L-19-038, Request for Approval of Decommissioning Quality Assurance Program, Revision 0 for the Davis-Besse Nuclear Power Station

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Request for Approval of Decommissioning Quality Assurance Program, Revision 0 for the Davis-Besse Nuclear Power Station
ML19120A209
Person / Time
Site: Davis Besse Cleveland Electric icon.png
Issue date: 04/30/2019
From: Bezilla M
FirstEnergy Nuclear Operating Co
To:
Document Control Desk, Office of Nuclear Reactor Regulation
References
L-19-038
Download: ML19120A209 (73)


Text

FENOC 5501 North State Route 2 FirstEnergy Nuclear Operating Company Oak Harbor, Ohio 43449 Mark B. Bezilla 419-321-7676 Site Vice President Fax: 419-321-7582 April 30, 2019 L-19-038 10 CFR 50.54(a)(4)

ATTN: Document Control Desk U. S. Nuclear Regulatory Commission Washington, DC 20555-0001

SUBJECT:

Davis-Besse Nuclear Power Station, Unit No. 1 Docket No. 50-346, License No. NPF-3 Request for Approval of Decommissioning Quality Assurance Program, Revision 0 for the Davis-Besse Nuclear Power Station Pursuant to 10 CFR 50.54(a)(4), FirstEnergy Nuclear Operating Company (FENOC) is submitting a proposed Decommissioning Quality Assurance Program (DQAP) in preparation for the transition of the Davis-Besse Nuclear Power Station (DBNPS), Unit No. 1, to a permanently defueled condition.

By letter dated April 25, 2018 (Accession No. ML18115A007), FENOC provided formal notification to the U.S. Nuclear Regulatory Commission (NRC) that DBNPS will permanently cease power operation by May 31, 2020. Once DBNPS permanently ceases operations and submits the certifications required by 10 CFR 50.82(a)(1)(i) and (ii),

pursuant to 10 CFR 50.82(a)(2), the 10 CFR Part 50 license for DBNPS will no longer authorize operation of the reactor or placement or retention of fuel in the reactor vessel.

The proposed DQAP will be implemented at DBNPS after the required certifications pursuant to 10 CFR 50.82(a)(1) have been docketed. The DQAP is a new document based on the existing FENOC Fleet Quality Assurance Program Manual (QAPM) that is currently used at all operational FENOC nuclear sites. The DQAP reflects changes and simplifications based on a decommissioned status of the DBNPS. In some cases, changes have been identified as reductions in commitment. The changes that limit regulatory guidance and standards to those that are applicable to a facility undergoing decommissioning results in deletion of regulatory guides and standards previously committed to in the FENOC QAPM and are identified as a reduction in commitment. The DBNPS DQAP assures compliance with 10 CFR 50, Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants; 10 CFR 71, Subpart H, Quality Assurance; and 10 CFR 72, Subpart G, Quality Assurance.

Davis-Besse Nuclear Power Station, Unit No. 1 L-19-038 Page 2 The proposed changes associated with the DQAP include:

  • Changes in applicability due to reclassification of systems, structures, and components.
  • Implementation methodology details found in the FENOC Fleet QAPM that are not included in the DBNPS DQAP.
  • Streamlining organizational functions to accommodate changing and consolidating responsibilities.
  • Application of regulations applicable to a facility undergoing decommissioning.
  • Extensive editorial changes that eliminate redundancy, provide clarity, and improve readability.

In accordance with 10 CFR 50.54(a)(4)(ii), Enclosure A provides a comparison of the changes between the DBNPS DQAP and the FENOC Fleet QAPM, including those changes determined to be a reduction in commitment from the previously approved FENOC Fleet QAPM. This provides a basis for concluding that the DBNPS DQAP will continue to meet the applicable regulatory requirements. Enclosure B provides the complete DQAP document. Once approved, the DQAP will become the basis for the DQAP at other FENOC plants undergoing decommissioning.

To support the current schedule that reflects DBNPS transitioning to a permanently shutdown and defueled facility, FENOC requests review and approval of the proposed DBNPS DQAP by May 1, 2020. FENOC is also requesting a 60-day implementation period following the effective date of the DQAP. FENOC requests that the approved DQAP become effective following submittal of the required 10 CFR 50.82(a)(1 )(ii) certification that DBNPS has been permanently defueled.

There are no regulatory commitments contained in this submittal. If there are any questions, or if additional information is required, please contact Mr. Thomas A. Lentz, Manager, Nuclear Licensing & Regulatory Affairs, at (330) 315-6810.

?iil~

Mark B. Bezilla

Enclosures:

A. 10 CFR 50.54(a) Evaluation with Comparison of Davis-Besse Decommissioning QuaHty Assurance Program and FENOC Fleet Quality Assurance Program Manual B. FE NOC Decommissioning Quality Assurance Program for the Davis-Besse Nuclear Power Station, Revision 0

Davis-Besse Nuclear Power Station, Unit No. 1 L-19-038 Page 3 cc: NRC Region III Administrator NRC Resident Inspector NRC Project Manager Utility Radiological Safety Board

Enclosure A L-19-038 10 CFR 50.54(a) Evaluation with Comparison of Davis-Besse Decommissioning Quality Assurance Program and FENOC Fleet Quality Assurance Program Manual (28 pages, excluding this page)

10 CFR 50.54(a) EVALUATION NOP-LP-2022-01 Rev. 01 Page 1 of 5 Instructions: Use this form as a template for the 10 CFR 50.54(a) Evaluation Report Attach additional pages and supporting documentation as necessary. Refer to NOP-LP-2022, , for guidance for performing the evaluation.

Summary of Change(s): This is the initial issuance of the Davis-Besse Decommissioning Quality Assurance Program (DQAP) that is applicable to a site where operation has permanently ceased and all the fuel has been permanently removed from the reactor vessel. Changes made utilized input from:

  • Request for Approval of Decommissioning Quality Assurance Program, Revision O for Oyster Creek Nuclear Generating Station dated November 30, 2017 (ML17334A798).
  • Response to Request for Additional Information (RAI) Regarding Request for Approval of Decommissioning Quality Assurance Program, Revision O for Oyster Creek Nuclear Generating Station dated June 6, 2018 (ML18157A227).
  • Oyster Creek Nuclear Generating Station and Independent Spent Fuel Storage Installation -

Review and Acceptance of Changes RE: Decommissioning Quality Assurance Program (EPID L-2017-LLQ-0003) dated June 27, 2018 (ML18165A136).

  • Proposed Revision to the Entergy Vermont Yankee Quality Assurance Program Manual (VY QAPM) dated September 19, 2017 (ML17268A152).
  • Entergy Vermont Yankee Quality Assurance Program Manual Vermont Yankee Nuclear Power Station and Independent Spent Fuel Storage Facility - Review and Acceptance of Changes (EPID L-2017-DP3-0002) dated May 1, 2018 (ML18099A166).

A detailed evaluation of the changes associated with moving from a FENOC Fleet Quality Assurance Program (QAPM) to a Davis-Besse Decommissioning Quality Assurance Program (DQAP) is contained in an attachment.

The DQAP reflects changes and simplifications based on site decommissioning status. The removal of commitment to Regulatory Guides and associated standards is considered a reduction in commitment to that stated in the previously approved QAPM. The proposed DQAP includes a change in focus on systems, structures, and components that are important to safety based on the decommission status, moving implementation methodology to procedures, and limiting regulatory guidance and quality standards to those that are applicable to a decommissioning facility. The Davis-Besse DQAP assures compliance with 10 CFR 50 Appendix B Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, 10 CFR 72, Subpart G Quality Assurance, and 10 CFR 71 Packaging And Transportation of Radioactive Material, Subpart H Quality Assurance.

The proposed changes for development of the DQAP include:

  • Changes in applicability due to reclassification of structures, systems, and components.
  • Implementation methodology details found in the QAPM are not included in the DQAP.
  • Streamlining organizational functions to accommodate changing and consolidating responsibilities.
  • Applies regulations applicable to a decommissioning facility.

Proposed Change(s): Regulatory guides, industry standards, and exceptions to those standards that are only applicable to an operating facility will not be carried over to the DQAP. The remaining regulations and quality standard will be added to Appendix C in the DQAP. These are:

10 CFR 50.54(a) EVALUATION NOP-LP-2022-01 Rev. 01 Page 2 of 5

  • NUREG/CR 6407 Additional regulatory guides, regulations, and industry standards are listed in the DQAP Appendix E Davis-Besse Site Specific Administrative Requirements and Technical Specifications. Removal of section A. 7 and Table 1 removes commitment to Regulatory Guides and associated standards and is considered a reduction in commitment to the previously approved QAPM. This is considered acceptable because the proposed revision continues to satisfy the criteria of 10 CFR 50 Appendix B, 10 CFR 71 Subpart H, and 10 CFR 72 Subpart G. This approach in removal of Regulatory Guides and associated standards has been previously approved by the NRC for other facilities in decommissioning status. The NRC approved the removal of commitment to specific Regulatory Guides and standards for:
  • Oyster Creek Nuclear Generating Station and Independent Spent Fuel Storage Installation -

Review and Acceptance of Changes Re: Decommissioning Quality Assurance Program (EPID L-2017-LLQ-0003) dated June 27, 2018 (ML18165A136).

  • Entergy Vermont Yankee Quality Assurance Program rv4!anual Vermont Yankee Nuclear Power Station and Independent Spent Fuel Storage Facility- Review and Acceptance of Changes (EPIID L-2017-DP3-0002) dated May 1, 2018, ML18099A166.

The evaluation questions below are answered based upon the change removing specific Regulatory Guides and associated standards previously committed to in the QAPM.

Evaluation Questions:

No. Question Yes, No, or N/A 1 Does the proposed change involve administrative improvements and clarifications, spelling corrections, punctuation, or editorial items? NO Basis for response: There are no administrative improvements for removing specific Regulatory Guides and associated standards.

2 Does the proposed change involve the use of a QA standard approved by the NRC, which is more recent than the QA standard in the licensee's NO current QA program at the time of the change?

Basis for response: The DQAP is not adopting a more recent QA standard.

3 Does the proposed change involve the use of a quality assurance alternative or exception approved by an NRC safety evaluation, provided the bases of the NRC approval are applicable to the licensee's facility? ~ NO If yes, explain how the NRC approval bases from the SER are incorporated or covered by the QAPM.

10 CFR 50.54(a) EVALUATION NOP-LP-2022-01 Rev. 01 Page 3 of 5 Basis for response: For the most part the proposed changes are based upon:

  • Request for Approval of Decommissioning Quality Assurance Program, Revision O for Oyster Creek Nuclear Generating Station dated November 30, 2017 (ML17334A798).
  • Response to Request for Additional Information (RAI) Regarding Request for Approval of Decommissioning Quality Assurance Program, Revision O for Oyster Creek Nuclear Generating Station dated June 6, 2018 (ML18157A227).
  • Oyster Creek Nuclear Generating Station and Independent Spent Fuel Storage Installation - Review and Acceptance of Changes RE: Decommissioning Quality Assurance Program (EPID L-2017-LLQ-0003) dated June 27, 2018 (ML18165A136).
  • Proposed Revision to the Entergy Vermont Yankee Quality Assurance Program Manual (VY QAPM) dated September 19, 2017 (ML17268A152).
  • Entergy Vermont Yankee Quality Assurance Program Manual Vermont Yankee Nuclear Power Station and Independent Spent Fuel Storage Facility - Review and Acceptance of Changes (EPID L-2017-DP3-0002) dated May 1, 2018 (ML18099A166).

The attached comparison between the existing FENOC QAPM and the proposed Davis-Besse DQAP includes the review of the NRC approval bases from previously issued SERs.

Changes made are similar to those approved by the SERs referenced above. However, applicability of the bases for approval are not identical to the changes in the proposed DQAP. Oyster Creek utilized NQA-1 as the basis for it's QA program while Davis-Besse utilized ANSI N45.2 and associated daughter standards. The Vermont Yankee change was approved based upon the plant having removed all fuel from the fuel pool and placed upon the dry fuel storage pad. Davis-Besse will be implementing the DQAP with fuel still in the spent fuel pool. This change is considered acceptable because the proposed revision will continue to satisfy the criteria of 10 CFR 50 Appendix B, 10 CFR 71 Subpart H, and 10 CFR 72 Subpart G.

4 Does the proposed change involve the use of generic organizational position titles that clearly denoted the position function, supplemented as NO necessary by descriptive text, rather than specific titles?

Basis for response: This change involves removal of commitments to specific Regulatory Guides and associated standards, not a change in generic orgnizational position titles.

5 Does the proposed change involve the use of generic organizational charts to indicate functional relationships, authorities, and NO responsibilities, or, alternatively the use of descriptive text?

Basis for response: This change involves removal of commitments to specific Regulatory Guides and associated standards, not a change in generic organizational charts or use of descriptive text.

6 Does the proposed change continue to ensure that persons and organizations performing quality assurance functions continue to have the requisite authority and organizational freedom, including sufficient NO independence from cost and schedule when opposed to safety considerations?

Basis for response: This question is answered no because this change re_ moves commitments to specific Regulatory Guides and associated standards. This change does not impact the persons and organizations performing quality assurance functions and thus does not affect the authority and organizational freedom.

10 CFR 50.54(a) EVALUATION NOP-LP-2022-01 Rev. 01 Page 4 of 5 7 Does the proposed change involve the elimination of quality assurance program information that duplicates language in quality assurance NO regulatory guides and quality assurance standards to which the licensee is committed?

Basis for response: No duplicate language is elmiminated for the proposed change.

Results:

D Change does not represent a reduction in commitment and does not require NRC approval prior to implementation (at least one question above is answered "Yes" for each evaluated change.)

Summary:

IZ! Change represents a reduction in commitment and requires NRC approval prior to implementation (all questions above are answered "No" for any change evaluated.)

Summary: Removal of section A.7 and Table 1 removes commitment to Regulatory Guides and associated standards and is considered a reduction in commitment to that stated in the previously approved QAPM. This is considered acceptable because the proposed revision will continue to satisfy the criteria of 10 CFR 50 Appendix B, 10 CFR 71 Subpart H, and 10 CFR 72 Subpart G. This approach in removal of Regulatory Guides and associated standards has been previously approved by the NRC for other facilities in decommissioning status. The NRC approved the removal of commitment to specific Regulatory Guides and standards for:

  • Oyster Creek Nuclear Generating Station and Independent Spent Fuel Storage Installation -

Review and Acceptance of Changes RE: Decommissioning Quality Assurance Program (EPID L-2017-LLQ-0003) dated June 27, 2018 (ML18165A136).

  • Entergy Vermont Yankee Quality Assurance Program Manual Vermont Yankee Nuclear Power Station and Independent Spent Fuel Storage Facility - Review and Acceptance of Changes (EPID L-2017-DP3-0002) dated May 1, 2018 (ML18099A166).

References:

  • Request for Approval of Decommissioning Quality Assurance Program, Revision O for Oyster Creek Nuclear Generating Station dated November 30, 2017 (ML17334A798).
  • Response to Request for Additional Information (RAI) Regarding Request for Approval of Decommissioning Quality Assurance Program, Revision O for Oyster Creek Nuclear Generating Station dated June 6, 2018 (ML18157A227).
  • Oyster Creek Nuclear Generating Station and Independent Spent Fuel Storage Installation -

Review and Acceptance of Changes RE: Decommissioning Quality Assurance Program (EPID L-2017-LLQ-0003) dated June 27, 2018 (ML18165A136).

  • Proposed Revision to the Entergy Vermont Yankee Quality Assurance Program Manual (VY QAPM) dated September 19, 2017 (ML17268A152) . .
  • Entergy Vermont Yankee Quality Assurance Program Manual Vermont Yankee Nuclear Power Station and Independent Spent Fuel Storage Facility - Review and Acceptance of Changes (EPID L-2017-DP3-0002) dated May 1, 2018 (ML18099A166).

10 CFR 50.54(a) EVALUATION NOP-LP-2022-01 Rev. 01 Page 5 of 5 Review and Approvals (Print/Sign Name):


77~L~ - I Date I ~11 (7-0 ' ~

Supervis r, Compliance Audi Date

~~I=- D. #c/1~/-Y~,i::../~ ~~ I 3* 7;eo1'1 Manager, Fleet Oversight - Approval Date

Decommissioning DQAP Rev 0 Fleet QAPM to Davis-Besse DQAP Change(s) Evaluation and Justification Reduction in Commitment?

Specific Changes from the FENOC Fleet QAPM to the Davis-Besse DQAP Table of Contents A.1 Methodology replaced Changes to the table of No 50.54 (a)(3) with Policy Statement. contents are considered Administrative improvement editorial changes that do not / editorial changes A.2 Organization combined reduce the effectiveness or with A.3 in new 1.0 commitments to the technical Organization. requirements of the DQAP.

A.3 Responsibility combined with A.2 in new 1.0 Organization.

A.4 Authority moved to new 2.0 Quality Assurance Program section.

A.5 Personnel Training and Qualification moved to new 2.0 Quality Assurance Program section.

A.6 Corrective Action combined with 15.0 Nonconforming Material, Parts, or Components and 16.0 Corrective Action.

A.7 Regulatory Commitments now Appendix C Regulatory Commitments.

B.1 Methodology deleted.

B.2 Design Control moved to new 3.0 Design Control.

B.3 Design Verification combined in new 3.0 Design Control.

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B.4 Procurement Control moved to new 4.0 Procurement Document Control.

B.5 Procurement Verification combined in new 4.0 Procurement Document Control and new 18.0 Audits.

B.6 Identification and Control of Items moved to new 8.0 Identification and Control of Materials, Parts and Components.

B.7 Handling, Storage, and Shipping moved to new 13.0 Handling, Storage, and Shipping.

B.8 Test Control moved to new 11.0 Test Control.

B.9 Measuring and Test Equipment Control moved to new 12.0 Control of Measuring and Test Equipment.

B.10 Inspection, Test, and Operating Status moved to new 14.0 Inspection, Test, and Operating Status.

B.11 Special Process Control moved to new 9.0 Control of Special Processes.

B.12 Inspection moved to new 10.0 Inspection.

B.13 Corrective Action moved to new 16.0 Corrective Action.

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B.14 Document Control moved to new 6.0 Document Control.

B.15 Records moved to new 17.0 Quality Assurance Records.

C.1 Methodology deleted.

C.1 and C.2 combined to form new section 18.

C.2 Audit moved to new 18.0 Audits D.1 Description deleted.

Table 1 - Regulatory Commitments now Appendix C Regulatory Commitments.

In addition to the new DQAP table of contents sections listed above the following new sections were added:

  • 5.0 Instructions, Procedures, and Drawings
  • 7.0 Control of Purchased Material, Equipment, and Services
  • 17.0 Quality Assurance Records
  • Appendix A Terms and Definitions
  • Appendix B Writing Reference Documents
  • Appendix D General Administrative Requirements
  • Appendix E Davis-Besse Site Specific Administrative Requirements 3

A. Management 1. Methodology A. Management 1. Implementation methodology No 50.54 (a)(3)(ii)

Methodology, Reduced details found in the QAPM The use of a quality assurance specific detail and included are not included in the alternative or exception applicable statements in new DQAP. The intent of the approved by an NRC safety Policy Statement, 2.0 Quality DQAP is to describe evaluation. The NRC Assurance Program, and appropriate and sufficient approved the reduced level of Appendix D General requirements to establish how implementation details for:

Administrative Requirements. the DQAP meets 10 CFR 50

  • The Oyster Creek Appendix B while allowing Nuclear Generating flexibility in the manner by Station and which a requirement is met. Independent Spent This reduction in Fuel Storage implementation details Installation DQAP in provides flexibility of the an attached safety implementation of the DQAP evaluation by letter while maintaining appropriate dated June 27, 2018 and sufficient guidance to (ML18165A136).

ensure QA program requirements are met.

A.2 Organization This is a complete rewrite to Changes to the organizational No 50.54(a)(3)(iii) The reflect the plant responsibilities are changes continue to provide decommissioning status and considered administrative and descriptive text for is now Section 1.0 do not impact the reporting organizational position titles Organization. A number of relationships with the Chief and functions with clear changes were made by Nuclear Officer (CNO). The alignment to the CNO.

streamlining organizational station top level management functions to accommodate position and the corporate changing and consolidating management position for responsibilities. Nuclear Oversight continue to report to the CNO.

A.3 Responsibility Reduced specific detail and Implementation methodology No 50.54 (a)(3)(ii) included applicable details found in the QAPM The use of a quality assurance statements in 1.0 are not included in the alternative or exception Organization. DQAP. The intent of the approved by an NRC safety DQAP is to describe evaluation. The NRC appropriate and sufficient approved the reduced level of requirements to establish how implementation details for:

the DQAP meets 10 CFR 50

  • The Oyster Creek Appendix B while allowing Nuclear Generating flexibility in the manner by Station and which a requirement is met. Independent Spent This reduction in Fuel Storage Installation DQAP in 4

implementation details an attached safety provides flexibility of the evaluation by letter implementation of the DQAP dated June 27, 2018 while maintaining appropriate (ML18165A136).

and sufficient guidance to ensure QA program requirements are met.

A.4 Authority Reduced specific detail and Implementation methodology No 50.54 (a)(3)(ii) included applicable details found in the QAPM The use of a quality assurance statements in 2.0 Quality are not included in the alternative or exception Assurance Program. DQAP. The intent of the approved by an NRC safety DQAP is to describe evaluation. By letter dated appropriate and sufficient June 27, 2018 requirements to establish how (ML18165A136) the NRC the DQAP meets 10 CFR 50 approved the reduced level of Appendix B while allowing implementation details for the flexibility in the manner by Oyster Creek Nuclear which a requirement is met. Generating Station and This reduction in Independent Spent Fuel implementation details Storage Installation DQAP in provides flexibility of the an attached safety evaluation.

implementation of the DQAP while maintaining appropriate and sufficient guidance to ensure QA program requirements are met.

A.5 Personnel Training and Qualification Included applicable Removal of step d. is No 50.54 (a)(3) statements in 2.0 Quality considered administrative due Administrative / editorial Assurance Program. to the deletion of A.7 and changes Removed step d. which Table 1. See discussion of provided reference to the changes for these sections.

Regulatory Guides and associated standards committed to in Section A.7 and Table 1.

A.6 Corrective Action Included applicable Some specific details found No 50.54 (a)(3)(ii) statements in 16.0 Corrective in the QAPM are not included The use of a quality assurance Action in the DQAP. The intent of alternative or exception the DQAP is to describe approved by an NRC safety appropriate and sufficient evaluation. By letter dated requirements to establish how June 27, 2018 the DQAP meets 10 CFR 50 (ML18165A136) the NRC Appendix B while allowing approved the reduced level of 5

flexibility in the manner by implementation details for the which a requirement is met. Oyster Creek Nuclear This reduction in Generating Station and implementation details Independent Spent Fuel provides flexibility of the Storage Installation DQAP in implementation of the DQAP an attached safety evaluation.

while maintaining appropriate and sufficient guidance to ensure QA program requirements are met.

A.7 Regulatory Commitments Regulatory guides, industry Commitments to standards Yes 50.54 (a)(4) standards, and exceptions to and regulatory guides with a Removal of section A.7 and those standards that are only focus on operating facilities Table 1 removes commitment applicable to an operating are out of scope for a to Regulatory Guides and facility will not be carried decommissioning plant. The associated standards is over to the DQAP. The DQAP will reflect regulatory considered a reduction in remaining regulations and standards that apply to commitment to the previously quality standard will be added decommissioning activities. approved QAPM. This is to Appendix C in the DQAP. Written procedures applicable considered acceptable These are: to safe storage of nuclear fuel because the proposed revision

  • 10 CFR 50, Appendix B recommended in Appendix A continues to satisfy the
  • 10 CFR 72 Subpart G shall be established, Appendix B, 10 CFR 71
  • NUREG/CR 6407 implemented, and Subpart H, and 10CFR72 Additional commitment to maintained. This commitment Subpart G. This approach in site specific regulatory is contained in new Appendix removal of Regulatory guides, regulations, and E, Davis-Besse Site Specific Guides and associated industry standards are listed Administrative Requirements. standards has been previously in the DQAP Appendix E Other regulatory approved by the NRC for Davis-Besse Site Specific commitments are contained in other facilities in Administrative Requirements new Appendix C. decommissioning status. The and Technical Specifications. NRC approved the removal of commitment to specific Regulatory Guides and standards for:
  • The Oyster Creek Nuclear Generating Station and Independent Spent Fuel Storage Installation DQAP in an attached safety evaluation by letter dated June 27, 2018 (ML18165A136).

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  • Vermont Yankee Nuclear Power Station and Independent Spent Fuel Storage Facility - Review and Acceptance of Changes by letter dated May 1, 2018, ML18099A166.

B. Performance/Verification 1. Methodology

1. Methodology deleted Some specific details found No 50.54 (a)(3)(ii) removing unnecessary detail in the QAPM are not included The use of a quality assurance that is covered by new 3.0 in the DQAP. The intent of alternative or exception Design Control. the DQAP is to describe approved by an NRC safety appropriate and sufficient evaluation. By letter dated requirements to establish how June 27, 2018 the DQAP meets 10 CFR 50 (ML18165A136) the NRC Appendix B while allowing approved the reduced level of flexibility in the manner by implementation details for the which a requirement is met. Oyster Creek Nuclear This reduction in Generating Station and implementation details Independent Spent Fuel provides flexibility of the Storage Installation DQAP in implementation of the DQAP an attached safety evaluation while maintaining appropriate and sufficient guidance to ensure QA program requirements are met.

B.2. Design Control B.2 Design Control is now Some specific details found No 50.54 (a)(3)(ii) contained in new 3.0 Design in the QAPM are not included The use of a quality assurance Control. While the exact in the DQAP. The intent of alternative or exception wording is not the same the the DQAP is to describe approved by an NRC safety new DQAP includes the appropriate and sufficient evaluation. By letter dated design control provisions to requirements to establish how June 27, 2018 control design inputs, the DQAP meets 10 CFR 50 (ML18165A136) the NRC performance, interfaces, Appendix B while allowing approved the reduced level of verification, changes and flexibility in the manner by implementation details for the records. The design control which a requirement is met. Oyster Creek Nuclear provisions include This reduction in Generating Station and requirements for verifying the implementation details Independent Spent Fuel acceptability of design provides flexibility of the Storage Installation DQAP in activities and documents, implementation of the DQAP an attached safety evaluation.

consistent with their effects while maintaining appropriate Also, within this safety on safety for SSCs that have and sufficient guidance to evaluation the NRC approved important-to-safety functions.

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ensure QA program the Design Control section of requirements are met. the Oyster Creek DQAP.

B.3 Design Verification B.3 Design Verification is Some specific details found No 50.54 (a)(3)(ii) now combined in new 3.0 in the QAPM are not included The use of a quality assurance Design Control. While the in the DQAP. The intent of alternative or exception exact wording is not the same the DQAP is to describe approved by an NRC safety the new DQAP includes the appropriate and sufficient evaluation. By letter dated design control provisions to requirements to establish how June 27, 2018 control design inputs, the DQAP meets 10 CFR 50 (ML18165A136) the NRC performance, interfaces, Appendix B while allowing approved the reduced level of verification, changes and flexibility in the manner by implementation details for the records. The design control which a requirement is met. Oyster Creek Nuclear provisions include This reduction in Generating Station and requirements for verifying the implementation details Independent Spent Fuel acceptability of design provides flexibility of the Storage Installation DQAP in activities and documents, implementation of the DQAP an attached safety evaluation.

consistent with their effects while maintaining appropriate Also, within this safety on safety for SSCs that have and sufficient guidance to evaluation the NRC approved important-to-safety functions. ensure QA program the Design Control section of requirements are met. the Oyster Creek DQAP.

B.4 Procurement Control B.4 Procurement Control is Some specific details found No 50.54 (a)(3)(ii) now contained in new 4.0 in the QAPM are not included The use of a quality assurance Procurement Document in the DQAP. The intent of alternative or exception Control. While the exact the DQAP is to describe approved by an NRC safety wording is not the same the appropriate and sufficient evaluation. By letter dated new DQAP establishes requirements to establish how June 27, 2018 controls to assure that the DQAP meets 10 CFR 50 (ML18165A136) the NRC procured items and services Appendix B while allowing approved the reduced level of are subject to quality and flexibility in the manner by implementation details for the technical requirements at which a requirement is met. Oyster Creek Nuclear least equivalent to those This reduction in Generating Station and specified for original implementation details Independent Spent Fuel equipment or specified by provides flexibility of the Storage Installation DQAP in properly reviewed and implementation of the DQAP an attached safety evaluation.

approved revisions to assure while maintaining appropriate Also, within this safety the items are suitable for the and sufficient guidance to evaluation the NRC approved intended service, and are of ensure QA program the Procurement Document acceptable quality, consistent requirements are met. Control section of the Oyster with their effects on safety. Creek DQAP.

The DQAP requires a list of approved suppliers to be periodically audited and evaluated at an established periodicity.

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B.5 Procurement Verification B.5 Procurement Verification Some specific details found No 50.54 (a)(3)(ii) is now combined in new 4.0 in the QAPM are not included The use of a quality assurance Procurement Document in the DQAP. The intent of alternative or exception Control. While the exact the DQAP is to describe approved by an NRC safety wording is not the same the appropriate and sufficient evaluation. By letter dated new DQAP establishes requirements to establish how June 27, 2018 controls to assure that the DQAP meets 10 CFR 50 (ML18165A136) the NRC procured items and services Appendix B while allowing approved the reduced level of are subject to quality and flexibility in the manner by implementation details for the technical requirements at which a requirement is met. Oyster Creek Nuclear least equivalent to those This reduction in Generating Station and specified for original implementation details Independent Spent Fuel equipment or specified by provides flexibility of the Storage Installation DQAP in properly reviewed and implementation of the DQAP an attached safety evaluation.

approved revisions to assure while maintaining appropriate Also, within this safety the items are suitable for the and sufficient guidance to evaluation the NRC approved intended service, and are of ensure QA program the Procurement Document acceptable quality, consistent requirements are met. Control section of the Oyster with their effects on safety. Creek DQAP.

The DQAP requires a list of approved suppliers to be periodically audited and evaluated at an established periodicity.

B.6 Identification and Control of Items B.6 Identification and Control Some specific details found No 50.54 (a)(3)(ii) of Items is now contained in in the QAPM are not included The use of a quality assurance new 8.0 Identification and in the DQAP. The intent of alternative or exception Control of Materials, Parts, the DQAP is to describe approved by an NRC safety and Components. While the appropriate and sufficient evaluation. By letter dated exact wording is not the same requirements to establish how June 27, 2018 the new DQAP establishes the DQAP meets 10 CFR 50 (ML18165A136) the NRC the necessary measures for Appendix B while allowing approved the reduced level of the identification and control flexibility in the manner by implementation details for the of items such as materials, which a requirement is met. Oyster Creek Nuclear including consumables and This reduction in Generating Station and items with limited shelf life, implementation details Independent Spent Fuel parts, components, and provides flexibility of the Storage Installation DQAP in partially fabricated implementation of the DQAP an attached safety evaluation.

subassemblies. Identification while maintaining appropriate Also, within this safety is maintained on the items or and sufficient guidance to evaluation the NRC approved in documents traceable to the ensure QA program the Identification and Control items. Provisions are included requirements are met. of Materials, Parts, and for the maintenance or Components section of the Oyster Creek DQAP.

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replacement of markings due to aging or handling.

B.7 Handling, Storage, and Shipping B.7 Handling, Storage, and Some specific details found No 50.54 (a)(3)(ii)

Shipping is now contained in in the QAPM are not included The use of a quality assurance new section 13. Handling, in the DQAP. The intent of alternative or exception Storage, and Shipping. While the DQAP is to describe approved by an NRC safety the exact wording is not the appropriate and sufficient evaluation. By letter dated same the new DQAP requirements to establish how June 27, 2018 establishes the necessary the DQAP meets 10 CFR 50 (ML18165A136) the NRC measures to control the Appendix B while allowing approved the reduced level of handling, storage, packaging, flexibility in the manner by implementation details for the shipping, cleaning, and which a requirement is met. Oyster Creek Nuclear preservation of items to This reduction in Generating Station and prevent damage or implementation details Independent Spent Fuel deterioration. The DQAP provides flexibility of the Storage Installation DQAP in establishes provisions to implementation of the DQAP an attached safety evaluation.

control situations in which while maintaining appropriate Also, within this safety special requirements might be and sufficient guidance to evaluation the NRC approved needed to ensure important- ensure QA program the Handling, Storage, and to-safety SSCs will be requirements are met. Shipping section of the handled, stored and shipped Oyster Creek DQAP.

adequately.

B.8 Test Control B.8 Test Control is now Some specific details found No 50.54 (a)(3)(ii) contained in new section 11. in the QAPM are not included The use of a quality assurance Test Control. While the exact in the DQAP. The intent of alternative or exception wording is not the same the the DQAP is to describe approved by an NRC safety new DQAP establishes appropriate and sufficient evaluation. By letter dated measures for a test program requirements to establish how June 27, 2018 to demonstrate that the DQAP meets 10 CFR 50 (ML18165A136) the NRC important-to-safety SSCs will Appendix B while allowing approved the reduced level of perform satisfactorily in flexibility in the manner by implementation details for the service in accordance with which a requirement is met. Oyster Creek Nuclear decommissioning technical This reduction in Generating Station and specifications, license implementation details Independent Spent Fuel conditions and design provides flexibility of the Storage Installation DQAP in documentation. The DQAP implementation of the DQAP an attached safety evaluation.

establishes the necessary while maintaining appropriate Also, within this safety measures and governing and sufficient guidance to evaluation the NRC approved provisions to demonstrate that ensure QA program the Test Control section of items subject to these requirements are met. the Oyster Creek DQAP.

provisions will perform satisfactorily in service.

10

B.9 Measuring and Test Equipment Control B.9 Measuring and Test Some specific details found No 50.54 (a)(3)(ii)

Equipment Control is now in the QAPM are not included The use of a quality assurance contained in new section 12. in the DQAP. The intent of alternative or exception Control of Measuring and the DQAP is to describe approved by an NRC safety Test Equipment. While the appropriate and sufficient evaluation. By letter dated exact wording is not the same requirements to establish how June 27, 2018 the new DQAP establishes the DQAP meets 10 CFR 50 (ML18165A136) the NRC measures to control the Appendix B while allowing approved the reduced level of calibration, maintenance, flexibility in the manner by implementation details for the handling, storage and use of which a requirement is met. Oyster Creek Nuclear measuring and test equipment This reduction in Generating Station and (M&TE), including installed implementation details Independent Spent Fuel plant instrumentation that provides flexibility of the Storage Installation DQAP in provides information implementation of the DQAP an attached safety evaluation.

important-to-safety. The while maintaining appropriate Also, within this safety DQAP establishes provisions and sufficient guidance to evaluation the NRC approved for organizational ensure QA program the Control of Measuring and responsibilities to ensure an requirements are met. Test Equipment section of the effective calibration program Oyster Creek DQAP.

and designates the management position responsible for production as the oversight organization of the M&TE calibration process and is also responsible for governance and oversight of the site M&TE control. The DQAP also requires performance of an evaluation on the impact for important-to-safety activities conducted with as found out-of-tolerance M&TE.

B.10 Inspection, Test, and Operating Status B.10 Inspection, Test, and Some specific details found No 50.54 (a)(3)(ii)

Operating Status is combined in the QAPM are not included The use of a quality assurance in new section 11. Test in the DQAP. The intent of alternative or exception Control. While the exact the DQAP is to describe approved by an NRC safety wording is not maintained appropriate and sufficient evaluation. By letter dated and level of detail is reduced requirements to establish how June 27, 2018 the new DQAP establishes the DQAP meets 10 CFR 50 (ML18165A136) the NRC measures for a test program Appendix B while allowing approved the reduced level of to demonstrate that flexibility in the manner by implementation details for the important-to-safety SSCs will which a requirement is met. Oyster Creek Nuclear 11

perform satisfactorily in This reduction in Generating Station and service in accordance with implementation details Independent Spent Fuel decommissioning technical provides flexibility of the Storage Installation DQAP in specifications, license implementation of the DQAP an attached safety evaluation.

conditions and design while maintaining appropriate Also, within this safety documentation. The DQAP and sufficient guidance to evaluation the NRC approved establishes the necessary ensure QA program the Test Control section of measures and governing requirements are met. the Oyster Creek DQAP.

provisions to demonstrate that items subject to these provisions will perform satisfactorily in service.

B.11 Special Process Control B.11 Special Process Control Some specific details found No 50.54 (a)(3)(ii) is now contained in new in the QAPM are not included The use of a quality assurance section 9.0 Control of Special in the DQAP. The intent of alternative or exception Processes. While the exact the DQAP is to describe approved by an NRC safety wording is not the same the appropriate and sufficient evaluation. By letter dated new DQAP establishes requirements to establish how June 27, 2018 provisions to assure that the DQAP meets 10 CFR 50 (ML18165A136) the NRC special processes that require Appendix B while allowing approved the reduced level of interim process controls such flexibility in the manner by implementation details for the as welding, heat treating, which a requirement is met. Oyster Creek Nuclear chemical cleaning and This reduction in Generating Station and nondestructive examination, implementation details Independent Spent Fuel are controlled and provides flexibility of the Storage Installation DQAP in accomplished by qualified implementation of the DQAP an attached safety evaluation.

personnel using approved while maintaining appropriate Also, within this safety written procedures in and sufficient guidance to evaluation the NRC approved accordance with applicable ensure QA program the Control of Special codes, standards, requirements are met. Processes section of the specifications, criteria and Oyster Creek DQAP.

other special requirements.

B.12 Inspection B.12 Inspection is now Some specific details found No 50.54 (a)(3)(ii) contained in new section 10. in the QAPM are not included The use of a quality assurance Inspection. While the exact in the DQAP. The intent of alternative or exception wording is not the same the the DQAP is to describe approved by an NRC safety new DQAP establishes appropriate and sufficient evaluation. By letter dated measures for inspection of requirements to establish how June 27, 2018 important-to-safety activities the DQAP meets 10 CFR 50 (ML18165A136) the NRC to verify conformance with Appendix B while allowing approved the reduced level of specified requirements and flexibility in the manner by implementation details for the meet the acceptance criteria which a requirement is met. Oyster Creek Nuclear established in applicable This reduction in Generating Station and design documentation. Independent Spent Fuel 12

implementation details Storage Installation DQAP in provides flexibility of the an attached safety evaluation.

implementation of the DQAP Also, within this safety while maintaining appropriate evaluation the NRC approved and sufficient guidance to the Inspection section of the ensure QA program Oyster Creek DQAP.

requirements are met.

B.13 Corrective Action B.13 Corrective Action is Some specific details found No 50.54 (a)(3)(ii) now contained in new section in the QAPM are not included The use of a quality assurance 16 Corrective Action. While in the DQAP. The intent of alternative or exception the exact wording is not the the DQAP is to describe approved by an NRC safety same the new DQAP appropriate and sufficient evaluation. By letter dated establishes the necessary requirements to establish how June 27, 2018 measures to promptly the DQAP meets 10 CFR 50 (ML18165A136) the NRC identify, control, document, Appendix B while allowing approved the reduced level of classify, and correct flexibility in the manner by implementation details for the conditions adverse to quality. which a requirement is met. Oyster Creek Nuclear The DQAP requires This reduction in Generating Station and personnel to identify known implementation details Independent Spent Fuel conditions adverse to quality. provides flexibility of the Storage Installation DQAP in Significant conditions implementation of the DQAP an attached safety evaluation.

adverse to quality are while maintaining appropriate Also, within this safety documented and reported to and sufficient guidance to evaluation the NRC approved responsible management. ensure QA program the Corrective Action section requirements are met. of the Oyster Creek DQAP.

B.14 Document Control B.14 Document Control is Some specific details found No 50.54 (a)(3)(ii) now contained in new section in the QAPM are not included The use of a quality assurance 6.0 Document Control. While in the DQAP. The intent of alternative or exception the exact wording is not the the DQAP is to describe approved by an NRC safety same the new DQAP appropriate and sufficient evaluation. By letter dated establishes provisions to requirements to establish how June 27, 2018 specify the format and the DQAP meets 10 CFR 50 (ML18165A136) the NRC content, control the Appendix B while allowing approved the reduced level of development, review, flexibility in the manner by implementation details for the approval, issue, use, revision, which a requirement is met. Oyster Creek Nuclear and temporary changes of This reduction in Generating Station and documents that prescribe implementation details Independent Spent Fuel activities affecting quality to provides flexibility of the Storage Installation DQAP in assure that the correct implementation of the DQAP an attached safety evaluation.

documents are being while maintaining appropriate Also, within this safety employed. and sufficient guidance to evaluation the NRC approved ensure QA program the Document Control section requirements are met. of the Oyster Creek DQAP.

13

B.15 Records B.15 Records is now Some specific details found No 50.54 (a)(3)(ii) contained in new section 17. in the QAPM are not included The use of a quality assurance Quality Assurance Records. in the DQAP. The intent of alternative or exception While the exact wording is the DQAP is to describe approved by an NRC safety not the same the new DQAP appropriate and sufficient evaluation. By letter dated establishes the necessary requirements to establish how June 27, 2018 measures to ensure that the DQAP meets 10 CFR 50 (ML18165A136) the NRC sufficient records of items Appendix B while allowing approved the reduced level of and activities affecting flexibility in the manner by implementation details for the quality are identified, which a requirement is met. Oyster Creek Nuclear generated, collected, stored, This reduction in Generating Station and maintained, and retained. The implementation details Independent Spent Fuel DQAP establishes provisions provides flexibility of the Storage Installation DQAP in to ensure retrievable records implementation of the DQAP an attached safety evaluation.

show objective evidence of while maintaining appropriate Also, within this safety compliance with regulations and sufficient guidance to evaluation the NRC approved and the DQAP implementing ensure QA program the Quality Assurance procedures. Concerning use requirements are met. Records section of the Oyster of electronic records storage Creek DQAP.

and management, the DQAP complies with the NRC guidance given in Regulatory Issue Summary (RIS) 2000-18, Guidance on Managing Quality Assurance Records in Electronic Media, dated October 23, 2000.

C. Assessment 1. Methodology C.1 Methodology is Some specific details found No 50.54 (a)(3)(ii) combined in new section 18. in the QAPM are not included The use of a quality assurance Audits. While the exact in the DQAP. The intent of alternative or exception wording is not maintained the DQAP is to describe approved by an NRC safety and level of detail is reduced appropriate and sufficient evaluation. By letter dated the new DQAP establishes requirements to establish how June 27, 2018 the necessary measures to the DQAP meets 10 CFR 50 (ML18165A136) the NRC implement audits to verify Appendix B while allowing approved the reduced level of compliance and flexibility in the manner by implementation details for the implementation with all which a requirement is met. Oyster Creek Nuclear aspects of the DQAP. The This reduction in Generating Station and DQAP establishes an internal implementation details Independent Spent Fuel audit program frequency provides flexibility of the Storage Installation DQAP in commensurate with the status implementation of the DQAP an attached safety evaluation.

and importance of the activity while maintaining appropriate Also, within this safety without exceeding a 24- and sufficient guidance to evaluation the NRC approved month period unless approved 14

for extension as delineated by ensure QA program the Audits section of the the DQAP. The DQAP requirements are met. Oyster Creek DQAP.

provides provisions for audit schedule, preparation, personnel selection, personnel qualification, performance, reporting, follow-up, and records management. Audits are performed by personnel having no direct responsibilities in the areas to be audited. The internal audit schedule is maintained, reviewed, and revised at least annually to ensure quality programs met regulations and standards. External audits of suppliers are conducted to ensure adequate implementation of the suppliers Quality Assurance Program at a frequency of not more than three years unless an extension is approved in accordance with the DQAP requirements. The DQAP ensures audit results are reviewed and approved in accordance with approved procedures.

C.2. Audit C.1 Methodology is Section 18 of the DQAP No 50.54 (a)(3)(ii) combined with C.2 in new describes the audit process The use of a quality assurance section 18, Audits. The listing including frequency of audits alternative or exception of specific audits and their but in less detail. The audit approved by an NRC safety frequency was removed. program procedures will evaluation. By letter dated While the exact wording is provide the necessary June 27, 2018 not maintained and level of implementation details to (ML18165A136) the NRC detail is reduced the new meet regulations. This approved the reduced level of DQAP establishes the reduction in implementation implementation details for the necessary measures to details provides flexibility of Oyster Creek Nuclear implement audits to verify the implementation of the Generating Station and compliance and DQAP while maintaining Independent Spent Fuel implementation with all appropriate and sufficient Storage Installation DQAP in aspects of the DQAP. The guidance to ensure QA an attached safety evaluation.

DQAP establishes an internal Also, within this safety 15

audit program frequency program requirements are evaluation the NRC approved commensurate with the status met. the Audits section of the and importance of the activity Oyster Creek DQAP.

without exceeding a 24-month period unless approved No 50.54(a)(3) for extension as delineated by The change from performing the DQAP. The DQAP external audits at a frequency provides provisions for audit of not less than three years to schedule, preparation, not more than three years is a personnel selection, personnel clarification. Not more than qualification, performance, three years is more restrictive reporting, follow-up, and than not less than three years.

records management. Audits are performed by personnel having no direct responsibilities in the areas to be audited. The internal audit schedule is maintained, reviewed, and revised at least annually to ensure quality programs met regulations and standards. External audits of suppliers are conducted to ensure adequate implementation of the suppliers Quality Assurance Program at a frequency of not more than three years unless an extension is approved in accordance with the DQAP requirements. The DQAP ensures audit results are reviewed and approved in accordance with approved procedures.

The Oyster Creek DQAP stated that External audits of suppliers are conducted to ensure adequate implementation of the suppliers Quality Assurance Program at a frequency of not less than three years . This was corrected in the Davis-Besse DQAP to a frequency 16

of not more than three years.

D. Independent Safety Review 1. Description Regulatory guides, The requirement for No 50.54 (a)(3)(ii) requirements, industry Independent Safety Review is The use of a quality assurance standards, and exceptions to found in NUREG-0737, alternative or exception those standards that are only Clarification of TMI Action approved by an NRC safety applicable to an operating Plan Requirements, which evaluation. By letter dated facility will not be carried was applicable to licensees of June 27, 2018 over to the DQAP. operating power reactors. (ML18165A136) the NRC Independent Safety Review is This is not applicable to a approved the removal of deleted and a new Safety decommissioning plant. standards and regulatory Review Committee is now guides that are out of scope described in new Appendix D for a decommissioning plant General Administrative for the Oyster Creek Nuclear Requirements. The Safety Generating Station and Review Committee serves the Independent Spent Fuel CNO as an on-site review Storage Installation DQAP in body that performs procedure an attached safety evaluation.

and program reviews for Also, within this safety decommissioning activities evaluation the NRC approved and ISFSI operation as the Appendix D General necessary on matters of Administrative Requirements Nuclear Safety. that describe the new Safety Review Committee.

Table 1 - Regulatory Commitments A. Regulatory Guide 1.8 - September 1975 / ANSI N18.1 - 1971 B. Regulatory Guide 1.30 - August 1972 / ANSI N45.2.4 - 1972 C. Regulatory Guide 1.33 - February 1978 / ANSI N18.7 - 1976 / ANS 3.2 D. Regulatory Guide 1.37 - March 1973 / ANSI N45.2.1 - 1973 E. Regulatory Guide 1.38 - May 1977 / ANSI N45.2.2 - 1978 F. Regulatory Guide 1.39 - September 1977 / ANSI N45.2.3 - 1973 G. Regulatory Guide 1.58 - September 1980 / ANSI N45.2.6 - 1978 H. Regulatory Guide 1.64 - June 1976 / ANSI N45.2.11 - 1974 I. Regulatory Guide 1.74 - February 1974 / ANSI N45.2.10 - 1973 J. Regulatory Guide 1.88 - October 1976 / ANSI N45.2.9 - 1974 K. Regulatory Guide 1.94 - April 1976 / ANSI N45.2.5 - 1974 L. Regulatory Guide 1.116 - May 1977 / ANSI N45.2.8 - 1975 M. Regulatory Guide 1.123 - July 1977 / ANSI N45.2.13 - 1976 N. Regulatory Guide 1.144 - September 1980 / ANSI N45.2.12 - 1977 O. Regulatory Guide 1.146 - August 1980 / ANSI N45.2.23 - 1978 Table 1 - Regulatory Commitments to standards Yes 50.54 (a)(4)

Commitments is deleted and and regulatory guides with a Removal of section A.7 and Regulatory Commitments are focus on operating facilities Table 1 removes commitment now contained in new are out of scope for a to Regulatory Guides and 17

Appendix C. This is a decommissioning plant. The associated standards is complete rewrite to reflect the DQAP will reflect regulatory considered a reduction in plant decommissioning status. standards that apply to commitment to the previously Regulatory guides, industry decommissioning activities. approved QAPM. This is standards, and exceptions to Written procedures applicable considered acceptable those standards that are only to safe storage of nuclear fuel because the proposed revision applicable to an operating recommended in Appendix A will continue to satisfy the facility will not be carried of Regulatory Guide 1.33, criteria of 10CFR50 over to the DQAP. The shall be established, Appendix B, 10 CFR 71 remaining regulations and implemented, and Subpart H, and 10CFR72 quality standard will be added maintained. This commitment Subpart G. This approach in to new Appendix C in the is contained in new Appendix removal of Regulatory DQAP. These are: E, Davis-Besse Site Specific Guides and associated

  • NUREG/CR 6407 decommissioning status. The NRC approved the removal NUREG/CR 6407 of commitment to specific "Classification of Regulatory Guides and Transportation Packaging and standards for:

Dry Fuel Storage System

  • The Oyster Creek Components According to Nuclear Generating Importance to Safety Station and (Revision 1 - October 2013) Independent Spent Fuel Storage Additional commitment to Installation DQAP in site specific regulatory an attached safety guides, regulations, and evaluation by letter industry standards are listed dated June 27, 2018 in the DQAP new Appendix (ML18165A136).

E, Davis-Besse Site Specific

  • Vermont Yankee Administrative Requirements Nuclear Power Station and Technical Specifications. and Independent Spent Fuel Storage Facility - Review and Acceptance of Changes by letter dated May 1, 2018, ML18099A166.

New DQAP Sections not previously included in FENOC QAPM 5.0 Instructions, Consolidation of No 50.54 (a)(3)

Procedures, and Drawings requirements from various Administrative improvement.

Instructions, Procedures and sections is considered an Drawings was not previously administrative improvement. By letter dated June 27, 2018 contained as a separate The Oyster Creek Nuclear (ML18165A136) for the 18

section in the FENOC Generating Station and Oyster Creek Nuclear QAPM. Previous Independent Spent Fuel Generating Station and requirements were found in Storage Installation DQAP Independent Spent Fuel various sections such as was used as a guide. Storage Installation DQAP A.3.f.; Procedures that the NRC approved an implement the QAPM are identical section 5.0 approved by the management Instructions, Procedures and responsible for the applicable Drawings.

quality function. These procedures are to reflect the QAPM and work is to be accomplished in accordance with them.

7.0 Control of Purchased Consolidation of No 50.54 (a)(3)

Material, Equipment, and requirements from various Administrative improvement.

Services sections is considered an This section was not administrative improvement. By letter dated June 27, 2018 previously contained as a The Oyster Creek Nuclear (ML18165A136) for the separate section in the Generating Station and Oyster Creek Nuclear FENOC QAPM. Previous Independent Spent Fuel Generating Station and requirements were found in Storage Installation DQAP Independent Spent Fuel various sections such as B.4, was used as a guide. Storage Installation DQAP Procurement Control, B.5 the NRC approved an Procurement Verification, identical (except change of B.6, Identification and company name) section 7.0 Control of Items. Control of Purchased Material, Equipment, and Services.

17.0 Quality Assurance Consolidation of No 50.54 (a)(3)

Records requirements from various Administrative improvement.

This section was not sections is considered an previously contained as a administrative improvement. By letter dated June 27, 2018 separate section in the The Oyster Creek Nuclear (ML18165A136) for the FENOC QAPM. Previous Generating Station and Oyster Creek Nuclear requirements were found in Independent Spent Fuel Generating Station and various sections such as Storage Installation DQAP Independent Spent Fuel B.2.h; Design Documentation was used as a guide. Storage Installation DQAP and records, which provide the NRC approved an evidence that the design and identical section 17.0 Quality design verification process Assurance Records.

was performed in accordance with this program, shall be collected, stored, and maintained in accordance with documented procedures.

19

Appendix A Terms and Consolidation of No 50.54 (a)(3)

Definitions requirements from various Administrative improvement.

This section was not sections is considered an previously contained in the administrative improvement. By letter dated June 27, 2018 FENOC QAPM. Previous The Oyster Creek Nuclear (ML18165A136) for the terms and definitions were Generating Station and Oyster Creek Nuclear found in various Independent Spent Fuel Generating Station and commitments such as ANSI Storage Installation DQAP Independent Spent Fuel N45.2.10 - 1973, Quality was used as a guide. Storage Installation DQAP Assurance Terms and the NRC approved a similar Definitions. Appendix A Terms and Definitions.

Added: DC Phase 5 and 6; ANSI N45.2.10 - 1973, Quality Assurance Terms and Definitions; NUREG-1536 Revision 1, Standard Review Plan for Spent Fuel Dry Storage Systems at a General License Facility; and NUREG-1757 Vol.1, Rev.2, Consolidated Decommissioning Guidance as references to the approved Oyster Creek DQAP.

Appendix B Writing Addition of these reference No 50.54 (a)(3)

Reference Documents documents is for information Administrative improvement.

This section was not only. This information does previously contained in the not affect the technical Addition of reference FENOC QAPM. requirements of the DQAP or documents is for information regulatory and industry only and follows the example Using the approved Oyster standards. in the letter dated June 27, Creek Nuclear Generating 2018 (ML18165A136) the Station and Independent NRC approved the Oyster Spent Fuel Storage Creek Nuclear Generating Installation DQAP as a guide Station and Independent and adding: NUREG-1536 Spent Fuel Storage Revision 1, Standard Review Installation DQAP in an Plan for Spent Fuel Dry attached safety evaluation Storage Systems at a General which included approval of License Facility, Section 14 section Appendix B Writing Quality Assurance Reference Documents.

Evaluation; and NUREG-1757 Vol.1, Rev.2, Consolidated Decommissioning Guidance, 20

Section 17.6 Decommissioning Plan:

Quality Assurance Program; and SAFETY EVALUATION BY THE OFFICE OF NUCLEAR REACTOR REGULATION DECOMMISSIONING QUALITY ASSURANCE PROGRAM, REVISION 0 EXELON GENERATION COMPANY, LLC OYSTER CREEK NUCLEAR GENERATING STATION AND INDEPENDENT SPENT FUEL STORAGE INSTALLATION DOCKET NOS. 50-219 AND 72-15 to the approved Oyster Creek DQAP; and Entergy Vermont Yankee Quality Assurance Program Manual Vermont Yankee Nuclear Power Station and Independent Spent Fuel Storage Facility - Review and Acceptance of Changes (EPID-L-2017-DP3-0002)

May 1, 2018, ADAMS Accession No. ML18099A166.

Appendix C Regulatory The DQAP will reflect No 50.54 (a)(3)

Commitments regulatory standards that Administrative improvement.

The Appendix did not apply to decommissioning previously exist in the activities and that are not By letter dated June 27, 2018 FENOC QAPM. Regulatory already reflected in site (ML18165A136) the NRC Commitments were FSAR, DSAR. or Technical approved the identical previously contained in Table Specifications. The Appendix C Oyster Creek

- 1 Regulatory requirement for written DQAP containing Commitments. The table was procedures applicable to safe commitments to:

deleted and this Appendix storage of nuclear fuel 10 CFR 50, Appendix B created. recommended in Appendix A 10 CFR 71 Subpart H of Regulatory Guide 1.33, 10 CFR 72 Subpart G shall be established, NUREG/CR 6407 implemented, and maintained 21

is contained in new Appendix Also, contained in the E, Davis-Besse Site Specific approved DQAP Appendix E Administrative Requirements. is a commitment to establish, Creation of the Appendix for implement and maintain this proposed revision is an written procedures applicable administrative improvement. to safe storage of nuclear fuel recommended in Appendix A of Regulatory Guide 1.33.

Appendix D General Addition of these No 50.54(a)(3)

Administrative administrative requirements Administrative Improvement Requirements does not affect the technical This section was not requirements of the DQAP. No 50.54 (a)(3)(ii) previously contained in the Including this level of detail The use of a quality assurance FENOC QAPM. This new is an administrative alternative or exception section contains requirements improvement. approved by an NRC safety for: evaluation. By letter dated

1. Fire Protection June 27, 2018 describing program (ML18165A136) the NRC requirements for a approved the Oyster Creek decommissioning Nuclear Generating Station facility. and Independent Spent Fuel
2. Transport of Storage Installation DQAP in Radioactive Waste an attached safety evaluation describing shipping which included approval of requirements. section Appendix D General
3. Services describing Administrative Requirements.

requirements for Meterology, Offsite Dose Calculation Manual, and Radiological Environmental Monitoring.

4. License Renewal requirements for aging management.

Note: this was contained in the FENOC QAPM A.1.f.

5. Safety Review Committee description.

Appendix E Davis-Besse Addition of this Appendix No 50.54 (a)(3)(ii)

Site Specific Administrative describes the level of The use of a quality assurance Requirements commitment for a alternative or exception decommissioning facility to approved by an NRC safety 22

This section was not RG 1.33, how the ISFSI evaluation. By letter dated previously contained in the quality program requirements June 27, 2018 FENOC QAPM. This new are performed, and which (ML18165A136) the NRC section contains requirements records are maintained and approved the Oyster Creek for: their duration. The FENOC Nuclear Generating Station

1. RG 1.33 requirement QAPM previously committed and Independent Spent Fuel for procedures to RG 1.33 concerning Storage Installation DQAP in applicable to safe procedures and to ANSI an attached safety evaluation storage of nuclear N45.2.9-1974 for records. which included approval of fuel. Commitments to standards section Appendix E Oyster
2. Independent Spent and regulatory guides with a Creek Site Specific Fuel Storage focus on operating facilities Administrative Requirements.

Installation (ISFSI) are out of scope for a describing QA decommissioning plant. No 50.54(a)(3) Changing the program requirements Therefore, the applicable title from Oyster Creek to are performed in requirements are now Davis-Besse is considered a accordance with the captured in this Appendix. No clarification.

applicable changes were made to the 10CFR72.2212 report. NRC approved Appendix E

3. Records Retention other than change the title describing which from Oyster Creek to Davis-records are Besse. See discussion on maintained for a changes to Table 1 for decommissioning discussion regarding removal facility. of commitments.

23

Enclosure B L-19-038 FENOC Decommissioning Quality Assurance Program for the Davis-Besse Nuclear Power Station, Revision 0 (40 pages, excluding this page)

FENOC DECOMMISSIONING QUALITY ASSURANCE PROGRAM (DQAP)

Revision 0 Davis-Besse Nuclear Power Station Docket No. 50-346 License No. NPF-3 Approved By: ______________________________Date ______________

Vice President, Fleet Oversight

This Page Intentionally Left Blank Decommissioning Quality Assurance Program TABLE OF CONTENTS Policy Statement. 2 1.0 Organization.... 3 2.0 Quality Assurance Program.. 6 3.0 Design Control 8 4.0 Procurement Document Control.. 11 5.0 Instructions, Procedures, and Drawings. 13 6.0 Document Control.. 14 7.0 Control of Purchased Material, Equipment, and Services 15 8.0 Identification and Control of Materials, Parts, and Components. 18 9.0 Control of Special Processes 19 10.0 Inspection... 20 11.0 Test Control. 21 12.0 Control of Measuring and Test Equipment. 22 13.0 Handling, Storage, and Shipping.. 24 14.0 Inspection, Test, and Operating Status... 25 15.0 Nonconforming Material, Parts, or Components....... 26 16.0 Corrective Action.... 27 17.0 Quality Assurance Records... 28 18.0 Audits 29 Appendix A Terms and Definitions... 30 Appendix B Writing Reference Documents. 32 Appendix C Regulatory Commitments. 34 Appendix D General Administrative Requirements 35 Appendix E Davis-Besse Site Specific Administrative Requirements 37 Page 1 of 38 Revision 0

Decommissioning Quality Assurance Program Policy Statement The Decommissioning Quality Assurance Program (DQAP) is the highest tiered document that assigns major functional responsibilities for decommissioning facilities owned and operated by FirstEnergy Nuclear Operating Company (FENOC) (the Company).

Implementing documents assign more specific responsibilities and define the organizational interfaces involved in conducting safety-related and important to safety activities within the scope of this DQAP. These requirements apply to those organizations and positions, which manage and perform activities within its scope.

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

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

Page 2 of 38 Revision 0

Decommissioning Quality Assurance Program

1. ORGANIZATION The Company is responsible for the establishment and execution of the DQAP at sites that have submitted a Certification of Permanent Cessation of Operations and Certification of Permanent Removal of Fuel from the Reactor Vessel to the NRC per 10 CFR 50.82(a)(1)(i) and (ii), respectively. The titles of managers used in the DQAP are generic, or functional titles and their formal titles may vary. Unless otherwise specifically prohibited, responsibilities of managers described in the DQAP may be delegated to, and be performed by, other qualified individuals. Positions below the Chief Nuclear Officer (CNO) may report through an additional layer of management but shall maintain sufficient authority and organizational freedom to implement their assigned responsibilities. Establishment of site organizations will be commensurate with the activities and risks associated with Decommissioning (DC) Phases 2, 3, 4, 5, and 6. The different phases are defined in Appendix A of this DQAP.

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

These activities include both performing the functions of attaining quality objectives and the Quality Assurance functions.

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

1.1.3. The overall responsibility for operation, maintenance, inspection, test, modification, decommissioning, and storage of spent fuel resides with the Chief Nuclear Officer (CNO), FENOC. The top level management position responsible for the administration and implementation of the DQAP at Davis-Besse resides at the station and reports to the CNO.

1.1.4. The DQAP is reviewed and approved by the management position responsible for Nuclear Oversight. The management position responsible for Nuclear Oversight is responsible for periodically apprising the CNO on the effectiveness of the DQAP implementation and immediately apprises the CNO of significant problems affecting quality.

1.1.5. Management of line organizations at Davis-Besse are responsible to ensure that the quality of work and activities meets the requirements set forth in the technical specifications, this DQAP, and implementing procedures.

Page 3 of 38 Revision 0

Decommissioning Quality Assurance Program 1.2. Corporate Organizations 1.2.1. The Chief Nuclear Officer (CNO), FENOC, has overall responsibility for the safe and reliable operation of the Company's nuclear stations. This is the management position responsible for setting and implementing policies, objectives, expectations, and priorities to ensure activities are performed in accordance with the DQAP and other requirements. The Safety Review Committee provides periodic updates to the CNO. The following management positions report to and/or receive direction from the CNO with respect to their assigned roles and responsibilities associated with the execution of this DQAP:

  • The station top level management position described in Section 1.3.1.
  • A corporate management position responsible for Nuclear Oversight reports to the CNO and is responsible to provide management and oversight to ensure compliance with the DQAP. The following management position reports to this position:
  • A management position responsible for Davis-Besse Nuclear Oversight maintains a staff to verify the DQAP is effectively implemented. Nuclear Oversight personnel shall have sufficient authority and organizational freedom to identify any quality problems and to verify implementation of corrective actions. Additionally, Nuclear Oversight personnel shall have direct access to appropriate levels of management necessary to perform their function and shall be independent from cost and schedule when opposed to quality and safety considerations. This position may be responsible for a single station or for multiple stations. Functional responsibilities include:

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

o Establishing quality assurance practices and policies.

o Authority and obligation to raise any conditions adverse to quality to the CNO for resolution as necessary.

o Assuring quality activities are performed in accordance with implementing procedures.

o Reporting on oversight activities to the CNO.

o Authority to stop work when quality is adversely affected.

1.2.2. Additional support organizational activities such as emergency preparedness, licensing, calibrations, procurement, training, legal, communications, records and document control, information technology, business operations, and human resources may be provided by the station or by corporate or contracted organizations.

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Decommissioning Quality Assurance Program 1.3. Station Management 1.3.1. The following station management positions describe the typical station DQAP functional responsibilities, which may be delegated to others as established in this document. The specific organization titles for the quality assurance functions are identified in procedures. The authority to accomplish the quality assurance functions described is delegated to the incumbents staff as necessary to fulfill the identified responsibility. These functions may be performed by the same individuals and may report through an additional layer of management but shall maintain sufficient authority and organizational freedom to implement the assigned responsibilities.

  • The station top level management position reports to the CNO and is responsible for station activities and the implementation of quality assurance policies, goals and objectives. These responsibilities also include, but are not limited to functional areas, such as maintenance, engineering, projects, operations, emergency planning, and security. The following positions report to this individual:
  • A management position responsible for production with responsibility for station maintenance, procurement, projects, and planning that support nuclear and personnel safety within the constraints of the decommissioning license and regulatory requirements.
  • A management position responsible for engineering is responsible for the development and maintenance of engineering programs, facility design bases, engineering services and information technology.
  • A management position responsible for implementation of the Radiation Protection Program, Radiological Environmental Monitoring Program, Radiological Effluent Controls Program, radioactive waste shipping, Process Control Program and chemistry activities.
  • A management position responsible for overall operational activities is accountable for maintaining the facility within the constraints of the applicable regulatory requirements and the license.
  • A management position responsible for regulatory assurance is accountable for implementation of the Emergency Plan, Corrective Action Program, Security Plan, and licensing activities.

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2. QUALITY ASSURANCE PROGRAM 2.1. The Davis-Besse QA Program is described in this DQAP which provides control over activities affecting quality to an extent consistent with their importance to safety and compliance. The DQAP includes specific monitoring activities which are measured against acceptance criteria in a manner sufficient to provide Company management assurance that the activities affecting quality are performed in an acceptable manner. The DQAP requirements apply to (i.e. the following are in the scope of the DQAP) systems, structures, or components (SSCs) designated as safety related and important to safety, regulatory programs, and for other activities and SSCs identified in either the facility specific Defueled Safety Analysis Report (DSAR) or Appendix of this DQAP.

2.2. The DQAP satisfies the requirements of 10 CFR 50 Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Processing Plants, 10 CFR 71 Subpart H, Quality Assurance for Packaging and Transportation of Radioactive Material, and 10 CFR 72 Subpart G, Quality Assurance for Independent Storage of Spent Nuclear Fuel and High-Level Radioactive Waste. Regulatory commitments are listed within Appendix C of the DQAP.

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

2.3. Activities affecting quality shall be accomplished under suitably controlled conditions. Controlled conditions include the use of appropriate equipment; suitable environmental conditions for accomplishing the activity, such as adequate cleanliness; and assurance that all prerequisites for the given activity have been satisfied. The DQAP takes into account the need for special controls, processes, test equipment, tools, and skills to attain the required quality, and the need for verification of quality by inspection and test where required.

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

2.5. Program Control and Authority 2.5.1. The management position responsible for Nuclear Oversight is responsible for ensuring the applicable portions of the DQAP are properly documented, approved and implemented. Disputes arising between departments or organizations on any QA matter that cannot be resolved at a lower level of management will be referred to the CNO.

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Decommissioning Quality Assurance Program 2.5.2. Additional requirements for specific programs are described in Administrative Controls of technical specifications or in the DQAP, with the exception of security requirements which are contained in the Physical Security Plan; and Emergency Plan requirements which are contained within the Site Emergency Plan. Fire Protection Program requirements are addressed in Appendix D of this DQAP.

2.6. Program Review 2.6.1 The status and effectiveness of the DQAP and its implementation is periodically reviewed by the management of the organization responsible for its execution. In addition, the effectiveness of the DQAP is evaluated and reported by Nuclear Oversight through the audit and inspection functions.

2.7. Personnel Training and Qualifications 2.7.1. Personnel assigned to implement elements of the quality assurance program are capable of performing their assigned tasks.

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

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

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Decommissioning Quality Assurance Program 3.0. DESIGN CONTROL 3.1. Measures shall be established to assure that the designs, including applicable regulatory requirements and design bases, technical and quality requirements are correctly translated to design documents which include specifications, drawings, procedures and instructions. The Company has overall responsibility for design and design control activities including, preparing, reviewing, approving, and verifying design documents related to the facility's SSCs within the scope of the DQAP.

3.2. Design changes to SSCs within the scope of this DQAP shall be properly controlled using design control measures commensurate with those applied to the original design. Design changes are reviewed and approved by the same design groups cognizant in the discipline affected by the change that reviewed and approved the original documentation unless alternative design groups are designated. Design activities associated with the facility changes or modifications may be performed by the Company or qualified contractors.

Design groups shall have access to background information, shall be competent in the specific area of design interest, and shall understand the requirements and intent of the original design.

3.3. Measures shall be established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to SSCs that have current safety-related and important to safety functions.

Design control implementing procedures shall define responsibility for the following:

  • Design Input
  • Design Performance
  • Design Interface Control
  • Design Verification
  • Design Change 3.4. Design inputs shall be identified, documented and correctly translated into design outputs. Design inputs shall be specified to a level of detail necessary to allow the design activities to be carried out in a controlled manner. The final design output shall relate to the design input in sufficient detail to facilitate design verification.

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Decommissioning Quality Assurance Program 3.5. The design organization shall prescribe and document the design activities to the level of detail necessary to permit the design process to be completed in a correct manner which permits verification that the design meets requirements.

Design documents shall support facility design, construction, safe storage and handling of spent fuel, and decommissioning projects. Appropriate quality standards shall be identified and documented, and their selection reviewed and approved. Deviations from original design standards shall be reviewed to ensure that the designated quality requirements remain in the design of SSCs as applicable.

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

3.7. Design interfaces for SSCs within the scope of this DQAP shall be identified and controlled. Interface controls shall include the assignment of responsibility and the establishment of procedures among participating design organizations.

Controls shall be established for the review, approval, release, distribution and revision of documents involving design interfaces. Design information transmitted across interfaces shall be documented and controlled.

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

3.9. Design verification for SSCs within the scope of this DQAP shall provide assurance that the final design is correct and has been performed in accordance with approved procedures describing position responsibilities and authorities for the design reviews. Documentation to be reviewed for this design work includes the necessary calculations and/or analysis, design criteria specifications, drawings, procedures, and instructions to permit a comprehensive review.

3.10. Design verification may be accomplished through design reviews, alternate calculations, or qualification testing. These methods of design verification are defined in design procedures as applicable. The results of the design verification activities shall be documented with the identification of the verifier Page 9 of 38 Revision 0

Decommissioning Quality Assurance Program clearly documented. Design verification shall be performed by competent individual(s) other than those who performed the original design but may be from the same organization. This verification may be performed by the originators supervisor, provided the supervisor did not specify a singular design approach, rule out certain design considerations, did not establish the design inputs used in the design, or the supervisor is the only individual in the organization competent to perform the verification. Cursory supervisory reviews do not satisfy the intent of design verification. Design verification shall be completed prior to relying upon the SSC to perform its important to safety function.

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

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

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Decommissioning Quality Assurance Program 4.0. PROCUREMENT DOCUMENT CONTROL 4.1. Measures shall be established for the preparation, review, and approval of procurement documents for those items and activities within the scope of this DQAP. Procurement documents include or reference the appropriate regulatory, technical, and quality requirements necessary to assure adequate quality for those materials, equipment, and services that are within the scope of this DQAP. Measures are established to assure that, to the extent necessary, contractors or subcontractors provide a QA Program consistent with the provisions of 10 CFR 50 Appendix B, 10 CFR 71 Subpart H, or 10 CFR 72 Subpart G, and 10 CFR 21, as applicable.

4.2. The Company maintains a controlled list of evaluated suppliers that are audited on a triennial basis. The evaluated list of such vendors, suppliers, and contractors is described in controlling procedures for the appropriate important to safety classification except for procurement from other licensees that have a NRC approved quality program.

4.3. Procurement documents require the vendors to incorporate quality assurance program requirements in sub-tier procurement documents and allow right of access to the vendors, sub-tier vendors, and contractors facilities and records for inspection or audit by the Company or its designated representative.

4.4. Procurement document control applies to SSCs within the scope of this DQAP and any spare or replacement parts for those SSCs. Procurement documents shall include those requirements necessary to assure that the items and services to be provided meet the specified technical and quality requirements.

Specifically, the procurement system assures that the appropriate technical and quality requirements are specified for procurement of items and services considering the important to safety function, complexity of the design, manufacturing, degree of inspection/testability upon receipt and other factors which affect the quality of products and services.

4.5. 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 evaluation; identification of replacement parts where applicable; and review and evaluation of supplier's QA Program prior to release for bid and contract award for activities within the scope of this DQAP.

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Decommissioning Quality Assurance Program 4.6. Procedures shall be established to review the adequacy of the technical and QA requirements specified within procurement documents.

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

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Decommissioning Quality Assurance Program 5.0. INSTRUCTIONS, PROCEDURES AND DRAWINGS 5.1. Measures shall be established to assure that quality activities are prescribed by and performed in accordance with documented instructions, procedures, and drawings. Documented and approved instructions, procedures, and drawings are required to accomplish work on SSCs within the scope of this DQAP.

5.2. These instructions, procedures, and drawings include, as appropriate, quantitative or qualitative acceptance criteria for determining that activities have been satisfactorily accomplished. Procedures may include reference to vendor equipment manuals, design drawings and specifications, prerequisites, special precautions, and the delineation of work to be performed. Equipment manuals and manufacturers instructions shall be readily available for use as appropriate.

5.3. Controls are established which ensure that instructions, procedures, and drawings are current and accurately reflect plant design and regulatory requirements. Documents comprising of instructions, procedures, specifications, and drawings prepared by outside contractors for the performance of site activities are reviewed and approved by the responsible manager or designated representative.

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Decommissioning Quality Assurance Program 6.0. DOCUMENT CONTROL 6.1. Measures shall be established to control the issuance of documents, such as instructions, procedures, drawings, including changes thereto, which prescribe activities affecting quality and activities within the scope of this DQAP. These measures assure that documents, such as procedures, instructions and drawings, are reviewed for adequacy by qualified personnel other than the personnel that prepared the document, approved for release and use, and available at the location where the activity is performed. Written procedures shall define the type of documents to which the document control system applies. These procedures also define the process for controlling the preparation, review, approval, issuance, and distribution.

6.2. Documents and changes to documents that prescribe or verify activities within the scope of this DQAP shall be controlled in a manner that precludes the use of inappropriate or outdated documents. The document control system procedures shall be established to identify the current revision of instructions, procedures, specifications, drawing and procurement documents.

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

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Decommissioning Quality Assurance Program 7.0. CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES 7.1. Measures shall be established for the control of purchased material, equipment, and services to assure they conform to the procurement documents as they apply to activities within the scope of this DQAP. These measures provide for the following as appropriate: source evaluation and selection, evaluation of objective evidence of quality furnished by the supplier, source inspection, audit, and examination of items or services. Procedures shall describe each organization's responsibilities for the control of purchased material, equipment, and services, including the interfaces between all affected organizations.

7.2. Verification that a supplier can meet the specified technical and quality requirements shall be documented. The Company maintains a controlled list of evaluated suppliers that are audited on a triennial basis. Documented supplier performance monitoring is performed in accordance with approved procedures as an acceptable alternate to the performance of the annual evaluation of suppliers. The evaluated list of such vendors, suppliers, and contractors is described in controlling procedures for the appropriate important to safety classification except for procurement from other licensees that have an NRC approved quality program. Suppliers of commercial grade calibration or testing 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 as described below.

7.3. This DQAP considers that other 10 CFR Parts 50 and 52 licensees, Authorized Nuclear Inspection Agencies, National Institute of Standards and Technology, or other State and Federal agencies which may provide items or services to the facility are not required to be evaluated or audited.

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

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Decommissioning Quality Assurance Program 7.4.1. A documented review of the supplier's accreditation is performed and includes a verification of the following:

  • The calibration or test laboratory holds accreditation by an accrediting body recognized by the ILAC MRA. The accreditation encompasses ISO/IEC-17025:2005, "General Requirements for the Competence of Testing and Calibration Laboratories."
  • For procurement of calibration services, the published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.
  • For procurement of testing services, the published scope of accreditation for the test laboratory covers the needed testing services including test methodology and tolerances / uncertainty.

7.4.2. The purchase documents require that:

  • The service must be provided in accordance with their accredited ISO/IEC-17025:2005 program and scope of accreditation.
  • As found calibration data must be reported in the certificate of calibration when calibrated items are found to be out-of-tolerance. (For calibration services only)
  • The equipment /standards used to perform the calibration must be identified in the certificate of calibration. (For calibration services only)
  • The customer must be notified of any condition that adversely impacts the laboratorys ability to maintain the scope of accreditation.
  • Additional technical and quality requirements, as necessary, based upon a review of the procured scope of services, which may include, but are not necessarily limited to, tolerances, accuracies, ranges, and industry standards.

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

  • The contracted calibration or test service has been performed in accordance with their ISO/IEC-17025:2005 program, and has been performed within their scope of accreditation; and
  • The purchase order's requirements are met.

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Decommissioning Quality Assurance Program 7.5. The effectiveness of contractors and supplier's QA program 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, audit, or a combination to ensure continued acceptable supplier performance. Receiving inspection shall verify, by objective evidence, the acceptability of items in accordance with facility procedures. Accepted items are appropriately marked and located in a controlled storage area until use. Documentary evidence shall be retained in accordance with facility requirements and applicable regulatory requirements and shall be sufficient to identify the specific requirements, such as codes, standards, or specifications, met by the purchased material and equipment.

7.6. For acquiring of services only, such as: third-party inspection, engineering and consulting services; auditing and installation; and repair, overhaul, or maintenance work from suppliers whose QA Program has not been reviewed or accepted; those suppliers may be used provided additional controls such as technical verification of data produced, surveillance and/or audit of the activity, or review of objective evidence are employed. These additional controls shall be documented in the request for services and approved by the appropriate level of management.

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

7.8. Designated quality personnel or other personnel with appropriate qualifications are responsible for assuring source inspections, surveys, or audits of suppliers are performed as necessary. Documentation of acceptance shall be available prior to installation or acceptance for use.

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Decommissioning Quality Assurance Program 8.0. IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS 8.1. Measures shall be established for the identification and control of material, parts, and components, including partially fabricated assemblies and consumables, to assure that only correct and accepted items are used or installed. Identification is maintained on the items or in documents traceable to the items, and physical identification shall be used to the maximum extent possible. If physical identification is either impractical or insufficient for proper control, the Company controls an item by physical separation, procedural control or other appropriate means.

8.2. Markings are applied using materials and methods that are clear, legible and do not detrimentally affect the function or service life of the items that are marked. Markings are transferred to each part of an identified item prior to being subdivided. Markings are not obliterated or masked by surface treatments or coatings unless alternative identification methods are established. When codes, standards, or specifications require specific identification or traceability requirements of an item, procedures shall describe how to maintain traceability as applicable.

8.3. Provisions are made in procedures for maintenance or replacement of markings or identification due to damage from handling or aging, excessive deterioration due to environmental exposure, and for updating records while in storage. Items having limited shelf or operating life are controlled to preclude use after the shelf life or operating life has expired.

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Decommissioning Quality Assurance Program 9.0. CONTROL OF SPECIAL PROCESSES 9.1. Measures shall be established to assure that special processes that require interim process controls to assure quality, such as welding, heat treating, and nondestructive examination, are controlled. These provisions include assuring that special processes are accomplished by qualified personnel using instructions, procedures, drawings, checklists, or other appropriate means.

Personnel are qualified and special processes are performed in accordance with applicable codes, standards, specifications, criteria or other specially established requirements. Special processes are those where the results are highly dependent on the control of the process or the skill of the operator, or both, and for which the specified quality cannot be fully and readily determined by inspection or test of the final product. Records are maintained, as appropriate, for the qualified personnel, processes, and equipment.

9.2. The Company qualifies NDE personnel in accordance with the applicable editions of the codes and standards accepted by the NRC as identified in Company NDE procedures.

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

10.2. A comprehensive program of inspections shall be established and implemented to verify conformance of an item or activity with the specified requirements and inspection methods used and will be performed by personnel qualified to validate that the activities meet the acceptance criteria specified in applicable design documents. Inspections shall be performed by qualified individuals other than those who perform or directly supervise the activity being inspected.

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

10.4. Inspections shall be planned to ensure the characteristic to be inspected and the methods used to perform the inspection and acceptance criteria are documented. If inspection of processed or fabricated items is impractical, monitoring of the processing method and equipment shall be utilized.

Process monitoring shall be performed by qualified personnel or a qualified automated process. Inspection and process monitoring shall both be used if quality control is inadequate without both.

10.5. Final inspections shall include record review and examinations, measurements/tests as appropriate to verify adequate quality measures were employed in the construction, fabrication and/or processing. Final inspection results shall document the as-found condition including final acceptanceIrejection criteria evaluation.

10.6. Unacceptable inspection results shall be evaluated and resolved in accordance with approved procedures. Any modifications, repairs, and replacements are re-inspected to the same standard or method to verify acceptability of the items. Inspection records shall identify the item inspected, date of inspection, inspectors identity, results of inspection, and reference to information taken in connection with nonconformances.

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

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

Test results are evaluated by qualified personnel to determine compliance with established acceptance criteria. Test results which do not meet acceptance criteria, shall be documented and evaluated in order to determine the appropriate corrective actions. The test program shall require that modifications, repairs, and replacement of items that have a current important to safety function be tested, utilizing the same criteria as the original items to the extent applicable to the current important to safety function. If alternative tests are required, the alternative tests must be reviewed and approved by the same organization that established the original requirements unless the applicable manager designates another responsible organization. Test records shall be maintained in accordance with approved procedures.

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

12.2. Organizational responsibilities shall be delineated for establishing, implementing, and assuring the effectiveness of the calibration program for M&TE. Reference standards used to determine the acceptability of items and activities, shall be of appropriate type, and maintained within prescribed accuracy limits, suitable range and accuracy in order to verify conformance to specified requirements.

12.3. The management position responsible for production is responsible for the governance of M&TE and oversight of the site calibration process for Davis-Besse. This includes the establishment of calibration practices, intervals, accuracy requirements, certification/de-certification, and equivalency decisions, as well as the resolution of technical issues regarding M&TE calibration. This management position is also responsible for governance and oversight of site M&TE Control. This includes assessment of site compliance to the control of M&TE as defined in corporate maintenance procedural guidance.

12.4. Procedures for the control and calibration of permanently installed plant equipment that are within the scope of this DQAP shall specify identification requirements (labeling, codes, or other documented control system), the recall process and calibration process and frequencies (including documented pre-calibration checks) of the M&TE to nationally recognized standards.

Calibration methods are documented and performed by competent personnel in an environment that does not adversely affect the calibration. The calibration procedures shall specify recording of as-found conditions and a means for determining which equipment shall be included in the calibration program. M&TE used in the calibration of permanently installed plant equipment shall have ranges, precision, and accuracy equal to or greater than that to be calibrated and where this is impractical; the cognizant authority shall document rationale for accuracy.

12.5. 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 in order to maintain accuracy and operating characteristics of the M&TE.

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Decommissioning Quality Assurance Program 12.6. Calibration reference standards shall be based on nationally recognized standards or accepted values of natural physical constants. Where national standards do not exist, the basis for the calibration shall be documented.

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

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

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13. HANDLING, STORAGE, AND SHIPPING 13.1. Measures shall be established to control the handling, storage, shipping, packaging, cleaning and preservation of items, material and equipment within the scope of this DQAP, in accordance with applicable design, work, and procurement requirements in order to prevent damage or deterioration during handling, packaging, preservation, storage, and shipping.

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

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

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14. INSPECTION, TEST, AND OPERATING STATUS 14.1. Measures shall be established for indicating the status of items within the scope of this DQAP undergoing inspections and tests to prevent the inadvertent bypassing or altering the sequence of such inspections or tests and avoid inadvertent operation. Where necessary to preclude inadvertent bypassing of inspections or tests, or to preclude inadvertent operation, these measures require the inspection, test, or operating status be verified before release, fabrication, receipt, installation, test or use. These measures also establish the necessary authorities and controls for the application and removal of status indicators or labels. The methods used to indicate inspection, test and operating status, including control of these indicators, are prescribed by approved procedures and shall be readily apparent and verifiable.

14.2. In addition, temporary design changes (temporary modifications), such as temporary bypass lines, electrical jumpers and lifted wires, and temporary trip-point settings, are controlled by procedures that include requirements for appropriate installation and removal, independent/concurrent verifications where necessary, and status tracking.

14.3. Deviations from the required sequence shall be subject to the same level of control as the generation of the original sequence to prevent the bypassing or omission of required test or inspection. The operating status of nonconforming, inoperable or malfunctioning SSCs shall be identified and documented to prevent inadvertent operation.

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

15.2. Measures shall require that the individual (or designee), discovering a nonconformance, identify, describe, and document the nonconformance in accordance with the requirements of the corrective action program. Actions taken to address nonconforming items shall be documented. Controls are provided to address conditional release of nonconforming items for use on an at-risk basis prior to resolution and disposition of the nonconformance, including maintaining identification of the item and documenting the basis for such release. Conditional release of nonconforming items for installation requires the approval of designated management. Nonconformances are corrected or resolved prior to depending on the item to perform its intended important to safety function. Nonconformances to design requirements dispositioned as repair or use-as-is are subject to design control measures commensurate with those applied to the original design. Significant trends in nonconformances are reported to management in accordance with applicable procedures, regulatory requirements, and industry standards.

15.3. Nonconforming items that are being used for training must be controlled (e.g., administratively controlled, permanently identified, marked, have obliterated Material ID Tag or Q level indicators) to prevent inadvertent or inappropriate use of the item.

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

16.2. In the case of suppliers performing activities within the scope of this DQAP, or other similar situations, the applicable manager may delegate specific responsibilities for corrective actions but maintains responsibility for the effectiveness of corrective action measures.

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

17.2. Distribution of records shall be controlled in accordance with written procedures. Measures are established for replacement, restoration, or substitution of lost or damaged records. A system for receipt control of records is established. Receipt control is required for records transferred between Company locations, vendors and the Company, and from Company department files to final storage locations.

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

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

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

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

17.5. Record retention periods are established to meet regulatory, Updated Final Safety Analysis Report (UFSAR)/DSAR, DQAP, and License requirements. The most stringent retention period is implemented when multiple requirements exist. Records are dispositioned at the end of the prescribed retention period.

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

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

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

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

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

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

D. Item B applies to supplier audits and evaluations except that a total combined interval for any three (3) consecutive inspection or audit intervals does not exceed 3.25 times the specified inspection or audit interval.

18.3. Audit scheduling, preparation, personnel selection, personnel qualification, performance, reporting, response, follow-up, and records management for audits are performed in accordance with written procedures. Audit scopes and schedules are based upon the status of work progress, activities being performed, regulatory requirements, and/or experience with the organization being audited. An audit schedule shall be maintained, reviewed, and revised as necessary at least annually, to ensure that programs receive necessary audits to support regulatory compliance.

18.4. External audits of suppliers providing materials, parts, equipment or services within the scope of this DQAP are scheduled and performed based on the importance of the activity and to confirm implementation of the supplier's Quality Assurance Program at a frequency of not more than three (3) years with an audit extension period identified in 18.2.D above.

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

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Decommissioning Quality Assurance Program APPENDIX A TERMS AND DEFINITIONS A.1. DC Phase 1

  • The period from Permanent Shutdown until permanent fuel removal A.2. DC Phase 2
  • The period from permanent fuel removal until end of the Zirconium (Zr)

Fire Analysis (a.k.a. zirc-fire) period A.3. DC Phase 3

  • The period from the end of the Zr Fire Analysis period until fuel pool is empty (fuel is in the Independent Spent Fuel Storage Installation (ISFSI))

A.4. DC Phase 4

  • The period from fuel in the ISFSI until all fuel removed from the ISFSI A.5. DC Phase 5
  • The period from all fuel removed from site until start of decontamination A.6. DC Phase 6
  • The period from start of decontamination until License termination Note: Some decontamination of SSCs may occur in any DC Phase.

A.7. Important to safety (for this DQAP)

  • SSCs whose functions are to protect spent fuel and/or the capability to prevent or mitigate the consequences of accidents that could result in potential for offsite exposure comparable to the guidelines in 10 CFR 50.34(a)(1), 10 CFR 50.67(b)(2) or 10 CFR 100.11, as applicable. These SSCs are typically listed in site specific DSARs or ISFSI design documents. Refer to NUREG/CR-6407, Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety, for application of this term to transportation packaging and dry fuel storage systems for compliance with 10 CFR 71 and 10 CFR 72.
  • Safety Related - SSCs, which are considered important to safety because they perform safety actions, are required to avoid or mitigate the consequences of abnormal conditions or accidents. These SSCs are typically listed in site specific DSARs or ISFSI design documents.

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Decommissioning Quality Assurance Program A.8. For other terms and definitions refer to the applicable standard or regulatory guidance such as:

  • ASME NQA-1, 1994, Quality Assurance Requirements for Nuclear Facility Applications
  • NUREG-1536 Revision 1, Standard Review Plan for Spent Fuel Dry Storage Systems at a General License Facility
  • NUREG-1757 Vol.1, Rev.2, Consolidated Decommissioning Guidance Page 31 of 38 Revision 0

Decommissioning Quality Assurance Program APPENDIX B WRITING REFERENCE DOCUMENTS B.1. Quality Standards and Regulatory Guidance

  • Regulatory Guide 7.10, Establishing Quality Assurance Programs for Packaging Used in the Transportation of Radioactive Materials (Revision 2-March 2005).
  • NUREG-1536 Revision 1, Standard Review Plan for Spent Fuel Dry Storage Systems at a General License Facility, Section 14 Quality Assurance Evaluation.
  • NUREG-1757 Vol.1, Rev.2, Consolidated Decommissioning Guidance, Section 17.6 Decommissioning Plan: Quality Assurance Program.

B.2. Safety Evaluation Reports

  • Revision 1, U.S. NRC, Safety Evaluation by the Office of Nuclear Reactor Regulation quality assurance independent review program alternative, Duane Arnold Energy Center, Kewaunee Nuclear Power Plant, Monticello Nuclear Plant, Palisades Nuclear Plant, Point Beach Nuclear Plant, Units 1 and 2, Docket No. 50-331, 50-305, 50-263, 50-255, 50-266, 50-301, 50-282, and 50-306, Dated January 13, 2005, ADAMS Accession No. ML050210276.
  • U.S. NRC, Safety Evaluation by the Office of Nuclear Reactor Regulation related to revision 15 of the operational quality assurance manual, Entergy operations, Inc. Grand Gulf Nuclear Station, Unit 1, Docket No. 50-416, November 18, 1997.
  • U.S. Nuclear Regulatory Commission, Safety Evaluation by the Office of Nuclear Reactor Regulation request for change to the operating quality assurance manual, revision 31, change notice 15-002, Union Electric Company, Callaway Plant, Unit 1, Docket No. 50-483, April 1, 2016, ADAMS Accession No. ML16089A167.
  • U.S. NRC, Safety Evaluation by the Office of Nuclear Reactor Regulation proposed change to the Quality Assurance Program Common Safety Review Board Conduct of Operations Southern Nuclear Operating Company, Inc. for Joseph M. Farley Nuclear Plants, Units 1 and 2; Edwin I. Hatch Plant, Units 1 and 2; Vogtle Electric Generating Plant, Units 1 and 2, Docket Nos. 50-348, 50-364, 50-321, 50-366, 50-424, and 50-425. June 17, 2005, ADAMS Accession No. ML051570349.
  • U.S. NRC, Safety Evaluation by the Office of Nuclear Reactor Regulation Decommissioning Quality Assurance Program changes San Onofre Nuclear Generating Station, Units 1, 2, and 3 and the Independent Spent Fuel Storage Installation, Docket Nos. 50-206, 50-361, 50-362, and 72-041 Common Safety Review Board Conduct of Operations. July 23, 2015, ADAMS Accession No. ML15191A461.

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  • U.S. NRC, Safety Evaluation by the Office of Nuclear Reactor Regulation, Decommissioning Quality Assurance Program, Revision 0, Exelon Generating Company, LLC, Oyster Creek Nuclear Generating Station and Independent Spent Fuel Storage Installation, Docket Nos. 50-219 and 72-15, June 27, 2018, ADAMS Accession No. ML18165A136.
  • U.S. NRC, Safety Evaluation of the Nuclear Operations, Inc, Vermont Yankee Nuclear Power Station, Quality Assurance Program Manual, Revision 7, May 1, 2018, ADAMS Accession No. ML18099A166.

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Decommissioning Quality Assurance Program APPENDIX C REGULATORY COMMITMENTS C.1. 10 CFR 50 Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Processing Plants C.2. 10 CFR 71 Subpart H, Quality Assurance C.3. 10 CFR 72, Subpart G, Quality Assurance C.4. NUREG/CR-6407, Classification of Transportation Packaging and Dry Fuel Storage System Components According to Important to Safety (2/1996)

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Decommissioning Quality Assurance Program APPENDIX D GENERAL ADMINISTRATIVE REQUIREMENTS D.1. Fire Protection 10 CFR 50.48(f) requires that licensees that have submitted the certification required under 50.82(a)(1) shall maintain a fire protection program to address the potential for fires that could cause the release or spread of radioactive materials. The quality assurance program established for these fire protection SSCs ensures that design, procurement, instruction, procedures, drawings, inspection, installation, testing, maintenance, operations, nonconforming Items, corrective action, records, audits and administrative controls meet the applicable quality assurance guidelines as described in Appendix A to BTP APCSB 9.5-1 during decommissioning and permanent shutdown. Engineering determines what fire protection SSCs are required to prevent fires, rapidly detect, control, and extinguish fires that do occur and could result in a radiological hazard and, minimize the risk the public, environment, and plant personnel resulting from fires that could result in a release of radioactive materials. Engineering also establishes the requirements for the design, procurement, fabrication, installation and/or modification of these fire protection SSCs. All other fire protection equipment and supplies will be of commercial quality, in accordance with National Fire Protection Association (NFPA) guidelines.

D.2. Transport of Radioactive Waste D.2.1 When the Company contracts with vendors to transport radioactive waste in NRC approved shipping packages, it meets the requirements of 10 CFR 71, Subpart H. The Company assures that this service is procured from an organization with a QA program and if applicable, includes a NRC licensed transport system. Loading, surveying, closure, placarding, and inspections are conducted in accordance with written procedures and instructions.

Transport casks and trailers are inspected before release in accordance with Department of Transportation (DOT) 49 CFR. Shipping manifests, including final radiation surveys, are completed and retained. Radioactive waste shipments not meeting the requirements for NRC approved packaging, shall meet the requirements of DOT 49 CFR.

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Decommissioning Quality Assurance Program D.3. Services D.3.1. The Company procures services from qualified suppliers. It is not necessary that these suppliers have a quality assurance program approved by the licensee, however, suppliers should provide a quality assurance program that includes the quality assurance program elements presented in Regulatory Guide 4.15, Quality Assurance for Radiological Monitoring Programs (Normal Operations) - Effluent Streams and the Environment, and routinely provide program data summaries sufficiently detailed to permit evaluation of the program for the following areas:

  • Meteorology.
  • Radiological environmental monitoring.

D.4. License Renewal D.4.1. Consistent with the requirements of 10 CFR 54.21(a)(3), the Company implements the requirements of DQAP Section 1 through 18 for aging management activities related to safety related SSCs as described by licensing documents for those systems that remain active.

D.4.2. Additionally, to manage the aging effects of non-safety related SSCs that were determined to be within the scope of License Renewal, the Company implements the administrative controls, corrective actions and confirmation processes described in DQAP Sections 6 and 16 for those systems that remain active.

D.5. Safety Review Committee D.5.1. The Safety Review Committee (SRC) serves the CNO as an on-site review body that performs procedure and program reviews for decommissioning activities and ISFSI operation as necessary on matters of Nuclear Safety.

Details regarding the membership, quorum, agenda, and meeting schedule are contained in implementing procedures.

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Decommissioning Quality Assurance Program APPENDIX E DAVIS-BESSE SITE SPECIFIC ADMINISTATIVE REQUIREMENTS E.1. Regulatory Guide 1.33 E.1.1. Written procedures applicable to safe storage of nuclear fuel recommended in Appendix A of Regulatory Guide 1.33, shall be established, implemented, and maintained. (ref. Davis-Besse Technical Specification Section 5.4, Procedures)

E.2. Independent Spent Fuel Storage Installation (ISFSI) SSC E.2.2. ISFSI quality assurance program requirements are performed in accordance with the applicable 10 CFR 72.212 report which invokes the portions of the NRC approved 10 CFR 50 Appendix B quality assurance program as described in this DQAP, commensurate with the safety classification of the component and quality requirements specified in the cask vendor Final Safety Analysis Report (FSAR) or site-specific license.

E.3. Records Retention E.3.1 The following records shall be retained for at least five years:

  • Records and logs of activities related to the safe storage of irradiated fuel.
  • Records and logs of principle maintenance activities, inspections, repair and replacement of principal items of equipment related to safe storage of irradiated fuel.
  • All Licensee Event Reports.
  • Records of surveillance activities, inspections and calibrations required by technical specifications.
  • Records of changes made to the procedures required by technical specification.
  • Records of sealed source leak tests and results.
  • Records of annual physical inventory of all source material of record.

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Decommissioning Quality Assurance Program E.3.2 The following records shall be retained for the duration of the Facility License:

  • Records and drawing changes reflecting facility design modification made to systems and equipment needed for the safe storage of irradiated fuel as described in the Updated Final Safety Analysis Report.
  • Records of irradiated fuel inventory, fuel transfers and assembly burnup histories.
  • Records of facility radiation and contamination surveys.
  • Records of doses received by all individuals for whom monitoring was required.
  • Records of gaseous and liquid radiative material released to the environs.
  • Records of training and qualification for current members of the facility staff.
  • Records of reviews performed for changes made to procedures or equipment or reviews of tests and experiments pursuant to 10 CFR 50.59.
  • Records of results of analyses required by the Radiological Environmental Monitoring Program.
  • Records of radioactive shipments.

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