ML20280A327
| ML20280A327 | |
| Person / Time | |
|---|---|
| Site: | 99902089 |
| Issue date: | 10/14/2020 |
| From: | Savwoir N NRC/NRR/DRO/IQVB |
| To: | Ross W EnerSys |
| Savwoir N | |
| References | |
| EPID I-2020-201-0060 IR 2020201 | |
| Download: ML20280A327 (14) | |
Text
October 14, 2020 Mr. William Ross Director Manufacturing Quality Systems and EAS Enersys 2366 Bernville Road Reading, PA 19605
SUBJECT:
NUCLEAR REGULATORY COMMISSION VENDOR INSPECTION REPORT OF ENERSYS, NO. 99902089/2020-201
Dear Mr. Ross:
From September 14 through September 18, 2020, the U.S. Nuclear Regulatory Commission (NRC) staff conducted a limited-scope virtual inspection of EnerSys facilities in Reading, PA.
The purpose of this limited-scope virtual inspection was to verify that EnerSys corrective actions initiated during the NRC inspection performed in February 2020 were adequately implemented and met the applicable requirements of Criterion XVI, Corrective Action, of Appendix B, Quality Assurance Program 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.
This technically-focused virtual inspection specifically evaluated Enersys implementation of the corrective actions taken in response to the NRC inspection teams identification of instances of untimely or inadequate evaluations of material review reports (MRRs) and corrective action reports (CARs) documented in the NRCs Inspection Report No. 99901435/2020-201, dated April 13, 2020 (Agencywide Documents Access and Management System Accession (ADAMS)
No. ML20097F449). During the February 2020 inspection, the NRC inspection team noted that Enersys headquarters in Reading, PA failed to open their own CARs to address the supplier corrective action reports (SCARs) that Westinghouse documented in their external audit report for the audit performed at EnerSys in Hays, Kansas. This oversight was considered a minor issue by the NRC inspection team. Based on the review of the corrective actions, no findings of significance were identified by the NRC inspection team. The enclosed report presents the results of the inspection. This NRC inspection report does not constitute NRC endorsement of EnerSys overall quality assurance (QA) program.
This inspection was performed virtually due to the ongoing worldwide pandemic associated with the novel Coronavirus. The NRC may review the implementation of your corrective actions for the associated MRRs and CARs during a future on-site inspection to determine whether full implementation of the associated corrective actions have been achieved and maintained.
Based on the results of this virtual inspection, the NRC inspection team found that the implementation of your QA program with regards to the corrective actions associated with the NRCs Inspection Report 9901435/2020-201-01 met the applicable requirements of Criterion XVI of Appendix B to 10 CFR Part 50. No findings of significance were identified.
In accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding, of the NRC's Rules of Practice, a copy of this letter and its enclosures will be made available electronically for public inspection in the NRCs Public Document Room and in ADAMS, accessible from the NRCs public web site at http://www.nrc.gov/reading-rm/adams.html.
Sincerely, Kerri A. Kavanagh, Chief /RA/
Quality Assurance and Vendor Inspection Branch Division of Reactor Oversight Office of Nuclear Reactor Regulation Docket No.:
99902089 EPID No.:
I-2020-201-0060
Enclosures:
Inspection Report No. 99902089/2020-201 and Attachment
ML20280A327 *via email NRR-106 OFFICE NRR/DRO/IQVB NRR/DRO/IQVB NRR/DRO/IQVB NAME NSavwoir*
PPrescott*
KKavanagh*
DATE 10/5/2020 10/6/2020 10/14/2020
Enclosure U.S. NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR REACTOR REGULATION DIVISION OF REACTOR OVERSIGHT VENDOR INSPECTION REPORT Docket No.:
99902089 Report No.:
99902089/2020-201 Vendor:
EnerSys 2366 Bernville Road Reading, PA 196505 Vendor
Contact:
Mr. William Ross Director Manufacturing Quality Systems and EAS Email: Bill.Ross@enersys.com Phone: 610-208-1974 Nuclear Industry Activity:
EnerSys provides Class 1E batteries and associated safety-related components for U.S. nuclear power plants and for the AP1000 plants currently under construction.
Inspection Dates:
September 14 - 18, 2020 (virtual)
Inspectors:
Paul Prescott NRR/DRO/IQVB Team Leader Nicholas Savoir NRR/DRO/IQVB Approved by:
Kerri A. Kavanagh, Chief Quality Assurance and Vendor Inspection Branch Division of Reactor Oversight Office of Nuclear Reactor Regulation
EXECUTIVE
SUMMARY
ENERSYS 99902089/2020-201 From September 14 through September 18, 2020, the U.S. Nuclear Regulatory Commission (NRC) staff conducted a limited-scope virtual inspection of EnerSys, located in Reading, PA.
The purpose of this limited-scope virtual inspection was to evaluate EnerSys implementation of the corrective actions taken in response to the NRC inspection teams identification of instances of untimely or inadequate evaluations of material review reports (MRRs) and corrective action reports (CARs) documented in the NRCs Inspection Report No. 99901435/2020-201, dated April 13, 2020 (Agencywide Documents Access and Management System Accession (ADAMS)
No. ML20097F449). During the February 2020 inspection, the NRC inspection team noted that Enersys headquarters in Reading failed to open their own CARs to address the supplier corrective action reports (SCARs) that Westinghouse documented in their external audit report for the audit performed at EnerSys in Hays, Kansas. This oversight was considered a minor issue by the NRC inspection team.
This technically-focused virtual inspection specifically evaluated Enersys corrective actions initiated during the NRC inspection performed in February 2020 to ensure they were adequately implemented and met the applicable requirements of Criterion XVI, Corrective Action, of Appendix B, Quality Assurance Program 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.
The regulation that served as the basis for the NRC inspection:
Appendix B to 10 CFR Part 50 During this virtual inspection, the NRC inspection team implemented portions of Inspection Procedure (IP) 43002, Routine Inspections of Nuclear Vendors, dated January 27, 2017; and IP 43004, Inspection of Commercial-Grade Dedication Programs, dated January 27, 2017.
This inspection was performed virtually due to the ongoing worldwide pandemic associated with the novel Coronavirus. Due to the challenges and limitations associated with performing a virtual inspection, the NRC inspection team could not perform an assessment of EnerSys Safety Conscious Work Environment (SCWE) due to the inspection being performed virtually.
The NRC may review the corrective actions to determine whether full implementation has been achieved and maintained and to assess EnerSys SCWE during a future on-site inspection.
The results of the inspection are summarized below.
Corrective Action The NRC inspection team reviewed EnerSys policies and implementing procedures that govern the implementation of its corrective action program to determine compliance with the requirements of Criterion XVI of Appendix B to 10 CFR Part 50. Specifically, the NRC inspection team reviewed the implementation and closure of the corrective actions which focused on EnerSys lack of sufficient evidence that commercial-grade dedication was adequately conducted.
The NRC inspection team reviewed the documentation that provided objective evidence all corrective actions were completed and adequately implemented. Based on this review and interviews with EnerSys staff responsible for implementing the corrective actions, the NRC inspection team determined that EnerSys has taken adequate corrective actions to resolve the non-conforming conditions identified in the Westinghouse SCARs. No findings of significance were identified.
Design Control and Commercial-Grade Dedication The NRC inspection team reviewed EnerSys policies and implementing procedures that govern the commercial-grade dedication program to verify compliance with the requirements of Criterion III, Design Control, of Appendix B to 10 CFR Part 50. The NRC inspection team reviewed a sample of EnerSys commercial-grade dedication documents. No findings of significance were identified.
REPORT DETAILS
- 1.
Design Control and Commercial-Grade Dedication
- a. Inspection Scope The NRC inspection team reviewed EnerSys policies and implementing procedures that govern the implementation of its commercial-grade dedication (CGD) to verify compliance with the requirements of Criterion III, Design Control, and Criterion VII of Appendix B Quality Assurance Program 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.
The NRC inspection team reviewed the design control of EnerSys nuclear-qualified battery (GN product type), GN related purchased parts and auxiliary components.
EnerSys GN parts use the CERT suffix designation for nuclear safety-related applications. The NRC inspection team also reviewed purchase orders for the GN-29 battery systems to ensure they included the appropriate regulatory requirements specified by the customers in accordance with applicable Class 1E batteries for nuclear power generating stations Institute of Electrical and Electronics Engineers (IEEE) qualification standards.
The NRC inspection team reviewed the CGD methodology for items and services to be installed in Class 1E batteries, including the development of critical characteristics (CCs), technical evaluations, failure mode and effects analysis, acceptance criteria methods, sampling methodology, checklists, reports, and associated Purchase Orders (POs). The NRC inspection team reviewed the CGD process for the GN-29 product types. The NRC inspection team evaluated a sample of technical evaluations and concluded that the technical evaluations in the dedication methodology appropriately identified the CCs necessary to provide reasonable assurance that the item or service would perform its intended safety function.
The NRC inspection team reviewed a sample of commercial-grade dedicated battery accessories and components supplied as basic components and controlled under EnerSys Appendix B to 10 CFR Part 50 program. Accessories included, but were not limited to rack assemblies, bolt packages, terminal plates, lugs, washers, and cables. The NRC inspection team reviewed EnerSys sampling methodology and the GN product type single sampling plan for inspections. The attachment to this inspection report lists the documents reviewed and personnel interviewed by the NRC inspection team.
- b. Observation and Findings No findings of significance were identified.
c. Conclusion
The NRC inspection team concluded that EnerSys is implementing its CGD program activities in accordance with the regulatory requirements of Criterion III and Criterion VII of Appendix B to 10 CFR Part 50. Based on the limited sample of documents reviewed and activities observed, the NRC inspection team determined that EnerSys
is implementing its policies and procedures associated with CGD program and oversight of contracted activities. No findings of significance were identified.
- 2.
Corrective Action
- a. Inspection Scope The Nuclear Regulatory Commission (NRC) inspection team reviewed EnerSys policies and implementing procedures that govern the implementation of its corrective action program to verify compliance with the regulatory requirements of Criterion XVI, Corrective Action, of Appendix B to 10 CFR Part 50. Specifically, the NRC inspection team reviewed the implementation and closure of the corrective actions opened in NRC Inspection Report 99901435/2020-201.
The attachment to this inspection report lists the documents reviewed by the NRC inspection team.
- b. Observations and Findings b.1 Corrective Action Associated with CAR 150252-022020 (SCAR # IR-2020-201)
EnerSys opened CAR 150252-022020 on February 27, 2020 to capture an issue with EnerSys CGD documentation process associated with the objective evidence for the review of the International Organization for Standardization (ISO) certification, scope of accreditation and PO requirements.
The NRC inspection team discussed EnerSys transactions in enterprise software SAP for product release with EnerSys quality assurance manager and the objective evidence for the completion of the corrective actions. The NRC inspection team reviewed EnerSys incoming quality assurance documentation inspection and acceptance process. EnerSys generated Work Instruction (WI)-
023-2-C in conjunction with the dedication of commercial grade items procedure, QAP 70.0, as a process improvement. CAR 150252-022020 was closed March 11, 2020. The NRC inspection team determined that EnerSys corrective actions were adequate to address the CAR and no findings of significance were identified.
b.2 Corrective Action Associated with CAR 150253-022020 (SCAR # IR-2020-201)
EnerSys opened CAR 150253-022020 February 27, 2020 to address lab testing analysis documentation which did not reference that testing was performed in accordance with International Laboratory Accreditation Cooperation (ILAC) /
MRA ISO 17025:2017 or 2005 program.
The NRC inspection team discussed with EnerSys their process for verifying the testing labs in accordance with ILAC and reviewed the documentation that provided the objective evidence for the completion of the corrective actions.
EnerSys corrective actions included updating PO requests to require an A2LA report. CAR 150253-022020 was closed March 25, 2020. The NRC inspection team determined that EnerSys corrective actions were adequate to address the CAR and no findings of significance were identified.
b.3 Corrective Action Associated with CAR 150254-022020 (SCAR # IR-2020-202)
EnerSys opened CAR 150254-022020 on February 27, 2020 to clarify EnerSys sampling plan lot acceptance and rejection documentation.
The NRC inspection team discussed the sampling plan with EnerSys quality assurance manager and reviewed the documentation that provided the objective evidence for the completion of the corrective actions. EnerSys corrective actions included an engineering change order (ECO) 1002183 that revised quality assurance procedure (QAP) 106.0. CAR 150254-022020 was closed April 6, 2020. The NRC inspection team determined that EnerSys corrective actions were adequate to address the CAR and no findings of significance were identified.
b.4 Corrective Action Associated with CAR 150255-022020 (SCAR # IR-2020-202)
EnerSys opened CAR 150255-022020 on February 27, 2020 to address a critical characteristic documenting issue with commercial grade surveys regarding lot traceability and an increased sampling size.
The NRC inspection team discussed EnerSys identification of critical characteristics and the CGD process associated with the manufacturing EnerSys GN safety related batteries under their Appendix B to 10 CFR Part 50 program.
EnerSys corrective actions included implementation of ECO 1002194 that revised QAP 31.0 to clarify the process of documenting critical characteristics during commercial grade surveys and the survey reports. The NRC inspection team determined that EnerSys corrective actions were adequate to address the CAR and no findings of significance were identified.
b.5 Corrective Action Associated with CAR 150256-022020 (SCAR # IR-2020-204)
EnerSys opened CAR 150256-022020 on February 27, 2020 to address issues with documenting justifications in accordance with verifying critical characteristics.
The NRC inspection team discussed EnerSys technical evaluations and reviewed the documentation that provided the objective evidence for the completion of the corrective actions. EnerSys corrective actions included revising QAP 106.0 and EnerSys Hays level work instructions regarding sampling plan justifications. CAR 150256-022020 was closed April 6, 2020. The NRC inspection team determined that EnerSys corrective actions were adequate to address the CAR and no findings of significance were identified.
b.6 Corrective Action Associated with CAR 150257-022020 (SCAR # IR-2020-205)
EnerSys opened CAR 150257-022020 February 27, 2020 to address material verification sub-supplier issues. The NRC inspection team discussed commercial grade dedication and controls on their supplier, their sub-suppliers and additional to testing upon receiving. During the NRC inspection EnerSys CAR 150257-022020 was not closed and was extended to October 31, 2020.
The NRC inspection team acknowledged that EnerSys corrective actions were still in-process. However, the corrective actions appeared adequate to address the issue. No findings of significance were identified.
b.7 Corrective Action Associated with CAR 150258-022020 (SCAR # IR-2020-201)
EnerSys opened CAR 150258-022020 February 27, 2020 to address PO issues with ILAC accreditation process ISO version years.
The NRC inspection team discussed ILAC accreditation process conducted at EnerSys. EnerSys corrective actions included revising the PO template to capture the clauses of 17025 2005 and/or 2017. CAR 150258-022020 was closed April 6, 2020. The NRC inspection team determined that EnerSys corrective actions were adequate to address the CAR and no findings of significance were identified.
c. Conclusion
The NRC inspection team concluded that EnerSys has adequately implemented its program for corrective actions associated with NRC inspection 99901435/2020-201.
Based on the limited sample of documents reviewed, the NRC inspection team determined that EnerSys has taken adequate corrective actions to resolve the non-conforming conditions identified in the Westinghouse SCARs. No findings of significance were identified
- 3.
Entrance and Exit Meetings On September 14, 2020, the NRC inspection team discussed the scope of the inspection with Mr. William Ross, EnerSys Director Manufacturing Quality Assurance, Systems and EAS and other members of Enersys management and technical staff. On September 18, 2020, the NRC inspection team presented the inspection results and observations during an exit meeting with Mr. William Ross, and other members of EnerSys management and technical staff. The attachment to this report lists the attendees of the entrance and exit meetings, as well as those individuals whom the NRC inspection team interviewed.
Att ATTACHMENT
- 1. ENTRANCE/EXIT MEETING ATTENDEES Name Title Affiliation Entrance Exit Interviewed William Ross Director Manufacturing Quality Assurance, Systems and EAS EnerSys X
X X
Nanette Murphy Sr. Quality Management Systems Manager Americas EnerSys X
X X
Tracey Hager Mechanical Engineering Manager EnerSys X
X George Brendahl Product Manager EnerSys X
X Patricia Gamboa Senior Quality Supplier Manager Americas EnerSys X
X Christine Nihart Customer Service Manager EnerSys X
X Paul Prescott Inspection Team Leader Nuclear Regulatory Commission (NRC)
X X
Nicholas Savwoir Inspector NRC X
X Kerri Kavanagh Branch Chief NRC X
- 2. INSPECTION PROCEDURES USED Inspection Procedure 43002, Routine Inspections of Nuclear Vendors, dated January 27, 2017 IP 43004, Inspection of Commercial-Grade Dedication Programs, dated January 27, 2017
- 3. LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED No items were opened or closed.
Att
- 4. DOCUMENTS REVIEWED Policies and Procedures QAP 30.0, Revision AD, Supplier Quality Control QAP 30.01, Revision AE, Nuclear Safety Related (NSR) Approved Supplier List QAP 62.0, Revision AC, Material Review Report (MRR) Procedure QAP 70.0, Revision AE, Dedication of Commercial Grade Items (CGI) Services &
Acceptance Criteria for Nuclear Safety Related Items QAP 106.0, Revision AB, Monitoring of Suppliers QAP 500.0, Revision AD, Quality Assurance Requirements for Purchased Material QAP 506.0, Revision AA, Inspection, Testing and Acceptance Sampling EnerSys Nuclear Safety Related Action In-Process Tracking Sheet Electronic Completion Notice for QAP 106 to clarify requirements for received items with nonconformities per WEC audit finding dated March 9, 2020 Design and Commercial-Grade Dedication Records EnerSys Inspection and Certification and Inspection Reports for GN Battery Jars for Purchase Order 4500010442, dated April 27, 2020 EnerSys Inspection and Certification and Inspection Reports for GN Battery Jars for Purchase Order 4500010442, dated March 23, 2020 EnerSys Inspection and Certification and Inspection Reports for GN Battery Jars for Purchase Order 4500010442, dated April 30, 2020 EnerSys Inspection and Certification and Inspection Reports for GN Battery Jars for Purchase Order 4500010442, dated March 30, 2020 EnerSys Inspection and Certification and Inspection Reports for GN Battery Jars for Purchase Order 4500010442, dated April 13, 2020 EnerSys Inspection and Certification and Inspection Reports for GN Battery Jars for Purchase Order 4500010442, dated April 20, 2020 EnerSys Inspection and Certification and Inspection Reports for GN Battery Jars for Purchase Order 4500010442, dated April 6, 2020
Att Survey for manufacturer of battery vent plugs and washers dated April 17, 2015 GN Cable Assembly Record Sheet dated July 8, 2020 Survey of manufacturer of battery separators dated June 8, 2016 Capacity Test (Discharge Data Sheet) for GN 29 Battery Serial No. HSF0000 dated August 16, 2018 Extent of Condition Dedication Matrix for Organic Components in DB01 Batteries Quality Plan of Class 1E Batteries (DB01) dated November 20, 2018 Nuclear Approved Suppliers List from SAP Dated September 10, 2020 MRR H-039-20, May 14, 2020 MRR H-041-20, June 26, 2020 MRR H-044-20, June 26, 2020 Engineering Change Order (ECO) 1002183 ECO 1002194 Work Instruction (WI) WI-023-2-C WI-023-5 Calibration and Test Records Test Lab QMS [Quality Management System] Accreditation Verification Enersys Memorandum dated July 22, 2019 Test Lab QMS Accreditation Verification EnerSys Memorandum dated April 16, 2019 Corrective Actions CAR 150252-022020 CAR 150253-022020 CAR 150254-022020
Att CAR 150255-022020 CAR 150256-022020 CAR 150257-022020 CAR 150258-022020 Corrective Actions Opened During the NRC Inspection None 10 CFR Part 21 Documents Supplier Quality Alert H-039-2019, September 17, 2019