BVY 17-023, Proposed Revision to the Entergy Vermont Yankee Quality Assurance Program Manual (VY QAPM)

Proposed Revision to the Entergy Vermont Yankee Quality Assurance Program Manual (VY QAPM)

ML17268A152
Person / Time
Site:	Vermont Yankee, 07100907
Issue date:	09/19/2017
From:	Chappell C Entergy Nuclear Operations
To:	Document Control Desk, Office of Nuclear Material Safety and Safeguards, Office of Nuclear Reactor Regulation
References
BVY 17-023, CNR0-2017-00017
Download: ML17268A152 (111)

Text

• • ~ Entergy Entergy Nuclear Operations, Inc.

Vermont Yankee Nuclear Power Station 320 Governor Hunt Road Vernon, VT 05354 Coley C. Chappell Manager, Design and Program Engineering 10 CFR 50.54(a)

CNR0-2017-00017 BVY 17-023 September 19, 2017 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington , DC 20555-0001

SUBJECT:

Proposed Revision to the Entergy Vermont Yankee Quality Assurance Program Manual (VY QAPM)

Vermont Yankee Nuclear Power Station Docket Nos. 50-271 , 72-59 and 71-0907 License No. DPR-28

REFERENCES:

1. Letter, USNRC to Entergy Nuclear Operations, Inc., "Entergy Vermont Yankee Quality Assurance Program Manual Vermont Yankee Nuclear Power Station and Independent Spent Fuel Storage Facility - Review and Acceptance of Changes (CAC No . L53120)," NVY 16-020, dated June 16, 2016(ML16165A465)

2. Letter, Entergy Nuclear Operations, Inc. to USNRC, "Technical Specifications Proposed Change No. 313, Revision to License and Permanently Defueled Technical Specifications to Reflect Permanent Removal of Spent Fuel from the Spent Fuel Pool ," BVY 17-004, dated July 20, 2017 (ML17206A200)

Dear Sir or Madam:

Pursuant to 10 CFR 50.54(a), Entergy Nuclear Operations, Inc. (ENO) is proposing changes to the Entergy Vermont Yankee Quality Assurance Program Manual (QAPM) for Vermont Yankee Nuclear*Power Station (VY) and Independent Spent Fuel Storage Installation (ISFSI). The proposed changes described below and in the attachments to this letter represent reductions in commitment to the previously approved VY QAPM (Reference 1):

• • The program basis is changed from ANSI/ANS standards to primarily use Regulatory Guide 7.10, "Establishing Quality Assurance Programs for Packaging Used in Transport of Radioactive Material, Revision 3, as a guidance document. Regulatory Guide 7.10, Revision 2 was previously included in QAPM Appendix C as an additional guidance document. This change involves the elimination of commitments to standards and Regulatory Guides that will no longer be necessary following completion of the transfer of {) bb f NJ.4~Sz4, NM .5 5.;fJ

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CNR0-2017-00017 BVY 17-023 I Page 2 of 3 all spent nuclear fuel from the spent fuel pool to dry fuel storage in the ISFSI. Subsequent to this transition, there will be no structures, systems and components (SSCs), items or activities classified as safety-related as defined in 10 CFR 50 Appendix B, and the highest level of safety significance for items and activities remaining at the facility are designated as Important-to-Safety (ITS) under 10 CFR 71 and 10 CFR 72, as defined in Appendix A of the QAPM. Regulatory Guide 7.10 includes Quality Assurance Program guidance for ITS activities under 10 CFR 71 and 10 CFR 72.

• The Safety Review Committee (SRC) is removed from Appendix D of the QAPM and replaced with the Independent Management Assessment (IMA) function described in QAPM Section A.3.f. The IMAs are periodically performed to monitor overall performance and confirm that activities affecting quality comply with the QAPM and that the QAPM is effectively implemented. IMAs are performed by individual(s) designated by the chief nuclear officer, who are independent of the activities assessed and provide the appropriate level of expertise. The IMAs will ensure that independent oversight of activities being performed at VY will continue during dry fuel storage and decommissioning.

• Requ irements for fire protection and loss prevention program inspections and audits have been eliminated from QAPM Section C.2.a.2, based on all spent nuclear fuel being moved from the spent fuel pool to the ISFSI. However, there continues to be a requirement for audits of the fire protection program and implementing procedures once every 24 months.

Other corresponding changes to the QAPM have also been designated as reductions in commitments to the previously approved QAPM, and are described in the attachments. The attachments also contain other changes to the QAPM that are not considered to be reductions in commitments. The changes that are not considered to be reductions in commitments are provided for information and are planned to be implemented in Revision 7 to the QAPM or in a separate revision. provides a detailed discussion and justification of the proposed changes, including a comparison to Regulatory Guide 7.10. The comparison matrix demonstrates that the provisions included in Regulatory Guide 7.10 have been adequately addressed in the QAPM and implementing procedures. Attachment 1 also includes a comparison of the 10 CFR 71, Subpart H requirements to the QAPM that demonstrates these criteria are adequately addressed. The proposed changes will also continue to meet the requirements of 10 CFR 50, Appendix B and 10 CFR Part 72, Subpart G. Attachment 2 includes a summary of the proposed changes. includes the revision to the QAPM with the proposed changes shown.

VY is currently implementing Revision 5 of the QAPM. A revision to the QAPM, based on the changes proposed in Reference 2, which included the relocation of administrative controls from the facility Technical Specifications to the QAPM, and other conforming changes, is anticipated to be implemented following NRC approval of Reference 2. Revisions to the QAPM other than those proposed in Reference 2 and in this submittal may also be warranted . Therefore, the QAPM revision numbers used in this submittal are for reference information only and are subject to change ENO requests review and approval of these changes by May 31 , 2018. Once approved, the changes will be implemented consistent with, but not earlier than, the implementation schedule described in Reference 2 (i.e., within 60 days following ENO notification to the NRC that all spent nuclear fuel has been transferred out of the spent fuel pool and placed within the ISFSI).

CNR0-2017-00017 BVY 17-023 /Page 3 of 3 This letter contains no new regulatory commitments . Should you have any questions, please contact me at (802) 451-3374.

Sincerely, CCC/jal Attachments:

1. Description and Justification of the Proposed Changes to the VY QAPM, Including a Comparison Matrix of Regulatory Guide 7.10

2. Summary of Proposed Changes to the VY QAPM

3. VY QAPM Proposed Revis ion 7 cc: Mr. Daniel H. Dorman Regional Administrator, Region I U.S . Nuclear Regulatory Commission 2100 Renaissance Blvd ., Suite 100 King of Prussia, PA 19406-2713 Mr. Jack D. Parrott, Senior Project Manager Mail Stop T-8F 5 U.S . Nuclear Regulatory Commission Washington, DC 20555 Ms. June Tierney, Commissioner Vermont Department of Public Service 112 State Street, Drawer 20 Montpelier, VT 05620-2601

CNR0-2017-00017 BVY 17-023 Docket Nos. 50-271 , 72-59 and 71-0907 ATTACHMENT 1 Vermont Yankee Nuclear Power Station Description and Justification of the Proposed' Changes to the VY QAPM ,

Including a Comparison Matrix of Regulatory Guide 7.10

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 1 of 40 Description and Justification of the Proposed Changes to the VY QAPM QAPM Change(s) Evaluation and Justification Section Cover Page No changes were made with the cover page. Since there were no changes made with the cover page, there are no reductions in commitments to the previously approved QAP.

Policy Statement No changes were made with the policy statement. Since there were no changes made with the policy statement, there are no reductions in commitments to the previously approved QAP.

Table of Contents Minor change was made to the table of contents to reflect The changes refl ects that the facility has completed the transfer of spent nuclear update made to Appendix A header. This is based on fuel from the Spent Fuel Pool to the ISFSI so there are no longer any safety-elimination of the term "safety-related" from items and related SSCs, items of activities at the VYNPS .

activities since there are no longer any SSCs classified as classified as safety-related.

Section A - Management A-1 Eliminated the term "safety-related" from items The changes reflects that the facility has completed the transfer of spent nuclear and activities since there are no longer any SSCs fuel from the Spent Fuel Pool to the ISFSI so there are no longer any safety-classified as classified as safety-related . related SSCs, items of activities at the VYNPS .

A-2 A number of changes were made with the These changes to the organizational responsibilities are considered Organization section to reflect modifications to administrative and do not impact the ultimate reporting relationship with the chief the proposed VY site specific organization that is nuclear officer. The quality assurance function continues to report up through responsible for the implementation of the QAPM the executive responsible for nuclear oversight to the chief nuclear officer. The functions. The changes eliminate positions that top level management position and the quality assurance organization (through are no longer necessary, modify position titles the nuclear oversight executive) continue to report to the chief nuclear officer, and realigning responsibilities for others, but which is consistent with previous organizational relationships for the QAPM there is no overall change to the reporting functions. The elimination and consolidation of positions, functions and relationship, which continues to report through a responsibilities are acceptable since the changes are being made, based on the top level site manager up to the chief nuclear site completing the transfer of spent nuclear fuel from the Spent Fuel Pool to the officer. ISFSI. The functions and positions being modified or eliminated are no longer necessary. The majority of these changes are considered clarifications or Also, the Safety Review Committee (SRC) has administrative and do not constitute a reduction in commitments to the previously been removed from the QAPM and has been

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 2 of 40 QAPM Change{s) Evaluation and Justification Section replaced with an Independent Management approved QA Program. These changes also are being made to reflect the Assessment (IMA) function. organizational changes that were approved by the NRC with the associated LAR for the Defueled Technical Specifications. The last change was the SRC being removed from Section A.2 .C and is being replaced with an IMA function , which is a reduction in commitments to the previously approved QA Program. The majority of the changes can be implemented without prior NRC approval, based on the guidance provided in 10 CFR 50.54.a.3 with the exception of the transition of the SRC to an IMA function . These changes do not reduce the effectiveness of the QAPM and continue to ensure compliance with 10 CFR 50, Appendix Band the SAR quality assurance program description commitments previously accepted by the NRC, but will require prior NRC approval.

A-3 A detailed discuss of the IMA function was added This is a corresponding change to the proposed modification with the SRC being in Section A-3.f. removed from Section A.2 .c and appendix D , section A.3.f was added to describe the IMA function . This describes the IMA function, which is a reduction in commitments to the previously approved QA Program. These changes do not reduce the effectiveness of the QAPM and continue to ensure compliance with 10 CFR 50, Appendix B and the SAR quality assurance program description commitments previously accepted by the NRC, but will require prior NRC approval.

A-4 No changes were made with this section. No changes were made with this section so there are no reductions in commitments to the previously approved QA Program .

A-5 & 6 Editorial changes were made with these sections The changes made with this section are editorial so there are no reductions in to eliminate associated regulatory guide commitments to the previously approved QA Program.

examples.

A-7 The primary changes made were to reflect that The changes reflect that the facility has completed the transfer of spent nuclear there are no longer any safety-related items or fuel from the Spent Fuel Pool to the ISFSI so there are no longer any safety-activities at the VYNPS and the change to related SSCs, items of activities at the VYNPS. Although the editorial changes are regulatory commitments provided in Appendix B not reductions in commitments to the previously approved QA Program, the of the QAPM . Some editorial changes were also change to regulatory commitments is a reduction in commitments . These made. changes do not reduce the effectiveness of the QAPM and continue to ensure compliance with 10 CFR 50, Appendix B and the SAR quality assurance program description commitments previously accepted by the NRC, but will require prior NRC approval.

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 3 of 40 QAPM Change(s) Evaluation and Justification Section Section B - PerformanceNerification Editorial changes were made with each section to eliminate The changes made with this section are editorial so there are not reductions in associated regulatory guide examples. commitments to the previously approved QA Program.

Section C - Audit The primary changes that were made to this section were to The changes reflect that the facility has completed the transfer of spent nuclear modify the fire protection audit requirements. There were fuel from the Spent Fuel Pool to the ISFSI, so the fire protection program audit previously three (3) separate audit requirements that requirements are being modified concurrently. Although the editorial change is not collectively included a minimum frequency of once per 24 a reduction in comm itments to the previously approved QA Program , the months. The change eliminates two (2) of the audit changes to the audit requirements of the fire protection program is a reduction in requirements, but the minimum frequency to perform an commitments. These changes do not reduce the effectiveness of the QAPM and audit of the fire protection program at least once per 24 continue to ensure compliance with 10 CFR 50, Appendix B and the SAR quality months remains . Also, an editorial change was made with to assurance program description commitments previously accepted by the NRC, eliminate associated regulatory guide examples. but will requ ire prior NRC approval.

Section D - Independent Safety Review Function Reworded the section to refer to the other parts of the The elim ination of the reference to NUREG-0737, Section l.B.1.2, "Independent QAPM that address the independent safety review function Safety Engineering Group" is a reduction in commitments to the previously and deleted the reference to NUREG-0737, Section l.B.1.2, approved QA Program ; however, it is not necessary for a facility that is in "Independent Safety Engineering Group." decommissioning and has transferred all spent nuclear fuel from the Spent Fuel Pool to the ISFSI. These changes do not reduce the effectiveness of the QAPM and continue to ensure compliance with 10 CFR 50, Appendix B and the SAR quality assurance program description commitments previously accepted by the NRC, but will require prior NRC approval.

Appendix A - Safety Related and Important-to-Safety Structures, Systems and Components Editorial changes were made to this Appendix header to The changes made to this entire section are editorial so there are no reductions reflect that there are no longer any safety-related items or in commitments to the previously approved QAPM . The note reflects that the activities at the VYNPS . In addition a note was added facility has completed the transfer of spent nuclear fuel from the Spent Fuel Pool further indicating that there are no longer any safety related to the ISFSI so there are no longer any safety-related SSCs, items of activities at SSCs at the VY facility. the VYNPS .

Appendix B - Regulatory Commitments

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 4 of 40 QAPM Change(s) Evaluation and Justification Section The program's Regulatory Commitments basis was Changing the QAPM's Regulatory Commitments basis from ANSI/ANS changed from ANSI/ANS standards to primarily using standards to primarily Regulatory Guide 7.10 "Establishing Quality Assurance Regulatory Guide 7 .10 "Establishing Quality Assurance Programs for Packaging Used in Transport of Radioactive Material." Revision 3 Programs for Packaging Used in Transport of Radioactive and modifying the specific exceptions to ANSI/ANS 3.1 are acceptable for a Material", Revision 3 as a guidance document. The only facility that is in decommissioning and has transferred all spent nuclear fuel previously remaining standard is ANSI/ANS 3.1, which from the Spent Fuel Pool to the ISFSI. Regulatory Guide 7.10 was previously was modified to eliminate those specific exceptions that included in Appendix C as an additional guidance document. The highest level are no longer applicable. of safety significance items and activities remaining at the VYNPS are designated as Important-to Safety (ITS) under 10 CFR 71 and 10 CFR 72 as defined in Appendix A There are no SSCs, items or activities remaining at the VYNPS site that are classified as safety-related as defined in 10 CFR 50 Appendix B. The NRC Quality Assurance Program guidance for ITS activities under 10 CFR 71 and 10 CFR 72 is included in Regulatory Guide 7.10. The change in base guidance documents is a reduction in commitment to the previously approved QA Program, but it is acceptable due to the current state of decommissioning at the VYNPS and the passive operational status of the VY ISFSI.

This is a reduction in commitment, but it is acceptable due to the current state of decommissioning at the VYNPS site and the passive operational status of the VY ISFSI. Similar changes have been previously approved by the NRC at other facilities in a similar configuration as is being described. These changes do not reduce the effectiveness of the QAPM and continue to ensure compliance with 10 CFR 50, Appendix B and the SAR quality assurance program description commitments previously accepted by the NRC, but will require prior NRC approval.

Appendix C - Administrative Controls Appendix C was modified to delete the guidance documents The changes made with this section are editorial so there are not reductions in references which were added to Appendix B. commitments to the previously approved QA Program.

Appendix D - Administrative Controls Appendix D was modified to reflect the removal of SRC and The change to remove the SRC from the QAPM and replacing it with an IMA some minor administrative changes. function is a reduction in commitments to the previously approved QA Program.

The other chanoes are considered administrative and reflect that all fuel has

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 5 of 40 QAPM Change(s) Evaluation and Justification Section been transferred from the Spent Fuel Pool to the ISFSI. The change with eliminating the SRC cannot be implemented without prior NRC approval, based on the guidance provided in 10 CFR 50.54.a.3. The other changes (i.e., title updates and some minor administrative modifications) can be implemented without prior NRC approval. The overall changes do not reduce the overall effectiveness of the QAPM and it continues to ensure compliance with 10 CFR 50, Appendix Band the SAR quality assurance program description commitments previously accepted by the NRC, but will require prior NRC approval.

I

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 6 of 40 VY QAPM Revision 7 "Regulatory Guide 7.10 (Revision 3} Compliance Matrix" Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References

1. GUIDANCE ON§ 71.103, QUALITY ASSURANCE ORGANIZATION An organizational discussion is provided in the QAPM Section A.2 consistent with the previou sly approved QAPM that has approved organizational charts 1.1 Structure and Authority maintained independent of th e QAPM. The organizational structure consists For each function, the structure of the organization and the of corporate and VY functions. As defined, the specific organization titles for assignment of responsibility should ensure that the following the quality assurance functions described are identified in procedures.

requirements are fulfilled:

Section A-4 states that "When VY delegates responsibility for planning, The formal structure of the organization is documented by esta blishing, or implementi ng any part of the overall QA program, sufficient organization charts that identify each organizational element that authority to accomplish the assigned responsibilities is delegated. The functions under the QA program.

manager responsible for quality assurance has t he responsibility and the

• The discussion specifies the required authority and authority to stop unsatisfactory work and control further processing, organizational responsibility, including sufficient delivery, installation, or use of non-conforming items or services. Cost and independence from influences of cost and schedule .

schedule con sid erations will not override safet y considerations."

• The specified quality requirements are achieved and maintained by those who have been assigned the The VYNPS organization has the authority to accomplish the quality responsibility for performing the work. assurance fun ctions described, which is delegated to the incumbent' s staff as

• The QA program user has established measures to provide necessary to fulfill the identified responsibility. The authority, duties, adequate control over activities important to safety (e.g., responsibilities, and interface requirements are addressed in QAPM . These inspecting, cleaning, purchasing, and preparing the packaging activities include performing activities affecting the functions of structures, for delivery). systems, and components, which are important to safety, those associated

• The conformance to established requirements is verified with attaining quality objectives and the QA functions.

by individuals and groups not directly responsible for Section B.l.c states that "Work is accomplished and verified using performing the work. instructions, procedures, or other appropriate means that are of a detail commen surat e with the act ivit y's complexity and importance to safety."

Note: If, because of staffing limitations, the same individuals perform multiple functions (including QA), the QA program user should Section A.2.b.4 st ates that "A manager respon sible for quality assurance who establish measures to ensure that the designated individuals has overall authority and responsibil ity for establishing, controlling, and performing QA and QC functions have the responsibility and authority verifying the implementation and adequacy of the quality assurance program to stop unsatisfactory work and delivery or installation of as described in this QAPM. This position has the authority and responsibility nonconforming material. These individuals also should have direct to escalate matters directly to the highest level nuclear executive officer access to management levels that can ensure that QA procedures when needed. This position reports to the executive responsible for nuclear important to safety have been accomplished . oversight through the corporate management position responsible for nuclear oversight (offsite)."

In addition, the QA program user should establish and document the Section A.2.b.4 st ates that "The executive responsible for oversight

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 7 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References required duties and qualifications for (1) the individual who has establishes the policies, goals, and objectives of the quality assurance policy overall authority and responsibility for the QA program, as well as (2) and provides guidance and interpretation for implementing the company other personnel performing Q£>. and QC functions. Individuals with QA quality assurance policy and is responsible for governance and and QC functions should have the written endorsement of upper implementation of the quality assurance program in accordance with management. regulatory requirements. Independent oversight groups report to this executive. The following management positions report to this executive :

1.2 Senior Management Endorsement of a QA Program

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

Senior management, the company or corporate president or chief This position provides overall direction for the implementation of the executive officer, should maintain a continuing involvement in QA quality assurance program.

matters to ensure that the QA program is effective. Senior management should establish a written company or corporate policy

• A management position that is responsible for oversight and governance to perform work on items important to safety in accordance with the of the QAPM. This manager has authority and responsibility for requirements of 10 CFR Part 71, Subpart H. This policy should be establishing, controlling, and verifying the implementation and adequacy described in or incorporated into the QA program plan and of the quality assurance program as described in this QAPM including implemented through the QA program procedures. activities related to vendor quality. This position has the authority for Stop Work and responsibility to escalate matters directly to the highest The policy statement should also identify the functions and positions level nuclear executive officer when needed ."

that have delegated authority for the following tasks:

Section A.5 Personnel Tra ining and Qualification states that "Personnel

• Implement and revise the provisions of the described QA assigned to implement elements of the quality assurance program are program.

capable of performing their assigned tasks. Tra ining programs are

• Regularly assess the scope, status, implementation, and established and implemented to ensure that personnel achieve and maintain effectiveness of the QA program . suitable proficiency. Personnel training and qualification records are maintained in accordance with procedures."

Commitments are provided within this section of the QAPM with ANSI/ANS 3.1-1978 being th e base commitment personnel training and qualifications.

The Policy Statement states that "the Quality Assurance Program (QAP) described herein and associated implementing documents provide for control of activities that affect the quality of safety-related nuclear plant structures, systems, and components (SSCs) . The QAP is also applied to SSCs classified as important-to-safety (ITS) to satisfy the requirements of 10CFR71 and 10CFR72."

Section A.2.a .1, 2 & 3 state that "the Entergy Corporation chief executive officer (CEO) is responsible for overall corpora t e policy and provides

CNR0-2017-00017 BVY 17-023 /Attachment 1 I Page 8 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References executive direction and guidance for the corporation as well as promulgates corporate policy through the Company's senior management staff.

Responsibility for developing, implementing, and verifying execution of the Quality Assurance Program is delegated to the chief nuclear officer, the highest level nuclear executive, and authority for developing and verifying execution of the program to the executive responsible for nuclear oversight.

The chief nuclear officer, the highest level nuclear executive officer, is responsible for providing top-level direction for the safe and reliable operation of VY's nuclear site. The highest level nuclear executive officer provides guidance with regards to company quality assurance policy. The Independent Management Assessments report to this executive.

The executive responsible for oversight establishes the policies, goals, and objectives of the quality assurance policy and provides guidance and interpretation for implementing the company quality assurance policy and is responsible for governance and implementation ofthe quality assurance program in accordance with regulatory requirements . Independent oversight groups report to this executive.

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

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

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

• A management position that is responsible for oversight and governance of the QAPM. This manager has authority and responsibility for establishing, controlling, and verifying the implementation and adequacy of the quality assurance program as described in this QAPM including activities related to vendor quality.

This position has the authority for Stop Work and responsibility to escalate matters directly to the highest level nuclear executive officer when needed.

Section A.3.f states that "the Independent Management Assessments are periodically performed to monitor overall performance and confirm that activities affecting quality comply with the QAPM and that the QAPM is

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 9 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References effectively implemented . This Independent Management Assessment is performed by individual(s) designated by the chief nuclear officer, independent of activities assessed and who provide the appropriate level of expertise in the activities assessed. The Independent Management Assessment results are communicated in an understandable form and in a timely fashion to a level of management having the authority to effect corrective action. In addition, these results are reported in a timely fashion to the chief nuclear officer."

Section A.3.f states that "The Independent Management Assessments are periodically performed to monitor overall performance and confirm that activities affecting quality comply with the QAPM and that the QAPM is effectively implemented. This Independent Management Assessment is performed by individual(s) designated by the chief nuclear officer, independent of activities assessed and who provide the appropriate level of expertise in the activities assessed . The Independent Management Assessment results are communicated in an understandable form and in a timely fashion to a level of management having the authority to effect corrective action. In addition, these results are reported in a timely fashion to the chief nuclear officer."

Policy V-EN-PL-100, "Nuclear Excellence Model" defines organizational roles and responsibilities, which are defined in organization charts that reflect the responsibilities contained within the QAPM .

2. GUIDANCE ON §71.105, "QUALITY ASSURANCE PROGRAM" The QAPM has been previously approved to the NRC under Appendix B to 10 CFR Part 50 and was also subsequently accepted under 10 CFR 2.1. General Guidance on QA Programs 71.lOl(f). This compliance matrix is intended to identify to the NRC how In its program description submittal, the QA program user should ea ch of the regulations in Subpart Hof 10 CFR Part 71 applies to the VY describe to the NRC how each of the requirements in Subpart Hof 10 situation and how it will be satisfied.

CFR Part 71 applies to its particular situation and how each The NRC also has been previously notified that the QAPM will be applied to requirement will be satisfied. The information supplied for NRC ITS SSCs and activities associated with dry fuel storage to satisfy the review will vary as a function of the nature of activities in which the requirements of 10 CFR 72 Subpart G.

QA program user is involved. For example, an individual or organization using a general license solely for transportation of Section A.7.b states that "The NRC is to be notified of QAPM changes in radioactive material in packages purchased or leased for that purpose accordance with 10 CFR S0.54(a)(3) or 10 CFR S0.54(a)(4)." These would be expected to address regulations governing activities such as requirements, along with 10 CFR 71.106 provide the requirements for procurement, shipment, and handling. By contrast, someone who making changes to the QAPM .

designs and fabricates packaging would be expected to address Section B.1.c states that "Work is accomplished and verified using

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 10 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References criteria for design and testing, as well as material procurement instructions, procedures, or other appropriate means that are of a detail activities. Elements common to all QA program descriptions include commensurate with the activity's complexity and importance to safety."

the quality organization and program, corrective action, QA records, For item (1), Appendix A addresses all SSCs to which the QAPM is applicable.

and audits.

For item (2), various sections of the QAPM identify the approach for verifying In developing its program, a prospective QA program user can refer to that the applicable components, structures, and systems meet design the NRC's guidance in this regulatory guide, as well as the additional objectives.

guidance on graded QA approach in NUREG/CR-6407 {Ref. 7). In developing its program, a QA program user should apply each of the For bullet 1, Section B identifies the controls and practices necessary to applicable Subpart H regulations in a graded approach {i.e., to an ensure that activities important to safety are performed using specified extent that is consistent with items important to safety). equipment and under suitable environmental conditions.

Following the NRC staff's technical review and determination that the For bullet 2, various sections of the QAPM specify the QA and QC QA program submittal meets regulatory requirements, the responsibilities applicable to the implementation of activities important to Commission issues a QA program approval. Changes to an approved safety.

QA program are specifically addressed in new §71.106 as described in Section B, "DISCUSSON," of this Regulatory Guide. For bullet 3, Section A.5 establishes the requirements for indoctrination and Based on NRC approval of its QA program description submittals, a QA training programs to ensure that personnel performing activities important to program user will translate the regulations discussed in its submittals safety are trained and qualified to perform those activities.

into lower-level {working-level) implementing procedures that govern Appendix A of the QAPM address the applicability of the QAPM, including all the conduct of QA activities important to safety. SSCs, In Appendix A, the Holtec Safety Analysis Report (SAR) for the storage system, the Holtec Safety Analysis Report (SAR) for the transportation system If the NRC staff reviews a QA program submittal and finds that it and associated Holtec specifications. NUREG/CR-6407 is identified as input inadequately describes how the requirements will be met or fails to reference for determining ITS classifications.

specifically address some Subpart H regulation{s), the staff will either reject the QA program submittal or ask the QA program user to The Policy Statement states "The Quality Assurance Program (QAP) described submit additional information to correct the deficiencies. herein and associated implementing documents provide for control of activities that affect the quality of safety-related nuclear plant structures, 2.2 . Scope of QA Program systems, and components (SSCs) . The QAP is also applied to SSCs classified as important-to-safety (ITS) to satisfy the requirements of 10CFR71 and The QA program user should establish measures for identifying: (1) 10CFR72."

the components, structures, and systems that the QA program will Section B.1.c states that "Work is accomplished and verified using cover, and (2) the approach for verifying that the applicable instructions, procedures, or other appropriate means that are of a detail components, structures, and systems meet design objectives. commensurate with the activity's complexity and importance to safety."

Although 10 CFR Part 71 allows the development of a "graded" QA (The Quality Assurance Criterion to Implementing Procedure Matrix is program, this does not preclude the alternative of defining a contained in Table 1 below) program with additional measures if such a program is deemed

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 11 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References necessary to attain the confidence needed for meeting design Section 2.0 "Quality Responsibilities" provides general responsibilities by objectives. In particular, the QA program user should establish functional areas.

measures to ensure that the following requirements are fulfilled :

Section 1.1 states that "The QAPM is implemented through the use of approved procedures (i.e., policies, directives, procedures, manuals,

• Activities important to safety are performed using specified instructions, or other documents) which provide written guidance for the equipment and under suitable environmental conditions.

control of important to safety items and activities and provides for the development of documentation to demonstrate objective evidence of

• QA and QC manuals specify the designated responsibilities complian ce with stated requirements."

for implementation of activities important to safety.

Section 3.5 states that " Management is responsible for ensuring that ITS

• The QA program user has established indoctrination activities are described in instructions, procedures, or drawings, which are programs to ensure that personnel performing activities prepared and approved prior to commencing activities. All project important to safety are trained and qualified to perform personnel are responsible to perform their activities in accordance with the those activities. requirements of these documents. These documents include appropriate quantitative and qualitative acceptance criteria to verify that the activity has 2.3. Applicability of QA Program been satisfactorily accomplished."

Measures that the QA program covers should be compatible with and emphasize characteristics identified in the manufacturer's QA program . The QA program user should establish the rationale for identifying items classified as important to safety and subject to the user's QA program.

2.4. Documentation The QA program user should ensure that written procedures and instructions: (1) describe all activities that are important to safety and applicable to the design, procurement, fabrication, and testing of packaging, and (2) will be in place before the QA program user engages in those activities.

If the QA program user has not yet initiated activities important to safety, the user should identify the implementing procedures for such activities by title and procedure number and provide a brief description of the content of those procedures with an estimated date for their completion . The following table shows a suitable format for listing procedures to demonstrate implementation of a documented QA program .

To demonstrate that written procedures fully implement and reflect

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 12 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References the current status of the documented QA program, the QA program user should establish and maintain a master index of QA procedures related to all activities important to safety, as well as a matrix of the QA procedures that implement each section of 10 CFR Part 71 I Subpart H. These written procedures should also address the use I management, and storage of electronic records and data .

2.5. Controlled Conditions and Assignment of Responsibilities The QA program user should establish measures to ensure that activities important to safety are accomplished using appropriate production and test equipment, suitable environmental conditions applicable codes and standards, and proper work instructions. The' QA program user should also document the assignment of responsibility for each task and method used to verify conformance to these quality requirements .

3. GUIDANCE ON §71.107, "PACKAGE DESIGN CONTROL" VY does not design pa ckages to be licensed under 10 CFR 71 or 10 CFR 72.

Per the Regulatory Guide 7.10, guidance on 10 CFR 71.07 (see left column),

Essential elements of adequate design control are (1) clearly-established "Since users of pa ckaging do not normally perform design activities, this working relationships among those responsible for preparing design section of Subpart H should not be applicable to users of packaging.

disclosures, (2) conducting independent design analyses, (3) coordinating However, use rs should establish and verify that the packaging was designed interfaces, and (4) maintaining lines of communication. To ensure an under th e control of an NRC-approved QA program."

adequate commitment to control of design activities, applicants should consider the three principal areas of (1) control of the design process, (2)

VY has verifi ed th at the Holtec System was designed under the control of an control of design input, and (3) control of design verification, as defined in NRC-approved QA Program (the Holtec QA Program). VY has also verified regulatory positions 4.1 - 4.3.

that 10 CFR 71 lice nsed shipments of Band C waste from the VY site Computer-aided design (CAD) is extensively used in current design contracted to EnergySolutions were designed under the control of an NRC-applications. Designs developed using CAD methods are prepared and approved QA Program (the EnergySolutions QA Program) .

stored electronically. Thus, applicable QA procedures for verification and validation, management of electronic records, and quality control of Therefore, th is section of Subpart H is not applicable to VY, as we are users electronic data should address the control of electronic data in design of the packaging was designed under the control of an NRC- approved QA applications to ensure authenticity and technical accuracy. The Nuclear program. However, guidance is provided in this Information and Records Management Association (NIRMA), ANSI, and the section prim arily for two purposes: 1) To provide for an appropriate Electric Power Research Institute (EPRI) provide guidance for use in interface w ith t he NRC packag ing Certifi cate Holder to ensure ISFSI or site developing QA programs for managing electronic data . In addition, NRC

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 13 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References Generic Letter 88-18, "Plant Record Storage on Optical Disks" (Ref. 11), and SSCs do not adversely affect the important-to safety SSCs at the ISFSI, and 2)

Regulatory Information Summary 00-18, "Guidance on Managing Quality To provide guidance for the engineering of ISFSI and decommissioning Assurance Records in Electronic Media" (Ref. 13), provide guidance on the activitie s, and ensuring adequate technical review is applied to changes, use of optical disc document imaging systems for retrieving record copies test s and experiments.

of QA records .

Appendix A t o the QAPM explains the interface between VY engineering and 3.1. Control of the Design Process design and the design authority for the packaging design (the Certificate Holder, Holtec) as follows : "The safety classification of NRC Licensed ISFSI The QA program user should establish measures such as Dry Fuel Sto rage Compon ents and Transportat ion Packages may not be "classification of characteristics" to ensure that packaging designs revised usi ng t he VY Design Control process. These modifications must be are reviewed to emphasize parameters important to safety that can made by the NRC Certificate Holder. The Certificate Holder is responsible for be controlled by inspections or tests and to identify test and design and lice nsing controls for these components under their NRC inspection criteria and quality standards. approved Qualit y Assurance Program. VY utilizes these types of components and pa ckages und er the provi sions of NRC General License for Radioactive To control the preparation of drawings and specifications, the QA Material Transportation Packages (10 CFR 71) and Spent Fuel Storage (10 program user should establish recognized engineering practices. CFR 72)."

Engineering practices may include: (1) prescribing drafting room standards, (2) checking methods, establishing review and approval Sect ion B.2.a st at es that "Th e design control program is established and and issuance and distribution requirements (including revisions to implemented to ass ure that the activities associated with the design of them), (3) maintaining current "as-built" configurations, and (4) systems, compo nents, structures, and equipment and modifications thereto, storing and controlling original and maste r copies. are executed in a planned, controlled, and orderly manner."

3.2 . Control of Design Input Sect ion B.2.b st at es that "The program includes provisions to control design inputs, processes, outputs, changes, interfaces, records, and organizational The QA program user should establish measures to ensure that interfaces."

appropriate codes and standards are used in t he design of the packaging. In the absence of such codes and standards fo r Section B.3. a stat es t hat "A program is establi shed and implemented to verify formulation of the design activities, the QA program user should the acceptabil ity of design activities and documents for the design of items.

identify alternative approaches. The sele ction and incorporation of design inputs and design processes, outputs, and changes are verified .

The QA program user should establish measures to ensure that (1) the Specific measures applicable for control of " records" are addressed in responsible design organization has properly considered, reviewed, subsequent sections of this matrix.

and approved all design parameters (e .g., criticality physics, cooling, and decontamination of an item), (2) the parameters are in accordance with the applicable performance codes, standards, and

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 14 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References regulatory requirements, and (3) design documents specify the related maintenance, repair, inservice inspection, handling, storage, and cleaning requirements.

3.3. Control of Design Verification The QA program user should establish methods for use in verifying the adequacy ofthe design (e.g., qualification testing, design review, or alternative calculations, including use of computer programs).

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

• The supervisor is the only technically qualified individual.

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

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

Changes to the final design may arise during the sequence of design verification. Consequently, the QA program user should establish measures to ensure that drawing and specification changes are reviewed and approved by the same individuals or organizations that reviewed and approved the original documents. Changes in design that could result in conditions different from those prescribed in the Certificate of Compliance (CoC) should be approved by the NRC prior to implementation.

Design verification, if other than by qualification testing of a prototype or lead production unit, should be satisfactorily completed before release (1) for procurement or fabrication and (2) to other organizations for use in other design activities, except when this timing cannot be met. In such cases, design verification may be

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 15 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References deferred, provided that the justification for this action is documented and the unverified portion of the design output documents are appropriately identified and controlled. When a test program is used to verify the adequacy of a design, the prototype should be subjected to the most adverse design conditions.

Even though users of packaging do not normally perform design activities, users should establish and verify that the packaging was designed under the control of an NRC-approved QA program.

14. GUIDANCE ON §71.109, "PROCUREMENT DOCUMENT CONTROL" Section B.4 states that:

The QA program user should establish measures to control the a. A program is established and implemented to ensure that purchased items preparation, review, concurrence, and approval of all procurement and services are of acceptable quality.

documents.

b. The program includes provisions for evaluating prospective suppliers and selecting only qualified suppliers.

4.1. Content of Procurement Documents

c. The program includes provisions for ensuring that qualified suppliers The QA program user should establish measures to ensure that continue to provide acceptable products and services."

procurement documents include the following information (to the Section B.5.a states that "A program is established and implemented to verify extent applicable to their respective operations) : the quality of purchased items and services at intervals and to a depth

• The scope of work to be performed by the prospective consistent with the item's or service's importance to safety, complexity, and supplier. quantity and the frequency of procurement."

• The design-basis technical requirements (or references thereto), including applicable regulatory requirements, Section B.5.b states that "The program is executed in all phases of material and component identification requirements, drawings, procurement. As necessary, this may require verification of activities of specifications, codes and standards, special process suppliers below the first tier."

instructions, and test and inspection requirements.

• Applicable Subpart H requirements that should be complied An approved procurement procedure (V-EN-MP-101, "Procurement") is in with and described in the supplier's QA program (e.g., place that controls all aspects of the procurement process. These procedures qualified QA personnel from the purchaser's organization provide for the review requirements, which do not include a specific QA should review and provide review concurrence on the personnel review and approval for technical and quality requirements as was supplier's QA program or portions thereof before the previously approved by the NRC.

purchaser initiates activities that the program affects. Also, if subtier suppliers are involved, the QA program user should Section B.1.b states that "Personnel performing work activities such as design, specify the QA provisions appropriate to those procurements. engineering, procurement, manufacturing, construction, installation, startup, maintenance, modification, operation, and decommissioning are responsible The extent of the supplier's and subtier supplier's QA

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 16 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References programs will depend on the particular item or service being for achieving acceptable quality."

procured).

Measures are provided for the review of and changes to procurement

• Permission to gain access to the supplier's and subtier documents.

supplier's plant facilities and records for inspection and audit purposes (e.g., procurement documents should identify the Section B.l.c states that "Criteria that define acceptable quality are specified, type of verification activities required of any subtier suppliers and quality is verified against these criteria ."

for supplied materials, as well for any design, fabrication, assembly, testing, maintenance, and repair services or activities supplied) .

• Identification of the documentation (e .g., drawings, specifications, procedures, inspection and fabrication plans, inspection and test records, personnel and procedure qualifications, results of chemical and physical tests on material) that the supplier(s) must prepare, maintain, and submit to the purchaser for approval.

• Requirements for reporting and approving disposition of nonconformances.

• Identification of records that the supplier must retain, control, and maintain, as well as those records that the supplier must deliver to the purchaser before installation of hardware. These records should include the pertinent documentation to be furnished with the procured materials or services (e.g., Coe, as-built drawings, photographs, sketches, and use and maintenance manuals). If the pertinent documentation is in an electronic format, the QA program user also should maintain information on the specific software applications and storage or computing hardware.

4.2. Replacement Part Procurement Measures should be established to require that the QA program user reviews procurements of replacement parts important to safety to ensure that appropriate technical and QA requirements are included in purchase orders and that the purchase orders are placed with suppliers previously qualified during packaging fabrication. If

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 17 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References replacement parts are purchased from suppliers not previously identified as qualified sources, the QA program user should ensure that the replacement parts meet requirements at least as stringent as the original criteria .

4.3. Review and Changes to Procurement Documents The QA program user should establish measures to ensure that review and approval of procurement documents are recorded before release, and that changes and revisions to those documents are subject to at least the same review and approval process as the original documents.

15. GUIDANCE ON §71.111, "INSTRUCTIONS, PROCEDURES, AND DRAWINGS" Section B.l.c states that " Work is accomplished and verified using instructions, procedures, or other appropriate means that are of a detail commensurate 5.1 . Quality Assurance Program Procedures with the activity's complexity and importance to safety."

The QA program user should establish measures to ensure that the following requirements are fulfilled : Section A.1.c states that "The QAPM applies to all activities associated with

• Activities important to safety are prescribed and structures, systems, and components that are ITS controlled by 10 CFR 72, as accomplished in accordance with current documented defined in Appendix A. The QAPM also applies to transportation packages instructions, procedures, or drawings that have been controlled by 10 CFR 71. The methods of implementation of the approved by appropriate levels of management. requirements of the QAPM are commensurate with the item's or activity's importance to safety. The applicability of the requirements of the QAPM to

• Instructions, procedures, and drawings specify the methods other items and activities is determined on a case-by-case basis as defined for complying with each of the applicable sections of within approved procedures. The QAPM implements 10 CFR 50 Appendix B, Subpart Hof 10 CFR Part 71.

10 CFR 71 Subpart H, and 10 CFR 72 Subpart G." (See Table 1 below for list of

• All work activities are coordinated with QA personnel to procedures.)

ensure that the work- controlling documents incorporate appropriate inspection and hold points to verify that initial Section A.3.e states that "Procedures that implement the QAPM are work, planned work, effective repairs, or rework have been approved by the management responsible for the applicable quality performed satisfactorily. function. These procedures are to reflect the QAPM and work is to be accomplished in accordance with them .

• Instructions, procedures, and drawings include quantitative acceptance criteria (e.g., dimensions, tolerances, and Procedure AP-0096, "Control of Procedure" describes the process for operating limits) and qualitative acceptance criteria (e.g.,

development, review approval and revision of procedures, including the

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 18 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References workmanship samples) to verify that activities important to review and approval by appropriate levels of management responsible for the safety have been accomplished satisfactorily. quality activity. This includes the interaction with quality assurance personnel for verification activities, including establishing the appropriate

• Written procedures address the use, management, qualitative and quantitative acceptance criteria.

storage, and protection of electronic records and data.

The QA program user should also maintain information Procedure V-EN-AD-103, " Document Control and Records Management on the specific software applications and storage or Programs" identifies the types of acceptable storage media and associated computing hardware.

acceptance and maintenance criteria for each. Records are processed to the 5.2. QA Review and Concurrence VY site electronic record s system in accordance with approved procedures, as are any supporting corporate Entergy records.

The QA program user should establish measures to ensure that the QA organization reviews and concurs in inspection plans; test, calibration, and special process procedures; and specifications as well as any changes thereto. Before fabrication of an item, the QA organization should review and concur in the related manufacturing plans, as they relate to scheduled witness and hold points during fabrication.

6. GUIDANCE ON §71.113 . "DOCUMENT CONTROL" Section B.14.a states, "A program is established and implemented to control 6.1. Controlled Documents t he development, review, approval, issue, use, and revision of documents."

The QA program user should maintain control of each of the In nearly each section of the QAPM where the various types of documents documents of the QA program to reflect the current status. As are described, the QAPM specifies appropriate controls for quality a minimum, the QA program user should exercise control over documents, rega rdless of the media and calls for specific controls to be the following : contained in implementing procedures.

• design documents (e .g., drawings, specifications, and computer codes) Procedure V-EN-AD-103, " Document Control and Records Management

• procurement documents Program s" describes the process for development, review approval and

• QA and QC manuals revision of procedures.

• operating, maintenance, and modification procedures

• inspection and test procedures Procurement documents, nonconformance reports and corrective action

• nonconformance reports reports are not controlled documents at VY. They function as QA records

• design change requests rather than controlled documents.

• corrective action reports Section B.14.a states that "A program is established and implemented to 6.2. Control of Document Generation and Issuance control the development, review, approval, issue, use, and revision of docum ents."

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 19 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References The QA program user should establish controls to ensure that all Section B.14.c states that "Revisions of controlled documents are reviewed for documents and any changes are adequately reviewed and approved adequacy and approved for release by the same organization that originally before they are issued. These controls should include measures (e .g., reviewed and approved the documents or by a designated organization that is the use of a master document list) to ensure that current issues of qualified and knowledgeable."

applicable documents are available at the location where the activity is being performed, to preclude use of obsolete or superseded The numerous implementing procedures that describe the creation and documents. The QA program user also should check all packaging control of the various types of documents generated identify (by function or affected by design changes to verify that it is in accordance with the position) the individuals or groups responsible for reviewing, approving, and appropriate revision . In addition, the QA program user should issuing documents and revisions thereto.

identify (by function or position) the individuals or groups responsible for reviewing, approving, and issuing documents and revisions Implementing Procedure V-EN-AD-103, " Document Control and Records thereto.

Management Programs" provides requirements for control of documents of all types of media .

6.3 . Control of Document Changes Procedure V-E N-AD-103, " Document Control and Records Management The QA program user should establish measures to ensure that Programs" identifies the types of acceptable storage media and associated changes to documents are reviewed and approved by the same acce ptance and maintenance criteria for each . Records are processed from organization that performed the original review and approval, and the the VY site into the Exelon electronic records system in accordance with changes are in accordance with established configuration control approved procedures.

procedures.

6.4. Control of Electronic Documents If the documents are stored electronically, the QA program user should establish controls over access to the documents to ensure that the latest versions are available and changes are properly authorized and implemented. The software and hardware systems used to store electronic information should be reliable and secure to avoid alteration or corruption of the information.

[7. GUIDANCE ON §71.115, "CONTROL OF PURCHASED MATERIAL, The QAPM (as delineated below) establishes the measures necessary to EQUIPMENT, AND SERVICES" assure that purchased material, equipment, and services, whether purchased directly or through contractors or subcontractors, conform to the The QA program user should establish measures in the areas identified requirements of the procurement documents. These measures shall be below to ensure that materials, equipment, and services conform to specified in implementing procedures. For Important to Safety procurement documents.

procurements, Procedure V-E N-MP-101, "Procurement" assigns

CN R0-2017-00017 BVY 17-023 I Attachment 1 I Page 20 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References 7.1. Procurement Document Planning responsibility for implementation of specific program elements.

The QA program user should establish procurement planning Section B.4.a states that "A program is established and implemented to ensure procedures that describe each procurement step leading to contract that purchased items and services are of acceptable quality."

award for items and services. These procedures should identify the organizations responsible for each procurement step. Section B.4.b states that "The program includes provisions for evaluating 7.2. Selection of Procurement Sources prospective suppliers and selecting only qualified suppliers."

The QA program user should establish measures for evaluating and Section B.4.c states that "The program includes provisions for ensuring that selecting procurement sources, including the extent of QA and qualified suppliers continue to provide acceptable products and services."

engineering involvement. Specifically, the QA program user should Section B.4.d states that "The program includes provisions (e.g., source consider establishing the following provisions (if applicable):

verification, receipt inspection, pre-installation and post-installation tests, and

• the supplier's capability to comply with applicable sections of certificates of conformance) for accepting purchased items and services."

Subpart H Section B.4.e states that "Applicable technical, regulatory, administrative, and

• results of the survey of the supplier's facility and QA program reporting requirements (e.g., specifications, codes, standards, tests,

• review of the supplier's previous records and performance inspections, special processes, and 10 CFR Part 21) are invoked for procurement of items and services."

7.3. Bid Evaluation and Award Section B.4.f states that "The program includes provisions for ensuring that The QA program user should establish measures to ensure that documented evidence of an item's conformance to procurement requirements designated individuals or organizations evaluate proposed suppliers, is available at the site before the item is placed in service or used unless as applicable to the type of procurement, based on technical otherwise specified in procedures."

considerations, conformance to QA requirements, production capability, and past performance. Before contract award, the QA Section B.4.g states that "The program includes provisions for ensuring that program user should resolve (if possible) all unacceptable conditions procurement, inspection, and test requirements have been satisfied before an identified during the bid evaluation. If any unacceptable conditions item is placed in service or used unless otherwise specified in procedures."

cannot be resolved before contract award, the QA program user Section B.4.h states that "The procurement of components, including spare and should obtain the supplier's commitment that the conditions will be replacement parts, is subject to quality and technical requirements suitable for resolved at a mutually agreeable date during the contract period. their intended service.

7.4. Supplier Performance Control Section B.4.i states that "Appropriate controls for the selection, determination The QA program user should establish measures for pre- and post- of suitability for intended use (critical characteristics), evaluation, receipt, and award activities. These activities may include meetings and other quality evaluation of commercial grade items are to be imposed to ensure that communications, to ensure that the supplier understands the items will perform satisfactorily in service."

procurement requirements, including, if applicable, "hold points" (i.e.,

pre-established inspection points in the manufacturing process that Section B.5.a states that "A program is established and implemented to verify require inspection approval and release by the QA organization the quality of purchased items and services at intervals and to a depth

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 21 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References before further processing) during manufacturing and testing and consistent with the item's or service's importance to safety, complexity, and before shipment. quantity and the frequency of procurement."

Section B.S.b states that "The program is executed in all phases of 7.5 . Verification Activities procurement. As necessary, this may require verification of activities of suppliers below the first tier."

The QA program user should establish the extent to which source surveillance will be performed during fabrication, assembly, Procedure V-EN-MP-101, " Procurement," in conjunction with other quality maintenance, modification, repair, inspection, testing, and shipment procedures provides guidance to ensure the following specific points are to ensure conformance with the purchase order requirements. The adequately addressed in procurement documents for important-to-safety source surveillance should cover the following aspects: scope:

• instructions specifying characteristics or processes to be

• ensure that the supplier understands procurement requirements, witnessed, inspected, or verified

• establishing, if applicable, "hold points"

• the documentation required

• provide for the evaluation of nonconforming items categorized by the

• identification of those responsible for implementing source supplier, along with technical justification and recommended disposition surveillance (e.g., "use as is" or "repair")

• establish requirements for supplier CofC The QA program user also should establish the extent to which

• establish documentation and records requirements, including inspection will be performed upon receipt of supplier-furnished requirements for electronic media, if applicable, and retention hardware to ensure that items are properly identified and correspond requirements.

with procurement documentation. When acceptance of an item is contingent on tests after installation in the package, the QA program Procedure V-EN-MP-120, "Quality Receipt Inspections" provides measures user and item supplier should mutually establish the relevant for performing receipt of supplier-furnished Important to Safety hardware acceptance documentation before its use. upon delivery to ensure the quality and technical requirements are satisfied .

In addition, the QA program user should take appropriate measures (such as source surveillance and audits of records) to ensure that the supplier performed the design and fabrication of packaging under the control of an NRC-approved QA program .

7.6. ControllingNonconformances The QA program user should establish measures to ensure the proper disposition of items or services that do not meet procurement requirements. These measures should include evaluation of nonconforming items categorized by the supplier, along with technical justification and recommended disposition (e .g., "use as is" or "repair").

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 22 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References 7.7. Records The QA program user should establish measures to ensure that the supplier furnishes the following records to the purchaser (as a minimum):

• documentation that identifies material or equipment and the specific procurement requirements (e.g., codes, standards, and specifications met by the items)

• documentation that identifies any procurement requirements that have not been met, along with a description of those nonconformances designated "use as is" or "repair"

• documentation that the supplied material and equipment meets the applicable procurement requirements before installation or use

• appropriate documentation, as identified in the purchase order, which will accompany the NRC-approved packaging during transport and be received at the destination by the user Such documents should (1) be referenced in the CoC, (2) relate to the use and maintenance of the packaging, and (3) identify necessary actions to be taken before delivery of the licensed material to a carrier for transport. If the pertinent documentation is in an electronic format, the QA program user should also maintain information on the specific software applications and storage or

• computing hardware that must be used to prepare and deliver the documentation.

The QA program user should retain the documentation at the facility or site of material or equipment use .

8. GUIDANCE ON §71.117, "IDENTIFICATION AND CONTROL OF MATERIALS, Section B.6.a states that "A program is established and implemented to identify PARTS, AND COMPONENTS" and control items to prevent the use of incorrect or defective items ."

Section B.6.b states that "Identification of each item is maintained throughout The QA program user should establish measures to ensure that materials, fabrication, erection, installation, and use so that the item can be traced to its parts, and components, including partially fabricated assemblies, are documentation. Traceability is maintained to an extent consistent with the adequately identified to preclude the use of incorrect or defective items.

item's importance to safety."

These measures should provide the means for physical identification (e.g.,

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 23 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References stamping, tags, labels, or lot-follower cards) and traceability to appropriate Procedure V-EN-MP-101, "Procurement" and Procedure V-EN-MP-125, documentation (e.g., mill reports, drawings, or specifications) throughout "Warehousing" includes guidance to ensure the identification and control are fabrication, installation, and use. Also, when replacement of limited-life adequately addressed for Important to Safety scopes of work in the items is specified, the QA program user should establish measures to procurement stages through its use.

preclude use of items for which the shelf life or prescribed operation time has expired . The implementation of any Important to Safety work at the ISFSI would In addition, the QA program user should establish measures to facilitate invoke the use of Procedure MTAP-10084, "Work Management Process" and continued processing, when required inspections or tests have not been the generation of a Work Order subject to Quality Assurance review. Any completed, to maintain physical identity and control over affected appropriate in- process inspections/ Hold Points would be included in the materials. Work Order to verify adequate identification and control of Important to Safety items.

9. GUIDANCE ON §71.119, "CONTROL OF SPECIAL PROCESSES" Section B.11.a states that "A program is established and implemented to ensure that special processes are properly controlled."

Special processes are not normally performed by the user of packaging.

However, if packaging maintenance requires the use of special processes Section B.11.b states that "The criteria that establish which processes are (e.g., welding or heat treating) or nondestructive testing, or if special special are described in procedures. The following are special processes:

processes are required to meet Coe requirements, the QA program user

1. welding, should establish measures to ensure that the special processes are controlled in accordance with the following suggested elements of 2. heat-treating, process control: 3. NDE {Non -Destructive Examination),

• Procedures, equipment, and personnel are qualified in accordance 4. chemical cleaning, and with applicable codes, standards, and specifications.

5. unique fabricating or testing processes that require in-process

• The operations are performed by qualified personnel and controls."

accomplished in accordance with written process or procedure sheets that direct the recording of evidence of verification. Section B.11.c states that "Special processes are accomplished by qualified personnel, using appropriate equipment, and procedures in accordance with

• Qualification records of procedures, equipment, and personnel are applicable codes, standards, specifications, criteria, and other special established, filed, and kept current. requirements ."

Procedure V-EN-MP-101, "Procurement" includes guidance to ensure the requirements for Important to Safety services are adequately addressed for applicable scope during the procurement stages.

The implementation of any Important to Safety work at the ISFSI would invoke the use of Procedure MTAP-10084, "Work Management Process" and the generation of a Work Order subject to Quality Assurance review. Any

CNR0-2017-00017 BVY 17-023 /Attachment 1 I Page 24 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References appropriate in-process inspections I Hold Points would be included in the Work Order to verify special process procedures, equipment, and personnel are currently qualified in accordance with applicable codes, standards, and specifications.

10. GUIDANCE ON §71.121, "INTERNAL INSPECTION" Section B.12.a states that "A program is established and implemented for 10.1. The QA program user should establish measures for internal inspections of activities in order to verify conformance to the documented inspection that consider the following recommendations: instructions, procedures and drawings for accomplishing the activity. The inspection program may be implemented by or for the organization performing

• The prerequisites to be satisfied before inspection are the activity to be inspected."

identified, including operator qualification and equipment calibration . Where sampling is used, the standard used as Section B.12 .b states that "Provisions to ensure inspection planning is properly the basis for verifying acceptability of a group of items accomplished are to be established. Planning activities are to identify the should be identified. characteristics and activities to be inspected, the inspection techniques, the acceptance criteria, and the organization responsible for performing the

• Inspection procedures, instructions, or checklists should be inspection."

available for each work operation, where necessary to ensure quality. Section B.12.c states that " Provisions to identify inspection hold points, beyond which work is not to proceed without the consent of the inspection

• Documents developed should include methods for identifying organization, are to be defined ."

characteristics and activities to be inspected, acceptance and rejection criteria, and the individuals or groups responsible for Section B.12.d states that "Inspection results are to be documented by the performing the inspection. inspector and reviewed by qualified personnel."

• "Hold" or witness points should be identified . Section B.12 .e states that "Unacceptable inspection results shall be evaluated and resolved in accordance with procedures."

• Inspection results should be recorded and objectively verifiable .

The implementation of any Important to Safety work at the ISFSI would

• The appropriate personnel should approve data to invoke the use of Procedure MTAP-10084, "Work Management Process" and ensure that all inspection requirements have been the generation of a Work Order subject to Quality Assurance review. Any satisfied . appropriate in-process inspections/ Hold Points would be included in the 10.2. Inspections Work Order.

10.2.1. Receiving Inspections For receiving inspections, Section B.5 .a states that "A program is established and implemented to verify the quality of purchased items and services at The QA program user should establish measures to ensure intervals and to a depth consistent with the item's or service's importance to that items that are important to safety meet the safety, complexity, and quantity and the frequency of procurement." This is requirements specified on the purchase order when the implemented through Procedure V-EN-MP-120, "Quality Receipt Inspections,"

items are received at the plant.

which provides measures for performing receipt of supplier-furnished The QA program user should establish the criteria for Important to Safety hardware upon delivery to ensure the quality and technical

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action to be taken, if noncompliance is encountered.

Procedure OP-0150 performs the daily inspections of temperature monitoring These visual inspections should include the following and Work Orders are used for the Annual Inspection of the Hi-Storm Spent aspects:

Fuel Cask on Storage Pad. These provide the measures for the maintenance

• surface conditions inspection to ensure adequate maintenance of the Important to Safety SSCs.

These measures include identification of the items to be maintained, criteria

• weld and structural integrity for acceptability or replacement, and frequencies of inspection assigned to

• the condition offlange faces or sealing areas, each item .

gaskets, seals, gauges, rupture disks, valves, and pressure relief devices Sections A.5 .a through c state that "Personnel assigned to implement elements of the quality assurance program are capable of performing their assigned

• the condition of tie-down members (if applicable) tasks. Training programs are established and implemented to ensure that

• labeling and marking personnel achieve and maintain suitable proficiency. Personnel training and qualification records are maintained in accordance with procedures."

• leak-tightness of the packaging Section B.12.d states that "Inspection results are to be documented by the In addition, the QA program user should establish provisions inspector and reviewed by qualified personnel."

to control accepted items until they are placed in stock or released for use, as well as provisions for the proper Section B.12.e states that "Unacceptable inspection results shall be evaluated disposition of rejected items. and resolved in accordance with procedures."

10.2.2. In-Process Inspections Section B.12.f states that "Inspections are performed by qualified personnel other than those who performed or directly supervised the work being The QA program user should establish measures to ensure that inspected . While performing the inspection activity the inspectors functionally process specifications and their supporting documentation report to the associated manager responsible for quality assurance."

provide for indirect control by monitoring processing methods, equipment, and personnel if direct inspection is impractical. Procedure V-EN-AD-103, "Document Control and Records Management Programs" identifies the types of records considered QA records, and 10.2.3. Final Inspections establishes the retention periods for each.

The QA program user should establish measures to ensure the following: (1) final inspections provide for resolution of nonconformances identified in earlier inspections, (2) the inspected item is identifiable and traceable to specific records and is adequately protected from physical or environmental damage, and (3) supervisors review inspection records to verify that all inspection requirements have been satisfied, as described in Section 11.2 of this document.

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 26 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References For packaging use, the QA program user should establish checklists to ensure that inspections are performed to verify the following:

• Packages are properly assembled.

• Moderators and neutron absorbers are present (if applicable).

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

• Valves are set to specifications.

• All shipping papers are properly completed.

• Packages are conspicuously and durably marked as required by the regulations set forth by the U.S.

Department of Transportation (DOT).

• Measures are established to ensure that appropriate personnel designated by the package user sign the shipping tags or indicators before authorization for shipping.

10.2.4. Maintenance Inspections The QA program user should establish measures for an inspection program to ensure adequate maintenance of packaging. This inspection program should identify the items to be maintained, criteria for acceptability or replacement, and the frequencies of inspection assigned to each item.

10.2.5. Inspectors The QA program user should establish measures to ensure that (1) inspectors are qualified in accordance with applicable codes, standards, and company training programs, (2) such qualifications and certifications are kept current, and (3) inspection personnel are independent from all individuals performing the activity being inspected.

10.2.6. Inspection Documentation The QA program user should maintain inspection records as QA records to document performance of inspection activities.

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11. GUIDANCE ON §71.123, "TEST CONTROL" implemented to demonstrate that items will perform satisfactorily in service ."

11.1. Requirements Section B.8.b states that "Criteria are defined that specify when testing is The QA program user should establish measures to ensure that required."

applicable test programs, including prototype qualification tests, Section B.8.c states that "The test control program includes, as appropriate, production tests, proof tests, and operational tests, are proof tests before installation, pre-operational tests, post-maintenance tests, accomplished in accordance with written procedures. The QA post-modification tests, and operational tests."

program user should also establish measures to ensure that modifications, repairs, and replacements are tested in accordance Section B.8.d states that "Test procedures are developed that include:

with the original design and testing requirements. instructions and prerequisites to perform the test, use of proper test equipment, acceptance criteria, and mandatory inspections as required ."

11.2. Procedures Section B.8.e states that "Test results are evaluated to assure that test The QA program user should establish measures to ensure that test objectives and inspection requirements have been satisfied."

prerequisites identified in the appropriate design disclosures are Section B.8.f states that "Unacceptable test results shall be evaluated."

properly translated into test procedures. For example, design closures may include instrument calibrations, monitoring to be performed, For 10 CFR 71 licensed Type B packages used for waste shipments offsite, mandatory "hold" points, suitable environmental conditions to be tests are conducted in accordance with the NRC packaging Certificate maintained, condition of the test equipment, methods for physical Holder's procedures and processes.

identification of test specimen, methods for documenting or In the case of the 10 CFR 72 licensed storage packages at the ISFSI, the testing recording test data, and criteria for acceptance of the package.

required for acceptance has already been completed during the fuel transfer 11.3. Acceptance Tests project. The implementation of any Important to Safety work at the ISFSI in the future would invoke the use of Procedure MTAP-10084, "Work The QA program user should establish measures, as appropriate, to Management Process" and the generation of a Work Order subject to ensure that acceptance tests are conducted before delivering Quality Assurance review . Any appropriate test guidance would be included packages for transport to a carrier. These measures should identify in the Work Order to verify acceptability of Important to Safety items.

the basis for acceptance criteria (e.g., CoC, maintenance and operational manuals furnished by the packaging manufacturers). Future Greater Than Class C (GTCC) waste requiring packaging for storage and Tests should typically include the following considerations: or transportation will be performed in a manner that satisfies the applicable regulatory requirements for Important to Safety SSCs (10 CFR 71 and or 10

• structural integrity CFR 72) as determined by the packaging material selected and associated

• leak-tightness (on containment vessel as well as auxiliary licensing strategy.

equipment and shield tanks)

Procedure V-EN -AD-103, "Document Control and Records Management

• component performance for valves, gaskets, and fluid transport Programs" identifies the types of records considered QA records, and devices establishes the retention periods for each .

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• shielding integrity

• thermal integrity 11.4. Maintenance Tests The QA program user should establish maintenance test programs to ensure that packages remain usable and free of excessive radiation and contamination. These test programs should include measures to ensure that qualified and responsible individuals document, evaluate, and assess the acceptability of all test results.

11.5. Results The QA program user should establish measures to ensure that test results are documented, evaluated, and maintained as QA records.

These records should be readily available if questions arise concerning operational aspects of the packages. In addition, a qualified individual or group should determine the acceptability of the records.

Section B.9.a states that " A program is established and implemented to control

12. GUIDANCE ON §71.125, "CONTROL OF MEASURING AND TEST the calibration, maintenance, and use of measuring and test equipment.

EQUIPMENT" Measuring and test equipment does not include permanently installed 12.1. Calibration Control operating equipment or test equipment used for preliminary checks where data obtained will not be used to determine acceptability or be the basis for design or engineering evaluation. Additionally, calibration and control The QA program user should establish guidelines to ensure that measures are not required for rulers, tape measures, levels and other such measurement and test equipment (e .g., gauges, fixtures, and devices devices if normal commercial manufacturing practices provide adequate used to measure product characteristics) is calibrated, adjusted, and accuracy."

maintained at prescribed intervals or before use. Such equipment should be labeled or tagged to indicate the planned date of its next Section B.9.b states that "The types of equipment covered by the program calibration. Calibration records should be identified, traceable, and (e .g., instruments, tools, gauges, and reference and transfer standards) are maintained as QA records . The QA program user should also defined in procedures ."

establish measures to ensure that in-house reference or transfer Section B.9.c states that "Measuring and test equipment is calibrated at standards used in calibrating measuring and test equipment are specified intervals or immediately before use on the basis of the item's traceable to nationally recognized standards. Calibrating standards required accuracy, intended use, frequency of use, and stability characteristics should have known valid relationships to nationally recognized

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user should document the basis for calibration.

Section B.9.d states that "Measuring and test equipment is labeled, tagged, or 12.2. Out-Of-Calibration Equipment otherwise controlled to indicate its calibration status and to ensure its traceability to calibration test data ."

When test and measuring equipment is found to be out of calibration, the QA program user should take measures to validate Section B.9.e states that "Measuring and test equipment is calibrated against previous inspection and test results up to the time of previous standards that have an accuracy of at least four times the required accuracy of calibration . the equipment being calibrated or, when this is not possible, have an accuracy that ensures the equipment being calibrated will be within the required In addition, the QA program user should repair or replace any tolerance."

measuring equipment that is consistently out of calibration.

Section B.9.f states that "If nationally recognized standards exist, calibration standards are to be traceable to them. Except where calibration standards with the same accuracy as the instruments being calibrated are shown to be adequate for the requirements, calibration standards are to have a greater accuracy than the standards being calibrated."

Section B.9.g states that "Measuring and test equipment found out of calibration is tagged or segregated . The acceptability shall be determined of items measured, inspected, or tested with an out-of-calibration device ."

The implementation of any Important to Safety work at the ISFSI in the future would invoke the use of Procedure MTAP-10084, "Work Management Process" and the generation of a Work Order subject to Quality Assurance review. Provisions for use of any M&TE in accordance with all requirements would be included in the Work Order for any M&TE used to verify acceptability of Important to Safety items.

13. GUIDANCE ON §71.127, "HANDLING, STORAGE, AND SHIPPING CONTROL" Section B.7.a states that "A program is established and implemented to control the handling, storage, shipping, cleaning, and preserving of items to ensure the 13.1. Preservation items ma intain acceptable quality."

The QA program user should establish measures to ensure that Section B.7 .b states that "Special protective measures (e .g., containers, shock cleaning, handling, storage, and shipping are accomplished in absorbers, accelerometers, inert gas atmospheres, specific moisture content accordance with design requirements to preclude damage or levels, and temperature levels) are specified and provided when required to deterioration by environmental conditions such as temperature and maintain acceptable quality."

humidity. When necessary, the QA program user also should Section B.7.c states that "Specific procedures are developed and used for establish provisions for the use of special handling, lifting, or storage cleaning, handling, storage, packaging, shipping, and preserving items when devices (e .g., cranes, shock absorbers, or special markings) to

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assemblies. In addition, the QA program user should ensure that Section B.7.a states that "Items are marked and labeled during packaging, conditions identified in the Coe are adhered to when unloading shipping, handling, and storage to identify, maintain, and preserve the items' packaging.

integrity and indicate the need for special controls."

13.2. Preparation, Release, and Delivery to Purchaser Transportation cask handling and operation shall conform to the handling and operating procedure for each licensed cask. Prior to the shipment of The QA program user should establish measures to ensure that a final radioactive material, applicable conditions of the NRC's Certificate of pre-release review has been completed. This review should ensure Compliance (specifications, tests, and inspections) shall be satisfied. Required that the packaging (1) is prepared for delivery to the purchaser in shipping papers shall be prepared and shall accompany the shipment in accordance with NRC-approved drawings, specifications, and accordance with regulatory requirements and approved procedures.

government regulations, (2) has passed all applicable inspections and For 10 CFR 71 licensed Type B packages used for waste shipments offsite, tests, (3) is properly identified by physical markings or tags, and (4) tests are conducted in accordance with the NRC packaging Certificate contains operating manuals, maintenance manuals, and generic Holder's procedures and processes.

procedures relating to its use.

In addition, the QA program user should establish measures to ensure In the case of the 10 CFR 72 licensed storage packages at the ISFSI, the testing that the following requirements are fulfilled: required for acceptance has already been completed during the fuel transfer project. The implementation of any Important to Safety work at the ISFSI in

• Cavities within gas-cooled package containments have been the future would invoke the use of Procedure MTAP-10084, "Work adequately dried, and cavities within liquid-cooled packages Management Process" and the generation of a Work Order subject to have been drained to allow adequate void space. Quality Assurance review. Any appropriate test guidance would be included

• All conditions (including specified operations, inspections, and in the Work Ord er to verify acceptability of Important to Safety items.

tests) have been completed before delivery to a carrier. Future Greater Than Class C (GTCC) waste requiring packaging for storage and

• All NRC and DOT requirements have been satisfied before or transportation will be performed in a manner that satisfies the applicable delivery to a carrier. regulatory requirements for Important to Safety SSCs (10 CFR 71 and or 10 CFR 72) as determined by the packaging material selected and associated

• All necessary shipping papers have been prepared as lice nsing strategy.

required and reviewed by qualified personnel to verify completeness and accuracy. Procedure V-E N-AD-103, "Document Control and Records Management Programs" identifies the types of records considered QA records, and establishes the retention periods for each .

Procedure V-E N-MP-125, " Warehousing" includes guidance to ensure handling, storage and shipping are adequately addressed for any Important To Safety items in storage prior to release to the field or prior to shipping offsite.

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14. GUIDANCE ON §71.129, "INSPECTION, TEST, AND OPERATING STATUS" Section B.10.a states that "The status of required inspections and tests and the operating status of items are verified before release, fabrication, receipt, The QA program user should establish measures to ensure that the installation, test, and use, as applicable. This verification is to preclude status of inspections, tests, and operating conditions (including inadvertent bypassing of inspections and tests and to prevent inadvertent maintenance of items) is known by organizations responsible for operation of controlled equipment."

ensuring quality. The QA program user should also establish measures to control the application and removal of status indicators (e.g., tags, Section B.10.b states that "The application and removal of inspection, test, and markings, stamps) and to ensure that bypassing a required inspection operating status indicators are controlled in accordance with procedures."

or test or any other required operation is procedurally controlled The implementation of any Important to Safety work at the ISFSI in the under the cognizance of the QA organization .

future would invoke the use of Procedure MTAP-10084, "Work Management Process" and the generation of a Work Order subject to Quality Assurance review.

15. GUIDANCE ON §71.131,"NONCONFORMING MATERIALS, PARTS, OR Section A.6.d states that "Non-conforming items are properly controlled to COMPONENTS" prevent their inadvertent test, installation, or use. They are reviewed and either accepted, rejected, repaired, or reworked ."

An acceptable program for controlling nonconforming items should include the following principal elements:

• proper identification

• segregation of discrepant or nonconforming items

• evaluation of the nonconforming items

• disposition of the nonconforming items

16. GUIDANCE ON §71.133,"CORRECTIVE ACTION" Section A.6.a states that "It is the responsibility of each individual to promptly 16.1. Reporting identify and report conditions adverse to quality. Management at all levels The QA program user should establish measures to ensure that the encourages the identification of conditions that are adverse to quality."

causes of conditions detrimental to quality (e .g., those resulting from Section A.6.b states that "A corrective action program is established and failures, malfunctions, deficiencies, deviations, or defective material implemented that includes prompt identification, documentation, and and equipment) are identified promptly and reported to appropriate correction of conditions adverse to quality. The corrective action program levels of management. In addition, the QA program user should for significant conditions adverse to quality shall require cause establish measures to obtain corrective actions from suppliers and determination and a corrective action plan that precludes repetition ." The ensure that followup actions are documented to verify that the approved QAPM guidance shall be used rather than the specific guidance corrective actions were implemented and effective .

provided within Regulatory Guide 7.10 16.2. Closeout, Retrieval, and Disposition of Records Section A.6.c states that "Specific responsibilities within the corrective action The QA program user should establish measures to ensure that program may be delegated, but VY maintains responsibility for the program's corrective actions designated by cognizant individuals have been effectiveness."

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documenting their resolution.

Section A.6.e states that "Reports of conditions that are adverse to quality are analyzed to identify trends in quality performance . Significant conditions adverse to quality and significant trends are reported to the appropriate level of management."

Section B.13 .a states that "Procedures shall provide for identification, evaluation, and resolution of conditions adverse to quality."

Section B.13.b states that "Reworked, repaired, and replacement items are to be inspected and tested in accordance with the original inspection and test requirements or specified alternatives."

Procedure V-E N-MP-101, "Procurement" includes guidance to ensure the requirements for corrective actions are applied to suppliers for Important To Safety scope .

Section B.15.a states that "A program is established and implemented to

17. GUIDANCE ON §71.135, "QUALITY ASSURANCE RECORDS" ensure that sufficient records of items and activities (e.g., design, engineering, 17.l. General procurement, manufacturing, construction, inspection and test, installation, QA records should furnish documentary evidence of the activities that pre-operation, startup, operations, maintenance, modification, affect quality and should provide sufficient information to allow each decommissioning, and audits) are generated and maintained to reflect record to be identified with the items or activities to which it applies. completed work."

In accordance with 10 CFR 71.135, QA records shall be retained for 3 Section B.15 .b states that "The program provides provisions for the years beyond the date when the QA program user last engaged in the administration, receipt, storage, preservation, safekeeping, retrieval, and activity for which the QA program was developed. If any portion of disposition of records."

the written procedures or instructions is superseded, the QA program Section B.15.c states that "The program includes provisions for the use of user shall retain the superseded material for 3 years after it is various record storage media to maintain QA records. Procedures are superseded. As a minimum, QA records should include the following developed to implement the regulatory guidance associated with the media information:

used."

• design, procurement, manufacturing, and installation records Procedure V-EN-AD-103, "Document Control and Records Management

• supplier evaluations Programs" identifies the types of records considered QA records, and

• nonconformance reports establishes the retention periods for each . The full range of records required to be retained and the retention periods, including those required by 10 CFR

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• results of inspections and tests media . Records are processed by VY into an electronic records system for

• failure analyses indexing, storage and retrieval in accordance with approved procedures . .

• as-built drawings and specifications Procedure V-EN-AD-103, "Document Control and Records Management Programs" establishes the overall guidance for the management of QA

• qualification of personnel, procedures, and equipment records.

• calibration procedures

• training and retraining records In addition, retention periods specified in various governing codes and standards (e.g. 10 CFR 71 & 10 CFR 72) are included in the retention

• corrective action reports requirements established in approved procedures for QA records.

• records demonstrating evidence of operational capability

• records verifying repair, rework, and replacement

• audit plans, audit reports, and corrective actions

• records that are used as a baseline for maintenance

• maintain records documenting changes to the QA program as required by 10 CFR 71.106 In addition, the QA program user should retain records that show evidence of package delivery to a carrier and proof that all NRC and DOT requirements have been satisfied (with their retention times identified).

Where applicable, inspection and test records should contain the following information:

• a description of the observation

• evidence of completion of the inspection or test operation

• results of inspections or tests with appropriate data

• conditions detrimental to quality

• names of inspectors, testers, or data recorders

• evidence of acceptability

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 34 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References 17.2. Generating Records The QA program user should establish measures to ensure that methods employed to generate and manage documents that are designated as QA records result in information that is retrievable, intelligible, and reliable. Such records should reflect the work accomplished and should be stored in a manner that avoids unnecessary delay when access to the record is needed . In addition, procedures for generating QA records should address both hard copy records and electronic information .

17.3. Indexing and Classification of Records The QA program user should classify QA records as either " lifetime" or

" nonpermanent":

• Lifetime records include those pertaining to package fabrication and those associated with a particular item while it is installed in the packaging or stored for future use. These records {1) demonstrate the capability for safe operation, provide evidence of repair, rework, replacement, or modification, (3) aid in determining the cause of an accident or malfunction of an item, and (4) provide a baseline for inservice inspection .

• Non permanent records are those that show evidence that an activity has been performed but do not meet the criteria for lifetime records . Records pertaining to use of a package should be retained for a period of 3 years after each shipment.

17.4. Receipt, Retrieval, and Disposition of Records The QA program user should establish measures to provide a receipt control system, including identification of functions or positions in each organization responsible for receiving records and assessing the current status of records in their possession. The QA program user should also establish measures to ensure that records maintained in- house or at other locations are identifiable and retrievable, and are not disposed of until prescribed conditions are satisfied. For electronic records, the software systems used to

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 35 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References image and store information should be compatible with new hardware as current technologies are implemented . In addition, the QA program user should have a procedure in place before installing any new hardware systems to ensure that the new systems can reliably store and retrieve information from existing software systems.

17.5. Storage, Preservation, and Safekeeping The QA program user should establish measures to ensure that the following outcomes are fulfilled :

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

• Records should be firmly attached in binders or placed in folde rs or envelopes for storage in steel file cabinets.

• Electronic records should be maintained in facilities that minimize or eliminate the potential for destruction of information as a result of demagnetization (Ref. 12).

• Electronic records should be backed up daily to eliminate the potential for loss of information as a result of equipment failure or human error (Ref. 12).

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

• The QA program user should take measures to protect special records

• (e.g., radiographs and microfilm) from excessive light, electromagnetic fields, and temperature.

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• The QA program user should take measures to prevent unauthorized personnel from entering record storage areas.

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

• The QA program user should establish measures to ensure prompt replacement of lost or damaged records.

Section C.l.a states that "Personnel responsible for carrying out audits are

18. GUIDANCE ON §71.137, "AUDITS" maintained cognizant of day-to-day activities by the ongoing involvement in 18.1. Elements of an Audit Program the quality assurance program requirements so that they can act in a A comprehensive audit program should include the following management advisory function."

elements: Section C.l.b states that "Organizations performing audits are to be technically and performance oriented commensurate with the activity being reviewed."

• assurance of the authority and organizational independence of the auditors Section C.l.c states that "Personnel performing audits have no direct responsibilities in the area they are assessing."

• a commitment to adequate manpower, funding, and facilities to implement the audit Section C.l.d states that "Audits are accomplished using instructions, procedures, or other appropriate means that are of a detail commensurate

• identification of audit personnel and their qualifications with the activity's complexity and importance to safety.

• provisions for reasonable and timely access of audit Section C.2.a states that "A program of planned and periodic audits is personnel to facilities, documents, and qualified personnel established and implemented to confirm that activities affecting quality compl~

necessary for performing audits with the QAPM and that the QAPM has been implemented effectively. Audit

• use of established procedures and checklists frequencies will be implemented as required by the applicable Code of Federal Regulations, safety analysis report, and commitments by various

• methods for reporting audit findings to responsible correspondences to the NRC. Audits will be conducted at a frequency in management of both the audited and auditing organizations accordance with either Section C.2.a.l or Section C.2.a.2 below.

• provisions for the audit team to gain access to levels of management that have responsibility and authority for 1. Audit frequencies are determined based on regulatory commitments or corrective action site requirements."

• methods for verifying that effective corrective action has been 2. Audit schedules assure that the technical areas are audited at the

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 37 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 References accomplished on a timely basis QAPM indicated frequencies, or more frequently as performance dictates.

• The QA program user also should establish and maintain a list to reflect the current status of the activities important to Note that these are the frequencies used to comply with the QAPM rather safety that are to be audited and the frequency at which each than the specific guidance provided within Regulatory Guide 7.10.

quality criterion is to be audited. The frequency of audits Section C.2 .b states that "Audits shall provide an objective evaluation of quality should be based on each activity's importance to safety; related practices, procedures, instructions, activities, and items and a review of however, each quality criterion should be audited at least once documents and records, as applicable."

each year.

Section C.2.c states that "Audits shall be performed in accordance with

• The QA program user also should establish measures to ensure approved written procedures or checklists. Items from previous audits shall be that packaging manufacturers are audited to assess the extent of reviewed and reaudited, as appropriate . The checklists are used as guides to their compliance with purchase orders and to verify that their the auditor."

work is controlled under an NRC-approved QA program. In addition, the QA program user also should identify (by function or Section C.2.d states that "Scheduling and resource allocation are based on the position) the individuals or groups that have the responsibility and status and safety importance of the activity or process being assessed ."

authority to ensure that corrective actions resulting from audit Section C.2.e states that "Scheduling' is dynamic and resources are findings are accomplished on a timely basis. The QA program user supplemented when the effectiveness of the quality assurance program is in should re-audit deficient areas on a timely basis to verify doubt."

implementation of corrective actions.

Section C.2.f states that "Audit reports are written and distributed to the 18.2. Scheduling of Audits appropriate levels of management for review. Follow-up action, including re-look at deficient areas, is initiated as deemed appropriate." .

• The QA program user should establish schedules for internal audits, external audits, and audits performed by management. Section C.2.g states that "Implementation of delegated portions of the quality These schedules should ensure that key activities of the QA assurance program is assessed."

program (e.g., design, fabrication) receive priority consideration. Section C.2.h states that " Audits are conducted using predetermined acceptance criteria ."

• For audits performed by management, the schedules should identify the level of management (usually from the corporate Audit Team Leaders (ATL) will continue to be qualified under our current office or another division) designated to assess the overall approved ATL training program and not under NQA-la-2009 as effectiveness of the implementation of the described in-house QA recommended in RG 7.10. The approved program is based on requirements program. The QA program user should also identify the activities contained in ANSI N45.2.23 and outline in V-EN-QV-117 Oversight Training important to safety (e .g., procurement, training of personnel) that Program.

should be included in the audit program. Management audits should be conducted at least once every 12 months. Additional guidance and requirements for audit team selection, including the

• For internal audits, the schedules should ensure that applicable use of technical specialists is contained in Implementing Procedure V-EN-QV-

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once within the life of the activity, whichever is shorter.

Implementing Procedure V-EN-QV-109 provides guidance on the conduct of

• For external audits, the schedules should ensure that all audits, including development of audit plans, the conduct of audits, the elements of a major supplier's (or major contractor's) QA conduct and purpose of audit exit meetings, the generation and transmittal program are audited on a triennial basis. The 3-year period or reports, the interface with corrective actions processes, and the required should begin with performance of an audit when sufficient work follow-up actions.

is in progress to demonstrate implementation of a QA program that has the required scope for purchases placed during the 3-year period .

18.3. Team Selection

• The QA program user should establish the qualifications of the lead auditor and audit team members and specify their respective responsibilities for evaluating and issuing audit reports. The auditing organizations should be responsible for establishing qualifications for prospective audit personnel and the requirements forthe use of technical specialists to accomplish auditing activities that are important to safety. The QA program user should select the lead auditor and audit team members from personnel who do not have direct responsibility in the areas being audited.

• Specific guidance for determining qualifications for the lead auditor and individual audit team members may be obtained from ANSl/ASME NQA 2008 with the NQA-la-2009 Addenda, "Quality Assurance Requirements for Nuclear Facility Applications (QA)" (Ref. 2).

18.4. Pre-Audit Conference Before an audit, the QA program user should specify the nature and scope of the pre-audit conference between management of the organizations being audited and the team conducting the audit. The purpose of the pre-audit conference should be to (1) meet counterparts, confirm the audit scope and dates, (3) establish channels of communication, (4) discuss the sequence and duration of

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 39 of 40 Regulatory Guide 7.10 Revision 3 QAPM Revision 7 Refere nces the audit, (5) prepare an agreed -upon agenda for the audit, and (6) set the time for the post-audit conference .

18.5. Post-Audit Conference The QA program user should establish measures to conduct a post-audit conference between management of the organizations being audited and the team conducting the audit to present the results and clarify any questions that may arise.

18.6. Reporting and Response The QA program user should establish measures to identify time constraints imposed for issuing audit reports and the requested date for a corrective action response by the audited organization . The response should clearly state the corrective action taken to prevent recurrence of nonconformances. If corrective action cannot be taken immediately, the response of the audited organization should include scheduled dates for initiation and completion of the corrective action.

18.7. Followup Action The audit team leader should verify that (1) the audited organization provides a timely response to the audit report, (2) the response is adequate, and (3) the corrective action has been accomplished within the prescribed schedule.

CNR0-2017-00017 BVY 17-023 I Attachment 1 I Page 40 of 40 Table 1 10 CFR 71 Criterion Key Implementing Procedure No. and Title 71.103 Quality assurance organization V-EN-PL-100, "Nuclear Excellence Model" V-EN-QV-100, "Conduct of Nuclear Independent Oversight at Vermont Yankee" 71.105 Quality assurance program Various Quality Procedures 71.107 Design control V-EN-DC series of procedures 71.109 Procurement document control V-EN-MP-101, "Procurement" 71.111 Instructions, procedures, and drawings AP-0096, "Control of Procedures" 71.113 Document control V-EN-AD-103, "Document Control and Records Management Programs" 71.115 Control of purchased material, V-EN-MP-101, "Procurement" equipment, and services V-EN-MP-120, "Quality Receipt Inspection" V-EN-MP-125, "Warehousing" V-EN-QV-109, "Audit Process" V-EN-QV-201, "Quality Control Inspection Program" 71.117 Identification and control of materials, V-EN-MP-120, "Quality Receipt Inspection" parts, and components V-EN-MP-125, "Warehousing" 71.119 Control of special processes MTAP-10084, "Work Management Process" 71.121 Internal inspection MTAP-10084, "Work Management Process" V-EN-QV-201, "Quality Control Inspection Program" 71.123 Test control MTAP-10084, "Work Management Process" EF-1, ISFSI Engineering Evaluations and Design Control Program OP-2, ISFSI Surveillance and Inspections Program OP-4, VCC and ISFSI Pad Inspection Program 71.125 Control of measuring and test MTAP-10084, "Work Management Process" equipment AD-16, Requisitioning Material, Equipment & Services 71.127 Handling, storage, and AD-16, Requisitioning Material, Equipment & Services shipping control AD-17, Receipt Inspection, Storage and Control of Purchased Equipment, Material & Services 71.129 Inspection, test, and operating status MTAP-10084, "Work Management Process" AD-17, Receipt Inspection, Storage and Control of Purchased Equipment, Material & Services 71.131 Nonconforming materials, parts, AD-21, Nonconformance Reporting or components AD-15, Evaluation of Component or Equipment Failure or Deviation for 10CFR21 Reportability 71.133 Corrective action V-EN-Ll-102, "Corrective Action Program" 71.135 Quality assurance records V-EN-AD-103, "Document Control and Records Management Programs" 71.137 Audits V-EN-QV-109, "Audit Process"

CNR0-2017-00017 BVY 17-023 Docket Nos. 50-271, 72-59 and 71-0907 ATTACHMENT 2 Vermont Yankee Nuclear Power Station Summary of Proposed Changes to the VY QAPM

CNR0-2017-00017 BVY 17-023 I Attachment 2 I Page 1 of 3

SUMMARY

OF PROPOSED CHANGES TO THE ENTERGY VERMONT YANKEE QUALITY ASSURANCE PROGRAM MANUAL (VY QAPM)

Purpose The purpose of this summary is to characterize the proposed changes to be included in the VY QAPM Revision 7. The proposed revision is a substantial revision to the QAPM and will replace the previous revision in its entirety. Several substantial changes are described , along with the justifications for those changes. In addition, the various minor editorial and administrative changes are discussed in a summary form.

Background

The revision reflects a simplification of the QAPM that is based on the decommissioning status of the VY facility with all spent nuclear fuel in dry storage on the VY Independent Spent Fuel Storage Installation (ISFSI) and the long-term passive operational status of the ISFSI. VY is currently undergoing a campaign to transfer all spent nuclear fuel from the spent fuel pool to dry storage. The campaign is expected to be completed by late 2018 (Reference 1)

Once the transfer of all spent nuclear fuel to the ISFSI is complete and the ISFSI transitions to long term passive operations, the radiological risk factors associated with decommissioning activities will have been significantly reduced . Additionally, although radioactive waste remains to be shipped offsite for disposal, the QAPM still applies to the applicable activities for shipping of radioactive material within shipping packages and activities as described by the VY QAPM .

QAPM Revision 7 applies to all activities associated with structures, systems and components (SSCs) which are classified as Important-to-Safety (ITS) under 10 CFR 72. The QAPM also applies to transportation packages and activities licensed by the NRC under 10 CFR 71 and designated as ITS. For other ISFSI and decommissioning activities, administrative programs and procedures ensure compliance with governing regulations and include appropriate controls for activities under the radiological control and monitoring programs previously contained in the Technical Specifications and relocated to Appendix D of the QAPM in Revision 6.

The proposed Revision 7 to the QAPM is appropriate for the remaining decommissioning activities and to support ISFSI operations. All safety-related SSCs will have been removed from service and/or have been reclassified. The ISFSI will have transitioned to long-term passive operations. The spent fuel storage system is inherently safe by design. The main function of the ISFSI organization is to monitor the environment in a way that demonstrates the integrity of the system. Maintaining appropriate quality standards that preserve the passive functionality of the system continues to be important, and can be accomplished satisfactorily through conformance to the guidance provided in Regulatory Guide 7.10, Revision 3.

The proposed revision will continue to satisfy the criteria of 10 CFR 50, Appendix B and the Quality Assurance (QA) requirements of 10 CFR 71, Subpart H and 10 CFR 72, Subpart G.

CNR0-2017-00017 BVY 17-023 /Attachment 2 /Page 2 of 3 Change 1 - Substantial Changes:

Change 1A: The program basis was changed from ANSI/ANS standards to use primarily Regulatory Guide 7 .10 "Establishing Quality Assurance Programs for Packaging Used in Transport of Radioactive Material", Revision 3 as a guidance document. This was previously included in Appendix C as an additional guidance document. The highest level of safety significance items and activities remaining at the VY facility are designated as Important-to Safety {ITS) under 10 CFR 71 and 10 CFR 72 as defined in Appendix A. There will be no systems, structure or components (SSCs), items or activities remaining at the VY site that are classified as safety-related as defined in 10 CFR 50 Appendix B. The NRC Quality Assurance Program guidance for ITS activities under 10 CFR 71 and 10 CFR 72 is included in Regulatory Guide 7.10. The change in base guidance documents is a reduction in commitment to the previously approved QA Program, but it is acceptable due to the current state of decommissioning at the VY facility and the passive operational status of the VY ISFSI.

Change 18: The Safety Review Committee (SRC) is replaced with the Independent Management Assessment (IMA) function as defined in Section A.3.f. IMAs are periodically performed to monitor overall performance and confirm that activities affecting quality comply with the QAPM and that the QAPM is effectively implemented. IMAs are performed by individual(s) who: are designated by the chief nuclear officer, are independent of activities assessed; and provide the appropriate level of expertise in the activities assessed. The IMA results are communicated in an understandable form and in a timely fashion to a level of management having the authority to effect corrective action. In addition, these results are reported in a timely fashion to the chief nuclear officer. These IMAs will ensure that independent oversight of activities being performed at the VY facility will continue during fuel storage at the ISFSI and decommissioning.

Specific changes are summarized as follows:

• Currently, the SRC is required to be composed of at least two (2) members plus a Chairman. The IMA will not be required to be performed by a committee .

• An IMA may be conducted by as few as one person appointed by the chief nuclear officer.

• The SRC is required, collectively, to have experience and competence in a number of technical areas. This revision does not specify qualification, experience, or competency requirements for personnel performing IMAs.

• There is no requirement for a minimum number of meetings per year as there is no committee to meet. IMAs will be performed periodically as directed by the chief nuclear officer.

• The IMAs will be governed by implementing procedure and will include implementation of the QAPM with focus on the safe storage of spent nuclear fuel, but can include other activities as directed by the chief nuclear officer.

The requirements for an independent review function was based on ANSI N18.7-1976 as endorsed by Regulatory Guide 1.33, Revision 2 and were satisfied by the SRC. The composition and function of the SRC as described in the previous QAPM revision follows the guidance provided in ANSI N18.7-1976, Section 4.3.1, with exceptions previously approved by the NRC. The program described therein was intended for operating nuclear power plants. 10 CFR 50, Appendix B, does not specifically require an independent review function (as described in ANSI N18.7) as part of its quality assurance program requirements. Appendix B, 10 CFR 50, Criterion II states in

CNR0-2017-00017 BVY 17-023 I Attachment 2 I Page 3 of 3 part: "The applicant shall regularly review the status and adequacy of the quality assurance program."

Change 1C: Modified Fire Protection Audit requirements based on all spent nuclear fuel being moved from the spent fuel pool to the ISFSI. There continues to be a requirement to perform Fire Protection Program Audits once every 24 months; however, the fire protection and loss prevention program inspection and fire protection and loss prevention program inspection audits have been eliminated.

Change 2 - Editorial I Administrative Improvements and Clarifications:

A number of editorial changes were made for consistency, clarity and to improve readability were made. The types of changes of this nature are as follows:

Editorial Changes Type 1: Eliminate discussion of safety-related items and activities.

Editorial Changes Type 2: Modified some organizational titles, responsibilities and positions to reflect the completion of the movement of spent fuel from the spent fuel pool to the ISFSI.

Editorial Changes Type 3: Modified Appendix A to reflect that there are no longer any safety-related SSCs at the facility.

Editorial Changes Type 4: Modified the exceptions to ANSI/ANS 3.1-1978 to reflect the transfer of all spent nuclear fuel from the spent fuel pool to the ISFSI.

Editorial Changes Type 5: Moved remaining information from Appendix D to Appendix C and modified information slightly to reflect that all spent nuclear fuel has been relocated from the Spent Fuel Pool to the ISFSI. The change with the SRC was previously described .

In summary, these types of changes are considered editorial and do not alter the intent or purpose of the QAPM and continue to satisfy the criteria of Appendix B to 10 CFR 50 and the Quality Assurance requirements of 10 CFR 71 and 10 CFR 72.

Overall Evaluation:

This revision is a substantial change to the QAPM. It includes editing to ensure consistency with the major changes being implemented, along with providing modifications to reflect a decommissioning nuclear facility that has moved all spent nuclear fuel from the spent fuel pool to an ISFSI. This editing, however, did not alter the effectiveness of the QAPM .

The changes were evaluated and determined to be acceptable based on the proposed state of decommissioning at the VY site required for implementation and the passive operational status of the VY ISFSI. The proposed revision continues to satisfy the criteria of Appendix B to 10 CFR 50 and the Quality Assurance requirements of 10 CFR 71 and 10 CFR 72 .

References:

1. Letter, Entergy Nuclear Operations, Inc. to USNRC, "Notification of Schedule Change for Dry Fuel Loading Campaign," BVY 17-013, dated April 12, 2017 (ML17104A050)

CNR0-2017-00017 BVY 17-023 Docket Nos. 50-271, 72-59 and 71-0907 ATTACHMENT 3 Vermont Yankee Nuclear Power Station VY QAPM Proposed Revision 7

Vermont Yankee Nuclear Power Station Docket No. 50-271 License No. DPR-28 Docket No. 72-59 Docket No. 71-0907 Quality Assurance Program Manual Effective: (DATE) Proposed Revision 7

~ EnferJ!.Y VY QUALITY ASSURANCE PROGRAM MANUAL POLICY STATEMENT Entergy Nuclear Vermont Yankee, LLC (ENVY) and Entergy Nuclear Operations, Inc. (ENOI) shall maintain and operate Vermont Yankee Nuclear Power Station (VY) in a manner that will ensure the health and safety of the public and workers. The facility shall be operated in compliance with the requirements of the Code of Federal Regulations, the applicable Nuclear Regulatory Commission (NRC) Facility Operating Licenses, and applicable laws and regulations of the state and local governments.

The Quality Assurance Program (OAP) described herein and associated implementing documents provide for control of activities that affect the quality of safety-related nuclear plant structures, systems, and components (SSCs). The OAP is also applied to SSCs classified as important-to-safety (ITS} to satisfy the requirements of 10CFR71 and 10CFR72.

The Quality Assurance Program Manual (QAPM) is the top-level policy document that establishes the manner in which quality is to be achieved and presents our overall philosophy regarding achievement and assurance of quality. Implementing documents assign more detailed responsibilities and requirements and define the organizational interfaces involved in conducting activities within the scope of the QAPM. Compliance with the QAPM and implementing documents is mandatory for personnel directly or indirectly associated with implementation of the OAP.

Responsibility for developing, implementing, and verifying execution of the Qual ity Assurance Program is delegated to the chief nuclear officer (highest level nuclear executive) and authority for developing and verifying execution of the program to the executive responsible for oversight.

Proposed Revision 7

• ~Enterw VY QUALITY ASSURANCE PROGRAM MANUAL TABLE OF CONTENTS SECTION PAGE A. MANAGEMENT

1. Methodology 1

2. Organization 1

3. Responsibility 4

4. Authority 4

5. Personnel Training and Qualification 5

6. Corrective Action 5

7. Regulatory Commitments 6 B. PERFORMANCENERIFICATION

1. Methodology 7

2. Design Control 7

3. Design Verification 8

4. Procurement Control 9

5. Procurement Verification 10

6. Identification and Control of Items 10

7. Handling, Storage, and Shipping 11

8. Test Control 11

9. Measuring and Test Equipment Control 12

10. Inspection, Test, and Operating Status 12

11. Special Process Control 13

12. Inspection 13 ii Proposed Revision 7

-~ Enferf!.Y VY QUALITY ASSURANCE PROGRAM MANUAL TABLE OF CONTENTS SECTION PAGE

8. PERFORMANCENERIFICATION (continued)

13. Corrective Action 14

14. Document Control 14

15. Records 15

c. AUDIT

1. Methodology 16

2. Performance 16 D. INDEPENDENT SAFETY REVIEW

1. Description 18 Appendix A Safety Related and Important-to-Safety Structures, Systems and 19 Components Appendix B - Regulatory Commitments 21 Appendix C - Other General Guidance Documents 51 Appendix D - Administrative Controls 52 iii Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL A. MANAGEMENT

1. Methodology

a. The Quality Assurance Program Manual (QAPM) provides an overview of the quality program controls which governs the operation and maintenance of VY safety related and important-to-safety {ITS) items and activities. The QAPM describes the quality assurance organizational structure, functional responsibilities, levels of authority, and interfaces.

b. The requirements and commitments contained in the QAPM are mandatory and must be implemented, enforced , and adhered to by all individuals and organizations. Employees are encouraged to actively participate in the continued development of the QAPM as well as its implementation . -Changes should be promptly communicated when identified.

c. The QAPM applies to all activities associated with structures, systems, and components that are safety related or ITS controlled by 10 CFR 72, as defined in Appendix A. The QAPM also applies to transportation packages controlled by 10 CFR 71 . The methods of implementation of the requirements of the QAPM are commensurate with the item's or activity's importance to safety. The applicability of the requirements of the QAPM to other items and activities is determined on a case-by-case basis as defined within approved procedures. The QAPM implements 10 CFR 50 Appendix B, 10 CFR 71 Subpart H, and 10 CFR 72 Subpart G.

d. The QAPM is implemented through the use of approved procedures (e.g.,

policies, directives, procedures, instructions, or other documents) which provide written guidance for the control of saf.ety related and ITS related activities (termed quality related activities) and provide for the development of documentation to provide objective evidence of compliance.

2. Organization The organizational structure responsible for implementation of the QAPM is described below. The organizational structure consists of corporate and VY functions. The specific organization titles for the quality assurance functions described are identified in procedures. The authority to accomplish the quality assurance functions described is delegated to the incumbent's staff as necessary to fulfill the identified responsibility.

Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL A. 2. {continued)

a. Corporate Organization

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

2. The chief nuclear officer, the highest level nuclear executive officer, is responsible for provid ing top-level direction for the safe and reliable operation of VY's nuclear site. The highest level nuclear executive officer provides guidance with regards to company quality assurance policy. The results of off site safetylndependent Management Assessments are revie*.v committee reporteds to this executive.

3. The executive responsible for oversight establishes the policies, goals, and objectives of the quality assurance policy and provides guidance and interpretation for implementing the company quality assurance policy and is responsible for governance and implementation of the quality assurance program in accordance with regulatory requirements. Independent oversight groups report to this executive.

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

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

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

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

2 Proposed Revision 7

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL A. 2. (continued)

b. VY Site Organization The following site management positions describe the typical site QAPM functional responsibilities, which may be delegated to others as established in this document. These individuals functions may be performed by the same individuals and may report through an add itional layer of management, but shall maintain sufficient authority and organizational freedom to implement the assigned responsibilities.

1. The VY executive top level management position (senior manager) reports to the chief nuclear officer and is responsible for VY site activities and implementing quality assurance policies, goals and objectives. These responsibilities also include, but are not limited to functional areas, such as engineering, procurement, security, information technology, project management, emergency planning, and technical services.

2. A+Re management positionf thatis is responsible for overall operational activities is accountable for maintaining the facility within the constraints of applicable regulatory requirements and the operating license, including training. Different aspects of these responsibilities may be fulfilled by separate managers. This manager is responsible for operation of the Independent Spent Fuel Storage Installation (ISFSI). The onsite independent safety review function reports to the manager responsible for facility operations.

3. A managOfment position that is responsible for engineering and technical services is responsible for the development and maintenance of engineering programs, facility design bases, policies, and procedures and for providing engineering services. Other responsibilities include licensing, corrective action program, records management, document control and information technology. Different aspects of these responsibilities may be fulfilled by separate managers.

4. A managOfment position that is responsible for quality assurance who has overall authority and responsibility for establishing, controlling, and verifying the implementation and adequacy of the quality assurance program as described in this QAPM. This position has the authority and responsibility to escalate matters directly to the highest level nuclear executive officer when needed. This position reports to the executive responsible for nuclear oversight through the corporate management position responsible for nuclear oversight (offsite).

3 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL A. 2.b. (continued)

5. A management position that isf responsible for materials, purchasing, and contracts is responsible for procurement, services, receipt, storage, and issue of materials, parts, and components. Different aspects of these responsibilities may be fulfilled by separate site managers. Supply chain and information technology are no longer a functional area exclusively within the nuclear organizational structure.

However, the oversight and governance of these functional areas remain within the nuclear organization through the VY executive top level management position. The site personnel organizationally report to an executive (supply chain - offsite) who has a functional interface with the VY executive top level management position .

6. A manager responsible for fuel transfer and storage related activities.

This manager is responsible for construction of the ISFSI pad and facility and fuel transfer activities.

+.:-6. A management position that isf responsible for radiation protection and chemistry activities. This manager is responsible for the implementation of the Rad iation Protection Program, Radiological Environmental Monitoring Program, Radiological Effluent Controls Program, radioactive waste shipping, Process Control Program and chemistry activities.

c. The on siteindependent and off site safety review function and Independent Management Assessments independently reviews activities to provide additional assurance that VY is maintained in accordance with the Operating License and applicable regulations that address nuclear safety. These independent safety review functions ara is described in Appendix D. The Independent Management Assessment function is described in A.3.f.

3. Responsibility

a. VY has the responsibility for the scope and implementation of an effective quality assurance program.

b. VY may delegate all or part of the activities of planning, establishing, and implementing the quality assurance program to others, but retains the responsibility for the program's effectiveness.

c. VY is responsible for ensuring that the applicable portion(s) of the quality assurance program is properly documented, approved , and implemented (people are trained and resources are available) before an activity within the scope of the QAPM is undertaken by VY or by others.

d. Individual managers are to ensure that personnel working under their management cognizance are provided the necessary training and resources to accomplish their assigned tasks within the scope of the QAPM.

4 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL A 3. (continued}

e. Procedures that implement the QAPM are approved by the management responsible for the applicable quality function. These procedures are to reflect the QAPM and work is to be accomplished in accordance with them .

f. The Independent Management Assessments are periodically performed to monitor overall performance and confirm that activities affecting quality comply with the QAPM and that the QAPM is effectively implemented. This Independent Management Assessment is performed by individual(s) designated by the chief nuclear officer, independent of activities assessed and who provide the appropriate level of expertise in the activities assessed .

The Independent Management Assessment results are communicated in an understandable form and in a timely fashion to a level of management having the authority to effect corrective action. In addition, these results are reported in a timely fashion to the chief nuclear officer.

4. Authority

a. When VY delegates responsibility for planning, establishing, or implementing any part of the overall QA program , sufficient authority to accomplish the assigned responsibilities is delegated.

b. The manager responsible for quality assurance has the responsibility and the authority to stop unsatisfactory work and control further processing ,

delivery, installation, or use of non-conforming items or services. Cost and schedule considerations will not override safety considerations.

5. Personnel Training and Qualification

a. Personnel assigned to implement elements of the quality assurance program are capable of performing their assigned tasks.

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

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

d. Additional details concerning Personnel Training and Qualification may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Appendix B (e.g., Regulatory Guides 1.8, 1.58, and 1.146).

6. Corrective Action

a. It is the responsibility of each individual to promptly identify and report conditions adverse to quality. Management at all levels encourages the identification of conditions that are adverse to quality.

5 Proposed Revision 7

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL A 6. (continued)

b. A corrective action program is established and implemented that includes prompt identification, documentation, and correction of conditions adverse to quality. The corrective action program for significant conditions adverse to quality shall require cause determination and a corrective action plan that precludes repetition .

c. Specific responsibilities within the corrective action program may be delegated, but VY maintains responsibility for the program's effectiveness.

d. Non-conforming items are properly controlled to prevent their inadvertent test, installation, or use. They are reviewed and either accepted, rejected ,

repaired, or reworked.

e. Reports of conditions that are adverse to quality are analyzed to identify trends in quality performance. Significant conditions adverse to quality and significant trends are reported to the appropriate level of management.

f. Additional details concerning corrective action activities may be found in the Regulatory Guides and associated Standards as committed to in Section A. 7 and Appendix B (e.g. , Regulatory Guido 1.33).

7. Regulatory Commitments

a. Except where alternatives are identified, VY complies with the QA guidance documents listed on Appendix B. If the guidance in one of these documents is in conflict with the QAPM, the guidance provided in the QAPM is the controlling guidance. Additionally, the following clarifications apply to all guidance documents listed in Appendix B:

1. For modifications and nonroutine maintenance of safety related or ITS SSCs, guidance applicable to construction-like activities is applicable to comparable facility activities. Except that the inspection of modifications, repairs, rework, and replacements shall be in accordance with the original design and inspection requirements or a documented approved alternative.

2. The definitions provided by Regulatory Guido 1.74 and associated clarifications as described in Appendix B apply wherever the defined term is used in the QAPM and associated guidance documents.

3. Clarification to a guidance document applies wherever the guidance document is invoked.

6 Proposed Revision 7

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL A 7. {continued)

4. In each of the ANSt-standards, other documents (e.g., other standards, codes, regulations, tables, or appendices) are referenced or described . These other documents are only quality assurance program requirements if explicitly committed to in the QAPM. If not explicitly committed to, these documents are not considered as quality assurance program requirements, although they may be used as guidance.

5. Guidance is applicable to saf.ety related items and activities is applicable to comparable ITS SSCs, items and activities controlled by 10 CFR 72 and transportation packages controlled by 10 CFR 71 . Regulatory Guide 7 .10, as defined in Appendix BG, provides guidance associated with quality assurance controls that are designated as ITS and the application of these controls in a graded approach. The associated ITS SSCs are defined in Appendix A.

b. The NRC is to be notified of QAPM changes in accordance with 10 CFR 50.54(a)(3) or 10 CFR 50.54(a)(4).

B. PERFORMANCENERIFICATION

1. Methodology

a. Personnel performing work activities such as design, engineering, procurement, manufacturing, construction, installation, startup, maintenance, modification, operation, and decommissioning are responsible for achieving acceptable quality.

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

c. Work is accomplished and verified using instructions, procedures, or other appropriate means that are of a detail commensurate with the activity's complexity and importance to safety.

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

2. Design Control

a. The design control program is established and implemented to assure that the activities associated with the design of systems, components, structures, and equipment and modifications thereto, are executed in a planned, controlled, and orderly manner.

7 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL B 2. (continued)

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

c. Design inputs (e.g., performance, regulatory, quality, and quality verification requirements) are to be correctly translated into design outputs (e.g., specifications, drawings, procedures, and instructions).

d. The final design output is to relate to the design input in sufficient detail to permit verification.

e. The design process is to ensure that items and activities are selected and independently verified consistent with their importance to safety to ensure they are suitable for their intended application.

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

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

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

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

3. Design Verification

a. A program is established and implemented to verify the acceptability of design activities and documents for the design of items. The selection and incorporation of design inputs and design processes, outputs, and changes are verified.

b. Verification methods include, but are not limited to, design reviews, alternative calculations , and qualification testing. The extent of this verification will be a function of the importance to safety of the item, the complexity of the design, the degree of standardization, the state of the art, and the similarity with previously proven designs. Standardized or previously proven designs will be reviewed for applicability prior to use.

8 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL B. 3. (continued)

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

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

e. Individuals or groups responsible for design reviews or other verification activities shall be identified in procedures and their authority and responsibility shall be defined and controlled. Design verification shall be performed by any competent individuals or groups other than those who performed the original design but who may be from the same organization. The designer's immediate supervisor may perform the design verification provided:

1. the supervisor is the only technically qualified individual capable of performing the verification,

2. the need is individually documented and approved in advance by the supervisor's management, and

3. the frequency and effectiveness of the supervisor's use as a design verifier are independently verified to guard against abuse.

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

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

4. Procurement Control

a. A program is established and implemented to ensure that purchased items and services are of acceptable quality.

b. The program includes provisions for evaluating prospective suppliers and selecting only qualified suppliers.

9 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL B. 4. (continued)

c. The program includes provisions for ensuring that qualified suppliers continue to provide acceptable products and services.

d. The program includes provisions (e.g., source verification, receipt inspection, pre-installation and post-installation tests , and certificates of conformance) for accepting purchased items and services.

e. Applicable technical, regulatory, administrative, and reporting requirements (e.g., specifications, codes, standards, tests, inspections, special processes, and 10 CFR Part 21) are invoked for procurement of items and services .

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

g. The program includes provisions for ensuring that procurement, inspection, and test requirements have been satisfied before an item is placed in service or used unless otherwise specified in procedures.

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

i. Appropriate controls for the selection, determination of suitability for intended use (critical characteristics), evaluation, receipt, and quality evaluation of commercial grade items are to be imposed to ensure that the items will perform satisfactorily in service.

j. Additional details concerning procurement control may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Appendix B (e.g., Regulatory Guidos 1.33 and 1.123).

5. Procurement Verification

a. A program is established and implemented to verify the quality of purchased items and services at intervals and to a depth consistent with the item's or service's importance to safety, complexity, and quantity and the frequency of procurement.

b. The program is executed in all phases of procurement. As necessary, this may require verification of activities of suppliers below the first tier.

c. Additional details concerning procurement verification may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Appendix B (e.g., Regulatory Guidos 1.123 and 1.144).

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~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL

6. Identification and Control of Items

a. A program is established and implemented to identify and control items to prevent the use of incorrect or defective items.

b. Identification of each item is maintained throughout fabrication, erection, installation, and use so that the item can be traced to its documentation .

Traceability is maintained to an extent consistent with the item's importance to safety.

c. Additional details concerning identification and control of items may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Append ix B (e.g., Regulatory Guide 1.33).

7. Handling, Storage, and Shipping

a. A program is established and implemented to control the handling, storage, shipping, cleaning, and preserving of items to ensure the items maintain acceptable quality.

b. Special protective measures (e.g., containers, shock absorbers, accelerometers, inert gas atmospheres, specific moisture content levels, and temperature levels) are specified and provided when required to maintain acceptable quality.

c. Specific procedures are developed and used for cleaning, handling, storage, packaging, shipping, and preserving items when required to maintain acceptable quality.

d. Items are marked and labeled during packaging, shipping, handling, and storage to identify, maintain, and preserve the items' integrity and indicate the need for special controls .

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

~ ).

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~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL

8. Test Control

a. A test control program is established and implemented to demonstrate that items will perform satisfactorily in service.

b. Criteria are defined that specify when testing is required.

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

d. Test procedures are developed that include:

1. instructions and prerequisites to perform the test,

2. use of proper test equipment,

3. acceptance criteria, and

4. mandatory inspections as required .

e. Test results are evaluated to assure that test objectives and inspection requirements have been satisfied.

f. Unacceptable test results shall be evaluated.

g. Additional details concerning test control may be found in the Regulatory Guides and associated Standards as committed to in Section A. 7 and Appendix B (e.g., Regulatory Guide 1.33). ,.

9. Measuring and Test Equipment Control

a. A program is established and implemented to control the calibration, maintenance, and use of measuring and test equipment. Measuring and test equipment does not include permanently installed operating equipment or test equipment used for preliminary checks where data obtained will not be used to determine acceptability or be the basis for design or engineering evaluation. Additionally, calibration and control measures are not required for rulers, tape measures, levels and other such devices if normal commercial manufacturing practices provide adequate accuracy.

b. The types of equipment covered by the program (e.g., instruments, tools, gauges, and reference and transfer standards) are defined in procedures .

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

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

12 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL B. 9. {continued)

e. Measuring and test equipment is calibrated against standards that have an accuracy of at least four times the required accuracy of the equipment being calibrated or, when this is not possible, have an accuracy that ensures the equipment being calibrated will be within the required tolerance .

f. If nationally recognized standards exist, calibration standards are to be traceable to them . Except where calibration standards with the same accuracy as the instruments being calibrated are shown to be adequate for the requirements, calibration standards are to have a greater accuracy than the standards being calibrated .

g. Measuring and test equipment found out of calibration is tagged or segregated . The acceptability shall be determined of items measured, inspected , or tested with an out-of-calibration device.

h. Additional details concerning measuring and test equipment control may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Appendix B (e.g., Regulatory Guides 1.30, 1.33, 1.94, 1.116, and 1.123).

10. Inspection, Test, and Operating Status

a. The status of required inspections and tests and the operating status of items is verified before release , fabrication, receipt, installation, test, and use, as applicable. Th is verification is to preclude inadvertent bypassing of inspections and tests and to prevent inadvertent operation of controlled equipment.

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

c. Additional details concerning inspection, test, and operating status control may be found in the Regulatory Guides and associated Standards as committed to in Section A. 7 and Appendix B (e.g., Regulatory Guide

~*

11. Special Process Control

a. A program is established and implemented to ensure that special processes are properly controlled.

b. The criteria that establish which processes are special are described in procedures. The following are special processes:

1. welding,

2. heat-treating,

3. NOE (Non-Destructive Examination),

4. chemical cleaning, and 13 Proposed Revision 7

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL B. 11.b (continued)

5. unique fabricating or testing processes that require in-process controls.

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

d. Additional details concerning special process control may be found in the Regulatory Guides and associated Standards as committed to in Section A. 7 and Appendix B (e.g., Regulatory Guide 1.33).

12. Inspection

a. A program is established and implemented for inspections of activities in order to verify conformance to the documented instructions, procedures and drawings for accomplishing the activity. The inspection program may be implemented by or for the organization performing the activity to be inspected.

b. Provisions to ensure inspection planning is properly accomplished are to be established . Planning activities are to identify the characteristics and activities to be inspected, the inspection techniques, the acceptance criteria, and the organization responsible for performing the inspection.

c. Provisions to identify inspection hold points, beyond which work is not to proceed without the consent of the inspection organization, are to be defined.

d. Inspection results are to be documented by the inspector and reviewed by qualified personnel.

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

f. Inspections are performed by qualified personnel other than those who performed or directly supervised the work being inspected. While performing the inspection activity the inspectors functionally report to the associated manager responsible for quality assurance.

g. Additional details concerning inspections may be found in the Regulatory Guides and associated Standards as committed to in Section A. 7 and Appendix B (e.g., Regulatory Guides 1.33 and 1.58).

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~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL

13. Corrective Action

a. Procedures shall provide for identification, evaluation, and resolution of conditions adverse to quality.

b. Reworked, repaired, and replacement items are to be inspected and tested in accordance with the original inspection and test requirements or specified alternatives.

c. Additional details concerning corrective action activities may be found in Section A.6 and the Regulatory Guides and associated Standards as committed to in Section A. 7 and Appendix B (e.g., Regulatory Guido

~-

14. Document Control

a. A program is established and implemented to control the development, review, approval, issue, use, and revision of documents.

b. The scope of the document control program includes:

1. safety analysis report,

2. design documents,

3. procurement documents,

4. Technical Specifications,

5. procedures, manuals, and plans,

6. corrective action documents, and

7. other documents as defined in procedures.

c. Revisions of controlled documents are reviewed for adequacy and approved for release by the same organization that originally reviewed and approved the documents or by a designated organization that is qualified and knowledgeable.

d. Copies of controlled documents are distributed to and used by the person performing the activity.

e. The distribution of new and revised controlled documents is in accordance with procedures. Superseded documents are controlled.

f. Additional details concerning document control may be found in the Regulatory Guides and associated Standards as committed to in Section A. 7 and Appendix B (e.g., Regulatory Guide 1.33).

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• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL

15. Records

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

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

c. The program includes provisions for the use of various record storage media to maintain QA records . Procedures are developed to implement the regulatory guidance associated with the media used . The NRC Generic Letter 88-18 "Plant Record Storage on Optical Disk" is implemented for optical disk media. The Regulatory Issue Summary 2000-1 8 "Guidance on Managing QA Records in Electronic Media" is implemented for electronic media.

d. Add itional details concerning record requirements may be fou nd in the Regulatory Guides and associated Standards as committed to in Section A.7 and Append ix B (e.g., Regulatory Guide 1.88).

C. AUDIT

1. Methodology

a. Personnel responsible for carrying out audits are maintained cognizant of day-to-day activities by the ongoing involvement in the quality assurance program requirements so that they can act in a management advisory function .

b. Organizations performing audits are to be technically and performance oriented commensurate with the activity being reviewed.

c. Personnel performing audits have no direct responsibilities in the area they are assessing .

d. Audits are accomplished using instructions, procedures, or other appropriate means that are of a detail commensurate with the activity's complexity and importance to safety.

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~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL

2. Performance

a. A program of planned and periodic audits is established and implemented to confirm that activities affecting quality comply with the QAPM and that the QAPM has been implemented effectively. Audit frequencies will be implemented as required by the applicable Code of Federal Regulations, safety analysis report, and commitments by various correspondences to the NRC. Audits will be conducted at a frequency in accordance with either Section C.2.a.1 or Section C.2.a.2 below.

1. Audit frequencies are determined based on regulatory commitments or site requirements .

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

a. The conformance of each unit's operation to provisions contained within the Technical Specifications and applicable license conditions is audited at least once every 24 months.

b. The performance, training, and qualifications of the entire staff are audited at least once every 24 months.

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

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

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

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

g. A fire protection and loss prevention program inspection and audit shall be performed using either off site licensee personnel or an outside fire proteetion firm at least once every 24 months.

i:hg. The fire protection program and implementing procedures audit shall be performed at least once every 24 months.

i. A fire protection and loss prevention program inspection and audit shall be performed using an outside fire eonsultant at least once every 36 months.

17 Proposed Revision 7

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL C. 2. (continued)

3. A grace period of 90 days may be applied to the 24-month frequency for internal audits. For activities deferred in accordance with the 90-day grace period, the next performance due date will be based on their originally scheduled date.

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

b. Audits shall provide an objective evaluation of quality related practices, procedures, instructions, activities, and items and a review of documents and records, as applicable.

c. Aud its shall be performed in accordance with approved written procedures or checklists. Items from previous audits shall be reviewed and reaudited , as appropriate. The checklists are used as guides to the aud itor.

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

e. Scheduling is dynamic and resources are supplemented when the effectiveness of the quality assurance program is in doubt.

f. Audit reports are written and distributed to the appropriate levels of management for review. Follow-up action, including re-look at deficient areas, is initiated as deemed appropriate.

g. Implementation of delegated portions of the quality assurance program is assessed.

h. Audits are conducted using predetermined acceptance criteria.

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

D. INDEPENDENT SAFETY REVIEW

1. Description

a. The lindependent safety review is performed to meet VY's commitment to NUREG 0737, Section l.B.1.2, "Independent Saf:ety Engineering Group,"

as desoribed in tho unit's saf:ety analysis report. This function is described in Section A.2.c and Appendix D, Section 1.0.

18 Proposed Revision 7

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix A SAFETY RELATED AND IMPORTANT-TO-SAFETY STRUCTURES SYSTEMS AND COMPONENTS The pertinent quality assurance requ irements of 10CFR50 Appendix B, 10CFR 71 Subpart H and 10 CFR 72 Subpart G will be applied , as a minimum, to all quality activities affecting safety related and Important-to-Safety SSCs associated with spent fuel storage and transportation package.

NOTE The safety classification of systems, structures and components (SSCs) at the VY facility and the VY Independent Spent Fuel Storage Installation (ISFSI) may be revised based on engineering evaluations and a revision to the VY safety analysis report. These modifications are controlled in accordance with the design control process and are not considered a reduction in the commitments to the QAPM .

The quality classification of NRC Licensed ISFSI Dry Fuel Storage Components and Transportation Packages may not be revised using the VY Design Control Process.

These modifications must be made by the NRC Certificate Holder. The Certificate Holder is responsible for design and licensing controls for these components under their NRC approved Quality Assurance Program. VY utilizes these types of components and packages under the provisions of a NRC General License for Radioactive Material Transportation Packages (10 CFR 71) and Spent Fuel Storage (10 CFR 72).

Safety related SSCs are defined within the site specific system safety function sheet process and are controlled through engineering processes.

Items and services associated with Radioactive Material Transport Packages as described in 10 CFR 71 and Spent Fuel Storage as described in 10 CFR 72 will also fall under the requirements of the OAP.

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

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

SSC Quality Design/License Category Responsible Multipurpose Canister and Fuel Basket Assembly A Holtec Intl.

Vertical Concrete Cask B Holtec Intl.

ISFSI Pad c VY Lifting Yoke A Holtec Intl.

DamaQed Fuel Container c Holtec Intl.

19 Proposed Revision 7

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix A SAFETY RELATED AND IMPORTANT-TO-SAFETY STRUCTURES, SYSTEMS AND COMPONENTS B. Transport of Spent Fuel and GTCC Waste (10 CFR 71)

SSC Quality Design/License Category Responsible Multipurpose Canister and Fuel Basket Assembly A Holtec Intl.

Damaged Fuel Container c Holtec Intl.

Transportable Storage Canister and Basket A TBD Assembly For GTCC Waste Containers Transport Cask A Holtec Intl.

C. Radioactive Material Transport Packages (10 CFR 71 )

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

NOTES:

1. There are no longer any safety related SSCs at the VY facility.

+.2. See Holtec Intl. Safety Analysis Report (SAR) and associated Holtec specifications for additional classification information. Holtec defines the classification of the SSCs and VY reflects this information in Appendix A for those SSCs described.

2,-3. See Holtec Transport Cask Safety Analysis Report (SAR) and associated Holtec specifications for additional classification information .

~4. For the definition of Quality Categories A, B, and C refer to NUREG/CR-6407.

54. VY engineering procedures define the safety classification assigned to the ISFSI pad .

20 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments A. Regulatory Guide 1.8 Revision 1, dated September 1975 Clarification/Exception

1. General VY is committed to Sections 1 - 4 of ANSI/ANS 3.1-1978 with following clarifications and exceptions.

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

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

2. General The following qualifications may be considered eq uivalent to a bachelor's degree:

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

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

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

d. any combination of the above totaling 4 years.

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

21 Proposed Revis ion 7

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments A. Regulatory Guide 1.8 (continued)

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

4. ANSI/ANS 3.1 Individuals who do not possess the formal education and minimum Section 4.4.5 experience requirements for the manager responsible for quality assurance should not be eliminated automatically when other factors provide sufficient demonstration of their abilities. These other factors are evaluated on a case-by-case basis and approved and documented by senior management. As a minimum, the Special Requirements of ANSI/ANS 3.1-1993 Section 4.3. 7 must be met if the manager responsible for Quality Assurance does not meet the requirements of section 4.4.5 of ANSI/ANS 3.1-1978.

5. ANSI/ANS 3.1 VY will maintain a training program for the unit staff that meets the Section 5 applicable regulations and meets the standards of section 5 of ANSI/ANS 3.1-1978.

22 Proposed Revision 7

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments

& Regulatory Guide 1.30, dated August 1972 Clarification/Exception

t. ANSI N45.2.4 ANSI N45.2.4 identifies various tests to be performed . The General applicability of these tests 'Nill be determined as discussed in QAPM Section B.8 and based upon the significance of change or modification.

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

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

4. ANSI N45.2.4 The last sentence of this section states: "Items requiring calibration Section 6.2.1 shall be tagged or labeled on completion indicating date of calibration and identity of the person that performed the calibration."

Instead of requiring the tagging or labeling of all equipment this statement is changed to require the equipment to be suitably marked to indicate the date of the next required calibration and the identity of the person that performed the calibration .

23 Proposed Revision 7

VY QUALITY ASSURANCE PROGRAM MANUAL

• Entergy Appendix B Reaul.aton.* Commitments C. Reaulatorv Guide 1.33 Re\fision 2. dated Februarv 1 Q78 Clarific:dinn/E YcAntinn

-1. Si::>r:.tinn C 1 VY V+'ill provide procedures for the guide's Appendix A activities as discussed, applicable to VY. However, VY does not consider all

~divitinR liRtrni tn hn "R~fnt 11 ml~tnrl" (n n ~dhiitinR in 7 n)

a. s;ndinn Q 4 This section establishes minimum 2 year audit frequency for all safety related functions and recommends audit frequencies specific to Corrective Action, Facility Operation, and Staff Performance, Training , and Qualifications. VY will perform audits at frequencies as discussed in OAPM Section C 2 a instead of this section.

3. ANSI N18 7 Sentences 4 and 5 state, "HO'tvever, applicable sections of this Sm:tinn 1 standard should be used as they apply to related activities. Activities included are: Design Changes, Purchasing, Fabricating ... " With regard to radioactive material transportation activities, VY will only implement tho requirements associated with those activities conducted in accordance with the applicable NRG Quality Assurance Proaram Aooroval for Radioactive Material Packaaes.

4. ANSI N18.7 The on and off site review committee requirements will be satisfied as Si::>dinn 4 2 rln,::r:rihnrl in "nnnnrlix n nf thn 0" PU

&. ANSI N18.7 DAIAtAd Si::>dinn d 2? 2 24 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments C. Regulatory Guide 1.33 (continued)

Clarification/Exception

6. ANSI N18.7 Deleted SeetieR 4.J.4 .(1) &

~

+. ANSI N18.7 Deleted SeetieR 4.J.4(2)

8. ANSI N18.7 Deleted SeetieR 4.J.4(J)

9. ANSI N18.7 Deleted SeetieR 4.J.4(4) to. A~JSI ~J18.7 Deleted SeetieR 4.J.4(5)

44. ANSI N18.7 This seetieR establishes miRimum 2 year audit frequeRey fer all safety SeetieR 4.5 related fuRotieRs. VY i.vill perform audits at froqueRoies as discussed iR QAPM SeetieR C.2.a iRstead ef this seetieR.

42. ANSI N18.7 Deleted SeetieR 4.5 25 Proposed Revision 7

~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix 8 Regulatory Commitments G. Regulatory Guide 1.33 (continued)

Clarification/Exception

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

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

46. ANSI N18.7 In addition to the temporary procedure change process described for Section 5.2.2 changes which clearly do not change the intent of a procedure, temporary procedure ohanges which may change tho intent of a procedure may be made following the process described in this section. E>ecept that the person normally responsible for approving revisions to tho prooodure is the approval authority for the ohango.

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

t7. ANSI N18.7 Tho requirement of tho fifth paragraph of this section to have a log of Seotion 5.2.6 the status of temporary modifioations is not applicable to temporary modifications for routine tasks installed in accordance with procedures. These procedures shall provide assuranoo that approvals are obtained, temporary modification activities are independently verified by an individual cognizant of the purpose and the effect of the temporary modifioation, and that activities are adequately documented to indicate the status of the temporary modifioation.

~ ANSI N18.7 This section will be implemented by adding the \*<<ords "Where Sootion 5.2.7.1 practioal" in front of the first and fourth sentences of the fifth paragraph. For modifications where the requirements of the fourth sentence are not considered practical, a review in accordance with tho provisions of 10 CFR 50.59 will be oonductod.

26 Proposed Revision 7

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments C. Regulatory Guide 1.33 (continued)

Clarification/Exception

-t-9.. ANSI N18.7 In lieu of a "master surveillance schedule," the following requirement Section 5.2.8 shall be complied *.vith: "A surveillance testing schedule(s) shall be established reflecting the status of all in plant sur1t<oillance tests and inspestions."

2-0. ANSI N18.7 Tho requirements of tho Physical Security Plan shall be implemented Section 5.2.9 in place of these general requirements.

2-1. ANSI N18.7 Consistent with ANSI N45.2.11 Section 7.2, minor changes to Section 5.2.13.1 documents, such as inconsequential editorial corrections, or changes to commercial terms and conditions may not require that the revised document receive the same review and appro*1al as the original documents.

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

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

24. ANSI N18.7 This section requires plant procedure review by an individual Section 5.2.15 knowledgeable in the area attested by the procedure no less frequently than every two years to determine if changes are necessary or desirable. Instead of this review, controls are in effect to ensure that procedures are reviewed for possible revision upon identification of new or revised source material potentially affecting the intent of procedures.

26. ANSI N18.7 Instead of tho requirements of this section, the format and content of Section 5.3.9 the emergency operating procedures follow the applicable NRG approved format for VY.

26. ANSI N18.7 VY's NRG accepted Emergency Plan will be implemented in lieu of Section 5.3.9.3 the requirements in this section.

27 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments

0. Regulatory Guide 1.37, dated March 1973 Clarification/Exception

t. General Instead of using the cleanliness level classification system of ANSI N45.2.1, the required cleanliness for specific items and activities is addressed on a case by case basis. Cleanliness is maintained, consistent *.vith the work being performed to prevent introduction of foreign material. As a minimum, cleanliness inspections are performed prior to system closure and such inspections are documented.

2. Section C.3 The water quality for final flushes of fluid systems and associated components is at least equivalent to the quality of the operating system

\\'ater, except for the oxygen and nitrogen content.

a. Section C.4 As an alternate to tho requirements of this section, contamination levels in expendable products may be based upon safe practices and industrial availability 'Nith documented engineering evaluations.

Contaminant levels are controlled such that subsequent removal by standard cleaning methods results in the achievement of final acceptable levels that are not detrimental to the materials.

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

28 Proposed Revision 7

~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments E-. Regulator}' Guide 1.38 Revision 2, dated May 1977 Clarification/Exception

-1. ANSI N45.2.2 Storage of an item in a higher level storage area meets the lo1.+1er level Section 3.2 storage requirements .

2. ANSI N45.2.2 As an alternate to the requirements in Section 3.2.1 items (4), (5), and Section 3.2 7, Section 3.2.2, Section 3.2.3 item (1 ), and Section 3.2.4 item (2), the storage atmosphere may be controlled such that it is free of harmful contaminants in concentration that could produce damage to the stored item and protesting weld end preparations and threads by controlling the manner in which the item is stored.

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

4. ANSI N45.2.2 Skids and runners will normally be fabricated from a minimum 2 X 4 Section 3.7.2 inch nominal lumber size and laid flat except where this is impractical because of the small dimensions of the container. If forklift handling is required, minimum floor clearance for forklift tines will be provided.

&. ANSI N45.2.2 Inspections of packages and/or preservative coatings are made Section 4.3. 4 immediately prior to loading rather than after loading.

6. ANSI N45.2.2 Warehouse personnel will normally visually scrutinize incoming Section 5.2.1 shipments for damage of the types listed in this section., this activity is not necessarily performed prior to unloading. Separate documentation of tho shipping damage inspection is not necessary.

Release ef the transport agent after unloading and the signing for receipt of the shipment provides adequate documentation of completion of tho shipping damage inspection. Any non conformances noted will be documented and dispositioned. Persons performing the visual scrutiny during unloading are not considered to be performing an inspection function as defined under Rog. Guido 1.74; therefore, while they 111ill be trained to perform this function, they may not be certified (N45.2.6) as an inspector.

29 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments E. Regulatory Guide 1.38 (continued)

Clarification/Exception

+. ANSI N45.2.2 The second division of this subsection requires six additional Section 5.2.2 inspection acti'1ities if an item was not inspected or examined at the source. VY will consider that a source inspection has been conducted if the supplier of the item is required to comply with ANSI N45.2.2 for the purchased item and if the supplier's program has been audited and found acceptable in the area (i.e ., the supplier performs a source inspection of his supplier or conducts a reoeipt inspection that includes, as applicable, the six additional items listed).

Instead of the requirement that receiving inspections be performed in an area equii.<alent to the level of storage required for the item, receiving inspections will be performed in a manner and in an environment which does not endanger the requisite quality of an item.

The receiving inspeotion's looation environmental controls may be less stringent than storage environmental requirements for that item; however, the short time spent in the less stringent receiving

• inspection area shall be of such duration that it will not ad*1ersely affect the item being reoeived .

3. ANSI f!>J45.2.2 The "Special Inspection" procedure is not required to be attached to Seotion 5.2.3 the item or oontainer but shall be readily available to inspeotion personnel.

9. ANSI N45.2.2 Items which fall within the Level D classification of the standard will Seotion 6.2.1 be stored in an area which may be posted to limit access, but other positive controls such as fencing or guards may not be provided.

to. ANSI N45.2.2 The sentence is replaced with the following: "Tho use or storage of Section 6.2.4 food, drinks, and salt tablet dispensers in any storage area shall be controlled and shall be limited to designated areas where such use or storage is not deleterious to stored items."

30 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments E. Regulatory Guide 1.38 (continued)

Clarification/Exception t. ANSI N45.2.2 The sentence is replaced with the following: "Exterminators or other Section 6.2.5 appropriate measures shall be used to control animals to minimize possible contamination and mechanical damage to stored material. If evidence of animal activity is detested, a survey or inspection will be utilized to determine the extent of the damage."

-t-2. ANSI N45.2.2 An alternate to the stated requirement is the follo*Ning: "Hazardous Section 6.3.3 chemicals, paints, solvents, and other materials of a like nature shall be stored in approved cabinets or containers which are not in close proximity to installed systems required for safe shutdown."

43. ANSI N45.2.2 Care of items in storage shall be exercised in accordance with the Section 6.4.2 following: "Types of components that could require maintenance while in storage shall be identified and evaluated for specific maintenance requirements . Maintenance activities 6.4.2 (6) through 6.4.2 (8) listed in this requirement shall be considered during this evaluation and any deviations shall be justified and documented."

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

46. ANSI N45.2.2 VY will comply with this section's requirements with the clarification Section 6.6 that, for record purposes, only the assess of personnel without key cards into indoor storage areas shall be recorded . Unloading or pickup of material shall not be considered "assess," nor shall inspection by NRG or other regulatory agents, nor shall tours by non licensee employees *.vho are accompanied by licensee employees.

31 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments

e. Regulatory Guide 1.38 (continued)

Clarification/Exception

-t6. i\NSI N45.2.2 Re rating hoisting equipment will be considered only when Section 7.3 necessary. Prior to performing any lift above the load rating, the equipment manufacturer must be contacted for his approval and direction. The manufacturer must be requested to supply a document granting approval for a limited number of lifts at the new rating and any restrictions involved, such as modifications to be made to the equipment and the test lift load . At all times, the codes governing re rating of hoisting equipment must be observed.

4-1. ANSI N45.2.2 During printing of the standard, a transposition occurred between Appendix (A 3) the last sentence of A3.4.1(4) and A3.4 .1(5). The correct Section A.3.4 .1 requirements are: (4) "However, preservatives for inaccessible inside surfaces of pumps, valves and pipe systems containing reactor coolant water shall be the 1Nater flushable type. " (5) "The name of tho preservative used shall be indicated to facilitate touch

~ 8. ANSI N45.2.2 There may be cases involving largo or complex shaped items for Appendix (A 3) which an inert or dry air purge is provided, rather than a static gas Section A.3.4.2 blanket, in order to provide adequate protection due to difficulty of providing a leak proof barrier. In these cases, a positive pressure purge flow may be utilized as an alternate to a leak proof barrier.

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

2-0-. ANSI N45.2.2 This paragraph limits halogen and sulfur content of tape. The use Appendix (A 3) of tapes containing greater amounts of halogens than those Section A.3 .5.2 identified will be allowed after appropriate evaluation; however, the quantities shall not be such that harmful concentrations could be leached or released by breakdown of tho compounds under expected environmental conditions.

32 Proposed Revision 7

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments E. Regulatory Guide 1.38 (continued)

Clarification/Exception 2-1-. ANSI N45.2.2 In lieu of A.3.7.1 (3) and (4), VY will oomply with the following:

Appendix (A 3) Fiberboard boxes shall be seourely olosed either with a water Seotion A.3.7.1 resistant adhesive applied to the entire area of oontaot between the flaps, or all seams and joints shall be sealed *11ith not less than 2 inoh wide, water resistant tape.

22. ANSI N45.2.2 Instead of the requirement that oontainer markings appear on a Appendix (/'< 3) minimum of two sides of the oontainer, preferably on one side and Seotion A.3.9 one end, VY will oomply *.vith the following: Containers are adequately marked for storage, identifioation, and retrieval.

Multiple marking requirements are imposed, where neoessary.

23-. ANSI N45.2.2, Instead of the requirement that oontainer markings be no less than Appendix (A 3) 3/4" high, VY *.viii oomply 'Nith the following: Container markings Seotion A.3.9 are of a size whioh permits easy reoognition.

24. A~JSI N45.2.2, Instead of the speoifio oontainer marl~ing requirements, VY will Appendix (A 3) oomply with the following: The information required in oontainer Seotion A.3.9 marking is evaluated on a ease by ease basis.

2S. ANSI N45.2.2 The last paragraph of A.3.9 oould be interpreted as prohibiting any Appendix (A 3) direst marking on bare austenitio stainless steel and niokel alloy Seotion A.3.9 metal surfaoes. As an alternate, paragraphs A.3.9.(1) and (2) may be used to oontrol marking on the surfaoe of austenitio stainless steels and niokel base alloys based on dooumented engineering evaluations. Contamination levels are oontrolled suoh that the material used for marking is not detrimental to the materials marked.

33 Proposed Revision 7

~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments

f. Regulatory Guide 1.39 Re*.*ision 2, dated September 1977 ClarifiGation/ExGeption

t. ANSI N4a.2.3 The ANSI fi'le le'lel zone designation system may not be utilized, but General the intent of the standard will be met for the areas of housekeeping, plant and personnel safety, and fire protection.

2. ,A,NSI N4a.2.3 This section is not applicable.

Section 3.1

3. ANSI N4a.2.3 The Fire Protection Program shall be used in lieu of the general Section 3.2.3 requirements in this section.

4. ANSI N4a.2.3 The first paragraph is not applicable to the operations phase.

Section 3.3

&. ANSI N4a.2.3 This section is not applicable.

Section 3.4

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

Section 3.a and (4) will be implemented.

34 Proposed Revision 7

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments G. Regulatory Guide 1.58 Revision 1, dated September 1980 Clarification/Exception

t. General VY may ohooso not to apply tho requirements of this guide to those personnel who are involved in day to day operations, survoillanoo, maintenanoe, and oertain teohnioal and support servioes whose qualifioations are oontrollod by other QAPM oommitment requirements.

2. General General oertifioation of inspeotors in aooordanoe with this guide is approved by a manager responsible for quality.

3. ANSI N45.2.6 Paragraph 4 requires that the standard be imposed on personnel Sootion 1.2 other than lioensee employees; the applioability of this standard to suppliers will be dooumonted and applied, as appropriate, in proourement doouments for suoh suppliers.

4. ANSI N45.2 .6 The requirements of this standard do not apply to personnel using Seotion 1.2 later editions of ASNT oontained within 10CFR50.55a approved ASME editions or addenda.

So ANSI N45.2.6 This seotion requires, in part, that any person who has not Seotion 2.3 performed inspeotion, examination, or testing aotivities in his qualified area for a period of one year shall be re evaluated. A 90 day graoe period may be applied to this aotivity. For aotivities deferred in aooordanoe \Vith tho 90 day graoo period, the next performanoe due date will be based on their originally soheduled eat&.

6. ANSI ~J45.2.6 This seotion's requirements are olarified with the stipulation that, Seotion 2 .5 *.vhere no speoial physioal oharaoteristios are required, none will be speoified . The oonverso is also true: if no speoial physioal requirements are stipulated , none are oonsiderod nooossary.

+. ANSI N45.2.6 VY reserves the right to use personnel who do not meet these Sootion 3.5 oxporionoo requirements but have shown oapability through training and testing or oapability demonstration.

35 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments H. Regulatory Guide 1.64 Revision 2, dated June 1976 ClarifiGation/ExGeption

-=I. ANSI N45.2.11 For the documentation of inter disciplinary design re 1iews, there must 1

Section 5.2.4 be documented evidence of the acceptability of design documents, or portions thereof, prior to release (material, stress, physics, mechanical, electrical, concrete, etc.). Indication of the positi'1e concurrence of those who determine tho design acceptability relati'1e to their respective disciplinary area of concern should be on the document or on a separate form traceable to tho document. A document that indicates the revie*Ner's comments need not be retained.

36 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments b Regulatory Guide 1.74, dated February 1974 ClarifiGation/ExGeption to ANSI N45.2.10, Definitions for "Certificate of Conf-ormanco" and "Certificate of Section 2 Compliance" 'Nill be exchanged based upon tho guidance in ANSI N45.2.13 Section 10.2.

37 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM M'ANUAL Appendix B Regulatory Commitments J. Regulatory Guide 1.88 Re\*ision 2, dated October 1976 Clarification/Exception

~ RG 1.88 VY will meet the requirements of NFPA No. 232 1975, "Standards for Section C the Protection of Records", as allowed by the Regulatory Guide 1.88 1976 or ANSI/ ASME NQA 1 1983, Supplement 17S 1 Section 4.4 in lieu of N45.2.9 Section 5.6 or the discussions in this section for Records Storage Facilities with the clarification that penetrations providing fire protection, lighting, temperature/humidity control, or communications are acceptable as long as the penetration maintains the required fire resistance .

Except that as an alternate to these requirements non permanent records (e.g. , 3 years retention records) may be stored and maintained by the originating organization in one hour minimum fire rated file cabinets located in environmentally controlled facilities that have suitable fire protection. Suitable fire protection is provided by either an automatic sprinkler system or a combination of two or more of the following: 1) automatic fire alarms, 2) hose stations, or 3) portable extinguishers.

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

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

4. ANSI N45.2.9 Instead of the requirements of this section, VY will comply with the Section 5.4.2 following: Records shall not be stored loosely. They shall be secured for storage in file cabinets or on shelving in containers. Methods other than binders, folders, or envelopes (e.g., dividers or boxes) may be used to organize records for storage. This section is not applicable to special processed records controlled in accordance with Section 5.4.3 when the requirements of this section are not appropriate for the record type.

38 Proposed Revision 7

• ~Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments J. Regulatory Guide 1.88 (Gontinued)

ClariJiGation/ExGeption S. ANSI N45.2.9 Instead of the requirements of this section, VY will comply with the Section 5.4.3 f.ollowing: Pro*1isions shall be made f.or special processed records such as radiographs, photographs, negatives, microfilm, and magnetic media to prevent damage from excessive light, stacking, electromagnetic fields, temperature, and humidity as appropriate to the record typo with appropriate consideration of packaging and storing recommendations as provided by the manufacturer of these materials.

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

+. ANSI N45.2.9 VY will meet the requirements of NFPA No. 232 1975, "Standards Section 5.6 f.or the Protection of Records", as allowed by tho Regulatory Guido 1.88 1976 or ANSl/ASME NQA 1 1983, Supplement 17S 1 Section 4.4 in lieu of this section f.or Records Storage Facilities with the Glarifisation that penetrations providing fire protection, lighting, temperature/humidity control, or communications are acceptable as long as the penetration maintains the required fire resistance.

Except that as an alternate to these requirements non permanent records (e.g., 3 years retention records) may be stored and maintained by tho originating organization in one hour minimum fire rated file cabinets located in environmentally controlled facilities that have suitable fire protection. Suitable fire protection is provided by either an automatic sprinkler system or a combination of two or more of the f.ollowing: 1) automatic fire alarms, 2) hose stations, or 3) portable extinguishers.

39 Proposed Revision 7

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments K. Regulatory Guide 1.94 Revision 1, dated April 1976 ClarifiGation/ExGeption 4-. ANSI N45.2.5 The last sentence requires that all items inspected with maintenance Section 2.5.2 and test equipment, which is f.ound to be out of calibration, shall be considered unacceptable. VY will comply with QAPM Section B.9.g as an alternate. QAPM Section B.Q.g requires an evaluation to determine the validity of previous measurements.

2. ANSI N45.2.5 When using ACI 305 72 and ACI 306 66, VY may apply tho f.ollowing Section 4.5 requirements:

PLACING TEMPERATURES OF CONCRETE A. During hot *1.1oathor concreting , placing temperatures of concrete will be limited to the following : 1) Concrete members less than 3 feet in least dimension will not exceed Q0°F; 2) Concrete members from 3 foot to 6 foot in least dimension will not exceed 70°F; and 3)

Concrete members more than 6 feet in least dimension *.viii have placing temperature as near 50°F as can be obtained by use of ice as necessary up to 100 percent of adding mixing *.vater; and by shading aggregate and sprinkling the coarse aggregate the day it is to be used.

Care will be taken so that no unmelted ice remains in the concrete at the end of the mixing period .

B. During cold weather concreting: In heating the water and aggregate, live steam to heat the fine and coarse aggregate shall not be used. The permissible range f.or concrete temperature shall be as f.ollows: 1) Sections loss than 3 foot in least dimensions 55°F to 75°F; and 2) Mass concrete 3 feet or more in least dimension 45°F to 65°F.

The mixing water and aggregate will be purchased as required. Tho materials will be free of ice, snow and frozen lumps before they enter the mixer.

3. ANSI N45.2.5 As an alternate to daily testing grout for compressive strength, f.or Table B prepackaged shelf item, non shrink grout, the grout's compressi .ie1 strength tests may be perf.ormed once on each batch of non shrink grout received, rather than each day grout is placed.

40 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments K. Regulatory Guide 1.94 (continued)

Clarification/Exception

4. ANSI N45.2.5 For the performance of correlation tests, the requirements of this Section 4.8 standard may be modified as discussed below:

Table B, REINFORCING STEEL: In process testing of reinforcing stool will include the mechanical properties of yield strength, tensile strength and percent elongation on full size specimens for each bar size for each 50 tons or fraction thereof from each mill heat. Bend tests are performed during material qualification testing only, except as noted below for bar sizes #14 through #18.

Table /\, "Required Qualification Tests" as applied to reinforcing steel

• .viii include bend tests as required by ASTM A615 and summarized in the follo*.ving: a) For bar sizes #3 through #11 , one full size specimen from largest bar size rolled from each mill heat, unless material from one heat differs by three or more designation numbers. When this occurs, one bend test shall be made from both the highest and lowest designation number of the deformed bars rolled ; b) For bar sizes #14 through #18 , Supplementary Requirements S1 of ASTM A615 will be applied, i.e., one fullsize specimen for each bar size for each mill heat.

If supplementary requirements are not followed for mill tests, they will be applied as in process tests.

In process test specimens may be selected at tho rebar fabrication shop, prior to start of fabrication of the rebar from the heat or fraction thereof represented by the test specimen.

Acceptance criteria for any failed test (qualifications as well as in process) may be the same as that for tensile tests specified in Subarticle CC 2331.2 of ASME Section Ill, Div. 2 Code (1975). This states that if a test specimen fails to meet the specified strength requirements, two (2) additional specimens from the same heat and of the same bar size *.vould be tested, and if either of the two additional specimens fails to meet the specified strength requirements, the material represented by tho tests would be rejected for the specified use. Alternati*;e use of rejected material under strict control may be subject to evaluation by engineering.

41 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments K. Regulatory Guide 1.94 (continued)

ClarifiGation/Exception

&. ANSI N45.2.5 VY may interpret the terms "horizontal, vertioal and diagonal bars" to Seotion 4.9 apply respectively to the following types of splioe positions: a.

Horizontal , inoluding 10° to horizontal; b. Vertical , including 10° to vertioal; and o. 45° angle, inoluding 10° to 80° angle. The words "splioing crev/' are interpreted to refer to all projeot members that are actively engaged in preparing and assembling oadweld meohanioal splioes at the final splioe looation. Separate test oyoles will be established for eaoh bar size and eaoh splioe position.

6. ANSI N45.2.5 VY will oomply with inspeotion requirements of the applioable welding Sootion 5.5 sades and any mmoptions instead of this seotion.

42 Proposed Revision 7

~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments b Regulatory Guide 1.116 Revision 0 R, dated June 1976 Clarification/Exception

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

43 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments M. Regulatory Guide 1.123 Re¥ision 1, dated July 1977 Clarification/Exception

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

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

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

3. /\NSI N45.2.13 Instead of the definition provided for QA Program Requirements, Section 1.3 VY .vill comply with the following: 'Those individual 1

requirements of tho QAPM which, when invoked in total or in part, establish quality assurance program requirements for the activity being controlled. Although not specifically used in the QAPM, A~JSI N45.2 may be imposed upon suppliers."

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

&. ANSI N45.2.13 Changes to procurement documents which are changes in Section 3.1 quantity, estimated price, cost codes, taxes, format or editorial changes that do not affect the quality of tho item or service do not require an equivalent lei.*el of review and approval as the original document.

44 Proposed Revision 7

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-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments M. Regulatory Guide 1.123 (continued)

Clarification/Exception

9. /\NSI N45.2.13 The section states that the certificate should be attested to by a Section 10.2 person who is responsible for this Q/\ function whose function Item d and position are described in the Purchaser's/Supplier's Q/\

program. /\s an alternate to this requirement, VY will use the follO'A'ing: "The person attesting to a certificate shall be an authorized and responsible employee of the supplier, and shall be identified by the supplier. "

46 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments N. Regulatory Guide 1.144 Revision 1, dated September 1980 Clarification/Exception

-t. RG 1.144 This section is not applicable.

Section C.3.a.(2)

2. RG 1.144 In addition to the requirements of this section, previously e*.ialuated Section C.3.b.(2) and approved active suppliers for which auditing is not the selected method of source verification should be evaluated concurrent with the award of a contract. Regardless of the evaluation results, active suppliers (except those excluded under C.3.b(1)) are source verified (audit, surveillance or inspection) within two years prior to award of a contract or ha*.ie source verification performed. Inactive suppliers are e*mluated prior to supplying items or services. An audit shall be conducted if required to determine the acceptability of procured items or serviees (i.e., acceptability eannot be determined by reeeipt inspeetion or another method allmvable under 10 CFR 50 Appendix B, Criterion VII).

3. RG 1.144 This section requires that supplier audits be performed on a Section C.3.b.(2) triennial basis. A 90 day grace period may be applied to this aetivity. For activities deferred in aceordanee with the 90 day graee period, the next performance date *11ill be based on their originally scheduled date.

4. RG 1.144 Instead of the annual doeumented evaluation of suppliers Section C.3.b.(2) diseussed in this section, an ongoing evaluation of supplier performaneo is eondueted 'Nhich takes into aeeount, where applicable, tho other considerations of this section and paragraph of the Regulatory Guide.

47 Proposed Revision 7

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments N. Regulatory Guide 1.144 (continued)

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

Section C.3.b.(2) calibration services .vith accreditation by NVL/\P or /\2LA, a 1

documented review of the supplier's accreditation by the purchaser may be used in lieu of performing an audit, accepting an audit by another licensee, performing a commercial grade survey, inspecting or testing following delivery, or performing in process SUF\'eillances during performance of the service. This review shall include, at a minimum, verification of all the following:

• The accreditation is to Al!'JSl/ISO/IEC 17025.

• The accrediting body is either NVL/\P /\2LA.

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

&. /\NSI N45.2.12 Pre audit and post audit conferences may be fulfilled by a variety of Section 4.3.1 communications, such as telephone conversation .

6. /\NSI N45.2.12 Pre audit and post audit conferences are only held when deemed Section 4.3.1 necessary by quality assurance or *.vhen requested by the audited organication.

+. /\NSI N45.2.12 This subsection could be interpreted to limit auditors to the review Section 4.3.2.2 of only objecti 1e evidence; sometimes and for some program 1

elements, no objective evidence may be available. VY will comply with an alternate sentence which reads: "When available, objective evidence shall be mcamined for compliance with Q/\PM requirements. If subjective evidence is used (e.g., personnel interviews) then the audit report must indicate ho*N the evidence v1as obtained."

48 Proposed Revision 7

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments N. Regulatory Guide 1.144 (continued)

Clarification/Exception

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

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

-to. ANSI N45.2.12 Instead of the last sentence of the last paragraph of the section, VY Section 4.4 will comply with the following : The audit report shall be issued

'Nithin thirty working days after the last day of the audit. The last day of an audit shall be considered to be the day of the post audit conference. If a post audit conference is not hold because it was deemed unnecessary, the last day of the audit shall be considered to be the date the post audit conference was deemed unnecessary as documented in tho audit report.

44. ANSI N45.2.12 Tho QAPM Section A.6 corrective action program may be used Section 4.5.1 instead of those requirements as long as tho appropriate time limits are applied to significant conditions adverse to quality. Also, no additional documentation is necessary if needed corrective actions are taken and verified prior to audit report issuance.

49 Proposed Revision 7

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments

0. Regulatory Guide 1.146 Revision 0, dated August 1980 Clarification/Exception

4. ANSI N45.2.23 Holders of NRG issued Reactor Operator/Senior Reactor Operator Section 2.3.1.3 Licenses comply with the requirements of this section and may be awarded t\vo credits.

2. ANSI N45.2.23 Prospective lead auditors shall demonstrate their ability to effectively Section 2.3.4 implement the audit process and lead an audit team . They shall have participated in at least one audit within the year preceding the individual's effective date of qualification. Upon successful demonstration of the ability to effectively lead audits, licensee management may designate a prospective lead auditor as a "lead auditor".

3. /\NSI N45.2.23 These sections require that an annual assessment be performed of Sections 3.2 and each lead auditor's qualification and that each lead auditor's records

~ be updated annually. A 90 day grace period may be applied to those activities. For activities deferred in accordance with the 90 day grace period, the next performance duo date will be based on their originally scheduled date.

B. Regulatory Guide 7.10, Revision 3 (6/15), "Establishing Quality Assurance Programs for Packaging Used in the Transportation of Radioactive Material" is used as a guidance document.

C. NUREG/CR-6407, "Classification of Transportation Packaging and Dry Fuel Storage System Components According to Important to Safety (2/96)" is used as a guidance document.

50 Proposed Revision 7

~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix C Other General Guidance Documents Regulatory Guide 7.10, Revision 2 (3105), "Establishing Quality Assurance Programs for Packaging Used in the Transportation of Radioactive Material."Documents Deleted-not currently used NUREG/CR 6407, "Classification of Transportation Packaging and Dry Fuel Storage System Components According to Important to Safety (2/96)."

51 Proposed Revision 7

• ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix D Administrative Controls 1.0 INDEPENDENT SAFETY REVIEW An Independent Safety Review shall be a thorough review conducted by one or more qualified Independent Safety Reviewers. Persons performing these reviews shall be knowledgeable in the subject area being reviewed . Independent Safety Reviews must be completed prior to implementation of proposed activities.

1. Independent Safety Reviewers shall be individuals without direct responsibility for the performance of these activities under review. These reviews may be from the same functionally cognizant organization as the individual or group performing the original work.

2. Independent Safety Reviewers shall have at least 5 years of professional experience and either a Bachelor's Degree in Engineering or the Physical Sciences or shall have equivalent qualifications in accordance with ANSI/ANS 3.1 -1978. The manager responsible for the overall operational activities (or designee) shall document the appointment of Independent Safety Reviewers.

3. The following subjects shall be independently reviewed by a qualified Independent Safety Reviewer:

a) Evaluations for changes to the facility as described in the Defueled Safety Analysis Report (DSAR). Changes to procedures as described in the DSAR and tests or equipment not described in the DSAR to verify that such actions do not involve a change to the Technical Specifications or will not require prior NRC approval as defined in 10CFR50.59 or 10CFR72.48, and b) Proposed changes to the programs required by the Technical Specifications to verify that such changes do not involve a change to the Technical Specifications or will not require prior NRC approval as defined in 10CFR50.59 or 10CFR72.48.

2.0 SAFETY REVIEW COMMITTEE (SRC)

The SRC is responsible for reviewing, auditing, and advising the chief nuclear officer and the VY executive on matters related to the safe storage of irradiated fuel. This review and audit function is independent of line organization responsibilities.

1. The SRC shall include a minimum of three members. Alternates may be substituted for regular members. The licensee shall designate in writing the chairman, the members, and alternates for the SRC. The Chairman shall not have management responsibilities for, or report to, the line organizations responsible for operation and maintenance of the facility.

2. The SRC shall oolleotively have experienoe and knowledge in the following funotional areas:

a) fuel handling and storage (inoluding the potential for oritioality),

b) ohemistry and radioohemistry, 52 Proposed Revision 7

~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL c) engineering, d) radiation protection and e) quality assurance.

3. The SRC shall collectively possess the necessary expertise and experience to provide an independent review of problems in the majority of the areas described in Section 2.2.

4. If necessary, individuals with knowledge and experience in other functional areas may be utilized to provide advice to the SRC.

5. As a minimum, the SRC shall conduct two designated meetings per year.

6. A quorum shall consist of not less than a majority of the number of standing SRC members, or their duly appointed alternates. Those members representing the line organizations responsible for the operation and maintenance of the facility shall not constitute a majority of the quorum. At least one member of the quorum shall be the Chairman or the Chairman's designated alternate.

7. As a minimum, the SRC shall perform the follo 1Ning functions:

a) Advise the Chief Nuclear Officer and the VY Executive on all matters related to safe storage of irradiated fuel.

b) Advise the management of the audited organization and the Chief Nuclear Officer and the VY Executive of revie*N results as they relate to safe storage of irradiated fuel.

c) Recommend to management of the assessed organization, and its management, any correctii.10 action to improve the safe storage of irradiated fuel.

d) Notify the Chief Nuclear Officer and the VY Executive of any safety significant disagreement between the SRC and Site Management 1Nithin 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.

8. The SRC shall be responsible for revimving:

a) The evaluations for procedures, and changes thereto, completed under the provisions of 10 CFR 50.59 or 10 CFR 72.48 to v-0rify that such actions do not require prior NRG approval or a license amendment as defined in 10 CFR 50.59 or 10 CFR 72. 48. This review may be completed after implementation of the affected procedure; b) Changes to structures, systems or components important to the safe storage of irradiated fuel to verify that such changes do not require prior NRG approval or a license amendment as defined in 10 CFR 50.59 or 10 CFR 72.48. This review may be completed after implementation of the change; c) Test or experiments involving the safe storage of irradiated fuel to verify that such tests or experiments do not require prior NRG approval or a license amendment as defined in 10 CFR 50.59 or 10 CFR 72.48. This rei.*iew may be completed after performance of the test or experiment; d) Proposed changes to the Technical Specifications or the operating license. This review may be completed after submittal; e) Violations of codes, regulations, orders, license requirements, or internal procedures/instructions having nuclear safety significance; f) Indications of unanticipated deficiencies in any aspect of design or operation of structures, systems, or components that could affect safe storage of irradiated fuel; 53 Proposed Revision 7

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL g) Significant accidental, unplanned, or uncontrolled radioactive releases. Including corrective action(s) to pro'IOnt recurrence; h) Significant operating abnormalities or deviations from normal and expected performance of equipment that affect safe storage of irradiated fuel; i) The performance of the corrective action system; and j) Internal and external experience information related to the safe storage of irradiated fuel that may indicate areas for improving facility safety.

Reports or records of these reviews shall be forwarded to the Chief Nuclear Officer and the VY Exocuti'IO *.vithin 30 days after completion of tho review.

9. The SRC's responsibility shall include oversight of the Audit Program. Audits shall be performed of tho activities and at tho associated frequencies defined in Section C.

10. Written records of reviews and audits shall be maintained. As a minimum, these records shall include:

a) Results of the activities conducted under the pro 1isions of QAPM; 1

b) Recommendations to the management of tho audited organization; c) Documentation of reviev<>affi-site nuclear safety and shall take any measures needed to ensure acceptable performance of the staff in operating, maintaining, and providing technical support to the f>>am-facility to ensure safe management of nuclear fuel.

4. The individuals that carry out health physics , or perform quality assurance functions may report to the appropriate on-site manager; however, these individuals shall have sufficient organizational freedom to ensure their ability to perform their assigned functions.

B. Facility Staff Qualifications

1. Each member of the facility staff shall meet or exceed the minimum qualifications of ANSI/ANS 3.1-1978 for comparable positions with exceptions specified in the Quality Assurance Program Manual ( QAPM~ .

2~. 3 PROCEDURES Written procedures shall be established , implemented, and maintained covering the following activities:

A. Normal startup, operation and shutdown of systems and components needed for the safe storage of nuclear fuel.

B. Actions to be taken to correct specific and foreseen potential malfunctions of systems or components needed for the safe storage of nuclear fuel.

C. Emergency conditions involving potential or actual release of radioactivity.

D. Preventative and corrective maintenance operations which could have an effect on the safety of nuclear fuel.

E. Surveillance and testing requirements.

F. Fire protection program implementation.

G. Process Control Program in-plant implementation.

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~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL H. Off-Site Dose Calculation Manual implementation

~2 .4 REPORTING REQUIREMENTS The following reports shall be submitted in accordance with 10 CFR 50.4.

A. Radioactive Effluent Release Report The Radioactive Effluent Release Report covering the operation of the facility shall be submitted by May 15 of each year and in accordance with 10 CFR 50.36a. The report shall include a summary of the quantities of radioactive liquid and gaseous effluents and solid waste released from the facility. The material provided shall be consistent with the objectives outlined in the Offsite Dose Calculation Manual (ODCM) and Process Control Program and in conformance with 10 CFR 50.36a and 10 CFR 50, Appendix I, Section IV.B.1.

B. Annual Rad iological Environmental Operating Report The Annual Radiological Environmental Operating Report covering the operation of the facility during the previous calendar year shall be submitted by May 15 of each year. The report shall include summaries, interpretations, and an analysis of trends of the resu lts of the radiological environmental surveillance activities for the report period. The material provided shall be consistent with the objectives outlined in the Offsito Dose Calculation Manual f ODCM), and in 10 CFR 50, Appendix I, Sections IV.B.2, IV.B.3, and IV.C.

The Annual Radiological Environmental Operating Report shall include summarized and tabulated results of all radiological environmental samples taken during the report period pursuant to the table and figures in the ODCM.

In the event that some results are not available for inclusion with the report, the report shall be submitted noting and explaining the reasons for the missing results. The missing data shall be submitted as soon as possible in a supplementary report.

2~ .5 PROGRAMS AND MANUALS The following programs shall be established, implemented and maintained:

A. OFF-SITE DOSE CALCULATION MANUAL (ODCM)

An Off-Site Dose Calculation Manual shall contain the current methodology and parameters used in the calculation of off-site doses due to radioactive gaseous and liquid effluents for the purpose of demonstrating compliance with 10 CFR 50, Appendix I, in the calculation of gaseous and liquid effluent monitoring alarm/trip setpoints, and in the conduct of the environmental radiological monitoring program.

56 Proposed Revision 7

~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL The ODCM shall also contain the radioactive effluent controls and radiological environmental monitoring activities and descriptions of the information that should be included in the Radioactive Effluent Release Report and the Annual Radiological Environmental Operating Report required by QAPM Section 3.4.A and QAPM Section 3.4.B., respectively.

1. Licensee initiated changes to the ODCM:

a. Shall be submitted to the Commission in the Radioactive Effluent Release Report for the period in which the change( s) was made effective. This submittal shall contain:

i. Sufficient information to support the change together with appropriate analyses or evaluations justifying the change(s) and ii. A determination that the change will maintain the level of radioactive effluent control required by 10 CFR 20.1302, 40 CFR 190, 10 CFR 50.36a, and Appendix I to 10 CFR Part 50, and do not adversely impact the accuracy or reliability of effluent dose or setpoint calculations.

b. Shall become effective upon approval by the manager responsible for overall operational activities.

c. Shall be submitted to the Commission in the form of a legible copy of the affected pages of the ODCM as a part of or concurrent with the Radioactive Effluent Release Report for the period of the report in which any change to the ODCM was made. Each change shall be identified by markings in the margin of the affected pages, clearly indicating the area of the page that was changed, and shall indicate the date (e.g., month/year) the change was implemented.

B. Radioactive Effluent Controls Program This program conforming to 10 CFR 50.36a provides for the control of radioactive effluents and for maintaining the doses to members of the public from radioactive effluents as low as reasonably achievable. The program shall be contained in the ODCM, shall be implemented by operating procedures, and shall include remedial actions to be taken whenever the program limits are exceeded. The program shall include the following elements:

a. Limitations on the functional capability of radioactive liquid and gaseous monitoring instrumentation including surveillance tests and setpoint determination in accordance with the methodology in the ODCM;

b. Limitations on the concentrations of radioactive material released in 57 Proposed Revision 7

~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL liquid effluents from the site to unrestricted areas, conforming to 10 times the concentration values in Appendix B, Table 2, Column 2, to 10 CFR 20.1001 - 20.2402;

c. Monitoring, sampling, and analysis of radioactive liquid and gaseous effluents pursuant to 10 CFR 20.1302 and with the methodology and parameters in the ODCM;

d. Limitations on the annual and quarterly doses or dose commitment to a member of the public from radioactive materials in liquid effluents released from the facility to unrestricted areas, conforming to 10 CFR 50, Appendix I;

e. Determination of cumulative and projected dose contributions from radioactive effluents for the current calendar quarter and current calendar year in accordance with the methodology and parameters in the ODCM at least every 31 days;

f. Limitations on the functional capability and use of the liquid and gaseous effluent treatment systems to ensure that appropriate portions of these systems are used to reduce releases of radioactivity when the projected doses in a period of 31 days would exceed 2 percent of the guidelines for the annual dose or dose commitment, conforming to 10 CFR 50, Appendix I;

g. Limitations on the dose rate resulting from radioactive material released in gaseous effluents from the site to areas at or beyond the site boundary shall be limited to the following:

1. For tritium, and for all radionuclides in particulate form with half lives greater than 8 days: less than or equal to a dose rate of 1500 mrems/yr to any organ;

h. Limitations on the annual and quarterly doses to a member of the public from tritium and all radionuclides in particulate form with half lives greater than 8 days in gaseous effluents released from the facility to areas beyond the site boundary, conforming to 10 CFR 50, Appendix I; and

i. Limitations on the annual dose or dose commitment to any member of the public, beyond the site boundary, due to releases of radioactivity and to radiation from uranium fuel cycle sources, conforming to 40 CFR 190.

58 Proposed Revision 7