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Category:Quality Assurance Program
MONTHYEARPNP 2024-030, Update Report for Holtec Decommissioning International Fleet Decommissioning Quality Assurance Program Rev. 3 and Palisades Transitioning Quality Assurance Plan, Rev 02024-08-0202 August 2024 Update Report for Holtec Decommissioning International Fleet Decommissioning Quality Assurance Program Rev. 3 and Palisades Transitioning Quality Assurance Plan, Rev 0 ML22215A1772022-08-0303 August 2022 Decommissioning International (HDI) Proposed Revisions to the Quality Assurance Program Approval Forms for Radioactive Material Packages ML20297A2382020-10-22022 October 2020 Fleet DQAP RAIs - Enclosure ML20297A2372020-10-22022 October 2020 Request for Additional Information - HDI Fleet Decommissioning Quality Assurance Program L-20-019, Request for Approval of HDI Fleet Decommissioning Quality Assurance Program, Revision 02020-08-27027 August 2020 Request for Approval of HDI Fleet Decommissioning Quality Assurance Program, Revision 0 ML19227A0442019-08-14014 August 2019 Request to Transfer the Quality Assurance Program Approval Form for Radioactive Material Packages ML19120A2152019-04-30030 April 2019 Submittal of the Entergy Pilgrim Quality Assurance Program Manual (QAPM) Pilgrim Nuclear Power Station (PNPS) ML19094B0782019-04-0303 April 2019 Entergy - 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 JAFP-19-0016, Summary of Changes to Quality Assurance Topical Report, NO-AA-10, and Decommissioning Quality Assurance Program, NO-DC-102019-02-0808 February 2019 Summary of Changes to Quality Assurance Topical Report, NO-AA-10, and Decommissioning Quality Assurance Program, NO-DC-10 ML18099A3672018-04-0909 April 2018 Entergy Nuclear Operations, Inc., 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 ML18141A6902018-03-0707 March 2018 Appendix F - Annual 2017 Quality Assurance Report RA-18-008, Summary of Changes to Quality Assurance Topical Report, NO-AA-102018-02-0808 February 2018 Summary of Changes to Quality Assurance Topical Report, NO-AA-10 RA-17-076, Request for Approval of Decommissioning Quality Assurance Program, Revision 0 for Oyster Creek Nuclear Generating Station2017-11-30030 November 2017 Request for Approval of Decommissioning Quality Assurance Program, Revision 0 for Oyster Creek Nuclear Generating Station ML17109A4872017-04-10010 April 2017 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 10CFR72 Subpart G RA-16-007, Summary of Changes to Quality Assurance Topical Report, NO-AA-10, Revision 88, 89 and 902016-02-0808 February 2016 Summary of Changes to Quality Assurance Topical Report, NO-AA-10, Revision 88, 89 and 90 CNRO-2015-00023, Request for Approval of Change to the Entergy Quality Assurance Program Manual (QAPM)2015-11-0606 November 2015 Request for Approval of Change to the Entergy Quality Assurance Program Manual (QAPM) CNRO-2015-00012, Arkansas, Units 1 & 2, Grand Gulf, River Bend, Waterford, Unit 3, Indian Point, Units 1, 2, & 3, Pilgrim, James A. FitzPatrick, Big Rock, Palisades - Submittal of Revision of Quality Assurance Program Manual2015-04-30030 April 2015 Arkansas, Units 1 & 2, Grand Gulf, River Bend, Waterford, Unit 3, Indian Point, Units 1, 2, & 3, Pilgrim, James A. FitzPatrick, Big Rock, Palisades - Submittal of Revision of Quality Assurance Program Manual RA-14-010, Summary of Changes to Exelon Generation Company,Llc, Quality Assurance Topical Report, NO-AA-102014-02-0606 February 2014 Summary of Changes to Exelon Generation Company,Llc, Quality Assurance Topical Report, NO-AA-10 CNRO-2013-00007, Annual Report for Quality Assurance Program Manual Changes Under 10 CFR 50.54(a) and 10 CFR 72.140(d) Notification of Application of Approved Appendix B to 10 CFR 72 Subpart G2013-04-26026 April 2013 Annual Report for Quality Assurance Program Manual Changes Under 10 CFR 50.54(a) and 10 CFR 72.140(d) Notification of Application of Approved Appendix B to 10 CFR 72 Subpart G CNRO-2012-00009, Entergy Responses to Request for Additional Information Regarding Changes to the Quality Assurance Program Manual & Associated Plant Technical Specifications Re Staff Qualifications2012-11-20020 November 2012 Entergy Responses to Request for Additional Information Regarding Changes to the Quality Assurance Program Manual & Associated Plant Technical Specifications Re Staff Qualifications CNRO-2012-00003, Annual Report for Quality Assurance Program Manual Changes Under 10CFR50.54(a)(3) and 10CFR72.140(d) Notification of Application of Approved Appendix B to 10CFR72 Subpart G2012-04-30030 April 2012 Annual Report for Quality Assurance Program Manual Changes Under 10CFR50.54(a)(3) and 10CFR72.140(d) Notification of Application of Approved Appendix B to 10CFR72 Subpart G RA-12-006, Summary of Changes to Exelon Generation Company, LLC, Quality Assurance Topical Report, NO-AA-102012-02-0606 February 2012 Summary of Changes to Exelon Generation Company, LLC, Quality Assurance Topical Report, NO-AA-10 CNRO-2011-00006, Request for Approval of Change to the Entergy Quality Assurance Program Manual (QAPM) and Associated Plant Technical Specifications Regarding Staff Qualifications2011-12-13013 December 2011 Request for Approval of Change to the Entergy Quality Assurance Program Manual (QAPM) and Associated Plant Technical Specifications Regarding Staff Qualifications RA-10-050, Technical Specification Change Request No. 340, Proposed Revision to Appendix B Environmental Technical Specifications of the Facility Operating License2010-06-11011 June 2010 Technical Specification Change Request No. 340, Proposed Revision to Appendix B Environmental Technical Specifications of the Facility Operating License CNRO-2010-00002, Entergy Nuclear Operations, Inc., Annual Report for Quality Assurance Program Manual Changes Under 10CFR50.54(a)(3) and 10CFR72.140(e) Notification of Application of Approved Appendix B to 10CFR72 Subpart G2010-04-29029 April 2010 Entergy Nuclear Operations, Inc., Annual Report for Quality Assurance Program Manual Changes Under 10CFR50.54(a)(3) and 10CFR72.140(e) Notification of Application of Approved Appendix B to 10CFR72 Subpart G RA-10-001, Submittal of Exelon Generation Company, LLC, Quality Assurance Topical Report, NO-AA-10, Revision 842010-02-0505 February 2010 Submittal of Exelon Generation Company, LLC, Quality Assurance Topical Report, NO-AA-10, Revision 84 CNRO-2009-00006, Entergy Operations, Inc., Annual Report for Quality Assurance Program Manual Changes Under 10CFR50.54(a)(3) and 10CFR72.140(e) Notification of Application of Approved Appendix B to 10CFR72 Subpart G2009-04-13013 April 2009 Entergy Operations, Inc., Annual Report for Quality Assurance Program Manual Changes Under 10CFR50.54(a)(3) and 10CFR72.140(e) Notification of Application of Approved Appendix B to 10CFR72 Subpart G ML0817603042008-06-16016 June 2008 Amergen Energy Company, LLC Quality Assurance Topical Report, NO-AA-10, Revision 81 ENOC-08-00024, Annual Report for Quality Assurance Program Manual Changes Under 10 CFR 50.54(a)(3) and 10 CFR 72.140(e) Notification of Application of Approved Appendix B to 10 CFR 72 Subpart G2008-04-23023 April 2008 Annual Report for Quality Assurance Program Manual Changes Under 10 CFR 50.54(a)(3) and 10 CFR 72.140(e) Notification of Application of Approved Appendix B to 10 CFR 72 Subpart G ML0904103222008-04-15015 April 2008 Entergy'S Quality Assurance Program Manual, Revision 18; Effective: April 15, 2008 RA-08-006, Submittal of Exelon Generation Company, LLC and Amergen Energy Company, LLC Quality Assurance Topical Report, NO-AA-10, Revision 802008-02-0606 February 2008 Submittal of Exelon Generation Company, LLC and Amergen Energy Company, LLC Quality Assurance Topical Report, NO-AA-10, Revision 80 ML0732400402007-11-13013 November 2007 Technical Specification Request No. 336 and Three Mile Island Technical Specification Change Request No. 330 Deletion of Technical Specification Requirements for Review and Audit, and Additional Administrative Changes ENOC-07-00020, Entergy Nuclear Operations, Inc., Annual Report for Quality Assurance Program Manual Changes, Revision 162007-06-15015 June 2007 Entergy Nuclear Operations, Inc., Annual Report for Quality Assurance Program Manual Changes, Revision 16 ML0610404932006-04-10010 April 2006 Quality Assurance Topical Report (QATR) NO-AA-10 Revision 77 CNRO-2005-00024, Entergy Quality Assurance Program Manual, Revision 122005-04-0606 April 2005 Entergy Quality Assurance Program Manual, Revision 12 ML0321706062003-07-24024 July 2003 Changes to Quality Assurance Program Description for Pilgrim Nuclear Power Station ML0312600022003-04-24024 April 2003 Issuance of Entergy Quality Assurance Program Manual (Qapm), Revision 8 CNRO-2003-00013, Entergy Quality Assurance Program Manual, Revision 82003-04-24024 April 2003 Entergy Quality Assurance Program Manual, Revision 8 ML0212805922002-04-25025 April 2002 Entergy Nuclear South Quality Assurance Program Manual, Revision 7 RS-02-071, Request for Approval of Quality Assurance Program Changes for Exelon Generation Company, LLC, and Amergen Energy Company, LLC, Nuclear Power Plants2002-04-0909 April 2002 Request for Approval of Quality Assurance Program Changes for Exelon Generation Company, LLC, and Amergen Energy Company, LLC, Nuclear Power Plants 2024-08-02
[Table view] Category:Request for Additional Information (RAI)
MONTHYEARML24284A1962024-10-16016 October 2024 Enclosure 1 Revised Request for Supplemental Information ML24284A2032024-10-16016 October 2024 Enclosure 2 Revised Pending Request for Additional Information ML24269A0492024-10-0404 October 2024 Enclosure 1, Oyster Creek Nuclear Generating Station, License Amendment Request, License Termination Plan, Request for Supplemental Information ML24269A0462024-10-0404 October 2024 Cover Letter for Oyster Creek Nuclear Generating Station, License Amendment Request, License Termination Plan, Acceptance Review Request for Additional Information ML21223A2422021-08-16016 August 2021 Enclosure - Pilgrim Nuclear Power Station - Request for Additional Information Regarding Pilgrim - License Amendment Request Independent Spent Fuel Storage Installation Only Emergency Plan ML21161A1072021-07-0909 July 2021 Request for Additional Information Regarding Pilgrim License Amendment Request ISFSI Only Emergency Plan ML21099A0442021-04-0808 April 2021 Enclosure - Request for Additional Information Related to Request for Approval of Oyster Creek Nuclear Generating Station Independent Spent Fuel Storage Installation Only Emergency Plan Holtec Decommissioning International, LLC ML21013A5232021-01-15015 January 2021 Request for Additional Information Regarding the Request to Change the Physical Security Plan - Alternative Measures ML20335A3102020-11-30030 November 2020 RAI November 2020 Part 73 FOF Exemption Request ML20297A2372020-10-22022 October 2020 Request for Additional Information - HDI Fleet Decommissioning Quality Assurance Program ML20297A2382020-10-22022 October 2020 Fleet DQAP RAIs - Enclosure ML20142A2422020-05-26026 May 2020 Acceptance of Requested Licensing Action Physical Security Plan Revision and License Amendment Request to Incorporate Additional Independent Spent Fuel Storage Installation with Requests for Additional Information ML20134H8732020-05-12012 May 2020 E-mail - Request for Additional Information: Oyster Creek Request for Temporary Exemption from Part 73, Appendix B Requirements ML20280A1912020-04-17017 April 2020 Request for Additional Information- Clarifying Information for Pilgrim ISFSI Physical Security Amendment Application ML19263D2142019-09-20020 September 2019 Hdi PSDAR Environmental RAI Enclosure (002) ML19207B3662019-07-26026 July 2019 NRR E-mail Capture - Pilgrim - RAI Direct and Indirect Transfer of Lic.; Conforming Lic. Amend.; Req. for Exemption 10 CFR 50.82(A)(8)(I)(A) for Holtec Decom. International, Llc ML19154A5242019-06-0303 June 2019 NRR E-mail Capture - RAI - Pilgrim Post-Decommissioning Technical Specifications (PDTS) License Amendment Request (LAR) ML19158A2772019-05-28028 May 2019 NRR E-mail Capture - Oyster Creek ESA Consultation: Information Requests from NMFS ML19086A3492019-03-21021 March 2019 NRR E-mail Capture - Pilgrim Power Station - Request for Additional Information Application for Order Consenting to Direct and Indirect Transfers of Control of Licenses and Approving Conforming License Amendment (EPID: L-2018-LL0-0003) ML19036A6512019-02-0404 February 2019 NRR E-mail Capture - RAI - Pilgrim EP Exemption ML19025A1172019-01-24024 January 2019 NRR E-mail Capture - for Your Action - RAI for Oyster Creek EP Exemption (Change to Adiabatic Heat-Up Calculation) ML18320A1292018-11-16016 November 2018 NRR E-mail Capture - Request for Additional Information (RAI) - Pilgrim Post-Decommissioning Technical Specifications (PDTS) License Amendment Request (LAR) ML18323A1192018-11-15015 November 2018 CAL 5 Document Request #2 ML18317A2202018-11-11011 November 2018 NRR E-mail Capture - (External_Sender) Questions and Comments Regarding Pilgrim EP Exemption RAI, October 16, 2018 ML18317A2192018-11-0808 November 2018 NRR E-mail Capture - (External_Sender) RAI EP 11.06.18-Question ML18310A0212018-11-0606 November 2018 NRR E-mail Capture - RAI - Pilgrim EP Exemption ML18289A4072018-10-16016 October 2018 NRR E-mail Capture - RAIs - Pilgrim EP Exemption ML18285A8182018-10-12012 October 2018 NRR E-mail Capture - for Your Action: RAIs - Pilgrim - LAR - EP and EAL Scheme to Address Permanently Defueled Condition ML18256A0022018-09-12012 September 2018 NRR E-mail Capture - for Your Action: RAIs for Oyster Creek Post Shutdown Decommissioning Activities Report (PSDAR) ML18135A0732018-05-15015 May 2018 NRR E-mail Capture - RAIs - Oyster Creek - Request Approval of the Decommissioning Quality Assurance Program ML18124A1392018-05-0404 May 2018 NRR E-mail Capture - RAI - Pilgrim ERO Staffing License Amendment Request ML18094B0922018-04-0505 April 2018 Enclosurequest for Additional Information (Letter to B. S. Ford RAI Regarding Entergy Operations, Inc.'S Decommissioning Funding Plan Update for ISFSI Docket Nos.: 72-43, 72-51, 72-1044, 72-07, 72-12, and 72-59) ML18068A6582018-03-0909 March 2018 NRR E-mail Capture - RAIs - Oyster Creek Defueled TS LAR ML18067A1482018-03-0808 March 2018 Enclosurequest for Additional Information (Letter to P. R. Simpson Request for Additional Information Regarding Exelon Generating Company, Llc'S Decommissioning Funding Plan Update for Independent Spent Fuel Storage Installation) ML18024B0642018-01-24024 January 2018 NRR E-mail Capture - for Your Action - RAI for Oyster Creek Permanently Defueled EP and EAL Scheme LAR (CAC No. MG0160; EPID: L-2017-LLA-0307) ML18012A0782018-01-12012 January 2018 NRR E-mail Capture - for Your Review - Draft RAI for Oyster Creek Permanently Defueled EP and EAL Scheme LAR (CAC No. MG0160; EPID: L-2017-LLA-0307) ML18005A5422018-01-0505 January 2018 NRR E-mail Capture - Second Round of RAI for DAEC Fifth Inservice Inspection Interval Program Plan, Relief Request RR-03 - EPID: L-2017-LLR-0110 ML18003A4122018-01-0303 January 2018 NRR E-mail Capture - for Your Action - RAI - Oyster Creek BWRVIP LAR (CAC No. MG0180; EPID No. L-LLA-2017-0304) ML17320A6372017-11-16016 November 2017 NRR E-mail Capture - Oyster Creek Nuclear Generating Station - Request for Additional Information Regarding License Amendment Request for Emergency Plan Exemption (CAC No. MG0153; EPID L-2017-LLE-0020) ML17319A9422017-11-15015 November 2017 NRR E-mail Capture - Oyster Creek Nuclear Generating Station - Request for Additional Information Regarding License Amendment Request for Emergency Plan Exemption (CAC No. MG0153; EPID L-2017-LLE-0020) ML17208A7472017-09-14014 September 2017 Request for Additional Information, License Amendment Request to Revise the Site Emergency Plan for On-Shift and Emergency Response Organization Staffing for Permanently Defueled Condition ML17136A3852017-05-12012 May 2017 NRR E-mail Capture - (External_Sender) Oyster Creek Response to NRC Flood MSA Audit Review Questions ML17038A5152017-02-0303 February 2017 NRR E-mail Capture - (External_Sender) Oyster Creek Nuclear Generating Station Response to Environmental Questions Regarding the Mitigating Strategies Final Integrated Plan and SPF Instrumentation Compliance Letter ML16347A0042016-12-0909 December 2016 NRR E-mail Capture - Pilgrim: Request for Additional Information for Relief Requests on Volumetric Exam Requirements, PNPS-ISI-001, 002 and 003 ML16244A3112016-10-0707 October 2016 Request for Additional Information Regarding License Amendment Request for Technical Specifications Section 6.0, Administrative Controls for Permanently Defueled Condition ML16125A2452016-05-16016 May 2016 Request for Additional Information Regarding Request for Approval of a Certified Fuel Handler Training and Retraining Program ML16060A1722016-03-0707 March 2016 Request for Additional Information Regarding Preliminary Decommissioning Cost Estimate and Spent Fuel Management Program ML16056A0012016-02-24024 February 2016 NRR E-mail Capture - Request for Additional Information - Oyster Creek Security Plan - Revision 14 ML16013A0642016-01-13013 January 2016 NRR E-mail Capture - Request for Additional Information Entergy CNRO-2015-00023 - Revision to Entergy Quality Assurance Program Manual (Fleet Submittal CAC Nos. MF7086-MF7097) ML15341A1662015-12-0707 December 2015 NRR E-mail Capture - Entergy Fleet RR-EN-15-1, Request for Additional Information (CACs MF6341-MF6349) 2024-10-04
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REQUEST FOR ADDITIONAL INFORMATION RELATED TO REQUEST FOR APPROVAL OF HDI FLEET DECOMMISSIONING QUALITY ASSURANCE PROGRAM, REVISION 0 OYSTER CREEK NUCLEAR GENERATING STATION PILGRIM NUCLEAR POWER STATION HOLTEC DECOMMISSIONING INTERNATIONAL, LLC DOCKET NOS. 50-219, 50-293, 72-15, 72-1044 By letter dated August 27, 2020 (Agencywide Documents Access and Management System Accession No. ML20240A342), Holtec Decommissioning International (HDI) submitted an application seeking U.S. Nuclear Regulatory Commission (NRC) review and approval of Revision 0 of the Decommissioning Quality Assurance Program (DQAP) for the HDI fleet, in accordance with the provisions of Title 10 of the Code of Federal Regulations (10 CFR) paragraph 50.54(a)(4). The proposed Fleet DQAP provides for the transition of the individual site-specific DQAPs currently in use at Oyster Creek Nuclear Generating Station (Oyster Creek) and Pilgrim Nuclear Power Station (PNPS) to a fleet-based DQAP.
The NRC staff has reviewed HDI's submittal and determined that additional information is required to NRC staff to make an independent assessment regarding its technical review.
Question 1:
Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities, Criterion I, in part, states that The persons and organizations performing quality assurance functions shall have sufficient authority and organizational freedom to identify quality problems; to initiate, recommend, or provide solutions; and to verify implementation of solutions. The persons and organizations performing quality assurance functions shall report to a management level so that the required authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations, are provided. of the submittal included a list of changes that detail the changes between the proposed Fleet DQAP (Enclosure 1), Oyster Creek DQAP (Enclosure 3) and PNPS DQAP (Enclosure 4). In Section 1.1 of this table, the licensee states that The Fleet DQAP Station Management Section does not include the PNPS site Quality Assurance Manager position and responsibilities. In the Fleet DQAP, the management position responsible for Nuclear Oversight is part of the corporate organization. It further states that "Not including in the Fleet DQAP, the Quality Assurance Manager position and associated responsibilities from the Station Management Section of the PNPS DQAP, is a reduction in commitment since there is no longer a requirement for a Quality Assurance Manager permanently stationed at the PNPS site. This change is a reduction in commitment and requires NRC approval prior to implementation in accordance with 10 CFR 50.54(a)(4). This change does not reduce the overall effectiveness of
the DQAP. Site Quality assurance personnel will report to a Manager at the Corporate level with a reporting chain up through the Chief Nuclear Officer.
Section 1.3.1 of the PNPS DQAP states that The Pilgrim Nuclear Power Station (PNPS) site Quality Assurance Manager is responsible for site execution of the PNPS quality assurance program. This position has overall authority and responsibility for establishing, controlling and verifying the implementation and adequacy of the quality assurance program as described in this DQAP under the direction of the HDI Vice President of Quality Assurance. This position has the authority and responsibility to escalate matters directly to the highest-level nuclear executive of HDI if necessary.
It is unclear to the staff that how the elimination of a site Quality Assurance Manager will not reduce the overall effectiveness of the DQAP. Therefore, the licensee is requested to provide additional information for the following:
a) Without a site QA Manager, who would be the point of contact between the site QA personnel and Corporate? Whom, in the Corporate level, will site QA personnel report to?
b) Who would resume the overall responsibilities that a site QA Manager would have, such as establishing, controlling, and verifying the implementation and adequacy of the QA program to ensure that the QA program is still in compliance with the requirement delineated in Appendix B to 10 CFR Part 50?
c) Who, on site, would have authority and responsibility to escalate matters directly to the highest level nuclear executive of HDI if necessary?
d) In addition, Section 1.2.3 of the proposed Fleet DQAP details the functional responsibilities of the HDI Vice President Quality Assurance and Nuclear Oversight.
Similar language is found in Section 1.2.1 of the Oyster Creek DQAP for a management position responsible for Nuclear Oversight. However, two of the responsibilities, 1) assuring quality activities are performed in accordance with implementing procedures, and 2) Employee Concern Program, are not included in the proposed Fleet DQAP.
Therefore, the licensee is requested to provide information on who would be responsible for 1) assuring quality activities are performed in accordance with implementing procedures, and 2) Employee Concerns Program.
Question 2:
Appendix B to 10 CFR Part 50, Criterion I, in part, states that The persons and organizations performing quality assurance functions shall have sufficient authority and organizational freedom to identify quality problems; to initiate, recommend, or provide solutions; and to verify implementation of solutions. The persons and organizations performing quality assurance functions shall report to a management level so that the required authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations, are provided. Because of the many variables involved, such as the number of personnel, the type of activity being performed, and the location or locations where activities are performed, the organizational structure for executing the quality assurance program may take various forms, provided that the persons and organizations assigned the quality assurance functions have the required authority and organizational freedom.
Section 2.5.1 of both the Oyster Creek DQAP and PNPS DQAP state that The management position responsible for Nuclear Oversight (or the HDI VP Quality and Nuclear Oversight) is responsible for ensuring that the applicable portions of the DQAP are properly documented, approved and implemented before an activity within the scope of the DQAP is executed.
Disputes arising between departments or organizations on any QA matter that cannot be resolved at a lower level of management will be referred to the CNO [Chief Nuclear Officer].
Similar language is found in Section 2.5.1 of the proposed Fleet DQAP. However, the proposed Fleet DQAP does not provide details how disputes arising between departments or organizations on any QA matters will be resolved.
It is unclear to the staff that should disputes arise on any QA matter between departments or organizations, how would these disputes be resolved and who will have the authority to decide on these disputes. Therefore, the licensee is requested to provide additional information on how QA matters will be resolved when disputes arise between departments or organizations, and who will have the final authority when disputes arise.
Question 3:
Appendix B to 10 CFR Part 50, Criterion I, in part, states that the applicant may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or any part thereof, but shall retain responsibility for the quality assurance program.
Section 5.3 of the Oyster Creek DQAP and PNPS DQAP both state that Controls are established which ensure that instructions, procedures, and drawings are current and accurately reflect plant design and regulatory requirements. Documents comprising of instructions, procedures, specifications, and drawings prepared by outside contractors for the performance of site activities are reviewed and approved by the responsible manager or designated representative. Section 5.3 of the proposed Fleet DQAP has similar language; however, it does not have any specific instructions for documents prepared by outside contractors and how these documents are reviewed and approved, and who is responsible for the accuracy of these documents.
Section 1.2.1 of the Fleet DQAP delineates that the HDI Chief Operating Officer (COO) has the overall responsibility for the safety, operation, and decommissioning of the nuclear sites. This position is responsible for providing management direction, oversight and support to the site organizations and for setting and implementing policies, objectives, expectations, and priorities to ensure activities are performed in accordance with the DQAP and other requirements.
It is unclear to the staff how documents prepared by outside contractors are reviewed and approved. Therefore, the licensee is requested to provide additional information regarding documents such as instructions, procedures, specifications, and drawings prepared by outside contractors, how these documents are reviewed and approved, and who has the overall responsibility for the accuracy of these documents.
Question 4:
Appendix B to 10 CFR Part 50, Criterion VII, in part, states that Measures shall be established to assure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents. These measures shall include provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery. Documentary evidence that material and equipment conform to the procurement requirements shall be available at the nuclear power plant or fuel reprocessing plant site prior to installation or use of such material and equipment. This documentary evidence shall be retained at the nuclear power plant or fuel reprocessing plant site and shall be sufficient to identify the specific requirements, such as codes, standards, or specifications, met by the purchased material and equipment.
Section 7.2 of both the Oyster Creek DQAP and PNPS DQAP state that Verification that a vendor can meet the specified technical and quality requirements shall be documented. HDI maintains an Approved Vendor List (AVL) for those vendors qualified to perform safety significant work that are audited on a triennial basis. Documented vendor performance monitoring is performed in accordance with approved procedures as an acceptable alternate to the performance of the annual evaluation of vendors. The evaluated list of such vendors is described in controlling procedures for the appropriate safety significant classification except for procurement from other licensees that have an NRC approved quality program. Vendors of commercial grade calibration and testing services may be qualified based on their accreditation by a nationally-recognized accrediting body, as an alternative to qualification by vendor audit, commercial grade survey, or in-process surveillance as described below.
Section 7.2 of the proposed Fleet DQAP states that Verification that a vendor can meet the specified technical and quality requirements shall be documented. HDI maintains an Approved Vendor List (AVL) for those vendors qualified to perform safety significant work. The qualification requirements for vendors on the AVL are described in controlling procedures.
Vendor qualification processes use a graded approach based on the qualification level of the vendor.
It is unclear to the staff what is this graded approach for vendor qualification processes as stated in the proposed Fleet DQAP. Therefore, the licensee is requested to provide additional information and describe what is this graded approach for vendor qualification process.
Specifically, what measures, including documentary evidence, are in place to assure that purchased material, equipment, and services, conform to the procurement documents.