HBL-14-017, Independent Spent Fuel Storage Installation Humboldt Bay Quality Assurance Plan Proposed Changes

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Independent Spent Fuel Storage Installation Humboldt Bay Quality Assurance Plan Proposed Changes
ML14176A080
Person / Time
Site: Humboldt Bay
Issue date: 06/10/2014
From: Halpin E
Pacific Gas & Electric Co
To:
Document Control Desk, NRC/FSME, Office of Nuclear Material Safety and Safeguards
References
HBL-14-017, HIL-14-007
Download: ML14176A080 (42)
v • d • e


Text

-PacificElectricGas and Company" Edward D.Halpin Diablo Canyon Power Plant Senior Vice President Mail Code 104/6 Nuclear Generation & Chief Nuclear Officer P.0. Box 56 Avila Beach, CA 93424 805.545.4100 June 10, 2014 E-Mail: E1H8@pge.com 10 CFR 50.54 PG&E Letter HBL-14-017 PG&E Letter HIL-14-007 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, D.C. 20555-0001 Docket No. 50-133, License No. DPR-7 Humboldt Bay Power Plant, Unit 3 Docket No. 72-27, License No. SNM-2514 Humboldt Bay Independent Spent Fuel Storage Installation Humboldt Bay Quality Assurance Plan Proposed Changes

Dear Commissioners and Staff:

In accordance with 10 CFR 50.54(a)(4), Pacific Gas and Electric Company (PG&E) is submitting a proposed revision to the Humboldt Bay Quality Assurance Plan (HBQAP) for NRC review and approval. The proposed revision, Revision 32, is a complete revision and will replace Revision 31 of the HBQAP in its entirety. A discussion of the proposed changes to the HBQAP is contained in Enclosure 1, and the proposed Revision 32 to the HBQAP is provided in Enclosure 2. Because proposed Revision 32 is a complete revision of the HBQAP, a mark-up was not determined to be practical and, thus, it is not provided.

PG&E is submitting HBQAP Revision 32 as a proposed change to the HBQAP that reduces commitments to the previously approved HBQAP. The reductions in commitments primarily involve a transition from the ANSI Standards and NRC Regulatory Guides, currently identified in HBQAP, Revision 31, Appendix C, to an adoption of the guidance provided within NRC Regulatory Guide 7.10, Revision 2.

In addition, proposed changes to the HBQAP result from the following:

0 Reduce the level of detail associated with methodology. Methodology details will be implemented in PG&E-approved procedures.

  • Integrate some of the current appendices into the body of the HBQAP.
  • Review functions to be performed through an Independent Management Review instead of the Nuclear Safety Oversight Committee.

In accordance with 10 CFR 50.54(a)(4)(ii), Enclosure 1 identifies changes that are considered to be a reduction in commitments to the previously approved HBQAP and provides a basis for concluding the HBQAP will continue to meet the criteria of 10 CFR 50, Appendix B. In addition, HBQAP Revision 32 will also continue to f'j6ss

Document Control Desk PG&E Letter HBL-14-017 June 10, 2014 PG&E Letter HIL-14-007 Page 2 satisfy the Quality Assurance requirements of 10 CFR 71, Subpart H and 10 CFR 72, Subpart G.

In accordance with 10 CFR 50.54(a)(4)(iv), PG&E will implement proposed Revision 32 to the HBQAP upon approval by the NRC or after 60 days from the date of this letter, whichever occurs first.

PG&E makes no new or revised regulatory commitments (as defined by NEI 99-04) in this letter.

If you have any questions about this information, please contact Mr. David Sokolsky at (415) 973-5024.

Edward D. Halpin Senior Vice PresidentNuclear Generation and Chief Nuclear Officer Enclosures cc/enc: William C. Allen, NRC Project Manager Kristina L. Banovac, NRC Project Manager Marc L. Dapas, Regional Administrator, NRC Region IV John B. Hickman, NRC Project Manager

Enclosure 1 PG&E Letter HBL-14-017 PG&E Letter HIL-14-007 Page 1 of 9 10 CFR 50.54 (a) EVALUATION

SUMMARY

Purpose The purpose of this enclosure is to evaluate proposed changes to be included in Humboldt Bay Quality Assurance Plan (HBQAP), Revision 32. The proposed revision is a complete rewrite of the HBQAP, and will replace the current HBQAP, Revision 31 in its entirety. Major or substantial changes are described along with the justifications for those changes. This evaluation will determine if these changes require prior Nuclear Regulatory Commission (NRC) approval pursuant 10 CFR 50.54(a).

Background

The revision reflects a simplification of the HBQAP for the Humboldt Bay Power Plant (HBPP) Unit 3 (U3) and Humboldt Bay (HB) Independent Spent Fuel Storage Installation (ISFSI) that is based on the current decommissioning status of HBPP U3, the remaining decommissioning activities, and the long-term passive operational status of the ISFSI.

Radiological risk factors associated with U3 decommissioning activities have been significantly reduced. All spent fuel and Greater-Than-Class C (GTCC) waste have been transferred to the HB ISFSI. The HB ISFSI has transitioned to long-term passive operations. Additionally, the last of the known Class B and Class C radioactive waste has been-shipped offsite for disposal. Modifying the HBQAP to reflect the current status of decommissioning activities models a number of other nuclear power plants in a similar stage of decommissioning as well as spent fuel and GTCC waste storage. The scope of this HBQAP revision includes the following activities:

" Removing commitments in the current plan to industry standards that apply to operating nuclear power reactors, and establishing standards appropriate for HBPP U3 decommissioning and long-term ISFSI operations.

  • Removing implementation details from the HBQAP that are contained in PG&E-approved administrative procedures.
  • Streamlining organizational functions to accommodate changing work scopes.
  • Providing extensive editorial changes to eliminate redundancy, provide clarity, and improve readability.

These revisions clarify the position established in HBQAP Revision 27 that the scope of the HBQAP is limited to Important to Safety (ITS) Structures, Systems and Components (SSCs) and related activities. For HBPP U3, administrative programs and procedures ensure compliance with governing regulations and include appropriate controls for activities that affect quality. The proposed revision to the HBQAP is appropriate for the remaining U3 decommissioning activities and ISFSI operations. The proposed revision

Enclosure 1 PG&E Letter HBL-14-017 PG&E Letter HIL-14-007 Page 2 of 9 will continue to satisfy the criteria of 10 CFR 50, Appendix B and the Quality Assurance (QA) requirements of 10 CFR 71, Subpart H and 10 CFR 72, Subpart G.

Significant changes found in Revision 32 can be summarized as follows:

Change 1 - Editorial Type Administrative Improvements and Clarifications:

Extensive editorial changes to eliminate redundancy, provide clarity, and improve readability were made. Three editorial changes were made repeatedly throughout the revision.

" The phrase "apply to those SSCs and associated activities that are designated as important to safety described in Appendix A, which support the HB ISFSI, Radioactive Materials Transport Packages, and the HBPP Unit 3" was revised to read: "apply to SSCs designated as important to safety in Appendix A."

  • The term "Associated Activities" has been removed from each section. The applicability of ITS and "Associated Activities" is established in the HBQAP Introduction section.
  • The term "Quality Related" was removed throughout the HBQAP. In the context of the HBQAP, the term "Quality Related" is considered synonymous with ITS and is regarded as redundant.

Evaluation:

These types of changes are considered editorial, do not alter the intent or purpose of the HBQAP, and continue to satisfy the criteria of Appendix B to 10 CFR 50 and the QA requirements of 10 CFR 71, Subpart H and 10 CFR 72, Subpart G.

==

Conclusion:==

10 CFR 50.54(a)(3) does not consider QA program changes involving administrative improvements and clarifications, spelling corrections, punctuation, or editorial items, as reductions in commitments. Therefore, the proposed changes may be made without prior approval of the NRC.

Change 2 - Nuclear Safety Oversight Committee (NSOC) versus Independent Management Review (IMR):

The description of the NSOC has been removed from HBQAP, Appendix B. In its place, Section 1.0 "Organization" identifies an IMR function. In anticipation of the reductions in the number of ITS and/or radiological items that will require safety reviews at the HB ISFSI and remaining HBPP U3 decommissioning activities, this revision incorporates significant changes to the safety review functions described in the HBQAP. Individual(s) that perform IMRs are assigned by the Chief Nuclear Officer (CNO). This is the same change implemented at other nuclear facilities in a similar stage of decommissioning as well as spent fuel and GTCC waste storage.

Enclosure 1 PG&E Letter HBL-14-017 PG&E Letter HIL-14-007 Page 3 of 9 Specific changes are summarized as follows:

" Currently, the NSOC is required to be composed of at least four members plus a Chairman. The IMR will not be required to be performed by a committee.

  • An IMR may be conducted by as few as one person appointed by the CNO.
  • The current members of the NSOC must have a minimum of 5 years of experience. The Chairman must have 6 years and meet or exceed the qualification recommendations of ANSI/ANS 3.1 1978. Additionally, the NSOC is required, collectively, to have experience and competence in a number of technical areas. This revision does not specify qualification, experience, or competency requirements for personnel performing IMRs.

" There would be no requirement for quarterly meetings because there is no committee to meet. IMRs will be performed periodically as directed by the CNO.

  • The IMRs will include implementation of the HBQAP, decommissioning activities, the safe storage of spent nuclear fuel, and other activities as directed by the CNO.

Evaluation:

The requirements for an independent review function were based on ANSI N18.7-1976 as endorsed by Regulatory Guide 1.33, Revision 2. The composition and function of the NSOC as described in HBQAP, Revision 31 follows the guidance provided in ANSI N18.7-1976, Section 4.3.1. The program described therein is intended for operating nuclear power plants. 10 CFR 50, Appendix B does not specifically require an independent review function (as described in ANSI N 18.7) as part of its QA program requirements. Appendix B, 10 CFR 50, Criterion II states in part: "The applicant shall regularly review the status and adequacy of the quality assurance program."

PG&E considers that the provisions contained in the proposed revision of the HBQAP will continue to satisfy the 10 CFR 50, Appendix B Criterion II requirements and those associated with 10 CFR 71 and 10 CFR 72. These requirements are contained in HBQAP, Section 1.0 "Organization" under the heading IMR and in Section 18.0, "Audits."

==

Conclusion:==

This change is a reduction in commitment, and as such, will need to be reviewed and approved by the NRC. This reduction in commitment is acceptable due to the advanced state of decommissioning at HBPP U3 and the passive operational status of the HB ISFSI. The proposed revision continues to satisfy the criteria of 10 CFR 50, Appendix B and the QA requirements of 10 CFR 71 and 10 CFR 72.

Enclosure 1 PG&E Letter HBL-14-017 PG&E Letter HIL-14-007 Page 4 of 9 Change 3 - Regulatory Guides and Standards:

The proposed revision to the HBQAP deletes Appendix C, "Commitments," that includes reference to applicable regulatory guides, industry standards, and exceptions to those standards listed. Aspects of the standards applicable to ongoing activities have been incorporated in the body of the HBQAP. Regulatory commitments are now addressed in HBQAP, Section 2.4, "Regulatory Commitments."

Revision 32 refers to other license documents, including the HBPP U3 Defueled Safety Analysis Report (DSAR), HB ISFSI Final Safety Analysis Report (FSAR), Technical Specifications for HBPP U3 and for the HB ISFSI, and the HBPP U3 and the HB ISFSI Licenses, as source reference documents for regulatory commitments. This is the same change implemented at other nuclear facilities in a similar stage of decommissioning as well as spent fuel and GTCC waste storage. The following regulatory guides and industry standards have been retained and are referenced in the body of HBQAP, Revision 32:"

  • Regulatory Guide 7.10, "Establishing Quality Assurance Programs for Packaging Used in Transport of Radioactive Material" Regulatory Guide 4.15, "Quality Assurance for Radiological Monitoring Programs (Normal Operations) - Effluent Streams and the Environment" Regulatory Guide 1.8, "Qualification and Training of Personnel for Nuclear Power Plants" NUREG/CR 6407 "Classification of Transportation Packaging and Dry Fuel Storage System Components According to Importance to Safety" Evaluation:

The current commitment to the referenced ANSI standards and regulatory guides is unnecessary for the current state of HBPP U3 and the remaining decommissioning activities. All of the spent fuel and GTCC waste has been transferred to the ISFSI.

Additionally, the last of Class B and Class C radioactive waste has been shipped offsite for disposal. There are no safety-related systems in U3 or the ISFSI. The only systems that remain subject to the QA program are ISFSI-related, which have been categorized as ITS in accordance with Regulatory Guide 7.10, Revision 2.

The HB ISFSI has transitioned to long-term passive operations. The system is inherently safe by design. The main function of the HB ISFSI organization is to monitor the environment in a way that demonstrates the integrity of the system. While it continues to be important to maintain an appropriate quality standard that preserves the passive functionality of the system, it can be accomplished satisfactorily through conformance to Regulatory Guide 7.10, Revision 2.

Enclosure 1 PG&E Letter HBL-14-017 PG&E Letter HIL-14-007 Page 5 of 9

==

Conclusion:==

The deletion of commitments to the specified regulatory guides and standards is considered a reduction in commitment and, therefore, needs to be reviewed and approved by the NRC prior to implementation. This reduction in commitment is acceptable due to the advanced state of decommissioning at HBPP U3 and the passive operational status of the HB ISFSI. The proposed revision continues to satisfy the criteria of 10 CFR 50, Appendix B and the QA requirements of 10 CFR 71 and 10 CFR 72.

Change 4 - Implementation Detail:

Throughout Revision 32, Sections 1.0 through 18.0, implementation methodology details that exist in administrative procedures are being removed from the HBQAP. This change provides flexibility in the implementation of the QA program to accommodate changes of the scope of decommissioning activities and transition to a stand-alone ISFSI.

Details regarding implementation methodology existing in the current HBQAP are not included in Revision 32 of the HBQAP. Implementation methodology is contained in appropriate administrative and implementing procedures. Table 1, "Correlation Between QA Criteria and Implementing Procedures," provides a correlation between HBQAP, Revision 32 criteria and the implementing procedures. Table 1 is at the end of this enclosure.

Evaluation:

As noted previously, implementation methodology details found in the HBQAP, Revision 31 are not included in the proposed revision. The intent of the HBQAP is to describe appropriate and sufficient requirements to establish how the HBQAP meets 10 CFR 50, Appendix B while allowing flexibility in the manner by which a requirement is met. This reduction in implementation details provides flexibility of the implementation of the HBQAP while maintaining appropriate and sufficient guidance to ensure QA program requirements are met.

==

Conclusion:==

The reduction in the details regarding implementation methodology is considered a reduction in commitments described in the HBQAP and therefore must receive NRC approval prior to implementation. This reduction in commitment is acceptable due to the advanced state of decommissioning at HBPP U3 and the passive operational status of the HB ISFSI. The proposed revision continues to satisfy the criteria of 10 CFR 50, Appendix B and the QA requirements of 10 CFR 71 and 10 CFR 72.

OVERALL EVALUATION:

Revision 32 is a major rewrite of the HBQAP. It includes extensive editing to eliminate redundancy, provide clarity, and improve readability. Detailed implementation

Enclosure 1 PG&E Letter HBL-14-017 PG&E Letter HIL-14-007 Page 6 of 9 methodology found in HBQAP, Revision 31 is contained in PG&E-approved administrative procedures. Revision 32 does not alter the effectiveness of the HBQAP.

Where content in sections of the revised HBQAP differs in any substantial way from the content in Revision 31, the differences were evaluated and determined to be acceptable due to the advanced state of decommissioning at HBPP U3 and the passive operational status of the HB ISFSI. The proposed revision continues to satisfy the criteria of Appendix B to 10 CFR 50 and the QA requirements of 10 CFR 71 and 10 CFR 72.

Enclosure 1 PG&E Letter HBL-14-017 PG&E Letter HIL-14-007 Page 7 of 9 TABLE 1 CORRELATION BETWEEN QA CRITERIA AND IMPLEMENTING PROCEDURES QA Plan QA Criterion Title Implementing Programs and Procedures Section 1.0 Organization 9 HBAP A-1, "HBPP Staff Organization and Staff Qualifications"

  • HBAP A-5, "Independent Safety Review" 0 IAP A-8, "Humnboldt Bay ISFSI Organization and Administrative Controls" 2.0 Quality Assurance Program
  • QAPP-1, "Quality Assurance Plan and Manual"
  • ODCM "SAFSTOR / Decommissioning Offsite. Dose Calculation Manual" 0 HBAP C-200, "Requirements for the HBPP Radiation Protection Program",

0 HBAP C-800, "Quality Control Program"

  • HBAP A-13, "Fire Loss Prevention Program" 9 HBAP B-2, "General Training Requirements for On-Site Personnel"
  • HBAP B-200, "Radiation Protection Training Program" 9 IAP B-300, "ISFSI Training and Certification Program" 3.0 Design Control 0 HBAP C-300, "Design Control Program" 4.0 Procurement Document Control 0 HBAP D-3, "Procurement" 5.0 Instructions, Procedures and 0 HBAP E-4, "Procedure Controls" Drawings 0 HBAP E-7, "Procedure Use and Adherence"
  • HBAP E-2, "Plant Drawing Control"

Enclosure 1 PG&E Letter HBL-14-017 PG&E Letter HIL-14-007 Page 8 of 9 6.0 Document Control 0 HBAP E-2, "Plant Drawing Control" 0 HBAP E-4, "Procedure Controls"

  • HBAP C-i19, "Licensing Bases Impact Evaluation (LBIE)"

7.0 Control of Purchased Material, a HBAP D-3 "Procurement" Equipment and Services 0 HBAP C-305, "Processing of Documents Received from Suppliers."

8.0 Identification and Control of 0 HBAP C-45, "Work Control Process" Materials, Parts and Components 0 HBAP C-17, "Work Control Process for Civil Works Projects" 9.0 Special Processes

  • HBAP D-6, "Special Processes" 10.0 Inspection
  • HBAP C-800, "Quality Control Program"
  • I-SP-500, "ISFSI Surveillances and Monitoring" 11.0 Test Control 0 HBAP C-45, "Work Control Process" 0 HBAP C- 17, "Work Control Process for Civil Works Projects" 0 IAP C-100, "Conduct of ISFSI Tests."

12.0 Control of Measuring and Test 0 Plant Manual Volume 5, 1-200, "Off-site Servicing and Equipment Calibration of Measuring and Test Equipment (M&TE)"

13.0 Handling, Storage and Shipping 0 HBAP D-3, "Procurement" 14.0 Inspection, Test and Operating 0 HBAP C-45, "Work Control Process" Status 0 HBAP C- 17, Work Control Process for Civil Works Projects" 0 I-SP-500, "ISFSI Surveillances and Monitoring" 15.0 Control of Nonconforming 0 HBAP C-12, "Problem Identification and Resolution,"

Conditions 16.0 Corrective Action 0 HBAP C-12, "Problem Identification and Resolution,"

17.0 Quality Assurance Records o HBAP E-1, "Retention and Storage of HBPP Unit 3 and ISFSI Records" 0 HBAP E-2, "Drawing Control"

Enclosure 1 PG&E Letter HBL-14-017 PG&E Letter HIL-14-007 Page 9 of 9 18.0 Audits

  • QAPP-1, "Humboldt Bay Quality Assurance Plan and Manual" NOTE: Additional procedures that implement the HBQAP are identified in the procedures listed in Table 1.

Enclosure 2 PG&E Letter HBL-14-017 PG&E Letter HIL-14-007 HUMBOLDT BAY QUALITY ASSURANCE PLAN PROPOSED REVISION 32 30 PAGES (COVER SHEET PLUS 29 PAGES OF THE PLAN)

S Nuclear Power Generation NUMBER L-4 VOLUME 4 Humboldt Bay REVISION 32 EFFEC DATE Power Plant PAGE I of 1 4

TITLE APPROVED 2Y HUMBOLDT BAY QUALITY ASSURANCE PLAN (HBQAP)

DIRECTOR/PLANT MANAGER / DATE HB NUCLEAR (Procedure Classification - Quality Related)

1.0 DESCRIPTION

This document describes the Quality Assurance Plan to be applied to Humboldt Bay Power Plant Unit 3 during decommissioning, and includes Humboldt Bay Independent Spent Fuel Storage Installation (HB ISFSI) activities. The HBQAP satisfies the requirements of 10 CFR 50 Appendix B, and 10 CFR 72 Subpart G. In addition, NRC Approval No. 202, Revision 8 "Quality Assurance Program for Radioactive Material Packages" has approved the HBQAP as satisfying the provisions of 10 CFR 71 subpart H for the procurement, maintenance, repair and use of radioactive materials transport packages.

2.0 ATTACHMENTS 2.1 Humboldt Bay Quality Assurance Plan (HBQAP), Revision 32.

3.0 RESPONSIBLE ORGANIZATION Director, Quality U'

L-4 Attachment 2.1 Rev. 32 Page 1 of 29 HUMBOLDT BAY QUALITY ASSURANCE PLAN (HBQAP)

TABLE OF CONTENTS Section Title Page INTRODUCTION 2 1.0 ORGANIZATION 3 2.0 QUALITY ASSURANCE PROGRAM 8 3.0 DESIGN CONTROL 10 4.0 PROCUREMENT DOCUMENT CONTROL 11 5.0 INSTRUCTIONS, PROCEDURES, AND DRAWINGS 12 6.0 DOCUMENT CONTROL 13 7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES 14 8.0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS 15 9.0 SPECIAL PROCESSES 16 10.0 INSPECTION 17 11.0 TEST CONTROL 18 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT 19 13.0 HANDLING, STORAGE, AND SHIPPING 20 14.0 INSPECTION, TEST, AND OPERATING STATUS 21 15.0 CONTROL OF NONCONFORMING CONDITIONS 22 16.0 CORRECTIVE ACTION 23 17.0 QUALITY ASSURANCE RECORDS 24 18.0 AUDITS 25 APPENDIX A APPLICABLE STRUCTURES, SYSTEMS, AND COMPONENTS 26 B ADMINISTRATIVE CONTROLS 28

L-4 Attachment 2.1 Rev. 32 Page 2 of 29 HUMBOLDT BAY QUALITY ASSURANCE PLAN (HBQAP)

INTRODUCTION Pacific Gas and Electric (PG&E) has established and is inplementing a comprehensive Quality Assurance Program for Humboldt Bay Power Plant Unit 3 (HBPP Unit 3) and Humboldt Bay Independent Spent Fuel Storage Installation (HB ISFSI) to assure compliance with established regulatory requirements set forth by the Nuclear Regulatory Commission (NRC). This Quality Assurance Program is described in the Humboldt Bay Quality Assurance Plan (HBQAP).

The Humboldt Bay QA Program consists of the HBQAP and implementing procedures and instructions. The HBQAP describes the responsibilities for implementing quality requirements; establishing and maintaining the QA Program; and assessing the performance of activities subject to the HBQAP.

The HBQAP is a comprehensive statement of the quality assurance controls governing the Important to Safety (ITS) Structures Systems and Components (SSC). The HBQAP describes the organizational structure, functional responsibilities, levels of authority, line of communication, and interfaces. The HBQAP satisfies the requirements of 10 CFR 50 Appendix B, 10 CFR 71 Subpart H and 10 CFR 72 Subpart G. The requirements for management and administrative controls are described in appendix B of this HBQAP.

The requirements and commitments contained in the FIBQAP are mandatory and must be implemented, enforced, and adhered to by all individuals and organizations performing activities affecting quality. Workers are encouraged to actively participate in the continued improvement and implementation of the HBQAP. Any necessary changes should be promptly communicated and implemented.

The implementation of the requirements of the HBQAP is performed in a graded approach commensurate with any items or activities importance to safety. This graded approach is applicable to ITS SSCs and is responsive to NRC Regulatory Guide 7.10.

The HBQAP is implemented through the use of approved procedures (i.e. policies, procedures, manuals, instructions, or other documents) that provide written guidance for the control of ITS items and activities. The HBQAP also provides for development of documentation to demonstrate objective evidence of compliance with the stated requirements.

L-4 Attachment 2.1 Rev. 32 Page 3 of 29 1.0 ORGANIZATION PG&E's efforts are to assure the quality and safety of the decommissioning of the HBPP Unit 3, packaging and transportation of radioactive material and the operation and maintenance of the BB ISFSI utilizing the HBQAP. The program is organized in a structured manner with clearly defined levels of authority, assignments of responsibility and lines of communication.

Assignment of the responsibility for an item or activity includes responsibility for its quality. The Quality Organization provides independent oversight of quality activities and maintains lines of communication with Senior Management.

PG&E has assumed full responsibility for the establishment and execution of the HIBQAP prescribed herein, programs and administrative procedures. The work of executing selected portions of the HIBQAP may be delegated to organizations external to PG&E; however, in all such instances, PG&E retains overall responsibility.

Specific responsibilities pertaining to quality assurance matters are assigned by the HBQAP and its implementing procedures and instructions to various individuals throughout PG&E. In each instance, the assignment of a responsibility to an individual includes with it a commensurate delegation of sufficient authority that the person can, in fact, fulfill that responsibility. Unless otherwise specifically prohibited, it is understood that the functions, tasks and activities necessary to carry out a responsibility may be delegated to and perfonned by other qualified individuals.

All delegations of functions, tasks, activities and authority shall be documented. Individuals may fulfill more than one function unless prevented by the need to maintain independence as specified in the HBQAP.

Figure 1 illustrates the organizational structure, functional responsibilities, levels of authority, line of communication, and interfaces of persons and organizations performing activities governed by the HBQAP.

The functional responsibilities shown in Figure 1 are further described below. Generic titles are used for the functions and responsibilities. Differences (if any) between actual titles used in the organization are traceable to the HBQAP titles by the use of administrative procedures.

The PRESIDENT establishes the corporate policies, goals, and objectives related to all of PG&E's activities and operations.

The SENIOR VICE PRESIDENT - ENERGY SUPPLY reports to the President and oversees PG&E's energy procurement and power generation assets, including nuclear, fossil and hydroelectric, cogeneration and renewable sources, with a focus on planning for and delivering reliable, affordable and clean electricity and gas for distribution to PG&E's customers.

The SENIOR VICE PRESIDENT - CHIEF NUCLEAR OFFICER (CNO) is responsible for overall HBPP Unit 3 decommissioning, and HB ISFSI activities, safety and for taking measures needed to ensure acceptable performance of the BB ISFSI staff in designing, fabricating, constructing, testing, operating, modifying, decommissioning, and providing technical support to the liB ISFSI and during HBPP Unit 3 decommissioning.

L-4 Attachment 2.1 Rev. 32 Page 4 of 29 The CNO, or designee, as specified in administrative procedures, approves and signs official company correspondence to the U.S. Nuclear Regulatory Commission (NRC) or its representatives. The CNO approves revisions to the QA Program as described herein that constitute a reduction in a commitment made to the NRC. The CNO is responsible for designating individual(s) to perform an Independent Management Review to periodically assess the effectiveness of the HB QA Program.

The DIRECTOR - QUALITY (Quality Director) is responsible for assuring that the HBQAP and implementing procedures are effectively implemented and complied with by all involved organizations, both internal and external to PG&E. The Quality Director has the organizational freedom and requisite authority to assess, review, inspect, audit, and monitor the conduct of quality activities to assure compliance with the HIBQAP and other regulatory requirements. The Quality Director reports to the CNO, and has access to the President, NB Director, and appropriate managers for any significant quality problem or deficiency.

The Quality Director is responsible for maintaining and submitting for approval changes to the HBQAP. The Quality Director is responsible for the review of all regulatory submittals as they pertain to the HBQAP and his/her concurrence is required prior to submittal.

Reporting to the Quality Director are the quality assurance, supplier quality and independent quality control inspection functions. These individuals or groups do not have direct responsibility for performing the work being verified; are trained and qualified in QA concepts and practices; are independent of the organization responsible for performing the task and have direct access to management levels. The Quality Organization is sufficiently free from direct pressures for cost and schedule that assures the ability to: (a) identify quality problems; (b) initiate, recommend, or provide solutions through designated channels; and (c) verify implementation of solutions.

Individuals within the Quality Organization have the authority to stop unsatisfactory work and control further processing, delivery, or installation of nonconforming material. Organizational positions with stop work authority are identified in the implementing procedures.

The DIRECTOR - HUMBOLDT BAY (HB Director) is responsible for the conduct of activities related to the HBPP Unit 3 and the HB ISFSI. This includes responsibility for operation, maintenance, engineering, radiation protection, training, security, radioactive material packaging, transport and decommissioning. The day-to-day responsibilities are delegated to and executed by the NB management team that directly reports to the HB Director. Specific responsibilities are described in administrative procedures.

The HB Director is responsible for the Independent Safety Reviewer process. The HB Director is also responsible for the development of, programs, procedures, and instructions required for HBPP Unit 3 and NB ISFSI within the requirements and/or limits established in the HBQAP; HBPP Unit 3 and HB ISFSI Technical Specifications; and administrative guidelines established in the HBPP Unit 3 Defueled Safety Analysis Report (DSAR) and HB ISFSI Final Safety Analysis Report (FSAR). The HB Director is the Design Authority for the HBPP Unit 3 and HB ISFSI.

L-4 Attachment 2.1 Rev. 32 Page 5 of 29 The HB Director shall delegate these responsibilities to other members of the HB management team during his/her absence.

The ENGINEERING MANAGER is responsible for technical aspects of the engineering and design of HBPP Unit 3 and HB ISFSI SSCs established for monitoring system performance and trends; performance of modifications to the HB ISFSI; configuration control and design bases defense and management; quality classification of SSCs; and the specification of technical and quality requirements for the purchase of services, materials and equipment.

The ISFSI MANAGER is responsible for the operation and maintenance of the HB ISFSI.

The RADIATION PROTECTION MANAGER is responsible for implementing the radiation protection program for the protection of the workers and members of the public.

An INDEPENDENT MANAGEMENT REVIEW is periodically performed to assess the effectiveness of the HB QA Program, including audit program. Results of the Independent Management Review are provided to the CNO for corrective action, as necessary. Individual(s) that perform the Independent Management Review are appointed by the CNO. In addition, the Independent Management Review includes oversight of the HBQAP implementation and matters relating to decommissioning activities and safe storage of spent nuclear fuel, as directed by the CNO.

INDEPENDENT SAFETY REVIEWER(S) (ISR) performs independent safety reviews of proposed changes, tests and experiments to SSCs, activities, program documents and procedures that are subject to the HBQAP requirements. ISRs shall be individuals without direct responsibility for the performance of these activities under review, and shall be competent and knowledgeable in the subject area being reviewed. ISRrs are designated by the HIB Director.

CORPORATE SUPPORT for ITS activities includes, but is not limited to, procurement, records, employee concerns, and licensing. Each organization documents and maintains a written description of its internal organization.

SUPPLIERS that provide ITS SSCs or services are required to comply with the HBQAP or to a QA Program approved by PG&E. Supplier QA Programs are required to comply with the applicable portions of 10 CFR 50, Appendix B; 10 CFR 71, Subpart H; or 10 CFR 72, Subpart G.

The Quality Program requirements are defined in the contract or similar procurement document.

Suppliers to PG&E are required to document their internal organization, to the extent necessary for PG&E, to assure the supplier is capable of effectively managing, directing, and executing the requirements of the procurement documents.

L-4 Attachment 2.1 Rev. 32 Page 6 of 29 Staff Qualifications Except as specified in other portions of the HIBQAP, each member of the staff shall meet or exceed the following minimum qualifications:

For L-IBPP Unit 3, the minimum qualifications require individuals to be competent and knowledgeable for the assigned task.

For the liB ISFSI, the mininnim qualifications are described in the ISFSI FSAR.

The following requirements and clarifications apply to the positions listed below, and are applicable to both IIBPP Unit 3 and the HB ISFSI; The RADIATION PROTECTION MANAGER shall meet or exceed the requirements of Regulatory Guide 1.8, Revision 2, April, 1987.

The QUALITY DIRECTOR shall have knowledge of QA regulations, policies, practices, and standards; and experience working in QA, nuclear power plant, fuel storage facility, or in a similar highly technological industry. At the time of assignment to the active position, the Quality Director shall have six years of experience in implementing Quality Assurance.

At least one year of these six years of experience shall be nuclear power plant or fuel storage facility experience in the overall implementation of a Quality Assurance Program (QAP). A minimum of one year of this six-year experience requirement shall be related technical or academic training. A maximum of four years of this six-year experience requirement may be fulfilled by related technical or academic training.

The one year of qualifying nuclear power plant or fuel storage facility experience in the overall implementation of the Quality Assurance program can be obtained outside the Quality Assurance organizations.

L-4 Attachment 2.1 Rev. 32 Page 7 of 29 Figure 1 Organization Chart President PG&E Senior Vice President Energy Supply Corporate or Contract Support

  • Records
  • Licensing ~~~~1
  • Procurement
  • Employee Concerns Senior Vice President Chief Nuclear Officer
  • Other (as required)

Director Quality Director 1

Engineering ISFSI Radiation Protection Independent Safety Manager Manager Manager Reviewers

L-4 Attachment 2.1 Rev. 32 Page 8 of 29 2.0 QUALITY ASSURANCE PROGRAM 2.1 PROGRAM APPLICABILITY The HBQAP requirements, apply to SSCs designated as ITS in Appendix A.

The quality requirements for the management and administrative programs in Appendix B that support ITS SSCs in Appendix A are subject to the specific criterion in the HBQAP.

The quality requirements for the management and administrative programs that support HBPP Unit 3 are designated in administrative programs and procedures.

A graded approach is used to define the controls applied to quality activities commensurate with the activity's importance to safety. The graded approach also applies to the level of quality oversight for quality activities.

Activities that require review and concurrence by Quality personnel are delineated in administrative procedures and are based on the activity's importance to safety.

The effectiveness of the implementation of the HBQAP shall be assured through Quality Related programs, procedures and drawings.

2.2 PROGRAM CONTROL The status and adequacy of the HBQAP shall be regularly monitored and it shall be revised as necessary to improve its effectiveness or to reflect changing conditions.

The HBQAP, including any changes, supplements, or appendices are issued and maintained as controlled documents. Changes to the HBQAP requirements shall be made in accordance with 10 CFR 50.54.

Changes to the HBQAP that do not reduce commitments shall be included in the periodic updates required by 10 CFR 50.71. Prior to issuance for use, proposed changes to the HBQAP that reduce commitments are reviewed and concurred with in writing by the Quality Director and are approved by the CNO, or designee, prior to being submitted to and approved by the NRC in accordance with 10 CFR 50.54.

Implementation of the HBQAP is accomplished through separately issued procedures, instructions, and drawings. Each organization is responsible for the establishment and implementation of detailed procedures and instructions prescribing the quality activities for which they are responsible. Such documents are derived from the requirements and reflect the responsibilities specified in the HBQAP.

Questions or disputes involving interpretations of HBQAP requirements and commitments are referred to the Quality Director for resolution. Questions or disputes involving the responsibilities defined in the

-BQAP are referred to the CNO.

Questions or disputes involving other quality matters are resolved by referring the matter, in a timely manner, to successively higher levels of management until, if necessary, the matter reaches the management level which has direct authority over all contesting parties.

L-4 Attachment 2.1 Rev. 32 Page 9 of 29 2.3 INDOCTRINATION AND TRAINING Indoctrination and training for personnel implementing ITS activities are conducted to assure suitable proficiency is achieved and maintained. The extent of indoctrination and training is commensurate with the scope, complexity and importance to safety of the assigned task; in conjunction with the education and experience of the individual. Personnel involved in implementing the activities within the scope of the HBQAP shall be responsible for the quality of their work. At a minimum, these personnel shall receive:

" Indoctrination in the requirements of the HBQAP;

  • Indoctrination in their organization's implementing procedures; and
  • Training and qualification in tasks requiring special skills or knowledge, as required.

Indoctrination, training, qualification, and re-qualification (when applicable) shall be prescribed and performed in accordance with written procedures; and applicable codes, standards and regulatory requirements; which specify the management responsibilities; training areas; frequency of training; method of qualification and requalification; and documentation requirements.

Training and qualification records are maintained in accordance with implementing procedures.

2.4 REGULATORY COMMITMENTS Regulatory commitments, where applicable, are specified in the Unit 3 DSAR, ISFSI FSAR, Technical Specifications or Licenses.

L-4 Attachment 2.1 Rev. 32 Page 10 of 29 3.0 DESIGN CONTROL Design Control applies to the 10 CFR 72 SSCs designated as ITS in Appendix A. Design activities shall be controlled to assure that design, technical, and quality requirements are correctly translated into design documents and that changes to design and design documents are properly controlled. Design control procedures shall address responsibilities for:

(1) Interface control (2) Design input (3) Design perfonrmance (4) Design verification (5) Design change Systematic methods shall be established and documented for communicating needed design information across the external and internal design interfaces, including changes to the design information, as work progresses. Document control measures shall be established for design documents that reflect commitments in applicable design basis documents (e.g., specifications, calculations, computer programs, system descriptions, drawings).Provisions for design input shall define the technical objectives for SSCs being designed or analyzed. Design inputs shall be documented, reviewed and approved and translated to design documents. Required design analyses (such as stress, thermal, hydraulic and accident analysis; material compatibility; maintenance and repair and ALARA considerations) shall be performed in a planned, controlled, and correct manner. PG&E procedures shall identify the review and approval responsibilities for design analyses.

PG&E shall provide for reviewing, confirming, or substantiating the design to assure that the design meets the specified design inputs. Design verification shall be performed by competent individuals or groups other than those who performed the original design, but who may be from the same department.

The results of the design verification efforts shall be documented with the identification of the verifier clearly provided. The design verification shall be completed prior to relying upon the component system or structure to perform its function. Procedures shall assure that verified computer codes are certified for use and that their applicability is specified.

Changes or modifications to the designated SSCs in Appendix A shall be approved by the Design Authority, or designee, as specified in administrative procedures, prior to implementation. Procedures for implementing design changes, including field changes, shall assure that the impact of the change is carefully considered, required actions documented, and information concerning the change transmitted to affected persons and organizations. These changes shall be subjected to design control measures commensurate with those applied to the original design.

Nonconforming activities such as, deviations, errors or deficiencies in approved design documents, including design methods (such as computer codes), shall be controlled as described in Sections 15.0 and 16.0.

L-4 Attachment 2.1 Rev. 32 Page 11 of 29 4.0 PROCUREMENT DOCUMENT CONTROL Procurement Document Control applies to SSCs designated as ITS in Appendix A. Procurement documents shall include those requirements necessary to assure that the items and services to be provided will be of the desired quality.

Procedures that implement procurement document control shall describe the organizational responsibilities for procurement planning; preparation, review, approval and control of procurement documents; supplier selection; bid evaluations; identification of replacement parts, where applicable; and review and evaluation of the supplier's QA Program prior to initiation of activities affected by the program.

Procedures shall be established to review the adequacy of the technical and QA requirements stated in procurement documents; determine that requirements are correctly stated, inspectable, and controllable; assure adequate acceptance and rejection criteria; and provide for the preparation, review, and approval of procurement documents in accordance with applicable requirements. The review and documented concurrence of the adequacy of technical, and QA requirements stated in procurement documents shall be performed by independent personnel trained and qualified in applicable QA practices and concepts.

Changes to procurement documents shall be subject to the same controls as the original document.

L-4 Attachment 2.1 Rev. 32 Page 12 of 29 5.0 INSTRUCTIONS, PROCEDURES, AND DRAWINGS Controls for Instructions, Procedures, and Drawings apply to SSCs designated as ITS in Appendix A.

Activities, other than skill of the craft, shall be prescribed by and accomplished in accordance with documented instructions, procedures, and drawings. These documents shall include quantitative or qualitative acceptance criteria for verifying that an activity was satisfactorily accomplished, where applicable (i.e., verification activities for procurement, inspection tests).

Procedures prescribing a preplanned method of conducting activities required by the HIBQAP shall be established in accordance with the applicable regulation, codes, standards, and specifications.

Changes to or deviations from established instructions, procedures, or drawings require the same review and approval as the original document. Instructions, procedures, or drawings, including changes and deviations, subject to the HBQAP shall be maintained.

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

Temporary changes that clearly do not change the intent of the approved procedure from the standpoint of nuclear safety may be approved by two members of the HBPP/ISFSI management team. Such changes shall be documented and, if appropriate, incorporated into the next revision of the affected procedure.

Administrative controls for approval and timely notification or training of personnel affected by the temporaiy change shall be implemented.

Procedures subject to the HBQAP shall be periodically reviewed as described in administrative procedures.

L-4 Attachment 2.1 Rev. 32 Page 13 of 29 6.0 DOCUMENT CONTROL Document Control applies to SSCs designated as ITS in Appendix A, and the administrative programs described in Appendix B. Documents and changes to documents that prescribe or verify activities affecting quality shall be controlled in a manner that precludes the use of inappropriate or outdated documents.

A document control system shall be established to identify the current revision of instructions, procedures, specifications, drawings, and procurement documents. Written procedures shall identify those responsible for preparing, reviewing, approving, and issuing documents.

Procedures and instructions shall assure that documents, including changes, are prepared; reviewed by a qualified individual other than the person who generated the document; approved for release by authorized personmel; distributed to the location where the activity is performed prior to commencing work; and used in performing the activity.

Procedures, instructions and other documents that implement HBQAP requirements shall be reviewed and concurted with by the Quality Organization. Revisions to procedures, instructions and other documents shall also be reviewed and concurred with by the Quality Organization, as specified in administrative procedures.

L-4 Attachment 2.1 Rev. 32 Page 14 of 29 7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES Control of Purchased Material, Equipment, and Services applies to SSCs and associated activities that are designated as ITS in Appendix A. Supplier activities that provide purchased material, equipment, and services shall be monitored as necessary to assure such items and services meet procurement document requirements.

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

All materials, equipment, and services shall meet the specified technical and quality requirements.

Verification that a supplier can meet the specified technical and quality requirements shall be documented.

A Supplier's QA Program that satisfies specified quality requirements shall be listed on the PG&E Qualified Suppliers List. The PG&E Qualified Suppliers List shall be controlled.

Suppliers of commercial grade calibration services may be qualified based on their accreditation by a nationally-recognized accrediting body, as an alternative to qualification by supplier audit, commercial grade survey, or in-process surveillance.

The effectiveness of contractors and supplier's quality controls shall be assessed at intervals consistent with the importance, complexity, and quantity of the product or service. Supplier performance and compliance with procurement documents are monitored by source verification, receipt inspection, or a combination of the two.

Source verification and/or receipt inspection activities are performed to assure that the requirements of the procurement documents have been met. Accepted items are appropriately marked, removed from the inspection area, and located in a controlled storage area until use.

ITS SSCs and services from a supplier whose QA Program has not been reviewed or accepted may be used provided additional controls such as source inspection, special receipt instructions, and/or testing are imposed. These additional controls shall be documented and approved by the appropriate level of management.

Spare and replacement parts are procured such that their performance and quality are at least equivalent to those of the parts that will be replaced. Commercial grade items are controlled by written procedure.

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

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

L-4 Attachment 2.1 Rev. 32 Page 15 of 29 8.0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS The Identification and Control of Materials, Parts and Components apply to SSCs designated as ITS in Appendix A. Materials, parts, and components shall be identified and controlled in a manner to preclude the use of incorrect or defective items.

Implementing procedures shall describe the organizational responsibilities and controls to ensure that only correct and accepted items are used.

Materials, parts, and components, including partially fabricated subassemblies, batches, lots, and consumables, shall be identified in a manner that each can be traceable to its applicable drawing, specification, or other technical documentation at any stage from initial receipt through fabrication, installation, repair, modification or use of an item. When required by code, standard, or specification; traceability of materials, parts, or components to specific inspection or test records shall be provided for and verified.

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

Identification marking, where employed, shall be clear, unambiguous, and indelible and its application shall not impair the function of the identified item or any other item. When an item is subdivided, the identifying marking shall be transferred to each resulting part. Markings shall not be rendered illegible by treatment, process, assembly, installation, or coating unless other means of identification and determining acceptability are provided.

L-4 Attachment 2.1 Rev. 32 Page 16 of 29 9.0 SPECIAL PROCESSES Special Processes apply to SSCs designated as ITS in Appendix A. Special processes shall be controlled and performed by qualified personnel using written procedures or instructions in accordance with applicable codes, standards, specifications, criteria, or other special requirements.

A special process is an activity, in which the quality of the result is highly dependent upon either process variables or the skill and perfornance of the person doing the work, and the specified quality is difficult to verify by inspection and test after the process is completed.

Special processes include, but are not limited to: welding, heat treating, nondestructive examination, and chemical cleaning.

Equipment used for special processes shall be qualified, maintained, stored, issued in accordance applicable procedures and operated by qualified personnel.

The implementing instructions shall contain the criteria for assuring proper process control and compliance with applicable codes, standards, QA procedures, and design specifications. Records of qualifications and controls shall be maintained.

L-4 Attachment 2.1 Rev. 32 Page 17 of 29 10.0 INSPECTION Inspection activities apply to SSCs designated as ITS in Appendix A. A comprehensive program of inspection of items and activities affecting quality shall be conducted to verify conformance with established requirements. Procedures shall describe the organizational responsibilities necessary to carry out the inspection program.

Inspections shall be planned in accordance with approved procedures, and based on drawings, specifications, and other controlled documents. Inspections shall be performed in accordance with written and approved inspection plans and/or inspection procedures to verify that the quality of items and activities conforml to applicable and documented instructions, procedures, and drawings. Acceptance/rejection criteria and mandatory quality control inspection hold points shall be identified, where applicable. Work shall not proceed beyond such hold points without the appropriate documented concurrence by Quality personnel or assigned and authorized personnel.

The inspection results, including acceptance/rejection criteria, shall be documented and evaluated.

Unacceptable inspection results shall be evaluated and resolved in accordance with procedures. Where applicable, modifications, repairs and replacements; are re-inspected to the same standard or method to verify acceptability. Inspection records shall be maintained.

Inspections shall be performed by qualified individuals other than those who performed or directly supervised the activity being inspected.

L-4 Attachment 2.1 Rev. 32 Page 18 of 29 11.0 TEST CONTROL Test Control applies to the 10 CFR 72 SSCs designated as ITS in Appendix A.

A program of testing shall be conducted, as necessary, to demonstrate that SSCs will perform satisfactorily in service. This program shall ensure that the necessary testing is identified and performed at the appropriate time in accordance with written test procedures that incorporate or reference the requirements and acceptance limits contained in the applicable design documents.

The procedures that implement testing shall specify the appropriate prerequisites for the test (e.g.

environmental conditions, specification of instrumentation, and completeness of tested item), sufficient instruction for the performance of the test, witness or hold points, acceptance/rejection criteria and limits, and the required test documentation. The procedures shall provide for evaluation and documentation of the test results; data; and their acceptability as determined by a qualified person or group. Test results that do not meet the acceptance criteria shall be documented and evaluated to determine the appropriate corrective action. Where applicable, modifications, repairs, and replacements; are re-tested to verify acceptability. Test records shall be maintained.

L-4 Attachment 2.1 Rev. 32 Page 19 of 29 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT The Control of Measuring and Test Equipment applies to SSCs designated as ITS in Appendix A.

Organizational responsibilities shall be delineated for establishing, implementing, and assuring the effectiveness of the calibration program for measuring and test equipment (M&TE).

M&TE, including reference standards, used to determine the acceptability of items or activities shall be maintained within prescribed accuracy limits, suitable range, type, and accuracy to verify conformance with requirements.

Procedures for control of M&TE shall provide for the identification (labeling, codes, or alternate documented control system), recall, and calibration (including documented pre-calibration checks) of the M&TE. The calibration procedures shall delineate special controls, where applicable, for usage, handling, and storage required for environmental conditions such as temperature, humidity, cleanliness, or radiation to maintain accuracy or operating characteristics of the M&TE.

Calibrations standards shall be based on nationally recognized standards or accepted values of natural physical constants. Where national standards do not exist, the basis for the calibration shall be documented. Special calibration and control measures are not required when normal commercial practices provide adequate accuracy Instruments shall be calibrated prior to use. The calibration intervals, whether calendar- or usage-based, shall be predetermined and to the extent practical, consistent with the instrument manufacturer's guaranteed repeatability and/or the user's experience. Indication of expiration, if feasible, will be displayed on or with the M&TE. Special calibration shall be required whenever the accuracy of the equipment is suspect. M&TE or instrumentation found to be out of calibration shall be evaluated and documented.

Records of M&TE usage shall be maintained, such that measures may be taken to determine the validity of previous inspections performed and the acceptability of items inspected or tested since the previous calibration when the M&TE is suspect.

L-4 Attachment 2.1 Rev. 32 Page 20 of 29 13.0 HANDLING, STORAGE, AND SILPPING Handling, Storage and Shipping requirements apply to SSCs designated as ITS in Appendix A. Material and equipment shall be handled, stored, and shipped in accordance with design and procurement requirements in a manner that will prevent damage, deterioration, or loss.

Special coverings, equipment, and protective environments shall be specified and provided where necessary for the protection of items from damage or deterioration. When such special protective features are required, their existence shall be verified and monitored as necessary to assure they continue to serve their intended function.

Special handling tools and equipment shall be provided where necessary to ensure items can be handled safely and without damage.

Markings or labeling shall be used to indicate the presence of special environments or the need for special controls. Provisions shall be described for the storage of chemicals, reagents (including control of shelf life), lubricants, and other consumable materials.

Special handling, preservation, storage, cleaning, packaging, and shipping requirements are established and accomplished by suitably trained individuals in accordance with predeternrined work and inspection instructions.

L-4 Attachment 2.1 Rev. 32 Page 21 of 29 14.0 INSPECTION, TEST, AND OPERATING STATUS Inspection, Test and Operating Status requirements apply to SSCs designated as ITS in Appendix A. The inspection, test, and/or operating status of material, equipment, and operating systems shall be readily apparent and verifiable.

The procedures used to indicate status shall provide means for assuring that required inspections and tests are performed in the prescribed sequence; and acceptability is indicated; to prevent inadvertent use or operation. Items accepted and released are identified to indicate their inspection status prior to forwarding them to a controlled storage area or releasing them for installation or further work. Deviations from the prescribed sequence shall be subject to the same level of control as the generation of the original sequence to prevent the bypassing or omission of a required test or inspection.

The operating status of nonconforming, inoperable or malfinctioning ITS SSCs shall be identified and documented to prevent inadvertent operation. Identification of status may be by such means as, but not limited to, tags, stamps, markings, labels, or travelers. In some instances, records traceable to the item may be used.

The procedures implementing control of inspection, test, and operating status shall clearly delineate authority for the application, change, or removal of a status identifier.

L-4 Attachment 2.1 Rev. 32 Page 22 of 29 15.0 CONTROL OF NONCONFORMING CONDITIONS The Control of Nonconforming Conditions applies to SSCs designated as ITS in Appendix A. Items and activities that do not conform to requirements shall be controlled in a manner that will prevent their inadvertent use or installation. Nonconforming conditions are documented, reviewed and accepted, rejected, repaired or reworked in accordance with quality procedures. Organizations affected by nonconforming conditions shall be notified of such conditions.

Measures shall be established to identify, label and segregate nonconforming items to indicate their unacceptable status and to prevent inadvertent use or installation until the nonconformance is properly dispositioned. Labels associated with a nonconforming item shall only be removed by authorized personnel.

The acceptability of nonconforming items shall be verified and documented prior to use. Documentation shall include a description of the change, waiver, or deviation that has been accepted.

In cases where required documentary evidence that items have passed required inspections and tests is not available, the associated materials or equipment shall be considered nonconforming. Until suitable documentary evidence is available to show that the material or equipment is in conformance, affected systems shall be considered to be inoperable and reliance shall not be placed on such systems to fulfill their intended safety functions.

Nonconforming conditions shall be processed as conditions adverse to quality in accordance with Section 16.0.

L-4 Attachment 2.1 Rev. 32 Page 23 of 29 16.0 CORRECTIVE ACTION Corrective Action applies to SSCs designated as ITS in Appendix A. Conditions adverse to quality shall be identified, controlled, reviewed, and evaluated to determine remedial action and corrective action and implement those actions as soon as practicable.

A systematic review and evaluation of conditions adverse to quality shall be conducted and documented.

Conditions adverse to quality shall include, but not be limited to: engineering, design, and drafting errors; equipment failures and malfunctions; abnormal occurrences; deficiencies; deviations; and defective material, equipment, and services. The evaluation and corrective action taken should be based on safety significance.

Findings and actual or recommended corrective actions shall be reported to management for review and assessment. Corrective actions shall be accomplished in a timely manner commensurate with the safety significance.

Significant conditions adverse to quality shall be evaluated for reportability to the NRC. Significant conditions adverse to quality, the cause of the condition, and the corrective action taken to preclude recurrence shall be documented and reported to management. Follow-up reviews shall be conducted to verify that the corrective action was properly implemented and effective in correcting the identified condition.

L-4 Attachment 2.1 Rev. 32 Page 24 of 29 17.0 QUALITY ASSURANCE RECORDS The requirements for Quality Assurance Records apply to those SSCs that are designated as ITS described in Appendix A.

Sufficient records shall be maintained to furnish evidence of both the quality of items and activities affecting quality and to meet applicable code, standard, regulatory, and license requirements. The records include all documents referred to, or described in the HBQAP as records or required by quality procedures.

At a minimum quality records include operating logs, maintenance and modification procedures, related inspection results, and reportable occurrences and other records as required by the applicable license, Teclmical Specifications and Code of Federal Regulations. Additionally, records required by the HBQAP, and furnished by vendors, suppliers, subcontractors, and contractors that perform or supply quality-related activities or SSCs that ITS are also QA Records and shall be maintained.

A management control system for the collection, storage, and maintenance of completed quality assurance (QA) records shall be maintained. This records management program shall be designed and implemented to assure that the QA records are complete, readily retrievable when needed, and protected from damage or destruction during storage by fire, flooding, theft, environmental conditions, or other causes.

QA records stored electronically will follow the guidance for electronic records management given in the Nuclear Information and Records Management Association (NIRMIA) teclhical guidelines, TG 11-1998, "Authentication of Records;" TG 15-1998, "Management of Electronic Records;" TG 16-1998, "Software Configuration Management and Quality Assurance;" and TG 21-1998, "Electronic Records Protection and Restoration." QA records will be stored on electronic media (that is, optical disk, magnetic tape, network array, etc.) meeting the requirements of the NIRMA guidelines. Alternately, records stored on optical disks may meet the requirements of Generic Letter 88-18, "Plant Record Storage on Optical Disk," dated October 20, 1988. Information Systems will determine the appropriate electronic media. Regardless of the electronic media selected, the process must be capable of producing legible, accurate, and complete records during the required retention period.

Electronic QA records, including backup copies, are stored in two redundant electronic media storage systems at physically-independent electronic locations. QA records in electronic format (e.g., pdf format) may be filed and stored on the electronic media storage systems. Selected QA records on other media (e.g.,

paper hardcopies, microfilm, DVDs) are maintained in a Permanent Records Storage Facility.

Detailed records for items or activities shall be specified by instructions, procedures, drawings, or specification or other documents that prescribe the item or activity and shall be generated by the organization responsible for the item or activity including PG&E and non-PG&E organizations.

L-4 Attachment 2.1 Rev. 32 Page 25 of 29 18.0 AUDITS The requirements for Audits apply to SSCs designated as ITS in Appendix A. Measures shall establish a comprehensive system of planned and periodic audits. These assess, monitor and verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the HBQAP and implementing activities.

Internal and supplier audits are perforned in accordance with written procedures and/or check lists.

Audits are performed by qualified personnel not having direct responsibility in the areas audited.

Auditors shall have experience, training or qualifications commensurate with the scope and complexity of their audit responsibility.

Scheduling, preparation, personnel selection, performance, reporting, response, follow-up action, and records management are performed in accordance with written procedures. Audit scopes and schedules are established to meet applicable regulatory requirements and are based on the status and safety significance of the activities to be audited.

Detailed audit schedules are documented in accordance with Quality procedures. At a minimum, the conformance of decommissioning activities and ISFSI operations to applicable regulatory requirements is audited at least once every 24 months or more frequently as performance dictates.

External audits of suppliers providing ITS materials, parts, equipment or services are scheduled and performed based on the importance of an SSC or activity to confirm implementation of their Quality Program requirements, but not less than every 3 years.

Audits that are not mandated by regulation have a grace period of up to 90 days, when the urgency of other priorities makes meeting the specified schedule dates impractical. For audit activities deferred using a grace period, the next scheduled due date shall be based on the originally scheduled due date, but may not exceed the original due date plus 90 days.

Audit reports shall be prepared, issued to and reviewed by responsible management of both the audited and auditing organizations. Audit records shall be generated and retained. Follow-up action, including re-audit of deficient areas, shall be taken, where applicable.

L-4 Attachment 2.1 Rev. 32 Page 26 of 29 APPENDIX A 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 quality activities affecting the ITS SSCs associated with spent fuel storage and transportation package that are listed below. The quality category is based on the guidance in NUREG/CR-6407. In addition, the HB ISFSI FSAR, Holtec International HI-STORM Safety Analysis Report (SAR), Holtec International HIl-STAR SAR and associated specifications include additional classification infornation.

NOTE There are no HBPP safety related SSCs remaining at the site.

The quality classification of NRC Licensed HB ISFSI Dry Fuel Storage Components and Transportation Packages is made by the NRC Certificate Holder. The Certificate Holder is responsible for design and licensing controls for these components under their NRC approved Quality Assurance Program. PG&E utilizes these types of components and packages tinder the provisions of a NRC General License for Radioactive Material Transportation Packages (10 CFR 71) and Spent Fuel and GTCC Storage (10 CFR 72).

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

SSC Quality Category Design/License Responsible Multi-Purpose Canister A PG&E Fuel Basket and Basket Spacers A PG&E Damaged Fuel Container A PG&E Hi-Star 100 HB Overpack A PG&E Transporter Lift Links A PG&E GTCC Waste Container A PG&E Hi-Star HB GTCC Overpack A PG&E HB ISFSI Storage Vault B PG&E Fuel Spacers B PG&E Transporter Connector Pins B PG&E Helium Fill Gas B PG&E Lid Retention Device B PG&E Cask Transporter B PG&E Process Waste Container B PG&E B. Transport of Spent Fuel and GTCC Waste (10 CFR 71)

SSC Quality Category DesignALicense Responsible Multi-Purpose Canister A Holtec International Fuel Basket and Basket Spacers A Holtec International Damaged Fuel Container A Holtec International Hi-Star 100 HB Overpack A Holtec International GTCC Waste Container A Holtec International Hi-Star HB GTCC Overpack A Holtec International Fuel Spacers B Holtec International Helium Fill Gas B Holtec International

L-4 Attachment 2.1 Rev. 32 Page 27 of 29 C, Radioactive Material Transport Packages - Greater than Type A Shipments (10 CFR 71)

SSC Quality Category Design/License Responsible TBD* TBD* NRC Certificate Holder*

  • 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 HBQAP. SSC and Quality Category are as determined by the NRC Certificate Holder for the cask chosen for the shipment.

L-4 Attachment 2.1 Rev. 32 Page 28 of 29 APPENDIX B ADMINISTRATIVE CONTROLS 1.0 PROGRAMS AND PROCEDURES The program and procedures listed below shall be established and controlled to support HBPP Unit 3 and/or HB ISFSI.

a) Radiation Protection Program b) Emergency Plan c) Radioactive Effluent Control Program d) Security Program (as defined in security license bases documents) e) Radiological Environmental Monitoring Program The management and administrative programs quality requirements applicable to ITS SSCs in Appendix A are subject to the specific criterion in the IBQAP as described in administrative procedures. To assure compliance with applicable regulatory and quality requirements for the management and administrative programs that support 1I-BPP Unit 3 are designated in administrative programs and procedures.

2.0 RADIOLOGICAL MONITORING Administrative controls for radiological monitoring of gaseous effluents and the environment shall be controlled and implemented to ensure conformance with USNRC Regulatory Guide 4.15 (December 1977).

3.0 TECHNICAL SPECIFICATION ACTIVITIES In addition to the applicable quality assurance requirements specified in the HBQAP, Technical Specification activities shall be controlled in accordance with the Limiting Conditions for Operations (LCO) and Surveillance Requirements (SR).

4.0 OFFSITE DOSE CALCULATION MANUAL The Offsite Dose Calculation Manual (ODCM) shall contain the methodology and parameters used in the calculation of offsite doses resulting from radioactive gaseous and liquid effluents, calculation of gaseous effluent monitoring alarm and trip setpoints, and conduct of the radiological environmental monitoring program. The ODCM shall also contain the radioactive effluent controls and radiological enviromnental monitoring activities and descriptions of the information that should be included in the Annual Radiological Environmental Monitoring Report, and Annual Radioactive Effluent Release Report.

5.0 RADIOACTIVE EFFLUENT CONTROLS PROGRAM This program conforms to 10 CFR 50.36a for the control of radioactive effluents and for maintaining the doses to members of the public from radioactive effluents as low as reasonably achievable (ALARA). The program (1) shall be contained in the ODCM, (2) shall be implemented by written procedures, and (3) shall include remedial actions to be taken whenever the program limits are exceeded.

L-4 Attachment 2.1 Rev. 32 Page 29 of 29 6.0 REPORTING REQUIREMENTS The following reports shall be submitted in accordance with 10 CFR 50.4.

6.1 Occupational Radiation Exposure Report An annual report shall be made of personnel exposure, in accordance with the requirements of 10 CFR Part 20.2206. The report shall be submitted by April 30 of each year.

6.2 Annual Radiological Environmental Monitoring Report The Annual Radiological Environmental Monitoring Report covering the operation of the unit during the previous calendar year shall be submitted by May 1 of each year. The report shall include summaries, interpretations, and analyses of trends of the results of the Radiological Environmental Monitoring Program for the reporting period. The material provided shall be consistent with the objectives outlined in the ODCM, and in 10 CFR 50, Appendix I, Sections IV.B.2, IV.B.3, and IV.C.

The Annual Radiological Environmental Monitoring Report shall include the results of analyses of radiological environmental samples and of environmental radiation measurements taken during the period pursuant to the quality related locations specified in the table and figures in the ODCM, as well as summarized and tabulated results of these analyses and measurements. In the event that some individual 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 in the next annual report.

6.3 Annual Radioactive Effluent Release Report The Annual Radioactive Effluent Release Report covering the activities of the unit in the previous year shall be submitted prior to April 1 of each year in accordance with 10 CFR 50.36a. The report shall include a summary of the quantities of radioactive liquid and gaseous effluents and solid waste released from the unit. The material provided shall be consistent with the objectives outlined in the ODCM and in conformance with 10 CFR 50.36a and 10 CFR Part 50, Appendix I, Section 1V.B.1.

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