ML20274A247
| ML20274A247 | |
| Person / Time | |
|---|---|
| Site: | 99901385 |
| Issue date: | 10/14/2020 |
| From: | Kerri Kavanagh NRC/NRR/DRO/IQVB |
| To: | Grieb V C&D Technologies |
| Ortega-Luciano J | |
| References | |
| EPID I-20 20-201-0052 IR 2020201 | |
| Download: ML20274A247 (17) | |
Text
October 14, 2020 Mr. Vince Grieb, VP Quality Assurance C&D Technologies 1400 Union Meeting Rd Blue Bell, PA 19422
SUBJECT:
NUCLEAR REGULATORY COMMISSION VENDOR INSPECTION REPORT OF C&D TECHNOLOGIES, NO. 99901385/2020-201
Dear Mr. Grieb:
From September 14 through September 18, 2020, the U.S. Nuclear Regulatory Commission (NRC) staff conducted an inspection at C&D Technologies (hereafter referred to as C&D) facilities in Blue Bell and Horsham, PA. The purpose of this limited-scope inspection was to verify that C&Ds corrective actions initiated to address the findings identified during NRC inspections performed in March 2014, September 2015, and May 2017 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 inspection specifically evaluated C&Ds implementation and closure of the corrective actions taken in response to Notice of Nonconformance (NON) 99901385/2014-201-02, NON 99901385/2014-201-03, NON 99901385/2014-201-04 and NON 99901385/2014-201-05, documented in NRC inspection report (IR) No. 99901385/2014-201, dated April 21, 2014 (Agencywide Documents Access and Management System Accession (ADAMS) No.
ML14107A383); NON 99901385/2015-201-01 and NON 99901385/2015-201-02, documented in NRC IR No. 99901385/2015-201, dated January 8, 2016 (ADAMS No. ML15307A198); and NON 99901466/2017-201-01, documented in NRC IR No. 99901466/2017-201, dated June 19, 2017 (ADAMS No. ML17165A387). During this inspection, the NRC inspection team determined that C&Ds corrective actions were adequate to address the NONs mentioned above. Based on the review of the corrective actions, the NRC inspection team closed NON 99901385/2014-201-02, NON 99901385/2014-201-03, NON 99901385/2014-201-04, NON 99901385/2014-201-05, NON 99901385/2015-201-01, NON 99901385/2015-201-02, and NON 99901466/2017-201-01. The enclosed report presents the results of the inspection. This NRC inspection report does not constitute NRC endorsement of C&Ds overall quality assurance (QA) program.
V. Grieb 2
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.: 99901385 EPID No.:
I-2020-201-0052
Enclosure:
Inspection Report No. 99901385/2020-201 and Attachment
- via email NRR-106 OFFICE NRR/DRO/IQVB NRR/DRO/IQVB NRR/DRO/IQVB NRR/DRO/IQVB NAME AKeim*
DPark*
JOrtega-Luciano* KKavanagh*
DATE 9/28/2020 9/30/2020 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.:
99901385 Report No.:
99901385/2020-201 Vendor:
C&D Technologies 1400 Union Meeting Rd Blue Bell, PA 19422 Vendor
Contact:
Mr. Vince Grieb Vice President Quality Assurance Email: VGrieb@TrojanBattery.com Nuclear Industry Activity:
C&D provides Class 1E batteries for safety-related applications to U.S. nuclear power plants.
Inspection Dates:
September 14 - 18, 2020 Inspection Team Leader Jonathan Ortega-Luciano NRR/DRO/IQVB Inspectors:
Andrea Keim NRR/DRO/IQVB Dong Park 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
C&D TECHNOLOGIES 99901385/2020-201 The U.S. Nuclear Regulatory Commission (NRC) staff conducted a vendor inspection at the C&D Technologies (hereafter referred to as C&D) facilities located in Blue Bell and Horsham, PA, to evaluate C&Ds corrective actions initiated to address the findings identified during the NRC inspections performed in March 2014, September 2015, and May 2017 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 NRC inspection team conducted this inspection on September 14 - 18, 2020. This was the fourth NRC inspection of C&D in the last six years.
This technically-focused inspection specifically evaluated C&Ds implementation and closure of the corrective actions taken in response to Notice of Nonconformance (NON) 99901385/2014-201-02, NON 99901385/2014-201-03, NON 99901385/2014-201-04, and NON 99901385/2014-201-05, documented in NRC inspection report (IR) No. 99901385/2014-201, dated April 21, 2014 (Agencywide Documents Access and Management System Accession (ADAMS) No. ML14107A383); NON 99901385/2015-201-01 and NON 99901385/2015-201-02, documented in NRC IR No. 99901385/2015-201, dated January 8, 2016 (ADAMS No.
ML15307A198); and NON 99901466/2017-201-01, documented in NRC IR No. 99901466/2017-201, dated June 19, 2017 (ADAMS No. ML17165A387)..
These regulations served as the bases for the NRC inspection:
Appendix B to 10 CFR Part 50 10 CFR Part 21 During the course of this inspection, the NRC inspection team implemented portions of Inspection Procedure (IP) 36100, Inspection of 10 CFR Part 21 and Programs for Reporting Defects and Noncompliance, dated May 16, 2019; IP 43002, Routine Inspections of Nuclear Vendors, dated January 27, 2017; and IP 43004, Inspection of Commercial-Grade Dedication Programs, dated January 27, 2017.
The results of this inspection are summarized below.
10 CFR Part 21 The NRC inspection team reviewed C&Ds policies and implementing procedures that govern the implementation of its 10 CFR Part 21 program. The NRC inspection team: (1) reviewed the 10 CFR Part 21 postings, (2) reviewed a sample of purchase orders (POs), and (3) verified that C&Ds corrective action program provides a link to the 10 CFR Part 21 program. No findings of significance were identified.
Corrective Action The NRC inspection team reviewed C&Ds 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 taken by C&D in response to NON 99901385/2014-201-02, NON 99901385/2014-201-03, NON 99901385/2014-201-04, NON 99901385/2014-201-05, NON 99901385/2015-201-01, NON 99901385/2015-201-02, and NON 99901466/2017-201-01. The NRC inspection team reviewed the documentation that provided objective evidence that all the corrective actions were completed and adequately implemented. Based on the review of the corrective actions, the NRC inspection team closed NON 99901385/2014-201-02, NON 99901385/2014-201-03, NON 99901385/2014-201-04, NON 99901385/2014-201-05, NON 99901385/2015-201-01, NON 99901385/2015-201-02, and NON 99901466/2017-201-01.
During a review of recent condition reports (CRs) the NRC inspection team identified a minor issue related to CR 200022. Procedure BB-QOP 8.5.2 Condition Reporting, requires that for CRs with a significance categorized as Level A, a root cause evaluation be conducted to address the cause and prevent recurrence. The NRC inspection team identified that CR 200022 was categorized as Level A and a root cause evaluation was not performed. It was determined that the reference standard in question was not used to calibrate any data loggers during the period that the standard was affected by an out of tolerance condition. C&D initiated CR 200052 to address this issue. No findings of significance were identified.
REPORT DETAILS
- 1. Corrective Action
- a. Inspection Scope The Nuclear Regulatory Commission (NRC) inspection team reviewed C&D Technologies (hereafter referred to as C&D) 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, 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. Specifically, the NRC inspection team reviewed the implementation and closure of the corrective actions taken in response to Notice of Nonconformance (NON) 99901385/2014-201-02, NON 99901385/2014-201-03, NON 99901385/2014-201-04, and NON 99901385/2014-201-05, documented in NRC inspection report (IR) No. 99901385/2014-201, dated April 21, 2014 (Agencywide Documents Access and Management System Accession (ADAMS) No. ML14107A383);
NON 99901385/2015-201-01 and NON 99901385/2015-201-02, documented in NRC IR No. 99901385/2015-201, dated January 8, 2016 (ADAMS No. ML15307A198); and NON 99901466/2017-201-01, documented in NRC IR No. 99901466/2017-201, dated June 19, 2017 (ADAMS No. ML17165A387).
The NRC inspection team also discussed the corrective action program with C&Ds management and technical staff. The attachment to this inspection report lists the documents reviewed by the NRC inspection team.
- b. Observation and Findings b.1 Corrective Action Associated with NON 99901385/2014-201-02 Following the March 2014 inspection of C&D, the NRC issued NON 99901385/2014-201-02 for C&Ds failure to provide documentation to show that the LCR-21 batteries on C&D Order No. 2393760 were qualified under the most adverse conditions in accordance with the purchase order (PO) specification, Institute of Electrical and Electronics Engineers (IEEE) standard 535-1979, Standard for Qualification of Class 1E Lead Storage Batteries for Nuclear Power Generating Stations. Specifically, C&D referenced a previous type testing report to bound battery qualification for this C&D order; however, the referenced qualification report was not performed in accordance with IEEE 535-1979 with respect to properly aging the batteries to provide assurance that the batteries are capable of performing before, during, and after a seismic event. In its response dated May 21, 2014 (ADAMS No. ML14143A210), C&D stated that it had initiated Corrective Action (CA) No. RS-1037 14-15 to address this issue.
The response stated that C&D Engineering completed a review of Qualification Report (QR 207209) and determined that no issues exist which would compromise the seismic qualification of the LCR-21 batteries.
The NRC inspection team reviewed the documentation that provided the objective evidence for the completion and implementation of the corrective actions, including the review of QR-1-72042. The NRC inspection team confirmed during an interview with the Senior Director of Product Development that the cross-reference spreadsheet of differences with IEEE revisions, TR-00017 IEEE 1E Code Comparison Worksheet, identified IEEE 535-1979 referencing qualification testing per IEEE 323-1974, Qualifying Electrical Equipment to the Harsh Environments of Nuclear Power Plants, and seismic testing per IEEE 344-1975, Recommended Practices for Seismic Qualification of Class 1E Equipment for Nuclear Power Generating Stations, which aligns with the qualification guidelines listed in QR-1-72042. Based on the review of the corrective actions, the NRC inspection team closed NON 99901385/2014-201-02. No findings of significance were identified.
b.2 Corrective Action Associated with NON 99901385/2014-201-03 Following the March 2014 inspection of C&D, the NRC issued NON 99901385/2014-201-03 for C&Ds failure to take measures to review for suitability that ensures and adequately demonstrates that original type testing performed for K-line batteries envelop customer qualification requirements.
Specifically, C&D failed to provide any documentation to show how the differences between the IEEE versions required by PO 00472405 and original K-type testing were evaluated and/or dispositioned with the customer within the qualification report. Also, C&D failed to provide documentation to show that a qualification report existed for PO 00501212, Revision 3, to Exelon (Clinton Power Station). In its response dated May 21, 2014, C&D stated that it had initiated CA No. RS-1037 14-16 to address this issue. The response stated that C&D Engineering developed a formal cross-reference document which bridges the various standard revisions and the original K-type testing with regards to customer requirements. The document shows that the changes to the applicable IEEE standards had no impact on the qualification of the batteries.
The NRC inspection team reviewed the documentation that provided the objective evidence for the completion and implementation of the corrective actions, including review of TR-00017 IEEE 1E Code Comparison Worksheet.
The document showed that the changes to the applicable IEEE standards had no impact on the qualification of the batteries. With respect to PO 00501212, the NRC inspection team reviewed IEEE-323 qualification report to verify the batteries supplied via this PO were qualified and bounded to the original type testing document. Based on the review of the corrective actions, the NRC inspection team closed NON 99901385/2014-201-03. No findings of significance were identified.
b.3 Corrective Action Associated with NON 99901385/2014-201-04 Following the March 2014 inspection of C&D facility, the NRC issued NON 99901385/2014-201-04 for C&Ds failure to assure conditions adverse to quality are identified and corrected. In its response dated May 21, 2014, C&D stated that it had initiated CA No. RS-1037 14-17 to address this issue. The response stated that the procedure for customer complaints has been revised to require
all complaints related to nuclear 1E products require evaluations and verification in accordance with C&Ds 10 CFR Part 21 procedure.
The NRC inspection team reviewed the documentation that provided the objective evidence for the completion and implementation of the corrective actions, including review of the procedure for customer complaints and condition reporting to verify that it had controls in place for assessing nuclear related complaints for 10 CFR Part 21 applicability. Based on the review of the corrective actions, the NRC inspection team closed NON 99990135/2014-201-
- 04. No findings of significance were identified.
b.4 Corrective Action Associated with NON 99901385/2014-201-05 Following the March 2014 inspection of C&D, the NRC issued NON 99901385/2014-201-05 for C&Ds failure to review nonconforming items in accordance with documented procedures. Specifically, the NRC inspection team identified four examples related to commercial-grade dedication (CGD) process where nonconforming conditions were not properly entered in to the nonconformance process. In its response dated May 21, 2014, C&D stated that it had initiated CA No. RS-1037 14-18 to address this issue. The response stated that applicable personnel were trained on the requirements for nonconformances and CGD to ensure thorough understanding of procedural requirements. In addition, C&D reviewed all dedications completed since 2009 to identify those which were closed without generating a nonconformance. Any identified nonconformances were reviewed in accordance with C&Ds 10 CFR Part 21 process.
The NRC inspection team reviewed the documentation that provided the objective evidence for the completion and implementation of the corrective actions, including the attendance sheet for training, documentation for dedication packages review, and the 10 CFR Part 21 applicability review for those nonconformances identified. Based on the review of the corrective actions, the NRC inspection team closed NON 99901385/2014-201-05. No findings of significance were identified.
b.5 Corrective Action Associated with NON 99901385/2015-201-01 Following the September 2015 inspection of C&D, the NRC issued NON 99901385/2015-201-01 for C&Ds failure to take measures to preclude repetition of significant conditions adverse to quality. Specifically, the NRC inspection team identified three examples: 1) C&D closed a CR without correcting the issue that caused them to fail to initiate the 10 CFR Part 21 process and without performing a root cause evaluation to preclude repetition, 2) C&D performed an extent of condition and identified improperly documented nonconformances, however the condition adverse to quality was not corrected nor were the nonconformances entered into the nonconformance process and, 3) a procedure was not developed to ensure that as applicable IEEE standards are revised the qualification is reviewed and the cross-reference document updated to reflect that review, as proposed to address an issue during the 2014 NRC inspection.
In its response dated February 19, 2016 (ADAMS No. ML16054A816), C&D initiated condition report (CR) 16-22 to address this NON. C&D stated that in order to address these issues that changes were made to the customer complaint process and nonconformance program to ensure that all nuclear related product are assessed for applicability to 10 CFR Part 21; redesigned the nonconforming material system in the Attica facility; formed a material review board to review all nonconformances against the 10 CFR Part 21 process; and established periodic performance reviews of nonconforming material conditions and log entries.
The NRC inspection team reviewed the documentation that provided the objective evidence for the completion and implementation of the corrective actions, including the changes made to the customer complaint procedure and verified that it requires all nuclear related complaints be reviewed for applicability to initiate the C&D 10 CFR Part 21 process. Also, the NRC inspection team reviewed the process for nonconformances and had discussions with C&D management on the process and the function of the materials review board.
Furthermore, the NRC inspection team reviewed a sample of the qualification reports and the procedure developed to document the cross-reference for testing and IEEE specifications. Based on the review of the corrective actions, the NRC inspection team closed NON 99901385/2015-201-01.
To verify effectiveness of the corrective action the NRC inspection team selected a sample of eight CRs reports from 2017 through 2020 to ensure that technical deficiencies have been appropriately evaluated, dispositioned, and reported to customers, as applicable. During the review, the NRC inspection team noted that CR 200022 was categorize with a Significance Level A, for a reference voltage standard EDC #2, which was found out of tolerance when calibrated on December 2018 and an out of tolerance evaluation was not performed for this EDC #2.
C&Ds Quality Assurance (QA) manual states that the corrective action procedure provides requirements for determining the causes of nonconformities including the root cause evaluation of significant conditions adverse to quality.
Procedure BB-QOP 8.5.2, Condition Reporting, (previously called Corrective Action) step 6.1.3 states, If the issue is Significance (Level A), determine actions required to address the root causes of the condition and actions to prevent recurrence. It was determined that EDC #2 was not used to calibrate any data loggers during the period that the standard was affected by the out of tolerance condition, therefore no items were delivered to licensees that may have been affected by the out of tolerance condition.
Based on the objective evidence evaluated and that no items were delivered to licensee that could create a situation that the batteries would not be able to perform their intended safety function, the failure to comply with the requirements of procedure BB-QOP 8.5.2 for CR 200022 was considered a minor issue by the NRC inspection team. C&D issued CR 200052 dated September 17, 2020, to address this issue. No findings of significance were identified.
b.6 Corrective Action Associated with NON 99901385/2015-201-02 Following the September 2015 inspection of C&D, the NRC issued NON 99901385/2015-201-02 for C&Ds failure to ensure that portions of the QA program were effectively executed and to verify that activities affecting safety-related functions have been performed correctly. Specifically, C&D failed to take timely and effective corrective actions to address a significant condition adverse to quality. In its response dated February 19, 2016 C&D initiated CRs 16-21 and 16-22 to address this NON. C&D stated that management has been restructured to create a direct reporting of the quality function to the Chief Executive Officer (CEO); established monthly meetings to evaluate corrective actions; and redesigned the functions of the Safety Committee.
The NRC inspection team reviewed the documentation that provided the objective evidence for the implementation of the new restructured and redesigned organizations. Based on the review, the NRC inspection team closed NON 99901385/2015-201-02. No findings of significance were identified.
b.7 Corrective Action Associated with NON 99901466/2017-201-01 Following the May 2017 inspection of C&D, the NRC issued NON 99901466/2017-201-01 for C&Ds failure to verify that internal audits were performed by personnel not having direct responsibilities in the areas being audited. C&Ds QA manual designated a quality system manager responsible for auditing the nonconformance and Part 21 programs. Specifically, during Internal Audit IA-BB-2015-01, C&Ds Corporate Quality Systems Manager audited areas for which he had direct responsibility. In its response dated July 18, 2017 (ADAMS No. ML17216A027), under CR 16-21, C&D stated that actions were taken to enhance auditor independence such as the creation of a matrix to ensure that auditors do not audit an element for which they had direct responsibility; and provided training.
The NRC inspection team reviewed the documentation that provided the objective evidence for the completion of the corrective actions and C&Ds internal audits conducted after the May 2017 inspection. Based on this review, the NRC inspection team closed NON 99901466/2017-201-01. No findings of significance were identified.
c. Conclusion
The NRC inspection team concluded that with the exception of the minor issue identified herein, that C&D has adequately implemented its program for corrective actions associated with NON 99901385/2014-201-02, NON 99901385/2014-201-03, NON 99901385/2014-201-04, and NON 99901385/2014-201-05, described in NRC IR No. 99901385/2014-201, dated April 21, 2014; NON 99901385/2015-201-01 and NON 99901385/2015-201-02, described in NRC IR No. 99901385/2015-201, dated January 8, 2016; and NON 99901466/2017-201-01, described in NRC IR No. 99901466/2017-201, dated June 19, 2017. Based on the limited sample of documents reviewed, the NRC inspection team determined that C&D has taken adequate corrective actions to
resolve the nonconforming conditions identified in the subject NONs. No findings of significance were identified.
- 2. 10 CFR Part 21 Program
- a. Inspection Scope The NRC inspection team reviewed C&Ds policies and implementing procedures that govern the implementation of its Title 10 of the Code of Federal Regulations (10 CFR)
Part 21, Reporting of Defects and Noncompliance, program to verify compliance with the regulatory requirements. The NRC inspection team also evaluated the 10 CFR Part 21 postings and a sample of C&Ds purchase orders (POs) for compliance with the requirements of 10 CFR 21.21, Notification of Failure to Comply or Existence of a Defect and its Evaluation, and 10 CFR 21.31, Procurement Documents. In addition, the NRC inspection team also verified that C&Ds nonconformance and corrective action procedures provide a link to the 10 CFR Part 21 program. Furthermore, for a sample of 10 CFR Part 21 evaluations performed by C&D, the NRC inspection team verified that C&D had effectively implemented the requirements for evaluating deviations and failures to comply.
The NRC inspection team also discussed the 10 CFR Part 21 program with C&Ds management staff. The attachment to this inspection report lists the documents reviewed by the NRC inspection team.
- b. Observations and Findings No findings of significance were identified.
c. Conclusion
The NRC inspection team concluded that C&D is implementing its 10 CFR Part 21 program in accordance with the regulatory requirements of 10 CFR Part 21. Based on the limited sample of documents reviewed, the NRC inspection team also determined that C&D is implementing its policies and procedures associated with the 10 CFR Part 21 program. 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. Bob Malley, Vice President (VP) of Customer Experience, Mr. Vince Grieb, VP of Quality, and other members of C&Ds management and technical staff. On September 18, 2020, the NRC inspection team presented the inspection results and observations during an exit meeting with Mr. Malley, Mr. Grieb, and other members of C&Ds 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 and Persons Interviewed Name Title Affiliation Entrance Exit Interviewed Jonathan Ortega-Luciano Inspection Team Leader NRC X
X Andrea Keim Inspector NRC X
X Dong Park Inspector NRC X
X Kerri Kavanagh*
Chief, Quality Assurance and Vendor Inspection Branch X
Bob Malley Vice President (VP)
Customer Experience C&D Technologies (C&D)
X X
X Christopher Adams Attica Quality Manager C&D X
X Drew D. Heimer Senior Director Product Development C&D X
X X
Eric Lehmann Quality Services C&D X
Fernando Gonzalez Acevedo Attica Plant Manger C&D X
X Kristen Jamison Nuclear Application Engineer C&D X
X Lisa Smith Quality Associate C&D X
X Roger Capps Attica Customer Quality Coordinator C&D X
X Vince Grieb VP Quality C&D X
X Randy Clair Manager, Material Test Lab C&D X
- Teleconference call
- 2. INSPECTION PROCEDURES USED Inspection Procedure (IP) 36100, Inspection of 10 CFR Part 21 and Programs for Reporting Defects and Noncompliance, dated May 16, 2019 IP 43002, Routine Inspections of Nuclear Vendors, dated January 27, 2017 IP 43004, Inspection of Commercial-Grade Dedication Programs, dated January 27, 2017
Att
- 3. LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED Item Number Status Type Description 99901385/2014-201-02 CLOSED NON Criterion III 99901385/2014-201-03 CLOSED NON Criterion III 99901385/2014-201-04 CLOSED NON Criterion XVI 99901385/2014-201-05 CLOSED NON Criterion XV 99901385/2015-201-01 CLOSED NON Criterion XVI 99901385/2015-201-02 CLOSED NON Criterion I 99901466/2017-201-01 CLOSED NON Criterion XVIII
- 4. DOCUMENTS REVIEWED Policies and Procedures C&D Technology Quality Manual, Issue FF, dated March 2, 2018 A-14, Evaluation, Notification & Reporting Responsibilities in Accordance with USNRC 10CFR21 Regulations, Revision 14, dated May 4, 2017 Attica Quality Operating Procedure (AQOP) 8.7, Control of Nonconforming Processes Outputs, Products and Services, Revision E, dated May 27, 2020 AQOP 10, Improvement, Revision B, dated March 5, 2020 AQ Work instruction (WI) 8.2.4.3, Rework/Retest of Nuclear Commercial Grade or IE Safety Related Product, Revision E, dated November 18, 2015 Blue Bell (BB) Quality Operating Procedure (QOP) 7.4.1-b, Supplier Evaluation, Revision 9, dated August 4, 2020 BB-QOP-7.4.3, Commercial Grade Dedication, Revision 7, dated March 15, 2019 BB-QOP-7.4.3b, Suppliers Audit/Commercial Grade Surveys, Revision 8, dated November 30, 2018 BB-QOP-7.6.1, Laboratory Calibration Procedure, Revision 5, dated August 4, 2020 BB-WI 8.2.1-2, Customer Complaints, Revision 10, dated March 26, 2018 BB-QOP-8.2.2, Internal Audit Procedure, Revision 7, dated August 20, 2017 BB-QOP 8.5.2, Condition Reporting (CR), Revision 8, dated August 18, 2017 BB-WI-6.2.2-1, Auditor Qualification, Revision 3, dated August 31, 2017 WI-7.3.6-1, Standard Revision Review for Nuclear Qualifications, Revision 0, dated June 30, 2016
Att Procurement Documents (PO)
Entergy PO 10358362 (C&D order 2393760) for LCR21 Batteries and Accessories, Revision 3, January 8, 2013 PO 00472405 Exelon Braidwood to C&D, Release 1 Revision 2, dated November 09, 2011 PO 00472405 Exelon Byron to C&D, Release 3 Revision 2, dated February 27, 2012 PO 00501212 Exelon Clinton to C&D, Revision 3, dated October 1, 2013 Qualification Reports Nuclear Environmental Qualification Report QR-1-72042, Arkansas Power & Light PO No. 81162, dated February 7, 1983 Nuclear Environmental Qualification Report QR2-07209, Arkansas Power & Light PO No. 01013, dated March 22, 1984 IEEE-323 qualification report for PO K-2988, Clinton Power Station, dated March 20, 1978 Engineering Change Request (ECR)
ECR No. B16-0024 BB Work Instruction-IEEE Code Review, Dated March 2, 2016 ECR000449, PT-04 Test Procedure, Revision 03 (ECN [Engineering Change Notice]
15731 - PT-04 Test Procedure, Revision 03)
Battery Container Dip Test Performance Qualification (PQ) Summary Report, Revision A, dated October 17, 2018 ECR000453, Dedication Plan Redesign (ECN15701 - Consolidated Rib Block Dedication Plan)
Nonconformances (NCRs)
NCR 19-A00220, dated January 27, 2019 NCR 19-A02093, dated August 30, 2019 NCR 19-A03198, dated December 3, 2019 NCR 19-A03220, dated December 8, 2019 NCR 19-A03413, dated December 21, 2019 NCR 20-A00025 dated January 3, 2020 NCR 20-A01779 dated June 15, 2020 NCR 20-A01799 dated June 19, 2020 Customer Complaint (COMP)
COMP-2018-00051, dated March 13, 2018 COMP-2019-00096, dated May 7, 2019 COMP-2020-00063, dated March 11, 2020 Corrective Report (CR)
CR 14 NRC Inspection 99901385/2014-201-02, dated April 23, 2014 CR 14 NRC Inspection 99901385/2014-201-03, dated April 23, 2014
Att CR 16 NRC NON99901385/2015-201-02, dated February 19, 2016 CR 16 NRC NON 99901385 2015-201-01, dated February 19, 2016 CR 18 Wrong Batteries Shipped, dated January 7, 2018 CR 18 Failure to initiate a Deviation Evaluation, dated June 23, 2018 CR 18 Mis-stamped Parts, dated May 30, 2018 CR 18 Purchase order for calibration services contains conflicting requirements, dated July 26, 2018 CR 18 CR 17-68 from 2017 IA not extended in accordance with procedure, dated July 26, 2018 CR 18 Work Instruction is not in alignment with current process, dated July 26, 2018 CR 18 Quality Manager or designee did not approve / disapprove validation for V&V, dated August 2, 2018 CR 18 Use of Calibration Supplier no on C&Ds ASL, dated August 2, 2018 CR 18 Purchase order did not specify the requirements of ISO 17025 for calibration services, dated August 2, 2018 CR 18 Xcel Energy Finding during customer witness for order 2491600 on 9/7/2018, dated September 11, 2018 CR 18-122 - Lot Traceability, dated November 26, 2018 CR 19 Issue with shipped batteries, dated March 21, 2019 CR 19 Visual inspection flame arrestors, dated April 18, 2019 CR 19 CR system not sending automated reminders, dated December 2, 2019 CR 19 Management Review Practices, dated December 9, 2019 CR 20 QMS Internal Audit, dated January 7, 2020 CR 20 Out of Tolerance Reference standard EDC #2, dated April 7, 2020 CR 200017 - Quality program requirements not in alignment with NEI 14-05, dated April 7, 2020 CR 200018 - Contrary to quality manual requirements software formulas are used without been verified and validated, dated April 7, 2020 CR 200019 - Multiple issues recorded with dataloggers that have not resulted in a CAR or NCR, dated April 7, 2020 CR 200020 - Batteries were observed that did not meet FME requirements, dated April 7, 2020 CR 200021 - CFSI inspection not performed in accordance with operating procedure, dated April 7, 2020 CR 200022 - Calibration Standard found out of tolerance and no evaluation was performed, dated April 7, 2020 CR 200023 - Datalogger found listing incorrect error value, dated April 7, 2020 CR 200024 - Shunt calibrated with an incorrect tolerance allowance, dated April 7, 2020 CR 200025 - Nonconformance procedure contains conflicting tagging requirements, dated April 7, 2020 CR 200026 - Quality program requirements not in alignment with NEI 14-05, dated April 7, 2020 CR 200027 - Calibration sequence changed for MIC-1 and procedure not updated to reflect change, dated April 7, 2020 CR 200028 - IA excluded Procurement section for the Bluebell/Horsham locations, dated April 7, 2020
Att Corrective Actions generated during this inspection CR 200049 - Modify Procedure A-14 to correct details in terminology and to clarify responsibilities, dated September 17, 2020 CR 200050 - Document Nuclear Safety Committee standard work processes into a work instruction, dated September 17, 2020 CR 200051 - CSL [Critical Suppliers List] was not updated to include note indicating qualification of all locations of calibration supplier pending review of ISO 17025 certificate, dated September 17, 2020 CR 200052 - Lack of a documented root cause analysis in a Level A Condition Report CR 200022, dated September 17, 2020 Commercial-Grade Dedication Records Material Test Report (MTR) 0000096 - Rib Block, dated September 16, 2020 MTR0000097 - Support Rod, dated September 16, 2020 C&D Order No. 2511764 - Bolt Assembly, dated April 1, 2020 C&D Order No. 2506903 - Bolt Assembly, dated November 6, 2019 Commercial-Grade Surveys/Audit Reports C&D IA-A-2018-01, Nuclear Internal Audit Attica Facility, dated August 9, 2019 C&D IA-BB-2018-01, Nuclear Internal Audit Blue Bell and Horsham Facilities, dated August 8, 2018 C&D IA-A-2019-01, Nuclear Internal Audit Attica Facility, dated January 12, 2020 C&D IA-BB-2019-01, Nuclear Internal Audit Blue Bell, dated January 9, 2020 10 CFR Part 21 Documents NER000145 - Incorrect Connectors, dated May 24, 2018 NER000156 - Crack in Cover, dated July 3, 2018 NER000202 - Plates: Incorrect Markings, dated November 16, 2018 NER000212 - Poor Burn Quality, dated January 21, 2019 NER000234 - Low Electrolyte Level, dated October 28, 2019 NER000236 - Low Electrolyte Level, dated December 9, 2019 NER000242 - Loss of Control of Nuclear Qualified Builder, dated January 27, 2020 NER000247 - Site Inspection and Testing has Resulted in the Findings of One Battery with Cracks in the Post, dated June 10, 2020 NER000250 - Possible Cracked Jar, dated June 23, 2020 Miscellaneous Spreadsheet of differences with IEEE revisions, TR-00017 IEEE 1E Code Comparison Worksheet, Revision 1, dated February 16, 2016 PT-04, Crack and Craze Resistance of Molded Polycarbonate Jars and Parts ECR000449/ECN15731, Revision 3, dated February 12, 2020 DP-CDT-413-0001, Rib Block Dedication Plan, REF. BB-QOP-7.4.3, Revision 0, dated November 20, 2019