Text

& Big Rock Point Plant - Update Report for Holtec Decommissioning International (HDI) Fleet Decommissioning Quality Assurance Program (DQAP) Revision 2
	ML22215A147
Person / Time
Site:	Palisades, Big Rock Point File:Consumers Energy icon.png
Issue date:	08/03/2022
From:	Fleming J; Holtec Decommissioning International
To:	; Document Control Desk, Office of Nuclear Material Safety and Safeguards, Office of Nuclear Reactor Regulation
References
	CD-020
	Download: ML22215A147 (136)
	v • d • e

Krishna P. Singh Technology Campus, 1 Holtec Blvd., Camden, NJ 08104 HOLTEC Telephone (856) 797-0900 Fax (856) 797-0909 DECOMMISSIONING INTERNATIONAL 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 3, 2022 U.S. Nuclear Regulatory Commission Attn: Document Control Desk Washington, DC 20555-0001 Palisades Nuclear Plant Renewed Facility Operating License No. DPR-20 Docket Nos. 50-255 and 72-007 Big Rock Point Plant Facility Operating License No. DPR-6 Docket Nos. 50-155 and 72-043

Subject:

Update Report for Holtec Decommissioning International (HDI) Fleet Decommissioning Quality Assurance Program (DQAP) Revision 2

Reference:

[1] NRC Letter to HDI, Holtec Decommissioning International - Review and Acceptance of The Holtec Decommissioning International Fleet Decommissioning Quality Assurance Program (EPID L-2020-DP3-0000), (ADAMS Accession NumberML21011A106), dated January 12, 2021

[2] NRC email Indian Point Unit Nos. 1, 2 and 3 - NRC Assessment of HDI Fleet Decommissioning Quality Assurance Program and IPEC Quality Assurance Program Manual [EPID L-2021-LLQ-0000] (ADAMS Accession Number ML21197A200)

Holtec Decommissioning International (HDI) is submitting Revision 2 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)). The HDI Fleet DQAP Revision A (equivalent to Revision 0) was approved by the U.S. Nuclear Regulatory Commission (NRC) on January 12, 2021 (Reference 1). Since NRC approval of the DQAP Revision A, HDI has issued DQAP Revision 1 to add Indian Point Energy Center (IPEC)

Units 1, 2 and 3 (Reference 2), and DQAP Revision 2 adds Palisades Nuclear Plant (PNP) and Big Rock Point Plant (BRP) Independent Spent Fuel Storage Installation (ISFSI).

HDI PNP 2022-028

Krishna P. Singh Technology Campus, 1 Holtec Blvd., Camden, NJ 08104 HOLTEC Telephone (856) 797-0900 Fax (856) 797-0909 DECOMMISSIO ING I N TERNA T IONAL The adoption of HDI Fleet DQAP Rev A at PNP and BRP was evaluated in accordance with 10 CFR 50.54, Condition of licenses, paragraph (a)(3) and concluded that the NRC approved HDI Fleet DQAP Rev A addresses any reduction in commitments as the site transitions from the Quality Assurance Program Manual (QAPM) to the HDI Fleet DQAP. provides a copy of DQAP Revision 2, which includes a synopsis of the changes associated with Revision 1 and Revision 2. provides the Decommissioning Quality Control Program Change Evaluation Form associated with Revision 2.

Revision 2 of the HDI Fleet DQAP continues to satisfy the requirements of 10 CFR 50 Appendix B, and the Regulatory Guides and Standards referenced in the DQAP. As such, it also meets the requirements of 10 CFR 72, Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reactor-Related Greater than Class C Waste, Subpart G, Quality Assurance, Section 72.140, Quality assurance requirements, paragraph (d), (10 CFR 72.140(d)) for ISFSls and 10 CFR 71, Subpart H, Quality Assurance, Section 71.101, Quality assurance requirements, paragraph (f). (10 CFR 71 .101 (f)),

for Packaging and Transportation of Radioactive Material.

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, Jean A. Digitally signed by Jean A. Fleming FI em .1n9t:;~08:57:48-04'00'

a. 2022.08.03

e-c: _

Jean A. Fleming Vice President, Licensing, Regulatory Affairs, & PSA Holtec International, LLC

Enclosure:

1. Decommissioning Quality Control Program (DQAP) Revision 2

2. Decommissioning Quality Control Program Change Evaluation Form HDI PNP 2022-028

Krishna P. Singh Technology Campus, 1 Holtec Blvd., Camden, NJ 08104 HOLTEC Telephone (856) 797-0900 Fax (856) 797-0909 DECOMMISSIONING INTER NA TIO NAL cc:

USN RC Director- Nuclear Reactor Regulation (NRR)

USN RC Director- Nuclear Material Safety and Safeguards (NMSS)

USNRC Region Ill - Regional Administrator USN RC Resident lnspector(s) - Palisades Nuclear Plant and Big Rock Point USN RC Project Manager(s), NMSS - Palisades Nuclear Plant & Big Rock Point State of Michigan HDI PNP 2022-028

ENCLOSURE1 Decommissioning Quality Control Program (DQAP) Revision 2

HOLTEC DECOMMISSIONING INTERNATIONAL CD-020 Decommissioning Quality Assurance Program {DQAP)

Revision 02 Effective June 28, 2022

Holtec Decommissioning International DQAP 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 Palisades Nuclear Power Plant Docket No. 50-255 License No. DPR-20 Docket No. 72-07 Docket No. 71-0937 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 Letter#: N/A

Subject:

Palisades Nuclear Power Plant (PAL) and Big Rock Point Nuclear Plant-lSFSI (BRP), Addition to and Revision of Holtec Decommissioning International (HDI) Decommissioning Quality Assurance Plan (DQAP} Revision 03 Section I Revision Concurrence and A reement to Issue DQAP Revision 02 POSITION / NAME Action Signature concurrence, certification, etc. {sign, interoffice memo, e-mail, or telecom)

HDI- Quality Assurance Manager/Security Preparer Decommissioning Manager David Burke Holtec VP Quality Approver Assurance I Mark Soler CED VP Licensing, Approver Regulatory Affairs, and PSA I Jean Fleming

COIOIMENTS * *

NOTE: Individuals signing above confirm their review and concurrence with revision of the HDI DQAP and the com leteness and accurac of the information contained within in it.

Holtec Decommissioning International DQAP Revision Summary Revision Location Description of Changes Number

a. Updated revision number from 01 to 02.

02 Cover Page b. Effective date updated to June 28, 2022.

C. Relocated list of HDI Sites to next page.

a. Created new page for list of HDI Sites.

HDI Site

b. Added Palisades facility Docket information.

List C. Added Big Rock Point facility Docket information Signature a. Changed; Holtec VP Regulatory Affairs to CED Page VP Licensing, Regulatory Affairs, and PSA

a. Changed; Sr VP/COO to President

b. Changed; Holtec International Senior Vice 1.1.3 President and Chief Nuclear Officer (Holtec CNO) to Holtec International President and CEO

a. Changed; HDI Vice President, Quality Assurance and Nuclear Oversight. To Holtec Vice President of Quality Assurance.

b. Changed; The management position 1.1.4 responsible for Nuclear Oversight to Quality Assurance/Nuclear Oversight C. Changed; to the HDI COO and Holtec CNO

* (Pr&sident) to HDI President and Holtec Senior, Vice President of Business Development

a. Changed; The HDI COO to HDI President 1.2.1

b. Changed; COi to HDI.

1.2.2

a. Changed; Holtec CNO to Holtec President and CEO

a. Changed; The HDI Vice President Quality Assurance and Nuclear Oversight reports to the Holtec HDI President CNO and the HDI COO to The Holtec Vice President of Quality Assurance reports to the Holtec Sr. Vice President of 1.2.3 Business Development and the HDI President

b. Changed; the Holtec CNO and HDI COO to Holtec President and CEO, and HDI Senior Vice President of Business Development President (two places)

Holtec Decommissioning International DQAP Revision Summary Revision Location Description of Changes Number

a. Changed; the HDI COO to HDI President 1.2.4 b. Changed; The HDI Vice President, Regulatory &

Environmental Affairs to The CED Vice President of Licensing, Regulatory, and PSA

a. Changed; HDI VP of Regulatory and Environmental Affairs to CED VP of Licensing, 1.3.1 Regulatory Affairs, and PSA

b. Changed; Emergence to Emergency

a. Changed; The HDI VP Quality and Nuclear 2.5.1 Oversight to The Holtec VP of Quality Assurance A.5.1 a. Changed; HDI COO to HDI President

a. Revision number Oto 01 Cover 01 b. Effective Date updated to May 28, 2021 Sheet C. Added IPEC facility Docket information Signature

a. Added Signature Page behind cover page Page Revision

a. Added Revision Summary Page behind Summary signature page Page

Holtec Decommissioning International DQAP TABLE OF CONTENTS Policy Statement.................. .. . .. . . .. . . . .. . . .. . .. . .. .. . .. . . .. .. . .. . .. .. .. .. . .. . . . . . . . . . . . .. . . . .. . . 2 1.0 Organization................................................................................. 3 2.0 Quality Assurance Program............................................................ 7 3.0 Design Control............................................................................ 9 4.0 Procurement Document Control...................................................... 12 5.0 Instructions, Procedures, and Drawings............................................ 13 6.0 Document Control........................................................................ 14 7.0 Control of Purchased Material, Equipment, and Services...................... 15 8.0 Identification and Control of Materials, Parts, and Components.............. 18 9.0 Control of Special Processes.......................................................... 19 10.0 Inspection................................................................................... 20 11.0 Test Control................................................................................ 21 12.0 Control of Measuring and Test Equipment......................................... 22 13.0 Handling, Storage, and Shipping..................................................... 23 14.0 Inspection, Test, and Operating Status.............................................. 24 15.0 Nonconforming Material, Parts, or Components................................... 25 16.0 Corrective Action.......................................................................... 26 17.0 Quality Assurance Records............................................................ 27 18.0 Audits........................................................................................ 28 Appendix A General Administrative Requirements................................ 29 Appendix B Site Specific Administrative Requirements . . . .. . . . . . . .. .. . . . . .. . . . . 31 Page 1 of 31

Holtec Decommissioning International 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 (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 2 of 31

Holtec Decommissioning International DQAP

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 HDI. This is the senior executive responsible for providing strategic direction to the HDI organization Page 3 of 31

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

1.2.3. 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.

ft..uthority and obliga~on to raise any con~itions adverse to qyality 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.

1.2.4. 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. 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 4 of 31

Holtec Decommissioning International DQAP

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, 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 5 of 31

Holtec Decommissioning International DQAP 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 6 of 31

Holtec Decommissioning International DQAP

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 8, 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.

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Holtec Decommissioning International DQAP 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 8 of 31

Holtec Decommissioning International DQAP 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.

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Holtec Decommissioning International DQAP 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 10 of 31

Holtec Decommissioning International DQAP 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.

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.

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Holtec Decommissioning International DQAP 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.

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Holtec Decommissioning International DQAP 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.

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Holtec Decommissioning International DQAP 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.

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Holtec Decommissioning International DQAP 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 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.

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

Page 15 of 31

Holtec Decommissioning International DQAP 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 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.

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Holtec Decommissioning International DQAP 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.

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Holtec Decommissioning International DQAP 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.

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Holtec Decommissioning International DQAP 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.

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Holtec Decommissioning International DQAP

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, 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.

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Holtec Decommissioning International DQAP

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, equipmentrequirements), 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.

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Holtec Decommissioning International DQAP

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.

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Holtec Decommissioning International DQAP

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.

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Holtec Decommissioning International DQAP

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.

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Holtec Decommissioning International DQAP

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.

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Holtec Decommissioning International DQAP

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.

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Holtec Decommissioning International DQAP

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.

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Holtec Decommissioning International DQAP

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.

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Holtec Decommissioning International DQAP Appendix A Page 1 of 2 GENERAL ADMINISTRATIVE REQUIREMENTS A.1 Fire Protection 10 CFR 50.48(1) 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)

guid~lines. * * *

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.

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Holtec Decommissioning International DQAP 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.

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 nan-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.

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Holtec Decommissioning International DQAP Appendix B Page 1 of 1 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 (ISFSI) 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 NRC 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.

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ENCLOSURE 2 Decommissioning Quality Control Program Change Evaluation Form

HOLTEC

()[COMMISSIONING INT[llNATIONt\l.

DECOMMISSIONING QUALITY ASSURANCE PROGRAM CHANGE EVALUATION FORM, REVISION A Palisades Nuclear Power Plant and Big Rock Point-lSFSI QAPM Revision_1_

LBDCR NO: 22-016 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 ~rrors, 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, Quality Assurance Program Manual Change Evaluation NO,or N/A

1. Is this change an editorial change as defined in 10 GFR 50.54(a)(3) NO and 10 GFR 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: Many of these changes are not considered editorial.

See Attachment A for the details of the changes in each of the sections and the associated evaluation.

2. For any YES answer in the 10 GFR 50.54(a) Screening or for the QA- YES 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: The proposed revision to the Palisades Nuclear Power Plant and Big Rock Point Nuclear Plant-lSFSI (PAL-BRP) QAPM includes a number of changes that fall into two (2) different categories as follows: '

Organizational, administrative, editorial, clarifications or formatting, which do not require prior NRG approval.

Reductions in commitments to the approved QAP that were previously approved by the NRG for another decommissioning nuclear facility, with an associated Safety Evaluation Report (SER) issued by the NRG that has a similar approval basis, and thereby is applicable to PAL-BRP.

This review verified that the PAL-BRP QAPM replaced by the HDI Fleet DQAP, continues to comply with 10 GFR Part 50 Appendix B, Standard Review Plan 17.3, NUREG-0800 and 10GFR50.54(a)(3). It will also continue to satisfy the requirements of 10GFR71 Subpart H and 10GFR72 Subpart G. See Attachment A for the details of the changes in each of the sections and the associated evaluation.

Page 1 of 40

HOLTEC DECOMMISSIONING INTER Nt\T 10 NA I.

DECOMMISSIONING QUALITY ASSURANCE PROGRAM CHANGE EVALUATION FORM, REVISION A Palisades Nuclear Power Plant and Big Rock Point-lSFSI QAPM Revision..!...

LBDCR NO: 22-016

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

If YES, explain how all of the NRC approval bases from the SER are incorporated or covered by the PAL-BRP 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: The 10CFR50.54(a) evaluation concluded that all the proposed changes (organizational, administrative, editorial and clarification) can be made without prior NRC approval, based on the guidance provided within 10CFR50.54(a)(3). The five (5) changes that are considered reductions in commitments to the previously approved QAPM can be implemented without prior NRC approval for the following reasons:

The five (5) changes that are considered reductions in commitments to the currently approved PAL-BRP QAPM were previously approved by the NRC in an SER that was issued to Holtec Decommissioning International (HDI) in January 2021 providing review and acceptance of the HDI Fleet Decommissioning Quality Assurance Plan (DQAP) for Oyster Creek and Pilgrim Station based on their docketing of the cer.tifications of permanent cessation of operations and permanent

defueling under 10CFR50.82(a)(1) and entering decommissioning.

[Reference Letter to Holtec Decommissioning International (HDI), LLC from the NRC, dated January 12, 2021, (EPID L-2020-DP3-0000),

(ADAMS Accession Number ML21011A106). This approval basis corresponds to the condition at PAL-BRP. Certifications of permanent cessation of operations and permanent defueling milestones have been completed and docketed for PAL-BRP in accordance with 10CFR50.82(a)(1 ). This allows the changes to be implemented based on the SER without requiring prior NRC approval in accordance with 10CFR50.54(a)(3). The five (5) changes are as follows:

a) To be consistent with the HDI Fleet Decommissioning Quality Assurance Program (DQAP), the wording, level of detail, and format in the DQAP is different from that in the PAL-BRP QAPM Revision 1. The intent of the DQAP is to describe appropriate and sufficient requirements to establish how the DQAP meets 10CFR50 Appendix B while allowing flexibility in the manner by which a requirement is met. This reduction in implementation details provides flexibility of the implementation of the DQAP while maintaining appropriate and sufficient guidance to ensure QA program requirements are met.

Page 2 of 40

HOLTEC ll[C:OMMISSIONING INT E N 1\T ION/\l DECOMMISSIONING QUALITY ASSURANCE PROGRAM CHANGE EVALUATION FORM, REVISION A Palisades Nuclear Power Plant and Big Rock Point-lSFSI QAPM Revision.1_

LBDCR NO: 22-016 b) The detailed list of specific audits required in Section C.2.a.2 of the PAL-BRP QAPM was removed. Section 18 of the DQAP describes the audit process including frequency of audits but in less detail. Note: The audit program procedure HSP-101802, "Audits" provides the implementation details necessary to meet regulations.

c) Regulatory guides, industry standards, and exceptions to those standards that are only applicable to an operating facility will not be carried over into the DQAP.

d) The PAL-BRP Safety Review Committee in the QAPM Revision 1 fulfilled the requirement for periodic independent reviews involving the safe operation of the nuclear power plant. The Independent Safety Review section of the PAL-BRP QAPM Revision 1 was removed and is now the Safety Review Committee included in the DQAP.

e) The requirement for an Independent Safety Review (ISR) as described in QAPM Revision 1 remains; however, implementation details were removed from the DQAP ISR section. Note: The title for the ISR was changed to Safety Review Committee in the DQAP to be consistent.

See Attachment A for the details of the changes in each of the sections and the associated evaluation.

4. Is th~ proposed change a thange to a QA standard approved by the . NO NRG which is more recent than the QA standard currently established in the Program?

Basis for Answer: None of the proposed changes affect the current QA standards being applied to implement the Quality Assurance Program (QAP) requirements.

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

Basis for Answer: None of the proposed changes affect the use of generic organizational position titles. The approach to describing organizational positions and functions remain the same. See Attachment A for the details of the changes in each of the sections and the associated evaluation.

6. Is the proposed change a change involving the use of generic NO organizational charts to indicate functional relationships, authorities, and responsibilities, or alternatelv, the use of descriptive text?

Page 3 of 40

HOLTEC D[COMMISSIONING INffl!NATION,\I.

DECOMMISSIONING QUALITY ASSURANCE PROGRAM CHANGE EVALUATION FORM, REVISION A Palisades Nuclear Power Plant and Big Rock Point-lSFSI QAPM Revisionj_

LBDCR NO: 22-016 Basis for Answer: None of the proposed changes include the use of generic organizational charts to indicate functional relationships, authorities, and responsibilities. See Attachment A for the details of the changes in each of the sections and the associated evaluation.

7. Is the proposed change an elimination of Quality Assurance Program NO information that duplicates language in Quality Assurance Regulatory Guides and Quality Assurance Standards to which HDI is committed?

Basis for Answer: None of the proposed changes include the elimination of Quality Assurance Program information that duplicates language in Quality Assurance Regulatory Guides and Quality Assurance Standards. See Attachment A for the details of the changes in each of the sections and the associated evaluation.

8. Does the proposed change continue to ensure that persons and YES 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: There are no changes to the Quality Assurance functions or reporting lines.

9. Is a ch,ange to the QAPM reguired? If YES, proce~s change per the site License Base Document Change Process. If NO, distribute as

. YES indicated below.

Basis for Answer: The revision to the PAL-BRP QAPM requires an License Base Document Change to be implemented along with the development of an LBDCR.

Page 4 of 40

HOLTEC DECO,'l.l,\,\ISSIONING INTERNATIONAL

. DECOMMISSIONING QUALITY ASSURANCE PROGRAM CHANGE EVALUATION FORM, REVISION A Palisades Nuclear Power Plant and Big Rock Point-lSFSI QAPM Revisionj_

LBDCR NO: 22-016 QAPM CHANGE REVIEW RESULTS

[] 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)

[] 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)

[X] 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.

~~--~-~~-~-----------

N/A (same as above) / N/A Manager, QA / QA Supervisor Date Page 5 of 40

HOLTEC IJ[C:0/1.1,\,\ISSIONINC INTEl!NATIONAL DECOMMISSIONING QUALITY ASSURANCE PROGRAM CHANGE EVALUATION FORM, REVISION A Palisades Nuclear Power Plant and Big Rock Point-lSFSI QAPM Revision.L.

LBDCR NO: 22-016 QA Site Supervisor Review:

Applicable Site QA Supervisor Reviews Required IZ!No (see attached sheets for documentation of reviews)

I Palisades Nuclear Power Plant and Big Rock Point Nuclear Plant -ISFSI I Site Review Due Date: NIA Site Review Input:

Record references below. If there are none state None.

Palisades Nuclear Power Plant and Big Rock Point Nuclear Plant-lSFSI: NIA Site QA Supervisor acknowledges completion of reviews below Palisades Nuclear Power Plant and Big Rock Point Nuclear Plant-lSFSI D Site QA Supervisor acknowledgement (print & sign) /date NIA I Site QA Supervisor I Date Page 6 of 40

HOLTEC l)[C:OMI\IISSIONING 11'.TERN,\l IONAL DECOMMISSIONING QUALITY ASSURANCE PROGRAM CHANGE EVALUATION FORM, REVISION A Palisades Nuclear Power Plant and Big Rock Point-lSFSI QAPM Revisioni._

LBDCR NO: 22-016 QA Site Supervisor Review:

Applicable Site QA Supervisor Reviews Required ~No (see attached sheets for documentation of reviews)

Indian Point Oyster Creek Pilgrim Station Site Review Due Date: -""""N-"'/.:...;A:____ _ _ __

Site Review Input:

Record references below. If there are none state None.

IIndian Point Energy Center: N/A Site Regulatory Manager acknowledges completion of reviews below Indian Point D IOystsr Creek: N/A Site Regulatory Manager acknowledges completion of reviews below Oyster Creek D IPilgrim Station: N/A Site Regulatory Manager acknowledges completion of reviews below Pilgrim Station D QA Manager acknowledgement (print & sign) /date David J. Burke I 8-2-2022 Quality Assurance Date Page 7 of 40

HOLTEC DCCO.\IMISSIONING IN Tf. RN,\ T 10 N,\ L DECOMMISSIONING QUALITY ASSURANCE PROGRAM CHANGE EVALUATION FORM, REVISION A Palisades Nuclear Power Plant and Big Rock Point-lSFSI QAPM Revision.!_

LBDCR NO: 22-016 Change Disposition

[8] Approved for implementation D Disapproved D Approved for submittal to the NRC Approved b y / D a t e : - - - - - - - - - - - - - - - - - ~ ' - - - - - - -

Jean Fleming - CED VP of Licensing, Date Regulatory Affairs, and PSA Distribution: Original - Attach to Parent Document, Copy - Quality Assurance Page 8 of 40

Attachment A QAPM Change Request LIC 22-016-10CFR50.54(a) Evaluation, Revision A Purpose The purpose of this 10CFR50.54(a) Evaluation is to assess the changes being implemented, associated with preparing the PAL-BRP Quality Assurance Program Manual (QAPM) to be incorporated into the Holtec Decommissioning International (HDI)

Fleet Decommissioning Quality Assurance Program (DQAP). Revision 1 of the PAL-BRP QAPM was recently revised by the former licensee, prior to the transition to the HDI fleet DQAP (DQAP). This 50.54(a) evaluation is performed for the purposes of explaining the changes from the PAL-BRP QAPM Revision 1 (QAPM) to the DQAP does not require prior NRG approval pursuant to the requirements of 10CFR50.54(a)(3).

Discussion The QAPM Revision 1 was issued on June 15, 2022. The changes in the QAPM contained no changes in commitments and, therefore, did not require prior NRG approval.

The primary focus of the change is to transition the QAPM to the DQAP. This change removes the requirement for the Safety Review Committee (SRC). The wording, level of detail, and format in the DQAP is different from that in the QAPM. The intent of the DQAP is to describe appropriate and sufficient requirements to establish how the DQAP meets 10CFR50 Appendix B while allowing flexibility in the manner by which a requirement is met. This reduction in implementation details provides flexibility of the implementation of the DQAP while maintaining appropriate and sufficient guidance to ensure QA program requirements are met. In addition, Regulatory guides, industry standards, and exceptions to those standards that are only applicable to an operating facility are not addressed in the DQAP.

The evaluation of each of the changes and the conclusions are presented in the attached table on a section-by-section basis. Revision 2 of the DQAP is provided as Attachment A to this 10CFR50.54(a) Evaluation.

Conclusion The 10CFR50.54(a) evaluation concluded that all of the proposed changes (organizational, administrative, editorial and clarification) can be made without prior NRC approval, based on the guidance provided within 10CFR50.54(a)(3). There are five (5) changes that are considered reductions in commitments to the previously approved QAPM that can be implemented without prior NRG approval for the following reasons:

The five (5) changes that are considered reductions in commitments to the currently approved QAPM were previously approved by the NRC in an SER that was issued to Holtec Decommissioning International (HDI) in January 2021 providing review and acceptance of the HDI Fleet Decommissioning Quality Assurance Plan (DQAP) for Oyster Creek and Pilgrim Station based on their docketing of the certifications of permanent cessation of operations and permanent defueling under 10CFR50.82(a)(1) and entering decommissioning. [Reference Letter to Holtec Decommissioning International (HDI), LLC from the NRC, dated January 12, 2021, (EPID L-2020-DP3-0000), (ADAMS Accession Number ML21011A106). This approval basis corresponds to the condition at PAL-BRP. Certifications of permanent cessation of operations and permanent defueling milestones have been completed and docketed for PAL-BRP in accordance with 10CFR50.82(a)(1). This allows the changes to be implemented based on the SER without requiring prior NRG approval in accordance with 10CFR50.54(a)(3).

Page 9 of 40

Attachment A QAPM Change Request LIC 22-016-10CFR50.54(a) Evaluation, Revision A The following are the five (5) proposed changes that are considered reductions in commitments to the previously approved QAPM that can be implemented without requiring prior NRC approval for the following reasons:

a) To be consistent the wording, level of detail, and format in the DQAP is different from that in the QAPM. The intent of the DQAP is to describe appropriate and sufficient requirements to establish how the DQAP meets 10CFRS0 Appendix B while allowing flexibility in the manner by which a requirement is met. This reduction in implementation details provides flexibility of the implementation of the DQAP while maintaining appropriate and sufficient guidance to ensure QA program requirements are met.

b) The detailed list of specific audits required in Section C.2.a.2 of the QAPM was removed. Section 18 of the DQAP describes the audit process including frequency of audits but in less detail. Note: The audit program procedure HSP-101802, "Audits", provides the implementation details necessary to meet regulations.

c) Regulatory guides, industry standards, and exceptions to those standards that are only applicable to an operating facility will not be carried over into the DQAP.

d) The PAL-BRP Safety Review Committee in the QAPM fulfilled the requirement for periodic independent reviews involving the safe operation of the nuclear power plant. The Safety Review Committee (SRC) section of the QAPM was removed and is not included in the DQAP.

e) The requirement for an Independent Safety Review (ISR) as described in QAPM remains; however, implementation details were removed from the DQAP ISR section. Note: The title for the ISR was changed to Safety Review Committee in the DQAP.

This revision to the QAPM can be implemented without prior NRC approval in accordance with 10CFR50.54(a)(3). The specific discussion for each of the proposed

-changes for each of ti-le sections and the associated evaluation is- included in the attached table.

Page 10 of 40

Attachment A Table ~f Changes and the Associated Evaluation QAPM Change Request LIC 22-016 -10CFR50.54(a) Evaluation, Revision A QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A Cover Page The title was changed replacing "Entergy Quality Assuram;e These changes to the Cover Page and other editorial No Program Manual Palisades Nuclear Power Plant and Big changes are minor administrative changes, which are Rock Point Nuclear Plant-lSFSI (PAL-BRP)" with "Holtec considered editorial and do not constitute a reduction in Decommissioning International Decommissioning Quality commitments to the previously approved QAPM. These Assurance Program (DQAP)". changes can be implemented without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

Several editorial changes were made throughout the document. Some examples include: The terms "site" and "plant" are replaced with the term "decommissioning facility".

The term "supplier" was replaced with the term "vendor".

The QAPM incorporates the term "items" to encompass:

materials, parts, and components, including partially fabricated assemblies and consumables.

Policy Statement Changes were made to the Policy Statement modifying the These Policy Statement changes are minor administrative No language to that contained in the DQAP Policy Statement. changes, which are considered editorial and do not In addition, reference to Entergy Nuclear Operations, inc.

constitute a reduction in commitments to the previously (ENOI) was removed and replaced with Holtec approved QAPM. HDI is the licensee for PAL-BRP.

Decommissioning International (HDI). Discussion of Moving the discussion of applicability to safety-related and applicability to safety-related and important-to-safety important-to-safety SSCs and discussion of CNO (Holtec structures, systems, and components was moved from the equivalent) responsibilities to the Organization section of Policy Statement to Section 2. 1 of the DQAP. Discussion of the DQAP are editorial changes associated with the the Chief Nuclear Officer (CNO) was moved to DQAP document format. These changes can be implemented Section 1.1.3 and 1.2.1. Additionally, the title/designation of without prior NRC approval, based on the guidance CNO is not utilized in the Holtec/HDI business model. The provided in 10CFR50.54(a)(3).

position of Holtec International Senior Vice President of Business Development has the same duties and responsibilities as an "industry" CNO.

Page 11 of 40

QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A Table of Contents The table of contents for the HDI Decommissioning Quality The QAPM format was changed to mirror the DQAP. As a No Assurance Program (DQAP) was developed in a fleet result, the Table of Contents required a complete re-write.

aligned format and differs in many respects from the

Mapping from QAPM to the new DQAP is provided in the previous PAL-BRP Quality Assurance Program Manual left column. Changes to the Table of Contents are (QAPM) table of contents. considered editorial and do not constitute a reduction in commitments to the previously approved QAPM. These Below is a summary of the items from QAPM Revision 1 changes can be implemented without prior NRG approval, Table of Contents mapped to the Fleet DQAP (Revision 3) based on the guidance provided in 10CFR50.54(a)(3).

Section equivalent in the revised Table of Contents.

Evaluations for the changes in each section are addressed PAL-BRP QAPM R1 Fleet DQAP (R3) separately.

Section A Policy Statement

1. Methodology Section

2. Organization 1.0 Organization

3. Responsibility 2.0 Quality Assurance Program

4. Authority 3.0 Design Control

5. Personnel Training and Qual. 4.0 Procurement Document Control

6. Corrective Action 5.0 Instructions, Procedures, and Drawings

7. Regulatory Commitments 6.0 Document Control 7.0 Control of Purchased Material, Equipment, &

Services Section B 8.0 Identification and PerformanceNerification Control of Materials,

1. Methodology Parts, and Componel)ts

2. Design Control 9.0 Control of Special

3. Design Verification Processes

4. Procurement Control 10.0 Inspection

5. Procurement Verification 11.0 Test Control Page 12 of 40

QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A

6. Identification and Control of 12. 0 Control of Measuring Items and Teat Equipment

7. Handling, Storage, and 13.0 Handling, Storage, Shipping and Shipping

8. Test Control 14.0 Inspection, Test, and

9. Measuring and Test Operating Status Equipment 15.0 Nonconforming

10. Inspection, Test, and 16.0 Corrective Action Operating Status 17.0 QA Records

11. Special Process Control 18.0 Audits

12. Inspection

13. Corrective Action

14. Document Control .

15. Records Section C.

Audit

1. Methodology

2. Performance Section D. .

Independent Safety Review Table 1 Appendix A - General Regulatory Commitments Admin Requirements Appendix B - Site Specific Admin Requirements Section A - Management Page 13 of 40

QAPM/ Change(s) Evaluation and Justification PriorNRC DQAP Approval Section Yes, No or N/A A.1/1.0, There is no specific Management section in the These changes are considered editorial and administrative No 2.0, 16.0 DQAP titled Management. The associated improvements. These changes can be implemented information and direction discussed in the without prior NRC approval, based on the guidance Management section of the QAPM is included in provided in 10CFR50.54(a)(3).

Sections 1.0, 2.0, 16.0 of the DQAP.

a. The wording and format changes associated with the There are four paragraphs in QAPM Section A.1, function of the QAPM are considered editorial and do not Methodology. constitute a reduction in commitments to the previously approved QAPM.

a. The first paragraph states the function of the QAPM . This information is included in b. Though the wording in the DQAP is less specific, the DQAP Policy Statement and more responsibilities for requirements and commitments are specifically discussed in Sections 2.1 . delineated in Section 2 of the DQAP. These wording and through 2.3. format changes are considered editorial and do not constitute a reduction in commitments to the previously

b. The second paragraph in Section A.1 states approved QAPM.

in part: " ... requirements and commitment contained in the QAPM are mandatory and c. The information from A.1.c of the QAPM is included in must be implemented, enforced, and Section 2.2 of the DQAP. The wording and format changes adhered to by all individuals and associated with QAPM applicability are considered editorial organizations." Wording adopted in the and do not constitute a reduction in commitments to the DQAP is less specific; Section 2.2 states:

previously approved QAPM.

"Each organization is responsible for the

d. This editorial change does not constitute a reduction in establishment and implementation of commitments and can be implemented without prior NRC procedures and instructions prescribing the approval, based on the guidance provided in activities within the scope of this DQAP for 10CFR50.54(a)(3).

which they are responsible."

C. This paragraph specifies QAPM applicability: "The QAPM implements 10 CFR 50 Appendix B, 10 CFR 71 Subpart l;I, and 10 CFR 72 Subpart G. Applicability to regulations is in Section 2.2 of the DQAP.

d. This paragraph states the QAPM is implemented through the use of approved procedures. Section 2.2 of the DQAP Page 14 of 40

QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A states: "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." Note: Specific wording using the term approved procedures is included in DQAP Sections 3 (Design Control), 7, 10, 11, 12, 14, and 18.

A.2/1 Organization: This section is now Section 1 of the These changes to the organizational structure and No DQAP. Several changes were made with the responsibilities do not impact the ultimate QA reporting Organization section to mirror the DQAP and

relationship with the HDI President and the Holtec reflect the HDI organization. There is no overall President and CEO. Requisite authority and organizational change to the QA reporting function, which independence are maintained including sufficient continues to report through a site executive up to independence from cost and schedule. The quality the Holtec International Senior Vice President of assurance function continues to report up through the Business Development (Holtec's chief nuclear Holtec International Senior Vice President of Business officer). Development. These changes can be implemented without prior NRC approval, based on the guidance provided in

. 10CFRS0.54(a)(3) .

These changes are consistent with the reduced risk of a permanently shut down facility and commitments previously approved by the NRC in which the basis for HDI Fleet DQAP was requested and approved.

[Reference Letter to Holtec Decommissioning International (HDI), LLC from the NRC, dated January 12, 2021, providing review and acceptance of the HDI

. Fleet Decommissioning Quality Assurance Program (DQAP) (EPID L-2020-DP3-0000), (ADAMS Accession Number ML21011A106) and NRC email of the Indian Point Unit Nos. 1, 2 and 3 - NRC Assessment of HDI Fleet Decommissioning Quality Assurance Program and IPEC Quality Assurance Program Manual [EPID L-2021-LLQ-0000] (ADAMS Accession Number ML21197A200). The SER of the HDI Fleet DQAP Rev Page 15 of 40

QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A A permits changes to be implemented without prior

. NRC approval if the changes evaluated under 50.54(a) do not reduce commitments to the approved HDI Fleet DQAP Rev A. Certifications of permanent cessation of operations and permanent defueling milestones have been completed and docketed for PAL and BRP in accordance with 10CFR50.82(a)(1) (ADAMS Accession Number ML22164A067 and ML20141C247 respectfully).

These changes do not reduce the effectiveness of the

. QAPM and continues to ensure compliance with 10 CFR 50, Appendix B and the SAR quality assurance program description commitments previously accepted by the NRC. These changes can be implemented without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

A.3& 4/ The A.3 Responsibility and A.4 Authority sections The changes to the Responsibility and Authority sections of No 1.1, of the QAPM were revised to mirror the DQAP. the QAPM are administrative and do not impact ultimate 1.1.1, QAPM Section A.3 was moved to DQAP Sectio.n responsibility or authority. The reporting relationship with 2.5 1.1. The two paragraphs in QAPM Section A.4 the HDI President and/or the Holtec President and CEO is are now covered in DQAP Section 1.1.1 and not impacted. Requisite authority and organizational Section 2.5. independence are maintained including sufficient independence from cost and schedule. The quality assurance function continues to report up through the HDI President and/or the Holtec President and CEO. These changes can be implemented without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

A.5/2.7 QAPM Section A.5 Personnel Training and Wording and formatting changes are administrative so No Qualification was moved to DQAP Section 2.7. there are no reductions in commitments to the previously Format and wording were revised to mirror the approved QAPM. These changes can be implemented DQAP. Paragraph d. "Additional details without prior NRC approval, based on the guidance concerning Personnel Training and Qualification provided in 10CFR50.54(a)(3).

may be found in the Regulatory Guides and Deleting paragraph d. was required since commitments to associated Standards as committed to in Section the Regulatory Guides listed in the paragraph were A.7 and Aooendix B (e.g., Regulatory Guides 1.8, Page 16 of 40

QAPM/ Change(s) Evaluation and Justification PriorNRC DQAP Approval Section _,

Yes, No or NIA 1.58, and 1.146)" was deleted. Commitments t~ removed from the QAPM Appendix 8. Evaluation for these Regulatory Guides were removed from changes to Appendix 8 is documented later in this Appendix 8. Evaluation for changes to Appendix evaluation (page 29).

B is documented later in this document.

A.6/16 QAPM Section A.6, Corrective Action, Though the revised Corrective Action section in the DQAP No information was revised and moved to DQAP is more succinct than previous wording in the QAPM, Section 16. The wording was revised to mirror program effectiveness is not impacted. The wording and the DQAP. format changes are considered editorial and do not constitute a reduction in commitments to the previously Paragraph f. "Additional details concerning corrective action activities may be found in the

. approved QAPM. Requirements for non-conforming items are now in Section 3.11 of the DQAP. These changes can Regulatory Guides and associated Standards as be implemented without prior NRC approval, based on the committed to in Section A.7 and Appendix B guidance provided in 10CFR50.54(a)(3).

(e.g., Regulatory Guide 1.8)" was deleted.

Commitments to these Regulatory Guides were Deleting paragraph f. was required since commitments to removed from QAPM Appendix 8. the Regulatory Guides listed in the paragraph were removed from the QAPM Appendix 8. Evaluation for

. changes to Appendix B is documented later in this evaluation (page 29) .

A.7/2.4 QAPM Section A. 7, Regulatory Commitments, The DQAP now delineates the Regulatory Commitments. No was moved to DQAP. The QAPM clarifications to all guidance documents and reference to Appendix B were removed since commitments to the Regulatory Guides listed in the paragraph were removed from the QAPM Appendix B. Evaluation for changes to Appendix 8 is documented later in this

. evaluation (page 29). Paragraph b. regarding NRC notification was removed. Section 2.4 of the DQAP cites requirement for changes to the DQAP to be implemented in accordance with 10CFR54(a) which delineates required NRC notification and approvals for changes to the DQAP.

This is considered administrative and does not constitute a reduction in commitment to the previously approved QAPM.

Page 17 of 40

QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or NIA Section B - PerformanceNerification B.1/ The QAPM is being revised to mirror the DQAP. a: Personnel performing work activities ... are responsible No 1.1.2 Formatting of the QAPM has changed. There is for achieving acceptable quality." Though worded no longer a Section B. The DQAP contains a differently to be consistent with the DQAP, the separate section for each of the 10 CFR 50 responsibility for all personnel to achieve quality in their Appendix B criteria. As a result, B.1 work is covered in Section 1.1.2 of the DQAP.

Methodology section is deleted. The DQAP does

b. This paragraph was deleted; DQAP Section 10 covers not have a Methodology section. However, the the requirements for inspections and inspection personnel requirements and aspects in the QAPM including: "Inspections shall be performed by qualified methodology section are contained in multiple individuals other than those who perform or directly sections of the DQAP.

supervise the activity being inspected." (Section -10.2)

c. This paragraph was deleted; Section 5.0 of the DQAP now contains the requirements for Instructions, Procedures, and Drawings.

d. This paragraph was deleted; DQAP Section 2.1 covers the requirements for acceptance criteria: "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 methodology section was deleted; however, the requirements that were in the methodology section are covered in other sections of the DQAP. These changes are considered editorial and administrative and are not a reduction in commitment. These changes can be implemented without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

B.2, B.3/ The Design Control and Design Verification B.2 No 3 sections of the QAPM were revised to be

a. - h. To be consistent with the DQAP, the specific consistent with the DQAP. The information from wording in the DQAP is different from that in the QAPM; these sections is now located in Section 3 of the however, the intent of this paragraph is met in the DQAP Page 18 of 40

QAPM/ Change(s) Evaluation and Justification PriorNRC DQAP Approval Section Yes, No or N/A DQAP. under Section 3.0.

The statements in Section B.2.i and Section With the exception noted below, these changes are B.3.g where deleted. This was required since considered editorial and administrative and do not commitments to the Regulatory Guides listed in constitute a reduction in commitment to the previously the paragraph were removed from the QAPM. approved QAPM. The changes can be implemented without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

Additional details concerning design control activities may be found in the Regulatory Guides and associated

),

Standards as committed to in Section A. 7 and Appendix B (e.g., Regulatory Guide 1.64)." This paragraph was deleted and is not in the DQAP. Deleting paragraph i. was required since commitments to the Regulatory Guides listed in the paragraph were removed from the QAPM Appendix B.

Evaluation for changes to Appendix B is documented later in this evaluation (page 29).

8.3

a. -f. To be consistent with the DQAP, the specific wording in the DQAP is different from that in the QAPM; however, the intent of this paragraph is met in the DQAP under Sections 3.9 and 3.10. With one exception, section e. of the QAPM items 2. and 3. regarding supervisors performing design verifications are not specifically stated in the DQAP.

The DQAP does provide direction describing requirements for when the supervisor can perform the verification.

Documenting approval in advance by the supervisor's management and independent verification of the frequency and effectiveness of the supervisor's use as a design verifier are not included in the DQAP. This is not considered a reduction in commitment; the DQAP clearly states the conditions under which a supervisor may perform a design verification.

Page 19 of 40

QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A With the exception noted below, these changes are considered editorial and administrative and do not constitute a reduction in commitment to the previously approved QAPM. The changes can be implemented without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

g. "Additional details concerning design verification activities may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Appendix B (e.g., Regulatory Guide 1.64)."

This paragraph was deleted and is not in the DQAP.

Deleting paragraph g. was required since commitments to the Regulatory Guides listed in the paragraph were removed from the QAPM Appendix B. Evaluation for changes to Appendix B is documented later in this evaluation (page 29).

8.4, B.5/ The Procurement Control and Procurement To be consistent with the DQAP, the specific wording in the No 4, 7 Verification section of the QAPM were revised to DQAP is different from that in the QAPM; however, the be consistent with the DQAP. The information intent of these two sections is met in the DQAP under from these sections is now located in Sections 4, Section 4.0, Procurement Document Control, and Section Procurement Document Control, and Section 7, and 7.0, Control of Purchased Material, Equipment and Control of Purchased Material, Equipment and Services.

Services, of the DQAP.

With the exception noted below, these changes are The statements in Section B.4.j and Section considered editorial and administrative and do not 8.5.c where deleted. This was required since constitlife a reduction in commitment to the previously commitments to the Regulatory Guides listed in approved QAPM. The changes can be implemented the paragraph were removed from the QAPM without prior NRC approval, based on the guidance Appendix B. provided in 10CFR50.54(a)(3).

The statements in Section 8.4.j and Section 8.5.c where deleted. This was required since commitments to the Regulatorv Guides listed in the paragraph were removed Page 20 of 40

QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A from the QAPM Appendix B. Evaluation for changes to Appendix B is documented later in this evaluation (page 29).

B.6/8 The Identification and Control of Items section of To be consistent with the DQAP, the specific wording in the No the QAPM was revised to be consistent with the DQAP is different from that in the QAPM; however, the DQAP. The information from this section is now intent of this section is met in the DQAP under Section 8.0, located in Section 8, Identification and Control of Identification and Control of Materials, Parts, and Materials, Parts, and Components, of the DQAP. Components.

The statement in Section B.6.c was deleted. This With the exception noted below, these changes are was required since commitments to the considered editorial and administrative and do not Regulatory Guides listed in the paragraph were constitute a reduction in commitment to the previously removed from the QAPM Appendix B. approved QAPM. The changes can be implemented without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

The statement in Section B.6.c was deleted. This was required since commitments to the Regulatory Guides listed in the paragraph were removed from the QAPM Appendix B. Evaluation for changes to Appendix B is documented later in this evaluation (page 29).

B.7/13 The Handling, Storage, and Shipping section of To be consistent with the DQAP, the specific wording in the No the QAPM was revised to be consistent with the DQAP is different from that in the QAPM; however, the DQAP. The information from this section is now intent of this section is met in the DQAP under Section 13, located in Section 13, Handling, Storage, and Handling, Storage, and Shipping.

Shipping, of the DQAP.

With the exception noted below, these changes are The statement in Section B.7.e was deleted. This considered editorial and administrative and do not was required since commitments to the constitute a reduction in commitment to the previously Regulatory Guides listed in the paragraph were approved QAPM . .The changes can be implemented removed from the QAPM Appendix B. without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

Page 21 of 40

QAPM/ Change(s} Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or NIA The statement in Section B. 7 .e was deleted. This was required since commitments to the Regulatory Guides listed in the paragraph were removed from the QAPM Appendix B. Evaluation for changes to Appendix B is documented later in this evaluation (page 29).

B.8/11 The Test Control section of the QAPM was To be consistent with the DQAP, the specific wording in the No revised to be consistent with the DQAP. The DQAP is different from that in the QAPM; however, the information from this section is now located in intent of this section is met in the DQAP under Section 11.

Section 11, Test Control, of the DQAP. Splitting Section 11.2 into three separate sections is an editorial change. This change does not constitute a The statement in Section B.8.g was deleted. This reduction in commitments. With the exception noted below, was required since commitments to the these changes are considered editorial and administrative Regulatory Guides listed in the paragraph were and do not constitute a reduction in commitment to the removed from the QAPM Appendix B.

previously approved QAPM. The changes can be implemented without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

The statement in Section B.8.g was deleted. This was required since commitments to the Regulatory Guides listed in the paragraph were removed from the QAPM Appendix B. Evaluation for changes to Appendix B is documented later in this evaluation (page 29).

B.9/12 The Measuring and Test Equipment Control To be consistent with the DQAP, the specific wording in the No section of the QAPM was revised to be DQAP is different from that in the QAPM; however, the consistent with the DQAP. The information from intent of this section is met in the DQAP under Section 12, this section is now located in Section 12, Control Control of Measuring and Test Equipment.

of Measuring and Test Equipment.

With the exception noted below, these changes are The statement in Section B.9.h was deleted. This considered editorial and administrative and do not was required since commitments to the constitute a reduction in commitment to the previously Regulatory Guides listed in the paragraph were approved QAPM. The changes can be implemented removed from the QAPM Appendix B. without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

The statement in Section B.9.h was deleted. This was Page 22 of 40

QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A required since commitments to the Regulatory Guides listed in the paragraph were removed from the QAPM Appendix B. Evaluation for changes to Appendix B is documented later in this evaluation (page 29).

8.10/14 The Inspection, Test, and Operating Status To be consistent with the DQAP, the specific wording in the No section of the QAPM was revised to be DQAP is different from that in the QAPM; however, the consistent with the DQAP. The information from intent of this section is met in the DQAP under Section 14, this section is now located in Section 14, Inspection, Test, and Operating Status.

Inspection, Test, and Operating Status, of the With_ the exception noted below, these changes are DQAP.

considered editorial and administrative and do not The statement in Section 8.1 0.c was deleted. constitute a reduction in commitment to the previously This was required since commitments to the approved QAPM. The changes can be implemented Regulatory Guides listed in the paragraph were without prior NRG approval, based on the guidance removed from the QAPM Appendix B. provided in 10CFR50.54(a)(3).

The statement in Section 8.1 0.c was deleted. This was required since commitments to the Regulatory Guides listed in the paragraph were removed from the QAPM Appendix B. Evaluation for changes to Appendix B is documented later in this evaluation (page 29).

8.11/9 The Special Process Control section of the To be consistent with the DQAP, the specific wording in the No QAPM was revised to be consistent with the DQAP is different from that in the QAPM; however, the DQAP. The information from this section is now intent of this section is met in the DQAP under Section 9, located in Section 9, Control of Special Control of Special Processes.

Processes, of the DQAP.

With the exception noted below, these changes are The statement in Section B.11.d was deleted. considered editorial and administrative and do not This was required since commitments to the constitute a reduction in commitment to the previously Regulatory Guides listed in the paragraph were approved QAPM. The changes can be implemented removed from the QAPM Appendix B. without prior NRG approval, based on the guidance provided in 10CFR50.54(a)(3).

The ~tatement in Section B.11.d was deleted. This was required since commitments to the Regulatory Guides listed in the paraoraph were removed from the QAPM Page 23 of 40

QAPM/ Change{s) Evaluation and Justification PriorNRC DQAP Approval Section Yes, No or N/A Appendix B. Evaluation for changes to Appendix B is documented later in this evaluation (page 29).

B.12/10 The Inspection section of the QAPM was revised To be consistent with the DQAP, the specific wording in the No to be consistent with the DQAP. The information DQAP is different from that in the QAPM; however, the from this section is now located in Section 10, intent of this section is met in the DQAP under Section 10, Inspection, of the DQAP. Inspection.

The statement in Section 8.12.g was deleted. With the exception noted below, these changes are This was required since commitments to the considered editorial and administrative and do not Regulatory Guides listed in the paragraph were constitute a reduction in commitment to the previously removed from the QAPM Appendix B. approved QAPM. The changes can be implemented without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

The statement in Section B.12.g was deleted. This was required since commitments to the Regulatory Guides listed in the paragraph were removed from the QAPM Appendix B. Evaluation for changes to Appendix B is documented later in this evaluation (page 29).

B.13/16 The Corrective Action section of the QAPM was To be consistent with the DQAP, the specific wording in the No revised to be consistent with the DQAP. The DQAP is different from that in the QAPM; however, the information from this section is now located in intent of this section is met in the DQAP under Section 16, Section 16, Corrective Action, of the DQAP. Corrective Action, and (applicable to Section 8.13.b.) in Section 10.6.

The statement in Section 8.13.c was deleted.

This was required since commitments to the With the exception noted below, these changes are Regulatory Guides listed in the paragraph were considered editorial and administrative and do not removed from the QAPM Appendix B. constitute a reduction in commitment to the previously approved QAPM. The changes can be implemented without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

The statement in Section B.13.c was deleted. This was required since commitments to the Regulatory Guides listed in the paragraph were removed from the QAPM Appendix B. Evaluation for chanoes to Aooendix 8 is Page 24 of 40

QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A documented later in this evaluation (page 28).

8.14/6 The Document Control section of the QAPM was To be consistent with the DQAP, the specific wording in the No revised to be consistent with the DQAP. The DQAP is different from that in the QAPM. The intent of this information from this section is now located in section is met in the DQAP under Section 6, Document Section 6, Document Control, of the DQAP. Control. Section 8.14.b contained a partial list of scope of Section B.14.b regarding document control the document control program. New Section 6.1 in the program scope was not included in the DQAP. DQAP covers the intent in identifying scope and states:

"Written procedures shall define the type of documents to The statement in Section 8.14.f was deleted.

which the document control system applies."

This was required since commitments to the Regulatory Guides listed in the paragraph were With the exception noted below, these changes are removed from the QAPM Appendix 8. considered editorial and administrative and do not constitute a reduction in commitment to the previously approved QAPM. The changes can be implemented without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

The statement in Section 8.14.f was deleted. This was required since commitments to the Regulatory Guides listed in the paragraph were removed from the QAPM Appendix 8. Evaluation for changes to Appendix B is docum~nted later in this evaluation (page 29).

8.15/17 The Records section of the QAPM was revised to To be consistent with the DQAP, the specific wording in the No be consistent with the DQAP. The information DQAP is different from that in the QAPM. The intent of this from this section is now located in Section 17, section is met in the DQAP under Section 17, Quality Quality Assurance Records, and in Appendix E Assurance Records and Appendix E section E.3.2.

section E.4 of the DQAP.

With the exception noted below, these changes are The statement in Section B.15.d was deleted. considered editorial and administrative and do not This was required since commitments to the constitute a reduction in commitment to the previously Regulatory Guides listed in the paragraph were approved QAPM. The changes can be implemented removed from the QAPM Appendix B. without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

The statement in Section B.15.d was deleted. This was reauired since commitments to the Regulatory Guides Page 25 of 40

QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A listed in the paragraph were removed from the QAPM Appendix 8. Evaluation for changes to Appendix B is documented later in this evaluation (page 29).

Section C - Audit A complete rewrite of the Audits section of the QAPM was The methodology section was deleted; however, the No performed to be consistent with the implementation of a fleet requirements that were in the methodology section are DQAP. The information from this section is now located in covered in other sections of the DQAP. These changes are Section 18, Audits, of the DQAP. The level of detail in the considered editorial and administrative and do not QAPM is unnecessary to satisfy 10 CFR 50 Appendix B and constitute a reduction in commitment. These changes can the information can be captured in implementing be implemented without prior NRC approval, based on the procedures. guidance provided in 10CFR50.54(a)(3).

C.1 Methodology section was deleted.

To be consistent with the DQAP, the wording, level of The statement in Section C.2.i. was deleted. This was detail, and format in the DQAP is different from that in the required since commitments to the Regulatory Guides listed QAPM. The QAPM Audits section is now in the DQAP in the paragraph were removed from the QAPM Appendix B. under Section 18, Audits. The intent of the DQAP is to describe appropriate and sufficient requirements to establish how the DQAP meets 10CFR50 Appendix B while allowing flexibility in the manner by which a requirement is met. This reduction in implementation details provides flexibility of the implementation of the DQAP while maintaining appropriate and sufficient guidance to ensure QA program requirements are met.

The list of specific audits required in Section C.2.a.2 of the QAPM was removed. This section included a detailed list of each functional area audited. Section 18 of the DQAP describes the audit process including frequency of audits but in less detail. The audit program procedure HSP-101802, "Audits" provides the necessary implementation details to meet regulations.

This reduction in implementation details provides flexibility Page 26 of 40

QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A of the implementation of the DQAP while maintaining appropriate and sufficient guidance to ensure QA program requirements are met.

The reduction in details, including removal of the list of specific audits required, are considered reductions in commitments to the previously approved QAPM; they do not reduce the overall effectiveness of the QAPM. These changes are consistent with the reduced risk of a permanently shut down facility and commitments previously appr'bved by the NRC in which the basis for HDI Fleet DQAP was requested and approved. [Reference Letter to Holtec Decommissioning International (HDI), LLC from the NRC, dated January 12, 2021, providing review and acceptance of the HDI Fleet Decommissioning Quality Assurance Program (DQAP) (EPID L-2020-DP3-0000),

(ADAMS Accession Number ML21011A106) and NRC email of the Indian Point Unit Nos. 1, 2 and 3 - NRC Assessment of HDI Fleet Decommissioning Quality Assurance Program and IPEC Quality Assurance Program Manual [EPID L-2021-LLQ-0000] (ADAMS Accession Number ML21197A200). The SER of the HDI Fleet DQAP Rev A permits changes to be implemented without prior NRC approval if the changes evaluated under 50.54(a) do not reduce commitments to the approved HDI Fleet DQAP Rev A. Certifications of permanent cessation of operations and permanent defueling milestones have been completed and docketed for PAL and BRP in accordance with 10CFR50.82(a)(1) (ADAMS Accession Number ML22164A067 and ML20141C247 respectfully). These changes do not reduce the effectiveness of the QAPM and continues to ensure compliance with 10 CFR 50, Appendix B and the SAR quality assurance program description commitments previously accepted by the NRC. These chanoes can be implemented without orior NRC aonroval, Page 27 of 40

QAPM/ Change(s) Evaluation and Justification PriorNRC DQAP Approval Section Yes, No or N/A based on the guidance provided in 10CFR50.54(a)(3).

The statement in Section 2.i was deleted. This was required since commitments to the Regulatory Guides listed in*the paragraph were removed from the QAPM Appendix B. Evaluation for changes to Appendix B is documented later in this evaluation.

Section D - Independent Safety Review Function Section D - Independent Safety Review Function was To be consistent with the DQAP, Section D of the QAPM is No revised to be consistent with the DQAP. The title was now in Appendix A Section A.5 of the DQAP, the title was changed to Safety Review Committee (SRC) and changed to Safety Review Committee, and the specific information from this section is now located in Appendix A, wording in the DQAP is different from that in the QAPM.

General Administrative Requirements, Section A.5 in the Also, implementation details were removed from this DQAP. section. Implementation details for the SRC are formalized in EN-OM-119 (currently titled On-Site Safety Review Committee).

This reduction in implementation details provides flexibility of the implementation of the DQAP while maintaining appropriate and sufficient guidance to ensure QA program requirements are met.

This reduction in details is considered a reduction in commitments to the previously approved QAPM; this does not reduce the overall effectiveness of the QAPM . These changes are consistent with the reduced risk of a perman_ently shut down facility and commitments previously approved by the NRC in which the basis for HDI Fleet DQAP was requested and approved. [Reference Letter to Holtec Decommissioning International (HDI), LLC from the NRC, dated January 12, 2021, providing review and acceptance of the HDI Fleet Decommissioning Quality Assurance Program (DQAP) (EPID L-2020-DP3-0000),

(ADAMS Accession Number ML21011A106) and NRC email of the Indian Point Unit Nos. 1, 2 and 3 - NRC Page 28 of 40

QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A Assessment of HDI Fleet Decommissioning Quality Assurance Program and IPEC Quality Assurance Program Manual [EPID L-2021-LLQ-0000] (ADAMS Accession Number ML21197A200). The SER of the HDI Fleet DQAP Rev A permits changes to be implemented without prior NRC approval if the changes evaluated under 50.54(a) do not reduce commitments to the approved HDI Fleet DQAP Rev A. Certifications of permanent cessation of operations and permanent defueling milestones have been completed and docketed for PAL and BRP in accordance with 10CFR50.82(a)(1) (ADAMS Accession Number ML22164A067 and ML20141C247 respectfully). These changes do not reduce the effectiveness of the QAPM and continues to ensure compliance with 10 CFR 50, Appendix B and the SAR quality assurance program description commitments previously accepted by the NRC. These changes can be implemented without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

Appendix A - Safety-Related and Important-to-Safety Structures, Systems and Components Safety-Related and Important-to-Safety (ITS) Structures, Appe,ndix A in the DQAP Site Specific Administrative No Systems, and Components, is now included in Appendix A Requirements. However, Appendix A, Sections A., B., and and B of the DQAP. These Appendix were previously added Notes of the QAPM are not included in the DQAP Appendix to provide the discussion of safety related and ITS structures, A. The Appendix A and B was added to provide a systems and components (SSCs) to better clarify the reference to safety related and ITS SSCs. This change applicability of the DQAP to Independent Spent Fuel Storage was considered an administrative change. It provided more Installation (ISFSI) and future Greater than Class C (GTCC) visibility to the safety related and ITS SSCs that are waste SSCs. necessary for the safe storage of spent nuclear fuel in a shutdown nuclear facility. This is redundant to information already maintained in the PAL-BRP site Engineering Systems and Components data base. Removing this additional information from the QAPM is administrative only and not a reduction in commitment.

These chanQes are administrative only and not a reduction Page 29 of 40

QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A in commitment. This change can be implemented without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

Appendix B - Regulatory Commitments The DQAP is a complete replacement of the QAPM. Commitments to standards and regulatory guides with a No Regulatory guides, industry standards, and exceptions to focus on operating facilities are out of scope for a those standards that are only applicable to an operating decommissioning plant.

facility will not be carried over into the DQAP. The The PAL-BRP DQAP will reflect regulatory standards that remaining regulations and quality standards will be. These apply to decommissioning activities and that are not are: already discussed in the site DSAR or Technical

10 CFR 50, Appendix B Specifications. This includes the following two Regulatory

10 CFR 71, Subpart H Guides included in Appendix B of the DQAP: 1. The

10 CFR 72, Subpart G requirement that written procedures applicable to safe

NUREG/CR 6407 "Classification of Transportation storage of nuclear fuel recommended in Appendix A of Packaging and Dry Fuel Storage System Regulatory Guide 1.33, shall be established, implemented Components According to Importance to Safety" and maintained. 2. Procedures for the collection, storage, (Revision 1 - October 2013). and maintenance of nuclear plant quality assurance records will be consistent with Regulatory Guide 1.88 Additional regulatory guides, regulations, and industry Revision 2, dated October 1976.

standards are listed in the DQAP Appendix B Site Specific Administrative Requirements and in the Defueled Technical Although some of these changes are considered Specifications.

reductions in commitments to the previously approved QAPM, they do not reduce the overall effectiveness of the Commitments for Regulatory Guides 1.33 and 1.88 were DQAP. These changes are consistent with the reduced moved from Table 1 of the QAPM and relocated to the risk of a permanently shut down facility and commitments DQAP Appendix B. These Regulatory Guides apply to previously approved by the NRC in which the basis for decommissioning. HDI Fleet DQAP was requested and approved.

[Reference Letter to Holtec Decommissioning The following were deleted from QAPM or moved to DQAP International (HDI), LLC from the NRC, dated January 12, Appendix B as noted below: 2021, providing review and acceptance of the HDI Fleet A. Regulatory Guide 1.8 Revision 1 dated September Decommissioning Quality Assurance Program (DQAP) 1975. PAL-BRP is committed to Sections 1-4 of (EPID L-2020-DP3-0000}, (ADAMS Accession Number Page 30 of 40

QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A ANSI/ANS 3.1-1978 with exceptions and ML21011A106) and NRC email of the Indian Point Unit clarifications. (Selection and training of nuclear Nos. 1, 2 and 3 - NRC Assessment of HDI Fleet power plant personnel). Deleted Decommissioning Quality Assurance Program and IPEC Quality Assurance Program Manual [EPID L-2021-LLQ-B. Regulatory Guide 1.30, dated August 1972. (Quality 0000] (ADAMS Accession Number ML21197A200). The assurance requirements for the installation, SER of the HDI Fleet DQAP Rev A permits changes to be inspection, and testing of nuclear power plant implemented without prior NRC approval if the changes instrumentation and electric equipment). Deleted evaluated under 50.54(a) do not reduce commitments to the approved HDI Fleet DQAP Rev A. Certifications of C. Regulatory Guide 1.33 Revision 2, dated February perma,nent cessation of operations and permanent 1978. (Administrative controls for nuclear power defueling milestones have been completed and docketed plants during operation). Commitments moved to for PAL and BRP in accordance with 10CFR50.82(a)(1)

Appendix B of the DQAP. (ADAMS Accession Number ML22164A067 and ML20141C247 respectfully). These changes do not D. Regulatory Guide 1.37, dated March 1973. (Quality reduce the effectiveness of the QAPM and continue to assurance requirements for one-site cleaning of ensure compliance with 10 CFR 50, Appendix B and the materials and components, cleanness control, and SAR quality assurance program description commitments preoperational cleaning and layup of nuclear plant previously accepted by the NRC. These changes can be and fluid systems). Deleted implemented without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

E. Regulatory Guide 1.38 Revision 2, dated May 1977.

(Quality assurance requirements for the packaging, Notes:

shipping, receiving, storage, and handling of items A. 2.5.2 of DQAP states: "Additional requirements for for nuclear power plants). Deleted specific programs are described in Administrative Controls, of the applicable decommissioning facility F. Regulatory Guide 1.39 Revision 2, dated September Technical Specifications or in the DSAR." This is 1977. (Housekeeping During the Construction not a reduction in commitment; the PAL and BRP Phase of Nuclear Power Plants). Deleted Defueled Technical Specifications Amendment Number 272 and 120 respectfully. The G. Regulatory Guide 1.58 Revision 1, dated September Administrative section states: "Each member of the 1980. (Qualification of nuclear power plant facility staff shall meet or exceed the minimum inspection, examination, and testing personnel). qualifications of ANSI/ANS 3.1-1978 for comparable Deleted positions ... " This sentence goes on to say: "... with exceptions specified in the Quality Assurance H. Regulatory Guide 1.64 Revision 2, dated June 1976. Proaram Manual." Removal of these exceptions is Page 31 of 40

QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A (Quality assurance requirements for the design of not a reduction in effectiveness; the exceptions will nuclear power plants). Deleted no longer be applied. An editorial change to the PAL-8RP Defueled Tech. Specs. will be required to I. Regulatory Guide 1.74, dated February 1974. remove these words regarding the QAPM. This is (Quality assurance terms and definitions). Deleted captured and tracked by the sites Licensing group.

J. Regulatory Guide 1.88 Revision 2, dated October 8. No specific notes applicable to Appendix 8 sections 1976. (Collection, storage, and maintenance of 8, D, E, F, H, I, J, L, M, and 0.

nuclear power plant quality assurance records).

Commitments moved to Appendix E of the DQAP. C. Reference for Regulatory Guide 1.33 was moved to the DQAP Appendix 8. In addition, the PAL-8RP K. Regulatory Guide 1.94 Revision 1, dated April 1976. Defueled Technical Specifications for PAL and 8RP (Quality assurance requirements for installation, discusses the requirements for written procedures inspection, and testing of structural concrete and including: "The procedures applicable to the safe structural steel during the construction phase of storage of nuclear fuel recommended in Regulatory nuclear power plants). Deleted Guide 1.33, Revision 2, Appendix A, February 1978 ... "

L. Regulatory Guide 1.116 Revision 0-R, dated June 1976. (Quality assurance requirements for G. DQAP section 2.7, Personnel Training and installation, inspection, and testing of mechanical Qualifications, delineates training and qualification equipment and systems). Deleted requirements for personnel performing or verifying activities within the scope of the DQAP.

M. Regulatory Guide 1.123 Revision 1, dated July 1977. Qualification requirements are delineated in the (Quality assurance requirements for control of relevant Holtec Standard Procedure(s) that cover procurement of items and services for nuclear power the various training and qualification of personnel.

plants). Deleted K: Governing Codes and Regulations for concrete and N. Regulatory Guide 1.144 Revision 1, dated structural steel are discussed in the PAL-8RP September 1980. (Auditing of quality assurance Defueled Safety Analysis Report.

programs). Deleted N. Section 18.0 of the DQAP describes the O. Regulatory Guide 1.146 Revision 0, dated August requirements for internal and external audits.

1980. (Requirements and guidance for the qualification of personnel who participate in audits of quality assurance oroarams for nuclear power Page 32 of 40

QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A plants). Deleted Appendix C - Other General Guidance Documents The two references in the QAPM were relocated to the DQAP To be consistent, the information in the QAPM was No 2.2, Regulatory Commitments and A.2.1, General relocated to the DQAP 2.2 (NUREG/CR-6407) and A.2.1 Administrative Guidance. (Regulatory Guide 7.10 Revision 3).

These changes are considered editorial and administrative and do not constitute a reduction in commitment to the previously approved QAPM. The changes can be implemented without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

Appendix D- Administrative Controls The QAPM provides the details for the implementation of the To be c,onsistent, the Independent Safety Review No Independent Safety Review (ISR) and Safety Review information in QAPM is now in Appendix A Section A.5 of Committee (SRC) functions. the DQAP, the title was changed to Safety Review Committee, and the specific wording in the DQAP is The Independent Safety Review Function was revised. The different from that in the QAPM. Also, implementation title was changed to Safety Review Committee (SRC) and details were removed from this section. Implementation information from this section is now located in Appendix A, details for the SRC are formalized in procedure EN-OM-General Administrative Requirements, Section A.5 in the 119 (currently titled On-Site Safety Review Committee).

DQAP.

This reduction in implementation details provides flexibility of the implementation of the DQAP while maintaining The Safety Review Committee section of the QAPM was appropriate and sufficient guidance to ensure QA program removed and is not included in the PAL-BRP DQAP.

requirements are met.

This reduction in details is considered a reduction in Page 33 of 40

QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A commitments to the previously approved QAPM; this does not reduce the overall effectiveness of the QAPM. These changes are consistent with the reduced risk of a permanently shut down facility and commitments previously approved by the NRC in which the basis for HDI Fleet DQAP was requested and approved. [Reference Letter to Holtec Decommissioning International (HDI), LLC from the NRC, dated January 12, 2021, providing review and acceptance of the HDI Fleet Decommissioning Quality Assurance Program (DQAP) (EPID L-2020-DP3-0000),

(ADAMS Accession Number ML21011A106) and NRC email of the Indian Point Unit Nos. 1, 2 and 3 - NRC Assessment of HDI Fleet Decommissioning Quality Assurance Program and IPEC Quality Assurance Program Manual [EPID L-2021-LLQ-0000] (ADAMS Accession Number ML21197A200). The SER of the HDI Fleet DQAP Rev A permits changes to be implemented without prior NRC approval if the changes evaluated under 50.54(a) do not reduce commitments to the approved HDI Fleet DQAP Rev A Certifications of permanent cessation of operations and permanent defueling milestones have been completed and docketed for PAL and BRP in accordance with 10CFR50.82(a)(1) (ADAMS Accession Number ML22164A067 and ML20141C247 respectfully). These changes do not reduce the effectiveness of the QAPM and continues to ensure compliance with 10 CFR 50, Appendix B and the SAR QA program description commitments previously accepted by the NRC. These changes can be implemented without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

The Safety Review Committee section in QAPM was removed and is not included in the DQAP.

Note: The Safety Review Committee (SRC) in the QAPM was based on the ANSI N18.7-1976 as endorsed bv Page 34 of 40

QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A Regulatory Guide 1.33, Revision 2. This is different than the SRC now discussed in DQAP Section A.5.

Periodic independent reviews involving the safe operation of the nuclear power plant is removed from the DQAP. The requirements for independent review functions was based on ANSI N18.7-1976 as endorsed by Regulatory Guide 1.33 Revision 2. However, ANSI N18.7-1976 states: 18.7 is applicable during the "operational phase,* which is defin!3d within the standard as: "That period of time during which the principal activity is associated with normal operation of the plant. This phase of plant life is considered to begin with commencement of fuel loading and ends with plant decommissioning." PAL-BRP is no longer in the operational phase. Thus, the detailed requirement for independent review that was provided by the SRC in QAPM is not applied in the DQAP.

This is considered a reduction in commitment to the previously approved QAPM; this does not reduce the overall effectiveness of the QAPM. These changes are the same as those previously approved by the NRC in which a SER was issued for Holtec Decommissioning International (HDI) in January 2021 providing review and acceptance of the HDI Fleet Decommissioning Quality Assurance Plan (DQAP) for Oyster Creek and Pilgrim Station [Reference Letter to Holtec Decommissioning International (HDI), LLC from the NRC, dated January 12, 2021, (EPID L-2020-DP3-0000), (ADAMS Accession Number ML21011A106). This SER allows these changes to be implemented without prior NRC approval since the same basis approval exists for PAL-BRP. Certifications of permanent cessation of operations and permanent defueling milestones have been completed and docketed for PAL and BRP in accordance with 10CFR50.82(a)(1 ). (ADAMS Accession Number ML22164A067 and ML20141C247 respectfully). These Page 35 of 40

QAPM/ Change{s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A changes do not reduce the effectiveness of the QAPM and continues to ensure compliance with 10 CFR 50, Appendix B and the SAR quality assurance program description commitments previously accepted by the NRC. These changes can be implemented without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

Regarding DQAP - Appendix A Terms and Definitions (Not Used)

The QAPM is being revised to mirror the DQAP for the DQAP, Terms and Definitions is administrative providing No implementing of the Holtec Decommissioning International additional information but no additional requirements or (HDI) Fleet DQAP. However, Appendix A, Terms and commitments. This information was not previously included Definitions in the QAPM will not be incorporated in the revised in QAPM. Therefore, results in no reduction in commitment PAL-BRP DQAP. and no reduction in effectiveness of the QA Program.

Regarding DQAP - Appendix B Writing Reference Documents (Not Used)

The PAL-BRP QAPM was revised in anticipation of DQAP Appendix B, Writing Reference Documents is No implementing a Holtec Decommissioning International (HDI) administrative providing additional information but no Fleet DQAP. However, Appendix B, Writing Reference additional requirements or commitments. It is not Documents, will not be incorporated. anticipated that this will be included in the HDI fleet DQAP.

Since the information is not included in the current approved PAL-BRP QAPM, not including it in this revision results in no reduction in commitment and no reduction in effectiveness of the quality assurance program DQAP General Administrative Requirements (Appendix A)

Added new General Administrative Requirements. The QAPM is being revised for the implementing a Holtec No Decommissioning International (HDI) Fleet DQAP. To be consistent, Appendix A General Administrative Requirements was added to the DQAP.

As previously discussed, and evaluated in this document, General Administrative Requirements from the QAPM is now in Section A.5 of the DQAP. Also, the information in the Page 36 of 40

QAPM/ Change(s) Evaluation and Justification PriorNRC DQAP Approval Section Yes, No or NIA QAPM regarding Regulatory Guide 7 .10, "Establishing Quality Assurance Programs for Packaging Used in Transport of Radioactive Material", Revision 3 was also relocated to the DQAP. Otherwise, the remaining information in Appendix Bis newly added.

Adding this new information is an administrative change and does not constitute a reduction in commitment to the previously approved QAPM. This change can be implemented without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

PAL-BRP DQAP Appendix B PAL-BRP Site Specific Administrative Requirements (New Appendix)

Added new Appendix B, Site Specific Administrative The QAPM is being revised for implementing the Holtec No Requirements. The information from Sections A, B., and the Decommissioning International (HDI) Fleet DQAP. To be Notes of the QAPM are not included in the DQAP Appendix consistent, Appendix B Site Specific Administrative B. Requirements was added to the DQAP.

As previously discussed, and evaluated in this document, information from the QAPM is now located in the DQAP Appendix B, Site Specific Administrative Requirements.

However, Sections A, B., and the Notes of the QAPM are not included in the DQAP Appendix B. The new Appendix A was added to provide a reference to safety related and ITS SSCs at the highest quality category to better clarify the applicability of the QAPM. This change was considered an administrative change. It provided more visibility to the safety related and ITS SSCs that are necessary for the safe storage of spent nuclear fuel in a shutdown nuclear facility.

This is redundant to information already maintained in the PAL-BRP site Engineering Systems and Components data base. Removing this additional information from the QAPM is administrative only and not a reduction in commitment.

Page 37 of 40

QAPM/ Change(s) Evaluation and Justification Prior NRC DQAP Approval Section Yes, No or N/A Also, the reference for Regulatory Guides 1.33 and 1.88 in the QAPM were moved to the DQAP Appendix B.

Otherwise, the remaining information in Appendix B is newly added.

Adding this new information is an administrative change and does not constitute a reduction in commitment to the previously approved QAPM. This change can be implemented without prior NRC approval, based on the guidance provided in 10CFR50.54(a)(3).

Page 38 of 40

Attachment B Copy of HDI Fleet DQAP Revision 2 Page 39 of 40

Attachment C Copy of PAL-BRP QAPM Revision 1 Page 40 of 40

Quality Assurance Program Manual Palisades Nuclear Power Plant and Big Rock Point Nuclear Plant-ISFSI Palisades Nuclear Power Plant Big Rock Point Nuclear Plant-ISFSI Docket No. 50-255 Docket No. 50-155 License No. DPR- 20 License No. DPR-6 Docket No. 72-07 Docket No. 72-43 Docket No.: 71-0937 Docket No.: 71-0937 Effective: June 15, 2022 Revision 1

QUALITY ASSURANCE PROGRAM MANUAL POLICY STATEMENT The Entergy Nuclear Palisades Nuclear Power Plant, Big Rock Point Nuclear Plant-ISFSI (BRP) and Entergy Nuclear Operations, Inc. (ENOI) shall maintain and operate the Palisades and BRP facilities in a manner that will ensure the health and safety of the public and workers. The facilities shall be maintained 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 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 oversight.

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QUALITY ASSURANCE PROGRAM MANUAL TABLE OF CONTENTS SECTION PAGE A. MANAGEMENT

1. Methodology 1

2. Organization 1

3. Responsibility 5

4. Authority 5

5. Personnel Training and Qualification 6

6. Corrective Action 6

7. Regulatory Commitments 7 B. PERFORMANCE/VERIFICATION

1. Methodology 8

2. Design Control 8

3. Design Verification 9

4. Procurement Control 10

5. Procurement Verification 11

6. Identification and Control of Items 11

7. Handling, Storage, and Shipping 11

8. Test Control 12

9. Measuring and Test Equipment Control 13

10. Inspection, Test, and Operating Status 14

11. Special Process Control 14

12. Inspection 15 ii Revision 1

QUALITY ASSURANCE PROGRAM MANUAL TABLE OF CONTENTS SECTION PAGE B. PERFORMANCE/VERIFICATION (continued)

13. Corrective Action 15

14. Document Control 16

15. Records 16 C. AUDIT

1. Methodology 17

2. Performance 17 D. INDEPENDENT SAFETY REVIEW

1. Description 20 Table 1- Regulatory Commitments A. Regulatory Guide 1.8 Revision 1, dated September 1975 21 Personnel Qualification and Training B. Regulatory Guide 1.30, dated August 1972 23 Quality Assurance Requirements for the Installation, Inspection, and Testing of Instrumentation and Electric Equipment C. Regulatory Guide 1.33 Revision 2, dated February 1978 24 Quality Assurance Program Requirements D. Regulatory Guide 1.37, dated March 1973 28 Quality Assurance Requirements for Cleaning of Fluid Systems and Associated Components of Water-Cooled Nuclear Power Plants E. Regulatory Guide 1.38 Revision 2, dated May 1977 29 Quality Assurance Requirements for Packaging, Shipping, Receiving, Storage and Handling of Items for Water-Cooled Nuclear Power Plants F. Regulatory Guide 1.39 Revision 2, dated September 1977 34 Housekeeping Requirements for Water-Cooled Nuclear Power Plants iii Revision 1

QUALITY ASSURANCE PROGRAM MANUAL TABLE OF CONTENTS SECTION PAGE Table 1- Regulatory Commitments (continued)

G. Regulatory Guide 1.58 Revision 1, dated September 1980 35 Qualifications of Nuclear Power Plant Inspection, Examination, and Testing Personnel H. Regulatory Guide 1.64 Revision 2, dated June 1976 36 Quality Assurance Requirements for the Design of Nuclear Power Plants I. Regulatory Guide 1.74 dated February 1974 37 Quality Assurance Terms and Definitions J. Regulatory Guide 1.88 Revision 2, dated October 1976 38 Collection, Storage and Maintenance of Nuclear Power Plant Quality Assurance Records K. Regulatory Guide 1.94 Revision 1, dated April 1976 40 Quality Assurance Requirements for Installation, Inspection and Testing of Structural Steel during the Construction Phase of Nuclear Power Plants L. Regulatory Guide 1.116 Revision 0-R, dated June 1976 43 Quality Assurance Requirements for Installation, Inspection and Testing of Mechanical Equipment and Systems M. Regulatory Guide 1.123 Revision 1, dated July 1977 44 Quality Assurance Requirements for control of Procurement of Items and Services for Nuclear Power Plants N. Regulatory Guide 1.144 Revision 1, dated September 1980 47 Auditing of Quality Assurance Programs for Nuclear Power Plants O. Regulatory Guide 1.146 Revision 0, dated August 1980 50 Qualification of Quality Assurance Program Audit Personnel for Nuclear Power Plants iv Revision 1

I* Entergy QUALITY ASSURANCE PROGRAM MANUAL A. MANAGEMENT

1. Methodology

a. The Quality Assurance Program Manual (QAPM) provides a consolidated overview of the quality program controls associated with Palisades and BRP site quality related items and activities. The Palisades and BRP 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 activitys 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, Palisades, and BRP 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 incumbents staff as necessary to fulfill the identified responsibility.

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL A.2. (continued)

a. Corporate Organization

1. The chief executive officer (CEO) is responsible for overall corporate policy and provides executive direction and guidance for the corporation as well as promulgates corporate policy through the Companys senior management staff. Responsibility for developing, implementing, and verifying execution of the Quality Assurance Program is delegated to the chief nuclear officer, the highest level nuclear executive, and authority for developing and verifying execution of the program to the executive responsible for nuclear oversight.

2. The chief nuclear officer, the highest level nuclear executive officer, is responsible for providing top-level direction for maintaining the Palisades and BRP sites. This is the highest level nuclear executive officer and 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. The off-site safety review committee reports to this executive.

3. The following executives report to the highest level nuclear executive officer and provide governance and oversight in regards to implementing company quality assurance policy:

(a) A chief operating officer, the executive responsible for nuclear operations and operations support, is responsible for implementing quality assurance policies, goals, and objectives and the implementation of all activities associated with maintaining the Palisades and BRP sites. The following executives report to this chief operating officer:

Palisades and BRP Site Vice Presidents The executive responsible for operations support is responsible for implementing quality assurance policies, goals, and objectives of Palisades and BRPs corporate support activities.

(b) A chief operating officer, the executive responsible for nuclear operations and outage services, is responsible for implementing quality assurance policies, goals, and objectives and the implementation of all activities associated with maintaining the Palisades and BRP sites. The following executives report to this chief operating officer:

Applicable Site Vice President 2

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL A.2.a.3(b) (continued)

The executive responsible for production and outage services is responsible for providing outage services and implementing quality assurance policies, goals, and objectives of Entergys corporate support activities that include support for Palisades and BRP.

(c) The executive responsible for engineering and technical services is responsible for providing engineering services, project management services and implementing major projects and modifications including implementing quality assurance policies, goals, and objectives.

(d) The executive responsible for regulatory assurance is responsible for regulatory interfaces, licensing activities, corporate nuclear security, corporate emergency planning and implementing quality assurance policies, goals, and objectives.

(e) The executive responsible for oversight establishes the policies, goals, and objectives of the quality assurance policy and 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. Independent oversight groups report to this executive.

(1) The following management positions report to this executive:

A management position that is responsible for nuclear oversight activities and is independent of production.

This position provides overall direction for the implementation of the quality assurance program.

A management position that is responsible for oversight and governance of the QAPM. This position has authority and responsibility for establishing, controlling, and verifying the implementation and adequacy of the quality assurance program as described in this QAPM including activities related to vendor quality. This position has the authority for Stop Work and responsibility to escalate matters directly to the highest level nuclear executive officer when needed.

b. Palisades and BRP Site Organizations The following are integrated Palisades and BRP site management positions that 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.

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL A.2.b. (continued)

1. The Palisades and BRP executive management position reports through the applicable executive position responsible for the designated operating group. This position is responsible for overall nuclear safety at the Palisades and BRP sites, and is responsible for establishing the policies, goals, and objectives and the implementation of the QAPM at the respective site.

2. A management position responsible for overall facility operations that assures the safety of the fuel 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 facility operations.

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

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

(a) 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 nuclear oversight through the corporate management position responsible for nuclear oversight (offsite).

(b) 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.

This site position reports to an executive (supply chain - offsite) who has a functional interface with the executive responsible for engineering and technical services.

(c) A management position responsible for engineering, the development and maintenance of engineering programs, plant design bases, policies, and procedures and for providing engineering services. This position reports to the executive responsible for engineering through the corporate management (offsite). Different aspects of these responsibilities (e.g., fuel design) may be fulfilled by separate managers.

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL A.2.b.4. (continued)

(d) A management position responsible for regulatory assurance.

This position is responsible for maintaining the licensing basis and oversight of licensing and regulatory programs and reports to the executive responsible for regulatory assurance through the corporate management (offsite).

c. The on-site and off-site safety review committees independently review activities to provide additional assurance that the facilities are operated and maintained in accordance with the Operating License and applicable regulations that address nuclear safety.

3. Responsibility

a. Palisades and BRP have the responsibility for the scope and implementation of an effective quality assurance program.

b. Palisades and BRP 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 and BRP are 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 or BRP.

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 in accordance with them.

4. Authority

a. When Palisades or BRP 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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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL A. (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 in accordance with procedures.

d. Additional details concerning Personnel Training and Qualification may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table 1 (e.g., 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 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 and BRP maintain 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 A.7 and Table 1 (e.g., Regulatory Guide 1.33).

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL A. (continued)

7. Regulatory Commitments

a. Except where alternatives are identified, Palisades and BRP comply with the applicable QA guidance documents listed on Table 1. If the guidance in one of these documents is in conflict 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 activities. Except that the inspection of modifications, repairs, rework, and replacements shall be in accordance with 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 (e.g., 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 in accordance with 10 CFR 50.54(a)(3) or 10 CFR 50.54(a)(4).

c. For those sites who have received NRC authorization to use the alternative repair/replacement categorization and treatment requirements of Code Case N-752 in lieu of the corresponding sections of ASME Section XI, as referenced in 10 CFR 50.55a Codes and Standards, treatment of safety-related structures, systems, and components (SSCs) identified as low safety significant (LSS) Class 2 and 3 SSCs in accordance with ASME Code Case N-752 is not required to meet the requirements of this manual. Instead, treatment of these LSS SSCs is performed in accordance with existing QAP procedures and processes which include supplemental controls to ensure the capability and reliability of the SSCs design basis function.

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL B. PERFORMANCE/VERIFICATION

1. Methodology

a. Personnel performing work activities such as design, engineering, procurement, manufacturing, construction, installation, startup, maintenance, modification, operation, and decommissioning 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 (e.g., performance, regulatory, quality, and quality verification requirements) are to be correctly translated into design outputs (e.g., specifications, drawings, procedures, and instructions).

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.

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL B.2 (continued)

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

i. Additional details concerning design control activities may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table 1 (e.g., 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.

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:

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL B.3 (continued)

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 A.7 and Table 1 (e.g., Regulatory Guide 1.64).

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 (e.g., 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 (e.g., 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 items 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.

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL B.4 (continued)

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 A.7 and Table 1 (e.g., Regulatory Guides 1.33 and 1.123).

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 A.7 and Table 1 (e.g., 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 A.7 and Table 1 (e.g., 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.

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL B.7 (continued)

b. Special protective measures (e.g., 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.

e. Additional details concerning handling, storage, and shipping activities may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table 1 (e.g., 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 A.7 and Table 1 (e.g., Regulatory Guide 1.33).

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL B. (continued)

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.

b. The types of equipment covered by the program (e.g., instruments, tools, gauges, and reference and transfer standards) are 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 A.7 and Table 1 (e.g., Regulatory Guides 1.30, 1.33, 1.94, 1.116, and 1.123).

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL B. (continued)

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 in accordance with procedures.

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 A.7 and Table 1 (e.g., 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. NDE (Non-Destructive Examination),

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 in accordance with 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 A.7 and Table 1 (e.g., Regulatory Guide 1.33).

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL B. (continued)

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.

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. Unacceptable inspection results shall be evaluated and resolved in accordance with 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 A.7 and Table 1 (e.g., 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 in accordance with the original inspection and test requirements or specified alternatives.

c. Additional details concerning corrective action activities may be found in Section A.6 and the Regulatory Guides and associated Standards as committed to in Section A.7 and Table 1 (e.g., Regulatory Guide 1.33).

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL B. (continued)

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,

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 in accordance with 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 A.7 and Table 1 (e.g., Regulatory Guide 1.33).

15. Records

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

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

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL B.15 (continued)

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.

d. Additional details concerning record requirements may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table 1 (e.g., 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 in accordance with either Section C.2.a.1 or Section C.2.a.2 below. Audits of stand alone Independent Spent Fuel Storage Installations (ISFSIs) (e.g. those not sited with an operating nuclear power plant) may be conducted in accordance with Section C.2.a.4.

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL C.2.a (continued)

1. Audit frequencies will be determined in accordance with 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 in regard to the depth, scope, and scheduling of specific audits. Functional areas important to safety are assessed annually ( 25%) to identify strengths and weaknesses (if applicable) to determine the level and focus of independent oversight activities for the upcoming year. The basis for the assessment shall include the results of audits and surveillance, NRC inspections, LERs, self-assessments, and applicable conditions reports (e.g., 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.

This document is considered a quality assurance record and will be available for NRC review. Audit subject areas of Section C.2.a.2 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. The conformance of each units operation 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.

18 Revision 1

I* Entergy QUALITY ASSURANCE PROGRAM MANUAL C.2.a.2. (continued)

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

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

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

f. The radiological environmental monitoring program and the results thereof is audited at least once every 24 months.

g. A fire protection and loss prevention program inspection and audit shall be 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 in accordance with the 90-day grace period, the next performance due date will be based on their originally scheduled date.

4. The audit schedule for stand alone ISFSIs may combine audits to cover the areas defined in section C.2.a.2 that are invoked by the ISFSI technical specifications.

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 in accordance with 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.

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL C.2 (continued)

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

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.

i. Additional details concerning audits may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table 1 (e.g., Regulatory Guides 1.33 and 1.144).

D. INDEPENDENT SAFETY REVIEW

1. Description

a. Independent safety review is performed to meet each sites commitment to NUREG-0737, Section I.B.1.2, Independent Safety Engineering Group, as described in the units safety analysis report.

20 Revision 1

I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments A. Regulatory Guide 1.8 Revision 1, dated September 1975 Clarification/Exception

1. General Palisades and BRP are committed to Sections 1 - 4 of ANSI/ANS 3.1-1978 with following clarifications and exceptions.

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

a. The radiation protection manager shall meet or exceed the qualifications of Regulatory Guide 1.8, Revision 2, 1987.

b. Managers required to be a Certified Fuel Handler are specified in the Technical Specifications.

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.

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

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

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

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

d. any combination of the above totaling 4 years.

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

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments A. Regulatory Guide 1.8 (continued)

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

4. ANSI/ANS 3.1 Individuals who do not possess the formal education and minimum Section 4.4.5 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.

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

22 Revision 1

I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments B. Regulatory Guide 1.30, dated August 1972 Clarification/Exception

1. ANSI N45.2.4 ANSI N45.2.4 identifies various tests to be performed. The General applicability of these tests will be determined as discussed in QAPM Section B.8 and based upon the significance of change or modification.

2. ANSI N45.2.4 Documented routine inspections and audits of the storage area may Section 3 be performed instead of the requirements of this Section.

3. ANSI N45.2.4 In some cases, testing requirements may be met by post-Section 5.2 installation surveillance testing in lieu of a special post-installation test.

4. ANSI N45.2.4 The last sentence of this section states: "Items requiring calibration Section 6.2.1 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.

23 Revision 1

I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments C. Regulatory Guide 1.33 Revision 2, dated February 1978 Clarification/Exception

1. Section C.1 Palisades and BRP will provide procedures for the guides Appendix A activities as discussed. However, Palisades and BRP do not consider all activities listed to be "safety-related" (e.g., activities in 7.e).

2. Section C.4 This section establishes minimum 2-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 and BRP will perform audits at frequencies as discussed in QAPM Section C.2.a instead of this section.

3. ANSI N18.7 Sentences 4 and 5 state, "However, applicable sections of this Section 1 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 and BRP will only implement the requirements associated with those activities conducted in accordance with the applicable NRC Quality Assurance Program Approval for Radioactive Material Packages.

4. ANSI N18.7 The specific areas of experience described in this section are not Section 4.3.1 applicable to the on-site safety review committee but the committee must be comprised of site operating or engineering supervisory personnel. Additionally, the off-site safety review committee need contain experience in only a majority of the areas.

5. ANSI N18.7 Instead of the requirements of this section 4.3.2.2, the independent Sections 4.3.2.2 safety review committee will meet once per year. The statement that

& 4.3.2.3 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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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments C. Regulatory Guide 1.33 (continued)

Clarification/Exception

6. ANSI N18.7 10 CFR 50.59 was revised through Federal Register Notice Section 19991001 R1N3150-AF94 eliminating the terms "safety evaluation" 4.3.4.(1) & (2) 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.

7. ANSI N18.7 Reviews associated with changes to the technical specifications will Section 4.3.4(2) be performed in accordance with Section 4.3.4(3) instead of this section.

8. ANSI N18.7 Revision to proposed Technical Specification changes only requires Section 4.3.4(3) review in accordance with 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.

9. ANSI N18.7 In place of the requirements of this section, the on-site and off-site Section 4.3.4(4) safety review committees shall review facility operations to detect potential nuclear safety hazards and all reports made in accordance with 10 CFR 50.73.

10. ANSI N18.7 An example of the matters reviewed by the on-site safety review Section 4.3.4(5) committee in accordance with this section is a change to the Emergency Plan (except editorial changes).

11. ANSI N18.7 This section establishes minimum 2-year audit frequency for all safety Section 4.5 related functions. Palisades and BRP will perform audits at frequencies as discussed in QAPM Section C.2.a instead of this section.

12. ANSI N18.7 The independent review body discussed in this section is the off-site Section 4.5 safety review committee.

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments C. Regulatory Guide 1.33 (continued)

Clarification/Exception

13. ANSI N18.7 Instead of the requirements of this section to have a summary Section 5.1 document, a method of cross-referencing these requirements to the implementing procedures will be maintained.

14. ANSI N18.7 The person who is a Certified Fuel Handler approves a temporary Section 5.2.2 change to a procedure is not required to be in charge of the shift.

15. ANSI N18.7 In addition to the temporary procedure change process described for Section 5.2.2 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.

16. ANSI N18.7 Instead of the requirements of this section concerning non-Section 5.2.6 conforming conditions, non-conforming conditions will be evaluated and controlled in accordance with the corrective action program.

17. ANSI N18.7 The requirement of the fifth paragraph of this section to have a log of Section 5.2.6 the status of temporary modifications is not applicable to temporary modifications for routine tasks installed in accordance with 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.

18. ANSI N18.7 This section will be implemented by adding the words Where Section 5.2.7.1 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 in accordance with the provisions of 10 CFR 50.59 will be conducted.

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments C. Regulatory Guide 1.33 (continued)

Clarification/Exception

19. ANSI N18.7 In lieu of a master surveillance schedule, the following requirement Section 5.2.8 shall be complied with: A surveillance testing schedule(s) shall be established reflecting the status of all in-plant surveillance tests and inspections.

20. ANSI N18.7 The requirements of the Physical Security Plan shall be implemented Section 5.2.9 in place of these general requirements.

21. ANSI N18.7 Consistent with ANSI N45.2.11 Section 7.2, minor changes to Section documents, such as inconsequential editorial corrections, or changes 5.2.13.1 to commercial terms and conditions may not require that the revised document receive the same review and approval as the original documents.

22. ANSI N18.7 Where marking, tagging, or physical separation of the non-conforming Section 5.2.14 item is not feasible, the non-conforming item may be controlled by the use of appropriate documentation.

23. ANSI N18.7 Required procedure reviews following the occurrences discussed in Section 5.2.15 Section 5.2.15, paragraph 3, sentence 3, are determined and controlled in accordance with the QAPM Section A.6 instead of this section.

24. ANSI N18.7 This section requires plant procedure review by an individual Section 5.2.15 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.

25. ANSI N18.7 Instead of the requirements of this section, the format and content of Section 5.3.9 the emergency operating procedures follow the applicable NRC approved format for the specific unit.

26. ANSI N18.7 Palisades and BRPs NRC accepted Emergency Plan will be Section 5.3.9.3 implemented in lieu of the requirements in this section.

27 Revision 1

I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments D. Regulatory Guide 1.37, dated March 1973 Clarification/Exception

1. General 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 introduction of foreign material. As a minimum, cleanliness inspections are performed prior to system closure and such inspections are documented.

2. Section C.3 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.

3. Section C.4 As an alternate 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.

4. ANSI N45.2.1 Any nonhalogenated material may be used which is compatible with the Section 5 parent material not just plastic film.

28 Revision 1

I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments E. Regulatory Guide 1.38 Revision 2, dated May 1977 Clarification/Exception

1. ANSI N45.2.2 Storage of an item in a higher-level storage area meets the lower level Section 3.2 storage requirements.

2. ANSI N45.2.2 As an alternate to the requirements in Section 3.2.1 items (4), (5), and Section 3.2 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.

3. ANSI N45.2.2 Cleated, sheathed boxes may be used up to 1000 lb. rather than 500 Section 3.7.1 lb. as specified in 3.7.1(1). Special qualification testing may be required for loads over 1000 lb.

4. ANSI N45.2.2 Skids and runners will normally be fabricated from a minimum 2 X 4 Section 3.7.2 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.

5. ANSI N45.2.2 Inspections of packages and/or preservative coatings are made Section 4.3.4 immediately prior to loading rather than after loading.

6. ANSI N45.2.2 Warehouse personnel will normally visually scrutinize incoming Section 5.2.1 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 scrutiny during unloading are not considered to be performing an inspection function as defined under Reg. Guide 1.74; 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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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments E. Regulatory Guide 1.38 (continued)

Clarification/Exception

7. ANSI N45.2.2 The second division of this subsection requires six additional Section 5.2.2 inspection activities if an item was not inspected or examined at the source. Palisades and BRP 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 (i.e., 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 inspections 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.

8. ANSI N45.2.2 The Special Inspection procedure is not required to be attached to Section 5.2.3 the item or container but shall be readily available to inspection personnel.

9. ANSI N45.2.2 Items which fall within the Level D classification of the standard will Section 6.2.1 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.

10. ANSI N45.2.2 The sentence is replaced with the following: The use or storage of Section 6.2.4 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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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments E. Regulatory Guide 1.38 (continued)

Clarification/Exception

11. ANSI N45.2.2 The sentence is replaced with the following: Exterminators or other Section 6.2.5 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.

12. ANSI N45.2.2 An alternate to the stated requirement is the following: "Hazardous Section 6.3.3 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."

13. ANSI N45.2.2 Care of items in storage shall be exercised in accordance with the Section 6.4.2 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.

14. ANSI N45.2.2 The last sentence of this section is not applicable to the operations Section 6.5 phase.

15. ANSI N45.2.2 Palisades and BRP will comply with this sections requirements with Section 6.6 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 NRC or other regulatory agents, nor shall tours by nonlicensee employees who are accompanied by licensee employees.

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments E. Regulatory Guide 1.38 (continued)

Clarification/Exception

16. ANSI N45.2.2 Re-rating hoisting equipment will be considered only when Section 7.3 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.

17. ANSI N45.2.2 During printing of the standard, a transposition occurred between Appendix (A-3) the last sentence of A3.4.1(4) and A3.4.1(5). The correct Section A.3.4.1 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."

18. ANSI N45.2.2 There may be cases involving large or complex shaped items for Appendix (A-3) which an inert or dry air purge is provided, rather than a static gas Section A.3.4.2 blanket, in order 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.

19. ANSI N45.2.2 Instead of the requirement for non-metallic plugs and caps to be Appendix (A-3) brightly colored, non-metallic plugs and caps shall be an Section A.3.5.1 appropriately visible color.

20. ANSI N45.2.2 This paragraph limits halogen and sulfur content of tape. The use Appendix (A-3) of tapes containing greater amounts of halogens than those Section A.3.5.2 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.

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments E. Regulatory Guide 1.38 (continued)

Clarification/Exception

21. ANSI N45.2.2 In lieu of A.3.7.1(3) and (4), Palisades and BRP will comply with Appendix (A-3) the following: Fiberboard boxes shall be securely closed either Section A.3.7.1 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 2-inch wide, water resistant tape.

22. ANSI N45.2.2 Instead of the requirement that container markings appear on a Appendix (A-3) minimum of two sides of the container, preferably on one side and Section A.3.9 one end, Palisades and BRP will comply with the following:

Containers are adequately marked for storage, identification, and retrieval. Multiple marking requirements are imposed, where necessary.

23. ANSI N45.2.2, Instead of the requirement that container markings be no less than Appendix (A-3) 3/4 high, Palisades and BRP will comply with the following:

Section A.3.9 Container markings are of a size which permits easy recognition.

24. ANSI N45.2.2, Instead of the specific container marking requirements, Palisades Appendix (A-3) and BRP will comply with the following: The information required in Section A.3.9 container marking is evaluated on a case-by-case basis.

25. ANSI N45.2.2 The last paragraph of A.3.9 could be interpreted as prohibiting any Appendix (A-3) direct marking on bare austenitic stainless steel and nickel alloy Section A.3.9 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.

33 Revision 1

I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments F. Regulatory Guide 1.39 Revision 2, dated September 1977 Clarification/Exception

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

2. ANSI N45.2.3 This section is not applicable.

Section 3.1

3. ANSI N45.2.3 The Fire Protection Program shall be used in lieu of the general Section 3.2.3 requirements in this section.

4. ANSI N45.2.3 The first paragraph is not applicable to the operations phase.

Section 3.3

5. ANSI N45.2.3 This section is not applicable.

Section 3.4

6. ANSI N45.2.3 Subparagraph (1) is not applicable to the operations phase; (2), (3),

Section 3.5 and (4) will be implemented.

34 Revision 1

I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments G. Regulatory Guide 1.58 Revision 1, dated September 1980 Clarification/Exception

1. General Palisades and BRP 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.

2. General General certification of inspectors in accordance with this guide is approved by a manager responsible for quality.

3. ANSI N45.2.6 Paragraph 4 requires that the standard be imposed on personnel Section 1.2 other than licensee employees; the applicability of this standard to suppliers will be documented and applied, as appropriate, in procurement documents for such suppliers.

4. ANSI N45.2.6 The requirements of this standard do not apply to personnel using Section 1.2 later editions of ASNT contained within 10CFR50.55a approved ASME editions or addenda.

5. ANSI N45.2.6 This section requires, in part, that any person who has not Section 2.3 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 in accordance with the 90-day grace period, the next performance due date will be based on their originally scheduled date.

6. ANSI N45.2.6 This sections requirements are clarified with the stipulation that, Section 2.5 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.

7. ANSI N45.2.6 Palisades and BRP reserves the right to use personnel who do not Section 3.5 meet these experience requirements but have shown capability through training and testing or capability demonstration.

35 Revision 1

I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments H. Regulatory Guide 1.64 Revision 2, dated June 1976 Clarification/Exception

1. ANSI N45.2.11 For the documentation of inter-disciplinary design reviews, there must Section 5.2.4 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.

36 Revision 1

I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments I. Regulatory Guide 1.74, dated February 1974 Clarification/Exception

1. ANSI N45.2.10, Definitions for Certificate of Conformance and Certificate of Section 2 Compliance will be exchanged based upon the guidance in ANSI N45.2.13 Section 10.2.

37 Revision 1

I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments J. Regulatory Guide 1.88 Revision 2, dated October 1976 Clarification/Exception

1. RG 1.88 Palisades and BRP will meet the requirements of NFPA No. 232-Section C 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 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 (e.g., 3 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.

2. ANSI N45.2.9 Documents are considered completed when they are "completely filled Section 1.4 out" (i.e., when sufficient information is recorded to fulfill the records intended purpose) and the adequacy of the document (e.g., legibility) has been accepted by the document control or records management organizations or designees.

3. ANSI N45.2.9 The requirements for an index discussed in this section are Section 3.2.2 considered to only require that a method of retrieving the record and controlling the identified information be established.

4. ANSI N45.2.9 Instead of the requirements of this section, Palisades and BRP will Section 5.4.2 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 (e.g.,

dividers or boxes) may be used to organize records for storage. This section is not applicable to special processed records controlled in accordance with Section 5.4.3 when the requirements of this section are not appropriate for the record type.

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments J. Regulatory Guide 1.88 (continued)

Clarification/Exception

5. ANSI N45.2.9 Instead of the requirements of this section, Palisades and BRP will Section 5.4.3 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.

6. ANSI N45.2.9 Routine general office and nuclear site security systems and access Section 5.5 controls are provided; no special security systems are required to be established for record storage areas.

7. ANSI N45.2.9 Palisades and BRP will meet the requirements of NFPA No. 232 -

Section 5.6 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 (e.g., 3 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.

39 Revision 1

I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments K. Regulatory Guide 1.94 Revision 1, dated April 1976 Clarification/Exception

1. ANSI N45.2.5 The last sentence requires that all items inspected with maintenance Section 2.5.2 and test equipment, which is found to be out of calibration, shall be considered unacceptable. Palisades and BRP will comply with QAPM Section B.9.g as an alternate. QAPM Section B.9.g requires an evaluation to determine the validity of previous measurements.

2. ANSI N45.2.5 When using ACI-305-72 and ACI-306-66, Palisades and BRP may Section 4.5 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 3 feet in least dimension will not exceed 90°F; 2) Concrete members from 3 feet to 6 feet in least dimension will not exceed 70°F; and 3)

Concrete members more than 6 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 unmelted 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 3 feet in least dimensions 55°F to 75°F; and 2) Mass concrete 3 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.

3. ANSI N45.2.5 In accordance with ASME QA92-003 (ASME NQA-1 Interpretations),

Table B 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.

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments K. Regulatory Guide 1.94 (continued)

Clarification/Exception

4. ANSI N45.2.5 For the performance of correlation tests, the requirements of this Section 4.8 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, i.e., 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 Subarticle CC-2331.2 of ASME Section III, 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.

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments K. Regulatory Guide 1.94 (continued)

Clarification/Exception

5. ANSI N45.2.5 Palisades and BRP may interpret the terms "horizontal, vertical and Section 4.9 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.

6. ANSI N45.2.5 Palisades and BRP will comply with inspection requirements of the Section 5.5 applicable welding codes and any exceptions instead of this section.

42 Revision 1

I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments L. Regulatory Guide 1.116 Revision 0-R, dated June 1976 Clarification/Exception

1. ANSI N45.2.8 Documented routine inspections and audits of the storage area may Section 3 be performed instead of the requirements of this section.

43 Revision 1

I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments M. Regulatory Guide 1.123 Revision 1, dated July 1977 Clarification/Exception

1. RG 1.123 This paragraph shall be implemented as originally written in Paragraph C.6.e N45.2.13 (i.e., with the verb should" instead of the verb "shall").

Palisades and BRP retains the ultimate responsibility for performance of purchased equipment. The appropriate engineering discipline will exercise this management/engineering prerogative with respect to the final decision on post installation test requirements.

2. ANSI N45.2.13 Item c is an option which may be used to assure quality; Section 1.2.2 however, any option given in 10 CFR 50 Appendix B, Criterion VII as implemented by the QAPM may also be used.

3. ANSI N45.2.13 Instead of the definition provided for QA Program Requirements, Section 1.3 Palisades and BRP 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.

4. ANSI N45.2.13 The same degree of control" is stipulated to mean "equivalent Section 3.1 level of review and approval." The changed document may not always be reviewed by the originator; however, at least an equivalent level of management/supervision shall review and approve any changes.

5. ANSI N45.2.13 Changes to procurement documents which are changes in Section 3.1 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.

44 Revision 1

I* Entergy QUALITY ASSURANCE PROGRAM MANUAL M. Regulatory Guide 1.123 (continued)

Clarification/Exception 5a. ANSI N45.2.13 When purchasing commercial-grade (as defined in 10CFR21)

Section 3.2 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 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.

6. ANSI N45.2.13 The requirements of the QAPM will be implemented instead of Section 3.4 this section.

7.

ANSI N45.2.13 Supplier evaluations may be performed any time prior to placing Section 4.2 the purchased item in service.

8. ANSI N45.2.13 Non-conformance notices for conditions described in this section Section 8.2 are only required to be submitted to Palisades or BRP when the Item b non-conformance could adversely affect the end use of an item relative to safety, interchangeability, operability, reliability, integrity or maintainability.

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL M. Regulatory Guide 1.123 (continued)

Clarification/Exception

9. ANSI N45.2.13 The section states that the certificate should be attested to by a Section 10.2 person who is responsible for this QA function whose function Item d and position are described in the Purchasers/Suppliers QA program. As an alternate to this requirement, Palisades and BRP will use the following: The person attesting to a certificate shall be an authorized and responsible employee of the supplier, and shall be identified by the supplier.

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments N. Regulatory Guide 1.144 Revision 1, dated September 1980 Clarification/Exception

1. RG 1.144 This section is not applicable.

Section C.3.a.(2)

2. RG 1.144 In addition to the requirements of this section, previously evaluated Section C.3.b.(2) and approved active suppliers for which auditing is not the selected method of source verification should be evaluated concurrent with the award of a contract. 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 (i.e., acceptability cannot be determined by receipt inspection or another method allowable under 10 CFR 50 Appendix B, Criterion VII).

3. RG 1.144 This section requires that supplier audits be performed on a Section C.3.b.(2) 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.

4. RG 1.144 Instead of the annual documented evaluation of suppliers Section C.3.b.(2) 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.

47 Revision 1

I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments N. Regulatory Guide 1.144 (continued)

Clarification/Exception 4a. RG 1.144 For suppliers of commercial-grade (as defined in 10CFR21)

Section C.3.b.(2) calibration services with accreditation by NVLAP or A2LA, a documented review of the suppliers 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 ANSI/ISO/IEC 17025.

The accrediting body is either NVLAP A2LA.

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

5. ANSI N45.2.12 Pre-audit and post-audit conferences may be fulfilled by a variety of Section 4.3.1 communications, such as telephone conversation.

6. ANSI N45.2.12 Pre-audit and post-audit conferences are only held when deemed Section 4.3.1 necessary by quality assurance or when requested by the audited organization.

7. ANSI N45.2.12 This subsection could be interpreted to limit auditors to the review Section 4.3.2.2 of only objective evidence; sometimes and for some program elements, no objective evidence may be available. Palisades and BRP 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 (e.g.,

personnel interviews) then the audit report must indicate how the evidence was obtained."

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I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments N. Regulatory Guide 1.144 (continued)

Clarification/Exception

8. ANSI N45.2.12 Pre-audit and post-audit conferences are only held when deemed Section 4.3.3 necessary by quality assurance or when requested by the audited organization.

9. ANSI N45.2.12 Pre-audit and post-audit conferences may be fulfilled by a variety of Section 4.3.3 communications, such as telephone conversation.

10. ANSI N45.2.12 Instead of the last sentence of the last paragraph of the section, Section 4.4 Palisades and BRP 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.

11. ANSI N45.2.12 The QAPM Section A.6 corrective action program may be used Section 4.5.1 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.

49 Revision 1

I* Entergy QUALITY ASSURANCE PROGRAM MANUAL Table 1 Regulatory Commitments O. Regulatory Guide 1.146 Revision 0, dated August 1980 Clarification/Exception

1. ANSI N45.2.23 Holders of NRC-issued Reactor Operator/Senior Reactor Operator Section 2.3.1.3 Licenses comply with the requirements of this section and may be awarded two credits.

2. ANSI N45.2.23 Prospective lead auditors shall demonstrate their ability to effectively Section 2.3.4 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.

3. ANSI N45.2.23 These sections require that an annual assessment be performed of Sections 3.2 and each lead auditors qualification and that each lead auditors records 5.3 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.

50 Revision 1

ML22215A147

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