View source for BVY 18-012, Annual Report for Quality Assurance Program Manual Changes Under 10CFR50.54(a)(3), 10CFR71.106 and 10CFR72.140(d) Notification of Application of Approved Appendix B to 10CFR72 Subpart G

{{Adams
| number = ML18102B249
| issue date = 04/12/2018
| title = Annual Report for Quality Assurance Program Manual Changes Under 10CFR50.54(a)(3), 10CFR71.106 and 10CFR72.140(d) Notification of Application of Approved Appendix B to 10CFR72 Subpart G
| author name = Limpias O
| author affiliation = Entergy Nuclear Operations, Inc
| addressee name = 
| addressee affiliation = NRC/Document Control Desk, NRC/NMSS, NRC/NRR
| docket = 05000271, 07100907, 07200059
| license number = DPR-028
| contact person = 
| case reference number = BVY 18-012, CNRO-2018-00016
| document type = Letter type:BVY, Quality Assurance Program
| page count = 109
}}

=Text=
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*===--Enferpv        o.J Entergy Nuclear Operations, Inc.
Entergy Operations, Inc.
1340 Echelon Parkway Jackson, MS 39213 Oscar Limpias Vice President, Oversight CNR0-2018-00016 BVY 18-012 April 12, 2018 ATTN: Document Control Desk U. S. Nuclear Regulatory Commission Washington, DC 20555-0001

==SUBJECT:==
Annual report for Quality Assurance Program Manual changes under 10 CFR 50.54(a)(3), 10 CFR 71.106, and 10 CFR 72.140(d) Notification of Application of Approved Appendix B to 10 CFR 72 Subpart G.
Vermont Yankee Nuclear Power Station Docket No. 50-271 License No. DPR-28 Docket No. 72-59 Docket No. 71-0907

==REFERENCES:==
: 1. 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)
: 2. Letter, Entergy Nuclear Operations, Inc., to USNRC, "Proposed Revision to the Entergy Vermont Yankee Quality Assurance Program Manual (VY QAPM)," BVY 17-023, dated September 19, 2017 (ML17268A152)

==Dear Sir or Madam:==

Entergy Nuclear Operations, Inc., (ENO) is submitting the Entergy Vermont Yankee Quality Assurance Program Manual (VY QAPM) in accordance with 10 CFR 50.54(a)(3) and 10 CFR 71.106. The last submittal, dated April 4, 2016, encompassed VY QAPM Revision 3. Since that date there have been two updates, Revisions 4 and 5, incorporated to the VY QAPM. A synopsis of each revision is provided as Enclosure A. The 10 CFR 50.54(a)(3) and 10 CFR 71.106 evaluations are included as Enclosure B. The VY QAPM Revision 5, which encompasses Revision 4, remains effective and is included as Enclosure C. Revision 5 has an effective date of September 7, 2016.
There are two pending changes to the VY QAPM, Revision 6 and Revision 7. Revision 6 is based on changes proposed by a License Amendment Request (LAR) to revise the License and Permanently Defueled Technical Specifications to reflect removal of all spent nuclear fuel from the spent fuel pool and its transfer to dry cask storage within an Independent Spent Fuel

CNR0-2018-00016 Page 2 of 3 Storage Installation (ISFSI) (Reference 1). Proposed changes in the LAR include the relocation of certain administrative controls from the facility Technical Specifications to the QAPM.
Revision 6 is anticipated to be implemented following NRC approval of Reference 1. Revision 7 is also a pending change which has been submitted to NRC for prior approval and is a substantial revision to the VY QAPM which reflects the decommissioning status of the VY facility with all spent fuel in dry storage on the VY ISFSI (Reference 2). The proposed Revision 7 is a reduction in commitment since, along with other changes, the program basis will be changed from the ANSI/ANS standards to use primarily Regulatory Guide 7.10 "Establishing Quality Assurance Programs for Packaging Used in Transport of Radioactive Material", Revision 3. The highest level of safety significance items at the VY facility will be items designated as Important to Safety (ITS) under 10 CFR 71 and 10 CFR 72. There will not be any safety-related structures, systems or components at the VY facility as defined in 10 CFR 50 Appendix B. Once Reference 2 is approved, Revision 7 will be implemented consistent with, but not earlier than, the implementation schedule described in Reference 1.
The VY QAPM continues to satisfy the requirements of 10 CFR 50 Appendix B and the Regulatory Guides and ANSI Standards referenced in the VY QAPM Appendix B. As such, it also meets the requirements of 10 CFR 72.140(d) for Independent Spent Fuel Storage Installations and 10 CFR 71.101 (f) for Packaging and Transportation of Radioactive Material.
This letter contains no new regulatory commitments.
Should you have any questions, please contact Mr. Edward D. Harris, Manager - QA at (601) 368-5649.
    \.
7 OUEDH/BLH

==Enclosures:==
A. Synopsis of Entergy VY QAPM Revision Changes, Revisions 4 and 5 (1 page)
B. Entergy VY QAPM Revision 10 CFR 50.54(a)(3) AND 10 CFR 71.106 Evaluation Forms and Affected Pages (44 pages)
C. Entergy VY QAPM Revision 5 (58 pages)

CNR0-2018-00016 Page 3 of 3 cc:    C. Bakken (ECH)
C. Constanza (ECH)
: 0. Limpias (ECH)
C. Daniels (VY)
C. Chappell (VY)
K. Jury (ECH)
M. Halter (ECH)
R. Gaston (ECH)
B. S. Ford (ECH)
All above w/o enclosures NRC Region I Administrator NRC Project Manager (VY)
Vermont Department of Public Service

Enclosure A CNR02018-00016 Synopsis of Entergy VY QAPM Revision Changes Revisions 4 and 5

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ATTACHMENT 9.3                                10 CFR 50.54(a) QAPM CHANGE EVALUATION FORM Page 1 of 9                                      Vermont Yankee QAPM Rev. 4 Change No. 0 LBDCR LIC 2016-06 10 CFR 50.54(a) Evaluation NOTE - The basis for the answers should be of sufficient depth and detail to support the conclusions reached and allow for independent review. Simply stating the change does not decrease the effectiveness without stating why is not acceptable.
Editorial corrections (i.e., spelling, punctuation, typographical or grammatical errors, and incorrect cross-references) are not considered changes and therefore, a Quality Assurance Program Regulatory Review is not required. All boxes should be checked "N/A" and proceed to signature page of the evaluation form.
YES      NO        NIA
: 1. Is this change an editorial change as defined in 10CFR 50.54(a)(3)? (If yes, provide basis, mark remaining questions "NIA" and state "not a reduction                  X in commitment") Proceed to approval page of attachment.
Basis for Answer:
The proposed changes are not considered editorial as defined in 10 CFR 50.54(a)(3). See the Attachment A for the details of each change.
: 2. For any YES answer in the 10 CFR 50.54(a) Screen or for the QA-initiated change, does the proposed change represent a reduction in commitment or                 X process(es) described or established in the approved QA Program?
Basis for Answer:
Appendix B was modified to eliminate redundant training commitments between Licensed Basis Documents. The requirements for the training and qualification of Certified Fuel Handlers (CFH) are described in the VY approved Technical Specifications.
: 3. If item 2 above is YES, does the proposed change include the basis to conclude that the revised program incorporating the change continues to meet the criteria of 10CFR50, Appendix B and other                X previously accepted USAR commitments?
Basis for Answer:
The revised Technical Specification (TS) 6.2.C was issued in Amendment No. 260 to the VYNPS Administrative Controls Technical Specifications, by letter from NRC to Entergy, dated December 22, 2014 (ADAMS Accession No. Ml14217A072). The Safety Evaluation statements related to revised TS 6.2.C.2

ATTACHMENT 9.3                                 10 CFR 50.54(a) QAPM CHANGE EVALUATION FORM Page 2of 9                                       Vermont Yankee QAPM Rev. 4 Change No. 0 LBDCR LIC 2016-06 YES      NO       N/A reference the Certified Fuel Handler training and retraining program for VY, approved by the NRC staff on October 1, 2014 (ADAMS Accession No. ML14162A209), and concluded that this TS appropriately requires the establishment and maintenance of a program to train and retrain Certified Fuel Handlers for positions requiring such qualification that are specified in the TS.
: 4. Is the proposed change a change to a QA standard approved by the NRC which is more recent than the QA standard currently established in the Program?                            X Basis for Answer:
This review ensures continued compliance with 10CFR50 Appendix B, NUREG-0800 and 10CFR50.54(a)(3) commitments.
: 5. Is the proposed change a change involving the use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific         X titles?
Basis for Answer:
A number of changes were made with the Organization section to reflect changes to the proposed VY site specific organization that is responsible for the implementation of the QAPM functions. The changes add new positions responsible for ISFSI construction, fuel transfer activities, radiation protection and chemistry.
Responsibilities are realigned for other positions, but there is no overall change to the reporting function, which continues to report through a site senior management position up to the chief nuclear officer.
The site organizational positions and responsibilities continue to report up through a site executive with ultimate reporting to the chief nuclear officer. Generic titles continue to be used, which is consistent with Revisions 0, 1, 2 and 3 of the VY QAPM. These generic position titles remain in lower case in keeping with QAPM format and 10CFR50.54(a)(3).iii that allows ''the use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles."

ATTACHMENT 9.3                                10 CFR 50.54(a) QAPM CHANGE EVALUATION FORM Page 3 of 9                                     Vermont Yankee QAPM Rev. 4 Change No. 0 LBDCR LIC 2016*06 YES      NO       N/A
: 6. Is the proposed change a change involving the use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or alternately, the use of descriptive text?                                    X Basis for Answer:
The VY QAPM does not use organizational charts to indicate functional relationships, authorities, or responsibilities.
: 7. Is the proposed change an elimination of Quality Assurance Program information that duplicates language in Quality Assurance Regulatory Guides                              X and Quality Assurance Standards to which EN is committed?
Basis for Answer:
This revision does not eliminate a quality assurance standard to which the QAPM commits to, as denoted in Appendix B of the QAPM.
: 8. Does the proposed change continue to ensure that persons and organizations performing Quality Assurance functions continue to have the requisite authority and organizational freedom, including            X sufficient independence from cost and schedule when opposed to safety considerations?
Basis for Answer:
This revision changes the VY organization as defined in the VY QAPM due to the addition of new manager level positions to the VY organizational structure that are responsible for ISFSI construction and fuel transfer activities and also realigns some responsibilities. The changes add new positions responsible for ISFSI construction, fuel transfer activities, radiation protection and chemistry. Responsibilities are realigned for other positions, but there is no overall change to the reporting function, which continues to report through a site senior management position up to the chief nuclear officer. No responsibilities as previously committed to were eliminated.
No changes were made to the nuclear oversight organization. The vice president oversight remains responsible for governance and implementation of the Quality Assurance Program in accordance with regulatory requirements and the establishment of policies, goals, and objectives of the quality assurance

ATIACHMENT 9.3                                10 CFR 50.54(a) QAPM CHANGE EVALUATION FORM Page 4 of 9                                     Vermont Yankee QAPM Rev. 4 Change No. 0 LBDCR LIC 2016-06 YES      NO       NIA policy. This position provides guidance and interpretation for implementing the company quality assurance policy. Organizations performing quality assurance functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations. This revision does not change the reporting relationship of this executive up to the chief nuclear officer.
The organizational related changes are not reductions in commitments. The changes are enhancements to improve site organizational alignment support a shutdown facility and continue to maintain adequate independence between the performing and verifying activities. No responsibilities were eliminated. See the Attachment A for details of the proposed changes.
: 9. Is a change to the QAPM required? If YES, process change per EN-Ll-113. If NO, distribute as indicated below.                                                      X Basis for Answer:
The changes to organizational responsibilities and other minor changes are considered administrative and do not impact the ultimate reporting relationship with the chief nuclear officer. The quality assurance function continues to report up through the senior management position responsible for nuclear oversight to the chief nuclear officer. The executive management position and the quality assurance organization (through the nuclear oversight executive) continue to report to the chief nuclear officer, which is consistent with previous organizational relationships for the QAPM functions.
New positions of manager responsible for lSFSI construction and fuel transfer activities and a manager responsible for radiation protection and chemistry have been added to the organization. These clarifications and administrative changes do not constitute a reduction in commitment to the previously approved QAPM as defined in 10CFR50.54(a)(3). See the Attachment A for details of the proposed changes.

ATTACHMENT9.3                                                  10 CFR 50.54(a) QAPM CHANGE EVALUATION FORM Page 5 of 9                                                      Vermont Yankee QAPM Rev. 4 Change No. 0 LBDCR LIC 2016-06 10 CFR 50.54 REVIEW RESULTS
[]       Change is editorial in accordance with 10CFR50.54(a)(3) and thus, does not represent a reduction in commitment. The change can be implemented upon approval of parent change document. (Question 1 is YES}
[X]       Does not represent a reduction of commitment, and can be implemented upon approval of parent change document. (Questions 5, 6, 7, 8, and 9 are YES or N/A}
[]       Represents a reduction of commitment with prior NRG approval for another Licensee. The safety evaluation issued by the NRG has been evaluated and it directly applies to the changes being proposed for EN. The change can be implemented upon approval of parent change document. (Question 3 is YES}
[]       Represents a reduction of commitment; however, the change has sufficient basis to demonstrate continued compliance with Appendix B and USAA commitments.
Therefore, the proposed change should be submitted for NRG review/approval.
(Questions 2 and 4 are YES)
[]        Represents a reduction of commitment with insufficient basis to demonstrate continued compliance. Therefore, the activity should not be processed.
(Question 4 is NO) c__'~k~
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* Date Distribution: Original - Attach to Parent Document; Copy - Quality Assurance

ATTACHMENT 9.3                       10 CFR 50.54(a) QAPM CHANGE EVALUATION FORM Page 6 of 9                            Vermont Yankee QAPM Rev. 4 Change No. 0 LBDCR LIC 2016*06 CHANGE DISPOSITION IZ! Approved for implementation D Disapproved D Approved for submittal to the NRC Appr~                      -
 ~~    ~--=-~~~~~~~~' 11~~& ~
Vice President, Oversight                                            Date

Attachment A Supporting Information for the 10CFR50.54.a Evaluation QAPM                                                                                                               Reduction in Change(s)                                 Evaluation and Justification Section                                                                                                            Commitment?
Cover Page No changes                                                 N/A                                                           N/A Policy Statement Modified CNO title to lower case , and replaced            This is an administrative change that does not involve a       No executive responsible for oversight for the Vice           reduction in commitment.
President Nuclear Oversight to be consistent with the corporate oversight description in section A.2.a Table of Contents Aligned sections with starting page numbers.              This is an administrative change that does not involve a       No reduction in commitment.
Section A - Management A.1      The changes clarify procedures as the         This is an administrative change that does not involve a       No administrative controls.                      reduction in commitment.
A.2     A number of changes were made with the        These changes to the titles and organizational                  No Organization section to reflect changes to    responsibilities are considered administrative and do not the proposed VY site specific organization    impact the ultimate reporting relationship with the chief that is responsible for the implementation of nuclear officer. The quality assurance function continues the QAPM functions. The changes add           to report up through the senior management position new positions responsible for ISFSI           responsible for nuclear oversight to the chief nuclear construction , fuel transfer activities,      officer. The senior management position and the quality radiation protection and chemistry.           assurance organization (through the nuclear oversight Responsibilities are realianed for other      executive) continue to report to the chief nuclear officer,

QAPM                                                                                                               Reduction in Change(s)                                  Evaluation and Justification Section                                                                                                            Commitment?
positions, which continues to report through   which is consistent with previous organizational a site senior management position up to        relationships for the QAPM functions. New positions of the chief nuclear officer.                     manager responsible for ISFSI construction and fuel transfer activities and a manager responsible for radiation protection and chemistry have been added to the organization. These clarifications and administrative changes do not constitute a reduction in commitment to the previously approved QAPM.
A.3 to 7  No changes                                     NIA                                                           NIA Section B - PerformanceNerification No changes                                                NIA                                                           NIA Section C - Audit No changes                                                NIA                                                           NIA Section D - Independent Safety Review Function No changes                                                 NIA                                                           No Appendix A - Safety Related and Important-to-Safety Structures, Systems and Components A minor editorial change was made to a note.              This is an administrative change and does not constitute       No a reduction in commitment to the previously approved QAPM Appendix B - Regulatory Commitments The appendix has been modified to reflect "A Certified    This is an administrative change and does not constitute       No Fuel Handler shall be qualified in accordance with the    a reduction in commitment to the previously approved Technical Specifications."                                QAPM. The appendix was changed to eliminate redundant commitments between Licensed Basis

QAPM                                                                                                     Reduction in Change(s)                             Evaluation and Justification Section                                                                                                   Commitment?
Documents. The requirements for the training of and qualification of CFH are described in Technical Specifications. The revised Technical Specification (TS) 6.2.C was issued in Amendment No. 260 to the VYNPS Administrative Controls Technical Specifications, by letter from NRC to Entergy, dated December 22, 2014 (ADAMS Accession No. ML14217A072). The Safety Evaluation statements related to revised TS 6.2.C.2 reference the Certified Fuel Handler training and retraining program for VY, approved by the NRC staff on October 1, 2014 (ADAMS Accession No. ML14162A209), and concluded that this TS appropriately requires the establishment and maintenance of a program to train and retrain Certified Fuel Handlers for positions requiring such qualification that are specified in the TS.
Appendix C - Other General Guidance Documents No changes                                    IN/A                                                            N/A I
Appendix D -Administrative Controls No changes                                    IN/A                                                            N/A I

Vermont Yankee Nuclear Power Station Docket No. 50-271 License No. DPR-28 Docket No. 72-59 Quality Assurance Program Manual Effective: May 05 , 201 6                    Revision 4 I

 ~ Entere:v 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 (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. Approved administrative controls are also used to implement controls for certain quality-related equipment and activities that are not safety-related, but support safe storage of spent fuel, or where other regulatory or industry guidance establishes program requirements.
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 QAP.
Responsibility for developing, implementing, and verifying execution of the Quality 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.
Revision 4 I

-~ Entere.v VY QUALITY ASSURANCE PROGRAM MANUAL TABLE OF CONTENTS SECTION 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                Revision 4 I

*~ Enlerl!Y VY QUALITY ASSURANCE PROGRAM MANUAL TABLE OF CONTENTS SECTION B. 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                              Revision 4 I

*~ 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 quality related 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 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 8 , 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 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.
1                                        Revision 4 I

*~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL A. 2.b. (continued)
: 1. The VY executive management position 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. The manager 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 safety review function reports to the manager responsible for facility operations.
: 3. A manager 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 manager 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).
: 5. A manager 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 management position.
The site personnel organizationally report to an executive (supply chain - offsite) who has a functional interface with the VY executive management position.
3                                         Revision 4 I

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL A. 2.b. (continued)
: 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.
: 7. A manager responsible for radiation protection and chemistry activities. This manager is responsible for the implementation of the Radiation Protection Program, Radiological Environmental Monitoring Program, Radiological Effluent Controls Program, radioactive waste shipping, Process Control Program and chemistry activities.
: c. The on-site and off-site safety review function independently reviews activities to provide additional assurance that VY is maintained in accordance with the Operating License and applicable regulations that address nuclear safety.
: 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.
: 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.
: 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.
4                                       Revision 4

* ~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix A SAFETY RELATED AND IMPORTANT-TO-SAFETY STRUCTURES, SYSTEMS AND COMPONENTS The pertinent quality assurance requirements 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 QAP.
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.
Transfer Cask and Adapter Plate                                 B              Holtec Intl.
ISFSI Pad                                                      C                    VY Liftino Yoke                                                    B              Holtec Intl.
Damaged Fuel Can                                                A          Holtec Intl. {Later) 19                                          Revision 4 I

-~ 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.
: b. Managers required to be a Certified Fuel Handler are specified in the Technical Specifications.
: c. A Certified Fuel Handler shall be qualified in accordance with the Technical Specifications.
Individuals filling positions who met the previous commitment at the time of implementation of this commitment can be considered to meet any more restrictive aspects of the requirements of this commitment for that position without further review and documentation.
: 2. General            The following qualifications may be considered equivalent 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 facility 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                                      Revision 4 I

ATIACHMENT 9.3                                10 CFR 50.54(a) QAPM CHANGE EVALUATION FORM Page 1 of 5                                     Vermont Yankee QAPM Rev. 5 Change No. 0 LBDCR LIC 2016-08 10 CFR 50.54(a) Evaluation NOTE - The basis for the answers should be of sufficient depth and detail to support the conclusions reached and allow for independent review. Simply stating the change does not decrease the effectiveness without stating why is not acceptable.
Editorial corrections (i.e., spelling, punctuation, typographical or grammatical errors, and incorrect cross-references) are not considered changes and therefore, a Quality Assurance Program Regulatory Review is not required. All boxes should be checked "N/A" and proceed to signature page of the evaluation form.
YES      NO        N/A
: 1. Is this change an editorial change as defined in 1O GFR 50.54(a)(3)? (If yes, provide basis, mark remaining questions "N/A" and state "not a reduction                   X in commitment'') Proceed to approval page of attachment.
Basis for Answer:
The proposed changes are not considered editorial as defined in 1O GFR 50.54(a)(3).
: 2. For any YES answer in the 1O GFR 50.54(a) Screen or for the QA-initiated change, does the proposed change represent a reduction in commitment or                  X process(es) described or established in the approved QA Program?
Basis for Answer:
The changes to be implemented are a reduction in commitments to the previously approved program.
These were previously submitted to the NRG and were not implemented in Revision 4 of the QAPM because the reductions in commitments had not been approved by the NRG. Specifically, there are three (3) changes that are considered a reduction in commitments that will be implemented in Revision 5. The three (3) changes that are considered a reduction in commitments to the previously approved program are as follows:
* Reduction with the applicability of the QAPM to only include safety-related and important-to-safety (ITS) structures, systems and components (SSGs) and associated activities.
* Addition of exceptions to ANSI/ANS 3.1-1978 regarding staff qualification requirements, specifically with requirements for prior experience.
* Addition of exceptions to ANSI N18.7 regarding the on and off-site review functions, which specifically

ATTACHMENT 9.3                                10 CFR 50.54(a) QAPM CHANGE EVALUATION FORM Page 2 of 5                                     Vermont Yankee QAPM Rev. 5 Change No. 0 LBDCR LIC 2016-08 YES      NO       N/A includes the applicable requirements within Appendix D of the QAPM.
These changes were submitted to the NRC and have been reviewed and approved under NRC Letter from Jack D. Parrott, Senior Project Manager to Mr. Michael Perito, "Entergy Vermont Yankee Quality Assurance Program Manual and Independent Spent Fuel Storage Facility - Review and Acceptance of Changes (CAC NO.
L53120)" dated June 16, 2016. Revision 5 of the QAPM will implement these previously approved changes.
: 3. If item 2 above is YES, does the proposed change include the basis to conclude that the revised program incorporating the change continues to meet          X the criteria of 10CFR50, Appendix B and other previously accepted USAA commitments?
Basis for Answer:
The NRC review and approval concluded that the revised program continues to meet the criteria of 10 CFR 50, Appendix B and other previously accepted USAR/DSAR commitments. (ADAMS Accession No. ML16165A465)
: 4. Is the proposed change a change to a QA standard approved by the NRC which is more recent than the QA standard currently established in the Program?                  X Basis for Answer:
These changes are limited to modifications to existing standards through the use of new or modified exceptions. The details of each of the changes are discussed in Attachment 2. The changes continue to ensure compliance with 10 CFR 50 Appendix B, although prior NRC approval is required because several changes are considered reductions in commitments to the previously approved QAPM.
: 5. Is the proposed change a change involving the use of generic organizational position titles that clearly denote the position function, supplemented as                       X necessary by descriptive text, rather than specific titles?
Basis for Answer:
The Organization section of the QAPM was not changed as part of this revision .
: 6. Is the proposed change a change involving the use of generic organizational charts to indicate functional

ATTACHMENT 9.3                               10 CFR 50.54(a) QAPM CHANGE EVALUATION FORM Page3 of 5                                     Vermont Yankee QAPM Rev. 5 Change No. O LBDCR LIC 2016-08 YES      NO       N/A relationships, authorities, and responsibilities, or alternately, the use of descriptive text?                                    X Basis for Answer:
The QAPM does not use organizational charts to indicate functional relationships, authorities, or responsibilities.
: 7. Is the proposed change an elimination of Quality Assurance Program information that duplicates language in Quality Assurance Regulatory Guides and Quality Assurance Standards to which EN is                      X committed?
Basis for Answer:
This revision does not eliminate a quality assurance standard to which the QAPM commits to, as denoted in Appendix B of the QAPM. The changes do provide more detail on implementation criteria for Quality Assurance Regulatory Guides and Standards to which VY is committed.
: 8. Does the proposed change continue to ensure that persons and organizations performing Quality Assurance functions continue to have the requisite authority and organizational freedom, including             X sufficient independence from cost and schedule when opposed to safety considerations?
Basis for Answer:
This revision does not change the VY organization as defined in the QAPM. The vice president oversight remains responsible for governance and implementation of the Quality Assurance Program in accordance with regulatory requirements and the establishment of policies, goals, and objectives of the quality assurance policy. This position provides guidance and interpretation for implementing the company quality assurance policy. Organizations performing quality assurance functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations. This revision does not change the reporting relationship of this executive up to the chief nuclear officer.
: 9. Is a change to the QAPM required? If YES, process change per EN-Ll-113. If NO, distribute as indicated below.                                                     X Basis for Answer:

ATTACHMENT 9.3                              10 CFR 50.54(a) QAPM CHANGE EVALUATION FORM Page 4 of 5                                   Vermont Yankee QAPM Rev. 5 Change No. 0 LBDCR LIC 2016-08 YES       NO        N/A The QAPM does need to be changed to reflect the organizational changes, scope of the program to safety-related and ITS SSCs and activities and the modifications to regulatory commitments.
10 CFR 50.54 REVIEW RESULTS
[]      Change is editorial in accordance with 10CFR50.54(a)(3) and thus, does not represent a reduction in commitment. The change can be implemented upon approval of parent change document.
[]      Does not represent a reduction of commitment, and can be implemented upon approval of parent change document.
[X]      Represents a reduction of commitment with prior NRC approval. The safety evaluation issued by the NRC has been evaluated and it directly applies to the changes being proposed for EN. The change can be implemented upon approval of parent change document.
[]       Represents a reduction of commitment; however, the change has sufficient basis to demonstrate continued compliance with Appendix B and USAR commitments.
Therefore, the proposed change should be submitted for NRC review/approval.
[]       Represents a reduction of commitment with insufficient basis to demonstrate continued compliance. Therefore, the activity should not be processed.
____        ~a.-c.----J
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __.,!_ _ _....;.___ __  .es/~*/z.01~
Manager, Corporate QA Approver                                           Date Distribution: Original - Attach to Parent Document; Copy - Quality Assurance

ATTACHMENT 9.3                      10 CFR 50.54(a) QAPM CHANGE EVALUATION FORM Page 5 of 5                           Vermont Yankee QAPM Rev. 5 Change No. O LBDCR LIC 2016-08 CHANGE DISPOSITION C8] Approved for implementation D Disapproved D Approved for submittal to the NRC Approved ~                                                        e, /v:, /i le,
----       ~- - - # - - - -- -- - - - - - - - - - - - - " ' - - - - - - -
Vice Pres1aent, Oversight                                          Date

Vermont Yankee Nuclear Power Station Docket No. 50-271 License No. DPR-28 Docket No. 72-59 Quality Assurance Program Manual Effective: May-September 07&, 2016                Revision 54 I

 ~ Enferl!.Y POLICY STATEMENT VY QUALITY ASSURANCE PROGRAM MANUAL 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 (NRG) Facility Operating Licenses, and applicable laws and regulations of the state and local governments.
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 OAP is also applied to SSCs classified as important-to-safety (ITS) to satisfy the requirements of 10CFR71 and 10CFR72. Approved adm inistrative controls are also used to implement controls for certain quality rotated equipment and activities that are not safety related, but support safe storage of spent fuel , or where other regulatory or industry guidanee establishes program requirements.
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 Quality 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.
Revision 54 I

*~ 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 quality 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 safety-related and ITS quality 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.
1                                        Revision 54 I

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL A. 2.b. (continued)
: 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.
: 7. A manager responsible for radiation protection and chemistry activities. This manager is responsible for the implementation of the Radiation Protection Program, Radiological Environmental Monitoring Program, Radiological Effluent Controls Program, radioactive waste shipping, Process Control Program and chemistry activities.
: c. The on-site and off-site safety review function 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 functions are described in Appendix D.
: 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.
: 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.
: 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                                    Revision 54

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL A.2. (Gontinued)
: 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 Guide 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.
: 4.       In each of the ANSI 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 applicable to safety 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 C, 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 NRG is to be notified of QAPM changes in accordance with 10 CFR 50.54(a)(3) or 10 CFR 50.54(a)(4).
7                                       Revision 54 I

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL C. 2. (continued)
: 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. Independent safety review is performed to meet VY's commitment to NUREG-0737, Section 1.8.1.2, "Independent Safety Engineering Group,"
as described in the unit's safety analysis report. This function is described in Appendix D, Section 1.0.
19                                       Revision 54 I

-~ 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.
: b. Managers required to be a Certified Fuel Handler are specified in the Technical Specifications.
: c. A Certified Fuel Handler shall be qualified in accordance with the Technical Specifications.
Individuals filling positions who mot tho previous sommitmont at the time of implementation of this sornmitrnont san be sonsidered to meet any more rostristivo aspests of tho requirements of this sommitment for that position without further review and dosumentation.
: 2. General            The following qualifications may be considered equivalent 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 facility 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.
22                                     Revision 54 I

-~ 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 either a) is accredited by the National Nuclear Accrediting Board (NNAB) orb) meets the standards of section 5 of ANSI/ANS 3.1-1978.
: 6. ANSI/ANS 3.1        Nuclear power plant experience is amended to also include Sections 4.3.1 and  experience acquired at a defueled reactor site that is directly related 4.5.1              to the storage or handling of spent nuclear fuel in a spent fuel pool.
Specifically, individuals will obtain the necessary on site experience to fill the position of Certified Fuel Handler or operators, based on their assigned functions and validation of equivalent training and experience rather than requiring at least six months of the nuclear power plant experience at the plant for which an individual seeks a license or to be an operator as defined in Sections 4.3.1 and 4.5.1 of ANSI/ANS 3.1-1978.
23                                      Revision 54 I

*~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments C. Regulatory Guide 1.33 Revision 2, dated February 1978 Clarification/Exception
: 1. Section C.1      VY will provide procedures for the guide's Appendix A activities as discussed, applicable to VY. However, VY does not consider all activities listed to be "safety-related" (e.g., activities in 7.e).
: 2. Section C.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 QAPM Section C.2.a instead of this section.
: 3. ANSI N18.7       Sentences 4 and 5 state, "However, applicable sections of this Section 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 the requirements associated with those activities conducted in accordance with the applicable NRC Quality Assurance Program Approval for Radioactive Material Packages.
: 4. ANSI N18.7       The on and off-site review committee requirements will be satisfied as Section 4.3-4    described in Appendix D of the QAPM.Tho specific areas of experience described in this section are not applicable to the on site safety review committee, but the committee must be comprised of site operating or engineering supervisory personnel. Additionally, the off site safety review committee needs to contain experience in only a majority of the areas.
5.-10. ANSI N18.7       DeletedThe statement that "no more than a minority of the quorum Section 4 .3.2.3 shall have lino responsibility tor tho operation of the plant" is not applicable to the on site safety review committee .
25                                          Revision 54 I

VY QUALITY ASSURANCE PROGRAM MANUAL Appendix B Regulatory Commitments Regulatory Guide 1.33 (sontinued)
Clarifisation!Exeeption
: 6. ANSI N18.7           10 CFR 50.59 *.1.ias revised through Federal Register Notioe Sootion              1QQQ1001 R 1N3150 AFQ4 eliminating the terms "safety evaluation" 4.3.4.(1) & (2)      and "unreviewed safety question." Tho term "safety evaluation" has boon replaced with 10 GFR 50.5Q "evaluation ." Tho term "unroviowed safety question," as defined in tho previous &#xa5;ors ion of 10 CFR 50.5Q (a)(2) , was roplaoed by oritoria pro&#xa5;idod in 50.59(c)(2) to determine if a lioense amendment pursuant to 50.QO is required prior to implementing the ohange, test, or experiment.
h  ANSI N18.7           Reviews assooiated with ohanges to tho technioal specifioations will Sootion 4 .3.4 (2)   be performed in accordanoo with Seotion 4.3.4(3) instead of this section.
: a. .<<:\NSI N18.7        Revision to proposed Technical Spooifioation ohanges only requires Section 4.3.4(3)     review in aooordanoo with this section when the revision involves a significant change to the technioal basis for the proposed change .
Tho independent review body disoussod in this seotion is the on site safety review committee. Voting members having a potential confliot of interest refrain from voting on dooumonts under review.
: 9. ANSI N18.7           In place of the requirements of this sootion , tho on site and off silo Section 4.3.4(4)     safety review committees shall review faoility opOFations to detect potential nuclear safety hazards and all reports made in aocordanco with 10 GFR 50.73.
to. ANSI N18.7           An example of the matters ro&#xa5;iowod by tho on site safety review Seotion 4 .3 .4 (5) committee in aooordanco with this section is a change to the Emergency Plan (except editorial changes) .
: 11. ANSI N18.7           This section establishes minimum 2-year audit frequency for all safety Section 4.5          related functions. VY will perform audits at frequencies as discussed in QAPM Section C.2.a instead of this section.
~    ANSI N18.7           The independent review body discussed in this section is the off site Sootion 4.5          safety ro*,iew comm ittee.
26                                     Revision 54 I

 -~ 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 10CFRS0.59 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 collectively have experience and knowledge in the following functional areas:
a) fuel handling and storage (including the potential for criticality),
b) chemistry and radiochemistry, 51                                     Revision 5 I

 ~ 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 following 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 review results as they relate to safe storage of irradiated fuel.
c) Recommend to management of the assessed organization, and its management, any corrective 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 within 24 hours.
: 8. The SRC shall be responsible for reviewing:
a) The evaluations for procedures, and changes thereto, completed under the provisions of 10 CFR 50.59 or 10 CFR 72.48 to verify that such actions do not require prior NRC 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 NRC 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 NRC approval or a license amendment as defined in 10 CFR 50.59 or 10 CFR 72.48. This review 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; 52                                       Revision 5

-~ Entergy VY QUALITY ASSURANCE PROGRAM MANUAL g) Significant accidental, unplanned, or uncontrolled radioactive releases. Including corrective action(s) to prevent 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 Executive within 30 days after completion of the review.
: 9. The SRC's responsibility shall include oversight of the Audit Program. Audits shall be performed of the activities and at the 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 provisions of QAPM; b)  Recommendations to the management of the audited organization; c)  Documentation of reviews conducted by the SRC; and d)  Determination of whether changes to procedures and programs require prior NRC approval as defined in 10 CFR 50.59 and 10 CFR 72.48.
Written records of reviews and audits shall be maintained. As a minimum, these records shall include results of the activities conducted under the provisions of Section 8.15.
This appendix also provides for the future relocation of Administrative Controls from other license basis documents, such as from the defueled Technical Specifications.
53                                      Revision 5 I

VERMONT YANKEE LICENSING DEPARTMENT NRC INCOMING CORRESPONDENCE DISTRIBUTION NVY {b ...-C,;l.O                                                                                        Agency Letter Date: June l6, 2016

==SUBJECT:==
ENTERGY VERMONT YANKEE QUALITY ASSURANCE PROGRAM MANUAL VERMONT YANKEE NUCLEAR POWER STATION AND INDEPENDENT SPENT FUEL STORAGE FACILITY - REVIEW 1ND ACCEPTANCE Of CHANGES (CAC NO. L53120)                                                   ,m '- '''          bs A '{/6)
TECHNICAL LEAD: .Joe Laughney                                                RESPONSE DUE TO NRC:                     I     ,1//  A LICENSING LEAD: Tom Sitko (x3166)
O YES    )(No COMMITMENT IDENTIFIED:                            YES/NO (If yes, enter EN-LI-110)
I IOCFRl9.1 l(a)(4) action?~
posting is required within 2 working days of receipt.              I COMMENTS:
EXTERNAL DISTRIBUTION                                                               VERNON DISTRIBUTION FOR INFORMATION                                                                   FOR INFORMATION (ll!l = Receives copy directly rrom NRC)                                          (ll!J = Receives copy directly from NRC)
By 

==Subject:==

ll!J   Coley Chappell, Manager, Design & Program~ (see note 2)
D    Guy Davant, Manager, Licensing (WPO)                                        ltl    Dodi Emery (Chronological File) ltl Michael TTwomey, VP, External Affairs-Wholesale, WPO                         By 

==Subject:==

D   Other:                                                                     ":Sit. Jack Boyle, Decommissioning Director K       Corey Daniels, Senior Manager, Production l8<     Steve Naeck, Manager, Emergency Preparedness
                                                                                >>"&deg;     Ken Swanger, Manager Construction JR:     Patrick Ryan, Manager, Security (IR)
                                                                                )& Joe Laughney, Manager, QA (IR)
Decommissioning:                                                               "a:     Mike Pletcher, Manager, Chemistry/RP ltl John Card, State Liaison Engineer D Dodi Emery (all JR,; to SRC members)
D    Monique Hoffmeister            D Andy Cardine                              ) ( Tom Silko, Licensing (IR) Notes: 2 and 3 D    Elizabeth Hunter               D Mike Tessier                                ltl Joe Lynch, External Affairs Mgr.
D    Paul Paradis                   D Dave Duffy                                  li2I' Martin Cohn, Communications Manager (IR)
D    Tim Ngau                       D Susan Raimo                                 D Other:
611 Phil Couture                    D Robin Nilson D    Steven Scheurich              D P.L. Swigart D    JimCordell D    Jeff Wagner D     Paper distribution orP(Electronic distribution I  Distributed by:     J)JlkL.          Date:     ~P.~/1'1 I Latest update: May 9, 2016 (DME)
NOTES:
l)   ([R) - Inspection Rcpor!S
: 2)   For !Rs. Licensing verities that CRs geni:ratetl a1.kquately recogni1.c aml addrt-ss any violations/findings identified in the IR. If necessary. the responsible manager is contacted to resolve discrepancies (e.g. update CR, initiate a CRCA tn address, initiate new CR). Also ensun: a CA is created to perform u closure review per EN-LI-I02.
: 3)   For annual and semi-annual assessment letters. coordinate a SARB meeting to determine the- pre-inspection as~cssments that will he performed and ensure CA&A issues the as.~ociated LOs (EN-LI-!04).

UNITED STATES NUCLEAR REGULA TORY COMMISSION WASHINGTON, D.C. 20666-0001
                                         )/llj /6-0tUJ June 16, 2016 Mr. Michael Perito Vice President, Oversight Entergy Nuclear Operations, Inc.
1340 Echelon Parkway Jackson, MS 39213

==SUBJECT:==
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)

==Dear Mr. Perito:==

The U.S. Nuclear Regulatory Commission (NRC) has completed its review of the proposed changes to the Entergy Nuclear Operations, Inc. (ENO) Vermont Yankee Nuclear Power Station (WNPS) Quality Assurance Program Manual (QAPM) in response to your letter dated February 4, 2016 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML16035A506), as supplemented by letter dated May 5, 2016 .
The W QAPM is associated with license DPR-28 for the WNPS and docket no. 72-059 for the Independent Spent Fuel Storage Installation.
The proposed QAPM reflects changes and simplifications based on the WNPS decommissioning status. Changes include those to the scope of structures, systems and components, due to the decommissioning status; removing the need for maintaining NRC Licensed Operators as part of the site organization; the qualification of Certified Fuel Handlers; transitioning the onsite-review function to an independent review function; and, modifying the function of the off-site safety review to reflect the complexity of operations for a decommissioning facility. The changes, some of which are considered to be reductions in commitments, were submitted for NRC review and approval in accordance with the provisions of Title 10 of the Code of Federal Regulations (1 O CFR) paragraph 50.54(a)(4).
The NRC staff has completed its review of your request and has determined that the Quality Assurance Program, as described in the WNPS QAPM, is in conformance with the applicable portions of Appendix B to 10 CFR Part 50. The NRC staff concludes that the proposed Vermont Yankee QAPM Revision 4 follows the NRC guidance in the attached NRC safety evaluation, conforms to the format of NUREG-0800, Section 17.3, complies with Appendix B to 10 CFR Part 50 requirements for the QA program and is, therefore, acceptable.

M. Perito                                      2 If you have any questions, please contact me at (301) 415-6634 or via e-mail at Jack. Parrott@nrc.gov.
Sincerely,
                                              /RA/
Jack D. Parrott, Senior Project Manager Reactor Decommissioning Branch Division of Decommissioning, Uranium Recovery, and Waste Programs Office of Nuclear Material Safety and Safeguards Docket Nos. 50-271 and 72-059

==Enclosure:==

Safety Evaluation cc: Distribution via Listserv

ML16165A465
* via e-mail OFFICE      NMSS           NMSS       NMSS*           NRO*           NMSS          NMSS NAME      J. Parrott    C. Holston    P. Silva    K. Kavanagh      8. Watson     J. Parrott DATE     06/14/2016    06/14/2016   06/15/2016     06/14/2016     06/16/2016    06/16/2016 SAFETY EVALUATION OF THE ENTERGY VERMONT YANKEE QUALITY ASSURANCE PROGRAM MANUAL. REVISION 4 DOCKET NOS. 50-271 AND 72-59

==1.0       INTRODUCTION==

By letter dated February 4, 2016 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML16035A506), Entergy Nuclear Operations, Inc. (Entergy) submitted for the U.S. Nuclear Regulatory Commission (NRC) staffs review, a revision to the Vermont Yankee Quality Assurance Program Manual (QAPM), in accordance with Title 10 of the Code of Federal Regulations (10 CFR) section 50.54(a)(4).
The QAPM provides a top-level overview of the quality program controls applied to quality related items and activities at the Vermont Yankee Nuclear Power Plant during the decommissioning phase of the plant life. The QAPM is based on the applicable portions of Appendix B, "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," to 10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities,"
10 CFR Part 72, "Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reactor Related Greater than Class C Waste," Subpart G, "Quality Assurance," and 10 CFR Part 71, "Packaging and Transportation of Radioactive Material," Subpart H, "Quality Assurance."
2.0        REGULATORY BASIS The Commission 's regulatory requirements related to Quality Assurance (QA) programs are set forth in Appendix B to 10 CFR Part 50 (Appendix B), 10 CFR 50.34(b)(6}(ii), and 10 CFR 50 .54(a}. In addition, the Commission's regulatory requirements related to QA programs for the independent storage of spent nuclear fuel and packaging and transportation of radioactive material are addressed in 10 CFR Part 71, Subpart H, and 10 CFR Part 72, Subpart G.
Appendix B establishes the requirements for the design, fabrication, construction, and testing of structures, systems, and components (SSCs} for the facility. The pertinent requirements of Appendix B apply to all activities affecting the safety-related functions of those SSCs and include designing, purchasing , fabricating , handling, shipping, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, refueling, and modifying SSCs.
The regulations in 10 CFR 50.34, "Content of applications; technical information," require that every applicant for an operating license include information in its Final Safety Analysis Report on the managerial and administrative controls to be used to ensure safe operation. The information on the controls shall also include a discussion on how the applicable requirements of Appendix B will be satisfied.
2

The regulations in 10 CFR 50.54 require each power plant subject to the requirements of Appendix B to implement a QA program and 10 CFR 50.54(a)(4) require licensees to submit to the NRC, changes to their QA Program that reduce commitments.
The regulations in 10 CFR Part 71, Subpart H, establishes the quality assurance requirements applying to design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, and modification of components of packaging that are important to safety.
The regulations in 10 CFR Part 72, Subpart G, establishes the quality assurance requirements that apply to design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, modification of SSCs, and decommissioning that are important to safety.
3.0      EVALUATION The request for review and approval of the Vermont Yankee QAPM, considered a reduction in commitment, was submitted by the February 4, 2016, letter, in accordance with the provisions of 10 CFR 50 .54(a)(4). The letter included Revision 4 to the QAPM (provided in Enclosure 2 thereto).
In evaluating the adequacy of the revisions to the QAPM, the NRC staff used the guidance contained in NUREG-0800, "Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants," Section 17.3, "Quality Assurance Program Description," dated August 1990 (ADAMS Accession No. ML052350376), hereafter referred to as Section 17.3, which provides acceptance criteria for quality assurance program descriptions.
The changes made to the QAPM Revision 4 include the following:
: a. Changes to the policy statement and QAPM involving limiting the application of the QAPM to safety related and important to safety SSCs. In the proposed change, the QAPM is only applicable to safety related SSCs, important to safety SSCs controlled by 10 CFR 72 and transportation packages controlled by 10 CFR 71 . The applicability to other items and activities will be determined on a case-by-case basis and controlled by approved procedures. Limiting the application of the QAPM to safety related and important to safety SSCs is adequate after cessation of power operations. The staff determined these changes continue to meet the guidance of NUREG-0800, Section 17.3, and, therefore, meet the requirements of Appendix B.
: b. Changes involving removing the need for maintaining NRC Licensed Operators as part of the site organization. Upon the certification of the end of reactor operations, the 10 CFR Part 50 license no longer authorizes operation of the reactor or placement or retention of fuel into the reactor vessel. 10 CFR 50.54(m) is not applicable to a facility that has permanently ceased operations; therefore there are no longer requirements to maintain NRC Licensed Operators at a decommissioning facility . The staff determined 3

the change regarding NRC Licensed Operators is not considered to be a reduction in commitment.
: c. Changes made in response to the Request for Additional Information (RAI) (ADAMS Accession No. ML16090A029) issued on April 5, 2016, included in Entergy's response letter (ADAMS Accession ML16126A579) dated May 5, 2016. The RAI requested clarification on the Certified Fuel Handler Training Program under which non-licensed operators will be qualified. In response, Entergy included a statement in Revision 4 of the QAPM that stated Certified Fuel Handlers shall be qualified in accordance with Vermont Yankee Nuclear Power Station's (VYPS's) technical specification. The VYPS technical specification references an NRC approved training and retraining program for Certified Fuel Handlers, in accordance with 10 CFR 50.2. The proposed changes, upon implementation, will ensure that personnel achieve and maintain suitable proficiency through established training programs. The staff determined these changes continue to meet the guidance of NUREG-0800, Section 17.3, and, therefore, meet the requirements of Appendix 8.
: d. Changes involving adding an exception to American National Standards Institute (ANSI) and American Nuclear Society (ANS) 3.1-1978 to allow nuclear power plant experience to include experience acquired at a defueled reactor site, directly related to the storage or handling of spent fuel in a spent fuel pool. The QAPM also states individuals will obtain the necessary onsite experience to fill the position of Certified Fuel Handlers or operators, based on assigned functions and validation of equivalent training and experience rather than requiring at least 6 months of nuclear power plant experience to be attained at Vermont Yankee. The proposed exemption to ANSI/ANS 3.1-1978, when implemented, ensures personnel performing activities affecting quality achieve and maintain suitable proficiency. The staff determined these changes continue to meet the guidance of NUREG-0800, Section 17.3, and, therefore, meet the requirements of Appendix 8 .
: e. Changes involving transitioning the onsite-review function to an independent review function and modifying the function of the off-site safety review to reflect the complexity of operations for a decommissioning facility. The proposed changes to the QAPM include a description of the independent safety review and safety review committee organizational structure, functional responsibilities, level of authorities and interfaces.
The proposed organizational changes provide sufficient authority and organizational freedom. The staff determined these changes continue to meet the guidance of NUREG-0800, Section 17.3, and, therefore, meet the requirements of Appendix 8.

==4.0      CONCLUSION==

The NRC staff used the acceptance criteria of SRP Section 17.3 as the basis for evaluating the acceptability of the changes to the Entergy Vermont Yankee QAPM in conformance with the applicable portions of Appendix 8 to 10 CFR Part 50. The program description adequately describes the provisions to meet the requirements of Appendix 8 . The NRC staff concludes that the proposed Vermont Yankee QAPM Revision 4 follows the NRC guidance contained within, 4

and conforms to the format of NUREG-0800, Section 17.3, complies with Appendix B to 10 CFR Part 50 requirements for the QA program and is, therefore, acceptable.

==5.0    REFERENCES==
: 1. NUREG-0800, "Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants," Section 17.3, "Quality Assurance Program Description" dated August 1990 (ADAMS Accession No. ML052350376)
: 2. RG 1.28, "Quality Assurance Program Requirements (Design and Construction)"
Revision 4, dated June 2010 (ADAMS Accession No. ML100160003)
: 3. Perito, Michael, Entergy Nuclear Operations, Inc. letter to the U.S. Nuclear Regulatory Commission, "Entergy Vermont Yankee Quality Assurance Program Manual Yankee Nuclear Power Station Docket 50-271, License No. DPR -28, Docket No. 72-59," dated February 4, 2016 (ADAMS Accession No. ML16035A506)
: 4.      Parrott, Jack D., U.S. Nuclear Regulatory Commission, letter to Mr. Michael Perito, Entergy Nuclear Operations, Inc., "Request for Additional Information Related to Proposed Changes to Quality Assurance Program Manual, Vermont Yankee Nuclear Power Station (CAC No. L53120)," dated April 5, 2016 (ADAMS Accession No, ML16090A029)
: 5.      Perito, Michael, Entergy Nuclear Operations, Inc. letter to the U.S. Nuclear Regulatory Commission, "Response to Request for Additional Information Pertaining to a Change to Entergy Vermont Yankee Quality Assurance Program Manual (VY QAPM)," dated May 5, 2016 (ADAMS Accession No. ML16126A579)
: 6.      American National Standards Institute (ANSI) and American Nuclear Society (ANS), ANSI/ANS 3.1, "Selection and Training of Nuclear Power Plant Personnel," La Grange Park, IL, 1978.
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