ML22060A191

Response to Request for Additional Information Related to Submittal for Approval of the Kewaunee Solutions Decommissioning Quality Assurance Program (Dqap), Revision O for Kewaunee Power Station (KPS)

ML22060A191
Person / Time
Site:	Kewaunee
Issue date:	02/25/2022
From:	Jeffery Lynch EnergySolutions
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
ES-2022-002
Download: ML22060A191 (164)

Text

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===============ENERGYSOLUTIONS==========

February 25, 2022 ES-2022-002 U.S. Nuclear Regulatory Commission Attention: Document Control Desk Washington, DC 20555-0001

Subject:

Response to Request for Additional Information Related to Energy Solutions, LLC Submittal for Approval of the Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP), Revision O for Kewaunee Power Station (KPS)

Kewaunee Power Station NRC Docket No. 50-305 NRC License No. DPR-43

References:

1. Letter from Stoddard, D.G. (Dominion Energy Kewaunee, Inc.), and Robuck, K.

W. (EnergySolutions LLC), "Application for Order Approving Transfer of Control ofKPS License and Conforming License Amendments," dated May 10, 2021.

2. Letter from van Noordennen, Gerard P. (Energy Solutions), "Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP), Revision O,"

dated September 16, 2021.

3. Letter from van Noordennen, Gerald P. (EnergySolutions), "Resubmittal of Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP),

Revision O," dated September 29, 2021.

4. Letter from Watson, Bruce A. (U.S. Nuclear Regulatory Commission),

"Dominion Energy Kewaunee, Inc. - Request for Additional Information Regarding EnergySolutions, LLC Submittal for Approval of Decommissioning Quality Assurance Program (EPID L-2021-DP3-0000)," dated February 2, 2022.

Dominion Energy Kewaunee, Inc. (DEK) and Energy Solutions, LLC (]3,nergySolutions) submitted an "Application for Order Approving Transfer of Control ofKPS License and Conforming License Amendments" for Kewaunee Power Station (KPS) to the U.S. Nuclear Regulatory Commission (NRC) for review in a letter dated May 10, 2021 (Reference 1) (the "Application"). The Application stated Kewaunee Solutions, Inc. (the new name of the licensee DEK upon closing) would develop a Kewaunee Solutions Quality Assurance Program for KPS that would comply with 10 CPR 50.54(a).

EnergySolutions submitted the Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP) for approval on September 16, 2021 (Reference 2). However, in that submittal, Energy Solutions had inadvertently marked the DQAP as "Proprietary Information." This marking was removed as a minor change in accordance with the applicable Energy Solutions procedure, without advancing the revision level of the DQAP. In a letter, dated September 29,

Energy Solutions ES-2022-002 Page 2 of3 2021(Reference 3), EnergySolutions resubmitted Revision O of the Kewaunee Solutions DQAP for NRC approval prior to implementation.

On February 2, 2022 (Reference 4), the NRC issued a Request for Additional Information (RAI) as the NRC staff identified that additional information was needed to complete its review of the Kewaunee $olutions DQAP. The RAI states:

The NRC staff requests that EnergySolutions provide a 10 CFR Section 50.54(a)(4) evaluation of the differences between the Kewaunee Solutions DQAP and DOM-QA-I, Revision 30 to demonstrate that the criteria within Appendix B to 10 CFR Part 50; 10 CFR Part 71, Subpart H; and 10 CFR Part 72, Subpart G have been met.

This purpose of this letter is to provide the response to the RAI. provides Revision 1 of the Kewaunee Solutions DQAP. Attachment 2 provides the 10 CFR 50.54(a) Evaluation. Attachment 3 provides the Kewaunee Solutions DQAP Compliance Matrix to NUREG 1536. Attachment 4 provides the Kewaunee Solutions DQAP Compliance Matrix to NUREG 1757.

There are no regulatory commitments made in this submittal.

If the NRC has any questions, please contact me at 860-462-9707.

I declare under penalty of perjury that the foregoing is true and correct. Executed on the 25th day of February 2022.

~ Digitally signed by Joseph R.

Joseph R. Lynch~~li~\\022.02.2s 1s,04,32-os*aa*

for, Gerard van Noordennen Senior Vice President Regulatory Affairs EnergySolutions, LLC Attachments:

1. Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP), Revision 1 (30 Pages)

2. 50.54(a) Evaluation (44 Pages)

3. KS DQAP Compliance Matrix to NUREG 1536 (56 Pages)

4. KS DQAP Compliance Matrix to NUREG 1757 (27 Pages)

Energy Solutions ES-2022-002 Page 3 of 3 Cc: w/ Enclosures Mr. Karl Sturzebecher NRC Project Manager-Kewaunee Power Station U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 NRC Region Ill Administrator U.S. Nuclear Regulatory Commission 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 Daniel G. Stoddard President and Chief Nuclear Officer Dominion Energy Kewaunee, Inc.

5000 Dominion Blvd Glen Allen, Virginia 23060 Craig D. Sly Manager - Nuclear Fleet Licensing Nuclear Regulatory Affairs Dominion Energy Services, Inc.

5000 Dominion Blvd Glen Allen, Virginia 23060 Cc: w/o Enclosures Mr. JeffKitsembel Division of Energy Regulation & Analysis Public Service Commission of Wisconsin P.O. Box 7854 Madison, WI 53707-7854 Robert Busch, Jr.

Radiation Protection Section Bureau of Environmental and Occupational Health Division of Public Health Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701-2659

ATTACHMENT 1 KEWAUNEE SOLUTIONS DECOMMISSIONING QUALITY ASSURANCE PROGRAM (DQAP}

REVISION 1 30 PAGES KEWAUNEE POWER STATION

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KEWAUNEESOWTIONS Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP)

QA Manager Prepared By:

General Manager Approval:

Group Director QA, D&D Approval:

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VDl!n: @ 41 Anthony R. Bejma, Kewaunee Solutions QA Manager Ron WO rste r Digitally signed by Ron Worster Date: 2022.02.24 07:27:09 -07'00' Ron Worster, Kewaunee Solutions General Manager Robert G Otis "'

Robert Otis, EnergySolutions Group Director QA, D&D lllgftally-d byJ.,..h R.

Lynch Date:202202.2410.16:55 Date Date Date Sr. Vice President-Reg.

Affairs Approval:

Joseph R.

Lynch

[Joe Lynch for G. van Noordennen per desii!iiation]

Gerry van Noordennen, EnergySolutions Date Senior Vice President, Regulatory Affairs President and Chief Nuclear Officer (CNO) Approval:

Kewaunee Solutions Presi(Jent Approval:

John S SolutuJ!fS President and Chie Officei;.. 0*N. ), D&D Electronic docwnents, once printed, are uncontrolled and may become outdated.

Refer to the Intranet or the Document Control authority for the correct revision.

Date

Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP)

Introduction KS-QA-PG-001 Revision 1 On February 25, 2013 Dominion Energy Kewaunee (DEK) certifed to the Nuclear Regulatory Commission (NRC) that operations at Kewaunee Power Station (KPS) would permanenetly cease in accordance with 10 CFR 50.82(a)(l)(i). On May 14, 2013 DEK certified to the NRC that the fuel had been permanently removed from the reactor vessel in accordance with 10 CFR 50.82(a)(l )(i). The transfer of all spent fuel from the spent fuel pool to the Independent Spent Fuel Storage Facility (ISFSI) was completed in 2017, and the facility was placed in the SAFSTOR condition.

On May 10, 2021 DEK and Energy Solutions submitted a request to the NRC to transfer control of the renewed facility operating license DPR-43 ("License") for KPS, as well as the 10 CFR 72.210 general license for the on-site ISFSI, from DEK's parent entity, Dominion Nuclear Projects, Inc. (Dominion), to Energy Solutions so as to implement the accelerated decommissioning of the KPS. This will include changing the plant status from SAFSTOR to DECON. Upon license transfer, the name ofKPS Licensee will change to Kewaunee Solutions.

To address this changing environment at KPS, a Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP) has been developed to support station activities and the operation of the Independent Spent Fuel Storage Installation (ISFSI).

The DQAP reflects the quality activities pertaining to a decommissioning nuclear site through compliance with established regulatory requirements set forth by the NRC. The DQAP ensures the protection of the public health and safety through performance-based assessments and compliance-based auditing utilizing implementing procedures and instructions. The DQAP describes the responsibilities for implementing important to safety requirements, establishing and maintaining the DQAP, and assessing the performance of activities subject to the DQAP. The implementation of the DQAP is executed through implementing procedures in a graded approach commensurate with the items' and activities' importance to safety.

The DQAP includes a general description of the organizational structure and functional responsibilities of station management regarding the implementation of important to safety activities and key facility activities at KPS. The DQAP also outlines the key responsibilities for the Quality Assurance (QA) staff and program expectations for the various station organizations.

The DQAP satisfies the requirements of 10 CPR 50 Appendix B; 10 CPR 71 Subpart H; and 10 CPR 72 Subpart G. Additional regulatory commitments are listed within Appendix C of the DQAP.

The DQAP is considered a Quality Assurance Project Plan (QAPP) under the Energy Solutions QA Program (ES-QA-PG-001). The DQAP provides controls that are equivalent with the requirements of ES-QA-PG-001, and is subject to documented assessment versus future revisions to ES-QA-PG-001.

Page 2 of 30

Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP)

Table of Contents KS-QA-PG-001 Revision 1 Approvals....................................................................................................................................... 1 Introduction................................................................................................................................... 2 1

Organization......................................................................................................................... 4 2

Quality Assurance Program................................................................................................ 8 3

Design Control...................................................................................................................... 9 4

Procurement Document Control...................................................................................... 11 5

Instructions, Procedures and Drawings........................................................................... 12 6

Document Control.............................................................................................................. 13 7

Control of Purchased Materials, Equipment and Services............................................ 14 8

Identification and Control of Materials, Parts and Components.................................. 16 9

Control of Special Processes............................................................................................. 17 10 Inspection............................................................................................................................ 17 11 Test Control........................................................................................................................ 18 12 Control of Measuring and Test Equipment.................................................................... 19 13 Handling, Storage and Shipping....................................................................................... 19 14 Inspection, Test, and Operating Status............................................................................ 20 15 Nonconforming Materials, Parts or Components........................................................... 20 16 Corrective Action............................................................................................................... 21 17 Quality Assurance Records............................................................................................... 22 18 Audits.................................................................................................................................. 23 Appendix A:

AppendixB:

Appendix C:

AppendixD:

List of Appendices Organization Chart Important to Safety (ITS) Structures, Systems and Components Regulatory Requirements and Commitments Administrative Controls Page 25 26 28 29 Page 3 of30

Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP) 1 ORGANIZATION 1.1 General KS-QA-PG-001 Revision 1 1.1.1 Kewaunee Solutions (KS) is responsible for the establishment and execution of the Quality Assurance Program for the Kewaunee Power Station (KPS). The KS organizational structure of functions involved with implementing the DQAP as well as associated interfaces, is described below. A high level organizational structure of functional areas involved is also presented in Appendix A of the DQAP. The titles of managers used in the DQAP are generic; their functional titles and their formal titles may vary. Actual repo1iing structure may include intermediate positions not shown on Appendix A of the DQAP. Unless otherwise specifically prohibited, responsibilities of managers as described in the DQAP may be delegated to, and performed by, other qualified individuals.

1.1.2 The ultimate responsibility for operation, maintenance, inspection, test, modification, decommissioning, and storage of spent fuel resides with the Kewaunee Solutions President. The President has corporate resposibility for overall plant nuclear safety and shall take any measures needed to ensure acceptable performance of the staff in operating, maintaining, and providing technical support to the plant to ensure safe management of nuclear fuel. The.General Manager (GM) reports to the Kewaunee Solutions President, and has the overall responsibility for the establishment and execution of the DQAP.

1.1.3 Onsite and offsite organizations shall be established for decommissioning activities. The onsite and offsite organizations shall include the positions for activities affecting safety of the nuclear fuel.

1.1.4 Lines of authority, responsibility and communication shall be established and defined for the highest management levels through intermediate levels to include all organizational positions responsible for decommissioning activities. These relationships shall be documented and updated as appropriate, in the form of organization charts, functional descriptions of departmental responsibilities and relationships, and job descriptions for key personnel positions, or in equivalent forms of documentation.

1.2 Responsibilities 1.2.l The authorities and duties of persons and organizations performing activities affecting the important to safety functions of the Structures, Systems, and Components (SSC) as identified in Appendix B of the DQAP are established and delineated in writing. These activities include both the performing functions of attaining quality objectives and the QA functions.

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Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP)

KS-QA-PG-001 Revision 1 1.2.2 The General Manager (GM) is responsible for spent fuel safety, decommissioning of the station and nuclear oversight. The DQAP is reviewed and approved by the Quality Assurance Manager (QAM), and the GM.

1.2.3 The GM shall be responsible for overall management of the KPS decommissioning and associated site support functions. The individual shall delegate in writing the succession to this responsibility during their absence.

1.2.4 The GM is responsible for apprising management of the effectiveness of the DQAP implementation and is the arbitrator for non-conformances of unusual complexity.

The GM also directs actions to be taken based on reports and trending of quality issues submitted by the QAM. Direction for implementing the DQAP activities is provided by the GM through the QAM.

1.2.5 Management ofline organizations at KPS are responsible to ensure that the quality of organizational work and activities meets the requirements set forth in the DQAP and KPS implementing procedures.

1.3 Quality Assurance 1.3.1 The QAM reports to the GM and shall not be assigned responsibilities that would prevent the required attention to important to safety matters. Although reporting to the GM with other line organizations, the QAM shall have the necessary independence from other line management to ensure effective oversight for all organizations. The QAM while located off-site, shall delegate management of day-to-day oversight of implementation of the DQAP for all important to safety activities to on-site Quality Assurance (QA) personnel for which the QAM retains responsibility. The QAM has the following responsibilities:

A. Authority and obligation to raise any conditions adverse to quality that are not otherwise effectively resolved via the KS Corrective Action Program to the GM for resolution B. Assuring important to safety activities at KPS are performed in accordance with implementing procedures C. Managing the performance of audits, surveillances, and inspections in order to verify that important to safety activities have been correctly performed D. Establishing lines of communication and control measures between the QA organization and suppliers to ensure appropriate QA program direction and provide for resolution of QA issues E. Reporting on oversight activities to the GM F. Authority to stop work when quality is adversely affected Page 5 of30

Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP)

KS-QA-PG-001 Revision 1 1.3.2 Quality Assurance (QA) personnel report directly to the QAM and implement the relevant provisions of the DQAP utilizing written implementing procedures. They perform independent oversight of line functions and activities. A member of the QA organization shall not perform oversight of activities for which the member has direct responsibility. Further, they have the responsibility and authority to stop work when quality is adversely affected and immediately raise concerns to the QAM.

1.3.3 QA personnel shall have sufficient authority and organizational freedom to identify any quality problems and to verify implementation of corrective actions.

Additionally, QA personnel shall 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 nuclear safety considerations.

1.3.4 The individuals who carry out radiation protection and quality assurance fimctions may report to the appropriate onsite manager; however, they shall have sufficient organizational freedom to ensure their ability to perform their assigned functions.

1.4 Station Management 1.4.1 The GM delegates to the KS management team the day-to-day responsibilities for the ISFSI and decommissioning. The GM has periodic meetings with the management team to review plans and progress and to address stakeholder, quality, and project management issues. The managers described below report to the GM.

1.4.2 The Decommissioning Plant Manager (DPM) is responsible for overall safety of plant operations and decommissioning site operations, including fire protection activities at the decommissioning site, and shall delegate in writing the succession to this position during their absence. The DPM shall approve, prior to implementation, each proposed test, experiment, or modification to systems or equipment that affect the safe storage of nuclear fuel, and shall have control over those onsite activities necessary for safe storage of the nuclear fuel. The DPM is responsible for implementing the Independent Safety Review (ISR) function in accordance with Appendix D of the DQAP.

1.4.3 The Radiation Protection Manager is responsible for all Radiation Protection (RP) program implementation activities, including RP operations, RP engineering and the as low as reasonably achievable (ALARA) Program.

1.4.4 The Engineering Manager is responsible for the engineering ofISFSI and decommissioning activities, and ensuring adequate technical review is applied to changes, tests and experiments. This includes engineering related to dry fuel storage of fuel / Greater-than-Class C (GTCC) waste, as well as configuration control of the facility.

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Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP)

KS-QA-PG-001 Revision 1 1.4.5 The Licensing Manager (LM) is responsible for the day-to-day licensing activities, interfaces with the Nuclear Regulatory Commission (NRC), and is the Single Point of Contact for licensing and regulatory matters and concerns. The LM is responsible for assessing DQAP changes for determining compliance with licensing basis requirements, and for managing submittals to the NRC.

1.4.6 The Waste Manager is responsible for implementing radioactive waste, hazardous waste, mixed waste activities, and waste shipments, including Low Level Radioactive Waste (LLR W) products and services scope provided to KS by EnergySolutions or other suppliers.

1.4.7 The ISFSI Manager is responsible for overseeing all ISFSI activities, including ISFSI Operations and Maintenance, ISFSI Fire Protection, Security Plans, and Emergency Plan.

1.4.8 Management may be comprised of on-site and off-site staff, and individuals may be responsible for more than one functional area.

• Although not required to be named as separate functional managers in the DQAP, implementing procedures shall clearly establish roles and responsibilities in the organization that include but are not limited to the following activities as they may apply to DQAP scope: Training, Final Status Survey (FSS), Procurement, Corrective Actions, Document Control and Records.

1.5 Delegation of Work 1.5.l KS may delegate the execution of portions of the work under the DQAP to others such as contractors, agents, or consultants; however, KS retains overall responsibility for those activities and the DQAP. Delegation is clearly identified in documentation and KS retains the right to verify compliance with KS quality and regulatory requirements applicable to that organization's QA Program. QA program interactions, management responsibilities, and authority for the coordinated execution of the overall QA program, are established and documented.

1.6 Reporting 1.6.l KS management is involved with QA matters on a continuing basis. Periodic reports summarizing the quality of KPS activities are reviewed and approved by the QAM. These reports contain status of the program adherence to the DQAP, issues identified, unresolved items, and/or other items of interest. These reports are submitted to the GM and other KS management as deemed appropriate.

1.6.2 The GM shall periodically have an Independent Management Assessment (IMA) performed to evaluate the effectiveness of the DQAP, as described in Appendix D oftheDQAP.

Page 7 of30

Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP) 2 QUALITY ASSURANCE PROGRAM 2.1 General KS-QA-PG-001 Revision 1 2.1.1 The QA Program for the Kewaunee Power Station (KPS), hereafter referred to as the program, is described in the DQAP. The program includes the DQAP and its implementing procedures, instructions, and drawings. The DQAP provides control over impo1iant to safety structures, systems and components (SSCs) and selected decommissioning related activities to an extent consistent with their importance to ensure safety and compliance as defined in procedures. The DQAP includes specific monitoring activities which are measured against acceptance criteria in a manner sufficient to provide KS management assurance that the important to safety activities are performed in an acceptable manner. The DQAP requirements apply to SSCs designated as important to safety identified in Appendix B of the DQAP.

2.1.2 The DQAP satisfies the requirements of 10 CPR 5 0 Appendix B; 10 CPR 71 Subpart H; and 10 CPR 72 Subpart G. Additional regulatory commitments are listed within Appendix C of the DQAP.

2.1.3 Implementation of the DQAP is controlled through separately issued implementing procedures, instructions, and drawings. Each organization is responsible for ensuring that the applicable portions of the DQAP are properly documented, approved, and implemented (with trained staff, necessary materials, and approved procedures available) before an activity within the scope of the DQAP is executed.

2.1.4 Important to safety activities shall be accomplished under suitably controlled conditions. Controlled conditions include the use of appropriate equipment; suitable environmental conditions for accomplishing the activity, such as adequate cleanliness; and assurance that all prerequisites for the given activity have been satisfied. The program 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.

2.1.5 Changes to the DQAP will be implemented in accordance with 10 CPR 50.54( a) and 10 CPR 71.106.

2.1.6 Disputes arising between departments or organizations on QA matters that cannot be resolved at a lower level of management will be referred to the GM.

2.1.7 Additional requirements for specific programs are described in Appendix D, Administrative Controls of the DQAP.

Page 8 of30

Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP) 2.2 Personnel Training and Qualifications KS-QA-PG-001 Revision 1 2.2.1 Individual managers are responsible for ensuring that personnel working under their cognizance are provided with the necessary indoctrination training and resources to accomplish assigned activities which fall under the scope of the DQAP.

2.2.2 Members of the KS staff (including audit and inspection personnel) shall have the appropriate qualifications necessary to perform their assigned duties defined in implementing procedures. These implementing procedures provide the criteria utilized for determining and assessing appropriate staff qualification. Additionally, Appendix D of the DQAP cites references that stipulate the use of specific industry standards addressing qualifications. Training programs are established and implemented to ensure that personnel achieve and maintain suitable proficiency.

Personnel training and qualification records are maintained in accordance with approved procedures.

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

2.3 Performance / Verification 2.3.1 Personnel performing work activities such as design, engineering, procurement, installation, maintenance, modification, operation and decommissioning are responsible for achieving acceptable quality.

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

2.3.3 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.

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

3 DESIGN CONTROL 3.1 General 3.1.1 The program will ensure that the activities associated with the design of important to safety SSCs and modifications thereto, are executed in a planned, controlled, and orderly manner.

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Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP)

KS-QA-PG-001 Revision 1 3.1.2 The original design organizations for the important to safety SSCs are identified in Appendix B of the DQAP. Subsequent changes to the original design shall be made by the respective Design Authority in accordance with their NRC approved QA Program.

3.1.3 The program utilizes the guidance of NUREG/CR 6407, Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety, to classify SSCs such that appropriate quality requirements are identified and documented on drawings, component lists, or procurement documents, as applicable.

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

3.1.5 Design inputs (e.g., performance, conditions of the facility license, design bases, regulatory requirements, quality standards identified in Appendix C of the DQAP, and quality verification requirements) shall be identified and correctly translated into design outputs (e.g., specifications, drawings, procedures, and instructions).

3.1.6 The final design output shall relate to the design input in sufficient detail to permit verification. Design outputs shall specify design characteristics that can be controlled, inspected, and tested. Inspection and test criteria are identified.

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

3.1.8 Changes to final designs (including field changes and modifications) and dispositions of nonconforming items to either use-as-is or repair shall be subjected to design control measures commensurate with those applied to the original design and approved by the organization that performed the original design or a qualified designee.

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

3.1.1 0 Errors and deficiencies in the design or the design process that could adversely affect SSCs important to safety shall be entered into the corrective action process.

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

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Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP) 3.2 Design Verification KS-QA-PG-001 Revision 1 3.2.1 The program will verify the acceptability of design activities and documents for the design of items. The selection and incorporation of design inputs and processes, outputs and changes are verified.

3.2.2 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.

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

3.2.4 Independent design verification is to be completed before design outputs are used by other organizations for design work and before they are used to support other activities such as procurement, manufacture, or construction. When this timing cannot be achieved, the unverified portion of the design is to be identified and controlled. In all cases, the design verification is to be completed before relying on the item to perform its important to safety function.

3.2.5 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. At least one individual shall have a level of skill at least equal to that of the original designer. The designer's immediate supervisor or manager may perform the design verification and controls for this are defined in approved procedures.

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

4 PROCUREMENTDOCUMENTCONTROL 4.1 The program will ensure that purchased items and services are of acceptable quality.

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

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

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Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP)

KS-QA-PG-001 Revision 1 4.4 The program includes provisions for source verification (inspection, audit, etc.) for accepting purchased items and services identified as important to safety when determined necessary.

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

4.6 The program includes provisions that clearly delineate the sequence of actions to be accomplished in the preparation, review, approval, and control of procurement documents.

4.6.1 Procurement documents shall be reviewed and approved by QA for the adequacy of quality requirements, and to ensure that the quality requirements are correctly stated, inspectable, and controllable; and to ensure there are adequate acceptance and rejection criteria.

4.6.2 Qualified personnel shall ensure the procurement document has been prepared, reviewed, and approved in accordance with program requirements.

4.6.3 Changes and revisions to procurement documents are subject to the same or equivalent review and approval as the original documents.

4. 7 The program includes provisions for ensuring that documented evidence of an item's conformance to procurement requirements is available at the site before the item is placed in service or used unless otherwise specified in procedures. Procurement documents shall.

identify records to be retained, controlled, and maintained by the supplier and those records to be delivered to the purchaser before use or installation of the hardware.

4.8 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.

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

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

5 INSTRUCTIONS, PROCEDURES AND DRAWINGS 5.1 The program will ensure that quality activities are prescribed by and performed in accordance with documented instructions, procedures, or drawings.

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Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP)

KS-QA-PG-001 Revision 1 5.2 The program will ensure that the sequence of actions to be accomplished in the preparation, review, approval, and control of instructions, procedures, and drawings are clearly delineated. QA review and concurrence of instructions, procedures, drawings, and specifications related to inspection, tests, calibrations, and special processes shall be performed prior to implementation to verify adequate quantitative and qualitative criteria have been specified.

5.3 These instructions, procedures, and drawings include, as appropriate, quantitative or qualitative acceptance criteria for determining that activities have been satisfactorily accomplished. Controls are established which ensure that instructions, procedures, and drawings are current and accurately reflect the facility design and regulatory requirements.

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

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

6 DOCUMENTCONTROL 6.1 The program will control the development, review, approval, issue, use, and revision of documents, as applicable.

6.2 The program will ensure that the appropriate organizations review, approve, and issue documents and changes thereto before release to ensure that the documents are adequate and applicable quality requirements are stated.

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

A. Safety Analysis Report(s);

B. NRC License Documents, including Technical Specifications; C. Design Documents and Drawings; D. Procurement Documents; E. Procedures, Manuals, Plans, Directives, Policies, Instructions, etc., and; F. Other documents as defined in procedures.

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Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP)

KS-QA-PG-001 Revision 1 6.4 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. Administrative controls ensure periodic reviews are perfonned for procedures that have specific regulatory review requirements.

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

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

Superseded documents are controlled to prevent inadvertent use.

7 CONTROL OF PURCHASED MATERIALS, EQUIPMENT AND SERVICES 7.1 Procedures shall describe each organization's responsibilities for the control of purchased material, equipment, and services including the interfaces between all affected organizations.

Controls shall include the review and acceptance of supplier documents by the appropriate organization, including compliance to the technical and quality requirements specified in the procurement documents, as required.

7.2 The program will ensure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents as applicable to DQAP scope. The program includes provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery. The processes shall use a graded approach applying considerations of a material's, component's or service's importance to safety, complexity, and history of previous use.

. 7.2.1 Supplier evaluation and selection may be accomplished by direct audit of the supplier, in-process surveillance of the supplier's documented program, or by review of audit history perfonned by EnergySolutions or an approved third-party source. Verification that a supplier can meet the specified technical and quality requirements shall be documented. KS maintains an Approved Suppliers List (ASL) of evaluated suppliers.

A. External audits of suppliers are scheduled and perfonned based on the importance of the activity and to confirm implementation of the supplier's QA Program at a frequency of not greater than three (3) years with a 90 day grace period.

B. For external audits of suppliers, an overall 25% extension (9 months) for triennial audits or surveys may be exercised during periods where performance of such activities is not feasible as a result of extenuating circumstances. Examples of extenuating circumstances would include, but are not limited to: 1) declaration of a national emergency; 2) severe localized or national weather conditions or damage to licensee or supplier infrastructure; or 3) localized outbreak of a severe health concern to the public and licensee. Continued use of suppliers that have exceeded the maximum allowed audit or survey time due to extenuating circumstances is allowed if the following conditions are met:

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Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP)

KS-QA-PG-001 Revision 1

1. A documented evaluation must be performed to summarize why the audit or survey could not be performed prior to the end of the 90-day grace period and to provide the basis for maintaining the supplier as an approved supplier during the 25% (9-month) grace period. While implementing procedures must describe elements to be included in the documented evaluation, the following items should be considered as applicable:

a. For 10 CPR 50 Appendix B, 10 CPR 71 Subpart H, and 10 CPR 72 Subpart G suppliers, verification that the supplier's quality assurance program is still committed to meeting the requirements of 10 CPR 50 Appendix B, 10 CPR 71 Subpart H, and 10 CPR 72 Subpart G, respectively.

b. For commercial suppliers who are approved based on commercial grade survey, verification the supplier has maintained adequate documented programmatic controls in place for the activities affecting the critical characteristics of the item/services being procured.

c. Evaluation of any significant open issues with the NRC, 10 CPR Part 21 Notifications, and any open findings since the previous triennial audits describing impact on the items/services being procured from that supplier.

d. Review of procurement history since last triennial audit/survey including receipt inspection results to identify any potential issues. The results of the performance history must be included in the evaluation.

e. The degree of standardization of the items being procured. For instance, suppliers of catalog items which are used across multiple industry with widely accepted good performance histories would be considered good candidates for a 25% (9-month) grace period.

2. If concerns are identified based on the above evaluation, the following mitigating actions may be considered:

a. Enhanced receiving inspections beyond visual inspections and quality checks.

b. Identification of any additional requirements/restrictions to be placed on the supplier.

3. For audits/surveys performed during the 25% grace period, the audit/survey shall include a review of activities performed by the supplier since the 36-month audit/survey expiration date.

4. The allowance would only apply to existing suppliers on the Approved Supplier's List.

5. The 25% grace period discussed above is applicable to domestic and international suppliers.

6. For audits/surveys performed during the 25% grace period, the audit/survey "clock" does not have to reset backwards to the original expiration date for which the audit/survey should have been performed. The end of the audit or survey would determine the date of the next triennial audit/survey.

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KS-QA-PG-001 Revision 1 C. KS considers that other 10 CFR 50 licensees, Authorized Nuclear Inspection Agencies, National Institute of Standards and Technology (NIST), or other State and Federal agencies which may provide items or services to the KPS facilities are not required to be evaluated or audited.

D. Suppliers of commercial grade calibration and testing services may be qualified based on their accreditation by a nationally - recognized accrediting body in accordance with the provisions of the Nuclear Energy Institute (NEI) 14-05 guidelines, provided the conditions of the associated NRC Safety Evaluation are met.

7.2.2 Source verification may be performed at the contractor or subcontractor source via planned surveillance or in-process inspection and documented when it is determined advantageous to monitor or observe an item or activity to verify conformance.

7.2.3 For acquiring of services only, such as third-party inspection, engineering and consulting services, in cases where the suppliers QA Program has not been reviewed or accepted by KS, those suppliers 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. These additional controls shall be documented.

7.2.4 Receiving inspection shall verify, by review of objective evidence, the material and equipment conform to the procurement documents, including applicable technical and quality requirements.

7.2.5 Effectiveness of the control of quality by contractors and subcontractors will be assessed at intervals consistent with the importance, complexity, quantity of the product or services, and performance history. Supplier performance and compliance with procurement documents are monitored by audit, source verification, receipt inspection, or a combination to ensure continued acceptable supplier performance.

7.4 Documentary evidence that material and equipment conform to the procurement requirements shall be available before installation and use, and items accepted and released should be identified as to their inspection status. The documentary evidence shall be retained in accordance with applicable regulatory requirements and shall be sufficient to identify the specific requirements, such as codes, standards, or specifications, met by the purchased material and equipment.

7.5 General administrative controls for conduct of audit, surveillance, in-process inspection, receipt inspection are provided for in Sections 10 and 18 of the DQAP.

8 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMPONENTS 8.1 The program will identify and control important to safety items to prevent the use of incorrect or defective items.

8.2 The program will ensure replacement of installed limited-life items before their expiration, and will ensure items with a specified shelf-life in inventory are prevented from use beyond their expiration.

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Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP)

KS-QA-PG-001 Revision 1 8.3 Identification of each item is maintained by heat number, part number, serial number, or other appropriate means, either on the item or on records traceable to the item, as required 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. The location and method of identification shall not affect the fit, function, or quality of the item being identified.

9 CONTROL OF SPECIAL PROCESSES 9.1 This program will ensure that special processes identified as important to safety are properly controlled. The criteria that establish which processes are special are described in procedures. The following are examples of special processes:

A. Welding; B. Heat treating; C. NDE (Non-Destructive Examination);

D. Chemical cleaning; and E. Unique fabricating or test processes which require in-process controls.

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

10 INSPECTION 10.1 The program will ensure inspections of important to safety activities are planned, executed and documented in order to verify conformance with instructions, procedures, and drawings for accomplishing the activity.

10.2 Provisions to ensure inspection planning is properly accomplished are to be established.

Planning activities shall identify the characteristics and activities to be inspected, the inspection techniques, the acceptance criteria, and the organization responsible for performing the inspections. When sampling is used to verify acceptability of a group of items, the standard used as the basis for acceptance shall also be specified.

10.3 Provisions to identify inspection hold points, beyond which work is not to proceed without the consent of the inspection organizations are to be defined. Provisions shall be made for indirect control by monitoring processing methods, equipment, and personnel if direct inspection is not possible. Both inspection and process monitoring shall be provided when control is inadequate without both.

10.4 Inspection results are to be documented by the inspector and reviewed by qualified personnel. Inspection records shall include the following, as a minimum:

10.4.1 Item inspected; I 0.4.2 Date of inspection; Page 17 of30

Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP) 10.4.3 Inspector; 10.4.4 Type of observation; 10.4.5 Results or acceptability; and KS-QA-PG-001 Revision 1 10.4.6 Description of nonconforming conditions, or reference to applicable nonconformance or corrective action documents in cases where acceptance criteria

,vas not met.

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

10.6 Inspections are performed by qualified personnel other than those who performed or directly supervised the work inspected. While performing the inspection activity, inspectors functionally report to the QAM. QA surveillance will be conducted periodically to confirm sufficient independence from the individuals who performed the activities for inspections performed by groups other than QA.

11 TEST CONTROL

11. 1 The pro gram will demonstrate that items will perform satisfactorily in service using approved test procedures which incorporate the requirements and acceptance limits contained in applicable design documents.

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

11.3 Test procedures shall be developed which include:

A. Instructions and prerequisites to perform the test; B. Use of proper test equipment; C. Acceptance and rejection criteria; D. Mandatory inspections, as required; and E. Methods of documenting or recording test data results.

11.4 When practicable, the measures should ensure testing of the SSC occurs under conditions that will be present during normal and anticipated off-normal operations.

11.5 Test results are evaluated and documented by qualified personnel to assure that test objectives and inspection requirements have been satisfied.

11.6 Unacceptable test results shall be evaluated and documented for impact on safety and reportability.

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Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP) 12 CONTROL OF MEASURING AND TEST EQUIPMENT KS-QA-PG-001 Revision 1 12.1 The program consisting of implementing procedures reviewed and approved by the appropriate organizations will control the calibration, maintenance, and use of measuring and test equipment (M&TE) consistent with activities importance to safety to ensure accuracy.

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

12.3 The types of equipment covered by the program ( e.g., instruments, tools, gauges, and reference and transfer standards) and measures to document and maintain the status of all calibrated M&TE are defined in procedures.

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

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

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

13 HANDLING, STORAGE AND SHIPPING 13.1 General 13.1.1 The program will control the handling, storage, shipping, cleaning, and preserving of items to prevent damage or deterioration.

13.1.2 Special protective measures (e.g., containers, shock absorbers, accelerometers, inert gas atmospheres, specific moisture content levels, and temperature levels, etc.) are specified and provided when required to prevent damage or deterioration.

13.1.3 Specific procedures shall be developed and used for cleaning, handling, storage, packaging, shipping, and preserving items when required to prevent damage or deterioration.

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KS-QA-PG-001 Revision.I 13.1.4 Items are marked and labeled during packaging, shipping, handling, and storage to identify, maintain, and preserve the item's integrity and identify the need for any special controls.

13.2 USNRC-Licensed Packages 13.2.1 KS shall meet the requirements of 10 CFR 71 Subpart Hand 10 CFR 72 Subpart G and Department of Transportation (DOT) 49 CPR for restrictions concerning handling, storage, and shipping ofNRC Licensed packages, except as may be allowed by NRC and/or DOT exemptions granted for specialty packages.

13.2.2 Transportation cask handling and operation shall conform to the handling and operating procedure for each licensed cask.

13.2.3 Prior to the shipment of a transport cask, conditions of the NRC's Certificate of Compliance (specifications, tests, and inspections) shall be satisfied. Required shipping papers shall be prepared and shall accompany the shipment in accordance with regulatory requirements and approved procedures.

13.2.4 Established safety restrictions concerning handling, storage, and shipping shall be included in the handling and operating procedures for storage and transport casks.

14 INSPECTION, TEST, AND OPERATING STATUS 14.1 The program will ensure that required inspections and tests and the operating status of items important to safety is verified before release, fabrication, receipt, installation, test, and use, as applicable. This verification is to preclude inadvertent bypassing of inspections and tests and to prevent inadvertent operation of controlled equipment. Operating status is provided by the use of tags, markings, stamps, or other suitable means.

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

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

15 NONCONFORMING MATERIALS, PARTS OR COMPONENTS 15.1 The program will ensure that nonconforming important to safety materials, parts, components, associated services and activities are identified and controlled.

15.2 Nonconforming items are properly controlled by approved procedures describing the identification, documentation, segregation requirements, disposition and approval authority, and notification to the affected organizations to prevent their inadvertent installation or use. Nonconfonning items are reviewed and either accepted, rejected, repaired, or reworked in accordance with approved procedures.

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KS-QA-PG-001 Revision 1 15.3 Management at all levels and each individual working at the facility is responsible for promptly identifying and reporting the identification of nonconforming materials, parts, and components.

15.4 Interfaces,vith the Corrective Action Program described in Section 16 of the DQAP will be established to ensure the prompt identification, documentation, and correction of nonconforming materials, parts, and components installed in SSCs.

15.5 Verification of the acceptability of reworked or repaired materials, parts, and SSCs is by re-inspecting and retesting the item as originally inspected and tested, or by using a method that is at least equal to the original inspection and testing method.

15.6 Supplier nonconformance reports designated accept as is or repair for important to safety SSCs require KS review and approval.

15. 7 Nonconformance reports will be periodically evaluated for trends, provided sufficient quantity of data exists. Adverse trends will be entered into the Corrective Action Program.

16 CORRECTIVE ACTION 16.1 Each individual working at the facility is responsible for promptly identifying and reporting conditions adverse to quality. Management at all levels encourages the identification of conditions that are adverse to quality.

16.2 The program will ensure that conditions adverse to quality (such as nonconformance, failures, malfunctions, deficiencies, deviations, and defective material and equipment) are evaluated in accordance with established procedures to assess the need for corrective action to address the condition identified, and to preclude recurrence of the condition. Follow-up activities to verify proper implementation of corrective actions and close out of the corrective action documentation in a timely manner shall be performed in accordance with established procedures.

16.3 The QA organization will be included in the concurrence chain regarding the adequacy of the corrective action, and in the follow-up action to verify the proper implementation of corrective action, in accordance with approved implementing procedures.

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

16.5 In the case of contractors, agents, or consultants performing activities within the scope of the program, the applicable manager may delegate specific responsibilities for corrective actions, but maintains responsibility for the effectiveness of corrective action measures.

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

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Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP) 17 QUALITY ASSURANCE RECORDS KS-QA-PG-001 Revision 1 17.1 The program will ensure that sufficient records of important to safety items and activities affecting quality ( e.g., design, engineering, procurement, manufacturing, construction, inspection and test, installation, pre-operation, startup, operations, maintenance, modification, decommissioning, and audits) are generated and maintained to reflect the completed work, and are consistent with applicable codes, standards, and procurement documents. Records shall be identified and retrievable.

17.2 Controls for the administration, identification, receipt, storage, preservation, safekeeping, retrieval, and disposition of records are provided in procedures. Responsibilities for QA and other organizations for the identification of QA and other required records, and for implementation of activities related to the records, are provided in procedures.

17.2.1 Facilities used to store records should be constructed to minimize the risk from damage or destruction by severe natural conditions, such as wind, flood, fire, temperature, humidity, mold, or infestation by insects or rodents.

17.2.2 If dual storage facilities are used to ensure the record integrity, the storage facilities should be sufficiently remote from each other to preclude a single event (such as a fire or flood) from damaging both facilities.

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

17.3.1 NIRMA TGl 1-2011, Authentication of Records and Media 17.3.2 NIRMA TG15-2011, Management of Electronic Records 17.3.3 NIRMA TG 16-2017, Software Quality Assurance Documentation and Records 17.3.4 NIRMA TG21-201 l, Required Records Protection, Disaster Recovery and Business Continuation 17.4 In an approval dated May 10, 2017 [MLl 7069A394], DEK was granted exemptions by the NRC to allow elimination of the requirement to maintain records that are no longer necessary due to the permanently defueled condition and decommissioning status of the KPS.

The NRC granted DEK a partial exemption from the record keeping requirements of 10 CFR 50.71(c); 10 CFR Part 50 Appendix B, Criterion XVII; and 10 CFR 50.59(d)(3) for the KPS to advance the schedule to remove records associated with structures, systems, and components (SSCs) that have been or will be removed from NRC licensing basis documents by appropriate change mechanisms.

17.5 Records generated for SSCs that were once classified as safety-related or quality-related but no longer have a safety function do not need to be retained for purposes of the DQAP (but may need to be retained for other purposes, such as compliance with 10 CFR 50.75(g),

other regulations, or for business reasons).

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Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP) 18 AUDITS KS-QA-PG-001 Revision 1 18.1 The program will establish a system of planned and documented audits in order to verify compliance with all aspects of the DQAP, and determines the effective implementation of DQAP scope activities. QA internal and supplier audits are planned and performed by qualified auditors utilizing approved written procedures and/or checklists. External audits by licensees/utilities, Contractors, or Consultants acting for KS to satisfy KS audit requirements shall have the results evaluated by KS to ensure acceptability.

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

18.3 Scheduling, preparation, personnel selection, performance, reporting, response, follow-up, and records management for audits are performed in accordance with written procedures.

Audit scopes and schedules are based upon the status of work progress, important to safety activities being performed, and regulatory requirements.

18.4 Planned internal audits are scheduled and performed in accordance with approved procedures or checklists to provide comprehensive, independent verification, and evaluation of DQAP compliance, performance criteria, and program effectiveness.

Important to Safety (IO CFR 71 and 72) activities shall be audited based on the activity's importance to safety; however, each applicable quality criterion shall be audited at least once each year. Audit of DQAP elements applicable to other activities conducted under the DQAP shall be completed for each functional area at least once every two years.

18.4.1 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.

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

18.5 When specific audits are identified as requiring a more frequent periodicity, the shortest periodicity will be adhered to for activities covered by those specific regulatory requirements. The frequency of internal audits will be prescribed by the site implementing procedures which govern the conduct of QA audits.

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KS-QA-PG-001 Revision 1 18.6 Surveillances may be performed and documented when it is determined advantageous to monitor or observe an item or activity to verify conformance. Surveillance should be documented in sufficient detail to identify the activity covered, identify individuals doing surveillance, and to document results and corrective measures necessary. Surveillance conducted by or under the direction of a Lead Auditor may be integrated into and credited toward required audit activities.

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

18.8 Results of audits are reviewed with the management of the organization audited.

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

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

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Appendix A Kewaunee Solutions (KS) Organization Chart Kewaunee Solution President KS-QA-PG-001 Revision 1 Group QA Director, D&D I

I I

I I

General Manager QA Manager ISFSI Manager Radiation Protection Decommissioning Waste Manager Manager Plant Manager I

Engineering Manager I Licensing Manager I ates:

1. Functional Organization Chart using Generic Titles. Alignment with actual titles maintained current in approved company documents.

2. All positions are not defined and ultimate reporting is to the Kewaunee Solutions President.

3. Lines of authority, responsibility and communication shall be established between the organization depicted above and any offsite organizational elements that function under the cognizance of the DQAP.

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Appendix B KS-QA-PG-001 Revision 1 Important to Safety (ITS) Structures, Systems and Components (SSCs)

Section 1 - General I.1 The pertinent quality assurance requirements of the DQAP will be applied, as a minimum, to all quality activities affecting the ITS SSCs as defined by 10 CFR 71 and IO CFR 72 that are associated with spent fuel storage and transportation packages.

1.2 The safety classification of SSCs of the Plant and ISFSI Facility may be revised during decommissioning based on engineering evaluations and revision to the KPS Defueled Safety Analysis Report (DSAR). These modifications are controlled in accordance with the KS Design Control process, including implementation of §50.59 and §72.48 requirements, as applicable. These modifications are not considered a reduction in the commitments to the DQAP.

1.3 The safety classification of NRC Licensed ISFSI Dry Fuel Storage Components and Transportation Packages may not be revised using the KS Design Control process. These modifications must be made by the NRC Certificate Holder. The Certificate Holder is responsible for design and licensing controls for these components under their NRC approved Quality Assurance Program. KS utilizes these types of components and packages under the provisions of NRC General License for Radioactive Material Transportation Packages (10 CFR 71) and Spent Fuel Storage (10 CFR 72).

1.4 The storage of GTCC Waste Containers at the ISFSI in regard to 10 CFR 72 is addressed in NUREG-2215, Standard Review Plan for Spent Fuel Dry Storage Systems and Facilities (April, 2020).

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

1.6 Important-to-Safety SSCs associated with spent fuel storage and radioactive material transportation packages are identified below:

A.

Dry Spent Fuel Storage (10 CFR 72)

SSC Quality Design Authority Category Stainless Steel Fuel Storage Canister(s) and Internals Note 1 Note2 Concrete Cask Overpack(s)

Note 1 Note2 ISFSI Pad(s)

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Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP)

B.

Transport of Spent Fuel and GTCC Waste (10 CFR 71)

SSC Quality Category Stainless Steel Fuel Storage Canister(s) and Internals Note I Stainless Steel GTCC Waste Container(s) and Basket(s)

Note I Licensed Transport Cask(s)

Note I C.

Radioactive Material Transport Packages (10 CFR 71)

KS-QA-PG-001 Revision 1 Design Authority Note2 Note2 Note2 Radioactive Material Transport Packages subject to the provisions of 10 CPR 71 Subpart C, General Licenses are Important-to-Safety and subject to the applicable requirements of the DQAP.

Notes:

I.

See the applicable Certificate Holder's Final Safety Analysis Report (FSAR) and associated specifications for detailed quality category information (Transnuclear / Orano for NUHOMS system and NAC for NAC MAGNASTOR system).

2.

Design Authority is Transnuclear / Orano for NUHOMS system, and NAC for NAC MAGNASTOR system.

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KS-QA-PG-001 Revision 1 Appendix C Regulatory Requirements and Commitments Section 1 -Regulatory Requirements:

1.1 10 CFR 50, Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Processing Plants 1.2 10 CFR 71, Packaging and Transportation of Radioactive Material, Subpart H, Quality Assurance 1.3 10 CFR 72, Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reactor-Related Greater Than Class C Waste, Subpart G, Quality Assurance Section 2 - Regulatory Commitments:

Note: KPS has previously loaded NUHOMS and MAGNASTOR Dry Cask Storage Systems (DCSSs) in use at the ISFSI, and use of additional DCSS systems are planned for GTCC in the future.

The DCSS C of C holder QA Programs used for these DCSS systems may be committed to earlier revisions of Regulatory Guide 7.10.

2.1 Regulatory Guide 7.10, Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive *Material (Revision 3 - see Note above).

2.2 NUREG/CR-6407, Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety (2/96).

Note: The following is implemented through Management Controls (Ref.

Appendix D of the DQAP).

2.3 Regulatory Guide 4.15, Quality Assurance for Radiological Monitoring Programs (Normal Operations) - Ejjluent Streams and the Environment (Revision 1 -

February, 1979)

Section 3 - Alternatives:

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

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Appendix D Administrative Controls A. INDEPENDENT REVIEWS 1.0 Independent Management Assessment (IMA)

KS-QA-PG-001 Revision 1 The GM shall periodically have an lMA performed to evaluate the effectiveness of the KS QA Program as detailed in approved administrative procedures. These IMAs are performed by individual(s) designated by the GM who are independent of KS oversight activities and who have the appropriate level of expertise in the activities assessed. These periodic IMAs shall be performed on a 24-month frequency with a 90-day grace period, which is not to impact the established 24-month cycle for the assessment. The IMA results are communicated via a written report in a timely manner to a level of management having the authority to execute effective corrective action. In addition, these results are reported to the KS management team through the GM.

2.0 Independent Safety Review (ISR)

Independent Safety Reviewers perform ISRs of proposed changes, tests and experiments to important to safety SSCs, activities, program documents, and procedures that are subject to the DQAP requirements as detailed in approved administrative procedures. Independent Safety Reviewers shall be individuals without direct responsibility for the performance of activities under review, and shall be competent and knowledgeable in the subject area being reviewed. Independent Safety Reviewers shall have at least 5 years of professional experience and either a Bachelor's Degree in Engineering or the Physical Sciences or shall have equivalent qualifications in accordance with ANSI NI 8. l

• 1971. Independent Safety Reviews must be completed prior to implementation of proposed activities. The manager responsible for the overall operational activities (or designee) shall document the appointment of Independent Safety Reviewers as defined in procedures.

B. SCOPE SUBJECT TO MANAGEMENT CONTROLS IN LIEU OF DQAP CONTROLS 3.0 Facility Staff Qualifications 3.1 Facility staff responsible for the safe storage of nuclear fuel and selected decommissioning activities shall meet or exceed the minimum qualifications of ANSI NI 8.1-1971 for comparable positions as defined in approved procedures except for: a) the radiation protection manager who shall meet or exceed the qualifications of Regulatory Guide 1.8, September 1975.

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Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP) 4.0 Procedures, Programs and Manuals 4.1 Procedures KS-QA-PG-001 Revision 1 Note: The section below was previously moved from the KPS Technical Specifications to the Dominion Energy Nuclear Quality Assurance Program Description (QAPD).

4.1.1 Written procedures shall be established, implemented, and maintained covering the following activities:

A. Quality assurance for effluent and environmental monitoring (Regulatory Guide 4.15, Revision 1, Ref. Appendix C of the DQAP);

B. Fire Protection Program implementation; C. Radioactive Effluent Controls Program; and Note: The intention of including the next requirement is to ensure that, in the event radioactive storage tanks are brought online, then the requirement for procedures would apply. It is not intended to require that standing procedures are required in the absence of radioactive storage tanks.

D. Storage Tank Radioactivity Monitoring Program Page 30 of30

ATTACHMENT 2 50.54(a) EVALUATION 44 PAGES KEWAUNEE POWER STATION

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation, 10 CFR 50.54(a) / 10 CFR 71.106 Evaluation

Background

This 10 CFR 50.54(a) Evaluation is for use in responding to the N RC "Dominion Energy Kewaunee, Inc. -

Request for Additional Information Regarding EnergySolutions, LLC Submitta I for Approval of Decommissioning Quality Assurance Program," (EPID L-2021-DP3-0000), dated 2/2/22.

The Evaluation consists of the following:

Evaluation Section I: Overall Summary Evaluation Section II: 10 CFR 50.54/10 CFR 71.106 Evaluation Section Note: The format in this Section is based on Energy Solutions Procedure DDG-QA-PN-001, "QA Program Implementation Plan for D&D Projects," Attachment 5.2, "QAPP Revision Process", Rev. 6 Evaluation Section Ill: Detailed Comparison and Evaluation This Evaluation compares the following (2) QA Programs:

Topical Report DOM-QA-1, "Dominion Energy Nuclear Facility Quality Assurance Program Description," Rev. 30 [referred to as the QATR in the Evaluation]

KS-QA-PG-001, "Kewaunee Solutions Decommissioning Quality Assurance Program (DQAP)," Rev. 1

[referred to as the DQAP in the Evaluation]

Page 1 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation Evaluation Section I: Overall Summary

[See Evaluation Section Ill, for details in context of the Evaluation.]

Changes that are not a reduction in commitment per 10 CFR 50.54(a)(3):

1) Since the QATR is a fleet QA program, and Kewaunee Power Station (KPS) was the one unit in the fleet that was no longer commercially operational, the QATR exempts KPS from specific QATR requirements applicable to only the operating units. These types of differences between the QATR and the DQAP resulted in a conclusion that changes of this type are not a reduction in commitment as described in this Evaluation.

2) Since the QATR is a fleet QA program reflecting the Dominion organization and administrative practices, and the DQAP is focused on Kewaunee Power Station (KPS) only, reflecting the Energy Solutions I Kewaunee Solutions organization and administrative practices. There are administrative differences between the two documents based on differing titles, terminology and business practices not necessarily related to the QA program. In this Evaluation, where these differences did not differ in intent, and did not compromise the necessary independence of the organizations performing quality assurance functions, they resulted in a conclusion that changes of this type are not a reduction in commitment as described in this Evaluation.

3) The DQAP contains an increased grace period for external audits in comparison to the QATR. The increased grace period is specific to extenuating circumstances that was approved by the NRC with a Safety Evaluation Report (SER) in response to a request from Callaway Station (Ref. NRC SER dated August 6, 2020, ADAMS Accession No. ML20216A681). Therefore, this resulted in a conclusion that this change was not a reduction in commitment as described in this Evaluation.

4) The QATR includes detail regarding electronic record controls that duplicates language in the Nuclear Information and Records Management Association (NIRMA) standards committed to in the DQAP by reference. This resulted in a conclusion that changes of this type are not a reduction in commitment as described in this Evaluation.

5)

With respect to the DQAP committing to more recent NIRMA standards than the QATR, this change is not a reduction in commitment as described in this Evaluation.

Changes that are a reduction in commitment per 10 CFR S0.54(a)(4):

The Evaluation determined the following changes to be reductions in commitment that require NRC approva I prior to implementation:

QATR "Introduction" Section:

1) The quality assurance and administrative measures established in the DQAP are not comparable to those implemented during construction and operation of KPS. They are applicable to decommissioning activities only.

This change is aligned with the status of KPS in the decommissioning stage, with no plant Structures, Systems and Components (SSCs) classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the Independent Spent Fuel Storage Installation (ISFSI). It is no longer necessary to apply the level of control commensurate with construction and operational activities to the KPS nonsafety-related SSCs regulated under 10 CFR 50. The DQAP does apply the appropriate level of controls to the SSCs that are Important to Safety (ITS) under 10 CFR 71 and 10 CFR 72, via the controls aligned with Regulatory Guide 7.10. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by the NUREG 1536 and NUREG 1757 compliance matrices included in the Request for Additional Information (RAI) response. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

Page 2 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation QATR "Basis" Section: [Note that this 10 CFR 50.54(a)(4) analysis applies to multiple QATR Sections -

Refer to Evaluation Section 111 for specific details]

2)

In the aggregate, the QATR includes substantially more commitments to regulatory bases than the DQAP.

These changes are aligned with the status of KPS in the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the ISFSI. The regulatory commitments in the QATR that are not referenced in the DQAP are intended to apply a level of control that is no longer required for the KPS nonsafety-related SSCs regulated under 10 CFR 50. The DQAP does apply the appropriate regulatory and quality standards to the SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, via controls aligned with Regulatory Guide 7.10.

The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NUREG 1536 and NU REG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

QATR "Subsection 1.2: Responsibility and Authority": [Note that this 10 CFR 50.54(a)(4) analysis applies to multiple QATR Sections - Refer to Evaluation Section Ill for specific details]

3) The Facility Safety Review Group (FSRG) function in the QATR is replaced by the Independent Safety Review (ISR) function in the DQAP.

These changes are aligned with the status of KPS in the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the ISFSI.

The FSRG is a deliberative review body, and the ISR is one or more technically qualified independent individuals competent and knowledgeable in the subject area being reviewed. It is no longer necessary to apply the more complex FSRG administrative process that is suited for operating plants to review changes associated with the KPS nonsafety-related SSCs regulated under 10 CFR 50 specific to a facility in decommissioning. The ISR function described in the DQAP does apply comparable controls to review like changes to the SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NU REG 1536 and NU REG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

4)

The QATR includes specific mention of an Information Technology (IT) services management function, and the DQAP does not.

Section 1.2 ofthe QATR ascribes responsibilities to the IT position, of which several are not directly related to quality measures described in the QATR. For the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the ISFSI, the only potential area cited in the QATR applicable to KPS quality activities is development and maintenance of the software control program. For KPS, software controls associated with SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72 are to be developed and maintained by the Design Authority under their respective NRC approved QA programs, and are subject to oversight by KS as described in Section 7 of the DQAP. It is also recognized that IT services are a necessary support function to numerous areas of responsibility listed in DQAP Section 1.4. Notably in the case of document control/records management, DQAP Section 17 makes specific reference to the NIRMA standards. The IT management functions are integral to implementation of these standards, the details of which are included in EnergySo/utions implementing procedures. The DQAP changes, combined with the Page 3 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NU REG 1536 and NU REG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness ofthe DQAP as it is applied to the ISFSI and planned decommissioning activities.

QA TR "Subsection 2.2: Applicability":

5) The QATR states that numerous program documents further describe application of portions of the QA program, and the DQAP does not. The documents listed in the QATR are the Safety Analysis Report (SAR), nuclear design control program, physical security plan, emergency plan, radiological protection plan including radioactive material transport and radioactive waste processing, fire protection plan and nuclear chemistry laboratory quality assurance program.

6) The DQAP does not include a Risk Informed Categorization description and specific controls to be applied to nonsafety-related SSCs analogous to QATR, Appendix F.

These changes are commensurate with the status of KPS in the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the ISFSI. Although the DQAP does not make a statement comparable to the one in the QATR, the DQAP emphasizes that implementing procedures and program documents are required to include sufficient level of detail to meet applicable regulatory requirements. This will ensure that the applicability of the DQAP and the appropriate portions of the DQAP as they relate to implementing procedures and program documents will be clearly described. It is no longer necessary to apply the classification system represented by the Risk Informed Categorization, and pre-established minimum QA requirements, to nonsafety-related SSCs regulated under 10 CFR 50. DQAP Section D requires the continued application of formal administrative controls to those SSCs that warrant augmented quality requirements during all phases of decommissioning. KS will maintain other regulatory programs (e.g., physical security plan, emergency plan, radiological protection plan, radioactive material transport not addressed in 10 CFR 71, and radioactive waste processing) that establish measures to ensure KS decommissioning activities are conducted in accordance with the applicable regulatory requirements, with a focus on safety, quality and compliance. The absence of detail in the DQAP for these program areas does not diminish KS commitment or responsibility for compliance. Additionally, it is no longer necessary to apply the classification system represented by the Risk Informed Categorization, and pre-established minimum QA requirements, to nonsafety-related SSCs regulated under 10 CFR 50. DQAP Section D requires the continued application of administrative controls to those SSCs that warrant augmented quality requirements during decommissioning. The DQAP does apply the appropriate level of controls in the administrative processes associated with decommissioning and SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, via the controls aligned with Regulatory Guide 7.10. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NU REG 1536 and NUREG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

QA TR "Subsection 2.3: Oversight of the Quality Program Implementation":

7) The QATR Management Safety Review Committee (MSRC) was replaced with the Independent Management Assessment (IMA) in the DQAP.

These changes are aligned with the status of KPS in the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuei removed from the spent fuel pool and stored at the ISFSI.

The MSRC is a deliberative review body, and the IMA is one or more technically qualified independent individuals competent and knowledgeable in the subject area(s) being reviewed. It is no longer necessary to apply the composition of the MSRC to evaluate the KS QA program implementation and Page 4 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation effectiveness associated with the KPS nonsafety-related SSCs regulated under 10 CFR 50. The IMA is a comparable administrative process to evaluate the effectiveness of the KS QA program as it applies to decommissioning under 10 CFR 50, and for assessment of activities associated with the SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NU REG 1536 and NU REG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

QA TR "Subsection 2.5: Selection, Training, and Qualification of Personnel":

8) The QATR cites 10 CFR 50.120 and the DQAP does not.

9)

The detailed content of the QATR for training and qualifications for staff positions was replaced with DQAP Appendix D, Section B, 3.1.

These changes are aligned with the status of l<PS in the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the ISFSI.

It is no longer necessary to apply the level of control of the 10 CFR 50.120 Systems Approach to Training (SAT) process to staff qualifications associated with the l<PS nonsafety-related SSCs regulated under 10 CFR 50, nor is it necessary to provide detailed descriptions of the qualification requirements for plant staff positions in the QA program. KS will maintain required regulatory programs (e.g., Radiation Protection, Radioactive Waste, Final Status Survey, Security) that establish measures to require, conduct and control training/qualifications to ensure KS decommissioning activities are executed in accorda nee with the applicable regulatory requirements through the sets of implementing procedures. The DQAP Section 2 training requirements provide an appropriate level of controls for the training requirements for decommissioning and ISFSI/Operations staff performing activities under the scope of the DQAP, including any specific training required by the License. The DQAP Appendix D Section B, 3.1 requirement is an appropriate administrative process for establishing qualification requirements for staff conducting decommissioning activities conducted under 10 CFR 50, and for establishing qualification requirements associated with the SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, via the controls aligned with Regulatory Guide 7.10. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NU REG 1536 and NU REG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

QA TR "Section 3, Design Control":

10) The QATR includes controls for software and the DQAP does not.

This change is aligned with the status of KPS in the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the ISFSI. It is no longer necessary to apply the level of control to software associated with the KPS nonsafety-related SSCs regulated under 10 CFR 50. With respect to software controls associated with SSCs that are Important to Safety (ITS) under 10 CFR 71 and 10 CFR 72, DQAP Appendix B states that any design changes (that would employ software as part of the design process) to ITS SSCs would be made by the specific Design Authority, including EnergySolutions, under their QA Program, not the DQAP. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NU REG 1536 and NUREG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

Page 5 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation QATR "Section 7, Control of Purchased Material, Equipment, and Services":

11) The QATR includes some relevant detail related to selection of suppliers, measures for acceptance and quality verifications, and reference to NRC correspondence that is not included in the DQAP.

These changes are aligned with the status of KPS in the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the ISFSI.

It is no longer necessary to apply the level of detail to suppliers associated with the KPS nonsafety-related SSCs regulated under 10 CFR 50. With respect to suppliers associated with SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, these suppliers are identified in DQAP Appendix B, with the exception of the supplier which will be providing the GTCC transportation packages in the future. In this case, the potential list of suppliers is limited to those suppliers with NRC approved QA programs, that hold an NRC issued Certificate of Compliance (CoC) for the GTCC transportation package.

The DQAP does apply the appropriate thoroughness for the control of purchased items and services for the SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, via the controls aligned with Regulatory Guide 7.10. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NU REG 1536 and NU REG 1757 as detailed in individual compliance matrices.

Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

QATR "Section 11, Test Control":

12) The QATR includes some relevant detail related to preoperational testing, startup testing, and scheduling that is not included in the DQAP.

These changes are aligned with the status of KPS in the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the ISFSI.

It is no longer necessary to apply an operational plant level of control to tests associated with the KPS nonsafety-related SSCs regulated under 10 CFR 50. With respect to tests associated with SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, the DQAP does apply the appropriate controls to testing the SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, via the controls aligned with Regulatory Guide 7.10. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NU REG 1536 and NU REG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

QA TR "Section 14, Inspection, Test. and Operating Status":

13) The QATR includes some relevant detail related to the authority for implementing controls, temporary controls, independent verifications, and operational considerations particular to SSCs at an operating reactor that is not included in the DQAP.

These changes are aligned with the status of KPS in the decomn:,issioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the ISFSI.

It is no longer necessary to apply an operational plant level of detail related to authority for implementing controls, temporary controls, independent verifications, and operational considerations to the KPS nonsafety-related SSCs regulated under 10 CFR 50 and associated with a plant in decommissioning as compared to the operational considerations described in the QATR. With respect to these types of controls associated with SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, the DQAP does apply the appropriate controls for the SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, via the controls aligned with Regulatory Guide 7.10. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 Page 6 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NU REG 1536 and NUREG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

QA TR "Section 17, Quality Assurance Records /Appendix E":

14) The QATR includes detail related to records indexing (including the Appendix E) that is not included in the DQAP.

These changes are aligned with the status of KPS in the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the ISFSI.

It is no longer necessary to apply operational plant level of indexing and control to records associated with the nonsafety-related SSCs regulated under 10 CFR 50 and associated with a plant in decommissioning as compared to the operational requirements described in the QATR. With respect to the removal of records indexing detail from the DQAP, whether from the 10 CFR 50, 10 CFR 71 or 10 CFR 72 perspective, KS is committed to the Regulatory Requirements and Commitments listed on DQAP Appendix C, so this has no identified impact. The QATR Appendix E records indexing information, "QA Records Retention Requirements for Operating Facilities" is relevant to KPS in a historical sense only, given the NRC records exemptions cited in Section 17 of the QATR that are not reflected on Appendix C.

With respect to records associated with SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, the DQAP does apply the appropriate controls for records supporting the SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, via the controls aligned with Regulatory Guide 7.10. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NU REG 1536 and NUREG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

QATR "Section 18, Audits":

15) The QATR includes detail for the Fire Protection audit that the DQAP does not.

These changes are aligned with the status of KPS in the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the ISFSI.

The current KPS License Basis for Fire Protection is 10 CFR 50.48(f). The requirement in 10 CFR 50.48(f)(2) is for the licensee to assess the Fire Protection Program on a regular basis. DQAP Appendix D, Section B.4, includes the Fire Protection Program implementation. This is adequate to meet the requirement of 10 CFR 50.48(f). With respect to Fire Protection as related to the SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, the DQAP does apply the appropriate assessment of the Fire Protection Program related to the SSCs that are Important to Safety under 10 CFR 71 and 10 CFR

72. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NUREG 1536 and NUREG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness ofthe DQAP as it is applied to the ISFSI and planned decommissioning activities.

Page 7 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation Evaluation Section II: DDG-QA-PN-001, Attachment 5.2, "QAPP Revision Process", Section II: 10 CFR 50.54/10 CFR 71.106 Evaluation Section The table below is excerpted from EnergySolutions procedure DDG-QA-PN-001, "QA Program Implementation Plan For D&D Projects," Rev. 6, and includes the criteria of 10 CFR 50.54(a)(3), and 10 CFR 71.106(b). For purposes of clarity in this evaluation, the narrative refers to 10 CFR 50.54(a), without reference to 10 CFR 71.106.

Answer the following questions as they may apply to all changes. The question should be answered "NO" if any single change does not fit the description. If the response to all applicable questions is "YES",

the proposed change is not considered a reduction in commitment and can be made without prior NRC approval.

1.

Oves

[gjNo ON/A Does the proposed change involve administrative improvements and clarifications, spelling corrections, non-substantive punctuation, or editorial items?

Explain rationale/ provide basis.

Although numerous changes are of this type, there are also numerous other changes that cannot be characterized as such. See Evaluation Section Ill for details.

2.

[gives 0No ON/A Does the proposed change involve the use of a QA standard approved by the NRC which is more recent than the QA standard in the licensee's current QA program at the time of the change?

Explain rationale/ provide basis.

The only case of this type is in DQAP Section 17, Quality Assurance Records. The DQAP commits to more recent NIRMA standards than the QATR. See Evaluation Section Ill QATR Section 17 Quality Assurance Records for details.

3.

[gives 0No ON/A Does the proposed change involve the use of a quality assurance alternative or exception approved by an NRC safety evaluation, provided that the bases of the NRC approval are applicable to the licensee's facility? (§S0.54(a)(3) only)

Explain rationale/ provide basis.

The only change of this type is the additional external audit grace period that was approved for Callaway by the NRC SER. See Evaluation Section Ill QATR Section 18 Audits for details.

4.

Oves

[gjNo ON/A Does the proposed change (to the extent allowable by the applicable facility's Technical Specifications) involve the use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles, provided that there is no substantive change to either the functions of the position or reporting responsibilities?

Explain rationale/ provide basis.

Although numerous changes are of this type, there are also numerous other changes that cannot be characterized as such. See Evaluation Section Ill for details.

Page 8 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation

5.

Oves

[Z]No ON/A Does the proposed change (to the extent allowable by the applicable facility's Technical Specifications) involve the use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or, alternately, the use of descriptive text, provided that there is no substantive change to the functional relationships, authorities, or responsibilities?

Explain rationale/ provide basis.

Although numerous changes are of this type, there are also numerous other changes that cannot be characterized as such. See Evaluation Section Ill for details.

6.

[Z]Yes ONo ON/A Does the proposed change involve the elimination of quality assurance program information that duplicates language in quality assurance regulatory guides and quality assurance standards to which the licensee/quality assurance program approval holder is committed?

Explain rationale/ provide basis.

The only change of this type is the language regarding control of electronic records that is duplicated from the NIRMA Standards. See Evaluation Section Ill QATR Section 17 Quality Assurance Records for details.

7.

Oves ONo

[ZJN/A Does the proposed change involve organizational revisions that ensure that persons and 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?

Explain rationale/ provide basis.

Although there were numerous changes to the organization and associated responsibilities, there were no changes made relative to the organizations performing quality assurance functions to address issues with independence, authority and organizational freedom, or independence from cost and schedule.

8.

Oves ONo

[ZJN/A Does the proposed change, if not already evaluated above, not cause a reduction in commitment?

Explain rationale/ provide basis.

All changes were evaluated above, with the detail provided in Evaluation Section Ill.

Page 9 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation PREPARED BY/ DATE:

Digitally signed by Anthony R_ BeJma Ant h On Y R ON C=US, OU=QA, O=EnergySolutK>ns, CN=Anthony R_ BeJma, E=arbejma-ext@energysolut,ons com Bejma Anthony R. Bejma Reason I am approving thlS document Location Dafe 2022-02-25 14 15 40 Foxtt PbantomPQE ~

9 4 1 Kewaunee Solutions QA M anager REVIEWED BY/ DATE:

Chris R Roache Oigilatly 11gned by Chns R Roac:ha ON. C*US, ou.. o&o, O*Nudear Dversigt..

CN3':tv1s R Roache, Escrroache@energysolut1on.com Renon I am 1h11 author of tin document locahon Dale 2022-02-251 25-49 Foxit PhancomPOF VerslOfl 9

• 1 Chris R. Roache EnergySo/utions D&D QA Based on the 10 CFR 50.54 (a)/ 10 CFR 71.106 evaluation, do the proposed changes to the DQAP reduce the commitments of the current Dominion QATR, requiring submittal to the USN RC?

Yes X

No Joseph R.

Lynch Joseph R. Lynch

[J;gitally signed by Joseph R Lynch Date: 2022.02.25 14:31:32

-05'00' Kewaunee Solutions Licensing Manager Page 10 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP S0.54(a) Evaluation Evaluation Section Ill: Detailed Comparison and Evaluation Prior NRC QA TR Section Change(s)

Evaluation and Justification Approval?

Cover Page The title of the KS DQAP differs from the title of These changes are administrative improvements NO the QATR. With the new title, the revision was and clarifications, spelling corrections, punctuation, reset to 0. In addition, the DQAP title page or editorial items as described in 10 CFR 50.54(a)(3).

includes the signatures required by the Therefore, the changes are not a reduction in EnergySolutions administrative procedures.

commitment, and may be implemented without prior NRC approval.

Introduction The Introduction of the KS DQAP differs from Many of these changes are due to the different YES the Introduction of the QATR in several respects :

company names, and the fact that the QATR is a The company names and background fleet program, and the DQAP is not. Not describing information differ. The detail in the QATR activities affecting quality in this section is Introduction describing activities affecting inconsequential, since the full range of the 10 CFR quality is not in the DQAP Introduction. The 50 Appendix B criteria are included in the DQAP.

QATR states that controls are comparable to a These changes are administrative improvements full range of the stages of plant life. The DQAP and clarifications, spelling corrections, punctuation, language is specific to a plant in or editorial items as described in 10 CFR 50.54(a)(3),

decommissioning only, and describes a graded that are not a reduction in commitment, except as approach to quality.

follows:

1) The DQAP controls are not comparable to a full range of the stages of plant life. They are applicable to decommissioning activities only.

This change is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval.

Reduction #1: This change is aligned with the status of KPS in the decommissioning stage, with no plant Structures, Systems and Components (SSCs) classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the Independent Spent Fuel Storage Installation (ISFSI).

It is no longer necessary to apply the level of control Page 11 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation Prior NRC QA TR Section Change(s)

Evaluation and Justification Approval?

commensurate with construction and operational activities to the KPS nonsafety-related SSCs regulated under 10 CFR 50. The DQAP does apply the appropriate level of controls to the SSCs that are Important to Safety (ITS) under 10 CFR 71 and 10 CFR 72, via the controls aligned with Regulatory Guide 7.10. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by the NUREG 1536 and NUREG 1757 compliance matrices included in the Request for Additional Information (RAI) response. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

Policy There is no single Policy page in the DQAP as Although there is no specific Policy page in the NO there is for the QATR.

DQAP, the equivalent content of the QATR is collectively addressed in DQAP Sections 1 and 2.

Therefore, this change is an administrative improvement and clarifications, spelling corrections, punctuation, or editorial items as described in 10 CFR 50.54(a)(3). Therefore, the change is not a reduction in commitment, and may be implemented without prior NRC approval.

Basis The DQAP is stated as meeting the requirements The changes due to the fact that the QATR is a fleet YES of 10 CFR 50 Appendix B, 10 CFR 71, Subpart H, program and the DQAP is site-specific fit the and 10 CFR 72, Subpart G, with reference to description of administrative improvements and Kewaunee-specific regulatory requirements and clarifications, spelling corrections, punctuation, or commitments listed within Appendix C of the editorial items as described in 10 CFR 50.54(a)(3),

DQAP. The QATR includes additional regulatory that are not a reduction in commitment.

bases beyond those included in the DQAP in the In addition, the following changes also fit the aggregate. The QATR states commitment to Page 12 of 44

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carrying out the provisions of various NRC description of administrative improvements and Regulatory Guides and industry quality clarifications, spelling corrections, punctuation, or assurance standards of ASME, ANSI, and ANS editorial items as described in 10 CFR 50.54(a)(3),

that expound on the 18 criteria of 10 CFR 50, that are not a reduction in commitment, for the Appendix B, and states that specific reasons stated:

commitments, clarifications, and alternatives

• With respect to the listing of N UREG/CR-6407 in are described in detail within the QATR. The the DQAP, this standard is integral to the QATR includes information related to applicability to the various operating plants in implementation of Regulatory Guide (RG) 7.10.

the fleet, and the DQAP does not.

• Note that although the DQAP does not specifically list 10 CFR 21 as a program basis, 10 CFR 21 is integrally related to the commitment to 10 CFR 50, 10 CFR 71 and 10 CFR 72 in the following manner. 10 CFR 50, 10 CFR 71 and 10 CFR 72 are committed to in the DQAP. A defect in a Basic Component in the case of 10 CFR 50, or a defect in an Important-to-Safety (ITS) component in the case of 10 CFR 71 or 10 CFR 72 that creates a substantial safety hazard, is required to be reported under 10 CFR 21.

Therefore, imposition of 10 CFR 21 is implied.

Implementation details for reporting of defects and noncompliance in accordance with 10 CFR 21 are maintained in both the EnergySolutions and KS implementing procedures.

• With respect to the listing of RG 7.10 and RG 4.15 in the DQAP, this content is also aligned with the current governing QA Program at Kewaunee (Dominion Energy "Nuclear Facility Quality Assurance Program Description" Topical Report DOM-QA-1, Rev. 30, Page C-21), with the exception of the RG 7.10 revision level.

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• RG 7.10 in the QATR is Rev. 1, whereas the DQAP is Rev. 3 with consideration to the Certificate Holder RG 7.10 commitment. This is not a reduction in commitment per 10 CFR 50.54(a)(3)(i), and therefore may be implemented without prior NRC approval. This change is aligned with the following 10 CFR 50.54(a)(i) provision:

(i) "The use of a QA standard approved by the NRC which is more recent than the QA standard in the licensee's current QA program at the time of the change;"

However, the following change is a reduction in commitment per 10 CFR 50.54(a)(4):

2) In the aggregate, the QATR includes substant ially more commitments to regulatory bases than the DQAP.

This change is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approva l.

Reduction #2: These changes are aligned with t he status of KPS in the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the ISFSI. The regulatory commitments in the QATR that are not referenced in the DQAP are intended to apply a level of control that is no longer required for the KPS nonsafety-related SSCs regulated under 10 CFR 50. The DQAP does apply the appropriate regulatory and quality standards to the SSCs that Page 14 of 44

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are Important to Safety under 10 CFR 71 and 10 CFR 72, via the controls aligned with Regulatory Guide 7.10. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NUREG 1536 and NUREG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

Note: In subsequent sections of this Evaluation, where Regulatory Requirements and Commitments contained in the QATR but not in the DQAP are identified, the above justification is not repeated, reference is provided to this Basis Section.

List of Effective The List of Effective Sections in the QATR In the remainder of this Evaluation, each Section /

NO Sections / Contents includes the following Sections that are not Appendix of the QATR is evaluated in context. For discreetly included in the DQAP: Policy and purposes of this List of Effective Sections/ Contents, Basis. The QATR includes the following the differing indexing constitutes an administrative Appendices that are not included in the DQAP:

improvement and clarifications, spelling corrections, Appendix B, Management and Independent punctuation, or editorial items as described in 10 Review Activities; Appendix D, Terms and CFR 50.54(a)(3). Therefore, these changes are not a Definitions; Appendix E, QA Records Retention reduction in commitment, and may be implemented Requirements For Operating Facilities; Appendix without prior NRC approval.

F, Augmented Quality Assurance Requirements For Selected SSCs and Programs.

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Section 1, Organization Sub-Section 1.1:

The content of the QATR is general in nature, Although the content is different, the QATR content NO General Description and is specific to Dominion Energy Services, Inc.,

is general in nature, and the DQAP Section 1 does and/or Dominion Energy Kewaunee, Inc. The not differ in intent. Therefore, the changes in this content of the DQAP is different from the QA TR, section are aligned with the following 10 CFR and is specific to EnergySolutions I Kewaunee S0.54(a)(3) provisions:

Solutions. The DQAP Appendix A Organization (iii) "The use of generic organizational position Chart is substantially different from the QATR titles that clearly denote the position function, Organization Charts in Appendix A of the QA TR.

supplemented as necessary by descriptive text, rather than specific titles;"

(iv) "The use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or, alternately, the use of descriptive text;"

Therefore, the changes are not a reduction in commitment, and may be implemented without prior NRC approval.

Note that the evaluation of specific titles is included below, in the QATR section that contains the description of members of the Organization.

Subsection 1.2:

Much ofthe QATR content is fleet and not The changes due to fact that the QATR is a fleet YES Responsibility and relevant to KPS. In 1.2.1, the QATR describes a program and the DQAP is not fits the description of Authority CNO position, which is aligned with the administrative improvements and clarifications, responsibilities assigned to the President and spelling corrections, punctuation, or editorial items General Manager (GM) in the DQAP. As stated as described in 10 CFR 50.54(a)(3), that are not a in 1.2.1, the remainder of the KPS content is reduction in commitment.

contained in Subsections 1.2.4.2 through 1.2.6 For nearly all of the other changes, although the and Appendix A.

content is different, the DQAP Sections 1 and 2 are QATR 1.2.4.2 and 1.2.5 describe responsibilities consistent with the QATR in intent. Therefore, Page 16 of 44

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that are bounded by the responsibilities numerous changes in this section are aligned with ascribed to various positions in DQAP Section 1 the following 10 CFR 50.54(a)(3) provisions:

and Section 2, although the specific language (iii) "The use of generic organizational position and titles differ. QATR Section 1.2.6 describes titles that clearly denote the position fu net ion, the KPS organization as separate and distinct supplemented as necessary by descriptive text, from the fleet. The QATR description of titles rather than specific titles;"

and responsibilities are bounded by the responsibilities ascribed to various positions in (iv) "The use of generic organizational charts to DQAP Section 1 and Section 2, although the indicate functional relationships, authorities, and level of detail is more fully described in the responsibilities, or, alternately, the use of QATR and specific language and titles differ, descriptive text;"

with the following exception: The Facility However, the following change is a reduction in Safety Review Group (FSRG) function in the commitment per 10 CFR 50.54(a)(4), and therefore QA TR is replaced by the Independent Safety may not be implemented without prior NRC Review (ISR) function in the DQAP.

approval:

Subsections 1.2.7 through 1.2.9 are bounded by

3) The Facility Safety Review Group (FSRG) function the responsibilities ascribed to various positions in the QATR is replaced by the Independent in DQAP Section 1 and Section 2, although the Safety Review (ISR) function in the DQAP.

level of detail is more fully described in the QATR, and specific language and titles differ, Reduction #3: These changes are aligned with the with the following exception: Section 1.2.9 status of KPS in the decommissioning stage, with no includes specific mention of Information plant SSCs classified as safety-related, and all spent Technology (IT) services, and the DQAP does fuel removed from the spent fuel pool and stored at not.

the ISFSI. The FSRG is a deliberative review body, and the ISR is one or more technically qualified independent individuals competent and knowledgeable in the subject area being reviewed.

It is no longer necessary to apply the more complex FSRG administrative process that is suited for operating plants to review changes associated with the KPS nonsafety-related SSCs regulated under 10 CFR 50 specific to a facility in decommissioning.

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The ISR function described in the DQAP does apply comparable controls to review like changes to the SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NUREG 1536 and NUREG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

In addition, the following change is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval:

4) The QATR includes specific mention of an Information Technology (IT) services management function, and the DQAP does not.

Reduction #4: Section 1.2 of the QATR ascribes responsibilities to the IT position, of which several are not directly related to quality measures described in the QATR. For the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the ISFSI, the only potential area cited in the QATR applicable to KPS quality activities is development and maintenance of the software control program. For KPS, software controls associated with SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72 are to be developed Page 18 of 44

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and maintained by the Design Authority under their respective NRC approved QA programs, and are subject to oversight by KS as described in Section 7 of the DQAP. It is also recognized that IT services are a necessary support function to numerous areas of responsibility listed in DQAP Section 1.4. Notably in the case of document control/records management, DQAP Section 17 makes specific reference to the Nuclear Information and Records Management Association (NIRMA) standards. The IT management functions are integral to implementation of these standards, the details of which are included in EnergySolutions implementing procedures. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NUREG 1536 and NUREG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness of t he DQAP as it is applied to the ISFSI and planned decommissioning activities.

Subsection 1.3:

The QATR language applicable to KPS is bounded Although the content is different DQAP Section 1 NO Succession of by the DQAP Section 1 requirements for the GM does not differ from the QATR in intent. The Responsibility for and Decommissioning Plant Manager (DPM) to changes fit the description of administrative Overall Plant designate their functions when absent.

improvements and clarifications, spelling Operation corrections, punctuation, or editorial items as described in 10 CFR 50.54(a)(3), that are not a reduction in commitment.

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Therefore, the changes are not a reduction in commitment, and may be implemented without prior NRC approval.

Subsection 1.4:

Addressed as applicable to KPS in Subsection 1.1 Organization Charts and 1.2 above.

Subsection 1.5: Quality Addressed in Basis Section above.

Standards Commitment Section 2, Quality Assurance Program Subsection 2.1:

The content of the QATR is general in nature.

Although the content is different, DQAP Section 2 YES General Description The content of the DQAP is different from the does not differ from the QATR in intent. The QATR but bounds the QATR content with one changes fit the description of administrative exception: The QATR states that it is based on improvements and clarifications, spelling the requirements of the Regulatory Guides and corrections, punctuation, or editorial items as Industry Standards (with approved alternatives) described in 10 CFR 50.54(a)(3), that are not a described in Appendix C of the QATR.

reduction in commitment, except as noted below:

This section contains reference to Regulatory This section also contains reference to Regulatory Requirements and Commitments that are not Requirements and Commitments that are not included in the DQAP.

included in the DQAP. This is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval. [See Reduction #2 - "Basis Section"]

Subsection 2.2:

The applicability content in the QATR is general The renewed License AMP and Station Blackout are YES Applicability in nature, and is bounded by the DQAP not applicable to KPS, so not addressing these Introduction and Section 2, with the following requirements fits the description of administrative exceptions:

improvements and clarifications, spelling The QATR states that the following documents corrections, punctuation, or editorial items as further describe application of portions ofthe described in 10 CFR 50.54(a)(3), that are not a QA program, where appropriate: The Safety reduction in commitment.

Analysis Report (SAR), renewed license aging Page 20 of 44

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management program (AMP), nuclear design The following differences between the QATR and control program, physical security plan, the DQAP represent a reduction in commitment per emergency plan, radiological protection plan 10 CFR 50.54(a)(4), and therefore may not be including radioactive material transport and implemented without prior NRC approval:

radioactive waste processing, fire protection

5) The QATR states that numerous program plan, station blackout program, nuclear documents further describe application of chemistry laboratory quality assurance program.

portions of the QA program, and the DQAP does The DQAP does not make a similar statement.

not. The documents listed in the QATR are the Appendix F of the QATR provides specific Safety Analysis Report (SAR), nuclear design program controls to be applied to certain control program, physical security plan, nonsafety-related SSCs and includes a Risk emergency plan, radiological protection plan Informed Categorization description. The DQAP including radioactive material transport and Appendix D requires management controls be radioactive waste processing, fire protection applied to specific nonsafety-related SSCs but plan and nuclear chemistry laboratory quality specific controls are not included in the DQAP.

assurance program.

6) The DQAP does not include a Risk Informed Categorization description and specific controls to be applied to nonsafety-related SSCs analogous to QATR, Appendix F.

Reduction #5 and #6: These changes are commensurate with the status of KPS in t he decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the ISFSI. Although the DQAP does not make a statement comparable to the one in the QATR, the DQAP emphasizes that implementing procedures and program documents are required to include sufficient level of detail to meet applicable regulatory requirements. This will ensure that the applicability of the DQAP and the appropriate Page 21 of 44

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portions of the DQAP as they relate to implementing procedures and program documents will be clearly described. It is no longer necessary to apply the classification system represented by the Risk Informed Categorization, and pre-established minimum QA requirements, to nonsafety-related SSCs regulated under 10 CFR SO. DQAP Section D requ ires the continued application of formal administrative controls to those SSCs that warrant augmented quality requirements during all phases of decommissioning. KS will maintain other regulatory programs (e.g., physical security plan, emergency plan, radiological protection plan, radioactive material transport not addressed in 10 CFR 71, and radioactive waste processing) that establish measures to ensure KS decommissioning activities are conducted in accordance with the applicable regulatory requirements, wit h a focus on safety, quality and compliance. The absence of detail in the DQAP for these program areas does not diminish KS commitment or responsibility for compliance. Additionally, it is no longer necessary to apply the classification system represented by the Risk Informed Categorization, and pre-established minimum QA requirements, to nonsafety-related SSCs regulated under 10 CFR SO. DQAP Section D requires the continued application of administrat ive controls to those SSCs that warrant augmented quality requirements during decommissioning.

Summar't, tor Reduction #5 and #6: The DQAP does apply the appropriate level of controls in the administrative processes associated with decommissioning and SSCs that are Important to Page 22 of 44

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Safety under 10 CFR 71 and 10 CFR 72, via the controls aligned with Regulatory Guide 7.10. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NUREG 1536 and NUREG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

This section also contains reference to Regulatory Requirements and Commitments that are not included in the DQAP. This is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval. [See Reduction #2 - "Basis Section"]

Subsection 2.3:

The content in the QATR is general in nature and Although the content is different, DQAP Sections 2, YES Oversight of the is bounded by the DQAP Introduction and 10 and 18 in the aggregate do not differ from the Quality Program Sections 2, 10 and 18, with the following QATR in intent. The changes fit the description of Implementation exceptions: The review groups described in the administrative improvements and clarifications, QATR Appendix Bare the MSRC (offsite) and spelling corrections, punctuation, or editorial items FSRG (onsite). The DQAP replaces the MSRC as described in 10 CFR 50.54(a)(3), that are not a with the IMA, and the FSRG with the ISR.

reduction in commitment, except as follows:

7) The QATR Management Safety Review Committee (MSRC) was replaced with the Independent Management Assessment (IMA) in the DQAP.

(Note that the QATR FSRG was replaced with the DQAP ISR - this was addressed in Subsection 1.2 of this evaluation)

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Reduction #7: These changes are aligned with the status of KPS in the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the ISFSI. The MSRC is a deliberative review body, and the IMA is one or more technically qualified independent individuals competent and knowledgeable in the subject area(s) being reviewed. It is no longer necessary to apply the composition of the MSRC to evaluate the KS QA program implementation and effectiveness associated with the KPS nonsafety-related SSCs regulated under 10 CFR 50. The IMA is a comparable administrative process to evaluate the effectiveness of the KS QA program as it applies to decommissioning under 10 CFR 50, and for assessment of activities associated with the SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NUREG 1536 and NUREG 1757 as detailed in individual compliance matrices.

Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is a pp lied to the ISFSI and planned decommissioning activities.

This section also contains reference to Regulatory Requirements and Commitments that are not included in the DQAP. This is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval. rsee Reduction #2 - "Basis Section"l Page 24 of 44

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Subsection 2.4:

The content in the QATR is general in nature and Although the content is different DQAP Appendix B NO Identification of is bounded by the DQAP Appendix B.

does not differ from the QATR in intent. The Structures, Systems, changes fit the description of administrative and Components (SSC) improvements and clarifications, spelling corrections, punctuation, or editorial items as described in 10 CFR 50.54(a)(3), that are not a reduction in commitment.

Subsection 2.5:

The content in the QATR is general in nature and Although the content is different, except as noted, YES Selection, Training, is bounded by the DQAP Section 2 and Appendix DQAP Section 2 and Appendix D do not differ from and Qualification of D, except as follows: The QATR cites 10 CFR the QATR in intent. The changes fit the description Personnel 50.120, the DQAP does not. The QATR provides of administrative improvements and clarifications, detailed description and specific requirements spelling corrections, punctuation, or editorial items for the following specific positions, and the as described in 10 CFR 50.54(a)(3), that are not a DQAP does not: The Plant Manager, the KPS reduction in commitment, except as follows:

manager responsible for Operations and

8) The QATR cites 10 CFR 50.120 and the DQAP Maintenance, the KPS manager responsible for does not.

Technical Support functions, the KPS manager responsible for directing one or more Facility

9) The detailed content of the QATR for training Programs and Processes described in 1.2.6.4 and qualifications for staff positions was replaced (Facility Programs and Processes), the KPS with DQAP Appendix D, Section B, 3.1.

manager having overall responsibility for These changes are a reduction in commitment per directing Radiological Protection and Chemistry 10 CFR 50.54(a)(4), and therefore may not be activities (when other than the Radiation implemented without prior NRC approval.

Protection Manager), and Supervisory Personnel principally responsible for directing the actions Reduction #8 and #9: These changes are aligned of operators, technicians, or repairmen.

with the status of KPS in the decommissioning The DQAP Appendix D requires that facility stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool staff responsible for the safe storage of and stored at the ISFSI. It is no longer necessary to nuclear fuel and selected decommissioning apply the level of control of the 10 CFR 50.120 activities shall meet or exceed the minimum Systems Approach to Training (SAT) process to staff qualifications of ANSI N18.l-1971 for qualifications associated with the KPS nonsafety-comparable positions as defined in approved related SSCs regulated under 10 CFR SO, nor is it Page 25 of 44

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procedures except for: a) the radiation necessary to provide detailed descriptions of the protection manager who shall meet or qualification requirements for plant staff positions exceed the qualifications of Regulatory in the QA program. KS will maintain required Guide 1.8, September 1975, and relies upon regulatory programs (e.g., Radiation Protection, administrative procedures (management Radioactive Waste, Final Status Survey, Security) controls) to provide the details.

that establish measures to require, conduct and control training/qualifications to ensure KS decommissioning activities are executed in accordance with the applicable regulatory requirements through the sets of implementing procedures. The DQAP Section 2 training requirements provide an appropriate level of controls for the training requirements for decommissioning and ISFSI/Operations staff performing activities under the scope of the DQAP, including any specific training required by the License. The DQAP Appendix D Section B, 3.1 requirement is an appropriate administrative process for establishing qualification requirements for staff conducting decommissioning activities conducted under 10 CFR 50, and for establishing qualification requirements associated with the SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, via the controls aligned with Regulatory Guide 7.10. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NUREG 1536 and NUREG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

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Subsection 2.6:

The content in the QATR is general in nature and Although the content is different, the DQAP in the NO Control of Activities is bounded by all Sections in the DQAP.

aggregate does not differ from the QATR in intent.

The changes fit the description of administrative improvements and clarifications, spelling corrections, punctuation, or editorial items as described in 10 CFR 50.54(a)(3), that are not a reduction in commitment.

Subsection 2.7: Quality Addressed in Basis Section above.

Standards Commitment Section 3, Design The content in the QATR is general in nature and Although the content is different in general, and YES Control is bounded by the DQAP, with the following differs as related to setpoint control, DQAP Sections exceptions:

5 and 11 in the aggregate do not differ from the The QATR Subsection 3.2.5 includes specific QATR in intent. The changes fit the description of requirements for setpoint control. Although the administrative improvements and clarifications, DQAP does not include these requirements to spelling corrections, punctuation, or editorial items the level of detail as in the QATR, DQAP Sections as described in 10 CFR 50.54(a)(3), that are not a 5 and 11 bound the intent of the QATR.

reduction in commitment, except as noted below:

The QATR Subsection 3.2.4 includes lO)The absence of controls for software in the requirements for software design and control.

DQAP is a reduction in commitment per 10 CFR The DQAP does not.

50.54(a)(4) and therefore may not be implemented without prior NRC approval.

This section contains reference to Regulatory This change is a reduction in commitment per 10 Requirements and Commitments that are not included in the DQAP.

CFR S0.54(a)(4), and therefore may not be implemented without prior NRC approval.

Reduction #10: This change is aligned with the status of KPS in the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the ISFSI. It is no longer necessary to apply the level of control to software associated with the KPS Page 27 of 44

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nonsafety-related SSCs regulated under 10 CFR 50.

With respect to software controls associated with SSCs that are Important to Safety (ITS) under 10 CFR 71 and 10 CFR 72, DQAP Appendix B states that any design changes (that would employ software as part of the design process) to ITS SSCs would be made by the specific Design Authority, including EnergySo/utions, under their QA Program, not the DQAP. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NUREG 1536 and NUREG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

This section also contains reference to Regulatory Requirements and Commitments that are not included in the DQAP. This is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval. [See Reduction #2 - "Basis Section"]

Section 4, The content in the QATR is general in nature and Although the content is different in general, DQAP YES Procurement is bounded by the DQAP primarily in Section 4, Sections 1, 7 and 18 in the aggregate do not differ Document Control but additional language related to suppliers is from the QATR in intent. The changes fit the also included in DQAP Sections 1, 7 and 18.

description of administrative improvements and This section contains reference to Regulatory clarifications, spelling corrections, punctuation, or Requirements and Commitments that are not editorial items as described in 10 CFR 50.54(a)(3),

included in the DQAP.

that are not a reduction in commitment, with the following exception:

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This section also contains reference to Regulatory Requirements and Commitments that are not included in the DQAP. This is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval. [See Reduction #2 - "Basis Section"]

Section 5, The content of Subsections 5.1 through 5.3 in Although the content is different in general, DQAP YES Instructions, the QATR is general in nature and is bounded by Section 5 and Appendix D in the aggregate do not Procedures, and DQAP Section 5, and in numerous other DQAP differ from the QATR in intent. The detail in the Drawings sections in context, with the following QATR for the administrative execution of exceptions:

procedures is standard content found in QATR Sub-section 5.2 provides more explicit administrative procedure processes. The provision detail in the administrative execution of for suspending procedure adherence in emergency procedures than the DQAP, and includes a conditions is also a typical administrative provision for suspending procedure adherence component, one that is much more relevant to an in emergency conditions that is not included in operating reactor. The changes fit the description the DQAP.

of administrative improvements and clarifications, spelling corrections, punctuation, or editorial items QATR Sub-section 5.4 includes much detail as described in 10 CFR 50.54(a)(3), that are not a about the types of procedures but does allow reduction in commitment, with the following for flexibility in applicability of the procedure exception:

types by plant. In addition, there is a Sub-This section also contains reference to Regulatory section 5.4.17 specific to KPS. The DQAP does not provide the different types of procedures Requirements and Commitments that are not listed in the QATR, but the KPS procedures listed included in the DQAP. This is a reduction in in QATR Sub-section 5.4.17 are included in DQAP commitment per 10 CFR 50.54(a)(4), and therefore Appendix D.

may not be implemented without prior NRC approva I. [See Reduction #2 - "Basis Section"]

This section contains reference to Regulatory Requirements and Commitments that are not included in the DQAP.

Page 29 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation Prior NRC QATR Section Change(s)

Evaluation and Justification Approval?

Section 6, Document The content of Subsections 6.1 through 6.3 in Although the content is different in general, DQAP YES Control the QATR is general in nature, and is bounded by Section 6 and Append ix D in the aggregate do not DQAP Section 6, and in numerous other DQAP differ from the QATR in intent. The detail in the sections in context, with the following QATR for the administrative execution of exceptions:

procedures is standard content found in The QATR lists of documents to be controlled is administrative procedure processes. The provision more detailed than the DQAP. The QATR for suspending procedure adherence in emergency includes specific detail on review requirements conditions is also a typical administrative (e.g., a specific requirement for QA to review component, one that is much more relevant to an changes to inspection procedures), and the operating reactor. The changes fit the description DQAP does not.

of administrative improvements and clarifications, spelling corrections, punctuation, or editorial items QATR Section 6.4 includes additional operational as described in 10 CFR 50.54(a)(3), that are not a review controls, including the FSRG, and reduction in commitment, with the following includes controls for temporary procedure exceptions:

changes. The DQAP does not include additional This section also contains reference to Regulatory operational review controls in Section 6 and does not include controls for temporary Requirements and Commitments that are not procedure changes. However, DQAP Appendix included in the DQAP. This is a reduction in D includes the ISR, which replaces the FSRG.

commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC QATR Section 6.5 includes additional detail for approval. [See Reduction #2 - "Basis Section"]

administrative elements of control (e.g. use of an index) than the DQAP.

This section contains reference to Regulatory Requirements and Commitments that are not included in the DQAP.

Section 7, Control of The content in Subsections 7.1 through 7.4 in Although the content is different in general, DQAP YES Purchased Material, the QATR is general in nature, and is bounded by Sections 7, 10 and 18 in the aggregate do not differ Equipment, and DQAP Sections 7, 10 and 18, with the following from the QATR in intent. The changes fit the Services exceptions: The QATR includes NUPIC, which is description of administrative improvements and not applicable to the DQAP (ES/KS are not clarifications, spelling corrections, punctuation, or NUPIC members). The QATR specifically lists editorial items as described in 10 CFR 50.54(a)(3),

Page 30 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation Prior NRC QA TR Section Change(s)

Evaluation and Justification Approval?

NRC correspondence as it relates to supplier that are not a reduction in commitment, with the evaluation, the DQAP does not. The QATR has a following exception:

more detailed description than the DQAP on

11) The QATR has additional detail in the QATR on selection of suppliers, measures for acceptance selection of suppliers, measures for acceptance and quality verifications.

and quality verifications, and reference to NRC This section contains reference to Regulatory correspondence that the DQAP does not. DQAP Requirements and Commitments that are not is a reduction in commitment per 10 CFR included in the DQAP.

50.54(a)(4), and therefore may not be Note that the DQAP Section 7 includes content implemented without prior NRC approval.

for conduct of Supplier audits that was in QATR This is a reduction in commitment per 10 CFR Section 18. The changes are described in 50.54(a)(4), and therefore may not be implemented Section 18 of this Evaluation.

without prior NRC approval.

Reduction #11: These changes are aligned with the status of KPS in the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the ISFSI. It is no longer necessary to apply the level of detail to suppliers associated with the KPS nonsafety-related SSCs regulated under 10 CFR 50.

With respect to suppliers associated with SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, these suppliers are identified in DQAP Appendix B, with the exception of the supplier which will be providing the GTCC transportation packages in the future. In this case, the potential list of suppliers is limited to those suppliers with NRC approved QA programs, that hold an NRC issued Certificate of Compliance (CoC) for the GTCC transportation package. The DQAP does apply the appropriate thoroughness for the control of purchased items and services for the SSCs that are Important to Page 31 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation Prior NRC QATR Section Change(s)

Evaluation and Justification Approval?

Safety under 10 CFR 71 and 10 CFR 72, via the controls aligned with Regulatory Guide 7.10. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NUREG 1536 and NUREG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

This section also contains reference to Regulatory Requirements and Commitments that are not included in the DQAP. This is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval. [See Reduction #2 - "Basis Section"]

Section 8, The content in the QATR is general in nature and Although the content is different, DQAP Section 8 YES Identification and although somewhat more detailed than the does not differ from the QATR in intent. The Control of Materials, DQAP, is bounded by DQAP Section 8, except as changes fit the description of administrative Parts, and follows:

improvements and clarifications, spelling Components This section contains reference to Regulatory corrections, punctuation, or editorial items as Requirements and Commitments that are not described in 10 CFR 50.54(a)(3), that are not a included in the DQAP.

reduction in commitment, except as follows:

This section also contains reference to Regulatory Requirements and Commitments that are not included in the DQAP. This is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval. [See Reduction #2 - "Basis Section"]

Page 32 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation Prior NRC QA TR Section Change(s)

Evaluation and Justification Approval?

Section 9, Control of The content in the QATR is general in nature and Although the content is different, DQAP Section 9 YES Special Processes although somewhat more detailed than the does not differ from the QATR in intent. The DQAP, is bounded by DQAP Section 9, except as changes fit the description of administrative follows:

improvements and clarifications, spelling This section contains reference to Regulatory corrections, punctuation, or editorial items as Requirements and Commitments that are not described in 10 CFR 50.54(a)(3), that are not a included in the DQAP.

reduction in commitment, except as follows:

This section also contains reference to Regulatory Requirements and Commitments that are not included in the DQAP. This is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval. [See Reduction #2 - "Basis Section"]

Section 10, Inspection The content in the QATR is general in nature and Although the content is different, DQAP Sections 2 YES is bounded by DQAP Sections 2 and 10, except and 10 do not differ from the QATR in intent. The as follows:

changes fit the description of administrative This section contains reference to Regulatory improvements and clarifications, spelling Requirements and Commitments that are not corrections, punctuation, or editorial items as included in the DQAP.

described in 10 CFR 50.54(a)(3), that are not a reduction in commitment, except as follows:

This section also contains reference to Regulatory Requirements and Commitments that are not included in the DQAP. This is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval. [See Reduction #2 - "Basis Section"]

Section 11, Test The content in the QATR is general in nature and Although the content is different, DQAP Section 11 YES Control includes substantially more detail than DQAP does not differ from the QATR in intent. The Section 11. The additional detail includes detail changes fit the description of administrative related to preoperational testing, startup improvements and clarifications, spelling testing, and scheduling.

corrections, punctuation, or editorial items as Page 33 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation Prior NRC QATR Section Change(s)

Evaluation and Justification Approval?

This section contains reference to Regulatory described in 10 CFR 50.54(a)(3), that are not a Requirements and Commitments that are not reduction in commitment, except as follows:

included in the DQAP.

12) The additional detail related to preoperational testing, startup testing, and scheduling, is largely irrelevant, but not 100% irrelevant.

This represents a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval (Ref. Basis Section above).

Reduction #12: These changes are aligned with the status of KPS in the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the ISFSI. It is no longer necessary to apply an operational plant level of control to tests associated with the KPS nonsafety-related SSCs regulated under 10 CFR 50. With respect to tests associated with SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, the DQAP does apply the appropriate controls to testing the SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, via the controls aligned with Regulatory Guide 7.10.

The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NUREG 1536 and NUREG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

Page 34 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation QA TR Section Section 12, Control of Measuring and Test Equipment Page 35 of 44 Change(s)

The content in the QATR is general in nature and is at a comparable level of detail with DQAP Section 12. DQAP Section 12 contains additional detail on calibration accuracies, and more detail on general administrative processes associated with M&TE control. The QATR includes reference to commercial grade dedication of calibration services that is included in DQAP Section 4. The QATR describes installed Instrument and Control devices, the DQAP does not.

This section contains reference to Regulatory Requ irements and Commitments that are not included in the DQAP.

Evaluation and Justification This section also contains reference to Regulatory Requirements and Commitments that are not included in the DQAP. This is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval. [See Reduction #2- "Basis Section"]

Although the content is different, DQAP Sections 4 and 12 do not differ from the QA TR in int ent. With respect to the detail for installed Instrument and Control devices in the QATR, this is explicitly stated as being for the operations phase of the facilities.

Therefore it is not applicable to KPS decommissioning activities. Also, there is additional detail in the DQAP that is additive. The changes fit the description of administrative improvements and clarifications, spelling corrections, punctuation, or editorial items as described in 10 CFR 50.54(a)(3),

that are not a reduction in commitment, except as follows:

This section also contains reference to Regulatory Requirements and Commitments that are not included in the DQAP. This is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval. [See Reduction #2 - "Basis Section"]

Prior NRC Approval?

YES

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation QATR Section Section 13, Handling, Storage, and Shipping Section 14, Inspection, Test, and Operating Status Page 36 of 44 Change(s)

The content in the QATR is general in nature and is at a comparable level of detail with DQAP Section 13. DQAP Section 13 contains additional detail related to 10 CFR 71 licensed shipments that is not included in the QATR.

This section contains reference to Regulatory Requirements and Commitments that are not included in the DQAP.

The content in the QATR includes substantially more detail than DQAP Section 14. The additional detail includes authority for implementing controls, temporary controls, independent verifications, and operational considerations particular to SSCs at an operating reactor.

This section contains reference to Regulatory Requirements and Commitments that are not included in the DQAP.

Evaluation and Justification Although the content differs somewhat, DQAP Section 13 does not differ from the QATR in intent.

The additional detail in the DQAP is additive, and is acceptable based on the fact that the DQAP is considered a Quality Assurance Project Plan (QAPP) under the ES-QA-PG-001 "Energy Solutions Quality Assurance Program", which is approved by the NRC under 10 CFR 71, on Form 313, Approval Number 0935, Rev. 10, dated 7 /5/19 (included in this submittal. The changes fit the description of administrative improvements and clarifications, spelling corrections, punctuation, or editorial items as described in 10 CFR 50.54(a)(3), that are not a reduction in commitment, except as follows:

This section also contains reference to Regulatory Requirements and Commitments that are not included in the DQAP. This is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval. [See Reduction #2 - "Basis Section"]

Although there is substantially more detail in the QATR, the content that is in the DQAP Section 14 does not differ from the QATR in intent. The changes fit the description of administrative improvements and clarifications, spelling corrections, punctuation, or editorial items as described in 10 CFR 50.54(a)(3), that are not a reduction in commitment, except as follows:

13) The additional detail in the QATR that is not in the DQAP related to the authority for implementing controls, temporary controls, independent verifications, and operational Prior NRC Approval?

YES YES

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation Prior NRC QA TR Section Change(s)

Evaluation and Justification Approval?

considerations particular to SSCs at an operating reactor.

This is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval.

Reduction #13: These changes are aligned with the status of KPS in the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at the ISFSI. It is no longer necessary to apply an operational plant level of control to implementing controls, temporary controls, independent verifications, and operational considerations to the KPS nonsafety-related SSCs regulated under 10 CFR 50 and associated with a plant in decommissioning as compared to the operational considerations described in the QATR. With respect to these types of controls associated with SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, the DQAP does apply the appropriate controls for the SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, via the controls aligned with Regulatory Guide 7.10. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NUREG 1536 and NUREG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

Page 37 of 44

letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation Prior NRC QA TR Section Change(s)

Evaluation and Justification Approval?

This section also contains reference to Regulatory Requirements and Commitments that are not included in the DQAP. This is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval. [See Reduction #2 - "Basis Section"]

Section 15, The content in the QATR is general in nature and Although the content differs somewhat, DQAP YES Nonconforming is at a comparable level of detail with DQAP Section 15 does not differ from the QATR in intent.

Materials, Parts, or Section 15. The QATR includes a specific The reference to 10 CFR 21 is explained previously Components reference to 10 CFR 21 that is not in the DQAP.

in this Evlaution, see "Basis Section". A conditional The QATR includes detail related to a conditional release process is an administrative convenience, release process that is not in the DQAP.

not a requirement. The changes fit the description This section contains reference to Regulatory of administrative improvements and clarifications, Requirements and Commitments that are not spelling corrections, punctuation, or editorial items included in the DQAP.

as described in 10 CFR 50.54(a)(3), that are not a reduction in commitment, except as follows:

This section also contains reference to Regulatory Requirements and Commitments that are not included in the DQAP. This is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval. [See Reduction #2 - "Basis Section"]

Section 16, Corrective The content in the QATR is general in nature and Although the content differs somewhat, DQAP YES Action is at a comparable level of detail with DQAP Section 16 does not differ from the QATR in intent.

Section 16. The QATR includes a specific The reference to 10 CFR 21 is explained previously reference to 10 CFR 21 that is not in the DQAP.

in this Evia ution, see "Basis Section". The changes The QATR includes an independent assessment fit the description of administrative improvements of corrective actions that is included indirectly in and clarifications, spelling corrections, punctuation, the DQAP, by virtue of the internal audit or editorial items as described in 10 CFR 50.54(a)(3),

requirements for DQAP implementing activities.

that are not a reduction in commitment, except as follows :

Page 38 of44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation Prior NRC QATR Section Change(s)

Evaluation and Justification Approval?

This section contains reference to Regulatory This section also contains reference to Regulatory Requirements and Commitments that are not Requirements and Commitments that are not included in the DQAP.

included in the DQAP. This is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval. [See Reduction #2 - "Basis Section"]

Section 17, Quality The content in the QATR includes more detail Since the DQAP Section 17 commits to the NIRMA YES Assurance Records than DQAP Section 17. The additional detail standards, the fact that the DQAP does not include includes detail related to records indexing detail contained in the NIRMA standards is not a (including the Appendix E), implementation of reduction in commitment per 10 CFR 50.54(a)(3)(v),

NIRMA standards, and records control and and therefore may be implemented without prior storage measures.

NRC approval. This change is aligned with the The NIRMA standards cited in the DQAP are following 10 CFR 50.54(a)(v) provision :

more recent revisions that those cited in the (v) "The elimination of quality assurance program QATR. The QATR Section 17 commits to the information that duplicates language in quality following:

assurance regulatory guides and quality assurance NIRMA TG-11-1998 standards to which the licensee is committed;"

NIRMA TG-15-1998 With respect to the DQAP committing to more NIRMA TG-16-1998 recent NIRMA standards than the QATR, this is not a NIRMA TG-21-1998 reduction in commitment per 10 CFR 50.54(a)(3)(i),

The DQAP Section 17 commits to the following:

and therefore may be implemented without prior NRC approval. This change is aligned with the NIRMA TGll-2011 following 10 CFR 50.54(a)(i) provision:

NIRMA TGlS-2011 (i) "The use of a QA standard approved by the NIRMA TG16-2017 NRC which is more recent than the QA standard in NIRMA TG21-2011 the licensee's current QA program at the time of This section contains reference to Regulatory the change;"

Requirements and Commitments that are not included in the DQAP.

Page 39 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation Prior NRC QA TR Section Change(s)

Evaluation and Justification Approval?

Previous revisions of these NIRMA guidelines have been endorsed by RIS 2000-18, Guidance on Managing Quality Assurance Records in Electronic Media, dated October 23, 2000.

In the case of the additional detail related to records control and storage measures, although the content differs, the DQAP does not differ from the QATR in intent. The changes fit the description of administrative improvements and clarifications, spelling corrections, punctuation, or editorial items as described in 10 CFR 50.54(a)(3), that are not a reduction in commitment, except as follows:

14) The QATR includes detail related to records indexing (including the Appendix E) not included in the DQAP.

This is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval.

Reduction #14: These changes are aligned with the status of KPS in the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at thelSFSI. It is no longer necessary to apply operational plant level of indexing and control to records associated with the SSCs regulated under 10 CFR 50. With respect to the removal of records indexing detail from the DQAP, whether from the 10 CFR 50, 10 CFR 71 or 10 CFR 72 perspective, KS is committed to the Regulatory Requirements and Commitments listed on DQAP Appendix C, so this is without impact. The QATR Appendix E records Page 40 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation Prior NRC QATR Section Change(s)

Evaluation and Justification Approval?

indexing information, "QA Records Retention Requirements for Operating Facilities" is relevant to KPS in a historical sense only, given the NRC records exemptions cited in Section 17 of the QATR that are not reflected on Appendix C. With respect to records associated with SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, the DQAP does apply the appropriate controls for records supporting the SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, via the controls aligned with Regulatory Guide 7.10. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NUREG 1536 and NUREG 1757 as detailed in individual compliance matrices. Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

This section also contains reference to Regulatory Requirements and Commitments that are not included in the DQAP. This is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approva I. [See Reduction #2 - "Basis Section"]

Section 18, Quality The content in the QATR is at a comparable level In the DQAP, content related to Supplier audits was YES Assurance Audits of detail with DQAP Section 18. The QATR moved to Section 7. Subsection 7.2.1 includes a Section 18 includes a specific reference to 25% (i.e. 9 month) grace period for extenuating annual evaluation of suppliers, whereas the circumstances, with specific control measures. This DQAP Section 7 states timing of supplier change is not a reduction in commitment per 10 CFR evaluations at intervals commensurate with 50.54(a)(3)(ii), and therefore may be implemented Page 41 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation Prior NRC QA TR Section Change(s)

Evaluation and Justification Approval?

safety significance. The QATR includes a fire without prior NRC approval. This change is aligned protection equipment and program with the following 10 CFR 50.54(a)(ii) provision ::

implementation inspection and audit, utilizing (ii) "The use of a quality assurance alternative or either a qualified offsite licensed fire protection exception approved by an NRC safety evaluation, engineer, or an outside qualified fire protection provided that the bases of the NRC approval are consultant that the DQAP does not include.

applicable to the licensee's facility;"

The DQAP contains a 25% grace period applied This change is deemed acceptable based on the fact to external audits that the QATR does not the additional grace period for external audits for include. The DQAP contains provision to extenuating circumstances was approved by the conduct in-process surveillance to be credited NRC with an SER in response to a request from toward audit activity that the QATR does not Callaway station (Ref. SER dated August 6, 2020, include.

ADAMS Accession No. ML20216A681).

This section contains reference to Regulatory The use of in-process surveillances is an Requirements and Commitments that are not enhancement that fits the description of included in the DQAP.

administrative improvements and clarifications, spelling corrections, punctuation, or editorial items as described in 10 CFR 50.54(a)(3).

Other than as described above, although the content differs somewhat, DQAP Sections 7 and 18 do not differ from the QATR in intent, so the changes fit the description of administrative improvements and clarifications, spelling corrections, punctuation, or editorial items as described in 10 CFR 50.54(a)(3), that are not a reduction in commitment, except as follows:

15) The QATR contains detail related to the Fire Protection audit that the DQAP does not.

This is a reduction in commitment per 10 CFR S0.54(a)(4), and therefore may not be implemented without prior NRC approval.

Page 42 of 44

letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation Prior NRC QA TR Section Change(s)

Evaluation and Justification Approval?

Reduction #15: These changes are aligned with the status of KPS in the decommissioning stage, with no plant SSCs classified as safety-related, and all spent fuel removed from the spent fuel pool and stored at thelSFSI. The current KPS license Basis for Fire Protection is 10 CFR 50.48(f). The requirement in 10 CFR 50.48(f)(2) is for the licensee to assess the Fire Protection Program on a regular basis. DQAP Appendix D, Section B.4, includes the Fire Protection Program implementation. This is adequate to meet the requirement of 10 CFR 50.48(f). With respect to Fire Protection as related to the SSCs that are Important to Safety under 10 CFR 71 and 10 CFR 72, the DQAP does apply the appropriate assessment of the Fire Protection Program related to the SSCs that are Important to Safety under 10 CFR 71 and 10 CFR

72. The DQAP changes, combined with the implementing procedure commitments from Regulatory Guide 7.10, meet the 10 CFR 50, 10 CFR 71 and 10 CFR 72 regulations, as demonstrated by compliance with NUREG 1536 and NUREG 1757 as detailed in individual compliance matrices.

Therefore, the changes do not reduce the overall effectiveness of the DQAP as it is applied to the ISFSI and planned decommissioning activities.

This section also contains reference to Regulatory Requirements and Commitments that are not included in the DQAP. This is a reduction in commitment per 10 CFR 50.54(a)(4), and therefore may not be implemented without prior NRC approval. [See Reduction #2 - "Basis Section"]

Page 43 of 44

Letter No. ES-2022-02, Attachment 2, KS DQAP 50.54(a) Evaluation Prior NRC QATR Section Change(s)

Evaluation and Justification Approval?

Appendix A, Addressed as applicable to KPS in Subsection Organizational 1.2.1 and 1.2.2 above.

Relationships of Key Management and Functional Groups Appendix B, Addressed as applicable to KPS in Section 1 and Management and 2 above.

Independent Review Activities Appendix C, Addressed as applicable to KPS in Basis Section Regulatory Guides and above.

Quality Standards Commitments Appendix D, Terms The QATR Appendix Dis a detailed list of The definitions are a useful administrative tool, but No and Definitions definitions that is not included in the DQAP.

are not required, and the omission of these in the DQAP aligns with the description of adm inistrative improvements and clarifications, spelling corrections, punctuation, or editorial items as described in 10 CFR 50.54(a)(3), that are not a reduction in commitment.

Appendix E, QA Addressed as applicable to KPS in Section 17 Records Retention above.

Requirements For Operating Facilities Appendix F, Addressed as applicable to KPS in Section 2 Augmented Quality above.

Assurance Requirements For Selected SSCs and Programs Page 44 of 44

ATTACHMENT 3 KS DQAP Compliance Matrix to NUREG 1536 56 PAGES KEWAUNEE POWER STATION

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria 14.5.1 Quality Assurance Organization The QAPD should describe the structure, interrelationships, and areas of functional responsibility and authority for all organizational elements that will perform activities related to quality and safety.

KS DQAP References The structure, interrelationships, and areas offunctional responsibility and authority for all organizational elements that will perform activities related to quality and (radiological/ nuclear) safety are described throughout DQAP Section 1.

In addition, a high level organizational structure of functional areas is The following are examples of areas/items that may be also presented in DQAP Appendix A.

-~~-~~~-~~ ~-~ -~<?-~~-l?~?!_t_ !~~l_f:!1:'_f:!7_t_~!~<?!1 __ <?!_~~~ _g~_~(i_t_~-<:~i_t_f:~~~: ____________ ___ _____ __________________________________________________ ___ _________________ _

a. Measures to retain and exercise responsibility for the QA program. The assignment of responsibility for the overall QA program in no degree relieves line management of their responsibility for the achievement of quality.

b. Measures to identify and describe the QA functions performed by the applicant's QA organization or delegated to other organizations that will provide controls to ensure implementation of the applicable elements of the QA criteria.

Measures to retain and exercise responsibility for the QA program are described throughout DQAP Section 1.

The following excerpt from DQAP Section 1 addresses the line management responsibility for the achievement of quality:

"Management of line organizations at KPS are responsible to ensure that the quality of organizational work and activities meets the requirements set forth in the DQAP and KPS implementing

_procedures." [l.2.5} ____________ ___ _________ _________ ____ ____________ ________ _

Measures to identify and describe the QA functions performed by the applicant's QA organization are described in the "Quality Assurance" sub-section of DQAP Section 1.

The following excerpt from DQAP Section 1.5 addresses the QA functions delegated to other organizations: " KS may delegate the execution of portions of the work under the DQAP to others such as contractors, agents, or consultants; however, KS retains overall responsibility for those activities and the DQAP. Delegation is clearly identified in documentation and KS retains the right to verify compliance with KS quality and regulatory requirements applicable to that organization's QA Program. QA program interactions, management responsibilities, and authority for the coordinated execution of the overall QA program, are established and documented. "[1.5.1}

Page 1 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria

c. Measures to provide clear management controls and effective lines of communication should exist between the applicant's QA organizations and suppliers to ensure proper direction of the QA program and resolution of QA problems.

KS DQAP References The following excerpt from the "Quality Assurance" sub-section of DQAP Section 1 includes this responsibility assigned to the QAM:

"Establishing lines of communication and control measures between the QA organization and suppliers to ensure appropriate QA program direction and provide for resolution of QA issues." {1.3.1.D}

DQAP Section 7 states: "Procedures shall describe each organization's responsibilities for the control of purchased material, equipment, and services including the interfaces between all affected

---

-------------- --------- ----------- ----- -- ---------------- _C!:9-C!'!J!_G_~~°-'!J::~ [?:!) _ --------------------------------------------------------

d. Measures to identify onsite and offsite organizational elements The following excerpts from DQAP Section 1 include this that will function under the purview of the QA program and the requirement:

lines of responsibility.

• "Onsite and offsite organizations shall be established for decommissioning activities. The onsite and offsite organizations shall include the positions for activities affecting safety of the nuclear fuel. [1.1.3}

• Lines of authority, responsibility and communication shall be established and defined for the highest management levels through intermediate levels to include all organizational positions responsible for decommissioning activities. These relationships shall be documented and updated as appropriate, in the form of organization charts, functional descriptions of departmental responsibilities and relationships, and job descriptions for key personnel positions, or in equivalent forms of documentation." {1.1.4}

The following excerpt from the "Station Management" sub-section of DQAP Section 1 also addresses this requirement:

"Management may be comprised of on-site and off-site staff, and individuals may be responsible for more than one functional area." {1.4.8}

Page 2 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria

e. Measures to ensure that high-level management is responsible for documenting and promulgating the applicant's QA policies, goals, and objectives, and this management level should maintain a continuing involvement in QA matters. The application should also describe the lines of communication between intermediate levels of management and between this position and the Manager (or Director) of QA.

KS DQAP References The following excerpt from DQAP Section 1 establishes direct linkage from the highest management level to the GM: "The General Manager {GM} reports to the Kewaunee Solutions President, and has the overall responsibility for the establishment and execution of the DQAP." [1.1.2}

The GM responsibilities are included throughout DQAP Section 1, and include reviewing and approving the DQAP, which embodies the KS QA policies, goals, and objectives, as well as maintaining a continuing involvement in QA matters.

The following excerpts from DQAP Section 1 address the requirement for establishing communication through the various levels of the organization and between the GM and QAM :

• "Lines of authority, responsibility and communication shall be established and defined for the highest management levels through intermediate levels to include all organizational positions responsible for decommissioning activities. {1.1.4}

• The QAM reports to the GM and shall not be assigned responsibilities that would prevent the required attention to important to safety matters. Although reporting to the GM with other line organizations, the QAM shall have the necessary independence from other line management to ensure effective

_____________________________________ ____ _______________________ ________________ ___ _____ oversight for all organizations." {1.3.1} ___________ ____________________ _

f.

Measures to designate a position that retains overall authority The following excerpt from DQAP Section 1 addresses this and responsibility for the QA program.

requirement: "The General Manager {GM} reports to the Kewaunee Solutions President, and has the overall responsibility for the

____________________________________ ____ _________ __ ______ ________ ___________ _______ _ establishment_and execution _of the DQAP." [1.1.2} ______________________ _

g.

Measures to provide authority and independence of the individual responsible for managing the QA program should be such that he or she can direct and control the organization's QA The following excerpts from the "Quality Assurance" sub-section of DQAP Section 1 addresses this requirement:

• "The QAM reports to the GM and shall not be assigned program, effectively ensure conformance to quality requirements, responsibilities that would prevent the required attention to and remain sufficiently independent of undue influences and important to safety matters. Although reporting to the GM with

____ _ responsibilities_ of schedules and costs._ In addition, measures to ________________________________________________________________ ____________________ _

Page 3 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria have this individual report to at least the same organizational level as the highest line manager directly responsible for performing activities affecting quality.

KS DQAP References other line organizations, the QAM shall have the necessary independence from other line management to ensure effective oversight for all organizations." {1.3.1}

• "The individuals who carry out radiation protection and quality assurance functions may report to the appropriate onsite manager; however, they shall have sufficient organizational freedom to ensure their ability to perform their assigned functions." {l.3.4}

In addition, as shown on DQAP Exhibit A and as described in Section 1, line managers directly responsible for performing activities

---

-~!!~~_t_i!l_~ _g~-~!i~y_ ~~l?~r::t. ~~ _t_~~-~ ~ ! -~~-~ -~~~- ~~~ -~~~<?-~~-!?_ !~_': _~-~: --

h. Measures for individuals or groups responsible for defining and The following excerpt from DQAP Section 1 establishes the controlling the content of the QA program and related manuals to organizational position and authority for the DQAP: "The General have appropriate organizational position and authority, as should Manager (GM} reports to the Kewaunee Solutions President, and has the management level responsible for final review and approval.

the overall responsibility for the establishment and execution of the DQAP." {l.1.2}

DQAP review and approval responsibilities are addressed in this excerpt from the "Responsibilities" sub-section of DQAP Section 1:

"The DQAP is reviewed and approved by the Quality Assurance

_______________________________________________________________________ ____________ _ 'Y!~'!'?Sl~!-(q~_fY!l,_ ~'!9- _t!i_f! _(}_fY! :. P *_?:?/ ____________________________________ _

i.

Measures describing the qualification requirements for the The following excerpt from DQAP Section 2 applies to the QAM principal QA management positions so as to demonstrate position: "Members of the KS staff (including audit and inspection management and technical competence commensurate with the personnel} shall have the appropriate qualifications necessary to responsibilities of these positions.

perform their assigned duties defined in implementing procedures. These implementing procedures provide the criteria utilized for determining and assessing appropriate staff qualification. Additionally, Appendix D of the DQAP cites references that stipulate the use of specific industry standards addressing qualifications." {2.2.2}

The following excerpt from DQAP Appendix D, Section 3.1 applies to the QAM position: "Facility staff responsible for the safe

_storage of nuclear fuel and selected_decommissioning activities _______ _

Page 4 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NUREG 1536, Section 14, Acceptance Criteria KS DQAP References shall meet or exceed the minimum qualifications of ANSI N18.1 -

1971Property "ANSI code" (as page type) with input value "ANSI N18.1 -</br></br>1971" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process. for comparable positions as defined in approved

_ ______ _ _____ __ _ __ __ __ _ _ _ __ _ ___ __ __ _ __ __ __ _ _ _ _ ____ _ _ __ _ _ _ _ __ __ _ __ ___ ___ _ __ ___ ___ __ _ procedures... " ______ _____ __________________________ ___________________________ _

j.

Measures to ensure conformance to established requirements be The following excerpt from the "Quality Assurance" sub-section of verified by individuals or groups who do not have direct DQAP Section 1 addresses the first sentence of this requirement:

responsibility for performing the work being verified. The quality "Quality Assurance (QA) personnel report directly to the QAM and control function may be part of the line organization provided implement the relevant provisions of the DQAP utilizing written that the QA organization performs periodic surveillance to implementing procedures. They perform independent oversight of confirm sufficient independence from the individuals who line functions and activities. A member of the QA organization shall performed the activities.

not perform oversight of activities for which the member has direct responsibility." {1.3.2}

The following excerpt from DQAP Section 10 addresses the second sentence of the requirement: "QA surveillance will be conducted periodically to confirm sufficient independence from the individuals who performed the activities for inspections performed by groups

_________________________________ __________________________________________________ _ other_than _QA." _[10.6} ___ _______________________ ________ ____________________ _

k. Persons and organizations performing QA functions should have direct access to management levels that will ensure accomplishment of quality-affecting activities. These individuals should have sufficient authority and organizational freedom to perform their QA functions effectively and without reservation. In addition, they should be able to identify quality problems; initiate, recommend, or provide solutions through designated channels; and verify implementation of solutions.

The following excerpts from the "Quality Assurance" sub-section of DQAP Section 1 addresses the first two sentences of this requirement: "QA personnel shall have sufficient authority and organizational freedom to identify any quality problems and to verify implementation of corrective actions. Additionally, QA personnel shall 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 nuclear safety considerations." {1.3.3}

The following excerpts from the "Quality Assurance" sub-section of DQAP Section 1 addresses the last sentence of this requirement:

"QA personnel shall have sufficient authority and organizational freedom to identify any quality problems and to verify implementation of corrective actions." {1.3.3}

Page 5 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NUREG 1536, Section 14, Acceptance Criteria I.

Designated QA individuals or organizations should have the responsibility and authority, delineated in writing, to stop unsatisfactory work and control further processing, delivery, or installation of nonconforming material. In addition, the application should describe how stop-work requests will be initiated and completed.

m. Measures to determine the extent of QA controls to be determined by the QA staff in combination with the line staff and to depend upon the specific activity or item complexity and level of importance to safety.

KS DQAP References The following excerpts from the "Quality Assurance" sub-section of DQAP Section 1 addresses the first two sentences of this requirement:

• "The QAM has the following responsibilities: Authority to stop work when quality is adversely affected." {1.3.1.F}

• "Quality Assurance (QA) personnel... have the responsibility and authority to stop work when quality is adversely affected and immediately raise concerns to the QAM." {1.3.2}

Details on the stop-work process are included in implementing procedures.

The DQAP Introduction states: "The implementation of the DQAP is executed through implementing procedures in a graded approach commensurate with the items' and activities' importance to safety."

DQAP Section 2 states: "Implementation of the DQAP is controlled through separately issued implementing procedures, instructions, and drawings. Each organization is responsible for ensuring that the applicable portions of the DQAP are properly documented, approved, and implemented (with trained staff, necessary materials, and approved procedures available) before an activity within the scope of the DQAP is executed." {2.1.3}

DQAP Section 2 sub-section "Performance/ Verification" includes the following requirement: "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." {2.3.3}

The following excerpts from the "Quality Assurance" sub-section of DQAP Section 1 assigns the following responsibilities to the QAM :

• "Assuring important to safety activities at KPS are performed in accordance with implementing procedures {1.3.1.B}

Page 6 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria 14.5.2 Quality Assurance Program The QAPD should provide acceptable evidence that the applicant's proposed QA program will be well-documented, planned, implemented, and maintained to provide the appropriate level of control over activities and SSCs consistent with their relative importance to safety.

The following are examples of areas/items that may be addressed to KS DQAP References

• Managing the performance of audits, surveillances, and inspections in order to verify that important to safety activities have been correctly performed" {1.3.1.C]

DQAP Section 7 states:

• "Procedures shall describe each organization's responsibilities for the control of purchased material, equipment, and services including the interfaces between all affected organizations. {7.1}

• The processes shall use a graded approach applying considerations of a material's, component's or service's importance to safety, complexity, and history of previous use."

{7.2}

The DQAP Introduction states: The DQAP reflects the quality activities pertaining to a decommissioning nuclear site through compliance with established regulatory requirements set forth by the NRC. The DQAP ensures the protection of the public health and safety through performance-based assessments and compliance-based auditing utilizing implementing procedures and instructions.

The DQAP describes the responsibilities for implementing important to safety requirements, establishing and maintaining the DQAP, and assessing the performance of activities subject to the DQAP.

11 DQAP Section 2 states the following: The DQAP includes specific monitoring activities which are measured against acceptance criteria in a manner sufficient to provide KS management assurance that the important to safety activities are performed in an acceptable manner." {2.1.1}

support implementation of_ the_ quality criteria: ________________ __ ______________________________________________________________________ ____________________ _

a.

Measures used to ensure that the QA program meets applicable acceptance criteria.

DQAP Section 2 states the following: "The DQAP includes specific monitoring activities which are measured against acceptance criteria in a manner sufficient to provide KS management assurance that the important to safety activities are performed in an acceptable

_'!!f!_n_ry_e_(j?_}._~l--------------------------------------------------------- -- ---

Page 7 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria

b. Measures for management to regularly assess the effectiveness of the QA program. In addition, measures for management (above and beyond the QA organization) to regularly assess the scope, status, adequacy, and compliance of the QA program to the requirements of 10 CFR Part 72. Measures to provide for management's frequent contact with program status through reports, meetings, and audits as well as performance of a periodic assessment that is planned and documented with corrective action identified and tracked.

KS DQAP References The following excerpts from the "Responsibilities" and "Reporting" sub-sections of DQAP Section 1 provides the means for management to regularly assess the effectiveness of the QA program, including the scope, status, adequacy, and compliance of the QA program to the requirements of 10 CFR Part 72:

• "The GM is responsible for apprising management of the effectiveness of the DQAP implementation and is the arbitrator for non-conformances of unusual complexity. The GM also directs actions to be taken based on reports and trending of quality issues submitted by the QAM. {1.2.4}

• Management of line organizations at KPS are responsible to ensure that the quality of organizational work and activities meets the requirements set forth in the DQAP and KPS implementing procedures. {1.2.5}

• The GM shall periodically have an Independent Management Assessment {!MA) performed to evaluate the effectiveness of the DQAP, as described in Appendix D of the DQAP." {1.6.2}

The following excerpt from the "Reporting" sub-section of DQAP Section 1 provides for management's frequent contact with program status through reports, meetings: "KS management is involved with QA matters on a continuing basis. Periodic reports summarizing the quality of KPS activities are reviewed and approved by the QAM.

These reports contain status of the program adherence to the DQAP, issues identified, unresolved items, and/or other items of interest.

These reports are submitted to the GM and other KS management as deemed appropriate." {1.6.1}

The following excerpt from DQAP Section 18 addresses the reporting of audits to management: "Results of audits are reviewed with the management of the organization audited. Responsible management in the areas audited shall implement the necessary corrective actions required to address deficiencies. These actions are documented and

---

_____ _______________ ___________________ __ ___________________ __ ________ _ c~~!f!_V!_e_c!_e_e_ci_o_c!!~C?J!'f_C!_nA _if_ '!_e_~<!_~~t _c~~f!l<_C!'!:!'!_e_q_~_u_'.~'!9_ '.~_-_a_'!_~~t-~?! _

Page 8 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NUREG 1536 NUREG 1536, Section 14, Acceptance Criteria KS DQAP References the subject area to verify deficient areas have completed corrective actions." {18.8}

The following excerpt from DQAP Appendix D, Section A, 1.0, provides additional detail on use of the IMA as a periodic assessment that is planned and documented with corrective action identified and tracked: "The /MA results are communicated via a written report in a timely manner to a level of management having the authority to execute effective corrective action. In addition, these

---

_results are reported to the_KS management team through the GM." __ _

c.

Measures used to ensure that trained, qualified personnel within the organization will be assigned to determine that functions delegated to contractors are properly accomplished.

DQAP Section 2 sub-section Personnel Training and Qualifications" states: "Individual managers are responsible for ensuring that personnel working under their cognizance are provided with the necessary indoctrination training and resources to accomplish assigned activities which fall under the scope of the DQAP." [2.2.1)

The following excerpt from DQAP Section 1.5 establishes that: "KS may delegate the execution of portions of the work under the DQAP to others such as contractors, agents, or consultants... Delegation is clearly identified in documentation and KS retains the right to verify compliance with KS quality and regulatory requirements applicable to that organization's QA Program."[1.5.1}

Sections 7 and 18 of the DQAP provides for the audit/surveillance of contractor QA programs, subcontractors, consultants, and vendors furnishing equipment or services to the KS or its contractors, and for

-~~~ f~~-g~-~!1-~Y-~!1-~ -~~-t-~?-~ -~U~!~ -~Y~.1~~!(?_~*-_______ ____ ________________ _

d. Summarizations of the corporate QA policies, goals, and The following excerpt from DQAP Section 1 establishes direct linkage objectives and establishment of a meaningful channel for from the highest management level to the GM: "The General transmittal of these policies, goals, and objectives down Manager {GM} reports to the Kewaunee Solutions President, and has through the levels of management.

the overall responsibility for the establishment and execution of the DQAP." [1.1.2)

The GM responsibilities are included throughout DQAP Section 1, and include reviewing and approving the DQAP, which embodies the KS QA policies, goals, and objectives.

Page 9 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References The following excerpt from DQAP Section 1 addresses the requirement for establishing communication through the various levels of the organization: "Lines of authority, responsibility and communication shall be established and defined for the highest management levels through intermediate levels to include all organizational positions responsible for decommissioning activities."

---

.. -------------------------------------------. ---. -. ------.. ----------------- _{1.1.41 -------------------------------------------------------------------------

e.

Measures to designate responsibilities for implementing the major activities addressed in the QA manuals.

Specific requirements for major delegation are included in the following sections of the DQAP:

For the GM, the "Responsibilities" sub-section of DQAP Section 1 states "The individual shall delegate in writing the succession to this responsibility during their absence." [1.2.3}

• The "Station Management" sub-section of DQAP Section 1 states: " The GM delegates to the KS management team the day-to-day responsibilities for the ISFSI and decommissioning", and that the DPM "... shall delegate in writing the succession to this position during their absence." [1.4.1, 1.4.2}

DQAP Section 1 sub-section " Delegation of Work" addresses delegation of the execution of portions of the work under the DQAP to others such as contractors, agents, or consultants.

________________________________________________________________________________________ {l.5.1} __________________________________________ __________________________ _

f.

Measures to control the distribution of the QA manuals and revisions.

The following excerpts from DQAP Section 6 include control and distribution of QA manual and revisions:

• " The program will control the development, review, approval, issue, use, and revision of documents, as applicable. {6.1}

The scope of the document control program includes, but is not limited to: Procedures, Manuals, Plans, Directives, Policies, Instructions, etc... " {6.3.E}

Page 10 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria

g.

Measures for communicating to all responsible organizations and individuals that policies, QA manuals, and procedures are mandatory requirements.

KS DQAP References The following excerpt from DQAP Section 1 establishes direct linkage from the highest management level to the GM: "The General Manager (GM} reports to the Kewaunee Solutions President, and has the overall responsibility for the establishment and execution of the DQAP." [1.1.2}

The GM responsibilities are included throughout DQAP Section 1, and include reviewing and approving the DQAP, which embodies the KS QA policies, goals, and objectives.

The "Responsibilities" sub-section of DQAP Section 1 directs management to ensure the requirements established in the DQAP and implementing procedures are met (i.e., made the requirements mandatory): "Management of line organizations at KPS are responsible to ensure that the quality of organizational work and activities meets the requirements set forth in the DQAP and KPS

_____ ______________________________________________________________________________ _implementing procedures." {1.2.5} ________________________________________ _

h. Measures to provide a comprehensive listing of QA procedures, The DQAP Introduction states: " The implementation of the OQAP is plus a matrix of these procedures cross-referenced to each of the executed through implementing procedures in a graded approach QA criteria, to demonstrate that the QA program will be fully commensurate with the items' and activities' importance to safety."

implemented by documented procedures.

DQAP Section 2 states: "Implementation of the DQAP is controlled through separately issued implementing procedures, instructions, and drawings. Each organization is responsible for ensuring that the applicable portions of the DQAP are properly documented, approved, and implemented (with trained staff, necessary materials, and approved procedures available) before an activity within the scope of the DQAP is executed." {2.1.3}

The following excerpts from the "Quality Assurance" sub-section of DQAP Section 1 assigns the following responsibilities to the QAM :

"Assuring important to safety activities at KPS are performed in accordance with implementing procedures" {1.3.1.B}

Page 11 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria

i.

Identification of the structures, systems, and components (SSCs) that are important to safety and how they will be controlled by the QA program.

j.

Measures for review and documents to show agreement with the QA program provisions of its suppliers to ensure implementation of a program meeting the QA criteria.

KS DQAP References Implementing procedures detail the administrative process of the identification of DQAP implementing procedures for each of the QA criteria.

DQAP Section 2 states: "The DQAP requirements apply to SSCs designated as important to safety identified in Appendix B of the DQAP." [2.1.1]

DQAP Appendix B provides a listing of these. As stated, the DQAP requirements apply to these ITS SSCs identified on Appendix B of DQAP.

DQAP Section 7 states:

• "Procedures shall describe each organization's responsibilities for the control of purchased material, equipment, and services... Controls shall include the review and acceptance of supplier documents by the appropriate organization, including compliance to the technical and quality requirements specified in the procurement documents, as required. {7.1}

• Receiving inspection shall verify, by review of objective evidence, the material and equipment conform to the procurement documents, including applicable technical and quality requirements. [7.2.4]

• Effectiveness of the control of quality by contractors and subcontractors will be assessed at intervals consistent with the importance, complexity, quantity of the product or services, and performance history. Supplier performance and compliance with procurement documents are monitored by audit, source verification, receipt inspection, or a combination to ensure continued acceptable supplier performance. {7.2.5]

• Documentary evidence that material and equipment conform to the procurement requirements shall be available before installation and use... The documentary evidence shall be retained

_______________________________________ ______ ________ ___ __ ______________ ___________ ___ __ in accordance_ with_applicable regulatory requirements and shall __

Page 12 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References be sufficient to identify the specific requirements, such as codes, standards, or specifications, met by the purchased material and

______________________________________________________________________________________ _ -~q~_ip_f!l_f:!1_~*-. f?_._~L __ ________________________ _______________________ _____ _

k.

Measures for the resolution of disputes involving quality arising from a difference of opinion between QA/Quality Control (QC) personnel and personnel from other departments (engineering, procurement, manufacturing, etc.).

I.

Measures for indoctrination, training, and qualification programs

_____ that fulfill the following_criteria: --- --------------------------------------

Personnel responsible for performing activities affecting quality should be instructed as to the purpose, scope, and implementation of the quality-related manuals, instructions,

_______ and procedures. __________________ __________________________ ____ ________ _

Personnel performing activities affecting quality should be trained and qualified in the principles and techniques of the

____ ___ activities being performed. --------------------------------------------

Maintenance of the proficiency of personnel performing quality-affecting activities by retraining, reexamining, and re-

---

certifying. _______________________________________________________________ _

Preparation and maintenance of documentation of completed

_______ training_and _qualification. _____________________________________________ _

Qualification of personnel in accordance with accepted codes and standards.

The following excerpt from the "Responsibilities" sub-section of DQAP Section 1 addresses these requirements: "The GM is responsible for apprising management of the effectiveness of the DQAP implementation and is the arbitrator for non-conformances of unusual complexity." [1.2.4}

The following excerpt from Section 2 also addresses these requirements: "Disputes arising between departments or organizations on QA matters that cannot be resolved at a lower level

_<?f_'!1_<:_n_q_g_f!!'.'_e_r:_t_ ~~1! _~f!_ '.f!!_e_cce_r!_ t~-_tti_e_ _ (}_":'!:'~ P}: ?! ____ ___ ______________ _

The following excerpt from DQAP Appendix D, Section 3.1 applies to the Personnel responsible for performing activities affecting quality: "Facility staff responsible for the safe storage of nuclear fuel and selected decommissioning activities shall meet or exceed the minimum qualifications of ANSI NlB.1-1971 for comparable positions as defined in approved procedures."

In addition, sub-section "Personnel Training and Qualifications" in DQAP Section 2 requires the following:

• "Individual managers are responsible for ensuring that personnel working under their cognizance are provided with the necessary indoctrination training and resources to accomplish assigned activities which fall under the scope of the DQAP. [2.2.1]

• Members of the KS staff (including audit and inspection personnel) shall have the appropriate qualifications necessary to perform their assigned duties defined in implementing procedures. These implementing procedures provide the criteria utilized for determining and assessing appropriate staff qualification. Additionally, Appendix D of the DQAP cites references that stipulate the use of specific industry standards addressing qualifications. Training programs are established and Page 13 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NUREG 1536, Section 14, Acceptance Criteria 14.5.3 Design Control The following are examples of areas/items that may be addressed to KS DQAP References implemented to ensure that personnel achieve and maintain suitable proficiency. Personnel training and qualification records are maintained in accordance with approved procedures." [2.2.2]

support implementation of_ the_quality criteria: _____________________________________________________________________________________ _______________________ _

a. Measures to carry out design activities in a planned, controlled, and orderly manner.

The following excerpt from DQAP Section 3 addresses the requirement: "The program will ensure that the activities associated with the design of important to safety SSCs and modifications thereto, are executed in a planned, controlled, and orderly manner."

--- ----- -- ------ ---- ------------------ -- ------------ ------------------------------- _(~:!:!}_ --------------------------------- --- ------- ------------ ----- ---------- ---

b. Measures to correctly translate the applicable regulatory requirements and design bases into specifications, drawings, written procedures, and instructions.

The following excerpt from DQAP Section 3 addresses the requirement: "Design inputs (e.g., performance, conditions of the facility license, quality standards identified in Appendix C of the DQAP, and quality verification requirements) shall be identified and correctly translated into design outputs (e.g., specifications,

_____________________ ___ ____________________ ___________ ____________________________ _ drawings, _procedures,_ and instructions)._[3.1.5 J _______ ____ ______________ _

c.

Measures to describe how the applicant will specify quality standards in the design documents and control deviations and changes from these quality standards.

The following excerpts from DQAP Section 3 addresses the requirements:

"The program will ensure that the activities associated with the design of important to safety SSCs and modifications thereto, are executed in a planned, controlled, and orderly manner. {3.1.1]

The program utilizes the guidance of NU REG/CR 6407, "Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety", to classify SSCs such that appropriate quality requirements are identified and documented on drawings, component lists, or procurement documents, as applicable.

{3.1.3}

Page 14 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References

• The final design output shall relate to the design input in sufficient detail to permit verification. Design outputs shall specify design characteristics that can be controlled, inspected, and tested. Inspection and test criteria are identified. [3.1.6}

• Changes to final designs (including field changes and modifications) and dispositions of nonconforming items to either use-as-is or repair shall be subjected to design control measures commensurate with those applied to the original design and approved by the organization that performed the original design

___________________________________________________________________________________ _____ or a qualified designee." {3.1.8} _______________ ________________________ _

d. Measures to describe how the applicant will review designs to ensure that design characteristics can be controlled, inspected, and tested and that inspection and test criteria are identified.

The following excerpt from DQAP Section 3 addresses the requirement: "The final design output shall relate to the design input in sufficient detail to permit verification. Design outputs shall specify design characteristics that can be controlled, inspected, and tested. Inspection and test criteria are identified." [3.1.6]

Additionally, the "Design Verification" subsection of DQAP Section 3 states:

• "The program will verify the acceptability of design activities and documents for the design of items. The selection and incorporation of design inputs and processes, outputs and changes are verified... [3.2.1]

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

___________________________________________________________________________________ _____ recorded." [3.2.6} _______________________________________________________ _

e. Measures to describe how the applicant will establish both internal and external design interface controls. These controls should include review, approval, release, distribution, and revision of documents involving design interfaces with

_____ participating design organizations. ________________________________ _____ _

The following excerpt from DQAP Section 3 addresses the requirement: "Interface controls (internal and external between participating design organizations and across technical disciplines) fo r the purpose of developing, reviewing, approving, releasing, Page 15 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NUREG 1536, Section 14, Acceptance Criteria KS DQAP References distributing, and revising design inputs and outputs shall be defined

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _;_n_ p_c<;>_c_e_c}_u_cf!~_-'.' _ [~: !: ~1-_______________ _______________________________________ _

f.

Measures to describe how they will properly select and perform design verification processes such as design reviews, alternative calculations, or qualification testing. When a test program is to be used to verify the adequacy of a design, the measures should be developed to describe how they will use a qualification test of a prototype unit under adverse design conditions.

The following excerpts from the "Design Verification sub-section of DQAP Section 3 addresses the requirements:

• 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. {3.2.2}

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

---

-----{3.2.31 ---------------------------------------------------------------------

g. Design verification constitutes confirmation that the design of the SSC is suitable for its intended purpose. Measures to ensure design verifications are completed by an individual with a level of skill at least equal to that of the original designer, recognizing design checking can be performed by a less experienced person.

(As an example, design checking, which should also be performed, includes confirmation of the numerical accuracy of computations and the accuracy of data input to computer codes. Confirmation that the correct computer code has been used is part of design verification.) Measures to describe how design verification will be performed by persons other than those performing design checking. In addition, measures to include how individuals or groups responsible for design verification will not include the original designer and normally not include the designer's immediate supervisor.

The following excerpts from the "Design Verification sub-section of DQAP Section 3 address the requirements:

"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. At least one individual shall have a level of skill at least equal to that of the original designer. The designer's immediate supervisor or manager may perform the design verification and controls for this are defined in approved procedures." {3.2.5}

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

_______________________ ____________________________________________________________ _ accomplished and the_results are properly recorded. "_{3.2.6} __________ _

Page 16 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria

h. Measures to ensure design and specification changes are subject to the same design controls and the same or equivalent approvals that were applicable to the original design.

KS DQAP References The following excerpt from DQAP Section 3 addresses the requirement: "Changes to final designs (including field changes and modifications) and dispositions of nonconforming items to either use-as-is or repair shall be subjected to design control measures commensurate with those applied to the original design and approved by the organization that performed the original design or a

_____ ____ _________ ___ _____ _________ ___ ____ ___ _________ __ ___ _______________________ _ _ qualified designee." [3.1.8] ____ ________ ___ ___ __ __ ___ ________ ________________ _

i.

Measures to ensure the documentation of all errors and The following excerpt from DQAP Section 3 addresses the deficiencies in the design or the design process that could requirement: "Errors and deficiencies in the design or the design adversely affect SSCs important to safety. In addition, the process that could adversely affect SSCs important to safety shall be applicant should provide measures for adequate corrective action, including root cause evaluation of significant errors and deficiencies, to preclude repetition.

entered into the corrective action process." [3.1.10}

The contents of DQAP Section 16 meet the requirements of the second sentence.

j.

Before selecting materials, parts, and equipment that are The following excerpt from DQAP Section 3 addresses the standard, commercial (off-the-shelf), or have been previously requirement: "The design process shall ensure that materials, parts, approved for a different application, measures should be equipment and processes are selected and independently verified provided to review the suitability of any materials, parts, and consistent with their importance to safety to ensure they are suitable

_____ E:!~~!P_l!I_E:!!1_~ !~~ !~E:!-~~!E:!_~9-~9_ ~RPJ!~~!!?_~: _______________________________ f_o_r_~~~!'._~n_~f!!l_c!~c!_o_ PJ?!~c_o_t~o_:1_.:: [?_*L~l-_______ ___________________________ _

k. Measures to provide written procedures to identify and control The following excerpts from DQAP Section 3 addresses the the authority and responsibilities of all individuals or groups requirements :

responsible for design reviews and other design verification activities.

• "The program will ensure that the activities associated with the design of important to safety SSCs and modifications thereto, are executed in a planned, controlled, and orderly manner. [3.1.1}

• 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."

[3.2.5}

Page 17 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria I.

Measures that include the use of valid industry standards and specifications for the selection of suitable materials, parts, equipment, and processes for SSCs that are important to safety.

14.5.4 Procurement Document Control The following are examples of areas/items that may be addressed to KS DQAP References The following excerpt from DQAP Section 3 address the requirement:

"Design inputs (e.g., performance, conditions of the facility license, design bases, regulatory requirements, quality standards identified in Appendix C of the DQAP, and quality verification requirements) shall be identified and correctly translated into design outputs (e.g.,

specifications, drawings, procedures, and instructions)." {3.1.5}

support implementation of_ the_quality criteria : ______________ ___ _________ ___________________________________________________ __ _ _______ ____ __ ______________ _

a.

Measures to establish procedures that clearly delineate the The following excerpt from DQAP Section 4 addresses the sequence of actions to be accomplished in the preparation, requirement: "The program includes provisions that clearly review, approval, and control of procurement documents.

delineate the sequence of actions to be accomplished in the preparation, review, approval, and control of procurement

___ ____________ ___ ______________ __ _______________ ______ __________ ___ ______________ _ _ documents." {4.6} ______________ ________________ __ _______ ____ _______________ _ _

b.

Measures to ensure that qualified personnel review and concur with the adequacy of quality requirements stated in procurement documents. These measures should also ensure that the quality requirements are correctly stated, inspectible, and controllable; there are adequate acceptance and rejection criteria; and the procurement document has been prepared, reviewed, and approved in accordance with QA program requirements.

The following excerpts from DQAP Section 4 address the requirement:

• "Procurement documents shall be reviewed and approved by QA for the adequacy of quality requirements, and to ensure that the quality requirements are correctly stated, inspectable, and controllable; and there are adequate acceptance and rejection criteria. {4.6.1}

• Qualified personnel shall ensure the procurement document has been prepared, reviewed, and approved in accordance with QA

________________________________________________________ __ ___________ ___ __ ______ __ _ _____ program_ requirements" {4.6.2} ________ ___ __ _______ ______ ___ ___________ _

c. Measures to document the review and approval of procurement The following excerpt from DQAP Section 4 addresses the documents before they are released, and the documentation requirement: "The program includes provisions that clearly should be available for verification.

delineate the sequence of actions to be accomplished in the preparation, review, approval, and control of procurement documents." {4.6}

The following excerpt from DQAP Section 17 addresses the

____________________________________________________________________________________ requirement:_"The_program _will ensure_ that sufficient records_ of _____ _

Page 18 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NUREG 1536, Section 14, Acceptance Criteria KS DQAP References important to safety items and activities affecting quality (e.g.,...,

procurement,... ) are generated and maintained to reflect the completed work, and are consistent with applicable codes, standards, and procurement documents. Records shall be identified

_______________________________________ ____ __ ______ _______________ ________________ _ _ and retrievable.,, (17.l] ___________________________________________ ____ ___ ___ _

d. Procurement documents should identify the applicable QA requirements that should be compiled and described in the supplier's QA program. In addition, the applicant should review and concur with the supplier's QA program.

e.

Measures to ensure procurement documents contain or reference the regulatory requirements, design bases, and other technical requirements.

The following excerpts from DQAP Section 4 addresses the requirements:

"The program includes provisions for evaluating prospective suppliers and ensuring that selected suppliers continue to provide acceptable products and services. {4.2}

Procurement documents shall be reviewed and approved by QA for the adequacy of quality requirements, and to ensure that the quality requirements are correctly stated, inspectable, and controllable; and there are adequate acceptance and rejection criteria. {4.6.1}

Qualified personnel shall ensure the procurement document has been prepared, reviewed, and approved in accordance with program requirements.,, [4.6.2}

Additional detail regarding supplier qualification are included in Section 7 and Section 18 of the DQAP.

The following excerpt from DQAP Section 4 addresses the requirement: "The program includes provisions for invoking applicable technical, regulatory, administrative, and reporting requirements (e.g., specification, codes, standards, tests, inspections, special processes, records, certifications, 10 CFR 21) applicable to the

_____ ___________________________________________________________ ___________________ J!!<?_~'!!~'!!~!1_~ _t_o_ _~~-~p_e_~if_i~1_(n_ !!!<?_~'!!~_'!!f:!1_~~ _c!?~'!'!!~'!~(~ J1:~l-______ _

f.

Measures to ensure procurement documents identify the The following excerpts from DQAP Section 4 address the documentation (e.g., drawings, specifications, procedures, requirement:

inspection and fabrication plans, inspection and test records, "The program includes provisions for invoking applicable personnel and procedure qualifications, and chemical and technical, regulatory, administrative, and reporting requirements physical test results of material) to be prepared, maintained, and (e.g., specification, codes, standards, tests, inspections, special

--- --~~-~r:1:1!!!~~!-~ _t_~~-J?~-~~~-~~~!-f?!_ !"~_"'.i_f:~ -~~-~ -~P_I?~?_"'.~!-_ -- -------------- --- ----------- ---------------------- ----- ---------------------- ---------- --------

Page 19 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NUREG 1536, Section 14, Acceptance Criteria KS DQAP References processes, records, certifications, 10 CFR 21} applicable to the procurement to be specified in procurements documents." [4.5]

Procurement documents shall be reviewed and approved by QA for the adequacy of quality requirements, and to ensure that the quality requirements are correctly stated, inspectable, and controllable; and there are adequate acceptance and rejection

___________________________________________________________________________________ ___ __ criteria." [4.6.1] _________________________________________________________ _

g. Measures to ensure procurement documents identify records to be retained, controlled, and maintained by the supplier and those records to be delivered to the purchaser before use or installation of the hardware.

h. Measures to ensure procurement documents specify the procuring agency's right of access to the supplier's facilities and records for source inspection and audit.

The following excerpt from DQAP Section 4 addresses the requirement: "The program includes provisions for ensuring that documented evidence of an item's conformance to procurement requirements is available at the site before the item is placed in service or used unless otherwise specified in procedures.

Procurement documents shall identify records to be retained, controlled, and maintained by the supplier and those records to be delivered to the purchaser before use or installation of the hardware." {4. 7}

The following excerpt from DQAP Section 4 addresses the requirement: "The program includes provisions for source verification (inspection, audit, etc.) for accepting purchased items and services identified as important to safety when determined

____________________________________________________________________________________ '!~-~f:~~!1_')!: ~J1*_1l_ _________ ______________________________________ _____________ _

i.

Measures to ensure that changes and revisions to procurement documents are subject to the same or equivalent review and approval as the original documents.

14.5.S Instructions, Procedures, and Drawings The following are examples of areas/items that may be addressed to The following excerpt from DQAP Section 4 addresses the requirement: "Changes and revisions to procurement documents are subject to the same or equivalent review and approval as the original documents." {4. 6.3}

support implementation of_ the_ quality criteria: ____________________________________________________________________________________________________________ _

a. Measures to ensure activities affecting quality are prescribed and The following excerpt from DQAP Section 5 addresses the accomplished in accordance with documented instructions, requirement: "The program will ensure that quality activities are procedures, or drawings.

prescribed by and performed in accordance with documented

_____________________________________ ____________________________ _______ _____ ______ _instructions, procedures,_ or drawings." {5.1} ___ ______ ____________________ _

Page 20 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References

b. Measures to establish provisions that clearly delineate the The following excerpt from DQAP Section 5 addresses the sequence of actions to be accomplished in the preparation, requirement: "The program will ensure that the sequence of actions review, approval, and control of instructions, procedures, and to be accomplished in the preparation, review, approval, and control drawings.

of instructions, procedures, and drawings are clearly delineated."

---

_{5.21 ----------------------------------------------------------------------------

c. Measures to ensure instructions, procedures, and drawings specify the methods for complying with each of the applicable QA criteria.

The following excerpts from DQAP Sections 2, 3 and 5 address the requirement:

• "Each organization is responsible for ensuring that the applicable portions of the DQAP are properly documented, approved, and implemented (with trained staff, necessary materials, and approved procedures available} before an activity within the scope of the DQAP is executed. [2.1.3]

• Important to safety activities shall be accomplished under suitably controlled conditions. Controlled conditions include the use of appropriate equipment; suitable environmental conditions for accomplishing the activity, such as adequate cleanliness; and assurance that all prerequisites for the given activity have been satisfied. The program 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. [2.1.4]

• Design inputs (e.g., performance, conditions of the facility license, design bases, regulatory requirements, quality standards identified in Appendix C of the DQAP, and quality verification requirements) shall be identified and correctly translated into design outputs (e.g., specifications, drawings, procedures, and instructions). (3.1.5]

The program will ensure that quality activities are prescribed by and performed in accordance with documented instructions, procedures, or drawings. [5.1]

Page 21 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References QA review and concurrence of instructions, procedures, drawings, and specifications related to inspection, tests, calibrations, and special processes shall be performed prior to implementation to verify adequate quantitative and qualitative

___________________________________________________________________________________ ___ __ criteria have been specified.,, [5.2}. -**............ _.. -* ___ -*- ___ -*.....

d. Measures to ensure instructions, procedures, and drawings The following excerpt from DQAP Section 5 addresses the include quantitative acceptance criteria (such as dimensions, requirement: "These instructions, procedures, and drawings tolerances, and operating limits) as well as qualitative acceptance include, as appropriate, quantitative or qualitative acceptance criteria (such as workmanship samples) as verification that criteria for determining that activities have been satisfactorily activities important to safety have been satisfactorily accomplished." [5.3}

..... accomplished..... _......... _................................. _....... _.. _........ _............ _. _. _......... _.. _. _...... _. _.. ______. ___ ___..................

e.

Measures to ensure the QA organization reviews and concurs with the procedures, drawings, and specifications related to inspection plans, tests, calibrations, and special processes as well as any subsequent changes to these documents.

14.5.6 Document Control The following are examples of areas/items that may be addressed to The following excerpts from DQAP Section 5 address the requirement:

"QA review and concurrence of instructions, procedures, drawings, and specifications related to inspection, tests, calibrations, and special processes shall be performed prior to implementation to verify adequate quantitative and qualitative criteria have been specified. [5.2]

• Changes or deviations from established instructions, procedures, or drawings for SSCs and other quality activities that have current important to safety functions, require the same review and approval as the original document.,, [5.4]

support implementation of. the. quality criteria:........... ***-*.............. -*......... _....... _. _.. _ -* _. ___.. _. _. _.. _. ____ -* _ *--________....... -*... -* __..

a. The QAPD should identify all documents to be controlled under The following excerpt from DQAP Section 6 addresses the this subsection. As a minimum, this should include design requirement: "The scope of the document control program includes, specifications; design and fabrication drawings; procurement but is not limited to: Safety Analysis Report(s); NRC License documents; QA manuals; design criteria documents; fabrication, inspection, and testing instructions; and test procedures.

Documents, including Technical Specifications; Design Documents and Drawings; Procurement Documents; Procedures, Manuals, Plans, Directives, Policies, Instructions, etc., and; Other documents as

• ----*--**--*---------------*--***--**---*-*******************************-********.defined in_procedures." [6.3, 6.3 A-D] ____ **--**--************-**-*-**-**-*-

Page 22 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References

b. Measures to ensure establishment of procedures to control the The following excerpt from DQAP Section 6 addresses the review, approval, and issuance of documents and changes thereto requirement: "The program will ensure that the review, approval, before release to ensure that the documents are adequate and and issuance of documents and changes thereto before release by applicable quality requirements are stated.

the appropriate organizations to ensure that the documents are

-- ------------------ --------------- --------- ------------- ------ -------------------- _adequate and applicable quality_requirements_are stated." {6.2} __ ____ _

c.

Measures to ensure establishment of provisions to identify individuals or groups responsible for reviewing, approving, and issuing documents and revisions thereto.

The following excerpt from DQAP Section 6 addresses the requirement: "The program will ensure that the review, approval, and issuance of documents and changes thereto before release by the appropriate organizations to ensure that the documents are

---

------ -- ----------------------------------------------- --- --- ---- ---- ------- _ _ adequate and applicable quality_requirements_are stated." {6.2] ______ _

d. Measures to ensure document revisions receive review and The following excerpts from DQAP Section 6 addresses the approval by the same organizations that performed the original requirements: "Revisions of controlled documents are reviewed for review and approval or by other qualified responsible adequacy and approved for release by the same organization that organizations designated by the applicant.

originally reviewed and approved the documents or by a designated

---

_____________________ _____ ____________________________ _______ __ __ ___ _____ ___ C!:9f!':J!_G_~~o_'}_ t~-°-~ _i~_ g_u_(!!if_i~c!_C!!1..c!_ ~'}_C!~!~~q~_o_~!~: ~'-(6:~J ________________ _

e. Measures to ensure that approved changes be included in The following excerpt from DQAP Section 6 addresses the instructions, procedures, drawings, and other documents before requirement: 'The program will ensure that the review, approval, the change is implemented.

and issuance of documents and changes thereto before release by the appropriate organizations to ensure that the documents are

_____ ___________ ___ __ ______ ____________________________________ __ ____ ___________ ___ _ adequate and applicable quality_requirements_are stated." {6.2} ______ _

f.

Measures to ensure the control of obsolete or superseded The following excerpt from DQAP Section 6 addresses the documents to prevent inadvertent use.

requirement: " The distribution of new and revised controlled documents is in accordance with procedures. Superseded documents

---

_C!:e_ ~_o_'}_t!?_lj~_d_ _~o_ P:~-~~'}-~ ['!?_c!y_e_c~~!1..~ -~~~: '.'_(~: ~l--------------------------

g.

Measures to ensure documents are available at the location The following excerpt from DQAP Section 6 addresses the where the activity is performed.

requirement: "Copies of controlled documents are distributed to and

---

-- --------- ------ ---- --------------------- __________________ ___ _____ __ _____ _ used_by the person performing_ the activity." {6.5} ___ ____ ___ __ ___________ _

h. Measures to ensure establishment of a master list (or equivalent) to identify the current revision number of instructions, procedures, specifications, drawings, and procurement documents. In addition, measures to ensure updating of the list and distribution of it to predetermined, res ponsible personnel to preclude use of superseded documents.

The following excerpt from DQAP Section 6 addresses the requirement: "The distribution of new and revised controlled documents is in accordance with procedures. Superseded documents are controlled to prevent inadvertent use." {6.6}

Page 23 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NUREG 1536, Section 14, Acceptance Criteria 14.5.7 Control of Purchased Material, Equipment, and Services The following are examples of areas/items that may be addressed to KS DQAP References Note that an administrative device like that described in the criteria is included in the administrative procedures controlling the distribution of new and revised controlled documents.

support implementation of_ the_quality criteria: ________________________________ ----------------------------------- _______ -------------- -------------- -------

a.

Measures to ensure qualified personnel evaluate the supplier's capability to provide services and products of acceptable quality before the award of the procurement order or contract. In addition, measures to ensure QA and engineering groups participate in the evaluation of those suppliers providing critical items and services important to safety, and the applicant should define the responsibilities for each group's participation.

The following excerpts from DQAP Sections 7 and 18 address the requirements:

• "Procedures shall describe each organization's responsibilities for the control of purchased material, equipment, and services including the interfaces between all affected organizations. [7.1}

• Supplier evaluation and selection may be accomplished by direct audit of the supplier, in-process surveillance of the supplier's documented program, or by review of audit history performed by EnergySolutions or an approved third-party source. Verification that a supplier can meet the specified technical and quality requirements shall be documented. KS maintains an Approved Suppliers List {ASL) of evaluated suppliers. {7.2.1}

• External audits of suppliers are scheduled and performed based on the importance of the activity and to confirm implementation of the supplier's QA Program at a frequency of not greater than three (3) years with a 90 day grace period." {7.2.1.A} Note that Section 7.2.1.8 contains additional grace period associated with extenuating circumstances.

"General administrative controls for conduct of audit, surveillance, in-process inspection, receipt inspection are provided for in Sections 10 and 18 of the DQAP. {7.5}

QA internal and supplier audits are planned and performed by qualified auditors utilizing approved written procedures and/or checklists. (18.1]

Page 24 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References

• Lead Auditors shall have experience, training or qualifications commensurate with the scope and complexity of their audit responsibility. (18. 2]

• Scheduling, preparation, personnel selection, performance, reporting, response, follow-up, and records management for audits are performed in accordance with written procedures."

(18.3]

Note that engineering and QA roles and responsibilities are bounded

--- ----- ---- ---- ---- ----- --- ---- ----- -- --- -- -- -- -- -- ------------ ----- ----- -- ----- -- -~y !~-~-~~-'?Y_~~ -------------------------------------------- ---------- -- --------

b. Measures to ensure evaluation of suppliers on the basis of one or

_ -- __ ~9-~~-<?U~~-!9_1!9_~_i!1JL~~~~~~~~: __ -- __ ---_ -- ___ -- _____ -- ___ -- _________ --- __

The supplier's capability to comply with the elements of the QA criteria that are applicable to the type of material, equipment,

_______ or service being procured. __________________________________________ __ _

Review of previous records and performance of suppliers who have provided similar articles or services of the type being

__ _____ procured. ____________ ___ ________________________________________________ _

A survey of the supplier's facilities and QA program to assess the capability to supply a product that meets applicable design, manufacturing, and quality requirements.

The following excerpts from DQAP Section 7 address the requirements:

• "The program will ensure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents as applicable to DQAP scope. The program includes provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery. " (7.2]

• Supplier evaluation and selection may be accomplished by direct audit of the supplier, in-process surveillance of the supplier's documented program, or by review of audit history performed by EnergySolutions or an approved third-party source. Verification that a supplier can meet the specified technical and quality requirements shall be documented. {7.2.1)

• External audits of suppliers are scheduled and performed based on the importance of the activity and to confirm implementation of the supplier's QA Program at a frequency of not greater than

___ _____________ ___ __________________________________________________ _______ ____________ !!I_C~~-(!)y~_<!:~-~~~~-<! _?9_ p_(!y_g!_(!~~-p_~:~'?p_.:: f?_.J}.(:-J __ f'!_o_~~-~~~~ ---

Page 25 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References Section 7.2.1.B contains additional grace period associated with extenuating circumstances.

• General administrative controls for conduct of audit, surveillance, in-process inspection, receipt inspection are provided for in Sections 10 and 18 of the DQAP.

11 {7.5}

The requirements of Section 18 include use of the QA audit procedure for supplier evaluation. The audit process includes

---

_elements from theist and 3 rd bullet of the requirements. ______________ _

c. Measures to ensure documentation and filing ofthe results of The following excerpt from DQAP Section 17 addresses the supplier eva luations.

requirement: " The program will ensure that sufficient records of important to safety items and activities affecting quality (e.g.,...

procurement,... inspection and test,.... and audits} are generated and maintained to reflect the completed work, and are consistent with applicable codes, standards, and procurement documents.

Records shall be identified and retrievable.

11 [17.1}

Documentation and filing of supplier evaluations, including supplier

____________________________________________________________________________________ audits, are _described _in implementing procedures. ______________________ _

d. Measures to ensure planning and performing adequate The following excerpts from DQAP Section 7 address the surveillance of suppliers during fabrication, inspection, testing, requirements :

and shipment of materials, equipment, and components in accordance with written procedures to ensure conformance to the purchase order requirements. In addition the measures should ensure that the procedures provide the following information :

Instructions that specify the characteristics or processes to be witnessed, inspected or verified, and accepted; the method of surveillance and the extent of documentation required; and

__ _____ those responsible for implementing these instructions. ___________ _

• "The program will ensure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents as applicable to DQAP scope. The program includes provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery. [7.2]

Procedures for audits and surveillance to ensure that the supplier complies with the quality requirements (surveillance should be performed for SSCs for which verification of

• Supplier evaluation and selection may be accomplished by direct audit of the supplier, in-process surveillance of the supplier's documented program, or by review of audit history performed by

________________________________________________________________________________________ EnergySolutions or an approved_ third-party source. __ Verification __

Page 26 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria procurement requirements cannot be determined upon receipt).

KS DQAP References that a supplier can meet the specified technical and quality requirements shall be documented. {7.2.1}

• External audits of suppliers are scheduled and performed based on the importance of the activity and to confirm implementation of the supplier's QA Program at a frequency of not greater than three (3) years with a 90 day grace period." {7.2.l.A} Note that Section 7.2.1.B contains additional grace period associated with extenuating circumstances.

• Source verification may be performed at the contractor or subcontractor source via planned surveillance or in-process inspection and documented when it is determined advantageous to monitor or observe an item or activity to verify conformance.

{7.2.2}

• General administrative controls for conduct of audit, surveillance, in-process inspection, receipt inspection are provided for in Sections 10 and 18 of the DQAP." {7.5}

The following excerpt from DQAP Section 18 in part addresses the first bullet: "QA internal and supplier audits are planned and performed by qualified auditors utilizing approved written procedures and/or checklists." {18.1}

Details regarding the planning of supplier audits are included in

____________________________________________________________________________ __ ______ implementing _procedures. __ ___________ ___ ___ __________ ____ ________________ _

e. Measures to ensure the supplier furnish the following records to The following excerpts from DQAP Sections 4, 7 and 15 address the

_____ the purchaser: _____________________________________________________________ requirements:

Documentation that identifies the purchased material or "The program includes provisions for ensuring that documented equipment and the specific procurement requirements (e.g.,

evidence of an item's conformance to procurement requirements

_______ codes, standards, and specifications) met_by the_items._______ _____

is available at the site before the item is placed in service or used Documentation that identifies any procurement requirements unless otherwise specified in procedures. {4. 7]

that have not been met and a description of any nonconformances designated "accept as is" or "repair."

Controls shall include the review and acceptance of supplier documents by the appropriate organization, including Page 27 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References compliance to the technical and quality requirements specified in the procurement documents, as required. {7.1}

• Receiving inspection shall verify, by review of objective evidence, the material and equipment conform to the procurement documents, including applicable technical and quality requirements. {7.2.4}

• Documentary evidence that material and equipment conform to the procurement requirements shall be available before installation and use, and items accepted and released should be identified as to their inspection status. The documentary evidence shall be retained in accordance with applicable regulatory requirements and shall be sufficient to identify the specific requirements, such as codes, standards, or specifications, met by the purchased material and equipment. [7.4]

• Supplier nonconformance reports designated accept as is or repair for important to safety SSCs require KS review and approval." {15.6]

Detailed instructions included in implementing procedures bound the requirements, because of the requirements and controls contained in DQAP Section 4, in combination with the fact that verification of requirements established in procurement documents

---

_are part_of_the processes described in Sections 7, 10 and_ 18. __________ _

f.

Measures to describe the proposed procedures for reviewing and The following excerpts from DQAP Section 7 address the accepting these documents and, as a minimum, to ensure that requirements:

this review and acceptance will be undertaken by a responsible QA individual.

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

Controls shall include the review and acceptance of supplier documents by the appropriate organization, including compliance to the technical and quality requirements specified in the procurement documents, as required. {7.1}

Page 28 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References

• The program will ensure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents as applicable to DQAP scope. The program includes provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery. {7.2}

Receiving inspection shall verify, by review of objective evidence, the material and equipment conform to the procurement documents, including applicable technical and quality requirements. {7.2.4}

General administrative controls for conduct of audit, surveillance, in-process inspection, receipt inspection are provided for in Sections 10 and 18 of the DQAP." [7.5)

Additionally, DQAP Section 15 states: "Supplier nonconformance reports designated accept as is or repair for important to safety SSCs require KS review and approval." [15.6)

Implementing procedures for both receipt inspection and the nonconformance process effectively address QA's responsibility for

_____ __ ____ ___ ________________________________ ______________________________________ verifying acceptability_ of the subject documents. ________________________ _

g.

Measures to ensure the conduct (of) periodic audits, independent The following excerpts from DQAP Section 7 address the inspections, or tests to ensure the validity of the suppliers' requirements:

certificates of conformance.

• "Supplier evaluation and selection may be accomplished by direct audit of the supplier, in-process surveillance of the supplier's documented program, or by review of audit history performed by EnergySolutions or an approved third-party source. {7.2.1}

• External audits of suppliers are scheduled and performed based on the importance of the activity and to confirm implementation of the supplier's QA Program at a frequency of not greater than

______ _________________________________ __ __________________________________________ ___ __ three (3)_years_ with a 90 day grace period." {7.2.1.A} Note_ that __ _

Page 29 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NUREG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References Section 7.2.1.B contains additional grace period associated with extenuating circumstances.

• Source verification may be performed at the contractor or subcontractor source via planned surveillance or in-process inspection and documented when it is determined advantageous to monitor or observe an item or activity to verify conformance.

{7.2.2]

• Receiving inspection shall verify, by review of objective evidence, the material and equipment conform to the procurement documents, including applicable technical and quality requirements. {7.2.4}

• Effectiveness of the control of quality by contractors and subcontractors will be assessed at intervals consistent with the importance, complexity, quantity of the product or services, and performance history. Supplier performance and compliance with procurement documents are monitored by audit, source verification, receipt inspection, or a combination to ensure continued acceptable supplier performance. {7.2.5}

• General administrative controls for conduct of audit, surveillance, in-process inspection, receipt inspection are provided for in Sections 10 and 18 of the DQAP." [7.5]

DQAP Section 10 states: 'The program will ensure inspections of important to safety activities are planned, executed and documented in order to verify conformance with instructions, procedures, and

- ------------ ------- -- --- --- -- --- -- ---- - --- -- -- -- --- --- -- -- -------- ----- - - - - - - --- -- _drawings_for accomplishing the_activity." _(10.1] _____ ______ _______________

h.

Measures to ensure the performance of a receiving inspection of The following excerpt from DQAP Section 7 addresses the the supplier-furnished material, equipment, and services to requirements, in part:

_____ ensure fulfillment of the following criteria: _______ ________ ______________

• Receiving inspection shall verify, by review of objective evidence, The material, component, or equipment should be properly the material and equipment conform to the procurement identified in a manner that corresponds with the identification documents, including applicable technical and quality

_______ on_the purchasing_and_receiving documentation. ___________________

Page 30 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References Material, components, equipment, and acceptance records requirements. {7.2.4}

should be inspected and judged acceptable in accordance with Documentary evidence that material and equipment conform to predetermined inspection instructions before installation or the procurement requirements shall be available before use.

installation and use, and items accepted and released should be Inspection records or certificates of conformance attesting to identified as to their inspection status. {7.4}

the acceptance of material, components, and equipment should be available before installation or use.

General administrative controls for conduct of audit, surveillance, in-process inspection, receipt inspection are Items accepted and released should be identified as to their inspection status before they are forwarded to a controlled provided for in Sections 10 and 18 of the DQAP." [7.5]

storage area or released for installation or further work.

Detailed instructions included in implementing procedures for inspection planning and execution bound the requirements.

Additional ly, DQAP Section 4 states: "The program includes provisions for ensuring that documented evidence of an item's conformance to procurement requirements is available at the site before the item is placed in service or used unless otherwise specified in procedures. Procurement documents shall identify records to be retained, controlled, and maintained by the supplier and those records to be delivered to the purchaser before use or installation of the hardware. [4. 7}

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."

- -- ----------------- -- --- ----- -------- - - -- --- ---- -- ---- -- -- --- -- --- -- --- ----- ---- -- _ {4.8} ___ -- ___ -- _ -- _ ---- _ ---- _____ -- _____ --- ___ --- _ -- ____ --- _ ---- ___ --- -- --- -- ---

i.

Measures to assess the effectiveness of suppliers' quality controls The following excerpts from DQAP Section 7 address the at intervals consistent with the importance to safety, complexity, requirements:

and quantity of the SSCs procured.

• "Effectiveness of the control of quality by contractors and subcontractors will be assessed at intervals consistent with the importance, complexity, quantity of the product or services, and performance history. Supplier performance and compliance with procurement documents are monitored by audit, source verification, receipt inspection, or a combination to ensure continued acceptable supplier performance. {7.2.5}

Page 31 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NUREG 1536 NU REG 1536, Section 14, Acceptance Criteria 14.5.8 Identification and Control of Materials, Parts, and Components The following are examples of areas/items that may be addressed to KS DQAP References

• General administrative controls for conduct of audit, surveillance, in-process inspection, receipt inspection are provided for in Sections Wand 18 of the DQAP." [7.5]

support implementation of_ the_quality criteria: ___ ____ __________ ___________ ____________________________________________________________ ____________________ _

a.

Measures to establish procedures to identify and control The following excerpts from DQAP Section 8 address the materials, parts, and components (including partially fabricated requirement:

subassemblies).

• " The program will identify and control important to safety items to prevent the use of incorrect or defective items. {8.1}

• Identification of each item is maintained by heat number, part number, serial number, or other appropriate means, either on the item or on records traceable to the item, as required 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

--- ---------- -- -------- ---------------------- -- ------------- ----------------------- -----~?ie.~'t: '.'_(?:~}_ -------------- ---------------------------------- -------------

b. Measures to determine identification requirements during generation of specifications and design drawings.

The following excerpt from DQAP Section 3 addresses the requirement:

"Design inputs (e.g., performance, conditions of the facility license, design bases, regulatory requirements, quality standards identified in Appendix C of the DQAP, and quality verification requirements) shall be identified and correctly translated into design outputs (e.g., specifications, drawings, procedures, and instructions). [3.1.5]

The final design output shall relate to the design input in sufficient detail to permit verification. Design outputs shall specify design characteristics that can be controlled, inspected, and tested. Inspection and test criteria are identified. [3. 1.6]

Design verification procedures are to be established and

---

_ --_ -----___ -___ -__________ -____________________________________________________ !:l:P..~e.'!!~_'!t~~ _t_o_ _e_'}~_L!C~-~~?_~_a_'}_<! Pf!!_D_f!!!<!_t_e_ _v_e_rJji~a_t~~'-1-:l'}_e_~~?_cj __ _

Page 32 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References is used, the appropriate design parameters to be verified are chosen, the acceptance criteria is identified, the verification is satisfactorily accomplished and the results are properly recorded." [3.2.6]

c. Measures to ensure that identification will be maintained either The following excerpt from DQAP Section 8 addresses the on the item or on records traceable to the item to preclude use of requirements : "Identification of each item is maintained by heat incorrect or defective items.

number, part number, serial number, or other appropriate means, either on the item or on records traceable to the item, as required 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." {8.3}

Detailed instructions included in implementing procedures establish

---

--- ------------- ------ -- ------------------------- -- ------------------- _':~!_i?_~~-~~-~~_s_f?_~~~!~~lj~~-i~~-~!1-~-~~_i!7_~~~~!~~~!.?_~~.?-~!l_i!Y: ___ ________ _

d. Measures to ensure Identification of materials and parts of The following excerpt from DQAP Section 8 addresses the important-to-safety items are traceable to the appropriate requirements: "Identification of each item is maintained by heat documentation (such as drawings, specifications, purchase orders, manufacturing and inspection documents, deviation reports, and physical and chemical mill test reports).

number, part number, serial number, or other appropriate means, either on the item or on records traceable to the item, as required 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." {8.3} ___ _

e.

Measures to ensure the location and method of identification do The following excerpt from DQAP Section 8 addresses the not affect the fit, function, or quality of the item being identified.

requ irements: "The location and method of identification shall not

________ _____________________________________________________________ __ ____________ _ affect the fit, function, or quality of the _item being identified." {8.3} __ _

f.

Measures to verify and document the correct identification of all materials, parts, and components before releasing them for fabrication, assembly, shipping, and installation.

The following excerpts from DQAP Sections 7, 8 and 10 address the requirements:

• "Documentary evidence that material and equipment conform to the procurement requirements shall be available before installation and use, and items accepted and released should be identified as to their inspection status. {7.4}

• Identification of each item is maintained by heat number, part number, serial number, or other appropriate means, either on the item or on records traceable to the item, as required Page 33 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria 14.5.9 Control of Special Processes The following are examples of areas/items that may be addressed to KS DQAP References 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. {8.3}

• The program will ensure inspections of important to safety activities are planned, executed and documented in order to verify conformance with instructions, procedures, and drawings for accomplishing the activity. {10.1}

• Provisions to ensure inspection planning is properly accomplished are to be established. Planning activities shall identify the characteristics and activities to be inspected, the inspection techniques, the acceptance criteria, and the organization responsible for performing the inspections." [10.2)

Detailed instructions included in implementing procedures for inspection planning and execution bound the requirements.

support implementation of_ the_quality criteria: ________________________________________________________________________________________ _______ _____________ _

a. Measures to establish procedures to control special processes The following excerpt from DQAP Section 9 addresses the (such as welding, heat treating, nondestructive testing, and requirements: "This program will ensure that special processes cleaning) for which direct inspection is generally impossible or identified as important to safety are properly controlled. The criteria disadvantageous. In addition, the applicant should provide a that establish which processes are special are described in listing of these special processes.

procedures. The following are examples of special processes:

b. Measures to qualify procedures, equipment, and personnel connected with special processes in accordance with applicable codes, standards, and specifications.

Welding; Heat treating; NOE (Non-Destructive Examination);

Chemical cleaning; and Unique fabricating or test processes which require in-process controls." {9.1 A-El The following excerpt from DQAP Section 9 addresses the requirements: "Special processes are accomplished by qualified personnel, using appropriate equipment, and procedures in accordance with applicable codes, standards, specifications, criteria,

_and other_special requirements." {9.2} _______________ ___________ ______ ____ _

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Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria

c. Measures to ensure qualified personnel perform special processes in accordance with written process sheets (or the equivalent) with recorded evidence of verification.

KS DQAP References The following excerpt from DQAP Section 9 addresses the requirements: "Special processes are accomplished by qualified personnel, using appropriate equipment, and procedures in accordance with applicable codes, standards, specifications, criteria, and other special requirements." {9.2}

Execution of qualification of personnel connected with special processes conducted in accordance with applicable codes, standards, specifications, and criteria includes generating the

____________________________________________________________________________________ appropriate documentation. __ ___________________________ ____ ______________ _

d. Measures to establish, file, and keep current qualification records The following excerpt from DQAP Section 17 includes control of of procedures, equipment, and personnel associated with special documents, including those associated with Special Processes: "The processes.

program will ensure that sufficient records of important to safety items and activities affecting quality (e.g.,... manufacturing, 14.5.10 Licensee Inspection The following are examples of areas/items that may be addressed to construction, inspection and test, installation,... maintenance, modification, decommissioning,... ) are generated and maintained to reflect the completed work, and are consistent with applicable codes, standards, and procurement documents. Records shall be identified and retrievable. " {17.1}

Documentation and filing of documents associated with Special Processes are described in implementing procedures.

support implementation of_ the_quality criteria: _________ _____________________ __________ _______________________________________ _________ ___ _________ ________ _

a.

Measures to establish, document, and conduct an inspection The following excerpt from DQAP Section 10 addresses the program that effectively verifies conformance of quality-affecting requirement: "The program will ensure inspections of important to activities with requirements in accordance with written, safety activities are planned, executed and documented in order to controlled procedures.

verify conformance with instructions, procedures, and drawings for

___________________________________________________________________________________ _ accomplishing the activity." {10.1} ___________ _________ ______ ___ ___________ _

b. Measures to ensure inspection personnel are sufficiently The following excerpt from DQAP Section 10 addresses the independent from the individuals performing the activities being requirement: "Inspections are performed by qualified personnel inspected.

other than those who performed or directly supervised the work

---

-------- -- --------------- ---------------------- ------------------- --------- _i_n_~[!_e_~~f!?_*_')J_q:~J __ -----------------------------------------------------------

Page 35 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NUREG 1536, Section 14, Acceptance Criteria KS DQAP References

c. Measures to ensure inspection procedures, instructions, and The following excerpt from DQAP Section 7 addresses the

____ _ check lists provide_the following_details: ________________________________ requirements, in part:

---~ ___ Identification of characteristics_and_activit ies_to_ be _inspected. ___ _

Identification of the individuals or groups responsible for

_______ performing t he inspection operation. ________________________________ _

---~ ___ Acceptance and rejection criteria. ____________________________________ _

---~--- A description of the_method of_inspection. _________________________ _

Procedures for recording evidence of complet ing and verifying a

_____ __ manufacturing,_inspection, or test operation. ____________ __ ________ _

Identification of the recording inspector or data recorder and the resu lts of t he inspection operation.

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

Controls shall include the review and acceptance of supplier documents by the appropriate organization, including compliance to the technical and quality requirements specified in the procurement documents, as required. [7.1}

• The program includes provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery." {7.2}

The following excerpts from DQAP Section 10 also address t he requirements, in part:

"The program will ensure inspections of important to safety activities are planned, executed and documented in order to verify conformance with instructions, procedures, and drawings fo r accomplishing the activity. [10.1}

Provisions to ensure inspection planning is properly accomplished are to be established. Planning activities shall identify the characteristics and activities to be inspected, the inspection techniques, the acceptance criteria, and the organization responsible for performing the inspections. (10.2]

Inspection results are to be documented by the inspector and reviewed by qualified personnel. Inspection records shall include the following, as a minimum: Item inspected; Date of inspection; Inspector; Type of observation; Results or acceptability; and

___________________________________________________________________________________ _____ Description of nonconforming conditions,_ or reference _to __________ _

Page 36 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References applicable noncanformance or corrective action documents in cases where acceptance criteria was not met. "{10.4, 10.4.1

________________________________________________________________________________________ through 10.4.6} __ _______________________________________________________ _

d. Measures to ensure the use of inspection procedures or instructions with the necessary drawings and specifications when performing inspection operations.

The following excerpt from DQAP Section 10 addresses the requirement: "The program will ensure inspections of important to safety activities are planned, executed and documented in order to verify conformance with instructions, procedures, and drawings for accomplishing the activity." {10.1}

Detailed instructions included in implementing procedures for

---

------------------------------- -------------- _inspection planning and execution bound the requirements. _________ _ _

e. Measures to qualify inspectors in accordance with applicable The following excerpt from DQAP Section 2 addresses the codes, standards, and company training programs and in addition requirement: "Members of the KS staff (including audit and keeping inspector's qualifications and certifications current.

inspection personnel) shall have the appropriate qualifications necessary to perform their assigned duties defined in implementing procedures. These implementing procedures provide the criteria utilized for determining and assessing appropriate staff qualification.

Additionally, Appendix D of the DQAP cites references that stipulate the use of specific industry standards addressing qualifications.

Training programs are established and implemented to ensure that personnel achieve and maintain suitable proficiency. Personnel training and qualification records are maintained in accordance with

_____ _________________ ______ ___________ _____ ___________ __ __________________________ _ approved procedures." {2.2.2} _____ __ ____________________________ __________ _

f.

Measures to inspect modifications, repairs, and replacements in accordance with the original design and inspection requirements or acceptable alternatives.

The following excerpt from DQAP Section 10 addresses the requirement:

"The program will ensure inspections of important to safety activities are planned, executed and documented in order to verify conformance with instructions, procedures, and drawings for accomplishing the activity. {10.1}

Planning activities shall identify the characteristics and activities to be inspected, the inspection techniques, the acceptance criteria, and the organization responsible for performing the

____ ___ _________________ ___________________________________________________________ _____ inspections." {10.2} _____________________________________________________ _

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Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NUREG 1536, Section 14, Acceptance Criteria

g. Measures to establish provisions that identify mandatory inspection hold points for witnessing by a designated inspector.

KS DQAP References The following excerpt from DQAP Section 10 addresses the requirement: "Provisions to identify inspection hold points, beyond which work is not to proceed without the consent of the inspection

_________________________ ____ __________________ __ ______ _____________________ __ _____ _ organizations are _to_be defined. " {10.3} ____ ___ ____ ___ ____________________ _

h. Measures to identify the individuals or groups who will perform The following excerpts from DQAP Section 10 address the receiving and process verification inspections, and should demonstrate that these individuals or groups have sufficient independence and qualifications.

requirements:

• "Planning activities shall identify the characteristics and activities to be inspected, the inspection techniques, the acceptance criteria, and the organization responsible for performing the inspections. [10.2}

• Inspections are performed by qualified personnel other than those who performed or directly supervised the work inspected."

---

-----[ 10.61 ----------------------------------------------------------------------

i.

Measures to establish provisions for indirect control by monitoring processing methods, equipment, and personnel if direct inspection is not possible.

14.5.11 Test Control The following are examples of areas/items that may be addressed to The following excerpt from DQAP Section 10 addresses the requirement: "Provisions shall be made for indirect control by monitoring processing methods, equipment, and personnel if direct inspection is not possible. Both inspection and process monitoring shall be provided when control is inadequate without both." {10.3}

support implementation of_ the_quality criteria: ____________________________________________________________________________________________________________ _

a.

Measures to establish, document, and conduct a test program to demonstrate that the item will perform satisfactorily in service in accordance with written, controlled procedures.

The following excerpts from DQAP Section 11 address the requirement:

" The program will demonstrate that items will perform satisfactorily in service using approved test procedures which incorporate the requirements and acceptance limits contained in applicable design documents. The program includes, as appropriate, proof tests before installation, pre-operational tests, post-maintenance tests, post-modification tests, and operational tests." {11.1, 11.2}

Page 38 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References

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

---

--- _[!_~:~!--------------------------------. ---------------- --------------------

b. Measures to ensure written test procedures incorporate or The following excerpts from DQAP Section 11 address the

_____ reference _the following_information:___ _ _ _ __ __ __ _ _ _ __ _ _ _ __ _ __ _ __ _ _ _ ___ _ _ requirement:

Requirements and acceptance limits contained in applicable

_______ design and procurement documents. ________________________________ _

---~ ___ Instructions for _performing the test. _______________________ __________ _

---~-__ Test _prerequisites. ___ __ ___________________ __ ____ ____________________ ___ _

__ -~-__ Mandatory_inspection hold points. ___________________________________ _

_ --~ ___ Acceptance and rejection criteria. _______________________ ____ __ __ ____ _ _

Methods of documenting or recording test data results.

• "The program will demonstrate that items will perform satisfactorily in service using approved test procedures which incorporate the requirements and acceptance limits contained in applicable design documents. [11.1]

A. Test procedures shall be developed which include: Instructions and prerequisites to perform the test; Use of proper test equipment; Acceptance and rejection criteria; Mandatory inspections, as required; and Methods of documenting or

___________________ __________ ___ ___ _________________ __________ _____ __ ___ ___ ___________ ______ recording test data results. " {11.3, 11.3.A-E} _____________________ _

c. Measures to ensure a qualified, responsible individual or group document test results and evaluate their acceptability. When practicable, the measures should ensure testing of the SSC occurs under conditions that will be present during normal and anticipated off-normal operations.

The following excerpt from DQAP Section 2 addresses the requirement: "Members of the KS staff (including audit and inspection personnel} shall have the appropriate qualifications necessary to perform their assigned duties defined in implementing procedures. These implementing procedures provide the criteria utilized for determining and assessing appropriate staff qualification.

Additionally, Appendix D of the DQAP cites references that stipulate the use of specific industry standards addressing qualifications.

Training programs are established and implemented to ensure that personnel achieve and maintain suitable proficiency." [2.2.2]

The following excerpts from DQAP Section 11 address the requirements:

• "When practicable, the measures should ensure testing of the SSC occurs under conditions that will be present during normal and anticipated off-normal operations. [11.4}

Page 39 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NUREG 1536, Section 14, Acceptance Criteria 14.5.12 Control of Measuring and Test Equipment The following are examples of areas/items that may be addressed to KS DQAP References

• Test results are evaluated and documented by qualified personnel to assure that test objectives and inspection requirements have been satisfied. {11.5}

• Unacceptable test results shall be evaluated and documented for impact on safety and reportability." {11.6}

support implementation of_ the_quality criteria : ______________________________ ____________________________________________________ ______ ___ ___ ______________ _

a. Measures to ensure documented procedures describe the calibration technique and frequency, maintenance, and control of all measuring and test equipment (instruments, tools, gauges, fixtures, reference and transfer standards, and nondestructive test equipment) that will be used in the measurement, inspection, and monitoring of SSCs that are important to safety.

The following excerpts from DQAP Section 12 address the requirements :

• "The program consisting of implementing procedures reviewed and approved by the appropriate organizations will control the calibration, maintenance, and use of measuring and test equipment (M& TE) consistent with activities important to safety to ensure accuracy. [12.1]

The types of equipment covered by the program (e.g.,

instruments, tools, gauges, and reference and transfer standards} and measures to document and maintain the status of all calibrated M& TE are defined in procedures. [12.3}

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

___________________________________________________________________________________ _____ performance. "_{12.4} ___________________________________________________ _

b. Measures to ensure measuring and test equipment are identified The following excerpt from DQAP Section 12 addresses the and traceable to the calibration test data.

requirements: "Measuring and test equipment is labeled, tagged, or otherwise controlled to indicate its calibration status and traceability

___________________________________________________________________________________ _ to_calibration test data." {12.5} ____________________________________________ _

c. Measures to ensure the use of labels, tags, or documents for The following excerpt from DQAP Section 12 addresses the measuring and test equipment to indicate the date of the next requirements: "Measuring and test equipment is labeled, tagged, or scheduled calibration and to provide traceability to calibration otherwise controlled to indicate its calibration status and traceability

_____ !~~!_9_~!~:- __________________________________________________________________ _ to_calibration_ test data." {12.5} _______________ __ _______ ____ _____________ ___ _

Page 40 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NUREG 1536, Section 14, Acceptance Criteria

d. Measures to calibrate measuring and test instruments at specified intervals on the basis of the required accuracy, precision, purpose, degree of usage, stability characteristics, and other conditions that could affect the accuracy of the measurements.

KS DQAP References The following excerpt from DQAP Section 12 addresses the requirements: "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, stability characteristics, and other conditions affecting its performance.

11

---

--------- --- _ ---- _ -- __ --- __ -- --- -- -- _ ----- ___ -- -- --- __ -- ___ -- _ -- _ -- _ -- --- __ _[12.4} __ -- _ -- --- -- _ -- --- __ -- ___ -- ________ -- ___ -- ________ --- ___ --- __ --- -- -- _ -- _ --

e.

Measures to assess the validity of previous inspections when measuring and test equipment is found to be out of calibration. In addition, measures should also be provided to document the assessment and take control of the out of calibration equipment.

f.

Measures to document and maintain the complete status of all items under the calibration system.

The following excerpt from DQAP Section 12 addresses the requirements:

"The... measures to document and maintain the status of all calibrated M& TE are defined in procedures. " {12.3}

"Measuring and test equipment found damaged or out of calibration is tagged or segregated. The acceptability of items measured, inspected, or tested with a damaged or out-of-calibration device, hall be evaluated, dispositioned and documented" [12.6]

The following excerpt from DQAP Section 12 addresses the requirements: "The types of equipment covered by the program (e.g., instruments, tools, gauges, and reference and transfer standards) and measures to document and maintain the status of all

___________________________________________________________________________________ -~<?!~~:~~!:.<! ~-~-~r <?!_

e_ _1f!f!'!~1_i_

n_ P:<:_c_!!_<!l.!:f!~: ~'_[!?_~l-____________. _______ _

g. Measures to ensure reference and transfer standards are traceable to nationally recognized standards; where national standards do not exist, the applicant should establish provisions to document the basis for calibration.

The following excerpt from DQAP Section 12 addresses the requirements: "Calibration reference standards shall be based on traceability to nationally recognized standards. Where national standards do not exist, measuring and test equipment is calibrated against standards that have an accuracy of at least four (4) times the required accuracy of the equipment being calibrated, or when this is not possible have an accuracy that ensures the equipment being calibrated will be within the required tolerance." {12.2}

Page 41 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References 14.5.13 Handling, Storage, and Shipping Control The following are examples of areas/items that may be addressed to support implementation of the quality_criteria : ___________________________ _______ _____________________________________________ ___ _______ __________ ________ __ _

a. Measures to establish and accomplish special handling, preservation, storage, cleaning, packaging, and shipping requirements in accordance with predetermined work and

_____ inspection _instructions. ______________________ __ _________________________ _ _

b. Measures to control the cleaning, handling, storage, packaging, shipping, and preservation of materials, components, and systems in accordance with design and specification requirements to preclude damage, loss, or deterioration by environmental conditions (such as temperature or humidity) 14.5.14 Inspection, Test, and Operating Status The following are examples of areas/items that may be addressed to The following excerpts from DQAP Section 13 address the requirements:

• "The program will control the handling, storage, shipping, cleaning, and preserving of items to prevent damage or deterioration. {13.1.1}

• Special protective measures (e.g., containers, shock absorbers, accelerometers, inert gas atmospheres, specific moisture content levels, and temperature levels, etc.) are specified and provided when required to prevent damage or deterioration. {13.1.2}

• Specific procedures shall be developed and used for cleaning, handling, storage, packaging, shipping, and preserving items when required to prevent damage or deterioration. {13.1.3}

• Items are marked and labeled during packaging, shipping, handling, and storage to identify, maintain, and preserve the item's integrity and identify the need for any special controls."

{13.1.4}

• Section 13 of the DQAP provides additional requirements specific to the handling, storage and shipping of licensed storage and transportation packages. [13.2]

support implementation of the quality_criteria: _____________________ __ ____ ______ _____ ____ _______________________________________ ________ _______ _____________ _

a. Measures to know the inspection and test status of items The following excerpt from DQAP Section 14 addresses the throughout fabrication.

requirements: "The program will ensure that required inspections and tests and the operating status of items important to safety is verified before release, fabrication, receipt, installation, test, and use, as applicable. Operating status is provided by the use of tags,

____________________________ _____ ______ _____ ______ ____ _____________________________ _ markings, _stamps, _or_other suitable means. "_{14. 1} __________ ______ ___ __ _

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Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria

b. Measures to establish procedures to control the application and removal of inspection and welding stamps and operating status indicators (such as tags, markings, labels, and stamps).

c. Measures to ensure procedures under the cognizance of the QA organization controls the bypassing of required inspections, tests, and other critical operations.

KS DQAP References The following excerpt from DQAP Section 5 addresses the requirement for establishing procedural controls : "The program will ensure that quality activities are prescribed by and performed in accordance with documented instructions, procedures, or drawings."

{5.1}

The following excerpt from DQAP Section 14 addresses the requirement for application and removal of the status indicators:

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

(14.3]

The following excerpt from DQAP Section 5 addresses the requirement: "The program will ensure that quality activities are prescribed by and performed in accordance with documented instructions, procedures, or drawings." [5.1}

The controls for required inspections, tests, and other critical operations on important to safety SSCs require procedures to control these activities, and these procedures are subject to QA review.

Additionally, DQAP Section 10 states: "Provisions to identify inspection hold points, beyond which work is not to proceed without the consent of the inspection organizations are to be defined.

11 (10.3]

The application of hold points with the application and removal of inspection, test, and operating status indicators described in 14

_____ __ _____________________________________________________________________________ provide the_respective controls. ___________________________________________ _

d. Measures to specify the organization responsible for The following excerpts from DQAP Sections 10, 11, 14 and 15 documenting the status of nonconforming, inoperative, or malfunctioning SSCs and identifying the item to prevent inadvertent use.

addresses the requirement "Inspection results are to be documented by the inspector and reviewed by qualified personnel." (10.4]

Page 43 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria 14.5.15 Nonconforming Materials, Parts, or Components The following are examples of areas/items that may be addressed to KS DQAP References "Unacceptable inspection results shall be evaluated and resolved in accordance with procedures." [10.5)

"Test results are evaluated and documented by qualified personnel to assure that test objectives and inspection requirements have been satisfied." (11.5]

"Unacceptable test results shall be evaluated and documented for impact on safety and reportability." (11.6)

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

(14.3]

The program will ensure that nonconforming important to safety materials, parts, components, associated services and activities are identified and controlled. (15.1)

Nonconforming items are properly controlled by approved procedures describing the identification, documentation, segregation requirements, disposition and approval authority, and notification to the affected organizations to prevent their inadvertent installation or use." (15.2]

support implementation of the quality_criteria: __ ___________________________________________________________________________________________________________ _

a. Measures to establish procedures to control the identification, documentation, tracking, segregation, review, disposition, and notification of affected organizations regarding nonconforming materials, parts, components, services, or activities.

The following excerpts from DQAP Section 15 address the requirements :

• "The program will ensure that nonconforming important to safety materials, parts, components, associated services and activities are identified and controlled. {15.1}

• Nonconforming items are properly controlled by approved procedures describing the identification, documentation,

_____ ~-e_w:~_g_f!_t!9.'! _ce_g_'!~ce_'!!~'!t~!.1~~f!(}_~~t!9.'!.C!!'.1. C!P.f!!(}_~f!!_C!~~~9.ciY! ____ _

Page 44 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References and notification to the affected organizations to prevent their

_______________________________________ __ ________________________________ __ _____ _______ _ !'}_a_<}y_f:~~~!1_~ j'}_s_~a_~l_a_~~o_'}_<}!_ !1_5_1: :~-(~?Jl ______ ____ ______________________ _

b.

Measures to provide for adequate documentation to identify nonconforming items and describe the nonconformance, its disposition, and the related inspection requirements. The measures should also provide for adequate documentation and include signatu re approval of the disposition.

The following excerpts from DQAP Section 15 address this requirement:

• " Management at all levels and each individual working at the facility is responsible for promptly identifying and reporting the identification of nonconforming materials, parts, and components." [15.3)

• "Nonconforming items are properly controlled by approved procedures describing the identification, documentation, segregation requirements, disposition approval authority, and notification to the affected organizations to prevent their inadvertent installation or use. Nonconforming items are reviewed and either accepted, rejected, repaired, or reworked in accordance with approved procedures." [15.2)

• "Verification of the acceptability of reworked or repaired materials, parts, and SSCs is by re-inspecting and retesting the item as originally inspected and tested, or by using a method that is at least equal to the original inspection and testing method." [15.5)

Required approval signatures of the disposition and its

____________________________________________________________________________________ i_l!l_l?!~!:'_E:~_t_~!i_~~-~-~E:-~~-s_~~i-~~-~ _i!: j~ _f!I_E:~~~!!~~ J!~?.C_E:~-~ ~~?_* ___________ _

c. Measures to establish provisions to identify those individuals or The following excerpt from DQAP Section 5 addresses the groups with the responsibility and authority for the disposition requirement: "The program will ensure that quality activities are and closeout of nonconformance.

prescribed by and performed in accordance with documented instructions, procedures, or drawings." [5.1)

The controls for the nonconformance process applied to important to safety SSCs require procedures to control these activities, and t hese procedures identify t hose individuals or groups with the responsibility and authority for the disposition and closeout of nonconformances.

Page 45 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NUREG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References Additional ly, DQAP Section 3 states: "Changes to final designs (including field changes and modifications} and dispositions of nonconforming items to either use-as-is or repair shall be subjected to design control measures commensurate with those applied to the original design and approved by the organization that performed the

___________________________________________________________________________________ _ original design or a _qualified designee." {3.1.8} __________________________ _

d. Measures to ensure nonconforming items are segregated from The following excerpt from DQAP Section 15 addresses the acceptable items and identified as discrepant until properly requ irement: "Nonconforming items are properly controlled by dispositioned and closed out.

approved procedures describing the identification, documentation, segregation requirements, disposition and approval authority, and notification to the affected organizations to prevent their inadvertent

______________________________________________ __________________ ___________________ _installation or use." {15.2} __________________________________________________ _

e.

Measures to verify the acceptability of reworked or repaired materials, parts, and SSCs by re-inspecting and retesting the item as originally inspected and tested or by using a method that is at least equal to the original inspection and testing method. In addition, the measures should provide for documentation of the relevant inspection, testing, rework, and repair procedures.

The following excerpts from DQAP Section 15 address the requirements : "Verification of the acceptability of reworked or repaired materials, parts, and SSCs is by re-inspecting and retesting the item as originally inspected and tested, or by using a method that is at least equal to the original inspection and testing method."

{15.5}

DQAP Section 17 states: "The program will ensure that sufficient records of important to safety items and activities affecting quality (e.g., design, engineering, procurement, manufacturing, construction, inspection and test, installation, pre-operation, startup, operations, maintenance, modification, decommissioning, and audits) are generated and maintained to reflect the completed work, and are consistent with applicable codes, standards, and

_______________________________ __________________________________________ __ _________ procurement _documents." [17. l] __________________________________________ _

f.

Measures to ensure nonconformance reports designated "accept The following excerpt from DQAP Section 15 addresses the as is" or "repair" are made part of the inspection records and requirement: "Supplier nonconformance reports designated accept forwarded with the hardware to the customer for review and as is or repair for important to safety SSCs require KS review and assessment.

approval." [15. 6}

DQAP Section 17 states: "The program will ensure that sufficient records of important to safety items and activities affecting quality

___________________________________________________________________________________ _(e.g., design, engineering, procurement, manufacturing, _______________ _

Page 46 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NUREG 1536, Section 14, Acceptance Criteria KS DQAP References construction, inspection and test, installation, pre-operation, startup, operations, maintenance, modification, decommissioning, and audits) are generated and maintained to reflect the completed work, and are consistent with applicable codes, standards, and

______________________________________________________________________ ______ _______ _procurement_documents." [17. l] __________________________________________ _

g.

Measures to periodically analyze nonconformance reports to The following excerpts from the DQAP address the requirements:

show quality trends and help identify root causes of nonconformance. Significant results should be reported to responsible management for review and assessment 14.5.16 Corrective Action The following are examples of areas/items that may be addressed to support implementation of the quality_criteria: ___________________________ _

a.

Measures to evaluate conditions adverse to quality (such as nonconformance, failures, malfunctions, deficiencies, deviations, and defective material and equipment) in accordance with established procedures to assess the need for corrective action.

• From DQAP Section 15: "Interfaces with the Corrective Action Program described in Section 16 will be established to ensure the prompt identification, documentation, and correction of nonconforming materials, parts, and components installed in SSCs. [15.4}

• Nonconformance reports will be periodically evaluated for trends, provided sufficient quantity of data exists. Adverse trends will be entered into the Corrective Action Program." [15. 7)

From DQAP Section 16: "Reports of conditions that are adverse to quality are analyzed to identify negative performance trends.

Significant conditions adverse to quality and significant trends are reported to the appropriate levels of management." {16.6}

The following excerpt from the DQAP Section 16 addresses the requirement: "The program will ensure that conditions adverse to quality (such as nonconformance, failures, malfunctions, deficiencies, deviations, and defective material and equipment) are evaluated in accordance with established procedures to assess the need for corrective action to address the condition identified, and to preclude Cf!~_ll_CCf!':_~f! _ ?f_

~~~-~-°-'!-~~t!<?_~: ~ P ?~?] ________________________________________ _

b. Measures to initiate corrective action to preclude recurrence of a The following excerpt from the DQAP Section 16 addresses the condition identified as adverse to quality.

requirement: "The program will ensure that conditions adverse to quality (such as nonconformance, failures, ma/functions, deficiencies,

___________________________________________________________________________ ________ _ deviations,_ and defective material and equipment)_ are evaluated in __ _

Page 47 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References accordance with established procedures to assess the need for corrective action to address the condition identified, and to preclude

___________________________________________________________________________________ _ recurrence _of the condition." {16.2} ______ _____ _____ ___ _____ ___ ______ __ ____ _

c. Measures to conduct follow-up activities to verify proper The following excerpts from DQAP Section 16 address the implementation of corrective actions and close out the corrective action documentation in a timely manner.

requirements :

• (for conditions adverse to quality): "Follo w-up activities to verify proper implementation of corrective actions and close out of the corrective action documentation in a timely manner shall be performed in accordance with established procedures. {16.2}

• (for significant conditions adverse to quality): Follow-up action shall be taken to verify effective implementation of the required corrective actions to prevent recurrence and to verify that they

________________________________________________________________________________________ ~ce_ f:tff!~_t!~~1r_!'!!t?J~_'!!f!!1..~e_<L~ f!_~*-1! __________________________________ _

d. Measures to document significant conditions adverse to quality, The following excerpt from DQAP Section 16 addresses t he as well as the root causes of the conditions, and the corrective requirement: "Significant conditions adverse to quality shall require actions taken to remedy the [condition] and preclude recurrence cause determination, corrective actions that should prevent of the conditions. In addition, this information should be reported recurrence, documentation and reporting to appropriate levels of to cognizant levels of management for review and assessment.

management. Follow-up action shall be taken to verify effective implementation of the required corrective actions to prevent recurrence and to verify that they are effectively implemented."

{16.4}

14.5.17 Quality Assurance Records The following are examples of areas/items that may be addressed to support implementation of the quality_criteria: _________ ____ ____ ___ ____ ____ ___ ___________________________________ _______ __ _______ ____ ___ ________________ ____ _

a. Measures to define the scope of the records program such that The following excerpt from DQAP Section 17 addresses the sufficient records will be maintained to provide documentary requirement: " The program will ensure that sufficient records of evidence of the quality of items and activities affecting quality.

important to safety items and activities affecting quality (e.g.,

To minimize the retention of unnecessary records, the records program should list records to be retained by "type of data" rather than by record title.

design, engineering, procurement, manufacturing, construction, inspection and test, installation, pre-operation, startup, operations, maintenance, modification, decommissioning, and audits) are generated and maintained to reflect the completed work, and are consistent with applicable codes, standards, and procurement documents." {17.1}

Page 48 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NUREG 1536, Section 14, Acceptance Criteria

b. Measures to ensure that QA records include operating logs; results of reviews, inspections, tests, audits, and material analyses; monitoring of work performance; qualification of personnel, procedures, and equipment; and other documentation such as drawings, specifications, procurement documents, calibration procedures and reports, design review and peer review reports, nonconformance reports, and corrective action reports.

c. Measures to ensure records are identified and retrievable.

d. Measures to ensure requirements and responsibilities for record creation, transmittal, retention (such as duration, location, fire protection, and assigned responsibilities), and maintenance subsequent to completion of work are consistent with applicable codes, standards, and procurement documents.

e. Measures to ensure inspection and test records contain the

_____ following information, where applicable: ________________ _____________ _ _

___ -_ ___ A description of the_type of _observation. ______________________ ___ ___ _

___ -_ ___ The date and results of the inspection _or test. __ ___ ________ ___ ______ _

___ -_ ___ lnformation_related to_conditions adverse to quality. ______________ _

KS DQAP References The identification and control of specific records types associated

_".'-'.i_t_~ _t_~~-~~-~<?!~~ J?~9-~~~~-?_r_E: -~~-s-~~~~~-~ _i~ }~ ~~E:~~~~!~~-P.~<?!=.E:9.~ ~~~-'-_

The following excerpt from DQAP Section 17 addresses the requirement: " Controls for the administration, identification, receipt, storage, preservation, safekeeping, retrieval, and disposition of records are provided in procedures. Responsibilities for QA and other organizations for the identification of QA and other required records, and for implementation of activities related to the records, are provided in procedures." {17.2}

The identification and control of specific records types associated

_".'-'.i_t_~ _t_~~-~~-~<?!~~ J?~9-~~~~-?_r_E: -~~-s-~~i-~~-~ _i~ }~ ~~E:~~~~!~~- P.~<?!=.E:9_~ ~~~-'- _

The following excerpt from DQAP Section 17 addresses the

-~~9..~ !~~~-1:~_t_:_ -~f}_e_~<}!_d_~ -~~-°-<<-~~ !(j_e_'}_t!f~e_<!_ q_n_q_ ~(}_t!!f!_v_a_~j(}_. :~ {!?-.~!---. -

The following excerpt from DQAP Section 17 addresses the requirement: " The program will ensure that sufficient records of important to safety items and activities affecting quality (e.g.,

design, engineering, procurement, manufacturing, construction, inspection and test, installation, pre-operation, startup, operations, maintenance, modification, decommissioning, and audits) are generated and maintained to reflect the completed work, and are consistent with applicable codes, standards, and procurement documents." {17.1}

The requirements and responsibilities for record creation, transmittal, retention (such as duration, location, fire protection, and assigned responsibilities), and maintenance associated with the

_records process_are described in_implementing_procedures. ______ __ ___ _

The following excerpts from DQAP Section 10 and 11 address inspection and test record content:

• "The program will ensure inspections of important to safety activities are planned, executed and documented in order to verify conformance with instructions, procedures, and drawings

___ -_ ___ Identification of the_inspector or_data recorder*--------------- ------'---- ------------------------~

Page 49 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix t o NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References

---~--- Evidence as to t he acceptability of the resu lts. ______________________

for accomplishing the activity. [10.1)

Action taken to resolve any noted discrepancies

• Provisions to ensure inspection planning is properly accomplished are to be established. Planning activities shall identify the characteristics and activities to be inspected, the inspection techniques, the acceptance criteria, and the organization responsible for performing the inspections. [10.2)

• Inspection results are to be documented by the inspector and reviewed by qualified personnel. [10.4)

• Unacceptable inspection results shall be evaluated and resolved in accordance with procedures. [10.5)

• Test procedures shall be developed which include: Methods of documenting or recording test data results. [11.3, 11.3.E)

• Test results are evaluated and documented by qualified personnel to assure that test objectives and inspection requirements have been satisfied. [11.5)

• Unacceptable test results shall be evaluated and documented for impact on safety and reportability." [11.6)

Specific details for inspection and test records, such as type of observation, inspector or data recorder and date, are addressed in implement ing procedures.

The following excerpt from DQAP Section 17 addresses genera l req uirements for all ITS records : "The program will ensure that sufficient records of important to safety items and activities affecting quality (e.g., design, engineering, procurement, manufacturing, construction, inspection and test, installation, pre-operation, startup, operations, maintenance, modification, decommissioning, and audits) are generated and maintained to reflect the completed work, and are consistent with applicable codes, standards, and

_ _ _ ___ _______ ___ ____ ___ __ _____ _ __ _ _ ____ ______ _ _ _ _ _ __ ___ __ _ __ __ __ _ __ __ ___ __ _ __ _ __ _ _ _ procurement documents." [17.1) __________________________________________ _

Page 50 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Com pliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References

f.

Measures to ensure record storage facilities are constructed, The following excerpts from DQAP Section 17 describes the general located, and secured to prevent destruction of the records by fire, requirements for the maintenance and preservation of records:

flood, theft, and deterioration by environmental conditions (such "Controls for the administration, identification, receipt, storage, as temperature or humidity). In addition, the facilities are to be preservation, safekeeping, retrieval, and disposition of records maintained by, or under the control of, the licensee throughout are provided in procedures. Responsibilities for QA and other the life of the DSS or the individual product.

organizations for the identification of QA and other required records, and for implementation of activities related to the records, are provided in procedures." [17.2]

"Facilities used to store records should be constructed to minimize the risk from damage or destruction by severe natural conditions, such as wind, flood, fire, temperature, humidity, mold, or infestation by insects or rodents." [17.2.1)

"If dual storage facilities are used to ensure the record integrity, the storage facilities should be sufficiently remote from each other to preclude a single event (such as a fire or flood) from damaging both facilities." [17.2.2]

The following excerpt from DQAP Section 17 describes the QA records repository requirements for electronic records:

"Management of the electronic storage of records will utilize the guidance provided in the following industry standards as described in approved procedures: NIRMA TGll-2011, Authentication of Records and Media; NIRMA TGlS-2011, Management of Electronic Records; NIRMA TG16-2017, Software Quality Assurance Documentation and Records; NIRMA TG21-2011, Required Records Protection, Disaster Recovery and Business Continuation" {17.3.1-4}

Previous revisions of these NIRMA guidelines have been endorsed by RIS 2000-18, Guidance on Managing Quality Assurance Records in Electronic Media, dated October 23, 2000.

Page 51 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria 14.5.18 Audits The following are examples of areas/items that may be addressed to KS DQAP References Note that records retention requirements for KPS are modified by NRC records exemption. The following excerpt from DQAP Section 17 describes this:

11ln an approval dated May 10, 2017

{ML17069A394}, DEK was granted exemptions by the NRC to allow elimination of the requirement to maintain records that are no longer necessary due to the permanently defueled condition and decommissioning status of the KPS. The NRC granted DEK a partial exemption from the record keeping requirements of 10 CFR 50. ll{c);

10 CFR Part 50, Appendix B, Criterion XVII; and 10 CFR 50.59(d)(3) for the KPS to advance the schedule to remove records associated with structures, systems, and components (SSCs) that have been or will be removed f ram NRC licensing basis documents by appropriate change mechanisms." [17.4)

This language is deemed acceptable based on the fact that this is from the current governing QA Program at Kewaunee (Dominion Energy "Nuclear Facility Quality Assurance Program Description" Topical Report DOM-QA-1, rev. 30, Page C-8).

support implementation of the quality_criteria : ___________ ____________________ __.. _.. _.. ___... __... ______________.... ___.... ___... ___ ___ _____ _.. _____...... __

a.

Measures to perform audits in accordance with written procedures or checklists; qualified personnel tasked with performing these audits should not have direct responsibility for the achievement of quality in the areas being audited.

The following excerpts from DQAP Section 18 address the requirements:

11QA internal and supplier audits are planned and performed by qualified auditors utilizing approved written procedures and/or checklists. {18.1}

Individuals performing audits shall not have direct responsibilities in the areas being audited. " {18.2)

Page 52 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria

b. Measures to ensure audit results are documented and reviewed with management having responsibility in the area audited.

KS DQAP References The following excerpts from DQAP Section 18 address the requirements:

• "The program will establish a system of planned and documented audits in order to verify compliance with all aspects of the DQAP, and determines the effective implementation of DQAP scope activities.

11 {18.l}

• Results of audits are reviewed with the management of the

• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • ---*-------*--* --*** organization audited." {18.8J...........................................

c.

Measures to establish provisions for responsible management to The following excerpt from DQAP Section 18 addresses the undertake appropriate corrective action as a follow-up to audit requirements: "Results of audits are reviewed with the management reports. In addition, the measures should ensure auditing of the organization audited. Responsible management in the areas organizations schedule and conduct appropriate follow-up to audited shall implement the necessary corrective actions required to ensure that the corrective action is effectively accomplished.

address deficiencies. These actions are documented and reviewed periodically and, if needed, re-examined during re-audits of the subject area to verify deficient areas have completed corrective

........................ **-*........ **-*..... *-***.. *--. **--........ **-** **-. *-*.... actions." {18.8}. *-**. *-*-* _ ---*................. ***-**-*......................

d. Measures to perform both technical and QA programmatic audits The following excerpts from DQAP Sections 7 and 18 address the

..... to. achieve the following objectives:-******-****************--***-*--**** requirements:

Provide a comprehensive independent verification and

-****.. evaluation of procedures. and. activities. affecting. quality. **-* *-**..

Verify and evaluate suppliers' QA programs, procedures, and activities.

• "The program will establish a system of planned and documented audits in order to verify compliance with all aspects of the DQAP, and determines the effective implementation of DQAP scope activities." {18.1}

• Individuals performing audits shall not have direct responsibilities in the areas being audited. {18.2}

External audits of suppliers are scheduled and performed based on the importance of the activity and to confirm implementation of the supplier's QA Program at a frequency of not greater than three (3) years with a 90 day grace period.

11 {7.2.1.A]

Page 53 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NU REG 1536 NU REG 1536, Section 14, Acceptance Criteria

e.

Measures to ensure audits are led by appropriately qualified and certified audit personnel from the QA organization. The measures should also ensure that the audit team membership include personnel (not necessarily QA organization personnel) having technical expertise in the areas being audited.

KS DQAP References The following excerpts from DQAP Section 18 address the requirements:

• "Lead Auditors shall have experience, training or qualifications commensurate with the scope and complexity of their audit responsibility. Individuals performing audits shall not have direct responsibilities in the areas being audited. JI {18.2}

• "Scheduling, preparation, personnel selection, performance, reporting, response, follow-up, and records management for audits are performed in accordance with written procedures.

11

[18.3]

Additional detail regarding audit team composition and use of technical specialists associated with the audit process are described

______________________ ______________________________________ _________ ______ _________ in _implementing procedures. ______________________________________ _________ _

f.

Measures to schedule regular audits on the basis of the status The following excerpt from DQAP Section 18 addresses the and importance to safety of the activities being audited. The requirements : "Scheduling, preparation, personnel selection, measures should also address that audits be initiated early performance, reporting, response, follow-up, and records enough to ensure effective QA during design, procurement, and contracting activities.

management for audits are performed in accordance with written procedures. Audit scopes and schedules are based upon the status of work progress, important to safety activities being performed, and regulatory requirements. JI {18.3}

Additional detail regarding schedule and timing of audit activities associated with the audit process are described in implementing procedures.

With respect to the periodicity of audits, note the following language is included in DQAP Section 18: "Planned internal audits are scheduled and performed in accordance with approved procedures or checklists to provide comprehensive, independent verification, and evaluation of DQAP compliance, performance criteria, and program effectiveness. Important to Safety (10 CFR 71 and 72) activities shall be audited based on the activity's importance to safety; however, each applicable quality criterion shall be audited at least once each

---

x~_a_c-__ ~_u_<!!t_C?f_f!_9~E'_~l~'!1_~'.'.~~-°-f?p_ij~?_~!~-~?_?_~~~!_<!_~~iyJ![~~-------------

Page 54 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NUREG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References conducted under the DQAP shall be completed for each functional area within a period of 2 years. Audits may be extended beyond their originally scheduled due date based on the following criteria:

Audits shall be performed at the intervals designated and the schedules are based on the month in which the audit starts; A maximum extension not to exceed 25 percent of the audit interval is allowed unless restricted by regulation. When an audit interval extension greater than one month is used, the next audit from that particular area is scheduled from the original anniversary month rather than from the month of the extended audit." {18.4, 18.4.A through 18.4.C}

With respect to the periodicity of external audits, note the following language is included in DQAP Section 7:

• "External audits of suppliers are scheduled and performed based on the importance of the activity and to confirm implementation of the supplier's QA Program at a frequency of not greater than three (3) years with a 90 day grace period." {7.2.1.A} Note that Section 7.2.1.8 contains additional grace period associated with extenuating circumstances.

This language is deemed acceptable based on the fact the additional grace period for external audits for extenuating circumstances was approved by the NRC with an SER in response to a request from Callaway station (Ref. SER dated August 6, 2020,

______________________ ____ ___ ___ __________ __ _________________________________________ ADAMS Accession No._ ML20216A681). ______________ ___________ _________ _

g.

Measures to analyze and trend audit deficiency data as well as ensuring resultant reports, indicating quality trends and the effectiveness of the QA program, should be given to management for review, assessment, corrective action, and follow-up.

The following excerpt from DQAP Section 18 addresses the requirements, in requiring issues to be entered into the corrective action process: "Results of audits are reviewed with the management of the organization audited. Responsible management in the areas audited shall implement the necessary corrective actions required to address deficiencies. These actions are documented and

---_. ---___________________________________________________________________________ _ ce_~!f!_~_e_cf_e_e_ci_o_cf!~<:1_l!t C!_nA _if. '!_e_e_c!_e_cjt _ce_~f!:<.C!'!:!':_e_cj_ c}_u_c~"!<J_ :~_-_a_ 1!.~~t_s_ ?f. _

Page 55 of 56

Letter No. ES-2022-02, Attachment 3, KS DQAP Compliance Matrix to NUREG 1536 NU REG 1536, Section 14, Acceptance Criteria KS DQAP References the subject area to verify deficient areas have completed corrective actions." {18.8}

The audit process requires issues to be entered into the corrective action process. Additional detail regarding the analysis and trending of audit deficiency is included within Section 16 of the DQAP, and

____ ______ ____________ ____ ____________ __________________________________ ___ _________ the associated implementing procedures. ________________________________ _

h. Measures to ensure that audits objectively assess the The following excerpts from DQAP Section 18 address the effectiveness and proper implementation of the QA program and requirements:

should address the technical adequacy of the activities being conducted.

"The program will establish a system of planned and documented audits in order to verify compliance with all aspects of the DQAP, and determines the effective implementation of DQAP scope activities. {18.1}

• Planned internal audits are scheduled and performed in accordance with approved procedures or checklists to provide comprehensive, independent verification, and evaluation of DQAP compliance, performance criteria, and program effectiveness. "{18.4}

Additional detail regarding the scope and breadth of audit activities

_____ ______________ ___ _____________________________ ____ _____________________ ________ are included _in the associated implementing procedures. ______________ _

i.

Measures to establish provisions requiring the performance of The following excerpt from DQAP Section 18 addresses the audits in all areas to which the requirements of the QA program requirement: "The program will establish a system of planned and apply.

documented audits in order to verify compliance with all aspects of the DQAP, and determines the effective implementation of DQAP scope activities." {18.1}

Additional detail regarding the scope and breadth of audit activities are included in the associated implementing procedures.

Page 56 of 56

ATTACHMENT 4 KS DQAP Compliance Matrix to NUREG 1757 27 PAGES KEWAUNEE POWER STATION

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NUREG 1757 NUREG 1757, Section 17.6, Acceptance Criteria 17.6.1: ORGAN IZATION EVALUATION CRITERIA: The staff's review should verify that the following information is included in the description of the QA KS DQAP References / Conclusion program organization: ___________________________________________________ ____ ________________ _______ __ __________________________________________________________ _

a description of the QA program management organization; The "Quality Assurance" sub-section of DQAP Section 1 addresses this

____ __ _________________________________________ ________ _________ __ _____ ___ ______ __ __ requirement. ______ _______________________________ _____________________________ _

a description of the duties and responsibilities of each unit within The DQAP Section 1 addresses the duties and responsibilities of each the organization and how delegation of responsibilities is unit within the organization.

managed within the decommissioning program; Specific requirements for delegation are included in the following sections of the DQAP:

• Section 1 of the DQAP states: "Unless otherwise specifically prohibited, responsibilities of managers as described in the DQAP may be delegated to, and performed by, other qualified individuals." [1.1.1}

For the General Manager (GM), the " Responsibilities" sub-section of DQAP Section 1 states "The individual shall delegate in writing the succession to this responsibility during their absence." {1.2.3)

• The "Station Management" sub-section of DQAP Section 1 states:

"The GM delegates to the KS management team the day-to-day responsibilities for the ISFSI and decommissioning" {1.4.1)

• The Decommissioning Plant Manager (DPM) "...shall delegate in writing the succession to this position during their absence."

{l.4.2)

DQAP Section 1 sub-section " Delegation of Work" addresses delegation of the execution of portions of the work under the DQAP to others such as contractors, agents, or consultants.

{1.5.1}

Page 1 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NUREG 1757, Section 17.6, Acceptance Criteria a description of how work performance is evaluated; KS DQAP References / Conclusion The "Quality Assurance" sub-section of DQAP Section 1 addresses this requirement.

DQAP Section 1 sub-section "Reporting" includes the following requirement: "The GM shall periodically have an Independent Management Assessment {/MA} performed to evaluate the effectiveness of the DQAP, as described in Appendix D of the DQAP."

{1.6.2}

DQAP Section 2 sub-section " Performance / Verification" includes the following requirements :

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

{2.3.2}

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. [2.3.3}

d. Criteria that define acceptable quality are specified, and quality is verified against these criteria. {2.3.4}

a description of the authority of each unit within the QA program; The structure, interrelationships, and areas of functional and responsibility and authority for all organizational units implementing

_______________________________ _____________________________________________________ the DQAP _are described throughout DQAP _Section_ 1. ____________________ _

an organization chart ofthe QA program organization.

17.6.1 EVALUATION CRITERIA: {continued)

The staff should verify that:

a. the organization or individual responsible for submitting the license application exercises and retains the responsibility for the establishment and execution of the overall program.

A high level organizational structure of functional areas is presented in DQAP Appendix A.

DQAP Section 1 states:" Kewaunee Solutions {KS} is responsible for the establishment and execution of the Quality Assurance Program for the Kewaunee Power Station (KPS}." {1.1.1]

KS is the organization that submitted the license transfer application for KPS.

Page 2 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NU REG 1757, Section 17.6, Acceptance Criteria

b. major delegations of work are fully described and that in each case, organizational responsibilities and methods for control of the work by the applicant are described, including how responsibility for delegated work is to be retained and exercised.

c. the licensee and its prime contractors describe how responsibility is exercised for the overall QA program and that the extent of management responsibility and authority are addressed.

d. policies regarding the implementation of the QA program are documented and made mandatory.

KS DQAP References / Conclusion Specific requirements for major delegation are included in the following sections of the DQAP:

For the GM, the "Responsibilities" sub-section of DQAP Section 1 states "The individual shall delegate in writing the succession to this responsibility during their absence." {1.2.3}

• The Decommissioning Plant Manager (DPM) "... shall delegate in writing the succession to this position during their absence."

{1.4.2}

• The "Station Management" sub-section of DQAP Section 1 states:

"The GM delegates to the KS management team the day-to-day responsibilities for the ISFSI and decommissioning... " [1.4.1}

DQAP Section 1 sub-section "Delegation of Work" addresses delegation of the execution of portions of the work under the

___ __ DQAP to_others such_ as contractors,_ agents,_ or consultants._ (1.5] __ _

A description of how responsibility is exercised for the overall DQAP implementation, and the extent of management responsibility and authority for the QA program, are described throughout DQAP Section 1. For Kewaunee decommissioning, the prime contractors will be seconded programmatically and integrated into the KS organization described in DQAP Section 1.

The following excerpt from DQAP Section 1 establishes direct linkage from the highest management level to the GM: "The General Manager (GM) reports to the Kewaunee Solutions President, and has the overall responsibility for the establishment and execution of the DQAP." [1.1.2}

The GM responsibilities are included throughout DQAP Section 1, and include reviewing and approving the DQAP, which embodies the KS QA policies, goals, and objectives.

Page 3 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NUREG 1757, Section 17.6, Acceptance Criteria KS DQAP References / Conclusion The "Responsibilities" sub-section of DQAP Section 1 directs management to ensure the requirements established in the DQAP and implementing procedures are met (i.e., made the requirements mandatory): " Management of line organizations at KPS are responsible to ensure that the quality of organizational work and activities meets the requirements set forth in the DQAP and KPS implementing procedures." {1.2.5}

DQAP Section 5 states: "The program will ensure that quality activities are prescribed by and performed in accordance with

___________ _______________________________________________________ _________________ _ documented instructions, _procedures,_ or drawings. "{5.1} ________________ _

e. the licensee and its contractors will evaluate the performance of The following excerpt from DQAP Section 1.5 addresses the QA work delegated to other organizations, including functions delegated to other organizations: "KS may delegate the audits/surveillances of the contractor's QA programs and execution of portions of the work under the DQAP to others such as audits/surveillances of subcontractors, consultants, and vendors contractors, agents, or consultants; however, KS retains overall furnishing equipment or services to the applicant or its responsibility for those activities and the DQAP. Delegation is clearly contractors. The frequency and method of this evaluation should identified in documentation and KS retains the right to verify be specified.

compliance with KS quality and regulatory requirements applicable to that organization's QA Program. QA program interactions, management responsibilities, and authority for the coordinated execution of the overall QA program, are established and documented. "{1.5.1}

Section 18 of the DQAP provides for the audit/surveillance of contractor QA programs, subcontractors, consultants, and vendors furnishing equipment or services to the KS or its contractors, and for

__________ __________________________________________________________________________ the frequency _and _method of this evaluation. ____________________________ _

f.

that the licensee and prime contractors identify a management The "Quality Assurance" sub-section of DQAP Section 1 establishes position that retains overall authority and responsibility for the the QAM position that addresses this requirement. [1.3]

_____ QA program _(normally, this position is _filled by the QA Manager). __________ ---------------------------------------------------------------------------

g. the QA Manager position is at the same or a higher organization level than the position of the highest line manager directly responsible for performing activities affecting quality (such as engineering, procurement, construction, and operation) and is The following excerpts from the "Quality Assurance" sub-section of DQAP Section 1 addresses this requirement:

• "The QAM reports to the GM and shall not be assigned responsibilities that would prevent the required attention to

___ --~~_f!!~(~!1-~ly_

!~-~~R~-~~~~! -~~'?~- ~-~~! -~~-~ -~~~-E:~-~~E:-~~~!!~_i!1_~~ _(!_~i_s _______________________________________________________________________________________ _

Page 4 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NU REG 1757, Section 17.6, Acceptance Criteria does not mean that the QA position must report outside of the project or program).

h. the authority and duties of persons and organizations performing functions related to meeting the performance objectives are clearly established and delineated in writing, including both the performing functions of attaining the requisite quality of work (quality achieving) and the assurance functions of verifying the attainment of quality (quality assuring).

i.

designated QA personnel, sufficiently free from direct pressures resulting from cost and schedule, have the responsibility, delineated in writing, to stop unsatisfactory work and control further processing or delivery of nonconforming material.

KS DQAP References / Conclusion important to safety matters. Although reporting to the GM with other line organizations, the QAM shall have the necessary independence from other line management to ensure effective oversight for all organizations." {1.3.1}

• "The individuals who carry out radiation protection and quality assurance functions may report to the appropriate onsite manager; however, they shall have sufficient organizational freedom to ensure their ability to perform their assigned functions." {1.3.4}

In addition, as shown on DQAP Exhibit A and as described in Section 1, line managers directly responsible for performing activities

-~!!~_c_t_i!')_~ _g~_~(iy ~_E:1?~~ !~ _t~~-~ r:v'.'! -~!1-~

-~~~- ~~r:v'.' -~~~?-~~-!?_ !~-~ -~-~ '. ---

The following excerpt from the "Responsibilities" sub-section of DQAP Section 1 addresses the performance functions of attaining the requisite quality of work: "Management of line organizations at KPS are responsible to ensure that the quality of organizational work and activities meets the requirements set forth in the DQAP and KPS implementing procedures." {1.2.5}

The "Quality Assurance" and "Station Management" sub-sections of DQAP Section 1 addresses the authority, duties, and the assurance functions of verifying the attainment of quality.

The following excerpts from the "Quality Assurance" sub-section of DQAP Section 1 addresses the this requirement:

• "The QAM has the following responsibilities: Authority to stop work when quality is adversely affected. {l.3.1. F}

• Quality Assurance (QA) personnel... have the responsibility and authority to stop work when quality is adversely affected and immediately raise concerns to the QAM." {1.3.2}

Page 5 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NUREG 1757, Section 17.6, Acceptance Criteria KS DQAP References/ Conclusion

j.

persons and organizations performing quality assurance functions The following excerpt from the "Quality Assu rance" sub-section of have sufficient authority and organizational freedom (1) to DQAP Section 1 addresses this requirement: "QA personnel shall identify quality problems, (2) to initiate, recommend, or provide have sufficient authority and organizational freedom to identify any solutions through designated channels, and (3) to verify quality problems and to verify implementation of corrective actions."

_____ implementation of solutions. ______________________________ ______________ _{1.3.3} _________________________________________________________________________ _

k. persons and organizations with the above authority are identified and a description of how those actions are carried out is provided.

The "Quality Assurance" sub-section of DQAP Section 1 describes the persons and organization performing the quality assurance functions.

The description of how these actions are carried are included in the

_________________ ___ ______________ _____________________________________ ____________ _ respective implementing procedures._ (1.3] _______________________ _________ _

I.

provisions are established for the resolution of disputes involving The following excerpt from the "Responsibilities" sub-section of quality arising from a difference of opinion between QA DQAP Section 1 addresses these requirements: "The GM is personnel and other department personnel.

responsible for apprising management of the effectiveness of the DQAP implementation and is the arbitrator for non-conformances of unusual complexity." [1.2.4}

m. the position description ensures that the individual directly responsible for the definition, direction, and effectiveness of the overall QA program has sufficient authority to implement responsibilities effectively. This position is to be sufficiently free from cost and schedule responsibilities.

The following excerpt from DQAP Section 2 also addresses these requirements : "Disputes arising between departments or organizations on QA matters that cannot be resolved at a lower level

_of management will be referred to the_GM." {2.1.6} ______________________ _

The following excerpts from the "Quality Assurance" sub-section of DQAP Section 1 address these requirements:

• "The QAM reports to the GM and shall not be assigned responsibilities that would prevent the required attention to important to safety matters. Although reporting to the GM with other line organizations, the QAM shall have the necessary independence from other line management to ensure effective oversight for all organizations." {1.3.1}

Page 6 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NUREG 1757 NU REG 1757, Section 17.6, Acceptance Criteria

n. the person responsible for the onsite QA program is identified by position and has the appropriate organizational position, responsibilities, and authority to exercise proper control over the KS DQAP References / Conclusion

• QA personnel shall have sufficient authority and organizational freedom to identify any quality problems and to verify implementation of corrective actions. Additionally, QA personnel shall 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 nuclear safety considerations." [1.3.3}

The "Quality Assurance" sub-section of DQAP Section 1 establishes the QAM position that addresses this requirement.

___ __ QA program. ____________ ___________ _______________________ ____________________ ______________________ ___ ___________________ _____ _________ _____________________ _

o. organization charts clearly identify all the onsite and offsite organizational elements that function under the cognizance of the QA program.

17.6.2: QUALITY ASSURANCE PROGRAM The staff should verify that the following information is included in A high level organizational structure of functional areas is presented in DQAP Appendix A that have responsibility for all onsite and offsite elements that function under the cognizance of the QA program.

the description _of the QA program: ________________ ____ __ ___ ____ ________ _______ _____ ____ ___ _____ ____ ______ _______ ___ ___ _____ _____ ____ _____ _____ ___ __ __ _________ _

a commitment that activities affecting the quality of site decommissioning will be subject to the applicable controls of the QA program and activities covered by the QA program are identified on program defining documents; Section 2 of the DQAP states: "The QA Program for the Kewaunee Power Station (KPS}, hereafter referred to as the program, is described in the DQAP. The program includes the DQAP and its implementing procedures, instructions, and drawings. The DQAP provides control over important to safety structures, systems and components (SSCs) and selected decommissioning related activities to an extent consistent with their importance to ensure safety and

___________________________________________ ____ _______ ____________ _________________ -~(!_'!'f!ti_a_'}_c_e_ -°-~-<!~f_i!1._e_<!_ !'!J?!_D_~f!_1f!!_e_~--'~ p_._~:n ______ _______________________ _

a brief summary of the company's corporate QA policies; There is no brief summary of the company's corporate QA policies in the DQAP.

The following excerpt from DQAP Section 1 establishes direct linkage from the highest management level to the GM: "The General Manager (GM} reports to the Kewaunee Solutions President, and has the overall responsibility for the establishment and execution of the DQAP." [1.1.2}

Page 7 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NU REG 1757, Section 17.6, Acceptance Criteria KS DQAP References / Conclusion The GM responsibilities are included throughout DQAP Section 1, and include reviewing and approving the DQAP, which embodies the KS

_________________________________________ ___________ ________________________ _____ ___ <;1/2_ P_<?(i~_i~-~'-~-<?~~?(_~~-~ _<?~)~~~i_\\,t~~: ____ ____________ ___ __________ _____ ________ _

a description of provisions to ensure that technical and quality The following excerpts from Section 5 ofthe DQAP address the assurance procedures required to implement the QA program are requirements:

consistent with regulatory, licensing, and QA program requirements and are properly documented and controlled; a description of the management reviews, including the documentation of concurrence in these quality-affecting procedures;

• "The program will ensure that quality activities are prescribed by and performed in accordance with documented instructions, procedures, or drawings. {5.1}

• Controls are established which ensure that instructions, procedures, and drawings are current and accurately reflect the

____ JC!_~i!(~y_ _c!~~!9-'!_

C!_n_<!_Cf!9-l!!C!_t?_cy__cf!g_u_(cf!'!!~-'!!~t _l5.} J _____ ________ __ __ __ _

The following excerpt from DQAP Section 2 states: "Each organization is responsible for ensuring that the applicable portions of the DQAP are properly documented, approved, and implemented (with trained staff, necessary materials, and approved procedures available) before an activity within the scope of the DQAP is executed." [2.1.3}

Additionally, the following excerpt from DQAP Appendix D, Section 2.0, establishes requirements for Independent Safety Review (ISR):

"Independent Safety Reviewers perform ISRs of... procedures that are subject to the DQAP requirements as detailed in approved administrative procedures."

See DQAP Exhibit D, Section 2.0, for additional detail.

a description of the quality-affecting procedural controls of the principal contractors, including documentation of the acceptance of the controls before the initiation of activities affected by the program; The following excerpts DQAP Section 2 address these requirements:

"Each organization is responsible for ensuring that the applicable portions of the DQAP are properly documented, approved, and implemented (with trained staff, necessary materials, and approved procedures available) before an activity within the scope of the DQAP is executed." [2.1.3}

Page 8 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NU REG 1757, Section 17.6, Acceptance Criteria a description of how NRC will be notified of changes (a) for review and acceptance in the accepted description of the QA program as presented or referenced in the DP before implementation and (b) in organizational elements within 30 days after the announcement of the changes (note that editorial changes or personnel reassignments of a non-substantive nature KS DQAP References / Conclusion Per Section 2 of the DQAP: "Changes to the DOAP will be implemented in accordance with 10 CFR 50.54(0) and 10 CFR 71.106."

{2.1.5]

_____ do not require NRC_ notification); __________________________________________________________________________________________________________________________ _

a description is provided of how management (above or outside the QA organization) regularly assesses the scope, status, adequacy, and compliance of the QA program; The following excerpts from the "Responsibilities" and "Reporting" sub-sections of DQAP Section 1 provides the means for management to regularly assess the effectiveness of the QA program, including the scope, status, adequacy, and compliance of the QA program to the requirements of 10 CFR Part 72:

• "The GM is responsible for apprising management of the effectiveness of the DQAP implementation and is the arbitrator for non-conformances of unusual complexity. The GM also directs actions to be taken based on reports and trending of quality issues submitted by the QAM. {l.2.4]

• Management of line organizations at KPS are responsible to ensure that the quality of organizational work and activities meets the requirements set forth in the DQAP and KPS implementing procedures. {1.2.5]

• The GM shall periodically have an Independent Management Assessment (/MA) performed to evaluate the effectiveness of the DQAP, as described in Appendix D of the DQAP." {1.6.2]

The following excerpt from the "Reporting" sub-section of DQAP Section 1 provides for management's frequent contact with program status through reports, meetings: "KS management is involved with QA matters on a continuing basis. Periodic reports summarizing the quality of KPS activities are reviewed and approved by the QAM.

These reports contain status of the program adherence to the DQAP,

___________________________ ________________________________________________________ _issues identified, _unresolved items, _and/or other items of interest. _____ _

Page 9 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NUREG 1757, Section 17.6, Acceptance Criteria a description of the instruction provided to personnel responsible for performing activities affecting quality pertaining to the purpose, scope, and implementation of the quality-related

_____ r:i:i~nuals,_ instructions, and procedures; ________________________________ _

a description of the training and qualifications of personnel verifying activities affecting quality in the principles, techniques,

---

-~!1_d_requirements of the_activity being performed; ________ ___ _______ _

for formal training and qualification programs, documentation includes attendees, date of attendance, and the objectives and content of the program; KS DQAP References / Conclusion These reports are submitted to the GM and other KS management as deemed appropriate." {1.6.1]

The following excerpt from DQAP Appendix D, Section 3.1 applies to the Personnel responsible for performing activities affecting quality: "Facility staff responsible for the safe storage of nuclear fuel and selected decommissioning activities shall meet or exceed the minimum qualifications of ANSI NlB.1-1971 for comparable positions as defined in approved procedures except for: a) the radiation protection manager who shall meet or exceed the qualifications of Regulatory Guide 1.8, September 1975."

In addition, sub-section "Personnel Training and Qualifications" in DQAP Section 2 requires:

• "Individual managers are responsible for ensuring that personnel working under their cognizance are provided with the necessary indoctrination training and resources to accomplish assigned activities which fall under the scope of the DQAP. [2.2.1]

• Members of the KS staff (including audit and inspection personnel) shall have the appropriate qualifications necessary to perform their assigned duties defined in implementing procedures. These implementing procedures provide the criteria utilized for determining and assessing appropriate staff qualification. Additionally, Appendix D of the DQAP cites references that stipulate the use of specific industry standards addressing qualifications. Training programs are established and implemented to ensure that personnel achieve and maintain suitable proficiency. Personnel training and qualification records

______________________________________________________________________________________ _ -~ce__'!!<!!f1_~a_t'!~_<!J_n_ _a_~~~cc!~'!~_e_ _i,yH~-~

1f!p_cC!"!~c!_f!!~~~~1!!~~-:J?*?_~l-_

a description of the self-assessment program to confirm that The following excerpts from the "Responsibilities" and "Reporting" activities affecting quality comply with the QA program; sub-sections of DQAP Section 1 provides for the assessment of DQAP implementation:

• "Management of line organizations at KPS are responsible to

---

-----___________________ __ ~'!~~ce_ _~~~~ !t1_e_ _q'!_a_U_ty_ C}f ~CrI~'![~q_tj9_n_qj_1-Y_<?!!<_ ~'!<! ~~t_~~~t!~-~ - ______ _

Page 10 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NUREG 1757 NUREG 1757, Section 17.6, Acceptance Criteria KS DQAP References / Conclusion meets the requirements set forth in the DQAP and KPS implementing procedures. [1.2.51

• The GM shall periodically have an Independent Management Assessment {!MA) performed to evaluate the effectiveness of the

.............................................. **-*...................................... ~q~t.. a_~.1~~~Ci.~~p_ !'-1JY!R~'-1.1(><..l?. ~.f. !~.~.~9-~~.-'.' U:?_*?}.............

a commitment that persons performing self-assessment activities The sub-section "Performance/ Verification" in DQAP Section 2 are not to have direct responsibilities in the area they are states: "Personnel performing independent verification activities ore assessing; responsible for verifying the achievement of acceptable quality and

• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • -*-**-*-**************-****-****************-**.are different personnel than those who performed.the work." [2.3.21...

a description of the organizational responsibilities for ensuring DQAP Section 2 states: "Each organization is responsible for ensuring that activities affecting quality are (a) prescribed by documented that the applicable portions of the DQAP are properly documented, instructions, procedures, and drawings; and (b) accomplished approved, and implemented (with trained staff, necessary materials, through implementation of these documents; and and approved procedures available) before an activity within the

• • • • • • • • • • • -**************************-**-*-*********-****-**************-****-****.scope of the DQAP is executed." [2.1.31.....................................

a description ofthe procedures to ensure that instructions, procedures, and drawings include quantitative acceptance criteria (such as those pertaining to dimensions, tolerances, and operating limits) and qualitative acceptance criteria (such as workmanship samples) for determining that important activities have been satisfactorily performed.

The following excerpts from Section 5 of the DQAP meet the requirements :

• "The program will ensure that quality activities are prescribed by and performed in accordance with documented instructions, procedures, or drawings. [5.1}

• These instructions, procedures, and drawings include, as appropriate, quantitative or qualitative acceptance criteria for determining that activities have been satisfactorily accomplished." [S.3]

Page 11 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NUREG 1757 NU REG 1757, Section 17.6, Acceptance Criteria 17.6.2 EVALUATION CRITERIA: (continued)

The staff should verify that: N/ A 17.6.3 DOCUMENT CONTROL The staff's review should verify that the following information is KS DQAP References / Conclusion

__ included in the_description of the QA document_ control_program: _____ ---------------------------------------- -------------------------------------------

a summary of the types of QA documents included in the program; and a description of how the licensee develops, issues, revises and retires QA documents.

17.6.3 EVALUATION CRITERIA: (continued)

The staff should verify that:

a. the scope of the document control program is described, and the types of controlled documents are identified. As a minimum, controlled documents include quality assurance, quality control manuals, quality-affecting procedures, and technical reports.

The following excerpt from DQAP Section 6 addresses the requirement: "The scope of the document control program includes, but is not limited to: Safety Analysis Report(s); NRC License Documents, including Technical Specifications; Design Documents and Drawings; Procurement Documents; Procedures, Manuals, Plans, Directives, Policies, Instructions, etc., and; Other documents as defined in procedures." {6.3.A-F]

DQAP Section 6 addresses the requirement. Note that cancellation (retiring) is accomplished by revision and removal of the superseded document from live use, or by processing a revision to cancel a document, as described in implementing procedures.

The following excerpt from DQAP Section 6 addresses the requirement: "The scope of the document control program includes, but is not limited to: Safety Analysis Report(s); NRC License Documents, including Technical Specifications; Design Documents and Drawings; Procurement Documents; Procedures, Manuals, Plans, Directives, Policies, Instructions, etc., and; Other documents as

_____________________________ ________ ______________________________________________ _ defined in_procedures." {6.3.A-F] _________________ ____ ______________________ _

b. procedures for the review, approval, and issuance of documents The following excerpt from DQAP Section 6 addresses the and changes will be established and described to ensure requirement: "The program will ensure that the appropriate technical adequacy and inclusion of appropriate quality organizations review, approve, and issue documents and changes requirements before implementation.

thereto before release to ensure that the documents are adequate and applicable quality requirements are stated." {6.2}

Page 12 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NU REG 1757, Section 17.6, Acceptance Criteria

c. procedures will be established to ensure that changes to documents are reviewed and approved by the same organizations as those that performed the initia l review and approval or by other qualified responsible organizations delegated by the applicant.

d. procedures will be established to ensure that documents are available at the location where the activity will be performed prior to commencing work.

e. procedures will be established to ensure that obsolete or superseded documents are removed and replaced by applicable revisions in work areas in a timely manner.

17.6.4 CONTROL OF MEASURING AND TEST EQUIPMENT The staffs review should verify that the following information is included in the description of the test and measurement equipment KS DQAP References / Conclusion The following excerpts from DQAP Section 6 addresses the requirements: "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." {6.4}

The following excerpt from DQAP Section 6 addresses the requirement: "Copies of controlled documents are distributed to and used by the person performing the activity." {6.5}

The following excerpt from DQAP Section 6 addresses the requirement: " The distribution of new and revised controlled documents is in accordance with procedures. Superseded documents are controlled to prevent inadvertent use." {6.6}

QA _program: _______ ___ ____ _______________________________ ___ ____ ____ ___ ______ ___________________________ ____ ___ ____ ___________________ ___ ___ ____ ____ _____________ _

a summary of the test and measurement equipment used in the program; The following excerpt from DQAP Section 12 addresses the requirement: "The types of equipment covered by the program (e.g.,

instruments, tools, gauges, and reference and transfer standards) are

_c!~f!r:_e_cj_ ~'!.l?!?.~f!P.l!!~~--.U_?}J _______________________ ________________________ _

a description of how and at what frequency the equipment will be The following excerpt from DQAP Section 12 addresses the calibrated; requ irement: "Measuring and test equipment is calibrated at specified intervals or immediately before use on the basis of the item's required accuracy, required calibration technique, intended use, frequency of use, stability characteristics, and other conditions

___________________________________________________________________________________ _ a_fff!~t!r:_g__i_t?_p_e_rfC!!'!'_a_r:_c_e_~':l~?~~J __________________________________ ---------

a description of the daily calibration checks that will be The following excerpts from DQAP Section 12 address the performed on each piece of test or measurement equipment; and requirement:

• "The program consisting of implementing procedures reviewed and approved by the appropriate organizations will control the

--- -- -------- -- ------------------ --------------- -- ---------- ---------- ------------- -----~-a_~i!J.~a_t[C!!1!_:':_G_~'?tf!!1.C1_!?_~f!! _(!'}_cj_(!~~ ~, '!}_e_a_?_u.'.~'!9. ~'!P. _t~~~ -------- ----

Page 13 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NUREG 1757, Section 17.6, Acceptance Criteria KS DQAP References / Conclusion equipment {M& TE} consistent with activities important to safety to ensure accuracy." {12.1}

• "Measuring and test equipment is calibrated at specified intervals or immediately before use on the basis of the item's required accuracy, required calibration technique, intended use, frequency of use, stability characteristics, and other conditions affecting its performance." {12.4}

Implementing procedures provide details for specific M& TE, e.g. a description of the daily calibration checks that will be performed on

__ _______ ___________________________________________________________________________ each_piece_of test or measurement equipment. _____ ______ ___ __ __________ _

a description of t he documentation that will be maintained to The following excerpts from DQAP Section 12 address the demonstrate that on ly properly calibrated and maintained requirement:

equipment was used during the decommissioning.

• "The program consisting of implementing procedures reviewed 17.6.4 EVALUATION CRITERIA: (continued)

The staff should verify that:

a.

the scope of the program for the control of measuring and test equipment is described and the types of equipment to be controlled are established.

and approved by the appropriate organizations will control the calibration, maintenance, and use of measuring and test equipment (M& TE) consistent with activities important to safety to ensure accuracy." [12.1]

• "The types of equipment covered by the program (e.g.,

instruments, tools, gauges, and reference and transfer standards) and measures to document and maintain the status of all calibrated M& TE are defined in procedures." [12.3]

• "Measuring and test equipment is labeled, tagged, or otherwise controlled to indicate its calibration status and traceability to calibration test data." [12.5]

The following excerpts from DQAP Section 12 address the requirements :

• "The program consisting of implementing procedures reviewed and approved by the appropriate organizations will control the

__ ______________________ _________________________________ _____ _____________________ ___ __ calibration,_ maintenance, and_use of measuring and test ___________ _

Page 14 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NUREG 1757, Section 17.6, Acceptance Criteria KS DQAP References/ Conclusion equipment (M& TE) consistent with activities important to safety to ensure accuracy. [12.1)

• 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). {12.2)

• The types of equipment covered by the program (e.g.,

instruments, tools, gauges, and reference and transfer standards)

___________________________________________________________________________________ _____ are _defined in_procedures." {12.3} __________ _______ _____________________ _

b. QA and other organizations' responsibilities are described for establishing, implementing, and ensuring effectiveness of the calibration and adjustment program.

The following excerpt from DQAP Section 12 addresses the requirement: "The program consisting of implementing procedures reviewed and approved by the appropriate organizations will control the calibration, maintenance, and use of measuring and test equipment (M& TE) consistent with activities important to safety to ensure accuracy." [12.1}

Implementing procedures provide details for QA and other organizations' responsibilities for establishing, implementing, and

---

_ensuring effectiveness of the_ calibration and adjustment program. ____ _

c.

procedures will be established for calibration (technique The following excerpts from DQAP Section 12 address the and frequency), maintenance, and control of the measuring requirements :

and test equipment.

• "The program consisting of implementing procedures reviewed and approved by the appropriate organizations will control the calibration, maintenance, and use of measuring and test equipment (M& TE) consistent with activities important to safety to ensure accuracy. [12.1}

• The types of equipment covered by the program (e.g.,

instruments, tools, gauges, and reference and transfer standards) are defined in procedures. {12.3}

Page 15 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NUREG 1757, Section 17.6, Acceptance Criteria KS DQAP References / Conclusion

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

---

--------------- -- --------------------------------------- ------------------- --- __ p_f:~f<!!.':'.C!'.'.~f:: ~-l~?:~L __ ------------------------------------- --------------

d. the review of and documented concurrence in these procedures are described, and the organization responsible for these functions is identified.

The following excerpt from DQAP Section 12 addresses the requirements : "The program consisting of implementing procedures reviewed and approved by the appropriate organizations will control the calibration, maintenance, and use of measuring and test equipment (M& TE) consistent with activities important to safety to

___________________________________________ __ _________________________ ______ ____ ___ _ ensure accuracy." {12.1} ____________________________ __ ________________ _______ _

e. measuring and test equipment are identified and traceable The following excerpt from DQAP Section 12 addresses the to the calibration test data.

requirements: "Measuring and test equipment is labeled, tagged, or otherwise controlled to indicate its calibration status and traceability

___________________________________________________________________________________ _ to_calibration_ test data." {12.5} _______________ __ _______ _____ ____ __ __________ _

f.

measuring and test equipment will be labeled or tagged or "otherwise controlled" to indicate due date of the next calibration. The method to "otherwise control" equipment should be described.

The following excerpt from DQAP Section 12 addresses the requirements: "Measuring and test equipment is labeled, tagged, or otherwise controlled to indicate its calibration status and traceability to calibration test data." {12.5}

Implementing procedures would provide details for any specific measures necessary for cases where a specific M& TE item requires control measures other than labeling or tagging. These would be

---

-- -- -------------------------------------------------------------------- -~~?.l:~~y_-_C:~~~!-~-~~~-~-~~-:'.E:~_p_~~~i_C:~)~~-~\\~~~-f!l-~~~~-~~?:_ ------------- ------

g.

measuring and test equipment will be calibrated at specified The following excerpt from DQAP Section 12 addresses the intervals on the basis of the required accuracy, purpose, requirements : "Measuring and test equipment is calibrated at degree of usage, stability characteristics, and other specified intervals or immediately before use on the basis of the item's conditions affecting the measurement.

required accuracy, intended use, frequency of use, stability characteristics, and other conditions affecting its performance. " {12.4}

Page 16 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Mat rix to NU REG 1757 NUREG 1757, Section 17.6, Acceptance Criteria 17.6.S CORRECTIVE ACTION The staffs review shou ld verify that the followi ng information is included in the description of the corrective action program portion KS DQAP References / Conclusion of the QA program: _________________________________________________________________________________________________________________________ ___ __________________ _

a description ofthe corrective action procedures for the facility, including a description of how the corrective action is determined to be adequate; and The following excerpt from the DQAP Section 16 addresses t he requirement: "The program will ensure that conditions adverse to quality (such as nonconformance, failures, ma/functions, deficiencies, deviations, and defective material and equipment) are evaluated in accordance with established procedures to assess the need for corrective action to address the condition identified, and to preclude

_____________ ______________________________________________________________________ _ recurrence_of the condition." {16.2} ___________________ _______ ______________ _

a description of t he documentation maintained for each The following excerpt from DQAP Section 16 addresses follow-up corrective action and any follow-up activities by t he QA activit ies by QA: "The QA organization will be included in the organization, after t he corrective action is implemented.

concurrence chain regarding the adequacy of the corrective action, and in the follow-up action to verify the proper implementation of corrective action, in accordance with approved implementing procedures." [16.3}

The following excerpt from DQAP Section 17 addresses the records req uirement: "The program will ensure that sufficient records of important to safety items and activities affecting quality (e.g., design, engineering, procurement, manufacturing, construction, inspection and test, installation, pre-operation, startup, operations, maintenance, modification, decommissioning, and audits) are generated and maintained to reflect the completed work, and are consistent with applicable codes, standards, and procurement documents." [17. l]

Page 17 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NUREG 1757, Section 17.6, Acceptance Criteria 17.6.5 EVALUATION CRITERIA: (continued)

The staff should verify that:

a. procedures will be established for a corrective action program and that the QA organization reviews and documents concurrence in the procedures.

KS DQAP References / Conclusion The following excerpt from DQAP Section 5 addresses the requirement: "The program will ensure that quality activities are prescribed by and performed in accordance with documented instructions, procedures, or drawings." [5.1]

The controls for the corrective action process that may be applied to important to safety SSCs require procedures to control these

---

------- ---------- -------- ------------ ------- _activities._ These _procedures are_subject_ to QA review_and_approval. __ _

b. corrective action will be documented and initiated following the The following excerpt from the DQAP Section 16 addresses the determination of a condition adverse to quality (such as requirement: "The program will ensure that conditions adverse to nonconformance, failure, malfunction, deficiency, deviation, and quality (such as nonconformance, failures, ma/functions, deficiencies, defective material and equipment) to preclude recurrence.

deviations, and defective material and equipment) are evaluated in accordance with established procedures to assess the need for corrective action to address the condition identified, and to preclude

____________________________________________________________________________________ Cf:~!1.CCf:':_~f:_C!U~~-~-°-'!-~~tj9_n_:':_U~:?J ___________________ ______________________ _

c. the QA organization will be included in the concurrence chain The following excerpt from the DQAP Section 16 addresses the regarding the adequacy of the corrective action.

requirement: "The QA organization will be included in the concurrence chain regarding the adequacy of the corrective action, and in the follow-up action to verify the proper implementation of corrective action, in accordance with approved implementing

_ __ ____ _ _____ _____ __ ___ _ _ __ _ _ ____ __ _ _ _ __ __ _ _ _ _____ _ _ _ __ __ __ _ __ __ _ _ _ __ _ _ _ __ _ __ _ ___ _ _ procedures." _{16.3} _______________________________ ____ _______________________ _

d. follow-up action will be taken by the QA organization to verify the The following excerpt from the DQAP Section 16 addresses the proper implementation of corrective action and to close out the requirement: "The QA organization will be included in the corrective action in a timely manner.

concurrence chain regarding the adequacy of the corrective action, and in the follow-up action to verify the proper implementation of corrective action, in accordance with approved implementing

________________________________________________________ ________ ___________________ _ procedures." _{16.3} ________________________________________________ __________ _

Page 18 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NUREG 1757 NUREG 1757, Section 17.6, Acceptance Criteria

e. significant conditions adverse to quality, the cause of the conditions, and the corrective action taken to preclude repetition will be documented and reported to immediate management and upper levels of management for review and assessment.

17.6.6 QUALllY ASSURANCE RECORDS The staff should verify that the following information is included in KS DQAP References / Conclusion The following excerpt from DQAP Section 16 addresses the requirement: "Significant conditions adverse to quality shall require cause determination, corrective actions that should prevent recurrence, documentation and reporting to appropriate levels of management. Follow-up action shall be taken to verify effective implementation of the required corrective actions to prevent recurrence and to verify that they are effectively implemented." {16.4}

the description _of_the QA records program: __________________ _____ ____ ___ __ _____________________________________________________ ________ ____________ _________ _

a description of the manner in which the QA records will be managed; The following excerpts from DQAP Section 17 address the requirement:

• "The program will ensure that sufficient records of important to safety items and activities affecting quality (e.g., design, engineering, procurement, manufacturing, construction, inspection and test, installation, pre-operation, startup, operations, maintenance, modification, decommissioning, and audits) are generated and maintained to reflect the completed work, and are consistent with applicable codes, standards, and procurement documents." {17.1}

"Controls for the administration, identification, receipt, storage, preservation, safekeeping, retrieval, and disposition of records are provided in procedures. Responsibilities for QA and other organizations for the identification of QA and other required records, and for implementation of activities related to the records, are provided in procedures." {17.2}

The specific requirements and responsibilities for record creation, transmittal, retention (such as duration, location, fire protection, and assigned responsibilities), and maintenance associated with the

_________________________________________ __________________________________________ -~~~-~~<:J_s_ ~~'?~-E:~~ -~~~-9-~~!=_r_i~-~9-!~-!r:r!P_l~-~~!1,~i-~~-P!_~~~-~~-r_E:~:- ___________ _

Page 19 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NUREG 1757, Section 17.6, Acceptance Criteria a description of the responsibilities of the QA organization as well as all other units involved in the decommissioning to implement and maintain QA records; and KS DQAP References / Conclusion The following excerpt from DQAP Section 17 addresses the requirement: "Controls for the administration, identification, receipt, storage, preservation, safekeeping, retrieval, and disposition of records are provided in procedures. Responsibilities for QA and other organizations for the identification of QA and other required records, and for implementation of activities related to the records, are provided in procedures." {17.2}

The identification and control of specific records types associated

--- ---------- ---------------------------------------------------------------------- _with the records _process are described in implementing procedures. __ _

a description of the QA records storage facility.

See 17.6.6 (c) below.

17.6.6 EVALUATION CRITERIA: (continued)

The staff should verify that:

a. the QA records program is described, and includes results of reviews, inspections, tests, audits, and material analyses; monitoring records of work performance; and records on the qualification of personnel, procedures, and equipment.

The following excerpt from DQAP Section 17 addresses the requirement: " The program will ensure that sufficient records of important to safety items and activities affecting quality (e.g., design, engineering, procurement, manufacturing, construction, inspection and test, installation, pre-operation, startup, operations, maintenance, modification, decommissioning, and audits} are generated and maintained to reflect the completed work, and are consistent with applicable codes, standards, and procurement documents. " {17.1}

The identification and control of specific records types associated

---

------- -------------------------------- ___________________________ with the records _process are described in implementing procedures. __ _

b. QA and other organizations are identified and their The following excerpt from DQAP Section 17 addresses the responsibilities are described for the definition and requirement: "Controls for the administration, identification, receipt, implementation of activities related to QA records.

storage, preservation, safekeeping, retrieval, and disposition of records are provided in procedures. Responsibilities for QA and other organizations for the identification of QA and other required records, and for implementation of activities related to the records, are provided in procedures." {17.2]

The identification and control of specific records types associated

--- ------ ----------- -------------------- ------------------------ ------------ -- ----- _with the records _process are described in implementing procedures. __ _

Page 20 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NUREG 1757, Section 17.6, Acceptance Criteria KS DQAP References / Conclusion C. suitable faci lities for the storage of records are described and The following excerpts from DQAP Section 17 describe the general satisfy the requirements of ANSI/ASME NQA-1. Alternatives to requirements for the maintenance and preservation of records:

the fire protection rating provisions are acceptable if record "Controls for the administration, identification, receipt, storage, storage facilities conform to National Fire Protection Association preservation, safekeeping, retrieval, and disposition of records Standard NFPA 232, Class 1, for permanent records and if the 2-are provided in procedures. Responsibilities for QA and other hour fire-rating requirement contained in proposed ANSI N45.2.9 organizations for the identification of QA and other required is met by the applicant in any one of the following three ways:

records, and for implementation of activities related to the (1) a 2-hour-rated vault meeting NFPA 232, (2) 2-hour-rated file records, are provided in procedures. (17.2]

containers meeting NFPA 232 (Class B), or (3) a 2-hour-rated fire resistant file room meeting NFPA 232.

If dual storage facilities are used to ensure the record integrity, the storage facilities should be sufficiently remote from each other to preclude a single event (such as a fire or flood) from damaging both facilities." (17.2.2]

The following excerpt from DQAP Section 17 describes the QA records repository requirements for electronic records:

"Management of the electronic storage of records will utilize the guidance provided in the following industry standards as described in approved procedures: NIRMA TGll -2011, Authentication of Records and Media; NIRMA TGlS-2011, Management of Electronic Records; NIRMA TG16-2017, Software Quality Assurance Documentation and Records; NIRMA TG21 -2011, Required Records Protection, Disaster Recovery and Business Continuation" {17.3.1-4}

These NIRMA guidelines have been endorsed by RIS 2000-18, Guidance on Managing Quality Assurance Records in Electronic Media, dated October 23, 2000.

Page 21 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NUREG 1757, Section 17.6, Acceptance Criteria KS DQAP References / Conclusion 17.6.7 AUDITS AND SURVEILLANCE The following information should be included in the

-~~~-~~i~!i_~~- ~~~~-~ -~~-~!! ~~~~~~~_: _ --------------- -- -------------------------- -------------------------------- -------- ------------------------------------- ------

a description of the audit program, including the procedures for conducting the audits or surveillances; The following excerpts from DQAP Section 18 address the requirements:

• "QA internal and supplier audits are planned and performed by qualified auditors utilizing approved written procedures and/or checklists. {18.1}

• Surveillances may be performed and documented when it is determined advantageous to monitor or observe an item or activity to verify conformance. Surveillance conducted by or under the direction of a Lead Auditor may be integrated into and

____________________________________________________________________________________ ____ credited toward required audit activities." {18.6} ____________________ _

a description of the records and documentation generated during The following excerpts from DQAP Section 18 address the the audits and the manner in which the documents are managed; requirements:

a description of all follow-up activities associated with audits or

___ --~~rveillances; and ________________________________________________________ _

a description of the trending/tracking that will be performed on the results of audits and surveillances.

• "Audit records shall be retained in accordance with approved implementing procedures. {18.9}

• Scheduling, preparation, personnel selection, performance, reporting, response, follow-up, and records management for audits are performed in accordance with written procedures."

_ -- __ {18.3}_ -- _ ---- _ --- __ --- __ --- ____ -- -- ___ -- -- ___ -- _ -- -- ______ --- _____ ------ _ -- _

The following excerpt from DQAP Section 18 addresses the requirements, in requiring issues to be entered into the corrective action process: "Results of audits are reviewed with the management of the organization audited. Responsible management in the areas audited shall implement the necessary corrective actions required to address deficiencies. These actions are documented and reviewed periodically and, if needed, re-examined during re-audits of the subject area to verify deficient areas have completed corrective actions." {18.8}

The audit process requires issues to be entered into the corrective action process. Additional detail regarding the follow-up, analysis Page 22 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NUREG 1757, Section 17.6, Acceptance Criteria 17.6.7 EVALUATION CRITERIA: (continued)

The staff should verify that:

a. audits and surveillances will be performed in accordance with pre-established written procedures or checklists and conducted by trained personnel not having direct responsibilities for the achievement of quality in the areas being audited.

KS DQAP References / Conclusion and trending of audit deficiencies is included within Section 16 of the DQAP, and the associated implementing procedures.

The following excerpts from DQAP Section 18 address the requirements:

• "QA internal and supplier audits are planned and performed by qualified auditors utilizing approved written procedures and/or checklists. {18.1}

• Lead Auditors shall have experience, training or qualifications commensurate with the scope and complexity of their audit responsibility. Individuals performing audits shall not have direct responsibilities in the areas being audited. {18.2}

• Surveillance conducted by or under the direction of a Lead Auditor may be integrated into and credited toward required audit activities." {18.6}

Administrative procedures include guidance for conduct of surveillance, and for audit team training and qualification associated

_____________________________________________________________________________________ with the audit and _surveillance process. _____ __ ___________________ __ ______ _

b. audit and surveillance results will be documented and then The following excerpts from DQAP Section 18 address the reviewed with management having responsibility in the area audited.

requirements:

• "Audit reports shall be prepared, reviewed, approved, and distributed in accordance with approved procedures. {18. 7}

• Results of audits are reviewed with the management of the organization audited." {18.8}

Administrative procedures associated with the audit process include guidance for conduct of surveillance as well.

Page 23 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NUREG 1757, Section 17.6, Acceptance Criteria

c. provisions exist such that appropriate follow-up corrective action to audit and surveillance reports will be undertaken by responsible management and that auditing organizations schedule and conduct appropriate follow-up to assure that the corrective action is effectively accomplished.

d. both technical and QA programmatic audits and surveillances will be performed to provide a comprehensive independent verification and evaluation of procedures and activities affecting quality.

KS DQAP References / Conclusion The following excerpt from DQAP Section 18 addresses the requirements, in requiring issues to be entered into the corrective action process: "Responsible management in the areas audited shall implement the necessary corrective actions required to address deficiencies. These actions are documented and reviewed periodically and, if needed, re-examined during re-audits of the subject area to verify deficient areas have completed corrective actions." {18.8}

The audit process requires audit and surveillance issues to be entered into the corrective action process. Additional detail regarding the analysis and trending of audit deficiency is included within Section 16

_'?!_~~~ _[?q~~ i -~ ~-~ _t_~~-9_s_~'?~}9_t_':9_ (~ p_l~-~ ~!1_~i-~~-P!_<?~~-~~-~':~: __ __________ _

The following excerpts from DQAP Section 18 address the requirements :

• "The program will establish a system of planned and documented audits in order to verify compliance with all aspects of the DQAP, and determines the effective implementation of DQAP scope activities. {18.1}

• Planned internal audits are scheduled and performed in accordance with approved procedures or checklists to provide comprehensive, independent verification, and evaluation of DQAP compliance, performance criteria, and program effectiveness.

Important to Safety {10 CFR 71 and 72) activities shall be audited based on the activity's importance to safety; however, each applicable quality criterion shall be audited at least once each year. Audit of DQAP elements applicable to other activities conducted under the DQAP shall be completed for each functional area at least once every two years. Audits may be extended beyond their originally scheduled due date based on the following criteria: Audits shall be performed at the intervals designated and the schedules are based on the month in which the audit starts. A maximum extension not to exceed 25 percent of the audit interval

---

------------ --------------- --------- --- -------- -- ---------- _____ is allowed unless restricted by regulation._ When an audit interval _

Page 24 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix t o NUREG 1757 NU REG 1757, Section 17.6, Acceptance Criteria KS DQAP References / Conclusion extension greater than one month is used, the next audit from that particular area is scheduled from the original anniversary month rather than from the month of the extended audit. {18.4, 18.4, 18.4.1.A through 18.4.1.C}

External audits of suppliers are scheduled and performed based on the importance of the activity and to confirm implementation of the supplier's QA Program... at a frequency of not greater than three (3) years with a 90 day grace period." {7.2.1.A]

_____________________________________________________________ __ _____________________ These requirements _bound_ the evaluation criteria. _______________________ _

e. audits and surveillances objectively assess the The following excerpts from DQAP Section 18 address the effectiveness and proper implementation of t he QA requirements:

program and address the t echnical adequacy of t he

• The program will establish a system of planned and documented activities being conducted.

audits in order to verify compliance with all aspects of the DQAP, and determines the effective implementation of DQAP scope activities. {18.l}

• Planned internal audits are scheduled and performed in accordance with approved procedures or checklists to provide comprehensive, independent verification, and evaluation of DQAP compliance, performance criteria, and program effectiveness.

Important to Safety {10 CFR 71 and 72} activities shall be audited based on the activity's importance to safety; however, each applicable quality criterion shall be audited at least once each year. Audit of DQAP elements applicable to other activities conducted under the DQAP shall be completed for each functional area at least once every two years. Audits may be extended beyond their originally scheduled due date based on the following criteria: Audits shall be performed at the intervals designated and the schedules are based on the month in which the audit starts. A maximum extension not to exceed 25 percent of the audit interval is allowed unless restricted by regulation. When an audit interval extension greater than one month is used, the next audit from

___________________________________________________ ____ ____________________________ _____ that particular area is scheduled from the original anniversary _____ _

Page 25 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NUREG 1757, Section 17.6, Acceptance Criteria KS DQAP References / Conclusion month rather than from the month of the extended audit.

11 {18.4, 18.4.1.A through 18.4.1.C}

___ _______ __________________________________________________________________________ These requirements_ bound_ the evaluation criteria. _______________________ _

f. provisions will be provided such that audits and The following excerpts from DQAP Section 18 address the surveillances are required to be performed in all areas where the requirements of the QA program are applicable.

g. audit and surveillance deficiency data are analyzed and trended.

requirements:

• "The program will establish a system of planned and documented audits in order to verify compliance with all aspects of the DQAP, and determines the effective implementation of DQAP scope activities. {18.1}

• Surveillances may be performed and documented when it is determined advantageous to monitor or observe an item or activity to verify conformance. Surveillance should be documented in sufficient detail to identify the activity covered, identify individuals doing surveillance, and to document results and corrective measures necessary. (18.6]

External audits of suppliers are scheduled and performed based on the importance of the activity and to confirm implementation of the supplier's QA Program at a freque ncy of not greater than three (3) years with a 90 day grace period.

11 [7.2.1.A]

_'.~~~~-_r~g~i!_f:~~-~!? _ ~~~-"!~-!~_<: _<:~~-1~-~!(<?_"! _<:~i!~~i-~--_. ____________________ _

The following excerpt from DQAP Section 18 addresses the req uirements, in requiring issues to be entered into the corrective action process: "Results of audits are reviewed with the management of the organization audited. Responsible management in the areas audited shall implement the necessary corrective actions required to address deficiencies. These actions are documented and reviewed periodically and, if needed, re-examined during re-audits of the subject area to verify deficient areas have completed corrective actions." {18.8}

Page 26 of 27

Letter No. ES-2022-02, Attachment 4, KS DQAP Compliance Matrix to NU REG 1757 NUREG 1757, Section 17.6, Acceptance Criteria KS DQAP References / Conclusion The audit process requires issues to be entered into the corrective action process. Additional detail regarding the analysis and trending of audit deficiency is included within Section 16 of the DQAP, and the

-~~~~~(~!~-~ _i_f:1_f?!~~-E:!1_t_i!1J~ _[?~~-~~~~!!:~*- ------------------------ --------------

h. reports that indicating quality trends and the effectiveness The following excerpt from DQAP Section 16 addresses the of the QA programs will be given to management for requirement: "Reports of conditions that are adverse to quality are review, assessment, corrective action, and follow up.

analyzed to identify negative performance trends. Significant conditions adverse to quality and significant trends are reported to the appropriate levels of management." {16. 6}

Page 27 of 27

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