ML12341A283

Boiling Water Reactor, Quality Assurance Program Description, Revision 25

ML12341A283
Person / Time
Site:	La Crosse File:Dairyland Power Cooperative icon.png
Issue date:	11/29/2012
From:	Berg W Dairyland Power Cooperative
To:	NRC/FSME
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Download: ML12341A283 (78)

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DAIRYLAND POWER C 00 P E RAT IVE INRCDockeliNo.56-409 TO: NRC Washington CONTROLLED DISTRIBUTION NO. 53 FROM: LACBWR Plant Manager 11/29/2012

SUBJECT:

Changes to LACBWR Controlling Documents I. The following documents have been revised or issued new:

LACBWR QUALITY ASSURANCE PROGRAM DESCRIPTION (QAPD),

Revision 25 Instructions:

Remove and replace all pages NOTE. 10 CFR 50.54(a) allowsfor distributionof QAPD revisions without written NRC approval,after a 60-day waitingperiod. Since a time period of at least 60 days has elapsed since submittal of this revision, with no NRC response having been received, no acceptance letter is included with this distribution.

IF] The material listed above is transmitted herewith. Please verify receipt of all listed material, destroy superseded material, and sign below to acknowledge receipt.

C3 The material listed above has been placed in your binder.

0 Please review listed material, notify your personnel of changes, and sign below to acknowledge your review and notification of personnel. [To be checked for supervisors for department specific procedures and LACBWR Technical Specifications.]

El The material listed above has been changed. [To be checked for supervisors when materials applicable to other departments are issued to them.]

0] Update Index with pen and ink change, as appropriate.

/S/ DATE Please return this notification to the LACBWR Administrative Assistant within ten (10) working days.

w~4 A Touchstone Energy' Cooperative Ox La Crosse Boiling Water Reactor (LACBWR)

• S4601 State Highway 35

• Genoa, WI 54632-8846

• 608-689-2331

• 608-689-4200 fax

DAIRYLAND POWER COOPERATIVE LA CROSSE BOILING WATER REACTOR QUALITY ASSURANCE PROGRAM DESCRIPTION REVISION 25 REVIEWED BY '~'Th0 4A DATE *- ';*.

Manager, Quality Assurance REVIEWED BY_ DATE 9 . O(-

ot PlantlFSI ManaflZr fZ APPROVED BY DATE 9-*-"2.01Z President and CEO U

DAIRYLAND POWER COOPERATIVE LA CROSSE BOILING WATER REACTOR STATEMENT OF QUALITY ASSURANCE POLICY The Quality Assurance Program Description (QAPD) described herein has been developed by Dairyland Power Cooperative (DPC) to provide a consolidated overview of the quality program controls that govern the decommissioning of the La Crosse Boiling Water Reactor (LACBWR) and operation and maintenance of the LACBWR Independent Spent Fuel Storage Installation (ISFSI). The QAPD describes the quality assurance organizational structure, functional responsibilities, levels of authority and interfaces.

The QAPD applies to the decommissioning activities performed under 10 CFR 50, Appendix B and all activities associated with structures, systems, and components which are Important to Safety under 10 CFR 72. The QAPD also applies to transportation packages licensed by the NRC under 10 CFR 71. Requirements of the QAPD are performed in a graded approach commensurate with an item's or an activity's importance to safety. This graded approach is responsive to NRC Regulatory Guide 7.10. The applicability of the requirements of the QAPD to other items and activities is determined on a case by case basis. The QAPD satisfies the requirements of 10 CFR 50 Appendix B, 10 CFR 71 Subpart H, and 10 CFR 72 Subpart G.

The Manager, Quality Assurance is responsible for the establishment and implementation of a quality assurance program which meets all regulatory requirements. The quality assurance program, as described in this QAPD, is implemented through the use of approved procedures (i.e., policies, directives, procedures, manuals, instructions, or other documents) which provide written guidance for the control of Important to Safety items and activities and provides for the development of documentation to demonstrate objective evidence of compliance with stated requirements.

President and C 9-19-2oat Date QAPD Rev. 25

DAIRYLAND POWER COOPERATIVE LA CROSSE BOILING WATER REACTOR QUALITY ASSURANCE PROGRAM DESCRIPTION TABLE OF CONTENTS SECTION PAGE STATEMENT OF POLICY ..................................................................................................... i

0.0 INTRODUCTION

................................................................................................................ 1 I. ORGANIZATION ................................................................................................................. 2 II. QUALITY ASSURANCE PROGRA M ....................................................................................... 5 III. DESIGN CONTROL AND REVIEW ......................................................................................... 8 IV. PROCUREMENT DOCUMENT CONTROL .............................................................................. 9 V. INSTRUCTION, PROCEDURES AND DRAW INGS .................................................................... 10 VI. DOCUMENT CONTROL ...................................................................................................... 11 VII. CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES ...................................... 12 VIII. IDENTIFICATION AND CONTROL OF MATERIAL, PARTS, AND COMPONENTS ......................... 13 IX. CONTROL OF SPECIAL PROCESSES ................................................................................... 14 X. INSPECTION ..................................................................................................................... 15 XI. TEST CONTROL ........................................................................ ..................................... 16 XII. CONTROL OF MEASURING AND TEST EQUIPMENT ............................................................... 17 XIII. HANDLING, STORAGE, AND SHIPPING ................................................................................. 18 XIV. INSPECTION, TEST, AND OPERATING STATUS ..................................................................... 19 XV. CORRECTIVE ACTION ........................................................................................................ 20 XVI. QUALITY ASSURANCE RECORDS ....................................................................................... 21 X VII. AUDITS ............................................................................................................................. 23 XVIII. OPERATIONS REVIEW COMMITTEE ............................................................... . ............... 25 APPENDIX A - IMPORTANT TO SAFETY STRUCTURES, SYSTEMS, AND COMPONENT .............. 27 APPENDIX B - REGULATORY COMMITMENTS, ALTERNATIVES, AND EXCEPTIONS .................. 29 APPENDIX C - ADMINISTRATIVE CONTROLS ........................................................................ 30 TABLE 1 - REGULATORY COMPARISON MATRIX .................................................................. 35 FIGURE 1 - LACBW R FACILITY ORGANIZATION .................................................................... 36 FIGURE 2 - DAIRYLAND POWER COOPERATIVE MANAGEMENT ORGANIZATION ..................... 37 QAPD ii Rev. 25

0.0 INTRODUCTION

A. General The LACBWR Quality Assurance Program Description (QAPD) is designed to meet the requirements of 10 CFR 50, Appendix B, 10 CFR 71, Subpart H, and 10 CFR 72, Subpart G and reflects the direction of applicable regulatory guides and industry standards, as they apply to decommissioning the LACBWR plant and the operation and maintenance of the LACBWR ISFSI, thereby assuring that risk to the health and safety of the public is not increased.

The quality assurance program described herein is applied by Dairyland Power Cooperative (DPC) to assure safe decommissioning of the LACBWR plant and safe operation of the LACBWR ISFSI. The QA program shall be applied to activities with a graded approach to quality that is commensurate with an item's or an activity's importance to safety such as design, engineering, procurement, installation, maintenance, modification, operations, and decommissioning by DPC or its contractors, and their subcontractors.

Quality Assurance (QA) as defined herein encompasses all those planned and systematic actions necessary to provide adequate confidence that an Important to Safety structure, system, or component will perform its intended function satisfactorily. QA is recognized as an interdisciplinary function and not the sole responsibility of QA personnel.

It is DPC's policy that the group performing and directly responsible for the work, such as project management, engineering, design, procurement, installation, maintenance, testing, and dismantlement shall be responsible for the quality of work. This includes quality control and verification that all work is performed in accordance with approved documents. QA personnel have responsibility for auditing these groups and assuring DPC management that the QA program is being fully and effectively implemented.

The requirements and commitments contained in this QAPD are mandatory and must be implemented, enforced, and adhered to by all individuals and organizations. Employees are encouraged to actively participate in the continued development of the QA program as well as its implementation.

B. Terms and Definitions The terms and definitions listed below are used frequently throughout this document.

COMPANY - Dairyland Power Cooperative (DPC)

LACBWR - La Crosse Boiling Water Reactor.

QUALITY ASSURANCE (QA) - All those planned and systematic actions necessary to provide adequate confidence that structures, systems, or components (SSCs) will perform satisfactorily in service.

QUALITY CONTROL (QC) - Those quality actions which provide a means QAPD 1 Rev. 25

to control and measure the characteristics of an item, process or facility to established requirements.

ORC - Operations Review Committee.

FACILITY - Encompasses the plant site, which is undergoing decommissioning, and the ISFSI site where spent fuel is stored. Excluded is the DPC transmission substation adjacent to the plant site and power transmission apparatus located beyond the LACBWR switchyard.

PLANT - Encompasses the buildings that functionally supported the operation of the LACBWR nuclear power facility.

ADMINISTRATIVE CONTROL PROCEDURE (ACP) - A document which establishes the guidelines and requirements governing functional activities.

QA MANUAL - A manual comprised of the QA Program Description.

SRC - Safety Review Committee.

SCHEDULE INTERVAL - A time frame within which a scheduled activity shall be performed with a maximum allowable extension not to exceed 25 percent of the schedule interval.

IMPORTANT TO SAFETY (ITS) - A classification given to structures, systems, and components (SSCs) that provide nuclear safety design functions. (See Appendix A for complete details).

I. ORGANIZATION A. General Requirements Figure 1 shows the organizational structure for the LACBWR facility and establishes the functional lines of authority and responsibility of various groups and individuals participating in the LACBWR QA program. The authority and duties of persons or groups responsible for the direction, implementation, and auditing of this program are as follows:

1. DPC President and CEO has corporate responsibility for all quality assurance matters relating to decommissioning the LACBWR plant and operation and maintenance of the LACBWR ISFSI. This individual has delegated the authority and responsibility for administration of quality assurance for LACBWR to the Manager, Quality Assurance.

2. Vice President (VP), Generation reports directly to the President and CEO and has corporate responsibility for the administration and operation of the LACBWR decommissioning and operation and maintenance of the LACBWR ISFSI.

3. Plant/ISFSI Manager, who reports directly to the VP, Generation, has on-site responsibility for LACBWR plant decommissioning and operation and maintenance of the LACBWR ISFSI within the limits set forth in the Decommissioning Plan, Technical Specifications and this QAPD. This individual has responsibility for implementing the quality assurance requirements at the decommissioning plant and operating QAPD 2 Rev. 25

ISFSI through administrative control procedures and procedures required to fulfill the requirements of this program. Activities performed by outside individuals or groups, including SRC, outside consultants, and representatives of NRC activities, with regard to the LACBWR facility are performed under the authority and responsibility of the Plant/ISFSI Manager.

The Plant/ISFSI Manager has overall responsibility for the groups designated in the organizational chart for the facility. The Plant/ISFSI Manager is the ISFSI Security Supervisor and has access to the DPC President and CEO if necessary for security matters, and is responsible for implementation and administration of the LACBWR ISFSI Physical Security Program.

4. Decommissioninq Proiect Manager (DPM) reports directly to the Plant/ISFSI Manager on all decommissioning project activities and is responsible for the implementation of quality administrative controls for the duration of the decommissioning project and other LACBWR activities as designated by the Plant/ISFSI Manager. This individual has full authority and accountability for successful project planning and execution including effective implementation of quality administrative controls. The DPM is responsible for contract management and development of contract deliverables in accordance with quality requirements defined in quality administrative controls.

5. Manager, Quality Assurance reports directly to the VP, Generation, with direct access to the DPC President and CEO, if necessary, for quality assurance matters. This individual has responsibility for establishing a quality assurance program and performing audits of the program to determine its effectiveness. This individual has the authority and organizational freedom to verify activities affecting quality and is independent of undue influences and responsibilities for schedules and costs. The Manager, Quality Assurance has the responsibility and authority to stop unsatisfactory work and control further processing, delivery, or installation of nonconforming materials.

This individual also has the responsibility and authority to identify quality problems, to recommend or provide solutions, and to verify their implementation. The individual is responsible for administration of the corrective action program.

6. Health & Safety/Maintenance Supervisor reports directly to the Plant/ISFSI Manager and is responsible for the administration, maintenance, and implementation of the Radiation Protection Program, Process Control Program, Offsite Dose Calculation Manual, Radioactive Effluent Controls Program, and Radiological Environmental Monitoring Program. This individual directly supervises and coordinates all activities relating to maintenance of the facility and is responsible for maintenance records and ensures that approved maintenance procedures are followed.

QAPD 3 Rev. 25

7. Safety/Training Coordinator reports directly to the Plant/ISFSI Manager and has responsibility for industrial safety practices at the plant as well as establishing and implementing a training and qualification program for plant personnel in accordance with applicable regulations.

8. ISFSI Security Project Manager reports directly to the Plant/ISFSI Manager and has responsibility for ensuring regulatory requirements are adequately met. This individual ensures that the Security Plan, related procedures, training and contingency requirements are developed and maintained current.

9. Technical Support Engineer, Licensing reports directly to the Plant/ISFSI Manager and has responsibility for facility licensing during decommissioning, and eventual license termination activities. This individual is the principle liaison on behalf of the Plant/ISFSI Manager for contact with the NRC and other regulatory agencies.

10. Operations Review Committee (ORC) is an advisory committee to the Plant/ISFSI Manager and has responsibility for performing independent safety reviews of ISFSI and plant activities prior to implementation of the proposed activity requiring the review. The safety review shall be a thorough review conducted by qualified independent safety reviewers who are knowledgeable in the subject area being reviewed.

11. Safety Review Committee (SRC) is an advisory committee responsible to the President and CEO for providing independent safety review and audit of designated activities on all matters pertaining to ISFSI safety and existing procedures which are a part of the ISFSI regulatory compliance requirements.

12. Administrative Staff reports directly to the Plant/ISFSI Manager and is responsible for maintenance of QA records, procedures, indexes, and providing general administrative support.

B. LACBWR Facility Organization Requirements Figure 1 shows the organization structure for the LACBWR facility which consists of the decommissioning team and ISFSI staff. Job descriptions have been provided for key supervisory and some support positions and identify the authority and responsibility that are associated with that position.

C. Dairyland Power Cooperative Manaqement Organization Figure 2 shows the organization structure for Dairyland Power Cooperative. The LACBWR facility is a responsibility of the President and CEO. The responsibility for all purchases as they apply to all generating stations, including LACBWR, and responsibility for control, identification, and issuance of all materials, parts, and components is the responsibility of the Vice President and Chief Financial Officer.

QAPD 4 Rev. 25

II. QUALITY ASSURANCE PROGRAM A. General The QA program described herein sets forth the requirements for the QA organization, personnel responsibilities, controls, and measures established to achieve, maintain, and document quality. These requirements include, but are not limited to, the following:

1. Incorporation of applicable regulatory criteria, codes, standards, and design bases for ITS SSCs into the ISFSI operations and maintenance procedures.

2. Performance of all installation, calibration, and testing on all necessary ITS SSCs in accordance with approved ISFSI procedures.

3. Approved procedures being used in the operation, maintenance, repair, and modification of the ISFSI in compliance with licensing regulations and consistent with quality practices established by DPC.

4. Maintenance of QA recordkeeping, including reports, test results, records, and logs.

5. Resolution of items identified as adverse to quality with appropriate notifications made to DPC Corporate Management.

6. Performance of audits and surveillances by QA personnel to verify that ISFSI administrative controls, procedures, and procurement documents contain the necessary QA input requirements and appropriate documentation thereof.

B. Applicability The LACBWR QAPD applies to plant decommissioning activities (10 CFR 50, Appendix B) and all activities associated with the ISFSI (10 CFR 72) and ITS SSCs. The QAPD also applies to transportation packages licensed by the NRC under 10 CFR 71. Requirements of the QAPD are performed in a graded approach to quality which is commensurate with an item's or an activity's importance to safety. This graded approach is responsive to NRC Regulatory Guide 7.10. The QAPD satisfies the requirements of 10 CFR 50 Appendix B, 10 CFR 71 Subpart H, and 10 CFR 72 Subpart G.

The LACBWR QA program utilizes the Important to Safety (ITS) classification process to apply and enforce a graded approach to quality in tasks related to ISFSI SSCs (refer to Appendix A for details).

C. Regulatory Commitments Except when alternatives or exceptions are identified, the implementing procedures for the QAPD shall comply with the quality assurance guidance documents listed in Appendix B. Additionally; the following clarifications apply to all guidance documents listed in Appendix B:

1. If the guidance in any of the listed documents is in conflict with the QAPID 5 Rev. 25

QAPD, the guidance provided in the QAPD is the controlling document.

2. Standards, guides, codes, etc., identified in any commitment document are not quality assurance program requirements unless that document is also listed in the Appendix.

3. Guidance applicable to safety related items and activities (10 CFR 50) are applicable to comparable items and activities (Important to Safety) required by 10 CFR 71 and 10 CFR72.

D. Administrative Controls The Administrative Controls defined in Appendix C were developed to support operation of the LACBWR plant while in SAFSTOR. These requirements were previously included in the Technical Specifications and were relocated to this QAPD during decommissioning. Some of these requirements are only needed to support decommissioning activities and will be deleted as decommissioning of LACBWR progresses. The remaining Administrative Controls will be only applicable to the LACBWR ISFSI.

E. Implementation Individuals that are assigned responsibilities as described in Section I, "ORGANIZATION," shall prepare administrative and quality assurance procedures as necessary to implement the requirements of this program in support of operation and maintenance of the LACBWR ISFSI. Procedures shall include appropriate quantitative and qualitative acceptance criteria necessary to determine that the activity is being properly performed. Audit or surveillance reports are distributed to DPC management for their review and assessment of the QA program, as to effectiveness, scope, adequacy, and implementation. Indoctrination in the QA program requirements shall be provided to all facility personnel and contractors performing activities that could affect the quality of structures, systems, or components.

F. Personnel Training and Qualification Each member of the facility staff (including audit, surveillance and inspection personnel) shall have sufficient qualifications to perform their assigned duties. Regulatory Guide 1.8 (Revision 1 dated 5/77) is used for determining and assessing appropriate staff qualifications.

Training programs are established and implemented to ensure that personnel achieve and maintain suitable proficiency. Additionally, personnel training and qualification records are maintained in accordance with procedures.

In addition to the above, the following specific qualification requirements are required:

1. The position of the Manager, Quality Assurance shall meet the following minimum qualifications:

a. Graduate of a four-year accredited engineering or science college or university, or the equivalent in practical experience plus five (5)

QAPD 6 Rev. 25

or more years in positions of leadership, such as lead engineer, project engineer, audit team leader, etc.

b. At least two years of this experience should be associated with nuclear quality assurance activities, and at least one year of this experience shall be in a quality assurance organization. An additional two years of quality assurance program implementation may be substituted for the one-year experience within a quality assurance organization.

c. A master's degree in engineering or business management is considered equivalent to two years of experience.

2. The position of Health & Safety/Maintenance Supervisor shall meet the following minimum qualifications:

a. Academic degree in an engineering/science field or equivalent as provided for in paragraph (c), below.

b. Minimum of five years professional experience in the area of radiological safety, three years of which shall be in applied radiation work in a nuclear facility.

c. Technical experience in the area of radiological safety beyond the five year minimum may be substituted on a one-for-one basis towards the academic degree requirement (four years of technical experience being equivalent to a four year academic degree).

d. Academic and technical experience must total a minimum of nine years.

3. The position of Operations Review Committee member shall meet the following minimum qualifications:

a. Knowledgeable of the regulatory requirements and operational aspect of an ISFSI.

b. 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 18.1-1971.

c. Knowledge in the subject areas requiring review.

The Plant/ISFSI Manager shall evaluate potential committee member's qualifications and document the appointment of a committee member(s) based on their qualifications.

QAPD 7 Rev. 25

III. DESIGN CONTROL AND REVIEW A. General This section establishes the requirements to assure that Important to Safety (ITS) structures, systems, and components (SSCs) of the LACBWR ISFSI are added, deleted, changed or modified in accordance with the codes, standards, and regulations that governed the original design, except as amended and approved. Measures shall be established for the review, evaluation, and approval of all design changes governing ISFSI SSCs. Design control and review for ITS SSCs shall be performed by a Design Authority utilizing their approved 10 CFR 50 Appendix B or 10 CFR 72 Subpart G Quality Assurance Program.

Design, fabrication, or modification of storage and shipping casks used for shipment of radioactive materials will not be conducted under this section.

B. Responsibilities

1. The LACBWR staff is responsible for establishing procedures to implement design control and the incorporation of design documents into work orders, procedures and instructions.

2. The Plant/ISFSI Manager is responsible for the review of design drawings, specifications, calculations, and procurement documents to assure that quality standards are included or referenced.

3. The Design Authority is responsible for the incorporation of design bases, regulatory requirements, codes and standards into drawings and specifications related to ITS SSCs design and changes thereto.

4. The ORC is responsible for reviewing all proposed changes and recommending approval or disapproval to the Plant/ISFSI Manager for ISFSI related changes. The review shall determine whether the proposed modifications require prior NRC approval.

5. The Plant/ISFSI Manager is responsible for reviewing the recommendations for ISFSI related activities from the ORC and taking appropriate action. If prior NRC approval is needed, any license amendment request shall be referred to the SRC.

6. The SRC is responsible for providing an independent review of changes to the ISFSI. They shall provide assurance that the modification meets the design bases, regulatory requirements, and applicable codes and standards.

C. Requirements

1. A Work Order shall be initiated for all modifications to ITS SSCs and systems maintained operational during ISFSI activities. Work Orders may be initiated by any knowledgeable person.

2. Design bases, regulatory requirements, and applicable codes and standards shall be delineated and specify appropriate quality standards and requirements for all proposed ISFSI modifications to ITS QAPD 8 Rev. 25

SSCs and systems maintained operational during ISFSI activities.

These conditions shall be incorporated into drawings, specifications, procurement documents, and procedures.

3. The Owner's Acceptance Review procedure and Work Control procedure shall describe and control design changes to ISFSI ITS SSCs.

4. All proposed ISFSI modifications shall be reviewed to determine whether they require prior NRC approval.

IV. PROCUREMENT DOCUMENT CONTROL A. General This section establishes the measures to assure that procurement documents (purchase requisitions and orders) covering material, equipment, and services for ISFSI ITS SSCs specify appropriate quality requirements. The purchase order specifies or references the applicable requirements, design bases, codes, and standards to assure quality.

B. Responsibilities

1. The LACBWR staff is responsible for developing procedures to control the preparation, review, and approval of purchase orders for material, equipment, and services covered by the QA program.

2. The LACBWR staff is responsible for initiation of purchase requisition worksheets for material, equipment, and services required for maintenance, repair, and modifications.

3. The Design Authority is responsible for preparing engineering specifications which detail the technical and quality requirements for ITS material, equipment, and services.

4. The LACBWR staff is responsible for preparing purchase requisition worksheets for material, equipment, and services.

5. Purchasing is responsible for preparing, reviewing, approving, issuing, and controlling purchase orders.

6. QA personnel are responsible for review of ITS procurement documents to ensure inclusion of appropriate quality requirements.

C. Requirements

1. Purchase requisitions for new material, equipment, and services and for spare or replacement parts shall be initiated by any department personnel. The purchase requisition shall contain the information such as quantity, item description, and technical and quality requirements necessary for procurement of the item.

2. Purchase orders shall include specifications that contain all the information necessary to assure material, equipment, and services are of adequate quality. This shall include material selection, design data, QAPD 9 Rev. 25

equipment description, source inspection and testing requirements, cleaning and packaging requirements, and required documentation as deemed necessary.

3. Documentation that is required to provide evidence that materials, equipment, and services are of adequate quality shall be clearly delineated in purchase orders. This shall include a listing of each item of documentation to be submitted, when it is to be submitted, what requires approval prior to manufacture, and to whom it shall be submitted.

4. To the extent necessary, ITS procurement documents shall require suppliers of material, equipment, and services to have a quality assurance program complying with the pertinent provisions of 10 CFR 21, 10 CFR 50, Appendix B, and/or 10 CFR 72, Subpart G. Suppliers shall be required to provide DPC access to their facilities and records for inspection and audit, as required, to determine compliance with provisions of the purchase order. These requirements shall extend to lower tier procurements, as determined by DPC management.

5. ITS purchase requisitions shall be reviewed by the QA personnel to assure that all necessary quality requirements are included or referenced.

6. Formal purchase orders that have been prepared from the purchase requisition shall be reviewed to assure all required information is correctly incorporated.

7. Changes in technical content in procurement documents shall be initiated and reviewed in accordance with the same procedures utilized in preparation of the original document.

V. INSTRUCTIONS, PROCEDURES, AND DRAWINGS A. General This section establishes the measures to assure that activities relating to ISFSI activities are performed in accordance with approved instructions, procedures, and drawings.

B. Responsibilities

1. The LACBWR staff is responsible for preparing or reviewing all procedures that are required for implementation of the QAPD.

2. The Plant/ISFSI Manager is responsible for approval of ISFSI related procedures.

3. The ORC is responsible for reviewing all initial and revised procedures that affect ISFSI operations and shall determine whether changes to these procedures require prior NRC approval.

4. The SRC shall review new procedures or changes to existing procedures when it is determined by the ORC that prior NRC approval is required.

QAPD 10 Rev. 25

C. Requirements

1. Detailed instruction for ISFSI activities shall be contained in procedures and checklists covering the following activities:

a. administrative control,

b. general security system operation,

c. Security Plan implementation,

d. quality assurance,

e. surveillance and test activities of equipment,

2. For activities other than those within normal craft expertise, instructions for maintenance and repair of ISFSI equipment or systems shall be contained in procedures. These procedures shall contain instructions for preparation, performance, testing, and return to service. The procedures may reference manufacturer's instruction manuals, drawings, and other sources, as applicable.

3. Instructions, procedures, or drawings for ITS activities shall delineate methods and sequences when an activity is to be performed. These documents shall include appropriate quantitative or qualitative acceptance criteria for determining that the activity has been satisfactorily performed.

4. The department responsible for an activity shall be required to provide the necessary technical input and review of changes to instructions, procedures, or drawings.

5. Changes to or deviations from established instructions, procedures, or drawings will require the same review and approval as the original document. However, temporary changes to procedures that do not change the intent of the original procedure may be made in ink, dated, and approved by two people of the management staff.

6. Procedures will be reviewed periodically as set forth in administrative procedures.

VI. DOCUMENT CONTROL A. General This section establishes the requirements for document control as it applies to the LACBWR ISFSI.

B. Responsibilities

1. The LACBWR staff is responsible for preparing a standard procedure for controlling the issuance of procedures and for preparing procedures for controlling the distribution of operating, maintenance, repair, and modification procedures for the ISFSI.

QAPD 11 Rev. 25

C. Requirements

1. Procedures shall be established for the issuance of procedures, drawings, and specifications. A document control procedure shall be prepared to provide a uniform system of document identification.

2. All documents shall have an identification number, title, date, and revision number. Documents shall be filed and controlled by use of this identification. Each type of document shall be filed in a central location identified in a document control procedure.

3. Drawings, specifications, and procedures, including revisions, shall be reviewed for adequacy and approved for release by authorized personnel. The required reviews and approvals shall be specified in a document control procedure.

4. The Administrative Staff shall assure that current documents are distributed to and used at the location where the prescribed activity is performed. Documents and revisions shall be distributed as specified in a document control procedure. Preliminary and superseded documents shall be clearly identified and closely controlled to preclude their misuse.

5. An index of each type of document shall be established and maintained to provide the current status of documents.

VII. CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES A. General This section establishes the requirements to assure that purchased ITS material, equipment, and services for the ISFSI, whether purchased directly or through contractors and subcontractors, conform to the procurement documents.

B. Responsibilities

1. QA personnel are responsible for developing procedures for supplier evaluation and qualification and for coordinating supplier evaluation, qualification, and evaluating supplier quality programs. QA personnel are responsible for developing procedures for receiving inspection of material and equipment.

2. LACBWR staff shall be responsible for evaluating supplier manufacturing and technical capabilities.

C. Supplier Qualification

1. Qualification of suppliers shall consist of DPC's experience with the supplier, supplier's reputation and experience in the field, and in the nuclear industry, a QA program and/or other factors, as appropriate.

2. Suppliers of casks used for shipment and storage of radioactive material shall be evaluated to ensure that the design and fabrication of packaging are performed under the control of an NRC-approved and QAPD 12 Rev. 25

DPC-accepted QA program.

D. Source Inspection

1. When appropriate, suppliers shall be requested to furnish DPC with sufficient information concerning their manufacturing and inspection plan to permit DPC or their designated agent to plan and implement a source inspection plan.

2. When appropriate, inspection plans shall include witness and hold points for inspection of items, witnessing of processes or tests, audit of required quality documentation, and verification that vendors have complied with the specification requirements and have documented any deviation from the specifications.

E. Receiving Inspection

1. Items shall be examined by appropriately trained staff upon receipt for shipping damage, correctness of identification, and specified quality documentation, in accordance with approved instructions.

2. Documentary evidence attesting that items conform to purchase order requirements shall be available at the plant prior to installation or use of the item.

3. Documentary evidence shall be sufficient in order to identify that the specific requirements, such as codes, standards, and specifications, can be confirmed for the purchased item. This requirement shall be satisfied by having available copies of the purchase order and appropriate documents referenced therein.

4. All ITS materials, parts, and components will be segregated upon receipt and will be placed in a receiving inspection hold area separate from storage facilities. After acceptance, the material will be identified as acceptable and placed in specified storage.

5. During receiving inspection, if a nonconformance or discrepancy exists, the material shall be placed on hold and will remain in a hold status until final disposition is determined. A Corrective Action Report (CAR) shall be initiated.

6. Items dispositioned as unacceptable for use shall be rejected and removed from the controlled receiving inspection area.

VIII. IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS A. General This section establishes the requirements for identification and control of ITS material, parts, and components, based on the ISFSI system designation, from receipt at the facility through installation or use.

B. Responsibilities

1. The LACBWR staff is responsible for establishing the overall QAPD 13 Rev. 25

requirements for the identification and control of materials, parts, and components from receipt through installation or use, and/or developing procedures and instructions for the control and issuance of quality related materials, parts, and components.

2. The Plant/ISFSI Manager shall approve and ensure implementation of procedures for the identification and control of materials, parts, and components.

3. Appropriately trained DPC staff is responsible for control of, identification, and issuance of all ITS material, parts, and components.

C. Requirements

1. Approved instructions and procedures shall be implemented for the identification and control of materials, parts, and components from receipt through installation or use. An identification system utilizing purchase order numbers shall be implemented for identification of material, parts, and components.

2. Specifications shall require that materials, parts, and components are identified in accordance with purchase order numbers and shall require that documentation have identification providing traceability to an item.

3. Physical identification by purchase order number shall be used to the maximum extent possible for relating an item at any time to applicable documentation. Identification shall be either on the item or records traceable to the item. Where physical identification is impractical, physical separation, procedural control, or other appropriate means shall be employed.

IX. CONTROL OF SPECIAL PROCESSES A. General This-section establishes the measures to assure special processes, including welding, heat treating, and non-destructive testing that are identified as ISFSI ITS, are controlled and accomplished by qualified personnel using qualified procedures in accordance with applicable codes, standards, specifications, criteria, and other special requirements.

B. Responsibilities

1. The LACBWR staff is responsible for establishing procedures that describe how personnel and procedures are qualified for special processes.

2. QA personnel are responsible for reviewing of procedures for welding, heat treating, cleaning, non-destructive examination, and filler metal control and for assuring maintenance, repair, and modification work involving special processes to be performed by qualified personnel in accordance with qualified procedures.

3. The Plant/ISFSI Manager is responsible for assuring the qualification of personnel in special processes and maintaining records of qualified QAPD 14 Rev. 25

personnel and procedures performing ISFSI activities.

C. Requirements

1. Welding, heat treating, cleaning, and non-destructive examination shall be accomplished under controlled conditions in accordance with applicable codes, standards, criteria, and other special requirements, using qualified personnel and procedures. Qualification of personnel and procedures shall comply with the requirements of applicable codes and standards.

2. Welders and welding procedures shall be qualified, as appropriate, in accordance with Section IX of the ASME Boiler and Pressure Vessel Code and/or appropriate American Welding Society (AWS) Welding Codes.

3. Non-destructive examination personnel shall be qualified in accordance with the American Society for Non-destructive Testing Standard SNT-TC-1A.

4. Procedures shall be established to describe the method used to control the receipt, storage, baking, drying, and disbursal of welding filler metals.

5. Equipment used for accomplishing special processes shall be calibrated, maintained, stored, handled, and issued in accordance with applicable procedures.

X. INSPECTION A. General This section establishes a program for inspection of ISFSI activities to verify conformance with approved procedures, drawings, and specifications.

B. Responsibilities

1. The LACBWR staff is responsible for assuring adequate inspection requirements are included in engineering specifications, and reviews of any inspection procedures implementing this section are completed.

2. QA personnel are responsible for establishing inspection procedures and assuring adequate inspection requirements are included in procedures. They are also responsible for coordinating the assignments of qualified inspection personnel.

3. The Plant/ISFSI Manager shall be responsible for approving ISFSI inspection procedures and shall ensure sufficient inspections are performed to provide adequate confidence that project activities meet predetermined requirements.

C. Requirements

1. Inspections shall be performed only by qualified personnel. In no case QAPID 15 Rev. 25

shall an acceptance inspection be performed by the individual who performed the activity.

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.

3. Mandatory inspection hold points, which require witnessing or inspecting of an activity before proceeding, shall be indicated in the appropriate procedure, specification, or work order. The inspection shall be documented to indicate approval and release prior to continuation of the activity.

4. Inspection requirements shall apply to all activities whether performed by company personnel or contractor personnel, and shall require that inspection procedures and instructions, along with necessary drawings, are provided prior to commencing inspection activities.

5. Inspection requirements governing modifications, repairs, and replacement shall be in accordance with the original design and inspection requirements or as amended by approved changes to the original design.

XI. TEST CONTROL A. General This section establishes the requirements for an ISFSI test program to demonstrate that ITS SSCs will perform satisfactorily in service. The test program shall include, but not be limited to, surveillance testing, special tests, post maintenance testing, and testing following ISFSI modification or significant changes in procedures.

B. Responsibilities

1. The LACBWR staff is responsible for establishing the requirements to control the test program and for preparation and review of test procedures, surveillance during testing, and review and documentation of test results. The LACBWR staff is also responsible for establishing specifications, requirements and acceptance criteria for testing following ISFSI modifications or installation activities and the review and approve of results for testing following modifications.

2. The Plant/ISFSI Manager is responsible for the approval of ISFSI test procedures.

3. The ORC is responsible for review of all ITS proposed test procedures, special testing procedures, performance testing procedures following ISFSI modification and 10 CFR 72.48 evaluations.

4. The SRC is responsible for reviewing 10 CFR 72.48 evaluations to verify that ISFSI tests do not require prior NRC approval.

QAPD 16 Rev. 25

C. Requirements

1. A program shall be established to assure all testing required to demonstrate that ITS SSCs will perform satisfactorily in service is identified and documented.

2. Testing shall be performed in accordance with approved test procedures that incorporate or reference the requirements and acceptance criteria contained in applicable design documents and Technical Specifications.

3. Test procedures shall incorporate, but not be limited to, requirements for such items as: hold points, witness points, caution notes, emergency requirements, and test jumper logs.

4. Test procedures shall include, as a minimum, provisions for assuring that:

a. Prerequisites have been completed that include, as a minimum:

1) Control of systems status as necessary.

2) Availability of calibrated instrumentation and special equipment.

b. Test objectives and applicable acceptance limits are stated.

c. Test results are documented.

d. Detailed instructions for performing the test are included.

e. Test results are reviewed and approved.

5. Test reports shall include identification of the inspector, individual conducting the test, the data recorder, the type of observation made, the equipment used, the test results, the acceptability of the test results, and approved disposition for any deviations.

6. Test results which fail to meet the requirements and acceptance criteria shall be properly noted and appropriate corrective action taken.

Xll. CONTROL OF MEASURING AND TEST EQUIPMENT A. General This section establishes the requirements for written procedures for the control, calibration, and periodic adjustment of tools, gauges, instruments, and other measuring and test equipment used to verify conformance to established ISFSI technical requirements.

B. Responsibilities

1. The LACBWR staff is responsible for establishing requirements for a program for the control, calibration, and periodic adjustment of tools, gauges, instruments, and other measuring and test equipment used.

QAPD 17 Rev. 25

2. Personnel using Measuring and Test Equipment are responsible for ensuring tools, gauges, instruments, and other measuring and test equipment are calibrated to assure compliance with the implementing procedures.

3. The Plant/ISFSI Manager is responsible for ensuring implementation of the requirements of this section of the manual for ISFSI activities and for approving ISFSI procedures.

C. Requirements

1. Inspection, test, and work procedures shall include provisions to assure tools, gauges, instruments, and other inspection, measuring, and test equipment and devices used in activities affecting quality are of the proper range, type, and accuracy to verify conformance to established requirements and test parameters.

2. To assure equipment accuracy, inspection, measuring, and test equipment shall be controlled, calibrated, adjusted, and maintained periodically, or prior to use. Calibrations are performed against certified measurement standards that are traceable to nationally recognized standards. Where national standards do not exist, provisions will be established to document the basis for calibration.

Control measures and procedures shall prevent the use of calibrated tools, gauges, instruments, and other measuring and test equipment by unauthorized personnel. Special calibration and control measures are not required for devices when normal commercial practices provide adequate accuracy.

3: When an item of measuring and test equipment is found to be out of calibration, an investigation will be conducted and documented to determine the validity of previous inspections, tests, or calibrations which were performed with the use of that item.

4. Records or logs of the calibration history of measuring and test equipment shall be maintained.

5. Measuring and test equipment shall be controlled by a permanently affixed serial number. Calibration decals, tags or stickers shall be displayed prominently on each device and shall reflect the date of calibration, due date of the next calibration (for recurring calibration) and identity of person performing the calibration.

XIII. HANDLING, STORAGE, AND SHIPPING A. General This section establishes the requirements for ISFSI procedures to control the handling, storage, shipping, cleaning, packaging, and preservation of ITS material and equipment to prevent damage, deterioration, or loss through shipment, installation or use.

B. Responsibilities

1. The LACBWR staff is responsible for establishing requirements for the QAPID 18 Rev. 25

handling, storage, and shipping of materials, parts, and components covered by the QA program.

2. The Plant/ISFSI Manager is responsible for approval of all implementing procedures related to the ISFSI and ensuring the implementation of the requirements of this section of the QAPD.

C. Requirements

1. The requirements for handling, storage, shipping, cleaning, and preservation of materials, and equipment shall be documented in approved procedures.

2. Procurement documents shall include instructions for the handling, storage, shipping, cleaning, and preservation of the item being supplied, as applicable.

3. Procurement documents specify marking requirements, special covering, and protective environments, such as inert gas atmosphere, moisture content levels, and temperature levels, as applicable.

4. Specifications and procedures establish the requirements for special handling tools and equipment to ensure safe and adequate handling of critical, sensitive, or radioactive items.

5. Special handling tools and equipment will be inspected and tested in accordance with approved procedures, at specified intervals, to verify that tools and equipment are adequately maintained.

6. Materials and equipment will normally be handled by materials handling personnel. Other special shipments which require special equipment and handling will be handled by knowledgeable and trained personnel.

7. Storage of material and equipment will be in areas free from fumes, vapors, and dust. Storage will be in areas protected from the weather, as appropriate, and in which chemical storage is excluded, except as may be specifically authorized in writing. Storage will be in areas which satisfy the handling and storage requirements specified for the item.

XIV. INSPECTION, TEST, AND OPERATING STATUS A. General This section describes the system for indicating the inspection, test, and operating status of ITS components and systems at the ISFSI.

B. Responsibilities

1. The LACBWR staff is responsible for ensuring that the status of operating equipment or systems to be removed from service for maintenance, test, inspection, repair, or modification is in accordance with the approved LACBWR procedures and shall monitor the status of activities for compliance with approved procedures and shall ensure QAPD 19 Rev. 25

inspection results are properly logged. They shall establish the procedures for implementing the work inspection or status sheets during maintenance, repair, and modifications and shall ensure inspection results are properly logged. The LACBWR staff is also responsible for the control of ISFSI status during modifications.

C. Requirements

1. Equipment or systems not ready for normal service shall be clearly identified by use of tags.

2. Equipment or system inspection and test status shall be indicated.

3. SSCs that are found to be unacceptable during or after testing shall have their status clearly identified.

XV. CORRECTIVE ACTION A. General This section establishes measures to assure that conditions adverse to quality at the ISFSI, such as failures, malfunctions, deficiencies, deviations, defective material and equipment, and non-conformances are promptly identified and corrected. This includes the control of materials, parts, or components that do not conform to requirements, thereby preventing their inadvertent use or installation.

B. Responsibilities

1. The LACBWR staff is responsible for establishing procedures for the identification, review, and correction of conditions adverse to quality which includes the control, evaluation, and disposition of deficient materials, parts, and components.

2. The LACBWR staff is responsible for reviewing nonconforming items that cannot be corrected by vendor action and recommending disposition. The LACBWR staff is also responsible for preparing procedures for repair and rework of nonconforming items.

3. The LACBWR staff is responsible for reviewing conditions adverse to quality to determine the cause of the condition and for recommending corrective action to preclude repetition.

4. The ORC is responsible for reviewing significant conditions adverse to quality and recommending corrective action.

C. Requirements

1. Conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations, defective material and equipment, shall be reported on a Corrective Action Report (CAR). Materials, parts, or components that do not conform to requirements shall be identified and placed in a hold status. Nonconforming items shall remain in a segregated area until approved disposition has been determined.

QAPD 20 Rev. 25

2. The CAR shall identify the condition, the cause of the condition, and the corrective action taken.

3. For vendor-supplied items or services, the vendor shall be notified of all nonconforming items and requested to correct the deficiencies.

LACBWR staff with assistance from Purchasing shall be responsible for coordinating the disposition of deficient items with vendors. QA personnel are responsible for inspecting and accepting or rejecting items that have been corrected by vendors.

4. Deficiencies which cannot be corrected by the vendor shall be reviewed by the LACBWR staff who will recommend repair, rework, accept, or reject. Items shall be repaired or reworked only in accordance with approved procedures and shall be re-inspected after repair by QA personnel. LACBWR staff shall ensure that documented and approved procedures are available prior to repair or rework.

5. Items which are accepted for use with a known deficiency shall be fully documented with the specification requirement, justification for acceptance, and effect of such use. All such items shall be approved by the Plant/ISFSI Manager prior to use.

6. Conditions adverse to quality which involve design deficiencies, or recommended corrective actions that involve a design change, shall be reviewed by LACBWR staff or applicable Design Authority.

XVI. QUALITY ASSURANCE RECORDS A. General This section establishes measures for maintaining ISFSI records which cover all documents and records associated with the operation, maintenance, installation, repair, and modification of SSCs covered by the QAPD. Also included are historical records gathered and collected during plant and ISFSI operations which are either required to support the dry cask storage systems stored at the ISFSI or ultimate shipment to a federal repository.

B. Responsibilities

1. The LACBWR staff is responsible for establishing the requirements of this section.

2. The Plant/ISFSI Manager is responsible for approving and ensuring implementation of procedures for this section.

C. Storage Requirements

1. Originals of special process records are stored in a fire-retardant area designed to accommodate such records.

2. On-site storage facility is constructed in such a manner as to safeguard the contents from fire, extreme temperature, and moisture variations.

QAPD 21 Rev. 25

3. Entry to the record storage areas is controlled, and only authorized personnel are permitted access.

4. Storage requirements shall meet ANSI N45.2.9, "Requirements for Collection, Storage, and Maintenance of Quality Assurance Records."

D. System Requirements

1. A system shall be established to identify all documents that must be kept permanently (lifetime records). An index of non-permanent records shall be established.

2. An approved document listing will be reviewed on a regular basis to verify that the record file contains the latest revisions of all required documents.

3. A system will be established to control the issuance and return of all records.

E. Record Retention In addition to the applicable record retention requirements of Title 10, Code of Federal Regulations, the following records shall be retained for at least the minimum period indicated.

1. The following records shall be retained for at least five years:

a. Records and logs of ISFSI operation.

b. Records and logs of principal maintenance activities, inspections, repair and replacement of principal items of equipment related to nuclear safety.

c. All Reportable Events submitted to the Commission.

d. Records of surveillance activities, inspections, and calibrations required by the NAC-MPC CoC and FSAR.

e. Records of changes made to the procedures required by the NAC-MPC CoC and FSAR.

f. Record of changes made to programs and procedures required by Appendix C.

g. Records of radioactive shipments.

h. Records of sealed source and fission detector leak tests and results.

i. Records of annual physical inventory of all sealed source material of record.

j. QA Audits.

2. The following records shall be retained for the duration of the LACBWR QAPD 22 Rev. 25

license:

a. Facility design modification packages and work order packages.

b. Records of new and irradiated fuel inventory, fuel transfers and assembly burn-up histories.

c. Records of radiation exposure for all individuals entering radiation control areas.

d. Records of facility radiation and contamination surveys.

e. Records of gaseous and liquid radioactive material released to the environs, and records of analyses required by the Radiological Environmental Monitoring Program.

f. Records of training and qualification for current members of the facility staff.

g. Records of in-service inspections performed pursuant to Technical Specifications.

h. Records of reviews performed for changes made to procedures or equipment or reviews of tests and experiments pursuant to 10 CFR 50.59 and 10 CFR 72.48.

i. Records of meetings of the ORC and the SRC.

j. Records of decommissioning and/or dismantlement of the facility.

k. Records of reviews performed for changes to the Offsite Dose Calculation Manual and the Process Control Program.

1. Records of the test results obtained in welding procedures and welder performance qualifications and a listing of qualified personnel and procedures shall be maintained.

m. Records of training, test results, and a listing of qualified personnel shall be maintained.

XVII. AUDITS A. General This section establishes the requirements for a system of planned and documented audits to verify compliance with all aspects of the QA program and to assess the effectiveness of the program as it applies to the ISFSI.

The system provides for the reporting and review of audit results by appropriate levels of supervision and management.

B. Responsibilities

1. QA personnel are responsible for developing audit checklists, designating and training audit personnel, and conducting audits.

QAPD 23 Rev. 25

2. The SRC performs independent review and audit to verify that the ISFSI is being maintained consistent with company safety, administrative, and licensing provisions. The evaluations of ISFSI activities shall be performed by QA personnel or a qualified offsite entity under the cognizance of the SRC.

C. Requirements Implementing procedure(s) for the internal audit/survey program shall include controls to ensure that the following are met:

1. Audits shall be performed in accordance with written procedures or checklists by appropriately trained personnel having no direct responsibilities in the area audited. Deficiencies from previous audits shall be reviewed and re-audited, as appropriate. The checklists are used as guides to the auditor.

2. Audits may be conducted by QA personnel or other qualified personnel, such as technical specialists from other company departments and outside consultants.

3. Audit and surveillance results shall be documented and reviewed with supervision responsible for the area audited, who shall take necessary action to correct reported deficiencies. Follow-up action, including re-audit/re-survey of deficient areas, is initiated as deemed appropriate.

4. QA personnel shall assess the following:

a. evaluation of quality assurance practices, procedures, and instructions;

b. effectiveness of implementation; and

c. conformance with approved procedures.

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

a. The conformance of ISFSI operation to provisions contained within the NAC-MPC CoC Technical Specifications and applicable license conditions is audited at least once every 24 months. The audit shall include elements such as:

• Training and qualifications of the staff.

• Actions taken to correct deficiencies occurring with equipment, structure, systems, or method of operation that affect nuclear safety.

• Performance of activities required by the QA program to meet the criteria of 10 CFR 50, Appendix B, 10 CFR 71, Subpart H and 10 CFR 72, Subpart G.

• Implementation of the programs required by Appendix C, 1.0 through 2.5.

QAPD 24 Rev. 25

b. Other activities/documents as requested by the President and CEO or SRC.

7. Deficiencies or nonconformances identified during an audit shall be documented and brought to the attention of the Plant/ISFSI Manager.

Follow-up shall be performed to verify that corrective actions have been taken to correct the deficiencies or nonconformances.

8. Audit reports are sent to DPC management for their review and assessment of the QA program.

9. Audit reports shall be forwarded to the President and CEO, and to the management positions responsible for the areas audited, within 30 days after completion of the audit.

10. External audits or surveys of suppliers providing Important to Safety materials, parts, equipment or services are performed at the indicated frequency or more frequently as performance dictates.

11. Suppliers providing commercial grade calibration services who are accredited by a nationally recognized accrediting body, using procedures consistent with those found in ANSI/ISO/IEC 17025 "General Requirements for the Competence of Testing and Calibration Laboratories", do not have to be periodically surveyed if the conditions of the NRC Safety Evaluation dated September 28, 2005 are met (see Appendix B). Controls shall be established in applicable procedures to ensure the requirements of the NRC Safety Evaluation are satisfied.

XVIII. OPERATIONS REVIEW COMMITTEE A. General This section establishes the requirements for the Operations Review Committee (ORC) for ISFSI activities which shall consist of thorough reviews conducted by qualified independent safety reviewers. Persons performing these reviews shall be knowledgeable in the subject area being reviewed. Independent safety reviews must be completed prior to implementation of the proposed activity requiring the review.

B. Responsibilities ORC members shall be individuals without direct responsibility for the performance of the activities under review. These reviewers may be from the same functionally cognizant organization as the individual or group performing the original work.

C. Requirements The following subjects shall be independently reviewed by a qualified ORC member:

1. Review of proposed changes to the LACBWR Technical Specifications, and review of those changes submitted to LACBWR by the Certificate Holder for the NAC-MPC System for implementation consideration.

QAPD 25 Rev. 25

2. Review of proposed tests and experiments not described in the NAC-MPC FSAR.

3. Review of proposed changes or modifications to the ISFSI site, ISFSI SSCs, or equipment that affect nuclear safety.

4. Review of all procedures and programs required by Appendix C and changes thereto that require an evaluation in accordance with 10 CFR 72.48.

5. Render determination in writing to the Plant/ISFSI Manager if any items considered under 1 through 4 above, as appropriate and as provided for in 10 CFR 50.90 or 10 CFR 72.48 as requiring prior NRC approval.

QAPD 26 Rev. 25

APPENDIX A (Page 1 of 2)

IMPORTANT TO SAFETY STRUCTURES, SYSTEMS AND COMPONENTS The pertinent quality assurance requirements of 10 CFR 50, Appendix B, 10 CFR 71 Subpart H and 10 CFR 72 Subpart G will be applied, as a minimum, to all quality activities affecting the Important to Safety (ITS) Structures, Systems and Components (SSCs) associated with spent fuel storage and transportation package.

NOTE The safety classification of SSCs of the LACBWR ISFSI facility may be revised based on engineering evaluations and a revision to the NAC-MPC FSAR. These modifications are controlled in accordance with the Design Control process and are not considered a reduction in the commitments to the QAPD.

The quality classification of NRC-licensed Dry Spent Fuel Storage Components and TransportationPackages may not be revised using the LACBWR Design Control process. These modifications must be made by the Certificate Holder. The Certificate Holder is responsible for design and licensing controls for these components under their NRC-approved Quality Assurance Program. DPC utilizes these types of components and packages under the provisions of a NRC General License for Radioactive Material TransportationPackages (10 CFR 71) and Spent Fuel Storage (10 CFR 72).

Items and services associated with Packaging and Transportation of Radioactive Material as described in 10 CFR 71, and Independent Storage of Spent Nuclear Fuel as described in 10 CFR 72, will also fall under the requirements of the QAPD.

ITS SSCs associated with spent fuel storage and radioactive material transportation packages are defined below:

IMPORTANT TO SAFETY AS DEFINED BY 10 CFR 71 AND 10 CFR 72 A. Dry Spent Fuel Storage (10 CFR 72)

SSC Quality Category Design/License SSC__QualityCategory Responsible Transportable Storage Canister and Fuel Basket Assembly A NAC Intl.

Vertical Concrete Cask B NAC Intl.

Transfer Cask and Adapter Plate B NAC Intl.

ISFSI Pad C LACBWR Lifting Yoke B NAC Intl.

Damaged Fuel Can A NAC Intl.

QAPD 27 Rev. 25

APPENDIX A (Page 2 of 2)

IMPORTANT TO SAFETY STRUCTURES, SYSTEMS AND COMPONENTS B. Transport of Spent Fuel and GTCC Waste (10 CFR 71)

SSC Quality Category Design/License Responsible Transportable Storage Canisters and Fuel Basket Assembly A NAC Intl.

Damaged Fuel Can A NAC Intl.

Transportable Storage Canister and Basket Assembly For A NAC Intl.

GTCC Waste Containers Storage Transport Cask (STC) A NAC Intl.

C. Radioactive Material Transport Packages (10 CFR 71)

Radioactive Material Transport Packages subject to the provisions of 10 CFR 71, Subpart C, "General Licenses," are Important to Safety and subject to the applicable requirements of the QAPD.

NOTES:

1. See NAC-MPC Final Safety Analysis Report for additional classification information.

2. See NAC Storage Transport Cask (STC) Final Safety Analysis Report and associated NAC specifications for additional classification information.

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

QAPD 28 Rev. 25

APPENDIX B REGULATORY COMMITMENTS, ALTERNATIVES AND EXCEPTIONS 1.0 REGULATORY COMMITMENTS 1.1 Regulatory Guide 1.8, 1-R-5/77, Personnel Selection and Training, Endorses ANSI N18.1-1971.

1.2 Regulatory Guide 7.10, Revision 2 (3/05), "Establishing Quality Assurance Programs for Packaging Used in the Transportation of Radioactive Material."

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

2.0 ALTERNATIVES 2.1 Letter from NRC to Arizona Public Service Company titled "Palo Verde Nuclear Generating Station, Units 1, 2 and 3 - Approval of Change to Quality Assurance Program (Commercial-Grade Calibration Services)

TAC Nos. MC4402, MC4403, and MC4404)" and associated NRC Safety Evaluation dated September 28, 2005.

3.0 EXCEPTIONS None QAPD 29 Rev. 25

APPENDIX C (Page 1 of 5)

ADMINISTRATIVE CONTROLS These Administrative Controls were developed to support operation of the LACBWR plant while in SAFSTOR. These requirements were previously included in the Technical Specifications and were relocated to this QAPD during decommissioning.

Some of these requirements are only needed to support decommissioning activities and will be deleted as decommissioning of the LACBWR plant progresses. The remaining Administrative Controls will only be applicable to the LACBWR ISFSI.

1.0 PROCEDURES 1.1 Written procedures shall be established, implemented, and maintained covering the activities referenced below:

1.1.1 ISFSI operations and maintenance.

1.1.2 All programs specified in Section 2 of this Appendix.

1.1.3 Fire Protection Program implementation.

1.1.4 Radiation Protection Program implementation.

1.1.5 Physical Security Plan implementation.

1.1.6 Emergency Plan implementation.

1.1.7 Procedure for controlling temporary changes.

1.2 Each procedure required by Section 1.1 above and programs listed in Section 2.1 through 2.5, and any changes thereto, shall be independently reviewed in accordance with Section XVIII and approved by the designated manager (i.e., Plant/ISFSI Manager) or designee prior to implementation.

2.0 PROGRAMS AND MANUALS 2.1 Process Control Program (PCP)

The PCP shall be maintained on-site and will be available for NRC review. Licensee-initiated changes to the PCP shall be submitted to the NRC in the annual Radioactive Effluent Release Report for the period in which the change(s) was made. This submittal shall contain:

2.1.1 Information to support the rationale for the change; 2.1.2 A determination that the change did not reduce the overall conformance of the solidified waste product to existing criteria for solid wastes; and 2.1.3 Documentation of the fact that the change has been reviewed and found acceptable by the ORC.

QAPD 30 Rev. 25

APPENDIX C (Page 2 of 5)

ADMINISTRATIVE CONTROLS 2.2 Offsite Dose Calculation Manual (ODCM)

The ODCM shall be maintained by the licensee. Changes to the ODCM will be outlined in the annual Radioactive Effluent Release Report per Section 2.5.2. This submittal shall contain:

2.2.1 Detailed information to support the rationale for the change.

Information submitted should consist of a package of those pages of the ODCM changed with each page numbered and provided with an approval and date box, together with appropriate analyses or evaluations justifying the change(s); and 2.2.2 A determination that the change will not reduce the accuracy or reliability of dose calculations or setpoint determinations.

2.3 Radioactive Effluent Controls ProQram A program shall be provided conforming to 10 CFR 50.36a for control of radioactive effluents and for maintaining the doses to members of the public from radioactive effluents as low as reasonably achievable. The program (1) shall be contained in the ODCM, (2) shall be implemented by operating procedures, and (3) shall include remedial actions to be taken whenever the program limits are exceeded. The program shall include the following elements:

2.3.1 Limitations on the operability of radioactive liquid and gaseous monitoring instrumentation, including surveillance tests and setpoint determination in accordance with the methodology in the ODCM; 2.3.2 Limitations on the concentrations of radioactive material released in liquid effluents to unrestricted areas conforming to 10 CFR 20, Appendix B, Table 2, and Column 2; 2.3.3 Monitoring, sampling and analysis of radioactive liquid and gaseous effluents in accordance with 10 CFR 20 and with the methodology and parameters described in the ODCM.

2.3.4 Limitations on the annual and quarterly doses or dose commitment to a member of the public from radioactive materials in liquid effluents released to unrestricted areas conforming to 10 CFR Part 50, Appendix I; 2.3.5 Determination of cumulative and projected dose contributions from radioactive effluents for the current calendar quarter and current calendar year in accordance with the methodology and parameters in the ODCM at least every year; QAPD 31 Rev. 25

APPENDIX C (Page 3 of 5)

ADMINISTRATIVE CONTROLS 2.3.6 Limitations on the annual and quarterly doses to a member of the public from tritium and all radionuclides in particulate form with half-lives greater than eight days in gaseous effluents released to areas beyond the site boundary conforming to 10 CFR 50, Appendix I; 2.3.7 Limitations on the annual dose or dose commitment to any member of the public due to release of radioactivity and to radiation from uranium fuel cycle sources conforming to 40 CFR Part 190.

2.4 Radiological Environmental Monitoring Program A program shall be provided to monitor the radiation and radionuclides in the environs of the plant. The program shall provide representative measurements of radioactivity in the highest potential exposure pathways. The program shall (1) be contained in the ODCM; (2) conform to the guidance of 10 CFR 50, Appendix I; and (3) include the following:

2.4.1 Monitoring, sampling, analysis, and reporting of radiation and radionuclides in the environment in accordance with the methodology and parameters described in the ODCM.

2.4.2 Participation in an Interlaboratory Comparison Program to ensure that independent checks on the precision and accuracy of the measurements of radioactive material in the environmental sample matrices are performed as part of the Quality Assurance Program for environmental monitoring.

2.5 Reporting Requirements In addition to applicable reporting requirements of Title 10, Code of Federal Regulations, the following reports shall be submitted prior to March 1 of each year in accordance with 10 CFR 50.4.

2.5.1 Annual Radiological Environmental Monitoring Report An Annual Radiological Environmental Monitoring Report which shall include summarized and tabulated results, including interpretations and analysis of data trends, of environmental samples taken during the previous calendar year. In the event that some results are not available for inclusion with the report, the report shall be submitted noting and explaining the reasons for the missing results. The missing data shall be submitted as soon as possible in a supplementary report.

QAPD 32 Rev. 25

APPENDIX C (Page 4 of 5)

ADMINISTRATIVE CONTROLS The report shall also include the following: a summary description of the Radiological Environmental Monitoring Program; a map of all sampling locations keyed to a table giving distances and directions from the plant; the results of the Interlaboratory Comparison Program; and a discussion of all analyses in which the lower limit of detection (LLD) was not achievable.

2.5.2 Annual Radioactive Effluent Release Report Paragraph (a)(2) of 10 CFR 50.36a, "Technical Specifications on Effluents from Nuclear Power Reactors," requires that a report be made to the Commission annually. The report shall specify the quantity of each of the principal radionuclides released to unrestricted areas by liquid or gaseous effluents during the previous year. With the exception of the collection of hourly meteorological data, the information submitted shall be in accordance with Appendix B of Regulatory Guide 1.21 (Revision

1) dated June 1974 with data summarized on at least a quarterly basis.

This same report shall include an assessment, performed in accordance with the ODCM, of radiation doses to members to the public from radioactive liquid and gaseous effluents released beyond- -the effluent-release--boundary. This -repor-t sha-ll-contain-any changes made to the ODCM during the previous twelve months.

2.6 High Radiation Area 2.6.1 In lieu of the "control device" or "alarm signal" required by paragraph (a) of 10 CFR 20.1601, each high radiation area in which the intensity of radiation, at 30 cm from the radiation source or surface that the radiation penetrates, is greater than 100 mRem/hr but less than 1000 mRem/hr shall be barricaded and conspicuously posted as a high radiation area and entrance thereto shall be controlled by requiring issuance of a Special Work Permit (SWP). 1 Any individual or group of individuals permitted to enter such areas shall be provided with one or more of the following:

a. A radiation monitoring device which continuously indicates the radiation dose rate in the area.

Radiation Protection personnel or personnel escorted by radiation personnel shall be exempt from the SWP issuance requirement during the performance of their assigned radiation protection duties, provided they are following plant radiation protection procedures for entry into high radiation areas.

QAPD 33 Rev. 25

APPENDIX C (Page 5 of 5)

ADMINISTRATIVE CONTROLS

b. A radiation monitoring device which continuously integrates the radiation dose rate in the area and alarms when a preset integrated dose is received. Entry into such areas with this monitoring device may be made after the dose rate levels in the area have been established and personnel have been made knowledgeable of them.

c. A radiation protection qualified individual (i.e. qualified in radiation protection procedures) with a radiation dose rate monitoring device, and who is responsible for providing positive exposure control over activities within the area, and who will perform periodic radiation surveillance at the frequency which will be established in the SWP.

2.6.2 For each area of radiation levels greater than 1000 mRem/hr, at 30 cm (but less than 500 Rad/hr at 1 meter) from the radiation source, or from any surface penetrated by the radiation, the control of Section 2.6.1 shall be implemented, and also:

a. Each entrance or access point to the area shall be maintained locked except during periods when access to the area is required. Positive control over each individual entry shall be by:

1. Maintaining the locked door keys under administrative control of the Plant/ISFSI Manager or delegate.

2. An approved SWP that specifies the dose rates in the immediate work area and the maximum allowable stay time for individuals in that area.

QAPD 34 Rev. 25

0 TABLE 1 REGULATORY COMPARISON MATRIX LACBWR REGULATORY GUIDE 7.10 QUALITY ASSURANCE PROGRAM 10 CFR 50 (SECTION) IMPLEMENTING PROCEDURES (SECTION) APPENDIX B (SECTION)

0.0 INTRODUCTION

I. ORGANIZATION ACP-03.01 1.1, 1.2 1 II. QUALITY ASSURANCE PROGRAM ACP-01.04, ACP-03.01, ACP-03.03 2.1,2.2, 2.3, 2.4, 2.5 II III. DESIGN CONTROL AND REVIEW ACP-03.03, ACP-04.01, ACP-07.03 3.1, 3.2, 3.3 Ill IV. PROCUREMENT DOCUMENT CONTROL ACP-05.01 4.1,4.2, 4.3 IV, V, VI INSTRUCTIONS, PROCEDURES, AND ACP-01.01, ACP-06.01, ACP-06.02, ECP-02 5.1,5.2 V DRAWINGS VI. DOCUMENT CONTROL ACP-06.01, ACP-07.01, ECP-02 6.1,6.2, 6.3, 6.4 VI CONTROL OF PURCHASED MATERIAL, ACP-05.0, ACP-11.01 7.1,7.2,7.3,7.4 VII, ViII VII. EQUIPMENT, AND SERVICES IDENTIFICATION AND CONTROL OF VIII. MATERIALS, PARTS, & COMPONENTS ACP-09.01 8 VIII IX. CONTROL OF SPECIAL PROCESSES ACP-10.01 9 IX X. INSPECTION ACP-11.01 10.1, 10.2 X XI. TEST CONTROL ACP-12.01 11.1, 11.2,11.3, 11.4,11.5 XI XII. CONTROL OF MEASURING AND TEST ACP-13.01 12.1,12.2 XII EQUIPMENT XIII. HANDLING, STORAGE, & SHIPPING ACP-05.01 13.1,13.2 XIII XIV. INSPECTION, TEST AND OPERATING ACP-1 1.01, ACP-12.01, ACP-15.01, ACP-15.02 14 XIV STATUS XV. CORRECTIVE ACTION PROGRAM ACP-16.0, ACP-17.02, ACP-17.04 15,16.1, 16.2 XV, XVI XVI. QUALITY ASSURANCE RECORDS ACP-18.01 17.1,17.2,17.3,17.4,17.5 XVII XVII. AUDITS ACP-03.01 18.1,18.2,18.3,18.4,18.5, XVIII 18.6,18.7 XVIII OPERATIONS REVIEW COMMITTEE ACP-02.13 N/A N/A QAPD 35 Rev. 25

FIGURE 1 LACBWR FACILITY ORGANIZATION QAPD 36 Rev. 25

FIGURE 2 DAIRYLAND POWER COOPERATIVE MANAGEMENT ORGANIZATION PC I Bo Iard ofDiretr ý-;j Ad~ministra ti~on 'DCPr'esi~dent% and CE(

)- [--- -- - LegalCounsel Vice President andice, Chief .Fihi

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t I. H .Vice President'

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QAPD 37 Rev. 25

QAPD, Revision 25 Summary and Evaluation of Changes LACBWR QUALITY ASSURANCE PROGRAM DESCRIPTION (QAPD)

Revision 25 Summary of Changes At the conclusion of the LACBWR site dry cask storage loading campaign, the roles and responsibilities of members of the management team will change and the focus of the QAPD will be realigned exclusively to ISFSI activities. The QAPD (Revision 25 attached) has been revised to address these changes which represent a number of reductions in commitment.

The following summarizes the changes made in each section of the QAPD:

Statement of Quality Assurance Policy:

1. The reference to being in "a SAFSTOR condition and transition to ISFSI" was deleted.

A reference to decommissioning was added.

Introduction, Part A, "General":

1. The reference to "a possession only condition and the installation" (of an ISFSI) were deleted. A reference to decommissioning and operation and maintenance of an ISFSI were added. These references are inserted throughout the QAPD.

Introduction, Part B, "Terms and Definitions":

1. Revised FACILITY to be the plant site which is undergoing decommissioning and the ISFSI site where spent fuel is stored.

2. Deleted Quality Assurance Instructions (QAIs) which are now Administrative Control Procedures (ACPs).

3. Deleted the Quality Assurance Project Plan (QAPP) from the QA Manual description.

4. Deleted the definition of the QAPP.

5. Abbreviated the definition of Important to Safety (ITS).

Section I, Organization, Part A, "Organization":

1. Deleted the President and CEO responsibilities for design, construction, installation, maintenance and testing of the LACBWR facility and added the responsibility for decommissioning and operation and maintenance of the ISFSI.

2. Changed the Vice President, Generation responsibility for the administration and operation of the LACBWR facility to decommissioning and operation and maintenance of the ISFSI.

3. Changed the title of Plant Manager to Plant/ISFSI Manager throughout QAPD and changed the on-site responsibility for the possession-only (SAFSTOR) condition of the facility to LACBWR plant decommissioning and operation and maintenance of the ISFSI.

Page 1 of 8

QAPD, Revision 25 Summary and Evaluation of Changes

4. Deleted the position of Assistant Plant Manager.

5. Added the position of Decommissioning Project Manager who reports directly to the Plant/ISFSI Manager and has responsibility for decommissioning activities.

6. The reporting line of the Manager, QA was changed from the Director, Generation Support Services to the VP, Generation. Also provided more details to the role of Manager, QA.

7. Deleted the position of Project Manager.

8. Deleted the reference to the position of Quality Assurance Department Personnel (position exists but no longer highlighted on organization chart).

9. Deleted the position of Director, Generation Support Services.

10. Deleted the position of Operations, Training/Relief Supervisor.

11. Deleted the position of Shift Supervisor.

12. Deleted the position of Fuel Handler.

13. Deleted the position of Fire Protection Supervisor.

14. Deleted the reference to the position of Health and Safety Foreman (position exists but no longer highlighted on organization chart).

15. Deleted the reference to the position of Health Physics Personnel (position exists but no longer highlighted on organization chart).

16. Deleted the reference to the position of Instrument Foreman (position exists but no longer highlighted on organization chart).

17. Deleted the reference to the position of Mechanical Foreman (position exists but no longer highlighted on organization chart).

18. Deleted the reference to the position of Instrument Personnel (position exists but no longer highlighted on organization chart).

19. Deleted the reference to the position of Mechanical and Utility Worker Personnel (position exists but no longer highlighted on organization chart).

20. Deleted the reference to the position of Electrical Personnel (position exists but no longer highlighted on organization chart).

21. Revised the title of the Technical Support Staff to Technical Support Engineer, Licensing.

22. Added the position of Safety/Training Coordinator who reports directly to the Plant/ISFSI Manager and has responsibility for industrial safety activities at the Plant and for the training and requalification program.

23. Added the position of ISFSI Security Project Manager who reports directly to the Plant/ISFSI Manager and has responsibility for managing the security force at the ISFSI.

24. Focused the Safety Review Committee on nuclear safety issues related to the ISFSI only.

The role and responsibilities of the SRC are defined in ACP-02.14.

25. Re-located the Operations Review Committee responsibilities to Section 18 of the QAPD.

Section I, Organization, Part B, "LACBWR Facility Organization Requirements":

1. Revised the organization chart to reflect changes in the decommissioning and ISFSI management staff.

Page 2 of 8

QAPD, Revision 25 Summary and Evaluation of ChangesSection II, Quality Assurance Program, Part A, "General":

1. Clarified the applicability of the QA program to activities that are limited to the ISFSI.

Applicability of the QAPD to decommissioning is addressed in Appendix C. Section also lists the QA program Title 10 CFR commitments.

2. Deleted the reference to the QAPP.

Section II, Quality Assurance Program, Part B, "Applicability":

1. Revised Table 1 to provide a matrix cross reference between the QAPD, 10 CFR 50, Appendix B and Regulatory Guide 7.10. Deleted reference to Regulatory Guide 1.33.

2. Added reference to QAPD, Appendix A for details on the ITS classification process.

Section II, Quality Assurance Program, Part C, "Regulatory Commitments":

1. Added a new subsection describing regulatory commitments.

Section II, Quality Assurance Program, Part D, "Administrative Controls":

1. Added a new subsection describing administrative controls that were relocated from the Technical Specifications to the QAPD, Appendix C for decommissioning.

Section II, Quality Assurance Program, Part E, "Implementation":

1. Renamed subsection from Part B to Part E.

Section II, Quality Assurance Program, Part F, "Personnel Training and Qualification":

1. Added a new subsection describing personnel training and qualification.

Section III, Design Control and Review

1. Clarified the applicability of this section of the QAPD to activities which are limited to the ISFSI.

2. Clarified Plant/ISFSI Manager title.

3. Deleted requirement for modification procedure necessary for SAFSTOR.

Section IV, Procurement Document Control

1. Clarified the applicability of this Section of the QAPD to activities which are limited to the ISFSI.

2. Clarified that a Design Authority is responsible for preparing engineering specifications for ITS materials, equipment and services.

3. Clarified that QA personnel will review all ITS procurement documents.

4. Added reference to 10 CFR Part 21.

Page 3 of 8

QAPD, Revision 25 Summary and Evaluation of ChangesSection V, Instructions, Procedures, and Drawings, Part A, "General":

1. Clarified the applicability of this Section of the QAPD to activities which are limited to the ISFSI.

Section V, Instructions, Procedures, and Drawings, Part B, "Responsibilities":

1. Deleted requirement for Operations Department to initiate and review changes to procedures.

Section V, Instructions, Procedures, and Drawings, Part C, "Requirements":

1. Deleted a number of activities that previously required procedures and checklists which include startup, operation and shutdown of systems, correction of abnormal, off-normal, or alarm conditions, control of emergencies or other significant events, radioactive control (see Appendix C), chemical and radiological control (see Appendix C), fuel handling, Emergency Plan implementation (see Appendix C), Fire Protection Program implementation (see Appendix C), Process Control Program implementation (see Appendix C), Offsite Dose calculation Manual implementation (see Appendix C), and any other procedure required by Regulatory Guide 1.33.

2. Clarified the need for the use of maintenance and repair instructions of ISFSI equipment and systems to be contained in procedures.

3. Deleted the redundant requirement that temporary changes be reviewed by the ORC and approved by the Plant/ISFSI Manager. Requirement is contained in Section 18 and in applicable ACPs.

4. Deleted the following misplaced statement, "Applicable sections of the appropriate procedures shall be followed in the review, processing of changes or deviations, filing, and distribution of procedures, drawings, and specifications".

Section VI, Document Control, Part A, "General":

1. Clarified the applicability of this Section of the QAPD to activities which are limited to the ISFSI.

Section VI, Document Control, Part B, "Responsibilities":

1. Deleted the Shift Supervisor responsibilities for maintaining an Operations Manual.

2. Deleted the Plant Manager responsibilities to control the issuance of project documents.

Section VII, Control of Purchased Material, Equipment, and Services, Part A, "General":

1. Clarified the applicability of this Section of the QAPD to activities which are limited to the ISFSI.

Section VII, Control of Purchased Material, Equipment, and Services, Part B, "Responsibilities":

1. Deleted Operations Department responsibilities in control of purchasing.

Page 4 of 8

QAPD, Revision 25 Summary and Evaluation of ChangesSection VII, Control of Purchased Material, Equipment, and Services, Part C, "Requirements":

1. Clarified that all ITS materials, parts, and components will be segregated upon receipt.

Section VIII, Identification of Material, Parts, and Components, Part A, "General":

1. Clarified the applicability of this Section of the QAPD to activities which are limited to the ISFSI.

Section VIII, Identification of Material, Parts, and Components, Part B, "Responsibilities":

1. Deleted the Assistant Plant Manager responsibilities.

2. Deleted reference to project activities.

Section VIII, Identification of Material, Parts, and Components, Part B, "Requirements":

1. Deleted the requirement that specifications shall require that materials, parts, and components be identified in accordance with purchase order numbers and shall require that documentation have identification providing traceability to the item. An alternate system for identification shall be used.

Section IX. Control of Special Processes, Part A, "General":

1. Clarified the applicability of this Section of the QAPD to activities which are limited to the ISFSI.

Section IX, Control of Special Processes, Part B, "Responsibilities":

1. Deleted the QA personnel responsibility to establish special processes procedures.

Section IX. Control of Special Processes, Part C, "Requirements":

1. Relocated the requirements for records of training, test results, and a listing of qualified personnel to Section 16.

2. Deleted requirement for plant procedures to be established to describe the requirements for qualification of personnel and procedures for special processes (only ISFSI).

Section X, Inspection, Part A, "General":

1. Clarified the applicability of this Section of the QAPD to activities which are limited to the ISFSI.

Section X, Inspection, Part B, "Responsibilities":

1. Deleted Assistant Plant Manager responsibilities.

Page 5 of 8

QAPD, Revision 25 Summary and Evaluation of ChangesSection X, Inspection, Part C, "Requirements":

1. Expanded the requirement that mandatory inspection hold points can be applied to work orders.

Section XI, Test Control, Part A, "General":

1. Clarified the applicability of this Section of the QAPD to activities which are limited to the ISFSI.

Section XI, Test Control, Part B, "Responsibilities":

1. Deleted the requirement for plant testing (only ISFSI).

2. Deleted Assistant Plant Manager responsibilities.

Section XI, Test Control, Part C, "Requirements":

1. Added reference to NAC Technical Specifications to applicable design documents with acceptance criteria for testing.

Section XII, Control of Measuring and Test Equipment, Part A, "General":

1. Clarified the applicability of this Section of the QAPD to activities which are limited to the ISFSI.

Section XII, Control of Measuring and Test Equipment, Part B, "Responsibilities":

1. Replaced facility personnel with LACBWR staff.

2. Deleted the reference to project testing.

3. Deleted Assistant Plant Manager responsibilities.

Section XIII, Handling, Storage, and Shipping, Part A, "General":

1. Clarified the applicability of this Section of the QAPD to activities which are limited to the ISFSI.

Section XIII, Handling, Storage, and Shipping, Part B, "Responsibilities":

1. Deleted Assistant Plant Manager responsibilities.

Section XIII, Handling, Storage, and Shipping, Part C, "Requirements":

1. Deleted the reference to proper use of fuel handling equipment described in procedures.

Section XIV, Inspection, Test, and Operating Status, Part A, "General":

1. Clarified the applicability of this Section of the QAPD to activities which are limited to the ISFSI.

Page 6 of 8

QAPD, Revision 25 Summary and Evaluation of ChangesSection XIV, Inspection, Test, and Operating Status, Part C, "Requirements":

1. Delete the use of the Control Room Log Book

2. Deleted references to handling of fuel assemblies, utilization of station test or shift log entries, and maintenance requests or work orders to be used at the plant.

Section XV, Nonconforming Materials, Parts, or Components

1. This section was merged with Section XVI.

Section XV, Corrective Action, Part A, "General" (formerly Section XVI):

1. Clarified the applicability of this Section of the QAPD to activities which are limited to the ISFSI.

2. Expanded the Section's applicability to include materials, parts, or components that do not conform to requirements.

Section XV, Corrective Action, Part C, "Requirements" (formerly Section XVI):

1. Deleted reference to Licensee Event Report (LER).

2. Expanded subsection to include materials, parts, or components that do not conform to requirements.

3. Deleted statement that the Maintenance Request process can create documented Correction Action Reports (CARs).

4. Deleted the redundant requirement that QA personnel shall audit corrective actions.

Section XVI, Quality Assurance Records, Part A, "General" (formerly Section XVII):

1. Clarified the applicability of this Section of the QAPD to activities which are limited to the ISFSI.

Section XVI, Quality Assurance Records, Part E, "Record Retention" (formerly Section XVII):

1. Changed records and logs of facility operation to ISFSI operation.

2. Added NAC-MPC system record requirements.

3. Added record of changes to programs and procedures noted in Appendix C.

4. Added records of facility radiation and contamination surveys.

5. Added records of reviews performed of the ODCM and PCP.

6. Added records of test results obtained in special processes.

7. Added records of training, test results, and a listing of qualified personnel.

8. Deleted records for reactor tests and experiments and in-service inspections.

Section XVI. Audits, Part A, "General" (formerly Section XVIII):

1. Clarified the applicability of this Section of the QAPD to activities which are limited to the ISFSI.

Page 7 of 8

QAPD, Revision 25 Summary and Evaluation of ChangesSection XVII. Audits, Part C, "Requirements" (formerly Section XVIII):

1. Deleted audits of facility operations per Appendix A Technical Specifications, training and qualification, Emergency Plan, Contingency Plan, Security Plan, fire protection, ODCM and REMP Radiation Protection and PCP, and any other facility operation (see Appendix C).

2. Deleted Assistant Plant Manager review requirement.

Section XVIII, Operations Review Committee:

1. Added new Section 18 defining the Operations Review Committee activities which are being relocated from Section 1, Organization.

Attachments:

1. Appendix A, "Important To Safety Structures, Systems and Components" - Added a new appendix that defines ITS structures, systems, and components.

2. Appendix B, "Regulatory Commitments, Alternatives and Exceptions" - Added a new appendix that defines regulatory commitments, alternatives, and exceptions.

3. Appendix C, "Administrative Controls" - Added a new appendix that defines the method of describing and controlling programs and processes to be use at the plant during decommissioning. The majority of the programs listed in this appendix were imported from the LACBWR Technical Specifications.

4. Table 1 - Has been updated to reflect new or deleted procedures and to reference Regulatory Guide 7.10.

5. Figure 1 - Facility Organization has been changed to only address ISFSI staffing and recognizes the addition of the Decommissioning Project Manager.

6. Figure 2 - DPC Management Organization remains substantively unchanged but does reflect minor administrative edits and reformatting.

- End of Changes -

Page 8 of 8

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 Corresponding Regulatory Guide 7.10, Revision 2 QAPD, Rev. 25 LACBWR Comments Requirement 1.1 Structure and Authority For each function, the structure of the organization and the assignment of responsibility should ensure that the following requirements are fulfilled:

• The formal structure of the organization is documented by Section 1.0 and - QAPD Figure 1 details the LACBWR facility organization organization charts that identify each organizational element Figures 1 and 2 and Figure 2 details the corporate management structure.

that functions under the QA program.

• The discussion specifies the required authority and Section I.A.5 - The Manager, QA has the authority and organizational organizational freedom, including sufficient independence from freedom to verify activities affecting quality and is influences of cost and schedule. independent of undue influences and responsibilities for schedules and costs.

" The specified quality requirements are achieved and maintained Section 0.0.A - It is DPC's policy that the group performing and directly by those who have been assigned the responsibility for responsible for the work, such as project management, performing the work. engineering, design, procurement, installation, maintenance, testing, and dismantlement shall be responsible for the quality of work.

• The QA program user has established measures to provide Section lI.E - Individuals that are assigned responsibilities shall prepare adequate control over activities important to safety (e.g. administrative and quality assurance procedures as inspecting, cleaning, purchasing, and preparing the packaging necessary to implement the requirements of this program for delivery), in support of operation and maintenance of the LACBWR ISFSI. Procedures shall include appropriate quantitative and qualitative acceptance criteria necessary to determine that the activity is being properly performed.

• Conformance to established requirements is verified by Section X,C.1 - Inspections shall be performed only by qualified personnel.

individuals and groups that are not directly responsible for In no case shall an acceptance inspection be performed by performing the work. the individual who performed the activity.

Note: If, because of staffing limitations, the same individuals perform Section I.A.5 The Manager, QA reports directly to the VP, Generation, with multiple functions (including QA), the QA program user should establish direct access to the DPC President and CEO, if necessary, measures to ensure that when performing QA and QC functions, the for quality assurance matters and has the responsibility and designated individuals have the responsibility and authority to stop authority to stop unsatisfactory work and control further unsatisfactory work and/or delivery or installation of nonconforming processing, delivery, or installation of nonconforming material, and have direct access to management levels that can ensure materials. This individual also has the responsibility and that QA procedures important to safety have been accomplished, authority to identify quality problems, to recommend or provide solutions, and to verify their implementation.

In addition, the QA program user should establish and document the QA Policy The Manager, QA is responsible for the establishment and required duties and qualifications for (1) the individual who has overall implementation of a quality assurance program which meets authority and responsibility for the QA program, as well as (2) other all regulatory requirements.

149

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 personnel performing QA and QC functions, and those individuals should have the written endorsement of top management.

1.2 Top Management Endorsement of a QA Program Top management should maintain a continuing involvement in QA QA Policy The QAPD provides a consolidated overview of the quality matters in order to ensure that the QA program is effective. To ensure program controls that govern the decommissioning of the La the commitment of top management, the company/ corporate president Crosse Boiling Water Reactor (LACBWR) and operation and or chief executive officer should establish a written policy stating that it maintenance of the LACBWR Independent Spent Fuel is company/corporate policy to perform work on items important to Storage Installation (ISFSI). The QAPD describes the quality safety in accordance with the requirements of Subpart H, as described assurance organizational structure, functional in the QA program plan and implemented in the QA program responsibilities, levels of authority and interfaces. The quality implementing documents. assurance program, as described in this QAPD, is implemented through the use of approved procedures (i.e.,

policies, directives, procedures, manuals, instructions, or other documents) which provide written guidance for the control of Important to Safety items and activities and provides for the development of documentation to demonstrate objective evidence of compliance with stated requirements.

The policy statement should also identify the functions and positions who have delegated authority for the following tasks:

• Implement and revise the provisions of the described QA QA Policy - The Manager, QA is responsible for the establishment and program. Section I implementation of a quality assurance program which meets all regulatory requirements.

• Regularly assess the scope, status, implementation, and - The Manager, QA has responsibility for establishing a effectiveness of the QA program. quality assurance program and performing audits of the program to determine its effectiveness.

2.1 General Guidance on QA Programs In its program description submittal, the QA program user should identify to the NRC how each of the regulations in Subpart H of 10 CFR LACBWR QAPD The LACBWR QAPD revision 24 was accepted by the NRC Part 71 applies to its particular situation and how it will be satisfied. The and is allowed to be used per 10 CFR 71.101(f).

information supplied for NRC review will vary as a function of the nature of activities in which the QA program user is involved. For example, an individual or organization using a general license solely for transportation of radioactive material in packages purchased or leased for that purpose would be expected to address regulations governing activities such as procurement, shipment, and handling. By contrast, someone who designs and fabricates packaging would be expected to address criteria for design and testing, as well as material procurement activities. Elements common to all QA program descriptions include the quality organization and programi corrective action, QA records, and audits.

2 of 29

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 In developing its programs, prospective QA program users can refer to the NRC's guidance in this regulatory guide, as well as the additional LACBWR QAPD The LACBWR QAPD revision 24 was accepted by the NRC guidance on graded QA in NUREG/CR-6407 (Ref. 2). In developing its and is allowed to be used per 10 CFR 71.101(f).

program, QA program users should apply each of the applicable Subpart H regulations in a graded approach (i.e., to an extent that is consistent with its importance to safety).

Following the NRC staff's technical review and determination that the QA program submittal meets regulatory requirements, the Commission LACBWR QAPD The LACBWR QAPD revision 24 was accepted by the NRC issues a QA Program Approval. The approval expires on the last day of and is allowed to be used per 10 CFR 71.101(f).

the month stated on the approval form and may be renewed (at the request of the QA program user and in accordance with 10 CFR 71.38) not less than 30 days prior to expiration.

All changes to the approved QA program description require NRC approval. Therefore, before implementing any change in the QA LACBWR QAPD The LACBWR QAPD revision 24 was accepted by the NRC program description that was used as the basis for NRC approval, the and is allowed to be used per 10 CFR 71.101(f).

QA program user should submit the proposed change for NRC review and approval. Requests for review and approval of such changes are handled through amendments to the QA Program Approvals and do not affect the renewal dates. The only exception to the requirement for NRC approval of any change relates to QA programs that the NRC staff approved under Appendix B to 10 CFR Part 50, which was subsequently accepted under 10 CFR 71.101 (f). This exception allows a nuclear power plant licensee to change such a QA Program to the extent permitted under 10 CFR 50.54(a)(3).

Based on NRC approval of its QA program description submittals, a QA program user will translate the regulations discussed in its submittals QA Policy The QAPD provides a consolidated overview of the quality into lower-level (working-level) implementing procedures that govern the program controls that govern the decommissioning of the La conduct of QA activities that are important to safety. Crosse Boiling Water Reactor (LACBWR) and operation and maintenance of the LACBWR Independent Spent Fuel Storage Installation (ISFSI). The QAPD describes the quality assurance organizational structure, functional responsibilities, levels of authority and interfaces. The QAPD is implemented through the use of approved procedures (i.e., policies, directives, procedures, manuals, instructions, or other documents) which provide written guidance for the control of Important to Safety items and activities and provides for the development of documentation to demonstrate objective evidence of compliance with stated I requirements.

If the NRC staff reviews a QA program submittal and finds that it inadequately describes how the requirements will be met or fails to N/A The LACBWR QAPD revision 24 was accepted by the NRC 0 0 3 of 29 0

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 specifically address some Subpart H regulation(s), the staff will ask the and is allowed to be used per 10 CFR 71.101(f).

QA program user to submit additional information to correct the deficiencies.

2.2 Scope of QA Program The QA program user should establish measures for identifying (1) the components, structures, and systems to be covered by the QA program, Section III.A and and (2) the approach for verifying that the applicable components, Appendix A structures, and systems meet design objectives. Although 10 CFR Part 71 allows the development of a "graded" QA program, this does not preclude the alternative of defining a program based on maximum controls if such a program is deemed necessary to attain the confidence needed for meeting design objectives. In particular, the QA program user should establish measures to ensure that the following requirements are fulfilled:

• Activities important to safety are performed using specified Section V.C This section establishes the requirements to assure that equipment and under suitable environmental conditions. Important to Safety (ITS) structures, systems, and components (SSCs) of the LACBWR ISFSI are added, deleted, changed or modified in accordance with the codes, standards, and regulations that governed the original design, except as amended and approved.

Measures shall be established for the review, evaluation, and approval of all design changes governing ISFSI SSCs.

" QA/QC manuals specify the designated QA and QC For activities other than those within normal craft expertise, responsibilities for implementation of activities important to instructions for maintenance and repair of ISFSI safety. equipment or systems shall be contained in procedures.

These procedures shall contain instructions for preparation, performance, testing, and return to service.

The procedures may reference manufacturer's instruction manuals, drawings, and other sources, as applicable.

• The QA program user has established indoctrination and Section I.E and Indoctrination in the QA program requirements shall be training programs to ensure that personnel performing activities F provided to all facility personnel and contractors important to safety are trained and qualified to perform those performing activities that could affect the quality of activities. structures, systems, or components. Each member of the facility staff (including audit, surveillance and inspection personnel) shall have sufficient qualifications to perform their assiqned duties.

2.3 Applicability of QA Program _

Measures covered by the QA program should be compatible with and Section II.A - The QAPD sets forth the requirements for the QA emphasize characteristics identified in the manufacturer's QA program. organization, personnel responsibilities, controls, and The QA program user should establish the rationale to identify items measures established to achieve, maintain, and document

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 that are classified as important to safety and subject to the user's QA quality which includes incorporation of applicable program. regulatory criteria, codes, standards, and design bases for ITS SSCs into the ISFS1 operations and maintenance procedures.

Section II.B - The QA program utilizes the Important to Safety (ITS) classification process to apply and enforce a graded approach to quality in tasks related to ISFSI SSCs.

2.4 Documentation The QA program user should ensure that (1) written procedures and QA Policy The QAPD provides a consolidated overview of the quality instructions describe all activities that are important to safety and program controls that govern the decommissioning of applicable to the design, procurement, fabrication, and testing of LACBWR and operation and maintenance of the LACBWR packaging, and (2) those procedures and instructions will be in place ISFSI. The QAPD is implemented through the use of before the QA program user engages in those activities. approved procedures (i.e., policies, directives, procedures, manuals, instructions, or other documents) which provide written guidance for the control of Important to Safety items and activities and provides for the development of documentation to demonstrate objective evidence of compliance with stated requirements.

Section VI.C.4 The Administrative Staff shall assure that current documents are distributed to and used at the location where the prescribed activity is performed.

With respect to anticipated activities important to safety that the QA Table 1 Table 1, Regulatory Comparison Matrix, identifies each program user has not yet initiated, the user should identify the implementing procedure for the applicable QAPD Section.

implementing procedures by title and procedure number, and should provide a brief description of the content of those procedures with an estimated date for their completion. The following table shows a suitable format for listing procedures to demonstrate implementation of a documented QA program.

To demonstrate that written procedures fully implement and reflect the Table 1 Table 1, Regulatory Comparison Matrix, identifies each current status of the documented QA program, the QA program user implementing procedure for the applicable QAPD sections.

should establish and maintain a master index of QA procedures related Section VI.C.1 An index of each type of document shall be established and to all activities important to safety, as well as a matrix of the QA and C.4 maintained to provide the current status of documents.

procedures that implement each section of Subpart H. These written Procedures shall be established for the issuance of procedures should also address the use, management, and storage of procedures, drawings, and specifications. A document electronic records and data. control procedure shall be prepared to provide a uniform system of document identification.

2.5 Controlled Conditions and Assignment of Responsibilities The QA program user should establish measures to ensure that Section V.C.1 to Detailed instruction for ISFSI activities shall be contained in activities important to safety are accomplished using appropriate C.4 procedures and checklists covering administrative control, production and test equipment, suitable environmental conditions, general security system operation, Security Plan 5v

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 applicable codes and standards, and proper work instructions. The QA implementation, quality assurance, and surveillance and test program user should also document the assignment of responsibility for activities of equipment. For activities other than those within each task and method used to verify conformance to these quality normal craft expertise, instructions for maintenance and requirements. repair of ISFSI equipment or systems shall be contained in procedures. These procedures shall contain instructions for preparation, performance, testing, and return to service. The procedures may reference manufacturer's instruction manuals, drawings, and other sources, as applicable.

.Instructions, procedures, or drawings for ITS activities shall delineate methods and sequences when an activity is to be performed. These documents shall include appropriate quantitative or qualitative acceptance criteria for determining that the activity has been satisfactorily performed. The department responsible for an activity shall be required to provide the necessary technical input and review of changes f I.

to instructions. Drocedures. or drawings.

3.1 Control of the Design Process The QA program user should establish measures such as "classification Section III.B.1 LACBWR subcontracts all ITS design activities to a Design of characteristics" to ensure that packaging designs are reviewed to and B.3 Authority with an approved 10 CFR 50, Appendix B or 10 emphasize critical parameters that can be controlled by inspections or CFR 72-Subpart G QA program. The Design Authority is tests and to identify test and inspection criteria and quality standards. responsible for the incorporation of design bases, regulatory requirements, codes and standards into drawings and specifications related to ITS SSCs design and changes thereto. The LACBWR staff is responsible for establishing procedures to implement design control and the incorporation of design documents into work orders, procedures and instructions via owner's acceptance reviews.

To control the preparation of drawings and specifications, the QA Section III.B.1 LACBWR subcontracts all ITS design activities to a Design program user should establish recognized engineering practices, such and B.3 Authority with an approved 10 CFR 50, Appendix B or 10 as prescribing drafting room standards, checking methods, establishing CFR 72, Subpart G QA program.

review/approval and issuance/distribution requirements (including revisions to them), maintaining current "as-built" configurations, and storing and controlling original and master copies/

3.2 Control of Design Input The QA program user should establish measures to ensure that Section III.B.1 LACBWR subcontracts all ITS design activities to a Design appropriate codes and standards are used in the design of the and B.3 Authority with an approved 10 CFR 50, Appendix B or 10 packaging. In the absence of such codes and standards for formulation CFR 72, Subpart G QA program.

of the design activities, the QA program user should identify alternative approaches.

The QA program user should establish measures to ensure that (1) the Section III.B.1 LACBWR subcontracts all ITS design activities to a Design 65f

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 responsible design organization has properly considered, reviewed, and and B.3 Authority with an approved 10 CFR 50, Appendix 8 or 10 approved all design parameters (e.g., criticality physics, cooling, and CFR 72, Subpart G QA program.

decontamination of an item); (2) the parameters are in accordance with the applicable performance codes, standards, and regulatory requirements; and (3) design documents specify the related maintenance, repair, in-service inspection, handling, storage, and cleaning requirements.

3.3 Control of Design Verification The QA program user should establish methods for use in verifying the Section III.B.1 LACBWR subcontracts all ITS design activities to a Design adequacy of the design (e.g., qualification testing, design review, or and B.3 Authority with an approved 10 CFR 50, Appendix B or 10 alternative calculations, including use of computer programs). CFR 72, Subpart G QA program.

Technically qualified individuals or groups responsible for design verification should not be in the administrative line of authority of the original designer, with the exception that the designer's immediate supervisor may perform the verification, provided that the following criteria are met:

" The supervisor is the only technically qualified individual.

• The supervisor's management documents and approves the need in advance.

" The QA audits cover the effectiveness of the use of supervisors as design verifiers to guard against abuse of this practice.

Changes to the final design may arise during the sequence of design Section III.B.1 LACBWR subcontracts all ITS design activities to a Design verification. Consequently, the QA program user should establish and B.3 Authority with an approved 10 CFR 50, Appendix B or 10 measures to ensure that drawing and specification changes are CFR 72, Subpart G QA program.

reviewed and approved by the same individuals or organizations that reviewed and approved the original documents. Changes in design that could result in conditions-different from those prescribed on the CoC should be approved by the NRC prior to implementation.

Design verification, if other than by qualification testing of a prototype or Section III.B.1 LACBWR subcontracts all ITS design activities to a Design lead production unit, should be satisfactorily completed prior to (1) and B.3 Authority with an approved 10 CFR 50, Appendix B or 10 release for procurement or fabrication and (2) release to other CFR 72, Subpart G QA program.

organizations for use in other design activities except when this timing cannot be met. In such cases, design verification may be deferred, provided that the justification for this action is documented and the unverified portion of the design output documents are appropriately identified and controlled. When a test program is used to verify the adequacy of a design, the prototype should be subjected to the most adverse design conditions.

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 4.1 Content of Procurement Documents The QA program user should establish measures to ensure that procurement documents include the following information (as applicable):

• the scope of work to be performed by the prospective supplier Section IV.C - Purchase requisitions for new material, equipment, and services and for spare or replacement parts shall be initiated by any department personnel. The purchase requisition shall contain the information such as quantity, item description, and technical and quality requirements necessary for procurement of the item.

" the design-basis technical requirements (or references thereto), - Purchase orders shall include specifications that contain all including applicable regulatory requirements, material and Section IV.C.2 the information necessary to assure material, equipment, component identification requirements, drawings, specifications, and services are of adequate quality. This shall include codes and standards, special process instructions, and test and material selection, design data, equipment, description, inspection requirements source inspection and testing requirements, cleaning and packaging requirements, and required documentation as deemed necessary.

- To the extent necessary, ITS procurement documents shall

• applicable Subpart H requirements that should be complied with require suppliers of material, equipment, and services to and described in the supplier's QA program (Qualified QA Section IV.C.4 have a quality assurance program complying with the personnel from the purchaser's organization should review and pertinent provisions of 10 CFR 21, 10 CFR 50, Appendix concur in the supplier's QA program or portions thereof before B, and/or 10 CFR 72, Subpart G. Suppliers shall be the purchaser initiates activities affected by the program. Also, if required to provide DPC access to their facilities and sub-tier suppliers are involved, the QA program user should records for inspection and audit, as required, to determine specify the QA provisions appropriate to those procurements. compliance with provisions of the purchase order. These The extent of the supplier's and sub-tier supplier's QA programs requirements shall extend to lower tier procurements, as will depend on the particular item or service being procured.) determined by DPC management.

permission to gain access to the supplier's and sub-tier Section IV.C.4 - ITS procurement documents shall require suppliers of supplier's plant facilities and records for inspection and audit material, equipment, and services to have a quality purposes (Procurement documents should identify the type of assurance program complying with the pertinent provisions verification activities required of any sub-tier suppliers for of 10 CFR 21, 10 CFR 50, Appendix B, and/or 10 CFR 72, supplied materials, as well for any design, fabrication, assembly, Subpart G. Suppliers shall be required to provide DPC testing, maintenance, and repair services or activities supplied.) access to their facilities and records for inspection and audit, as required, to determine compliance with provisions of the purchase order. These requirements shall extend to lower tier procurements, as determined by DPC management.

identification of the documentation (e.g., drawings, Section IV.C.3 - Documentation that is required to provide evidence that specifications, procedures, inspection and fabrication plans, materials, equipment, and services are of adequate quality inspection and test records, personnel and procedure shall be clearly delineated in purchase orders. This shall 0 86i

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 qualifications, results of chemical and physical tests on material) include a listing of each item of documentation to be that the supplier(s) must prepare, maintain, and submit to the submitted, when it is to be submitted, what requires purchaser for approval approval prior to manufacture, and to whom it shall be submitted.

• requirements for reporting and approving disposition of ACP-05.01 - Procedure requires the MQA to identify or confirm the nonconformances appropriate quality requirements, right-of-access, documentation requirements, non-conformance requirements (handling of NCRs, etc.), and-all technical codes and standards.

" identification of records that the supplier must retain, control, Section IV.C.4 - Suppliers shall be required to provide DPC access to their and maintain, as well as those records that the supplier must facilities and records for inspection and audit, as required, deliver to the purchaser prior to installation of hardware [These to determine compliance with provisions of the purchase records should include the pertinent documentation to be order. These requirements shall extend to lower tier furnished with the procured materials or services (e.g., CoC, as- procurements, as determined by DPC management.

built drawings, photographs, sketches, use and maintenance manuals). If the pertinent documentation is in an electronic format, the QA program user should specify the software system that must be used to prepare and deliver the documentation.1 4.2 Replacement Part Procurement Measures should be established to require that procurement of Section IV.C.5 ITS purchase requisitions shall be reviewed by the QA replacement parts important to safety be reviewed by QA personnel to personnel to assure that all necessary quality requirements ensure that appropriate technical and QA requirements are included in are included or referenced.

purchase orders and that the purchase orders are placed with suppliers previously qualified during fabrication of the packaging. If replacement parts are purchased from suppliers not previously identified as qualified sources, the QA program user must assure himself or herself that the replacement parts meet requirements at least as stringent as the original criteria.

4.3 Review and Changes to Procurement Documents The QA program user should establish measures to ensure that review Section IV.C.7 Changes in technical content in procurement documents and approval of procurement documents are recorded prior to release, shall be initiated and reviewed in accordance with the same and that changes and revisions to those documents are subject to at procedures utilized in preparation of the original document.

least the same review and approval as the original documents.

5.1 Quality Assurance Program Procedures The QA program user should establish measures to ensure that the following requirements are fulfilled:

• Activities important to safety are prescribed and accomplished QA Policy and - The QAPD is implemented through the use of approved in accordance with current documented instructions, Section V.B.2 procedures (i.e., policies, directives, procedures, manuals, procedures, or drawings that have been approved by instructions, or other documents) which provide written

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 appropriate levels of management. guidance for the control of Important to Safety items and activities and provides for the development of documentation to demonstrate objective evidence of compliance with stated requirements. The Plant/ISFSI Manager is responsible for approval of ISFSI related procedures.

" Instructions, procedures, and drawings specify the methods for QAPD Table 1 - Table 1, Regulatory Comparison Matrix, identifies each complying with each of the applicable sections of Subpart H of implementing procedure for the applicable QAPD Section.

10 CFR Part 71. - This procedure requires the MQA to monitor the project's

• All work activities are coordinated with QA personnel to ensure ACP-04.01 objectives through oversight activities of work activities.

that the work controlling documents incorporate appropriate The MQA shall place witness and hold points in work inspection and hold points to verify that initial work, planned orders and provide QC support.

work, effective repairs, or rework have been performed satisfactorily. - Instructions, procedures, or drawings for ITS activities shall

• Instructions, procedures, and drawings include quantitative Section V.C.3 delineate methods and sequences when an activity is to acceptance criteria (e.g., dimensions, tolerances, and operating be performed. These documents shall include appropriate limits) and qualitative acceptance criteria (e.g. workmanship quantitative or qualitative acceptance criteria for samples) to verify that activities important to safety have been determining that the activity has been satisfactorily satisfactorily accomplished. performed.

• Written procedures address the use, management, storage, and - A system shall be established to identify all documents that protection of electronic records and data. The QA program user Section XVI.D must be kept permanently (lifetime records). An index of should also maintain information on the specific software non-permanent records shall be established. An approved applications and storage or computing hardware. document listing will be reviewed on a regular basis to verify that the record file contains the latest revisions of all required documents. A system will be established to control the issuance and return of all records.

5.2 QA Review and Concurrence The QA program user should establish measures to ensure that the QA Section IX.B.2, - QA personnel are responsible for reviewing of procedures organization reviews and concurs in inspection plans; test, calibration, and Section for welding, heat treating, cleaning, non-destructive and special process procedures; and specifications as well as any X.B.2 examination, and filler metal control and for assuring changes thereto. Prior to fabrication of an item, the QA organization maintenance, repair, and modification work involving should review and concur in the related manufacturing plans, as they special processes to be performed by qualified personnel relate to scheduled witness and hold points during fabrication. in accordance with qualified procedures. QA personnel are responsible for establishing inspection procedures and assuring adequate inspection requirements are included in procedures. They are also responsible for coordinating the assignments of qualified inspection personnel.

6.1 Controlled Documents The QA program user should maintain each of the documents under the control of the QA program to reflect the current status. As a minimum, the QA program user should exercise control over the following:

104

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10

• design documents (e.g., drawings, specifications, and computer codes) Section VI.C.5 Procedures shall be established for the issuance of

• procurement documents procedures, drawings, and specifications. A document

" QA and QC manuals control procedure shall be prepared to provide a uniform

• operating, maintenance, and modification procedures system of document identification. All documents shall have

• inspection and test procedures an identification number, title, date, and revision number. An

" corrective action reports index of each type of document shall be established and

" nonconformance reports maintained to provide the current status of documents.

design change requests This procedure establishes the practices for controlling ACP-07.01 documents and changes thereto.

6.2 Control of Document Generation and Issuance The QA program user should establish controls to ensure that all Section IV.C.1 to - All documents shall have an identification number, title, documents and changes thereto are adequately reviewed and approved C.5 date, and revision number. Documents shall be filed and prior to their issuance. These controls should include measures (e.g., controlled by use of this identification. Each type of the use of a master document list) to ensure that current issues of document shall be filed in a central location identified in a applicable documents are available at the location where the activity is document control procedure.

being performed to preclude use of obsolete or superseded documents. Drawings, specifications, and procedures, including The QA program user should also check all packaging affected by revisions, shall be reviewed for adequacy and approved design changes to verify that it is in accordance with the appropriate for release by authorized personnel. The required reviews revision. In addition, the QA program user should identify (by function or and approvals shall be specified in a document control position) the individuals or groups responsible for reviewing, approving, procedure.

and issuing documents and revisions thereto. - The Administrative Staff shall assure that current documents are distributed to and used at the location where the prescribed activity is performed. Documents and revisions shall be distributed as specified in a document control procedure. Preliminary and superseded documents shall be clearly identified and closely controlled to preclude their misuse.

- An index of each type of document shall be established and maintained to provide the current status of documents.

6.3 Control of Document Changes The QA program user should establish measures to ensure that Section VI.C.4 - Drawings, specifications, and procedures, including changes to documents are reviewed and approved by the same revisions, shall be reviewed for adequacy and approved organization that performed the original review and approval and the for release by authorized personnel. The required reviews changes are in accordance with established configuration control and approvals shall be specified in a document control procedures. procedure.

- The Administrative Staff shall assure that current documents are distributed to and used at the location where the prescribed activity is performed. Documents and revisions shall be distributed as specified in a 11 1W* document control procedure.

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 6.4 Control of Electronic Documents If the documents are stored electronically, the QA program user should N/A LACBWR does not store its documents electronically.

establish controls over access to the documents to ensure that the latest versions of the documents are available and changes to the documents are properly authorized and implemented. The software and hardware systems used to store electronic information should be reliable to avoid alteration or corruption of the information.

7.1 Procurement Document Planning The QA program user should establish procurement planning Section IV.B - The LACBWR staff is responsible for developing procedures that describe each procurement step leading to contract procedures to control the preparation, review, and award for items and services. These procedures should identify the approval of purchase orders for material, equipment, and organizations responsible for each procurement step. services covered by the QA program. They are also responsible for initiation of purchase requisition worksheets for material, equipment, and services required for maintenance, repair, and modifications.

The Design Authority is responsible for preparing engineering specifications which detail the technical and quality requirements for ITS material, equipment, and services.

The LACBWR staff is responsible for preparing purchase requisition worksheets for material, equipment, and services.

Purchasing is responsible for preparing, reviewing, approving, issuing, and controlling purchase orders.

QA personnel are responsible for review of ITS procurement documents to ensure inclusion of appropriate quality requirements.

7.2 Selection of Procurement Sources The QA program user should establish measures for evaluating and selecting procurement sources, including the extent of QA and engineering involvement. Specifically, the QA program user should consider establishing the following provisions (if applicable):

" the supplier's capability to comply with applicable sections of Subpart H Section VI.C.4 To the extent necessary, ITS procurement documents shall require suppliers of material, equipment, and services to have a quality assurance program complying with the pertinent provisions of 10 CFR 21, 10 CFR 50, Appendix B, and/or 10 CFR 72, Subpart G.

" results of the survey of the supplier's facility and QA program Qualification of suppliers shall consist of DPC's experience

• review of the supplier's previous records and performance Section VII.C.1 with the supplier, supplier's reputation and experience in I the field, and in the nuclear industry, a QA program and/or 12 of 29 0

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 Section VII.C.1 other factors, as appropriate.

7,3 Bid Evaluation and Award The QA program user should establish measures to ensure that Section IV.B.1 The LACBWR staff is responsible for developing procedures designated individuals or organizations evaluate proposed suppliers, as and B.2 to control the preparation, review, and approval of purchase applicable to the type of procurement, based on technical orders for material, equipment, and services covered by the considerations, conformance to QA requirements, production capability, QA program. They are also responsible for initiation of and past performance. purchase requisition worksheets for material, equipment, and services required for maintenance, repair, and modifications.

Prior to contract award, the QA program user should resolve (if ACP-05.01 This procedure requires that the MQA shall review the possible) all unacceptable conditions identified during the bid returned RFP and resolve any questions or issues with the evaluation. If any unacceptable conditions cannot be resolved prior to perspective suppliers. The selected Supplier will be on the contract award, the QA program user should obtain the supplier's Approved Suppliers' List prior to issuance of a PO.

commitment that the conditions will be resolved at a mutually agreeable date during the contract period.

7.4 Supplier Performance Control The QA program user should establish measures for pre- and post- ACP-05.01 This procedure requires Purchasing, the Project Manager, award activities, such as meetings and other communications, to ensure and MQA to discuss and resolve any questions or issues that the supplier understands procurement requirements, including, if with the perspective suppliers (pre-award). Post award applicable, "hold points" (i.e., preestablished inspection points in the meetings and discussions are scheduled as required by the manufacturing process that require inspection approval and release by complexity and duration of the contract.

the QA organization prior to further processing) during manufacturing and testing and before shipment.

7.5 Verification Activities The QA program user should establish the extent to which source surveillance will be performed during fabrication, assembly, maintenance, modification, repair, inspection, testing, and shipment to ensure conformance with the purchase order requirements. The source surveillance should cover the following aspects:

• instructions specifying characteristics or processes to be witnessed, inspected, or verified Section IV.C.4 - Suppliers shall be required to provide DPC access to their facilities and records for inspection and audit, as required, to determine compliance with provisions of the purchase

• the documentation required order.

Section IV.C.3 - Documentation that is required to provide evidence that materials, equipment, and services are of adequate quality shall be clearly delineated in purchase orders. This shall include a listing of each item of documentation to be submitted, when it is to be submitted, what requires approval prior to manufacture, and to whom it shall be

" identification of those responsible for implementing source submitted.

131W

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 surveillance Section VII.B.1 - QA personnel are responsible for developing procedures for supplier evaluation and qualification and for coordinating supplier evaluation, qualification, and

~evaluating supplier quality programs.

The QA program user should also establish the extent to which Section VII.E.1 Items shall be examined by appropriately trained staff upon inspection will be performed upon receipt of supplier-furnished and E.2 receipt for shipping damage, correctness of identification, hardware to ensure that items are properly identified and correspond and specified quality documentation, in accordance with with procurement documentation. When acceptance of an item is approved instructions. .Documentary evidence attesting that contingent on tests after installation in the package, the QA program items conform to purchase order requirements shall be user and item supplier should mutually establish the relevant available at the plant prior to installation or use of the item.

acceptance documentation prior to its use.

In addition, the QA program user should take appropriate measures Section VII.C.1 Qualification of suppliers shall consist of DPC's experience (such as source surveillance and audits of records) to ensure that the and C.2 with the supplier, supplier's reputation and experience in the supplier performed the design and fabrication of packaging under the field, and in the nuclear industry, a QA program and/or other control of an NRC-approved QA program. factors, as appropriate. Suppliers of casks used for shipment and storage of radioactive material shall be evaluated to ensure that the design and fabrication of packaging are performed under the control of an NRC-approved and DPC-accepted QA program.

7.6 Controlling Nonconformances The QA program user should establish measures to ensure the proper Section VII.E.5 During receiving inspection, if a nonconformance or disposition of items or services that do not meet procurement discrepancy exists, the material shall be placed on hold and requirements. These measures should include evaluation of will remain in a hold status until final disposition is nonconforming items categorized by the supplier, along with technical determined. A Corrective Action Report (CAR) shall be justification and recommended disposition (e.g., "use as is" or "repair"). initiated.

7.7 Records The QA program user should establish measures to ensure that the supplier furnishes to the purchaser the following records (as a minimum):

• documentation that identifies material or equipment and the Section IV.C.3 - Documentation that is required to provide evidence that specific procurement requirements (e.g., codes, standards, and materials, equipment, and services are of adequate quality specifications met by the items) shall be clearly delineated in purchase orders. This shall include a listing of each item of documentation to be submitted, when it is to be submitted, what requires approval prior to manufacture, and to whom it shall be submitted.

" documentation that identifies any procurement requirements Section VII.E - Documentary evidence shall be sufficient in order to that have not been met, along with a description of those identify that the specific requirements, such as codes, 149

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 nonconformances designated "use as is" or "repair" standards, and specifications, can be confirmed for the purchased item. This requirement shall be satisfied by having available copies of the purchase order and

" documentation that the supplied material and equipment meets appropriate documents referenced therein.

the applicable procurement requirements prior to installation or Section VII.E.2 - Documentary evidence attesting that items conform to use purchase order requirements shall be available at the plant

" appropriate documentation, as identified in the purchase order, prior to installation or use of the item.

that will accompany the NRC-approved packaging during Section VII.E.2 - Reference above.

transport and be received at the destination by the user Such documents should (1) be referenced in the CoC, (2) relate to the Section IV.C. 2 Purchase orders shall include specifications that contain all use and maintenance of the packaging, and (3) identify necessary and C.3 the information necessary to assure material, equipment, actions to be taken prior to delivery of the licensed material to a carrier and services are of adequate quality. This shall include for transport. If the pertinent documentation is in an electronic format, material selection, design data, equipment description, the QA program user should specify the software system that must be source inspection and testing requirements, cleaning and used to prepare and deliver the documentation. packaging requirements, and required documentation as deemed necessary. Documentation that is required to provide evidence that materials, equipment, and services are of adequate quality shall be clearly delineated in purchase orders. This shall include a listing of each item of documentation to be submitted, when it is to be submitted, what requires approval prior to manufacture, and to whom it shall be submitted.

The QA program user should retain the documentation at the facility or Section XVI This section establishes measures for maintaining ISFSI site of material or equipment use. records which cover all documents and records associated with the operation, maintenance, installation, repair, and modification of SSCs covered by the QAPD. Also included are historical records gathered and collected during plant and ISFSI operations which are either required to support the dry cask storage systems stored at the ISFSI or ultimate shipment to a federal repository.

8. The QA program user should establish measures to ensure that Section VIII.C.1 This section states:

materials, parts, and components, including partially fabricated to C.3 - Approved instructions and procedures shall be assemblies, are adequately identified to preclude the use of incorrect or implemented for the identification and control of materials, defective items. These measures should provide the means for physical parts, and components from receipt through installation or identification (e.g., stamping, tags, labels, or lot-follower cards) and use. An identification system utilizing purchase order traceability to appropriate documentation (e.g., mill reports, drawings, or numbers shall be implemented for identification of specifications) throughout fabrication, installation, and use. Also, when material, parts, and components.

replacement of limited-life items is specified, the QA program user - Specifications shall require that materials, parts, and should establish measures to preclude use of items components are identified in accordance with purchase

• 1549

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 for which the shelf life or prescribed operation time has expired. order numbers and shall require that documentation have identification providing traceability to an item.

- Physical identification by purchase order number shall be used to the maximum extent possible for relating an item at any time to applicable documentation. Identification shall be either on the item or records traceable to the item.

Where physical identification is impractical, physical separation, procedural control, or other appropriate means shall be employed.

In addition, the QA program user should establish measures to facilitate Section VIII.C.3 Physical identification by purchase order number shall be continued processing when required inspections or tests have not been used to the maximum extent possible for relating an item at completed in order to maintain physical identity and control over any time to applicable documentation.

affected materials.

9. Special processes are not normally performed by the user of packaging. However, if packaging maintenance requires the use of special processes (e.g., welding or heat treating) or nondestructive testing, or if special processes are required to meet CoC requirements, the QA program user should establish measures to ensure that the special processes are controlled in accordance with the following requirements:

" Procedures, equipment, and personnel are qualified in Section IX.A - This section establishes the measures to assure special accordance with applicable codes, standards, and processes, including welding, heat treating, and non-specifications. destructive testing that are identified as ISFS1 ITS, are controlled and accomplished by qualified personnel using qualified procedures in accordance with applicable codes, standards, specifications, criteria, and other special requirements.

- Welding, heat treating, cleaning, and non-destructive

• The operations are performed by qualified personnel and Section IX.C.1 examination shall be accomplished under controlled accomplished in accordance with written process or procedure conditions in accordance with applicable codes, standards, sheets that direct the recording of evidence of verification, criteria, and other special requirements, using qualified personnel and procedures. Qualification of personnel and procedures shall comply with the requirements of applicable codes and standards.

- Records of the test results obtained in welding procedures

" Qualification records of procedures, equipment, and personnel and welder performance qualifications and a listing of are established, filed, and kept current. Section XVI.E.2.1 qualified personnel and procedures shall be maintained.

10.1 The QA program user should establish measures to ensure that the following requirements 16149

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 are fulfilled:

" Inspection procedures, instructions, or checklists are available Section X.A and - This section establishes a program for inspection of ISFSI for each work operation, where necessary to ensure quality. B.2 activities to verify conformance with approved procedures, drawings, and specifications. QA personnel are responsible for establishing inspection procedures and assuring adequate inspection requirements are included in

" Documents developed include methods for identifying procedures.

characteristics and activities to be inspected, acceptance and Section X.C.2 - Provisions to ensure inspection planning is properly rejection criteria, and the individuals or groups responsible for accomplished are to be established. Planning activities performing the inspection. shall identify the characteristics and activities to be inspected, the inspection techniques, the acceptance criteria, and the organization responsible for performing

• Objective evidence of inspection results is recorded. the inspections.

• Hold or witness points are identified. Section X.C.3 - Mandatory inspection hold points, which require witnessing or inspecting of an activity before proceeding, shall be indicated in the appropriate procedure, specification, or work order. The inspection shall be documented to indicate approval and release prior to continuation of the

• The appropriate personnel approve data to ensure that all activity.

inspection requirements have been satisfied. Section X.C.1 - Inspections shall be performed only by qualified personnel.

In no case shall an acceptance inspection be performed by

• The prerequisites to be satisfied prior to inspection are the individual who performed the activity.

identified, including operator qualification and equipment - Inspection requirements shall apply to all activities whether calibration. Where sampling is used to verify acceptability of a Section X.C.4 performed by company personnel or contractor personnel, group of items, the standard used as the basis for acceptance and shall require that inspection procedures and should be identified. instructions, along with necessary drawings, are provided prior to commencing inspection activities.

10.2.1 Receiving Inspections , ____

The QA program user should establish measures to ensure that items Section VII.C.1 Items shall be examined by appropriately trained staff upon that are important to safety (i.e., the features of a structure, component, and C.2 receipt for shipping damage, correctness of identification, or system under control of the QA program and necessary to ensure the and specified quality documentation, in accordance with integrity of the packaging and its capability to prevent or mitigate the approved instructions. Documentary evidence attesting that consequences that could result from release of radioactive material) items conform to purchase order requirements shall be meet the requirements specified on the purchase order when the items available at the plant prior to installation or use of the item.

are received at the plant.

The QA program user should establish the criteria for acceptance of Section VII.C.3 Documentary evidence shall be sufficient in order to identify each of these inspections, as well as the action to be taken if and C.5 that the specific requirements, such as codes, standards, noncompliance is encountered. These visual inspections should include and specifications, can be confirmed for the purchased item.

the following aspects: This requirement shall be satisfied by having available

• surface conditions copies of the purchase order and appropriate documents referenced therein. During receiving inspection, if a 169

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10

• weld and structural integrity nonconformance or discrepancy exists, the material shall be

• the condition of flange faces or sealing areas, gaskets, seals, placed on hold and will remain in a hold status until final gauges, rupture disks, valves, and pressure relief devices disposition is determined. A Corrective Action Report (CAR)

• the condition of tie-down members (if applicable) shall be initiated. (The noted aspects shall be included in the

• labeling and marking inspection plan).

• leak-tightness of the packaging In addition, the QA program user should establish provisions to control Section VII.C.4 All ITS materials, parts, and components will be segregated accepted items until they are placed in stock or released for use, as well upon receipt and will be placed in a receiving inspection hold as provisions for the proper disposition of rejected items. area separate from storage facilities. After acceptance, the material will be identified as acceptable and placed in specified storage.

10.2.2 In-Process Inspections The QA program user should establish measures to ensure that Implementing Where direct inspection of the processing is not possible, process specifications and their supporting documentation provide for Procedure ACP- alternate methods, such as a review of manufacturing indirect control by monitoring processing methods, equipment, and 11.01 Section 5.7 procedures and QA manual of the manufacturer may be personnel if direct inspection is impractical. utilized. A combination of the direct and indirect methods may be utilized where one method is not sufficient.

10.2.3 Final Inspections The QA program user should establish measures to ensure that (1) final Implementing For inspections which identify attributes which are not inspections provide for resolution of nonconformances identified in Procedure ACP- acceptable, the Inspector shall notify the responsible earlier inspections, (2) the inspected item is identifiable and traceable to 11.01 Appendix A personnel and initiate a CAR in accordance with ACP-1 6.0.

specific records and is adequately protected from physical or Upon rework, repair or replacement as defined in the CAR, environmental damage, and (3) supervisors review inspection records to the item shall be re-inspected. If acceptable, the Inspector verify that all inspection requirements have been satisfied. shall sign and date the WO documenting acceptance of the item or operation and record applicable information on the CAR. The nonconforming item is retained in an approved storage area until resolution (refer to receipt inspection requirements).

For packaging use, the QA program user should establish checklists to N/A LACBWR will be moving the dry cask storage systems to its ensure that inspections are performed to verify the following: local ISFSI site.

" Packages are properly assembled.

" Moderators and neutron absorbers are present, if applicable.

• Valves through which primary coolant flows are protected against tampering.

" Valves are set to specifications.

" All shipping papers are properly completed.

• Packages are conspicuously and durably marked as required by the regulations set forth by the U.S. Department of Transportation (DOT).

" Measures are established to ensure that appropriate personnel

• 18

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 designated by the package user sign the shipping tags or indicators orior to authorization for shippinq.'

~1- I 10.2.4 Maintenance Inspections The QA program user should establish measures for an inspection Implementing This procedure outlines the requirements and responsibilities program to ensure adequate maintenance of packaging. This inspection Procedure ACP- for the planning, scheduling, performing, documenting, and program should identify the items to be maintained, criteria for 11.01 Sections reviewing required inspections of LACBWR ISFSI systems, acceptability or replacement, and the frequencies of inspection 1.0 and 2.0 components, and structures. It applies to inspections as a assigned to each item. result of modifications, changes, repairs, and replacements of or on LACBWR ISFSI systems, components, or parts of the ISFSI and includes inspections required by maintenance procedures, special procedures, or specified on a maintenance request form.

10.2.5 Inspectors The QA program user should establish measures to ensure that (1) Section I.F and Each member of the facility staff (including audit, surveillance inspectors are qualified in accordance with applicable codes, standards, X.C.1 and inspection personnel) shall have sufficient qualifications and company training programs; (2) such qualifications and to perform their assigned duties.

certifications are kept current; and (3) inspection personnel are Inspections shall be performed only by qualified personnel.

independent from all individuals performing the activity being inspected. In no case shall an acceptance inspection be performed by the individual who performed the activity.

10.2.6 Inspection Documentation The QA program user should maintain inspection records as QA Section XVI.E.1.d Records of surveillance activities, inspections, and records to document performance of inspection activities, calibrations required by the NAC-MPC CoC and FSAR.

11.1 Requirements The QA program user should establish measures to ensure that Section XI.A and This section establishes the requirements for an ISFSI test applicable test programs, including prototype qualification tests, C.1 to C.2 program to demonstrate that ITS SSCs will perform production tests, proof tests, and operational tests, are accomplished in satisfactorily in service. The test program shall include, but accordance with written procedures. The QA program user should also not be limited to, surveillance testing, special tests, post establish measures to ensure that modifications, repairs, and maintenance testing, and testing following ISFSI modification replacements are tested in accordance with the original design and or significant changes in procedures. A program shall be testing requirements. established to assure all testing required to demonstrate that ITS SSCs will perform satisfactorily in service is identified and documented. Testing shall be performed in accordance with approved test procedures that incorporate or reference the requirements and acceptance criteria contained in applicable design documents and Technical Specifications.

11.2 Procedures The QA program user should establish measures to ensure that test Section XI.C.4 Test procedures shall include, as a minimum, provisions for prerequisites identified in the appropriate design disclosures (e.g., assuring that:

instrument calibrations, monitoring to be performed, mandatory hold 19E9

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 points, suitable environmental conditions to be maintained, condition of - Prerequisites have been completed that include, as a the test equipment, methods for physical identification of test specimen, minimum:

methods for documenting or recording test data, and criteria for 1) Control of systems status as necessary.

acceptance) are properly translated into test procedures. 2) Availability of calibrated instrumentation and special equipment.

- Test objectives and applicable acceptance limits are stated.

- Test results are documented.

- Detailed instructions for performing the test are included.

- Test results are reviewed and approved.

11.3 Acceptance Tests The QA program user should establish measures, as appropriate, to Section XI.B.1 The LACBWR staff is responsible for establishing the ensure that acceptance tests are conducted prior to delivering packages requirements to control the test program and for preparation for transport to a carrier. These measures should identify the basis for and review of test procedures, surveillance during testing, acceptance criteria (e.g., CoC, maintenance and operational manuals and review and documentation of test results. The LACBWR furnished by the packaging manufacturers). Tests should typically staff is also responsible for establishing specifications, include the following considerations: requirements and acceptance criteria for testing following

• structural integrity ISFSI modifications or installation activities and the review

• leak-tightness (on containment vessel as well as auxiliary and approve of results for testing following modifications.

equipment and shield tanks)

" component performance for valves, gaskets, and fluid transport devices

• shielding integrity

• thermal integrity 11.4 Maintenance Tests The QA program user should establish maintenance test programs to Implementing This procedure applies to surveillance tests, special tests ensure that packages remain usable and free of excessive radiation and Procedure ACP- conducted for engineering evaluations, tests following contamination. These test programs should include measures to ensure 12.01, Section completion of modifications, or significant changes in that qualified and responsible individuals document, evaluate, and 2.1 operating procedures and post-maintenance testing on assess the acceptability of all test results. selected equipment at the ISFSI. Test results are reviewed and approved (by the ORC).

11.5 Results The QA program user should establish measures to ensure that test Section XI.C.5 Test reports shall include identification of the inspector, results are documented, evaluated, and maintained as QA records. and XVI.E.2.m individual conducting the test, the data recorder, the type of These records should be readily available if questions arise concerning observation made, the equipment used, the test results, the operational aspects of the packages. In addition, a qualified individual or acceptability of the test results, and approved disposition for group should determine the acceptability of the records. any deviations. Records of training, test results, and a listing of qualified personnel shall be maintained.

12.1 Calibration Control 20E

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 The QA program user should establish measures to ensure that Section XII.C.1, Inspection, test, and work procedures shall include measurement and test equipment (e.g., gauges, fixtures, reference C.2, C.4, and C.5 provisions to assure tools, gauges, instruments, and other standards, and devices used to measure product characteristics) is inspection, measuring, and test equipment and devices used calibrated, adjusted, and maintained at prescribed intervals or prior to in activities affecting quality are of the proper range, type, use. Such equipment should be labeled or tagged to indicate the and accuracy to verify conformance to established planned date of its next calibration, and the calibration records should requirements and test parameters. To assure equipment be identified, traceable, and maintained as QA records. The QA accuracy, inspection, measuring, and test equipment shall be program user should also establish measures to ensure that in-house controlled, calibrated, adjusted, and maintained periodically, reference or transfer standards used in calibrating measuring and test or prior to use. Calibrations are performed against certified equipment are traceable to nationally recognized standards. Calibrating measurement standards that are traceable to nationally standards should have known valid relationships to nationally recognized standards. Where national standards do not recognized standards. If no known recognized standard exists, the QA exist, provisions will be established to document the basis for program user should document the basis for calibration. calibration. Control measures and procedures shall prevent the use of calibrated tools, gauges, instruments, and other measuring and test equipment by unauthorized personnel.

Special calibration and control measures are not required for devices when normal commercial practices provide adequate accuracy. Records or logs of the calibration history of measuring and test equipment shall be maintained.

Measuring and test equipment shall be controlled by a permanently affixed serial number. Calibration decals, tags or stickers shall be displayed prominently on each device and shall reflect the date of calibration, due date of the next calibration (for recurring calibration) and identity of person performing the calibration.

12.2 Out-Of-Calibration Equipment When test and measuring equipment is found to be out of calibration, Section XII.C.3 When an item of measuring and test equipment is found to the QA program user should take measures to validate previous be out of calibration, an investigation will be conducted and inspection and test results up to the time of previous calibration. In documented to determine the validity of previous inspections, addition, the QA program user should repair or replace any measuring tests, or calibrations which were performed with the use of equipment that is consistently out of calibration, that item.

13.1 Preservation The QA program user should establish measures to ensure that Section XIII.A, This section establishes the requirements for ISFSI cleaning, handling, storage, and shipping are accomplished in C.2, C.3, C.4, procedures to control the handling, storage, shipping, accordance with design requirements to preclude damage or and C.7 cleaning, packaging, and preservation of ITS material and deterioration by environmental conditions such as temperature and equipment to prevent damage, deterioration, or loss through humidity. When necessary, the QA program user should also establish shipment, installation or use.

provisions for the use of special handling, lifting, or storage devices (e.g. cranes, shock absorbers, or special markings) to adequately Storage of material and equipment will be in areas free from identify and preserve packaging components or assemblies. In addition, fumes, vapors, and dust. Storage will be in areas protected 0

21 of 29

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 the QA program user should ensure that conditions identified in the CoC from the weather, as appropriate, and in which chemical are adhered to when unloading packaging. storage is excluded, except as may be specifically authorized in writing. Storage will be in areas which satisfy the handling and storage requirements specified for the item.

Procurement documents shall include instructions for the handling, storage, shipping, cleaning, and preservation of the item being supplied, as applicable. Specifications and procedures establish the requirements for special handling tools and equipment to ensure safe and adequate handling of critical, sensitive, or radioactive items.

Procurement documents specify marking requirements, special covering, and protective environments, such as inert gas atmosphere, moisture content levels, and temperature

'I

• levels, as aoDlicable.

13.2 Preparation, Release, and Delivery to Purchaser The QA program user should establish measures to ensure that a final Section VII D. 1 LACBWR does not release components, but does receipt pre-release review has been completed. This review should ensure that and D.2 reviews and inspections. When appropriate, suppliers shall packaging (1) is prepared for delivery to the purchaser in accordance be requested to furnish OPC with sufficient information with approved drawings, specifications, and government regulations; (2) concerning their manufacturing and inspection plan to permit has passed all applicable inspections and tests; (3) is properly identified OPC or their designated agent to plan and implement a by physical markings or tags; and (4) contains operating manuals, source inspection plan. When appropriate, inspection plans maintenance manuals, and generic procedures relating to its use. shall include witness and hold points for inspection of items, witnessing of processes or tests, audit of required quality documentation, and verification that vendors have complied with the specification requirements and have documented any deviation from the specifications. Items shall be examined by appropriately trained staff upon receipt for shipping damage, correctness of identification, and specified quality documentation, in accordance with approved instructions.

In addition, the QA program user should establish measures to ensure Section VII D. 1 LACBWR does not release components, but does receipt that the following requirements are fulfilled: and 0.2 reviews and inspections. See detail above.

• Cavities within gas-cooled package containments have been adequately dried, and cavities within liquid-cooled packages have been drained to allow adequate void space.

° All conditions (including specified operations, inspections, and tests) have been completed prior to delivery to a carrier.

22,69

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10

" All NRC and DOT requirements have been satisfied prior to delivery to a carrier.

• All necessary shipping papers have been prepared as required and reviewed by qualified personnel to verify completeness and

• cctr.I iv_

14. The QA program user should establish measures to ensure that the Section XIV.A This section describes the system for indicating the status of inspections, tests, and operating conditions (including and B inspection, test, and operating status of ITS components and maintenance of items) is known by organizations responsible for systems at the ISFSl. It ensures that the status of operating ensuring quality, equipment or systems to be removed from service for maintenance, test, inspection, repair, or modification is in accordance with the approved LACBWR procedures and staff shall monitor the status of activities for compliance with approved procedures and shall ensure inspection results are properly logged.

The QA program user should also establish measures to control the Section XIV.B The LACBWR staff shall establish the procedures for application and removal of status indicators (e.g., tags, markings, implementing the work inspection or status sheets during stamps) and to ensure that bypassing a required inspection or test or maintenance, repair, and modifications and shall ensure any other required operation is procedurally controlled under the inspection results are properly logged. The LACBWR staff is cognizance of the QA organization. also responsible for the control of ISFSI status during modifications.

15. An acceptable program for controlling nonconforming items should Section XV.C.1 Conditions adverse to quality, such as failures, malfunctions, include the following principal elements: and C.2 deficiencies, deviations, defective material and equipment,

• proper identification shall be reported on a Corrective Action Report (CAR).

• segregation of discrepant or nonconforming items Materials, parts, or components that do not conform to

• disposition of the nonconforming items requirements shall be identified and placed in a hold status.

" evaluation of the nonconforming items Nonconforming items shall remain in a segregated area until approved disposition has been determined. The CAR shall identify the condition, the cause of the condition, and the corrective action taken.

16.1 Reporting The QA program user should establish measures to ensure that the Section XVI.A This section establishes measures to assure that conditions causes of conditions detrimental to quality (e.g., those resulting from and C.2 and C.3 adverse to quality at the ISFSI, such as failures, failures, malfunctions, deficiencies, deviations, or defective material and malfunctions, deficiencies, deviations, defective material and equipment) are promptly identified and reported to appropriate levels of equipment, and non-conformances are promptly identified management. In addition, the QA program user should establish and corrected.

measures to obtain corrective actions from suppliers and ensure that follow-up actions are documented to verify that the corrective actions For vendor-supplied items or services, the vendor shall be were implemented and effective, notified of all nonconforming items and requested to correct the deficiencies. LACBWR staff with assistance from Purchasing shall be responsible for coordinating the 232

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 disposition of deficient items with vendors. QA personnel are responsible for inspecting and accepting or rejecting items that have been corrected by vendors.

16.2 Closeout, Retrieval, and Disposition of Records The QA program user should establish measures to ensure that Implementing This procedure identifies the CAR Verifier as being corrective actions designated by cognizant individuals have been Procedure ACP- responsible for confirmation that approved dispositions and implemented to preclude recurrence. In addition, the QA program user 16.0 corrective and/or preventive actions have been should identify (by function or position) the individuals or organizations accomplished. It also identifies the Assignee as being responsible for closing out corrective actions and documenting their responsible for completing assigned corrective and/or resolution. preventive actions.

17.1 General QA records should furnish documentary evidence of the activities that Section XVI.A This section establishes measures for maintaining ISFSI affect quality and should provide sufficient information to allow each and E records which cover all documents and records associated record to be identified with the items or activities to which it applies. As Implementing with the operation, maintenance, installation, repair, and a minimum, QA records should include the following information: Procedure ACP- modification of SSCs covered by the QAPD. The listed

• design, procurement, manufacturing, and installation records 18.01 records are addressed in the QAPD and ACP.

" supplier evaluations

• nonconformance reports

" results of inspections and tests

" failure analyses

• as-built drawings and specifications

• qualification of personnel, procedures, and equipment

" calibration procedures

• training and retraining records

• corrective action reports

" records demonstrating evidence of operational capability

• records verifying repair, rework, and replacement

" audit plans, audit reports, and corrective actions

" records that are used as a baseline for maintenance In addition, the QA program user should retain records that show Implementing See discussion above.

evidence of package delivery to a carrier and proof that all NRC and Procedure ACP-DOT requirements have been satisfied (with their retention times 18.01 identified).

Where applicable, inspection and test records should contain the Implementing Where applicable, inspection and test records should contain following information: Procedure ACP- the following information:

" a description of the observation 18.01 - a description of the observation

• evidence of completion of the inspection or test operation - evidence of completion of the inspection or test operation

" results of inspections or tests with appropriate data - results of inspections or tests with appropriate data

• conditions that are detrimental to quality - conditions that are detrimental to quality 0

24 of 29 0

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10

" names of inspectors, testers, or data recorders - names of inspectors, testers, or data recorders

" evidence of acceptability - evidence of acceptability 17.2 Generating Records The QA program user should establish measures to ensure that Section XVI.D - A system shall be established to identify all documents that methods employed to generate and manage documents that are must be kept permanently (lifetime records).

designated as QA records result in information that is retrievable, - An index of non-permanent records shall be established.

intelligible, and reliable. Such records should reflect the work - An approved document listing will be reviewed on a regular accomplished and should be stored in a manner that avoids basis to verify that the record file contains the latest unnecessary delay when the record is needed. In addition, procedures revisions of all required documents.

for generating QA records should address both hard copy records and - A system will be established to control the issuance and electronic information, return of all records.

17.3 Indexing and Classification Records The QA program user should classify QA records as either "lifetime" or Section XVI.D "nonpermanent":

• Lifetime records include those pertaining to package fabrication A system shall be established to identify all documents that and those associated with a particular item while it is installed in must be kept permanently (lifetime records).

the packaging or stored for future use. These records demonstrate the capability for safe operation; provide evidence of repair, rework, replacement, or modification; aid in determining the cause of an accident or malfunction of an item; and provide a baseline for in-service inspection.

" Nonpermanent records are those that show evidence that an An index of non-permanent records shall be established.

activity has been performed but do not meet the criteria for Record types and duration of retention are defined on lifetime records. Records pertaining to use of a package should Subsection E, Record Retention.

be retained for a period of 3 years after the shipment.

17.4 Receipt, Retrieval, and Disposition of Records The QA program user should establish measures to provide a receipt Implementing Control of QA records includes maintenance, identification, control system, including identification of functions or positions in each Procedure ACP- record receipt, validation and authentication, indexing, organization responsible for receiving records and assessing the current 18.01 classification, retention, storage, preservation, safekeeping, status of records in their possession. The QA program user should also and final disposition.

establish measures to ensure that records that are maintained in-house or at other locations are identifiable and retrievable, and are not LACBWR does not utilize electronic record files.

disposed of until prescribed conditions are satisfied. For electronic records the software systems employed to image and store information should be compatible with new hardware as current technologies are implemented. In addition, before installing any new hardware systems, the QA program user should have a procedure in place to ensure that the new systems can reliably store and retrieve information from existing software systems.

259

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 17.5 Storage, Preservation, and Safekeeping The QA program user should establish measures to ensure that the Implementing following requirements are fulfilled: Procedure ACP- Measures are established to ensure the LACBWR Records 18.01 Storage Room is maintained to provide protections to:

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

" Records should be firmly attached in binders or placed in folders - Records are firmly attached in binders or placed in folders or envelopes for storage in steel file cabinets. or envelopes for storage in steel cabinets or on shelves;

" Electronic records should be maintained in facilities that - LACBWR does not utilize electronic record files.

minimize or eliminate the potential for destruction of information as a result of demagnetization.

" Electronic records should be backed up daily to eliminate the potential for loss of information as a result of equipment failure or human error.

" If dual storage facilities are used to ensure the record integrity, - LACBWR utilizes a single storage facility.

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.

• The QA program user should take measures to protect special - Storage of reproducible (sepias) of drawings, radiographs records (e.g., radiographs and microfilm) from excessive light, and copies of microfilms of QA Records shall be stored in electromagnetic fields, and temperature. such a manner as to inhibit deterioration.

• The QA program user should take measures to prevent - Unauthorized personnel are prevented from entering the unauthorized personnel from entering record storage areas. records storage areas.

" Electronic information storage systems should be accessible - LACBWR does not utilize electronic record files.

only through security measures such as passwords, and the number of personnel who have authorized access should be limited. In addition, personnel who have authorized access should have identified privileges, such as "read only" or "read and add only."

- When records are lost or damaged, the record is promptly

" The QA program user should establish measures to ensure replaced.

prompt replacement of a record that is lost or damaqed.

18.1 Elements of an Audit Program A comprehensive audit program should include the following elements: Implementing - Section 5.4.1 defines the independence of the audit team;

" assurance of the authority and organizational independence of Procedure ACP- - QAPD 0.0 (2) states Quality Assurance (QA) as defined the auditors 03.01 herein encompasses all those planned and systematic

• a commitment to adequate manpower, funding, and facilities to actions necessary to provide adequate confidence that an implement the audit Important to Safety structure, system, or component will perform its intended function satisfactorily. This includes 269 0

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 QA audits.

• identification of audit personnel and their qualifications Section 5.4.1 addresses the identification of the audit team and Section 5.9 defines the team's qualification requirements.

• provisions for reasonable and timely access.of audit personnel Section 5.5 describes the techniques and support to facilities, documents, and qualified personnel necessary for requirements that an audit requires.

performing audits

" use of established procedures and checklists Section 5.4.12 requires that audit checklist or procedures are prepared during the planning phase of the audit process.

" methods for reporting audit findings to responsible management Section 5.5.8 identifies the use of the CAR to report audit of both the audited and auditing organizations concerns to the auditee and upper management.

• provisions for the audit team to gain access to levels of Section 5.4.11 requires the audit team leader to discuss management that have responsibility and authority for corrective the audit planning with the auditee and notify the involved action organization(s) in writing.

• methods for verifying that effective corrective action has been Section 5.8.2 refers to follow-up to CARs per the accomplished on a timely basis requirements of ACP-1 6.0. The completion of CARs is tracked by the Manager, QA on a weekly basis.

The QA program user should also establish and maintain a list to reflect Implementing Section 5.3 requires the development and up keep of an the current status of the activities important to safety that are to be Procedure ACP- internal and external overview (audit, surveillance or audited and the frequency at which each quality criterion is to be 03.01 evaluation) schedule which has the most current status of audited. The frequency of audits should be based on each activity's audit progress.

importance to safety; however, each quality criterion should be audited at least once each year.

The QA program user should also establish measures to ensure that Implementing Section 5.3.5 identifies the scheduled due date, general area packaging manufacturers are audited to assess the extent of their Procedure ACP- of overview, project, suppliers, and contractors to be audited.

compliance with purchase orders and to verify that their work is 03.01 controlled under an NRC-approved QA program.

In addition, the QA program user should also identify (by function or Implementing ACP-1 6.0 identifies the CAR Verifier as being responsible for position) the individuals or groups that have the responsibility and Procedure ACP- confirmation that approved dispositions and corrective and/or authority to ensure that corrective actions resulting from audit findings 03.01 preventive actions have been accomplished. It also are accomplished on a timely basis. The QA program user should re- identifies the Assignee as being responsible for completing audit deficient areas on a timely basis to verify implementation of assigned corrective and/or preventive actions.

corrective actions. Follow-up to CARs is performed in accordance with ACP-16.0.

18.2 Scheduling of Audits The QA program user should establish schedules for internal audits, Section XVII.C This section requires the SRC to perform independent review external audits, and audits performed by management. These and audit to verify that the ISFSI is being maintained schedules should ensure that key activities of the QA program (e.g., consistent with company safety, administrative, and licensing design, fabrication) receive priority consideration. II provisions. The frequency of the audits is defined in this 2*~9

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 section. The evaluations of ISFSI activities shall be performed by QA personnel or a qualified offsite entity under the cognizance of the SRC.

Section XVIII.C This section identifies the subjects which are independently reviewed by the ORC members.

For audits performed by management, the schedules should identify the Section XVII.C This section requires the SRC to perform independent level of management (usually from the corporate office or another review/audit to verify that the ISFSI is being maintained division) designated to assess the overall effectiveness of the consistent with company safety, administrative, and licensing implementation of the described in-house QA program. The QA provisions. The frequency and areas of the audits are program user should also identify the activities important to safety (e.g., defined in this section. The evaluation of QA program shall procurement, training of personnel) that should be included in the audit be performed by the Manager QA or a qualified offsite entity program. Management audits should be conducted at least once every under the cognizance of the SRC.

12 months.

For internal audits, the schedules should ensure that applicable Section XVII.C The frequency for auditing internal site activities is defined in elements of the QA program are audited annually or at least once within this section.

the life of the activity, whichever is shorter.

For external audits, the schedules should ensure that all elements of a Implementing This procedure stipulates the areas that should be audited major supplier's (or major contractor's) QA programs are audited on a Procedure ACP- during external audits.

triennial basis. The 3-year period should begin with performance of an 03.01 audit when sufficient work is in progress to demonstrate implementation of a QA program that has the required scope for purchases placed during the 3-year period.

18.3 Team Selection The QA program user should establish the qualifications of the lead Implementing Section 5.9 of this procedure establishes the qualifications auditor and audit team members and specify their respective Procedure ACP- for the audit team staff (team leader, auditor, and technical responsibilities with respect to evaluating and issuing audit reports. The 03.01 specialist).

auditing organizations should have the responsibility to establish qualifications for prospective audit personnel and the requirements for use of technical specialists to accomplish auditing activities that are important to safety. The QA program user should select the lead auditor and audit team members from personnel who do not have direct responsibility in the areas being audited.

Specific guidance for determining qualifications for the lead auditor and Implementing This procedure is based upon the requirements of ASME individual audit team members may be obtained from ANSI/ASME Procedure ACP- NQA-1.

NQA-1 (Ref. 1). 03.01 18.4 Pre-Audit Conference Prior to an audit, the QA program user should specify the nature and Implementing Section 5.5, Audit Performance, addresses the purpose, scope of the pre-audit conference between management of the Procedure ACP- scope, and requirements for an audit entrance meeting.

organizations being audited and the team conducting the audit. The 03.01 purpose of the pre-audit conference should be to meet counterparts, 28#j9

Comparison of LACBWR QAPD with NRC Regulatory Guide 7.10 confirm the audit scope and dates, establish channels of communication, discuss the sequence and duration of the audit, prepare an agreed-upon agenda for the audit, and set the time for the post-audit conference.

18.5 Post-Audit Conference The QA program user should establish measures to conduct a post- Implementing Section 5.5, Audit Performance, addresses the purpose, audit conference between management of the organizations being Procedure ACP- scope, and requirements for a post-audit conference (audit audited and the team conducting the audit to present the results and 03.01 exit) meeting.

clarify any misunderstandings that may arise.

18.6 Reporting and Response The QA program user should establish measures to identify time Implementing Section 5.7, Audit/Surveillance Report, describes the audit constraints imposed for issuing audit reports and the requested date for Procedure ACP- reporting requirements including CAR responses to audit a corrective action response by the audited organization. The response 03.01 issues should clearly state the corrective action taken to prevent recurrence of nonconformances. If corrective action cannot be taken immediately, the response of the audited organization should include scheduled dates for initiation and completion of the corrective action.

18.7 Follow-up Action The audit team leader should verify that (1) the audited organization Implementing The audit team leader is responsible for evaluation of audit provides a timely response to the audit report, (2) the response is Procedure ACP- CAR responses to ensure the proposed actions are timely, adequate, and (3) the corrective action has been accomplished within 16.0 fully address the noted issue, and present a reasonable the prescribed schedule. timeframe to accomplish the commitments.

2429 S