individuals filling positions who met the previous commitment at the time of implementation of this commitment can be considered to meet any more restrictive aspects of the requirements of this commitment for that position without further review and documentation.

The following qualifications may be considered equivalent to a bachelor's degree:

a. four years of post-secondary schooling in science or engineering,
b. four years of applied experience at a nuclear facility in the area for which qualification is sought,
c. four years of operational or technical experience/training in nuclear power, or
d. any combination of the above totaling four 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.

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,~~"~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS A.

Regulatory Guide 1.8 (continued)

3.

ANSI/ANS 3.1 Section 4

4.

ANSI/ANS 3.1 Section 4.4.5

5.

ANSI/ANS 3.1 Section 5 Clarification/Exception Individuals assigned to professional-technical comparable positions shall have the authority and specified qualifications to accomplish the functional responsibilities of the position.

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.

Palisades Energy, LLC will maintain a training program for the unit staff that meets the applicable regulations and either a) is accredited by the National Nuclear Accrediting Board (NNAB) orb) meets the standards of section 5 of ANSI/ANS 3.1-1978.

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"~~"' PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULA TORY COMMITMENTS B.

Regulatory Guide 1.30, dated August 1972, "Quality Assurance Requirements for the Installation, Inspection, and Testing of Instrumentation and Electron Equipment"

1.

ANSI N45.2.4 General

2.

ANSI N45.2.4 Section 3

3.

ANSI N45.2.4 Section 5.2

4.

ANSI N45.2.4 Section 6.2.1 Clarification/Exception ANSI N45.2.4 identifies various tests to be performed. The applicability of these tests will be determined as discussed in QAPM Section O and based upon the significance of change or modification.

Documented routine inspections and audits of the storage area may be performed instead of the requirements of this Section.

In some cases, testing requirements may be met by post-installation surveillance testing in lieu of a special post-installation test.

The last sentence of this section states: "Items requiring calibration shall be tagged or labeled on completion indicating date of calibration and identity of the person that performed the calibration." Instead of requiring the tagging or labeling of all equipment this statement is changed to require the equipment to be suitably marked to indicate the date of the next required calibration and the identity of the person that performed the calibration.

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,~~,~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERCY TABLE 1: REGULATORY COMMITMENTS C.

Regulatory Guide 1.33 Revision 2, dated February 1978, "Quality Assurance Program Requirements"

1.

Section C.1

2.

Section C.4

3.

ANSI N18.7 Section 1

4.

ANSI N18. 7 Section 4.3.1

5.

ANSI N18.7 Sections 4.3.2.2 &

4.3.2.3 Clarification/Exception Palisades Energy, LLC will provide procedures for the guide's Appendix A activities as discussed. However, Palisades Energy, LLC does not consider all listed to be "safety-related" (eg activities listed in 7.e).

This section establishes minimum two-year audit frequency for all safety related functions and recommends audit frequencies specific to Corrective Action, Facility Operation, and Staff Performance, Training, and Qualifications. Palisades Energy, LLC will perform audits at frequencies as discussed in QAPM Section C.2.a instead of this section.

Sentences 4 and 5 state, "However, applicable sections of this standard should be used as they apply to related activities. Activities included are: Design Changes, Purchasing, Fabricating... " With regard to radioactive material transportation activities, Palisades Energy, LLC will only implement the requirements associated with those activities conducted per the applicable NRC Quality Assurance Program Approval for Radioactive Material Packages.

The specific areas of experience described in this section are not applicable to the on-site safety review committee, but the committee must be comprised of site operating or engineering supervisory personnel. Additionally, the NSRB need contain experience in only a majority of the areas.

Instead of the requirements of this section 4.3.2.2, the independent safety review committee will meet once per year. The statement that "no more than a minority of the quorum shall have line responsibility for the operation of the plant" in section 4.3.2.3 is not applicable to the on-site safety review committee.

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~~~~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS C.

Regulatory Guide 1.33 (continued)

6.
7.
8.
9.

ANSI N18.7 Sections 4.3.4.(1) &

4.3.4.(2)

ANSI N18.7 Section 4.3.4(2)

ANSI N18.7 Section 4.3.4(3)

ANSI N18.7 Section 4.3.4(4)

10. ANSI N18.7 Section 4.3.4(5)
11. ANSI N18.7 Section 4.5
12. ANSI N18.7 Section 4.5 Clarification/Exception 10 CFR 50.59 was revised through Federal Register Notice 19991001 R1 N3150-AF94 eliminating the terms "safety evaluation" and "unreviewed safety question." The term "safety evaluation" has been replaced with 10 CFR 50.59 "evaluation." The term "unreviewed safety question," as defined in the previous version of 10 CFR 50.59 (a)(2), was replaced by criteria provided in 50.59(c)(2) to determine if a license amendment pursuant to 50.90 is required prior to implementing the change, test, or experiment.

Reviews associated with changes to the technical specifications will be performed per Section 4.3.4(3) instead of this section.

B.

Revision to proposed Technical Specification changes only requires review per this section when the revision involves a significant change to the technical basis for the proposed change. The independent review body discussed in this section is the on-site safety review committee. Voting members having a potential conflict of interest refrain from voting on documents under review.

In place of the requirements of this section, the on-site safety review committee and Nuclear Safety review Board (NSRB) shall review facility operations to detect potential nuclear safety hazards and all reports made per 10 CFR 50.73.

An example of the matters reviewed by the on-site safety review committee per this section is a change to the Emergency Plan (except editorial changes).

This section establishes minimum two-year audit frequency for all safety related functions. Palisades Energy, LLC will perform audits at frequencies as discussed in QAPM Section C.2.a instead of this section.

The independent review body discussed in this section is the NSRB.

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,~~1'~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS C.

Regulatory Guide 1.33 ( continued)

13. ANSI N18.7 Section 5.1
14. ANSI N18.7 Section 5.2.2
15. ANSI N18.7 Section 4.3.1
16. ANSI N18.7 Section 5.2.6
17. ANSI N18.7 Section 5.2.6
18. ANSI N18.7 Section 5.2.7.1 Instead of the requirements of this section to have a summary document, a method of cross-referencing these requirements to the implementing procedures will be maintained.

The person who holds a senior reactor operator's license for the unit and approves a temporary change to a procedure is not required to be in charge of the shift.

In addition to the temporary procedure change process described for changes which clearly do not change the intent of a procedure, temporary procedure changes which may change the intent of a procedure may be made following the process described in this section. Except that the person normally responsible for approving revisions to the procedure is the approval authority for the change.

Instead of the requirements of this section concerning non-conforming conditions, non-conforming conditions will be evaluated and controlled per the corrective action program.

The requirement of the fifth paragraph of this section to have a log of the status of temporary modifications is not applicable to temporary modifications for routine tasks installed per procedures. These procedures shall provide assurance that approvals are obtained, temporary modification activities are independently verified by an individual cognizant of the purpose and the effect of the temporary modification, and that activities are adequately documented to indicate the status of the temporary modification.

This section will be implemented by adding the words "Where practical" in front of the first and fourth sentences of the fifth paragraph. For modifications where the requirements of the fourth sentence are not considered practical, a review per the provisions of 10 CFR 50.59 will be conducted.

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,~~~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS C.

Regulatory Guide 1.33 (continued)

19. ANSI N18.7 Section 5.2.8
20. ANSI N18.7 Section 5.2.9
21. ANSI N18.7 Section 5.2.13.1
22. ANSI N18.7 Section 5.2.14
23. ANSI N18.7 Section 5.2.15
24. ANSI N18.7 Section 5.2.15
25. ANSI N18.7 Section 5.3.9
26. ANSI N18.7 Section 5.3.9.3 In lieu of a "master surveillance schedule," the following requirement shall be complied with: "A surveillance testing schedule(s) shall be established reflecting the status of all in-plant surveillance tests and inspections."

The requirements of the Physical Security Plan shall be implemented in place of these general requirements.

Consistent with ANSI N45.2.11 Section 7.2, minor changes to documents, such as inconsequential editorial corrections, or changes to commercial terms and conditions may not require that the revised document receive the same review and approval as the original documents.

Where marking, tagging, or physical separation of the non-conforming item is not feasible, the non-conforming item may be controlled by the use of appropriate documentation.

Required procedure reviews following the occurrences discussed in Section 5.2.15, paragraph 3, sentence 3, are determined and controlled per the QAPM Section 0 instead of this section.

This section requires plant procedure review by an individual knowledgeable in the area affected by the procedure no less frequently than every two years to determine if changes are necessary or desirable. Instead of this review, controls are in effect to ensure that procedures are reviewed for possible revision upon identification of new or revised source material potentially affecting the intent of procedures.

Instead of the requirements of this section, the format and content of the emergency operating procedures follow the applicable NRG approved format for the specific unit.

The Palisades Energy, LLC NRG accepted Emergency Plan will be implemented in lieu of the requirements in this section.

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,~~~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS D.

Regulatory Guide 1.37, dated March 1973, "Quality Assurance Requirements for Cleaning of Fluid Systems and Associated Components of Water-Cooled Nuclear Power Plants"

1.

General

2.

Section C.3

3.

Section C.4

4.

ANSI N45.2.1 Section 5 Clarification/Exception Instead of using the cleanliness level classification system of ANSI N45.2.1, the required cleanliness for specific items and activities is addressed on a case-by-case basis.

Cleanliness is maintained, consistent with the work being performed to prevent the introduction of foreign material.

As a minimum, cleanliness inspections are performed prior to system closure and such inspections are documented.

The water quality for final flushes of fluid systems and associated components is at least equivalent to the quality of the operating system water, except for the oxygen and nitrogen content.

As an alternative to the requirements of this section, contamination levels in expendable products may be based upon safe practices and industrial availability with documented engineering evaluations. Contaminant levels are controlled such that subsequent removal by standard cleaning methods results in the achievement of final acceptable levels that are not detrimental to the materials.

Any nonhalogenated material may be used which is compatible with the parent material not just plastic film.

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HOLT.EC PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS E.

Regulatory Guide* 1.38 Revision 2, dated May 1977, "Quality Assurance Requirements for Packaging, Shipping, Receiving, Storage and Handling of Items for Water-Cooled Nuclear Power Plants"

1.

ANSI N45.2.2 Section 3.2

2.

ANSI N45.2.2 Section 3.2

3.

ANSI N45.2.2 Section 3. 7.1

4.

ANSI N45.2.2 Section 3.7.2

5.

ANSI N45.2.2 Section 4.3.4

6.

ANSI N45.2.2 Section 5.2.1 Clarification/Exception Storage of an item in a higher-level storage area meets the lower-level storage requirements.

As an alternate to the requirements in Section 3.2.1 items (4),

(5), and 7, Section 3.2.2, Section 3.2.3 item (1), and Section 3.2.4 item (2), the storage atmosphere may be controlled such that it is free of harmful contaminants in concentration that could produce damage to the stored item and protecting weld end preparations and threads by controlling the manner in which the item is stored.

Cleated, sheathed boxes may be used up to 1000 lb. rather than 500 lb. as specified in 3. 7.1 ( 1 ). Special qualification testing may be required for loads over 1000 lb.

Skids and runners will normally be fabricated from a minimum 2 X 4-inch nominal lumber size and laid flat except where this is impractical because of the small dimensions of the container. If forklift handling is required, minimum floor clearance for forklift tines will be provided.

Inspections of packages and/or preservative coatings are made immediately prior to loading rather than after loading.

Warehouse personnel will normally visually inspect incoming shipments for damage of the types listed in this section, this activity is not necessarily performed prior to unloading.

Separate documentation of the shipping damage inspection is not necessary. Release of the transport agent after unloading and the signing for receipt of the shipment provides adequate documentation of completion of the shipping damage inspection. Any non-conformances noted will be documented and dispositioned. Persons performing the visual inspection during unloading are not considered to be performing an inspection function as defined under Reg. Guide 1. 7 4; therefore, while they will be trained to perform this function, they may not be certified (N45.2.6) as an inspector.

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,~~~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS E.

Regulatory Guide 1.38 (continued)

7.

ANSI N45.2.2 Section 5.2.2

8.

ANSI N45.2.2 Section 5.2.3

9.

ANSI N45.2.2 Section 6.2.1

10. ANSI N45.2.2 Section 6.2.4 The second division of this subsection requires six additional inspection activities if an item was not inspected or examined at the source. Palisades Energy, LLC will consider that a source inspection has been conducted if the supplier of the item is required to comply with ANSI N45.2.2 for the purchased item and if the supplier's program has been audited and found acceptable in the area (ie, the supplier performs a source inspection of his supplier or conducts a receipt inspection that includes, as applicable, the six additional items listed).

Instead of the requirement that receiving inspections be performed in an area equivalent to the level of storage required for the item, receiving inspections will be performed in a manner and in an environment which does not endanger the requisite quality of an item. The receiving inspection's location environmental controls may be less stringent than storage environmental requirements for that item; however, the short time spent in the less stringent receiving inspection area shall be of such duration that it will not adversely affect the item being received.

The "Special Inspection" procedure is not required to be attached to the item or container but shall be readily available to inspection personnel.

Items which fall within the Level D classification of the standard will be stored in an area which may be posted to limit access, but other positive controls such as fencing, or guards may not be provided.

The sentence is replaced with the following: "The use or storage of food, drinks, and salt tablet dispensers in any storage area shall be controlled and shall be limited to designated areas where such use or storage is not deleterious to stored items."

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"~~~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERCY TABLE 1: REGULATORY COMMITMENTS E.

Regulatory Guide 1.38 (continued)

11.

ANSI N45.2.2 Section 6.2.5

12.

ANSI N45.2.2 Section 6.3.3

13.

ANSI N45.2.2 Section 6.4.2

14.

ANSI N45.2.2 Section 6.5

15.

ANSI N45.2.2 Section 6.6

16.

ANSI N45.2.2 Section 7.3 The sentence is replaced with the following: "Exterminators or other appropriate measures shall be used to control animals to minimize possible contamination and mechanical damage to stored material. If evidence of animal activity is detected, a survey or inspection will be utilized to determine the extent of the damage."

An alternate to the stated requirement is the following:

"Hazardous chemicals, paints, solvents, and other materials of a like nature shall be stored in approved cabinets or containers which are not in close proximity to installed systems required for safe shutdown."

Care of items in storage shall be exercised per the following:"

Types of components that could require maintenance while in storage shall be identified and evaluated for specific maintenance requirements. Maintenance activities 6.4.2 (6) through 6.4.2 (8) listed in this requirement shall be considered during this evaluation and any deviations shall be justified and documented."

The last sentence of this section is not applicable to the operations phase.

Palisades Energy, LLC will comply with this section's requirements with the clarification that, for record purposes, only the access of personnel without key cards into indoor storage areas shall be recorded. Unloading or pickup of material shall not be considered "access," nor shall inspection by NRG or other regulatory agents, nor shall tours by non-licensee employees who are accompanied by licensee employees.

Re-rating hoisting equipment will be considered only when necessary. Prior to performing any lift above the load rating, the equipment manufacturer must be contacted for his approval and direction. The manufacturer must be requested to supply a document granting approval for a limited number of lifts at the new rating and any restrictions involved, such as modifications to be made to the equipment and the test lift load. At all times, the codes governing re-rating of hoisting equipment must be observed.

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,~~, PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS E.

Regulatory Guide 1.38 (continued)

17. ANSI N45.2.2 Appendix (A-3)

Section A.3.4.1

18. ANSI N45.2.2 Appendix (A-3)

Section A.3.4.2

19. ANSI N45.2.2 Appendix {A-3)

Section A.3.5.1

20. ANSI N45.2.2 Appendix {A-3)

Section A.3.5.2

21. ANSI N45.2.2 Appendix {A-3)

Section A.3.7.1

22. ANSI N45.2.2 Appendix (A-3)

Section A.3.9 During printing of the standard, a transposition occurred between the last sentence of A3.4.1(4) and A3.4.1(5).

The correct requirements are: ( 4) "However, preservatives for inaccessible inside surfaces of pumps, valves and pipe systems containing reactor coolant water shall be the water flushable type." (5) "The name of the preservative used shall be indicated to facilitate touch up."

There may be cases involving large or complex shaped items for which an inert or dry air purge is provided, rather than a static gas blanket, to provide adequate protection due to difficulty of providing a leak proof barrier. In these cases, a positive pressure purge flow may be utilized as an alternate to a leakproof barrier.

Instead of the requirement for non-metallic plugs and caps to be brightly colored, non-metallic plugs and caps shall be an appropriately visible color.

This paragraph limits halogen and sulfur content of tape.

The use of tapes containing greater amounts of halogens than those identified will be allowed after appropriate evaluation; however, the quantities shall not be such that harmful concentrations could be leached or released by breakdown of the compounds under expected environmental conditions.

In lieu of A.3.7.1 (3) and (4), Palisades Energy, LLC will comply with the following: Fiberboard boxes shall be securely closed either with a water-resistant adhesive applied to the entire area of contact between the flaps, or all seams and joints shall be sealed with not less than two-inch wide, water-resistant tape.

Instead of the requirement that container markings appear on a minimum of two sides of the container, preferably on one side and one end, Palisades Energy, LLC will comply with the following: Containers are adequately marked for storage, identification, and retrieval. Multiple marking requirements are imposed, where necessary.

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~~~,~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL P,\\LISADES ENERGY TABLE 1: REGULATORY COMMITMENTS E.

Regulatory Guide 1.38 (continued)

23. ANSI N45.2.2 Appendix (A-3)

Section A.3.9

24. ANSI N45.2.2 Appendix (A-3)

Section A.3.9

25. ANSI N45.2.2 Appendix (A-3)

Section A.3.9 Instead of the requirement that container markings be no less than 3/4" high, Palisades Energy, LLC will comply with the following: Container markings are of a size which permits easy recognition.

Instead of the specific container marking requirements, Palisades Energy, LLC will comply with the following: The information required in container marking is evaluated on a case-by-case basis.

The last paragraph of A.3.9 could be interpreted as prohibiting any direct marking on bare austenitic stainless steel and nickel alloy metal surfaces. As an alternate, paragraphs A.3.9.(1) and (2) may be used to control marking on the surface of austenitic stainless steels and nickel base alloys based on documented engineering evaluations. Contamination levels are controlled such that the material used for marking is not detrimental to the materials marked.

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~~~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS F.

Regulatory Guide 1.39 Revision 2, dated September 1977, "Housekeeping Requirements for Water-Cooled Nuclear Power Plants"

1.

ANSI N45.2.3 General

2.

ANSI N45.2.3 Section 3.1

3.

ANSI N45.2.3 Section 3.2.3

4.

ANSI N45.2.3 Section 3.3

5.

ANSI N45.2.3 Section 3.4

6.

ANSI N45.2.3 Section 3.5 Clarification/Exception The ANSI five level zone designation system may not be utilized, but the intent of the standard will be met for the areas of housekeeping, plant and personnel safety, and fire protection.

This section is not applicable.

The Fire Protection Program shall be used in lieu of the general requirements in this section.

The first paragraph is not applicable to the operations phase.

This section is not applicable.

Subparagraph (1) is not applicable to the operations phase; (2), (3), and (4) will be implemented.

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,~I!~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS G.

Regulatory Guide 1.58 Revision 1, dated September 1980, "Qualifications of Nuclear Power Plant Inspection, Examination, and Testing Personnel"

1.

General

2.

General

3.

ANSI N45.2.6 Section 1.2

4.

ANSI N45.2.6 Section 1.2

5.

ANSI N45.2.6 Section 2.3

6.

ANSI N45.2.6 Section 2.5

7.

ANSI N45.2.6 Section 3.5 Clarification/Exception Palisades Energy, LLC may choose not to apply the requirements of this guide to those personnel who are involved in day-to-day operations, surveillance, maintenance, and certain technical and support services whose qualifications are controlled by the Technical Specifications or other QAPM commitment requirements.

General certification of inspectors per this guide is approved by a manager responsible for quality.

Paragraph 4 requires that the standard be imposed on personnel other than licensee employees; the applicability of this standard to suppliers will be documented and applied, as appropriate, in procurement documents for such suppliers.

The requirements of this standard do not apply to personnel using later editions of ASNT contained within 10 CFR 50.55a approved ASME editions or addenda.

This section requires, in part, that any person who has not performed inspection, examination, or testing activities in his qualified area for a period of one year shall be re-evaluated. A 90-day grace period may be applied to this activity. For activities deferred per the 90-day grace period, the next performance due date will be based on their originally scheduled date.

This section's requirements are clarified with the stipulation that, where no special physical characteristics are required, none will be specified. The converse is also true: if no special physical requirements are stipulated, none are considered necessary.

Palisades Energy, LLC reserves the right to use personnel who do not meet these experience requirements but have shown capability through training and testing or capability,demonstration.

Page 78 of96

~~

PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS H.

Regulatory Guide 1.64 Revision 2, dated June 1976, "Quality Assurance Requirements for the Design of Nuclear Power Plants"

1.

ANSI N45.2.11 Section 5.2.4 Clarification/Exception For the documentation of inter-disciplinary design reviews, there must be documented evidence of the acceptability of design documents, or portions thereof, prior to release (material, stress, physics, mechanical, electrical, concrete, etc). Indication of the positive concurrence of those who determine the design acceptability relative to their respective disciplinary area of concern should be on the document or on a separate form traceable to the document. A document that indicates the reviewer's comments need not be retained.

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~~"~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULA TORY COMMITMENTS I.

Regulatory Guide 1.74, dated February 1974, "Quality Assurance Terms and Definitions"

1.

ANSI N45.2.10 Section 2 Clarification/Exception Definitions for "Certificate of Conformance" and "Certificate of Compliance" will be exchanged based upon the guidance in ANSI N45.2.13 Section 10.2.

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,~~~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS J.

Regulatory Guide 1.88 Revision 2, dated October 1976, "Collection, Storage and Maintenance of Nuclear Power Plant Quality Assurance Records"

1.

RG 1.88 Section C

2.

ANSI N45.2.9 Section 1.4

3.

ANSI N45.2.9 Section 3.2.2 Clarification/Exception Palisades Energy, LLC will meet the requirements of NFPA No.

232-1975, "Standards for the Protection of Records", as allowed by the Regulatory Guide 1.88 - 1976 or ANSI/ ASME NQA 1983, Supplement 17S-1 Section 4.4 in lieu of N45.2.9 Section 5.6 or the discussions in this section for Records Storage Facilities with the clarification that penetrations providing fire protection, lighting, temperature/humidity control, or communications are acceptable as long as the penetration maintains the required fire resistance.

Except that as an alternate to these requirements non-permanent records (eg, three years retention records) may be stored and maintained by the originating organization in one-hour minimum fire rated file cabinets located in environmentally controlled facilities that have suitable fire protection. Suitable fire protection is provided by either an automatic sprinkler system or a combination of two or more of the following: 1) automatic fire alarms, 2) hose stations, or 3) portable extinguishers.

Documents are considered completed when they are "completely filled out" (ie, when sufficient information is recorded to fulfill the record's intended purpose) and the adequacy of the document

( eg, legibility) has been accepted by the document control or records management organizations or designees.

The requirements for an index discussed in this section are considered to only require that a method of retrieving the record and controlling the identified information be established.

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,~~.,, PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENUGV TABLE 1: REGULATORY COMMITMENTS J.

Regulatory Guide 1.88 (continued)

4.

ANSI N45.2.9 Section 5.4.2

5.

ANSI N45.2.9 Section 5.4.3

6.

ANSI N45.2.9 Section 5.5

7.

ANSI N45.2.9 Section 5.6 Instead of the requirements of this section, Palisades Energy, LLC will comply with the following: Records shall not be stored loosely.

They shall be secured for storage in file cabinets or on shelving in containers. Methods other than binders, folders, or envelopes ( eg, dividers or boxes) may be used to organize records for storage.

This section is not applicable to special processed records controlled per Section 5.4.3 when the requirements of this section are not appropriate for the record type.

Instead of the requirements of this section, Palisades Energy, LLC will comply with the following: Provisions shall be made for special processed records such as radiographs, photographs, negatives, microfilm, and magnetic media to prevent damage from excessive light, stacking, electromagnetic fields, temperature, and humidity as appropriate to the record type with appropriate consideration of packaging and storing recommendations as provided by the manufacturer of these materials.

Routine general office and nuclear site security systems and access controls are provided; no special security systems are required to be established for record storage areas.

Palisades Energy, LLC will meet the requirements of NFPA No.

232 -1975, "Standards for the Protection of Records", as allowed by the Regulatory Guide 1.88 - 1976 or ANSI/ASME NQA-1-1983, Supplement 17S-1 Section 4.4 in lieu of this section for Records Storage Facilities with the clarification that penetrations providing fire protection, lighting, temperature/humidity control, or communications are acceptable as long as the penetration maintains the required fire resistance.

Except that as an alternate to these requirements non-permanent records (eg, three years retention records) may be stored and maintained by the originating organization in one-hour minimum fire rated file cabinets located in environmentally controlled facilities that have suitable fire protection. Suitable fire protection is provided by either an automatic sprinkler system or a combination of two or more of the following: 1) automatic fire alarms, 2) hose stations, or 3) portable extinguishers.

Page82 of96

HOLTEC PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL rAUSADES ENERGY TABLE 1: REGULATORY COMMITMENTS K.

Regulatory Guide 1.94 Revision 1, dated April 1976, "Quality Assurance Requirements for Installation, Inspection and Testing of Structural Steel during the Construction Phase of Nuclear Power Plants"

1.

ANSI N45.2.5 Section 2.5.2

2.

ANSI N45.2.5 Section 4.5

3.

ANSI N45.2.5 Table B Clarification/Exception The last sentence requires that all items inspected with maintenance and test equipment, which is found to be out of calibration, shall be considered unacceptable. Palisades Energy, LLC will comply with QAPM Section O as an alternate. QAPM Section O requires an evaluation to determine the validity of previous measurements.

When using ACl-305-72 and ACl-306-66, Palisades Energy, LLC may apply the following requirements:

PLACING TEMPERATURES OF CONCRETE

a. During hot weather concreting, placing temperatures of concrete will be limited to the following: 1) Concrete members less than three feet in least dimension will not exceed 90°F; 2) Concrete members from 3-6 feet in least dimension will not exceed 70°F; and 3) Concrete members more than six feet in least dimension will have placing temperature as near 50°F as can be obtained by use of ice as necessary up to 100 percent of adding mixing water; and by shading aggregate and sprinkling the coarse aggregate the day it is to be used. Care will be taken so that no ice remains in the concrete at the end of the mixing period.
b. During cold weather concreting: In heating the water and aggregate, live steam to heat the fine and coarse aggregate shall not be used. The permissible range for concrete temperature shall be as follows: 1) Sections less than three feet in least dimensions 55°F to 75°F; and 2)

Mass concrete three feet or more in least dimension 45°F to 65°F. The mixing water and aggregate will be purchased as required. The materials will be free of ice, snow and frozen lumps before they enter the mixer.

Per ASME QA92-003 (ASME NQA-1 Interpretations), testing of non-shrink grout does not fall under the jurisdiction of N45.2.5 Table B; but the designer is responsible for identifying necessary testing and frequency requirements.

Page 83 of96

~~"~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS K.

Regulatory Guide 1.94 (continued)

4.

ANSI N45.2.5 Section 4.8 For the performance of correlation tests, the requirements of this standard may be modified as discussed below:

Table B, REINFORCING STEEL: In-process testing of reinforcing steel will include the mechanical properties of yield strength, tensile strength and percent elongation on full size specimens for each bar size for each 50 tons or fraction thereof from each mill heat. Bend tests are performed during material qualification testing only, except as noted below for bar sizes #14 through #18.

Table A, "Required Qualification Tests" as applied to reinforcing steel will include bend tests as required by ASTM A615 and summarized in the following: a) For bar sizes #3 through #11, one full size specimen from largest bar size rolled from each mill heat, unless material from one heat differs by three or more designation numbers. When this occurs, one bend test shall be made from both the highest and lowest designation number of the deformed bars rolled; b) For bar sizes #14 through #18, Supplementary Requirements S1 of ASTM A615 will be applied, ie, one fullsize specimen for each bar size for each mill heat. If supplementary requirements are not followed for mill tests, they will be applied as in-process tests.

In-process test specimens may be selected at the rebar fabrication shop, prior to start of fabrication of the rebar from the heat or fraction thereof represented by the test specimen.

Acceptance criteria for any failed test ( qualifications as well as in-process) may be the same as that for tensile tests specified in Sub article CC-2331.2 of ASME Section Ill, Div.

2 Code (1975). This states that if a test specimen fails to meet the specified strength requirements, two (2) additional specimens from the same heat and of the same bar size would be tested, and if either of the two additional specimens fails to meet the specified strength requirements, the material represented by the tests would be rejected for the specified use. Alternative use of rejected material under strict control may be subject to evaluation by engineering.

Page 84 of96

_T,~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS K.

Regulatory Guide 1.94 ( continued)

5.

ANSI N45.2.5 Section 4.9

6.

ANSI N45.2.5 Section 5.5 Palisades Energy, LLC may interpret the terms "horizontal, vertical and diagonal bars" to apply respectively to the following types of splice positions: a. Horizontal, including 10° to horizontal; b. Vertical, including 10° to vertical; and c.

45° angle, including 10° to 80° angle. The words "splicing crew" are interpreted to refer to all project members that are actively engaged in preparing and assembling cadweld mechanical splices at the final splice location. Separate test cycles will be established for each bar size and each splice position.

Palisades Energy, LLC will comply with inspection requirements of the applicable welding codes and any exceptions instead of this section.

Page85 of96

~~~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS L.

Regulatory Guide 1.116 Revision 0-R, dated June 1976, "Quality Assurance Requirements for Installation, Inspection and Testing of Mechanical Equipment and Systems"

1.

ANSI N45.2.8 Section 3 Clarification/Exception Documented routine inspections and audits of the storage area may be performed instead of the requirements of this section.

Page 86 of96

"~~~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS M.

Regulatory Guide 1.123 Revision 1, dated July 1977, "Quality Assurance Requirements for control of Procurement of Items and Services for Nuclear Power Plants"

1.

RG 1.123 Paragraph C.6.e

2.

ANSI N45.2.13 Section 1.2.2

3.

ANSI N45.2.13 Section 1.3

4.

ANSI N45.2.13 Section 3.1

5.

ANSI N45.2.13 Section 3.1 Clarification/Exception This paragraph shall be implemented as originally written in N45.2.13 (ie, with the verb "should" instead of the verb "shall"). Palisades Energy, LLC retains the ultimate responsibility for performance of purchased equipment.

The appropriate engineering discipline will exercise this management I engineering prerogative with respect to the final decision on post installation test requirements.

Item c is an option which may be used to assure quality; however, any option given in 10 CFR 50 Appendix B, Criterion VII as implemented by the QAPM may also be used.

Instead of the definition provided for QA Program Requirements, Palisades Energy, LLC will comply with the following: "Those individual requirements of the QAPM which, when invoked in total or in part, establish Quality Assurance program requirements for the activity being controlled. Although not specifically used in the QAPM, ANSI N45.2 may be imposed upon suppliers."

The "same degree of control" is stipulated to mean "equivalent level of review and approval." The changed document may not always be reviewed by the originator; however, at least an equivalent level of management I supervision shall review and approve any changes.

Changes to procurement documents which are changes in quantity, estimated price, cost codes, taxes, format or editorial changes that do not affect the quality of the item or service do not require an equivalent level of review and approval as the original document.

Page 87 of96

,~~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS M.

Regulatory Guide 1.123 (continued) 5a. ANSI N45.2.13 Section 3.2

6.
7.
8.

ANSI N45.2.13 Section 3.4 ANSI N45.2.13 Section 4.2 ANSI N45.2.13 Section 8.2 Item b When purchasing commercial-grade (as defined in 10 CFR 21) calibration services from NVLAP or A2LA accredited calibration laboratories, procurement documents are not required to impose a Quality Assurance program consistent with ANSI N45.2-1971. In such cases, accreditation may be accepted in lieu of the Purchaser imposing a QA Program consistent with ANSI N45.2-1971, provided all the following are met:

The accreditation is to ANSI/ISO/IEC 17025.

The accrediting body is either NVLAP or A2LA.

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

The purchase documents require calibration/report to include identification of the laboratory equipment/standards used.

The purchase documents require reporting as-found calibration data when calibrated items are found to be out-of-tolerance.

The requirements of the QAPM will be implemented instead of this section.

Supplier evaluations may be performed any time prior to placing the purchased item in service.

Non-conformance notices for conditions described in this section are only required to be submitted to Palisades Energy, LLC when the non-conformance could adversely affect the end use of an item relative to safety, interchangeability, operability, reliability, integrity or maintainability.

Page 88 of96

,~~"~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS M.

Regulatory Guide 1.123 (continued)

9.

ANSI N45.2.13 Section 10.2 Item d

The section states that the certificate should be attested to by a person who is responsible for this QA function whose function and position are described in the Purchaser's / Supplier's QA program. As an alternate to this requirement, Palisades Energy, LLC will use the following: "The person attesting to a certificate shall be an authorized anp responsible employee of the supplier and shall be identified by the supplier."

Page89 of96

~~~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS N.

Regulatory Guide 1.144 Revision 1, dated September 1980, "Auditing of Quality Assurance Programs for Nuclear Power Plants"

1.

RG 1.144 Section C.3.a.(2)

2.

RG 1.144 Section C.3.b.(2)

3.

RG 1.144 Section C.3.b.(2)

4.

RG 1.144 Section C.3.b.(2)

Clarification/Exception This section is not applicable.

In addition to the requirements of this section, previously evaluated and approved active suppliers for which auditing is not the selected method of source verification should be evaluated concurrent with the award of a coritract. Regardless of the evaluation results, active suppliers ( except those excluded under C.3.b( 1)) are source verified (audit, surveillance or inspection) within two years prior to award of a contract or have source verification performed. Inactive suppliers are evaluated prior to supplying items or services. An audit shall be conducted if required to determine the acceptability of procured items or services (ie, acceptability cannot be determined by receipt inspection or another method allowable under 10 CFR 50 Appendix B, Criterion VII).

This section requires that supplier audits be performed on a triennial basis. A grace period not to exceed 25% for audit interval may be applied to this activity. For activities deferred in accordance with the 25% grace period, the next performance date will be based on their originally scheduled date. A total combined time interval for any three consecutive inspection or audit intervals should not exceed 3.25 times the specified inspection or audit interval.

Instead of the annual documented evaluation of suppliers discussed in this section, an ongoing evaluation of supplier performance is conducted which takes into account, where applicable, the other considerations of this section and paragraph of the Regulatory Guide.

Page 90 of96

~~~"~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS N.

Regulatory Guide 1.144 (continued) 4a.

RG 1.144 Section C.3.b.(2)

5.

ANSI N45.2.12 Section 4.3.1

6.

ANSI N45.2.12 Section 4.3.1

7.

ANSI N45.2.12 Section 4.3.2.2

8.

ANSI N45.2.12 Section 4.3.3

9.

ANSI N45.2.12 Section 4.3.3 For suppliers of commercial-grade (as defined in 10 CFR 21) calibration services with accreditation by NVLAP or A2LA, a documented review of the supplier's accreditation by the purchaser may be used in lieu of performing an audit, accepting an audit by another licensee, performing a commercial-grade survey, inspecting or testing following delivery, or performing in-process surveillances during performance of the service. This review shall include, at a minimum, verification of all the following:

The accreditation is to ANSl/ISO/IEC 17025.

The accrediting body is either NVLAP or A2LA.

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

Pre-audit and post-audit conferences may be fulfilled by a variety of communications, such as telephone conversation.

Pre-audit and post-audit conferences are only held when deemed necessary by Quality Assurance or when requested by the audited organization.

This subsection could be interpreted to limit auditors to the review of only objective evidence; sometimes and for some program elements, no objective evidence may be available.

Palisades Energy, LLC will comply with an alternate sentence which reads: "When available, objective evidence shall be examined for compliance with QAPM requirements. If subjective evidence is used ( eg, personnel interviews), then the audit report must indicate how the evidence was obtained."

Pre-audit and post-audit conferences are only held when deemed necessary by Quality Assurance or when requested by the audited organization.

Pre-audit and post-audit conferences may be fulfilled by a variety of communications, such as telephone conversation.

Page 91 of96

~

PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS N.

Regulatory Guide 1.144 (continued)

10. ANSI N45.2.12 Section 4.4
11. ANSI N45.2.12 Section 4.5.1 Instead of the last sentence of the last paragraph of the section, Palisades Energy, LLC will comply with the following: The audit report shall be issued within thirty working days after the last day of the audit. The last day of an audit shall be considered to be the day of the post-audit conference. If a post-audit conference is not held because it was deemed unnecessary, the last day of the audit shall be considered to be the date the post-audit conference was deemed unnecessary as documented in the audit report.

The QAPM Section 0 corrective action program may be used instead of these requirements as long as the appropriate time limits are applied to significant conditions adverse to quality. Also, no additional documentation is necessary if needed corrective actions are taken and verified prior to audit report issuance.

Page 92 of96

~~~"~ PALISADES ENERGY, LLC QUALITY ASSURANCE PROGRAM MANUAL PALISADES ENERGY TABLE 1: REGULATORY COMMITMENTS

0.

Regulatory Guide 1.146 Revision 0, dated August 1980, "Qualification of Quality Assurance Program Audit Personnel for Nuclear Power Plants"

1.

ANSI N45.2.23 Section 2.3.1.3

2.

ANSI N45.2.23 Section 2.3.4

3.

ANSI N45.2.23 Sections 3.2 and 5.3 Clarification/Exception Holders of NRG-issued Reactor Operator/Senior Reactor Operator Licenses comply with the requirements of this section and may be awarded two credits.

Prospective lead auditors shall demonstrate their ability to effectively implement the audit process and lead an audit team. They shall have participated in at least one audit within the year preceding the individual's effective date of qualification. Upon successful demonstration of the ability to effectively lead audits, licensee management may designate a prospective lead auditor as a "lead auditor".

These sections require that an annual assessment be performed of each lead auditor's qualification and that each lead auditor's records be updated annually. A 90-day grace period may be applied to these activities. For activities deferred in accordance with the 90-day grace period, the next performance due date will be based on their originally scheduled date.

Page 93 of96

Appendix D Safety Related Systems, Structures, and Components applicable to Palisades Restart Efforts Prev.

Discussion of System/Component Interactions, Safety Item No.

Item ID Class Functions, Reasoning, and References (QP Denotes -

Augmented Quality)

1.

AFW SR Auxiliary Feedwater

2.

ASP SR Alternate Shutdown Panel

3.

CBA QP Concentrated Boric Acid

4.

ccs SR Component Cooling

5.

CIS SR Containment Isolation

6.

CLC QP Containment / Fuel Pool Cranes

7.

CLP QP Containment Bldg. / Misc Equip

8.

CPG QP Containment Purge

9.

CRD SR Control Rod Drive

10.

CRS SR Containment Air Coolers

11.

CRV SR Control Room HVAC

12.

css SR Containment Spray

13.

csw SR Critical Service Water

14.

eve QP Chemical and Volume Control

15.

DFS SR Dry Fuel Storage

16.

DGV SR Emergency DG Room HVAC

17.

DTA QP Datalogger

18.

EDC SR 125V Vital DC Power

19.

EOG SR Emergency Diesel Generators

20.

ELU QP Emergency Lighting

21.

EPS QP Emergency Power Page 94 of96

Appendix D Safety Related Systems, Structures, and Components applicable to Palisades Restart Efforts Prev.

Discussion of System/Component Interactions, Safety Item No.

Item ID Class Functions, Reasoning, and References (QP Denotes -

Augmented Quality)

22.

ESF SR Engineered Safeguards Actuation

23.

ESS SR Engineered Safeguards

24.

ESV SR Engineered Safeguards HVAC

25.

FHS SR Fuel Handling System

26.

FOS SR Fuel Oil System

27.

FPS QP Fire Protection

28.

HPA SR High Pressure Air

29.

HPI SR High Pressure Safety Injection

30.

LAC SR 480V AC Power

31.

LPI SR Low Pressure Safety Injection

32.

MAC SR 2400V AC Power

33.

MSS QP Main Steam

34.

NMS SR Neutron Monitoring

35.

PAC SR 120V Preferred AC Power

36.

PAS QP Post Accident Sampling

37.

PCS SR Primary Coolant System

38.

PZR SR Pressurizer Pressure and Level

39.

RIA QP Radiation Monitoring System

40.

RPS SR Reactor Protection System

41.

RVG SR Reactor Vessel

42.

RVI SR Reactor Vessel Internals Page 95 of96

Appendix D Safety Related Systems, Structures, and Components applicable to Palisades Restart Efforts Prev.

Discussion of System/Component Interactions, Safety Item No.

Item ID Class Functions, Reasoning, and References (QP Denotes -

Augmented Quality)

43.

scv QP Elec Equipment/ Switchgear/ Cable Spread HVAC

44.

SDC SR Shutdown Cooling

45.

SEC QP Security

46.

SFP QP Spent Fuel Pool Cooling

47.

SIT SR Safety Injection Tanks

48.

sss SR SIRW / Containment Sump

49.

SWS SR Service Water

50.

UHS SR Ultimate Heat Sink Page96 of96

Transitional Quality Control Program Change Evaluation Forms for Rev 0

EN-Ll-113 I

Rev.O I Page 18 of 30 Licensing Basis Document Change Process Page 1 of 3 I.

LBDCR INITIATION William Flick INITIATOR'S NAME (print or type)

LBDCR Form (typical)

(TYPICAL)

QA 2914 DEPARTMENT PHONE DESCRIPTION OF THE CHANGE 1

7/11/2024 24-004 UNIT DATE LBDCR#

(Attach additional pages if necessary; may also reference PAD Form)

Implementation of the Holtec Decommissioning International (HDI) Palisades Transition Quality Assurance Program (TQAP). See also PAD and 10CFR50.54(a) (attached).

LICENSING DOCUMENT(S) AFFECTED AFFECTED SECTION/PAGE(S (Attach marked-up pages)

Operating License (OL)

Technical Specifications (TS)

Environmental Protection Plan (EPP)

Anti-Trust Conditions (Appendix of OL}

NRC Orders DSAR sections 12.1, 12.3,

[8J Updated Final Safety Analysis Report (UFSAR) 12.4, and 15.1 - Update references from DQAP to TQAP TS Bases Technical Requirements Manual (TRM) (including TRM Bases) igi Quality Assurance Program Manual (QAPM)

See attached.

Security Plan/Cyber Security Plan (CSP)

Emergency Plan (EP)

Offsite Dose Calculation Manual (ODCM)

Post-Shutdown Decommissioning Activities Report (PSDAR)

Spent Fuel Storage Cask Final Safety Analysis Report (CFSAR)

Spent Fuel Storage Cask Certificate of Compliance (CoC)

EN-Ll-113 I

Rev.O I Page 19 of 30 Licensing Basis Document Change Process Spent Fuel Storage Cask Coe Bases Surveillance Frequency Control Program {SFCP)

Page 2 of 3 LBDCR Form (typical) 10 CFR 72.212 Evaluation Report (212 Report)

Fire Protection Program (FPP)/Fire Hazards Analysis {FHA)

Core Operating Limits Report (COLR)

D Other (Specify)

METHOD(S) ALLOWING THE CHANGE 18 PAD Review (Attach a copy) 10 CFR 50.48 / EN-DC-128 Review {Attach a copy) 10 CFR 50.59 Evaluation (Attach a copy) jg] 10 CFR 50.54 Review (Attach a copy) 10 CFR 72.48 Evaluation (Attach a Environmental Evaluation (Attach a copy) copy}

Approved NRC Change (Attach a copy of Editorial Change (LBDs controlled under 50.59 or NRC Letter or reference NRG letter number) 72.48, only}

D NRC Approval is Required Other Approval (Attach a copy of supporting documents)

D "UFSAR-only" Change (NEI 98-03)

Check the appropriate box below:

Reformatting D Replacing Detailed Drawing Referencing other Documents Check the appropriate box below and provide a basis for removing information, if applicable:

Removing Excessive Detail Removing Obsolete Information D Removing Redundant Information D Removing Commitments Removal Basis:

I Rev. O I Page 20 of 30 Licensing Basis Document Change Process Page 3 of 3 LBDCR Form (typical)

II.

LBDCR IMPLEMENT ATION1 ACTIONS SUPPORTING IMPLEMENTATION REQUIRED ACTIONS LBDSECTION ACTION TAKEN OR TRACKING METHOD ACTION RESP.DEPT TQAP Initial Issue QA LBOCR 24-004 and PAD 24-0273 Ill.

LBDCR REVIEW AND APPROVAL1 Department UFSAR Section Owner3 Peer Review LBD Owner N/A REVIEW AND APPROVAL of LBDCR (see Attachment 2)

Approved2 1

Add additional table rows as needed.

2 The printed name should be included on the form when using electronic means for signature or if the handwritten signature is illegible. Signatures may be obtained via electronic authentication, manual methods (eg, ink signature), e-mail, or telecommunication. Signing documents with indication to look at another system for signatures is not acceptable such as "See EC" or "See Asset Suite." Electronic signatures from other systems are only allowed if they are included with the documentation being submitted for capture in eB (eg, if using an e-mail, attach it to this form; if using Asset Suite, attach a screenshot of the electronic signature(s); if using PCRS, attach a copy of the completed corrective action).

3 UFSAR Section Owners should refer to EN-Ll-113-01, "Updated Final Safety Analysis Report Change Process," for review expectations. NIA if change does NOT update the UFSAR.

Date

EN-Ll-100 I

Rev.O Process Applicability Determination Process Applicability Determination Form I.

OVERVIEW I Page 21 of 58 Page 1 of 8 PAD Log#

24-0273 PAD Rev.#: __,O"---_

Facility: ___ P'--'a=l=is=a=d=es=------------------------------

Proposed Activity/ Document: Revision O of this PAD supports the implementation of the Transition Quality Assurance Program (TQAP) for the Palisades Nuclear Power Plant (PNPP) facility. The TQAP will contain the combined Holtec Decommissioning lnternation (HDI) Decommissioning Quality Assurance Plan {DQAP) Revision 2 dated June 28, 2022, the HDI Palisades Quality Assurance Program Manual (QAPM) Revision 0, and a listing of safety related systems, structures. and components (SSCs) applicable to Palisades restart activities. The changes do not represent a reduction in commitment since the current DQAP remains in effect without change and additional documents will be added along with the DQAP to support restart activities.

Change/Rev.#: _o_

Description of Proposed Activity: This activity implements the HDI Palisades TQAP to support decommissioning and restart quality related activities. The changes are not considered a reduction in commitment in that they do not change responsibilities. commitments, or reporting lines. The PAD also evaluates the effects on associated LBDs affected by the change. The documents being addressed are the HDI Palisades DQAP Revision 2. the Palisades QAPM Revision 0, Post-Shutdown Defueled Safety Analysis Report (PDSAR) Revision 36. and changes to the three (3) Palisades 1 O CFR 72.212 Reports (See below details).

1. HDI 0QAP Revision 2 - There are no changes to the HDI DQAP included in the TQAP. This document will remain in effect for decommissioning activities and is an adoption of the current HDI DQAP Revision 2 by Palisades. The changes do not represent a reduction in commitments in that the change does not alter or remove responsibilities. commitments or reporting lines. HDI is revising this document to remove Palisades from the DQAP however those changes are not being reviewed under this PAD.
2.

Palisades QAPM Revision O - This change is an adoption of the Entergy Fleet QAPM Revision 43 that was current when Palisades began decommissioning in June 2022. as the HDI Palisades QAPM.

The Entergy Palisades QAPM will be issued as Revision O of the HOI Palisades QAPM Revision 0.

The changes do not represent a reduction in commitments in that the change does not alter or remove responsibilities. commitments or reporting lines.

3. Palisades DSAR Revision O - Sections 12.1. 12.3. 12.4. and 15.1 of the DSAR reference the DQAP and should be changed to TQAP. The preface/intent of the TQAP states. "The intent of the TQAP is to continue to implement the quality requirements from the most recent DQAP (Revision 2). adopted at Palisades for those functions/activities not specifically intended to support the restart effort. but rather those functions/activities that would continue to progress during ongoing decommissioning activities until the Operational Technical Specifications/Licensing Bases are reimplemented."

This PAD is written to evaluate the proposed change against both the Palisades Nuclear Plant decommissioning licensing basis and against the restart project power operations license basis (POLB). The restart project POLB is a reinstatement of the Updated Final Safety Analysis Report (UFSAR) revision 35 and the other POLB basis documents that were in effect prior to implementation of the permanently defueled technical specifications (POTS). Hence the Licensing basis documents, process documents. and other references reviewed in this PAD include those which currently represent the decommissioning facility licensing basis and the POLB.

II.

DOCUMENT REVIEW METHOD Provide the requested information for each item below.

EN-Ll-100 I

Rev.O I Page 22 of 58 Process Aoolicability Determination Page 2 of 8 Process Applicability Determination Form

1. For documents available electronically:
a.

List search engine or documents searched, and keywords used:

Documents were searched using the following key words: Quality, QAPM, and QA with the searches being performed on the following documents:

PNPP License and Technical Specifications PNPP Operating Requirements Manual Revision 22 PNPPUFSAR PNPP DSAR

b.

List relevant sections of controlled electronic documents reviewed:

1. PNPP License and Technical Specifications No relevant sections
2. PNPP Operating Requirements Manual No relevant sections
3. PNPP UFSAR
a. Sections 12, 15.1, and 15.2 with no changes needed.
4. PNPP DSAR
a. Sections 12.1, 12.3, 12.4, 15.1 and 15.2 with changes to how the Quality Assurance Program is described, Licensing Basis Document Change Request {LBDCR)24-007 created to track and implement the changes needed. All referenced sections of the DSAR are impacted except section 15.2.
5.

PNPP 10 CFR 72.212 Evaluation Reports (3 documents)

2. Documents reviewed manually (hardcopy):
1.

Palisades 10 CFR 72.212 Report for the Holtec International HI-STORM FW Storage System, Report No. PLP 721032, Revision 5 - Updates to the associated QAPM referred to in Section 6.13.1.2 and Reference 7.5 will be needed to reflect the separation of the Entergy Palisades QAPM from the EOI Fleet QAPM with the specific reference provided (Revision 29).

2. Palisades NUHOMS 72.212 Report, No. PLP 721004, Revision 6 - Updates to the associated QAPM references in multiple areas within Section 4 and the associated References to reflect the separation of the Entergy Palisades QAPM from the EOI Fleet QAPM.
3. Palisades VSC-24, 72.212 Report, No. VSC-24 10CFR72.212-PLP Revision 5 - No change needed since QAPM terminology is sufficiently generic.
3.

For those documents that are not reviewed either electronically or manually, use the specific questions provided in Sections Ill and IV of Attachment 2 of EN-Ll-100 as needed. Document, below, the extent to which the Attachment 2 questions were used.

All questions in Section Ill and IV of Attachment 2 were reviewed and answered no with the exception of the 1 O CFR 72.212 Evaluation Reports discussed above in the summary of changes and the OAPM 50.54(a) evaluation. and the DSAR. Revisions to the three (3) 10 CFR 72.212 Evaluation Reports are being tracked via engineering change {EC) Hl-2230638, and the revision to the DSAR are being tracked by LBDCR number 24-007.

Ill.

PROCESS REVIEW Does the proposed activity affect, invalidate, or render incorrect, OR have the potential to affect, invalidate, or render incorrect, information contained in any of the following processes?

EN-Ll-100 I

Rev.O I Page 23 of 58 Process Applicability Determination Page 3 of 8 Process Applicability Determination Form Contact Program Owner if needed. Associated regulations and procedures are identified with each process below.

PROCESS (Regulations I Procedures)

YES NO REVIEW RESULTS Chemistry / Effluents

~

Radwaste / Process Control Program (PCP)

~

(EN-RW-105 or contact the Radiation Protection Dept.)

Radiation Protection / ALARA

~

( 10 CFR 20 / EN-RP-110 or contact the Radiation Protection Dept.)

lnservice Inspection Program

~

(10 CFR 50.55a I EN-DC-333, -342, -351. -352) lnservice Testing Program lRI (10 CFR 50.55a / EN-DC-332)

Maintenance Rule Program D

IZI (10 CFR 50.65 / EN-DC-203, -204, -205, -206, -207)

Containment Leakage Rate Testing (Appendix J) Program

~

(10 CFR 50 Appendix J / EN-DC-334)

FLEX Program (NRC Order EA-12-049/NRC Order EA-12-051/FLEX

~

Program) (10 CFR 50.59 / EN-OP-201 )

IF any box is checked "Yes," THEN contact the appropriate department to ensure that the proposed change is acceptable and document the results in the REVIEW RES UL TS column.

IV.

LICENSING BASIS DOCUMENT REVIEW Does the proposed activity affect, invalidate, or render incorrect, OR have the potential to affect, invalidate, or render incorrect, information contained in any of the following Licensing Basis Document(s)? Contact LBD Owner if needed. Associated regulations and procedures are identified with each Licensing Basis Document below.

LICENSING BASIS DOCUMENTS YES NO REVIEW RES UL TS OR SECTIONS (Regulations I Procedures)

AFFECTED OR LBDCR #

Quality Assurance Program Manual (QAPM)

The 10 CFR 50.54.a Evaluation has

[10 CFR 50.54(a), 10 CFR 50 Appendix B / EN-QV-104]

~

been developed to support the implementation of LBDCR 24-004 which is an adoption of Revision O of the Palisades TQAP.

Fire Protection Program (FPP) (includes the Fire Safety Analysis/Fire Hazards Analysis (FSA/FHA)]

~

OL Condition, 10 CFR 50.48 / EN-DC-128}

Emergency Plan (includes the On-Shift Staffing Analysis)

[ZJ (1 0 CFR 50.54(q) / 10 CFR 50.47 I EN-EP-305 / EN-NS-220]

Environmental Protection Plan (Appendix B of the OL, Environmental Evaluation / EN-EV-115, EN-EV-117,

~

EN-Ll-103)

EN-Ll-100 I

Rev.O I Page 24 of 58 Process Applicability Determination Page 4 of 8 Process Applicability Determination Form LICENSING BASIS DOCUMENTS YES NO REVIEW RES UL TS OR SECTIONS (Regulations I Procedures)

AFFECTED OR LBDCR #

Security Plan

/g]

(10 CFR 50.54(p) / EN-NS-210 / EN-NS-220 or contact site Security Dept.]

Cyber Security Plan

~

(10 CFR 50.54 (p) I EN-NS-21 OJ Operating License {OL) / Technical Specifications (TS)

/g]

(10 CFR 50.90 I EN-Ll-103)

TS Bases (1 0 CFR 50.59 / EN-Ll-100 / EN-Ll-101)

~

Technical Requirements Manual (TRM) (including TRM Bases)

[81 (10 CFR 50.59 1 EN-Ll-100 / EN-Ll-101)

Post-Shutdown Decommissioning Activities Report (PSDAR)

[81 (10 CFR 50.82(a)(7) I RG 1.185 / EN-Ll-100)

Surveillance Frequency Control Program (SFCP)

[81 (TS Administrative Controls/ EN-DC-355)

Core Operating Limits Report (COLR), and Pressure and Temperature Limits Report (PTLR) (TS Administrative Controls, EN-Ll-113, EN-U-100,

~

EN-Ll-101)

Offsite Dose Calculation Manual (ODCM)

~

(TS Administrative Controls / EN-Ll-113, EN-Ll-100)

Updated Final Safety Analysis Report (UFSAR)

Update OSAR sections 12.1, 12.3, (10 CFR 50.71 (e) / EN-Ll-113, EN-Ll-100. EN-Ll-101) l8l 12.4, and 15.1 to change reference of DQAP to TQAP - See LBDCR 24-007 Storage Cask Certificate of Compliance (10 CFR 72.244 / EN-Ll-113)

IZJ (10 CFR 72. 70 or 72.248 / EN-Ll-113, EN-Ll-100, EN-Ll-112) 10 CFR 72.212 Evaluation Report (212 Report)

The 3 Palisades 10 CFR 72.212 (10 CFR 72.48 / EN-Ll-100, EN-Ll-112)

Evaluation Reports were minimally impacted. The information was IZl reviewed with the Program Owner and is a simple change to the reference to the QAPM language in applicable sections to be more generic. Tracking is per (EC) Hl-2230638 NRC Orders (10 CFR 50.90 I EN-Ll-103 or as directed by the Order)

NRC Commitments and Obligations (EN-Ll-110)

[81 Site-Specific CFR Exemption IZJ (10 CFR 50.1 2, 10 CFR 55.11, 10 CFR 55.13, 10 CFR 72.7)

  • contact the site Regulatory Assurance Department if needed.

IF any box is checked "Yes," THEN ensure that any required regulatory reviews are performed in accordance with the referenced procedures. Prepare an LBDCR per procedure EN-Ll-113, as required, if a LBD is to be changed, and document any affected sections or the LBDCR #. Briefly discuss how the LBD is affected in Section VII.A.

EN-Ll-100 I

Rev.O I Page 25 of 58 Process Applicability Determination Page 5 of 8 Process Applicability Determination Form V.

10 CFR 50.59 / 10 CFR 72.48 APPLICABILITY Can the proposed activity be dispositioned by one or more of the following criteria? Check the appropriate box (if any).

An approved, valid 50.59/72.48 Evaluation covering associated aspects of the proposed activity already exists. Reference 50.59/72.48 Evaluation#

(if applicable) or attach documentation. Verify the previous 50.59/72.48 Evaluation remains valid.

The NRC has approved the proposed activity or portions thereof in a license amendment or a safety evaluation, or is being reviewed by the NRC in a submittal that addresses the proposed activity. Implementation of change requires NRC approval. Reference the approval document or the amendment in review.:

The proposed activity is administratively controlled by the Operating License (OL) or Technical Specifications (TS).

Examples of programs and manuals controlled by the OL or TS are:

Fire Protection Program (OL Condition) (EN-DC-128)

Offsite Dose Calculation Manual (TS Administrative Controls)

Surveillance Frequency Control Program (TS Administrative Controls) (EN-DC-355)

See NEI 96-07, Appendix E Section 2 for additional guidance on administrative controls.

Reference the administrative control{s):

~ The proposed activity is controlled by one or more applicable regulations.

Examples of programs controlled by regulations that establish specific criteria are:

Maintenance Rule (50.65) (EN-DC-203)

Quality Assurance Program (10 CFR 50 Appendix B)

Security Plan [50.54(p)) {EN-NS-210)

Cyber Security Plan [50.54(p)] (EN-NS-210)

Emergency Plan [50.54(q)] (EN-EP-305) lnservice Inspection Program (50.55a) (EN-DC-351, -352) lnservice Testing Program (50.55a) (EN-DC-332)

See NEI 96-07 Section 4.1 for additional guidance on specific regulations.

Reference the controlling specific regulation{s):

The Quality Assurance Program {10 CFR 50 A1;mendix 8), Procedure EN-QV-104 "Quality Assurance Program Manual Control", Procedure EN-Ll-113 "Licensing Basis Document Change Process", Procedure EN-Ll-112 "10 CFR 72.48 Evaluations", and 10 CFR 50.54{a}.

IF the entire proposed activity can be dispositioned by one of the criteria in Section V, THEN 50.59 and 72.48 Screenings are not required. Proceed to Section VII and provide basis for conclusion in Section VII.A.

EN-Ll-100 I

Rev. 0 I Page 26 of 58 Process Aoolicability Determination Page 6 of 8 Process Applicability Determination Form Otherwise, continue to Section VI to perform a 50.59 and/or 72.48 Screening, or perform a 50.59 and/or 72.48 Evaluation in accordance with EN-Ll-101 and/or EN-Ll-112.

VI.

50.59 / 72.48 SCREENING REVIEW (All proposed activities must be evaluated to determine if 50.59, 72.48 or both apply. Check the applicable boxes)

VI.A 50.59 SCREENING D

50.59 applies to the proposed activity, and all of the following 10 CFR 50.59 screening criteria are met; therefore, the proposed activity requires no further 50.59 review.

The proposed activity:

Does not adversely affect the design function of an SSC as described in the UFSAR; AND Does not adversely affect a method of performing or controlling a design function of an SSC as described in the UFSAR; AND Does not adversely affect a method of evaluation that demonstrates intended design function(s) of an SSC will be accomplished as described in the UFSAR; ANO Does not involve a test or experiment not described in the UFSAR.

Document the basis for meeting the screening criteria in Section VI.C, then proceed to Section VII.

[10 CFR 50.59(c)(1 )]

D The proposed activity does not meet the above criteria. Perform a 50.59 Evaluation in accordance with EN-Ll-101. Attach a copy of the Evaluation to this form and proceed to Section VII.

VI.B 72.48 SCREENING D

72.48 applies to the proposed activity, and all of the fol lowing 10 CFR 72.48 screening criteria are met; therefore, the proposed activity requires no further 72.48 review.

The proposed activity:

Does not adversely affect the design function of an SSC as described in the CFSAR; AND Does not adversely affect a method of performing or controlling a design function of an SSC as described in the CFSAR; AND Does not adversely affect a method of evaluation that demonstrates Intended design functlon(s) of an SSC will be accomplished as described in the CFSAR; ANO Does not involve a test or experiment not described in the CFSAR.

Document the basts for meeting the screening criteria in Section VI.C, then proceed to Section VII.

[10 CFR 72.48(c)(1))

D The proposed activity does not meet the above criteria. Perform a 72.48 Evaluation in accordance wfth EN-Ll-112. Attach a copy of the Evaluation to this form and proceed to Section VII.

EN-Ll-100 I

Rev.O I Page 27 of 58 Process Aoolicability Determination Page 7 of 8 Process Applicability Determination Form VI.C BASIS Provide a clear, concise basis for determining the proposed activity may be screened out such that a third-party reviewer can reach the same conclusions. Identify the relevant design function, as appropriate.

Refer to NEI 96-07 Section 4.2 for guidance. Refer to NEI 12-06 Section 11.4 for guidance regarding FLEX.

Provide supporting documentation or references as appropriate.

NIA VII.

REGULATORY REVIEW

SUMMARY

VII.A GENERAL REVIEW COMMENTS (Provide pertinent review details and basis for conclusions if not addressed elsewhere in form.)

The implementation of the TQAP is only applicable to HDI Palisades and is being performed and controlled under Procedure EN-QV-104 and the License Basis Document change process. The changes are controlled by specific regulations including 10 CFR 50 Appendix Band 10 CFR 50.54(a). The changes do not alter or remove responsibilities, commitments of reporting lines, so no requirements are lost or reduced. The changes support the incorporation of the previously accepted and implemented Entergy Palisades/Entergy Fleet QAPM, Revision 43 in whole with only the necessary changes in nomenclature to make it specific to Palisades. The identified documents that provide specific QAPM references rather than generic references and require updating are the three (3) Palisades 10 CFR 72.212 Evaluation Reports.

Revisions to the three (3) 10 CFR 72.212 Evaluation Reports are being tracked via engineering change (EC) Hl-2230638 and the DSAR for which changes are being tracked per LBDCR 24-007. The changes to the DSAR are to update the description of the QAPM in sections 12.1, 12.3, 12.4, and 15.1.

VII.B CONCLUSIONS

1.

Is a change to an LBD being initiated?

~ Yes IF "Yes," THEN enter the appropriate change control process and include No this form with the change package.

2.

Is a 10 CFR 50.59 Evaluation required?

Yes IF "Yes," THEN complete a 50.59 Evaluation in accordance with EN-Ll-101

~ No and attach a copy to the change activity.

3.

Is a 10 CFR 72.48 Evaluation required?

Yes IF "Yes," THEN complete a 72.48 Evaluation in accordance with EN-Ll-112 IZl No and attach a copy to the change activity.

EN-Ll-100 I

Rev.O Process Aoolicability Determination Process Applicability Determination Form

~~ -~)

I Page 28 of 58 Page 8 of 8 VIII.

SIGNATURES 1 ev;ll,'o..._ f~ :.:;~ ~

Preparer:

Michael Ginzel/ ~

/Holtec/ Radiation Protection / 08-02/2024 Name (print) / Signature I Company I Department I Date Reviewer:

/{l8vfot_fL ~

~~ t3N6i Name (print)/ Signature/ Company I Department f Date Process Applicability Exclusion Site Procedure N/A Champion or Owner:

Name (print)/ Signature/ Company/ Department I Date Upon completion, forward this PAD form to the appropriate organization for record storage. If the PAD form is part of a process that requires transmittal of documentation, including PAD forms, for record storage, then the PAD form need not be forwarded separately.

1 The printed name should be included on the form when using electronic means for signature or if the handwritten signature is illegible. Signatures may be obtained via electronic authentication, manual methods (eg, ink signature), e-mail, or telecommunication. Signing documents with indication to look at another system for signatures is not acceptable such as "See EC" or "See Asset Suite." Electronic signatures from other systems are only allowed if they are included with the documentation being submitted for capture in eB (eg, if using an e-mail, attach it to this fonn; if using Asset Suite, attach a screenshot of the electronic signature(s); if using PCRS, attach a copy of the completed corrective action).