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Category:Letter
MONTHYEARULNRC-06853, Submittal of 2023 Fitness for Duty Performance Data Per Per 10 CFR 26.7172024-01-29029 January 2024 Submittal of 2023 Fitness for Duty Performance Data Per Per 10 CFR 26.717 IR 05000483/20230042024-01-19019 January 2024 Integrated Inspection Report 05000483/2023004 ML24008A0552024-01-19019 January 2024 Acceptance of Requested Licensing Action - Proposed Alternative to the Requirements of the ASME Code (EPID L-2023-LLR- 0061) ML23353A1712024-01-18018 January 2024 Issuance of Amendment No. 237 to Clarify Support System Requirements for the Residual Heat Removal System and Control Room Air Conditioning System Under Technical Specifications 3.4.8, 3.7.11, and 3.9.6 ML23317A0012024-01-12012 January 2024 Audit Summary Regarding LAR to Clarify Support System Requirements for the Residual Heat Removal and Control Room Air Conditioning System Under Technical Specifications 3.4.8, 3.7.11, and 3.9.6 ML23347A1212024-01-11011 January 2024 Issuance of Amendment No. 236 to Adopt TSTF-501, Revision 1, Relocate Stored Fuel Oil and Lube Volume Values to Licensee Control EPID L-2023-LLA-0046) ML24011A1492024-01-11011 January 2024 Notification of Post-Approval Site Inspection for License Renewal and Request for Information (05000483/2024011) ULNRC-06847, Supplement to Relief Request from Requirements of ASME BPV Code, Section XI, Subsection Iwl Regarding Examination and Testing of the Unbonded Post-Tensioning System (Relief Request C3R-01)2023-12-21021 December 2023 Supplement to Relief Request from Requirements of ASME BPV Code, Section XI, Subsection Iwl Regarding Examination and Testing of the Unbonded Post-Tensioning System (Relief Request C3R-01) ULNRC-06849, License Renewal Resolution for Commitments 34 and 35 Perform Evaluation of Crack Initiation and Propagation in Steam Generator Divider Plate and Tube-To-Tubesheet Welds2023-12-20020 December 2023 License Renewal Resolution for Commitments 34 and 35 Perform Evaluation of Crack Initiation and Propagation in Steam Generator Divider Plate and Tube-To-Tubesheet Welds ML23346A0392023-12-14014 December 2023 Supplemental Information Needed for Acceptance of Requested Licensing Action Request for Relief from Requirements of ASME Code, Section Xl, Examination and Testing Unbonded Post-Tensioning System ULNRC-06844, Request for Exemption from Specific Requirements in 2023 Security Rule, Enhanced Weapons, Firearms Background Checks, and Security Event Notification2023-12-0707 December 2023 Request for Exemption from Specific Requirements in 2023 Security Rule, Enhanced Weapons, Firearms Background Checks, and Security Event Notification 05000483/LER-2023-001, Submittal of LER 2023-001-00 for Callaway, Unit 1, Inoperable Instrument Tunnel Sump Level Indication Resulted in Condition Prohibited by Technical Specifications2023-11-29029 November 2023 Submittal of LER 2023-001-00 for Callaway, Unit 1, Inoperable Instrument Tunnel Sump Level Indication Resulted in Condition Prohibited by Technical Specifications ULNRC-06827, Supplement to License Amendment Request Regarding Support System Requirements for Residual Heat Removal and Control Room Air Conditioning Systems Under Technical Specifications 3.4.8, 3.7.11, and 3.9.6 (LDCN 22-0029)2023-11-20020 November 2023 Supplement to License Amendment Request Regarding Support System Requirements for Residual Heat Removal and Control Room Air Conditioning Systems Under Technical Specifications 3.4.8, 3.7.11, and 3.9.6 (LDCN 22-0029) IR 05000483/20230102023-11-15015 November 2023 NRC License Renewal Phase 1 Inspection Report 05000483 2023010 IR 05000483/20233012023-11-0909 November 2023 NRC Examination Report 05000483-2023301 ML23311A2082023-11-0909 November 2023 Reassignment of U.S. Nuclear Regulatory Commission Branch Chief in the Division of Operating Reactor Licensing for Plant Licensing Branch IV ML23297A2502023-11-0606 November 2023 Individual Notice of Consideration of Issuance of Amendment to Renewed Facility Operating License, Proposed No Significant Hazards Consideration Determination and Opportunity for a Hearing (EPID L-2022-LLA-0176) - Letter IR 05000483/20240122023-10-24024 October 2023 Information Request for the Cybersecurity Baseline Inspection, Notification to Perform Inspection (05000483/2024012) ML23293A2652023-10-24024 October 2023 3rd Quarter 2023 Integrated Inspection Report ML23240A3692023-10-0505 October 2023 Issuance of Amendment No. 235 to Revise Technical Specifications to Use of Framatome Gaia Fuel (EPID L-2022-LLA-0150) (Non-Proprietary) ML23234A1522023-10-0505 October 2023 Exemption from the Requirements of 10 CFR Part 50, Section 50.46, and Appendix K Regarding Use of M5 Cladding Material (EPID L-2022-LLE-0030) (Letter) ML23305A0942023-10-0202 October 2023 10-CW-2023-09 Post-Exam Submittal ML23270B9662023-09-27027 September 2023 10 CFR 50.55a(z)(I) Request for Relief from ASME OM Code Pump and Valve Testing Requirements for Fifth 120-Month Inservice Testing Interval ML23228A0252023-09-25025 September 2023 Issuance of Amendment No. 234 to Revise Technical Specification 5.5.16, Containment Leakage Rate Testing Program, for Permanent Extension of Type a and Type C Leak Rate Test Frequencies ML23261C3852023-09-25025 September 2023 Safety Evaluation for Operating Quality Assurance Manual Revision 36A ML23166B0882023-09-20020 September 2023 Issuance of Amendment No. 233 for Adoption of Alternative Source Term and Revision of Technical Specifications ML23206A1992023-09-15015 September 2023 Regulatory Audit Summary Regarding License Amendment and Regulatory Exemptions Request for Fuel Transition to Framatome Gaia Fuel (Epids L-2022-LLA-0150 and L-2022-LLE-0030) IR 05000483/20234012023-09-13013 September 2023 NRC Security Baseline Inspection Report 05000483/2023401 ML23240A7572023-08-31031 August 2023 NRC Initial Operator Licensing Examination Approval 05000483/2023301 IR 05000483/20230052023-08-23023 August 2023 Updated Inspection Plan for Callaway Nuclear Power Plant, Unit 1 (Report 05000483/2023005) - Mid Cycle Letter 2023 ULNRC-06824, Response to Request for Additional Information Regarding Operating Quality Assurance Manual (Oqam) Revision 36A2023-08-17017 August 2023 Response to Request for Additional Information Regarding Operating Quality Assurance Manual (Oqam) Revision 36A ML23219A1392023-08-15015 August 2023 Request for Withholding Information from Public Disclosure ULNRC-06830, Transmittal of Updated Technical Specification Markup and Clean Pages for License Amendment Request to Revise Technical Specification 5.5.16, Containment Leakage Rate Testing Program, for Permanent Extension of Type a and Type C Leak2023-08-15015 August 2023 Transmittal of Updated Technical Specification Markup and Clean Pages for License Amendment Request to Revise Technical Specification 5.5.16, Containment Leakage Rate Testing Program, for Permanent Extension of Type a and Type C Leak ML23215A1972023-08-0303 August 2023 Supplement to License Amendment and Exemption Request Regarding Use of Framatome Gaia Fuel (LDCN 22-0002) ULNRC-06223, Minor Correction to License Amendment Request to Revise Technical Specification 5.5.16, Containment Leakage Rate Testing Program, for Permanent Extension of Type a and Type C Leak Rate Test Frequencies (LDCN 2020-0004)2023-07-25025 July 2023 Minor Correction to License Amendment Request to Revise Technical Specification 5.5.16, Containment Leakage Rate Testing Program, for Permanent Extension of Type a and Type C Leak Rate Test Frequencies (LDCN 2020-0004) ULNRC-06799, Submittal of Licensee Event Report 2022-003-01, Class 1E Electrical Air Conditioning System Thermal Expansion Valve Failure Resulted in Condition Prohibited by Technical Specifications2023-07-13013 July 2023 Submittal of Licensee Event Report 2022-003-01, Class 1E Electrical Air Conditioning System Thermal Expansion Valve Failure Resulted in Condition Prohibited by Technical Specifications IR 05000483/20230022023-07-10010 July 2023 Integrated Inspection Report 05000483/2023002 ML23174A1272023-06-23023 June 2023 Cw FFD Document Request List 2023 ML23171A9942023-06-22022 June 2023 Acceptance of Request for Approval of Operating Quality Assurance Manual Revision 36a ULNRC-06821, Post-Audit Follow-Up Information in Support of Callaway'S License Amendment Request and Proposed Exemption to Allow Use of Framatome Gaia Fuel (LDCN 22-0002) (EPID L-2022-LLA-0150 and EPID L-2022-LLE-00301)2023-06-21021 June 2023 Post-Audit Follow-Up Information in Support of Callaway'S License Amendment Request and Proposed Exemption to Allow Use of Framatome Gaia Fuel (LDCN 22-0002) (EPID L-2022-LLA-0150 and EPID L-2022-LLE-00301) IR 05000483/20230112023-06-15015 June 2023 Comprehensive Engineering Team Inspection (CETI) Inspection Report 05000483/2023011 ULNRC-06822, Additional Information Regarding Request for NRC Approval of Operating Quality Assurance Manual (Oqam) Revision 36a2023-06-14014 June 2023 Additional Information Regarding Request for NRC Approval of Operating Quality Assurance Manual (Oqam) Revision 36a ML23158A1462023-06-13013 June 2023 Notification of Post-Approval Site Inspection for License Renewal and Request for Information Inspection (05000483/2023010) ULNRC-06815, Request for NRC Approval of Operating Quality Assurance Manual, Revision 36a2023-06-0505 June 2023 Request for NRC Approval of Operating Quality Assurance Manual, Revision 36a ULNRC-06818, Response to Request for Additional Information Regarding License Amendment Request to Revise Technical Specification 5.5.16, Containment Leakage Rate Testing Program, for Permanent Extension of Type a and Type C Leak Rate .2023-06-0505 June 2023 Response to Request for Additional Information Regarding License Amendment Request to Revise Technical Specification 5.5.16, Containment Leakage Rate Testing Program, for Permanent Extension of Type a and Type C Leak Rate . ML23093A0952023-05-10010 May 2023 Issuance of Amendment No. 232 Regarding Technical Specification Changes for Spent Fuel Storage ULNRC-06816, Withdrawal of Previously Submitted Enclosures Regarding License Amendment Request for Adoption of Alternative Source Term and Revision of Technical Specifications (LDCN 21-0015)2023-05-0909 May 2023 Withdrawal of Previously Submitted Enclosures Regarding License Amendment Request for Adoption of Alternative Source Term and Revision of Technical Specifications (LDCN 21-0015) ML23129A7942023-05-0909 May 2023 Post-Audit Supplement to License Amendment Request and Exemption to Allow Use of Framatome Gaia Fuel (LDCN 22-0002) (Iepid L-2022-LLA-0150 and EPID L-2022-LLE-0030) ML23122A3172023-05-0808 May 2023 Review of the Spring 2022 Steam Generator Tube Inservice Inspections ML23118A3492023-05-0808 May 2023 Request for Withholding Information from Public Disclosure 2024-01-29
[Table view] Category:Safety Evaluation
MONTHYEARML23353A1712024-01-18018 January 2024 Issuance of Amendment No. 237 to Clarify Support System Requirements for the Residual Heat Removal System and Control Room Air Conditioning System Under Technical Specifications 3.4.8, 3.7.11, and 3.9.6 ML23347A1212024-01-11011 January 2024 Issuance of Amendment No. 236 to Adopt TSTF-501, Revision 1, Relocate Stored Fuel Oil and Lube Volume Values to Licensee Control EPID L-2023-LLA-0046) ML23234A1522023-10-0505 October 2023 Exemption from the Requirements of 10 CFR Part 50, Section 50.46, and Appendix K Regarding Use of M5 Cladding Material (EPID L-2022-LLE-0030) (Letter) ML23240A3692023-10-0505 October 2023 Issuance of Amendment No. 235 to Revise Technical Specifications to Use of Framatome Gaia Fuel (EPID L-2022-LLA-0150) (Non-Proprietary) ML23228A0252023-09-25025 September 2023 Issuance of Amendment No. 234 to Revise Technical Specification 5.5.16, Containment Leakage Rate Testing Program, for Permanent Extension of Type a and Type C Leak Rate Test Frequencies ML23261C3852023-09-25025 September 2023 Safety Evaluation for Operating Quality Assurance Manual Revision 36A ML23166B0882023-09-20020 September 2023 Issuance of Amendment No. 233 for Adoption of Alternative Source Term and Revision of Technical Specifications ML22361A0702023-02-24024 February 2023 Issuance of Amendment No. 231 for Revision to Radiological Emergency Response Plan Regarding Response and Notification Goals ML23019A1752023-01-30030 January 2023 Issuance of Amendment No. 230 to Revise Technical Specifications to Adopt TSTF-577, Revision 1, Revised Frequencies for Steam Generator Tube Inspections ML22301A0072022-12-0202 December 2022 Issuance of Amendment No. 229 to Revise Technical Specifications to Adopt TSTF-505, Revision 2, and TSTF-439, Revision 2 ML22220A1302022-10-21021 October 2022 Exemptions from the Requirements of 10 CFR 50.46 and 10 CFR Part 50 Appendix a, General Design Criteria 35, 38, and 41 (EPID L-2021-LLE-0021) (Cover Letter) ML22220A1322022-10-21021 October 2022 Issuance of Amendment No. 228 Re; Revise Technical Specifications to Address Generic Safety Isusue-191 and Respond to Generic Letter 2004-02 Using Risk-Informed Approach ML22053A2832022-04-0707 April 2022 Issuance of Amendment No. 227 Revise Technical Specifications to Adopt Technical Specifications Task Force (TSTF) Traveler TSTF-529, Revision 4, Clarify Use and Application Rules ML21344A0052021-12-29029 December 2021 Issuance of Amendment No. 226 Regarding Adoption of 10 CFR 50.69, Risk-Informed Categorization and Treatment of Structures, Systems and Components for Nuclear Power Plants ML21053A1262021-03-24024 March 2021 Issuance of Amendment No. 225 to Revise Technical Specification Administrative Control 5.3.1 to Remove Details Specified for the Qualification of Certain Positions within the Unit Staff ML20218A4102020-11-0303 November 2020 Issuance of Amendment No. 224 Performance Based Method Alternative for Thermal Insulation Material ML20246G5702020-10-16016 October 2020 Issuance of Amendment No. 223 One-Time Deferral of the Steam Generator Tube Inspections ML20230A3872020-08-31031 August 2020 Request to Use a Provision of a Later Edition of the American Society of Mechanical Engineers Boiler and Pressure Vessel Code, Section XI ML20216A6812020-08-0606 August 2020 Operating Quality Assurance Manual Change Revision 34B (EPID L-2020-LLQ-0004 (COVID-19)) ML20141L7452020-06-0808 June 2020 Operating Quality Assurance Manual Change Revision 34A ML20107H9782020-04-20020 April 2020 COVID-19 Relief Request CC-01 Containment Tendon Inspection ML19283C4812019-12-0606 December 2019 Issuance of Amendment No. 221 Main Turbine Control Slave Relay Testing ML19158A2902019-07-30030 July 2019 Issuance of Amendment No. 220 Regarding Emergency Action Level Scheme Changes ML19073A0012019-04-18018 April 2019 Issuance of Amendment No. 219 to Add New Technical Specification 3.7.20, Class 1E Electrical Equipment Air Conditioning (A/C) System ML19079A1482019-04-0101 April 2019 Request for Alternative I4R-05 to Reactor Vessel Nozzle Weld Examination Frequency Requirements (EPID L-2018-LLR-0051 ML18313A0692018-11-26026 November 2018 Request for Relief I4R-01 Related to the Inservice Inspection Program for Class 3 Buried High Density Polyethylene Piping ML18124A0262018-05-30030 May 2018 Issuance of Amendment No. 218 FSAR Revision Compliance with Regulatory Guide 1.106 Regarding MOV Thermal Overload Protection ML17262A7002017-10-0303 October 2017 Request for Alternative I4R-04 Applicable to the Fourth 10-Year Inspection Program Interval ML17254A1202017-09-25025 September 2017 Request for Alternative No. PR-07 from the Requirements of the ASME Code for the Fourth 10-Year Inservice Testing Interval ML17236A0822017-09-15015 September 2017 Issuance of Amendment No. 217 Replacement of Methodology in Technical Specification 5.6.5, Core Operating Limits Report (Colr), ML17170A3202017-06-20020 June 2017 Safety Evaluation Input - for Ameren Missouri Request to Amend Callaway Plant, Unit 1, Technical Specification 5.6.5, Core Operating Limits Report - ML17058A4432017-03-0606 March 2017 Request for Alternative I4R-03 Applicable to the Fourth 10-Year Inservice Inspection Program Interval ML17010A3322017-02-0202 February 2017 Safety Evaluation Regarding Implementation of Mitigating Strategies and Reliable Spent Fuel Pool Instrumentation Related to Orders EA-12-049 and EA-12-051 ML16223A7122016-08-30030 August 2016 Relief Request No. 13R-08 from Code Case N-460, Alternative Examination Coverage for Class 1 and Class 2 Welds, for Piping Welds, Third 10-Year Inservice Inspection Interval ML16089A1672016-04-0101 April 2016 Review and Approval of Quality Assurance Plan Change Per Nuclear Energy Institute (NEI) 14-05A, Revision 1 ML16055A4642016-03-17017 March 2016 Relief Requests 13R-09 (Steam Generator Tubesheet Weld), 13R-11 (Pressurizer Welds) from Code Case N-460 and 13R-18 (SG Weld), from Appendix Viii Requirements, Third 10-Year Inservice Inspection Interval (CAC MF6735-MF6737) ML16020A5162016-02-29029 February 2016 Issuance of Amendment No. 216, Revise Technical Specification (TS) 2.1.1.1 and TS 5.6.5, to Remove Uncertainties from Departure from Nucleate Boiling Ratio Safety Limit and Adopt WCAP-14565-P-A Methodology ML15324A1142016-02-0202 February 2016 Issuance of Amendment No. 215, Adopt Technical Specification Task Force (TSTF) Traveler TSTF-510, Revision 2, Revision to Steam Generator Program Inspection Frequencies and Tube Sample Selection ML16027A1582016-01-29029 January 2016 Relief Request I4R-02 from Requirements of ASME Code Section XI, Table IWF-2500-1 for 100% Visual Examination of Class 1 Supports, Fourth 10-Year Inservice Inspection Interval ML15328A0592016-01-28028 January 2016 Issuance of Amendment No. 214, Request to Revise Operating License Condition Related to Cyber Security Plan Milestone 8 Full Implementation Date ML15258A5102015-10-28028 October 2015 Issuance of Amendment No. 213, Adopt Technical Specification Task Force Traveler TSTF-523, Generic Letter 2008-01, Managing Gas Accumulation ML15251A4932015-10-0707 October 2015 Issuance of Amendment No. 212, Request to Upgrade the Emergency Action Level Scheme by Adopting Nuclear Energy Institute NEI 99-01, Revision 6 ML15064A1252015-05-12012 May 2015 Request for Relief I4R-01 from ASME Code Requirements for Replacement of Class 3 Essential Service Water Buried Piping with High Density Polyethylene Piping, for the Fourth 10-year Inservice Testing Interval ML15064A0282015-03-31031 March 2015 Issuance of Amendment No. 211, Request to Revise Final Safety Analysis Report Standard Plant Section 3.6 for High Density Polyethylene (Hdpe) Crack Exclusion ML15035A1482015-02-10010 February 2015 Relief Request 13R-17, Proposed Alternative to ASME Code, Section XI Requirements, Which Extends Reactor Vessel Inservice Inspection Frequency from 10 to 20 Years, Third 10-Year Interval ML14350B2392015-01-20020 January 2015 Issuance of Amendment No. 210, Revise Technical Specification LCO 3.4.12, Cold Overpressure Mitigation System (Coms), to Clarify No Limitation on Normal Charging Pump Use During Modes 4-6 ML14234A4512014-09-0404 September 2014 Relief Request I3R-16, Temporary Non-Code Repair of the Train a Component Cooling Water Heat Exchanger to Control ESW Leakage, Third 10-Year Inservice Inspection Interval ML14178A7692014-07-15015 July 2014 Requests for Relief PR-01, PR-02, PR-03, PR-04, and PR-06 (PR-05 Withdrawn), ASME OM Code Cases for Group a and B Pumps for Fourth 10-Year Inservice Testing Interval ML14175A3902014-07-0101 July 2014 Issuance of Amendment No. 209, Adoption of Technical Specification Task Force Change Traveler TSTF-522-A, Revision 0, Revise Ventilation System to Operate for 10 Hours Per Month, Using CLIIP ML14027A0572014-01-29029 January 2014 Relief Request PR-07, Testing Frequency for Pumps and Valves, Third 10-year Inservice Testing Interval 2024-01-18
[Table view] |
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August 6, 2020 Mr. Fadi Diya Senior Vice President and Chief Nuclear Officer Ameren Missouri Callaway Energy Center 8315 County Road 459 Steedman, MO 65077
SUBJECT:
CALLAWAY PLANT, UNIT NO. 1 - OPERATING QUALITY ASSURANCE MANUAL CHANGE REVISION 34b (EPID L-2020-LLQ-0004 [COVID-19])
Dear Mr. Diya:
By letter dated July 8, 2020 (Agencywide Documents Access and Management System Accession No. ML20190A195), Union Electric Company, dba Ameren Missouri (the licensee) submitted a request to the U.S. Nuclear Regulatory Commission (NRC) for approval of a revision to the Operating Quality Assurance Program as described in the Operating Quality Assurance Manual for Callaway Plant, Unit No. 1 (Callaway).
Due to actions taken in response to the Coronavirus Disease 2019 (COVID-19) public health emergency, the existing 90-day grace period for completing triennial vendor audits/surveys for some of Ameren Missouris suppliers will expire on August 31, 2020. As the length of the public health emergency is unknown, Ameren Missouri proposes to adopt a 25 percent grace period (9 months) for audits/surveys to address the current situation (as well as any similar situation in the future) provided that procedurally specified administrative controls are met. The proposed revision results in a reduction of commitment to the previously accepted quality assurance program that was submitted for NRC review and approval in accordance with Title 10 of the Code of Federal Regulations (10 CFR) Section 50.54(a)(4).
The NRC staff has reviewed the licensees request and concludes that the proposed changes to Operating Quality Assurance Manual, Revision 34b, for Callaway, complies with the applicable quality assurance requirements in Appendix B to 10 CFR Part 50 and Subpart G to 10 CFR Part 72 while implementing the 25 percent extension of audit or survey frequency during extenuating circumstances. Therefore, the NRC staff finds the licensees proposed changes to the Operating Quality Assurance Manual, Revision 34b, for Callaway are acceptable.
F. Diya If you have any questions, please contact me at 301-415-8371 or via e-mail at Mahesh.Chawla@nrc.gov.
Sincerely,
/RA/
Mahesh Chawla, Project Manager Plant Licensing Branch IV Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation Docket Nos. 50-483 and 72-1045
Enclosure:
Safety Evaluation cc: Listserv
SAFETY EVALUATION BY THE OFFICE OF NUCLEAR REACTOR REGULATION CHANGE TO THE OPERATING QUALITY ASSURANCE MANUAL, REVISION 34b UNION ELECTRIC COMPANY CALLAWAY PLANT, UNIT NO. 1 DOCKET NOS. 50-483 and 72-1045
1.0 INTRODUCTION
By letter dated July 8, 2020 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML20190A195), Union Electric Company, dba Ameren Missouri (the licensee), submitted a request to the U.S. Nuclear Regulatory Commission (NRC) for approval of a revision to the Operating Quality Assurance (QA) Program as described in the Operating Quality Assurance Manual (OQAM) for the Callaway Plant, Unit No. 1 (Callaway). The proposed revision results in a reduction of commitment to the previously accepted QA program that was submitted for NRC review and approval in accordance with Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities, Section 50.54(a)(4).
Specifically, the licensees submittal requested the wording within the Callaway OQAM, Section 18, Audits, to be expanded to permanently include provisions for an extended grace period for the completion of triennial vendor audits and surveys during extenuating circumstances. Due to the actions taken in response to the Coronavirus 2019 (COVID-19) public health emergency, the existing 90-day grace period for completing triennial vendor audits and surveys for some of the licensees suppliers will expire on August 31, 2020. As the length of the public health emergency is unknown, the licensee proposed to adopt a 25 percent grace period (i.e., 9 months) for audits and surveys to address the current public health emergency situation, as well as any similar situation in the future, provided that procedurally specified administrative controls are met.
2.0 REGULATORY BASIS The regulation in 10 CFR 50.54(a)(4) sets forth the NRCs regulatory requirements regarding changes to a QA program description. Changes to a QA program description that reduce the licensees commitments must be submitted and receive NRC approval prior to implementation.
This includes changes made to the QA program description as presented in the safety analysis report or in a topical report that must be submitted as specified in 10 CFR 50.54(a)(4).
The submittal of a change to the QA program description must include all pages affected by that change and must be accompanied by a forwarding letter identifying the change, the reason for Enclosure
the change, and the basis for concluding that the revised program incorporating the change continues to satisfy the criteria of Appendix B to 10 CFR Part 50, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, and the QA program description commitments previously accepted by the NRC.
The regulatory requirement for QA program audits of suppliers is set forth in Criterion VII, Control of Purchased Material, Equipment, and Services, of Appendix B to 10 CFR Part 50.
Criterion VII of Appendix B to 10 CFR Part 50, requires, in part, the establishing of measures for assuring 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.
The Callaway OQAM also supports the QA program for the Dry Cask Storage System and Independent Spent Fuel Storage Facility at the Callaway site; therefore, the proposed change also affects the requirement set forth in Subpart G, Quality Assurance, to 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.
The regulation in 10 CFR Part 72.154(a) requires, in part, the establishing of measures to ensure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents. These measures must 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.
3.0 TECHNICAL EVALUATION
The current version of the Callaway OQAM, Revision 34a, Section 18.11 states the following:
Applicable elements of suppliers quality assurance programs shall be audited (post-award) on a triennial basis. A 90-day grace period may be applied to this activity. Audits generally should be initiated when sufficient work is in progress to determine whether the organization in complying with the established quality assurance provisions. Subsequent contracts or contract modifications which significantly enlarge the scope of activities by the same suppliers shall be considered in establishing audit requirements. In addition, the need for a triennial audit may be precluded upon evaluation and documentation by the NOS
[Nuclear Oversight] Department that the results of mini audits performed during source verification and source surveillance activities confirm the adequacy and implementation of the suppliers QA program.
The licensee submitted the OQAM, Revision 34b for Callaway, and requested the addition of new Subsection 18.11.1 which states:
An overall 25% extension (9 months) for triennial audits or surveys may be exercised during periods where performance of such activities is not feasible as a result of extenuating circumstances. Examples of extenuating circumstances would include, but are not limited to: 1) declaration of a national emergency;
- 2) severe localized or national weather conditions or damage to licensee or supplier infrastructure; or 3) localized outbreak of a severe health concern to the public and licensee.
Continued use of suppliers that have exceeded the maximum allowed audit or survey time due to extenuating circumstances is allowed if the following conditions are met:
- a. A documented evaluation must be performed to summarize why the audit or survey could not be performed prior to the end of the 90-day grace period and to provide the basis for maintaining the supplier as an approved supplier during the 25% (9-month) grace period. While implementing procedures must describe elements to be included in the documented evaluation, the following items should be considered as applicable:
For 10 CFR 50, Appendix B suppliers, verification that the suppliers quality assurance program is still committed to meeting the requirements of 10 CFR 50, Appendix B.
For commercial suppliers who are approved based on commercial grade survey, verification the supplier has maintained adequate documented programmatic controls in place for the activities affecting the critical characteristics of the item/services being procured.
Evaluation of any significant open issues with the NRC, 10 CFR Part 21 Notifications, and any open findings since the previous triennial audits describing impact on the items/services being procured from that supplier.
Review of procurement history since last triennial audit/survey including receipt inspection results to identify any potential issues.
The results of the performance history must be included in the evaluation.
The degree of standardization of the items being procured. For instance, suppliers of catalog items which are used across multiple industry with widely accepted good performance histories would be considered good candidates for a 25% (9-month) grace period.
- b. If concerns are identified based on the above evaluation, the following mitigating actions may be considered:
Enhanced receiving inspections beyond visual inspections and quality checks.
Identification of any additional requirements/restrictions to be placed on the supplier.
- c. For audits/surveys performed during the 25% grace period, the audit/survey shall include a review of activities performed by the supplier since the 36-month audit/survey expiration date.
- d. The allowance would only apply to existing suppliers on the Qualified Suppliers List.
- e. The 25% grace period discussed above is applicable to domestic and international suppliers.
- f. For audits/surveys performed during the 25% grace period, the audit/survey clock does not have to reset backwards to the original expiration date for which the audit/survey should have been performed. The end of the audit or survey would determine the date of the next triennial audit/survey.
In evaluating the adequacy of the proposed change, the NRC staff considered the guidance of NUREG-0800, Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR [Light-Water] Edition, Section 17.5, Revision 1, Quality Assurance Program Description - Design Certification, Early Site Permit and New License Applicants, dated August 2015 (ADAMS Accession No. ML15037A441), and Regulatory Guide (RG) 1.28, Revision 5, Quality Assurance Program Criteria (Design and Construction), dated October 2017 (ADAMS Accession No. ML17207A293).
The extension of the audit frequency during extenuating circumstances as proposed by the licensee will provide greater flexibility in its consideration of other similar events, such as the ongoing COVID-19 pandemic. The current national emergency puts a restriction on domestic and international travel and limits access to vendor facilities by non-employees. As a result, the licensees existing 90-day grace period for completing triennial vendor audits and surveys will expire for some of its suppliers on August 31, 2020, and beyond. Without further extension, the affected suppliers would have to be removed from Callaways Qualified Suppliers List within 90 days of the triennial audit or survey expiration date, which would adversely impact the licensees ability to procure safety-related items and services for Callaway. As the duration of the current national emergency is unknown, the NRC staff agrees that an overall extension of 25 percent to the triennial audit frequency for supplier audits and surveys may be implemented for extenuating circumstances. This extension would not be limited to three consecutive audit and survey cycles as previously approved by an NRC safety evaluation (ADAMS Accession No. ML051570349) and would be applicable to all audit and survey cycles.
During the extenuating circumstances, the licensee may continue to use suppliers that have exceeded the maximum allowed audit or survey time based on the conditions set forth in new Subsection 18.11.1 within the Callaway OQAM, Revision 34b. The NRC staff finds that the descriptions provided in Subsection 18.11.1 and the existing language within the Callaway OQAM are consistent with the following NRC staffs considerations for allowing extension to the periodicity of audits and surveys for suppliers during extenuating circumstances:
- a. There is verification that the supplier is still implementing a QA program that meets Appendix B to 10 CFR Part 50.
- i. For suppliers with delinquent surveys, the entity shall ensure that the suppliers have maintained adequate documented programmatic controls in place for the activity affecting quality.
- b. The alternative method of the 25 percent extension is applicable to domestic and international suppliers.
- c. Receipt inspection and industry operating experience are reviewed on an ongoing basis as the information becomes available and documented. The results of the review are promptly considered for the effects on a suppliers continued qualification and adjustments made as necessary, including corrective actions.
- d. If there is no ongoing receipt inspection or operating experience with which to analyze the supplier for a period of 12 months since the last audit or survey, an annual documented evaluation shall be performed and include, as appropriate, the following:
- i. Review of supplier-furnished documents and records such as certificates of conformance, nonconformance notices, and corrective actions.
ii. Results of previous source verifications, audits, survey and receiving inspection activities.
iii. Operating experience of identical or similar products furnished by the same supplier.
iv. Results of audits and inspection from other sources (e.g. customer, ASME, or NRC inspection).
- e. If the contract or a contract modification significantly enlarges the scope or changes the methods or controls for activities performed by the same supplier, the supplier will provide documented justification the change(s) are adequately addressed by its QA program controls.
The overall 25 percent extension for supplier audits and surveys would only be applicable to extenuating circumstances such as 1) declaration of a national emergency; 2) severe localized or national weather conditions; or 3) localized outbreak of a severe health concern to the public and licensee, as described in the proposed revision to the Callaway OQAM.
The 25 percent extension for supplier audits and surveys during extenuating circumstances is a different alternative to the current 90-day grace period allowed in Subsection 18.11 of the current OQAM, Revision 34a. The current 90-day grace period will remain unchanged for conditions not meeting the extenuating circumstances threshold. Examples of conditions not meeting extenuating circumstances threshold include, but not limited to, 1) staffing limitations impacting the timeliness of an audit or survey; and 2) scheduling conflicts by either Ameren Missouri, its suppliers or sub-tier suppliers. The expectations for the use of the 25 percent extension would be limited to implementation for extenuating circumstances and that the licensee will attempt to maintain the current triennial audit or survey period before exercising the 25 percent extension.
Unlike the existing alternative on the use of a 90-day grace period, under the 25 percent extension, the licensee would not have to reset the audit clock backwards when the audit or survey is finally performed to the original date the audit or survey should have been performed.
The date that the audit or survey is finally performed would be the start of the new triennial audit or survey frequency. The NRC staff considered that should multiple events of a severe nature occur closely together, the requirement for not allowing the audit clock to be reset forward would result in an additional potential scheduling constraint on the licensee, its suppliers or sub-tier suppliers, in completing audits or surveys in a timely manner.
The NRC staff considered the maturity of the licensees QA program and its supply chain oversight in determining this allowance of a 25 percent extension for audits or surveys to be completed from the date of the expiration of the triennial audit or survey frequency. The NRC staff also considered the potential risk significance of extending the audit or survey frequency by 25 percent, as well as the potential impact on the operation of Callaway and its reliance on its suppliers and sub-tier suppliers on the licensees ability to secure safety-related items during extenuating circumstances. Based on the maturity of the licensees QA program, the expected duration that the licensee will be under extenuating circumstances, and the licensees continuous monitoring of ongoing and previous supplier performance, the NRC staff determined that there is minimal risk associated with implementing the extended audit or survey frequency during extenuating circumstances. Therefore, the NRC concluded that the conditions stated above ensure that reasonable assurance of the quality of items and services will continue to be maintained during this extension period.
4.0 CONCLUSION
The NRC staff reviewed the licensees OQAM, Revision 34b submittal for Callaway. As stated above, the NRC staff concludes that there is reasonable assurance that the licensees Operating QA Program for Callaway will continue to meet the requirements of Appendix B to 10 CFR Part 50 and Subpart G to 10 CFR Part 72 while implementing the 25 percent extension of audit or survey frequency during extenuating circumstances. Therefore, the NRC staff finds that the licensees proposed changes in the Callaway OQAM, Revision 34b, are acceptable.
Principal Contributor: Yiu Law Date: August 6, 2020
ML20216A681 *by SE memo via email **by e-mail OFFICE NRR/DORL/LPL4/PM NRR/DORL/LPL4/LA** NRR/DRO/IQVIB* NRR/DORL/LPL4/BC** NRR/DORL/LPL4/PM**
NAME MChawla PBlechman KKavanagh* JDixon-Herrity MChawla DATE 8/05/2020 8/05/2020 7/27/2020 8/6/2020 8/6/2020