ML23145A252
| ML23145A252 | |
| Person / Time | |
|---|---|
| Site: | 99900779 |
| Issue date: | 06/05/2023 |
| From: | Kerri Kavanagh NRC/NRR/DRO/IQVB |
| To: | Alexandra Smith Nutherm International |
| References | |
| EPID I-2023-201-0020 IR 2023201 | |
| Download: ML23145A252 (23) | |
Text
Ms. Adrienne Smith, Quality Assurance Manager Nutherm International, Inc.
501 South 11th Street Mount Vernon, IL 62864
SUBJECT:
NUCLEAR REGULATORY COMMISSION VENDOR INSPECTION REPORT OF NUTHERM INTERNATIONAL, INC NO. 99900779/2023-201
Dear Ms. Smith:
On April 24 - 28, 2023, the U.S. Nuclear Regulatory Commission (NRC) staff conducted an inspection at Nutherm International, Inc. (hereafter referred to as Nutherm) facility in Mount Vernon, IL. The purpose of this limited-scope routine inspection was to assess Nutherms compliance with provisions of Title 10 of the Code of Federal Regulations (10 CFR) Part 21, Reporting of Defects and Noncompliance, and selected portions of Appendix B, Quality Assurance Program Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities.
This technically focused inspection specifically evaluated Nutherms implementation of quality activities associated with the qualification and commercial-grade dedication (CGD) of class 1E components for U.S. nuclear power plants. The enclosed report presents the results of the inspection. In addition, the NRC inspection team evaluated Nutherms closure of the inspection findings documented in inspection report No. 99900779/2014-201, dated September 17, 2014 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML14239A200). This NRC inspection report does not constitute NRCs endorsement of Nutherms overall quality assurance (QA) or 10 CFR Part 21 programs.
Within the scope of this inspection, no violations or nonconformances were identified.
In accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding and the NRCs Rule of Practice, a copy of this letter, its enclosure(s), and your response will be made available electronically for public inspection in the NRCs Public Document Room or from the NRCs document system (ADAMS), accessible at http://www.nrc.gov/reading-rm/adams.html.
Sincerely, Kerri Kavanagh, Chief Quality Assurance Vendor Inspection Branch Division of Reactor Oversight Office of Nuclear Reactor Regulation June 2, 2023 Vega, Frankie signing on behalf of Kavanagh, Kerri on 06/02/23
ML23145A252 NRR-106 OFFICE NRR/DRO/IQVB NRR/DRO/IQVB NRR/DRO/IQVB NAME MFitzgerald DPark YDiaz-Castillo DATE 5/26/2023 5/26/2023 5/29/2023 OFFICE NRR/DRO/IQVB NRR/DRO/IQVB NAME OAyegbusi KKavanagh DATE 5/25/2023 6/2/2023
Enclosure U.S. NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR REACTOR REGULATION DIVISION OF REACTOR OVERSIGHT VENDOR INSPECTION REPORT Docket No.:
99900779 Report No.:
99900779/2023-201 Vendor:
Nutherm International, Inc 501 South 11th Street Mount Vernon, IL 62864 Vendor
Contact:
Ms. Adrienne Smith Quality Assurance Manager Phone: 618-244-6000 Ext. 3034 Email: adrienne.smith@nutherm.com Nuclear Industry Activity:
Nutherm International Inc.s scope of supply includes the qualification and commercial-grade dedication of class 1E components for U.S. nuclear power plants.
Inspection Dates:
April 24 - 28, 2023 Inspectors:
Odunayo Ayegbusi NRR/DRO/IQVB, Team Leader Yamir Diaz-Castillo NRR/DRO/IQVB Dong Park NRR/DRO/IQVB Michael Fitzgerald NRR/DRO/IQVB, Trainee Approved by:
Kerri Kavanagh, Chief Quality Assurance and Vendor Inspection Branch Division of Reactor Oversight Office of Nuclear Reactor Regulation
2 EXECUTIVE
SUMMARY
Nutherm International, Inc.
99900779/2023-201 The U.S. Nuclear Regulatory Commission (NRC) staff conducted a limited-scope routine vendor inspection at the Nutherm International, Inc (hereafter referred to as Nutherm) facility in Mount Vernon, IL, to verify it had implemented an adequate quality assurance (QA) program that complies with the requirements of Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to Title 10 of the Code of Federal Regulations (10 CFR)
Part 50, Domestic Licensing of Production and Utilization Facilities, and 10 CFR Part 21, Reporting of Defects and Noncompliance. The NRC inspection team conducted this inspection on-site from April 24 - 28, 2023. The last inspection at this facility was conducted in August 2014.
This technically focused inspection specifically evaluated Nutherms implementation of the quality activities associated with the qualification and commercial-grade dedication (CGD) of class 1E components being supplied to U.S. nuclear power plants. In addition, the NRC inspection team evaluated Nutherms closure of the inspection findings documented in inspection report No. 99900779/2014-201, dated September 17, 2014 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML14239A200).
The following regulations served as the bases for the NRC inspection:
Appendix B to 10 CFR Part 50
10 CFR Part 21 During this inspection, the NRC inspection team implemented Inspection Procedure (IP) 43002, Routine Inspections of Nuclear Vendors, dated February 10, 2023, IP 43004, Inspection of Commercial-Grade Dedication Programs, dated February 10, 2023; and IP 36100, Inspection of 10 CFR Part 21 and Programs for Reporting of Defects and Noncompliance, dated February 10, 2023.
The NRC inspection team observed the following specific activities:
Receipt inspection of six low voltage coils
Contact loading, operation test, and resistance measurement of an auxiliary contact block as part of CGD
Testing of an indicator light as part of CGD
Walkdown of the calibration laboratory and nonconformance storage locker The results of this inspection are summarized below.
Nonconforming Materials, Parts, or Components and Corrective Action The NRC inspection team reviewed the corrective actions that Nutherm took to address Nonconformances No. 99900779/2014-201-01 through 99900779/2014-201-04, documented in
3 inspection report No. 99900779/2014-201, dated September 17, 2014 (ADAMS Accession No. ML14239A200). The NRC inspection team reviewed the documentation that provided the objective evidence that all the corrective actions were completed and adequately implemented.
Based on this review, the NRC inspection team closed Nonconformances No. 99900779/2014-201-01 through 99900779/2014-201-04.
Other Inspection Areas The NRC inspection team determined that Nutherm established its programs for 10 CFR Part 21, nonconforming material, parts, or components, corrective action, design control and qualification, CGD, procurement document control and oversight of contracted activities, identification and control of materials, parts, and components, measuring and test equipment, and internal audits, in accordance with the applicable regulatory requirements of Appendix B to 10 CFR Part 50.
Based on the limited sample of documents reviewed and activities observed, the NRC inspection team also determined that Nutherm is implementing its policies and procedures associated with these programs. No findings of significance were identified in these areas.
4 REPORT DETAILS 1.
10 CFR Part 21 Program a.
Inspection Scope The U.S. Nuclear Regulatory Commission (NRC) inspection team reviewed Nutherm International, Inc.s (hereafter referred to as Nutherm) 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 evaluated the 10 CFR Part 21 postings and a sample of Nutherms purchase orders (POs) to verify 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. The NRC inspection team also verified that Nutherms nonconformance and corrective action procedures provide a link to its 10 CFR Part 21 program.
Furthermore, for a sample of 10 CFR Part 21 evaluations performed by Nutherm, the NRC inspection team verified that Nutherm had effectively implemented the requirements for evaluating deviations and failures to comply. The NRC inspection team verified that the notifications were performed in accordance with the requirements of 10 CFR 21.21, as applicable.
The NRC inspection team also discussed the 10 CFR Part 21 program with Nutherms management and technical staff. The attachment to this inspection report lists the documents reviewed and personnel interviewed by the NRC inspection team.
b.
Observations and Findings No findings of significance were identified.
c.
Conclusion The NRC inspection team concluded that Nutherm 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 Nutherm is adequately implementing its policies and procedures associated with the 10 CFR Part 21 program. No findings of significance were identified.
2.
Nonconforming Materials, Parts, or Components and Corrective Action a.
Inspection Scope The NRC inspection team reviewed Nutherms policies and implementing procedures that govern the implementation of its nonconforming materials, parts, or components and corrective action programs to verify compliance with the requirements of Criterion XV, Nonconforming Materials, Parts, or Components, and Criterion XVI, Corrective Action, of Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to 10 CFR Part 50, Domestic Licensing of Production and
5 Utilization Facilities. The NRC inspection team verified that Nutherms processes and procedures provide for the identification, documentation, segregation, evaluation, and disposition of nonconforming items. These processes also apply the principles of rework/repair, use-as-is, scrap/salvage, return to vendor, or no defect found.
The NRC inspection team observed Nutherms assembly floor operations and verified that nonconforming materials, parts, or components were properly identified, marked, and segregated, when practical, to ensure that they were not reintroduced into the production processes. The NRC inspection team reviewed nonconforming material reports (NCRs) generated between March 2020 to April 12, 2023, associated with the production of safety-related parts to confirm that Nutherm dispositioned the nonconforming materials in accordance with the applicable procedures, documented an appropriate technical justification for various dispositions, and took adequate corrective action regarding the nonconforming items to prevent recurrence, as appropriate.
The NRC inspection team also reviewed a sample of corrective action reports (CARs) to verify: (1) adequate documentation and description of conditions adverse to quality; (2) an appropriate analysis of the cause of these conditions and the corrective actions taken to prevent recurrence; (3) direction for review and approval by the responsible authority; (4) a description of the current status of the corrective actions; and (5) the actions taken to verify timely and effective implementation of the corrective actions.
In addition, the NRC inspection team reviewed Nutherms corrective actions in response to the inspection findings identified in the NRCs inspection report (IR) No.
99900779/2014-201, dated September 17, 2014 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML14239A200).
The NRC inspection team also discussed the nonconformance and corrective action programs with Nutherms management and technical staff. The attachment to this inspection report lists the documents reviewed and personnel interviewed by the NRC inspection team.
b.
Observations and Findings b1. Corrective Action Associated with Nonconformances 99900779/2014-201-01 through 99900779/2014-201-04 Following the NRCs August 2014 inspection at Nutherm as documented in NRCs IR No.
99900779/2014-201, the NRC issued four findings (99900779/2014-201-01 through 99900779/2014-201-04) for Nutherms failures to maintain adequate design control. The four findings consists of: (1) inadequate engineering evaluation for design changes; (2) failure to cite the specific revision of documents imposed by the customer; (3) failure to qualify components under the most severe test sequence as specified by Institute of Electrical and Electronics Engineers (IEEE) Standard 323-1974, Standard for Qualifying Class 1E Equipment for Nuclear Power Generating Stations; and (4) failure to identify critical characteristics for electromagnetic interference (EMI) and radio-frequency interference (RFI) testing, respectively.
In its response dated October 17, 2014 (ADAMS Accession No. ML14303A496), Nutherm stated it initiated a CAR for each finding and described the planned corrective actions to resolve and preclude recurrence of each finding. Specifically, Nutherms planned
6 corrective actions for each finding were to: (1) add an environmental qualification block to drawings to ensure review by the environmental qualification department upon issue or revision; (2) revise Quality Assurance Procedure (QAP) 4.0.00, Procurement Control, and QAP 9.7.6.03, Equipment Qualification, to require identification of a specific revision of documents and train affected staff on the last revision of these two procedures; (3) revise the template for qualification plans to include specific post-accident conditions and train affected staff on the need to include all applicable assumptions in test plans; and (4) revise the template for qualification plans to include specific post-accident conditions and train affected staff on the need to include all applicable assumptions in test plans, respectively.
The NRC inspection team reviewed the documentation that provided the objective evidence for the completion of the corrective actions. The NRC inspection team verified that Nutherm initiated CAR No. 14-CAR-06 for Nonconformance 99900779/2014-201-01.
The NRC inspection team verified that Nutherm added an environmental qualification block to drawings to ensure review by the environmental qualification department upon issue or revision. The NRC inspection team verified that Nutherm initiated CAR No. 14-CAR-07 for Nonconformance 99900779/2014-201-02. The NRC inspection team verified that Nutherm revised QAP 4.0.00 and QAP 9.7.6.03 to require identification of a specific revision of documents and Nutherm trained affected staff on the last revision of these two procedures. The NRC inspection team verified that Nutherm initiated CAR No. 14-CAR-08 for Nonconformance 99900779/2014-201-03. The NRC inspection team verified that Nutherm revised the template for qualification plans to include specific post-accident conditions and Nutherm trained affected staff on the need to include all applicable assumptions in test plans. The NRC inspection team verified that Nutherm initiated CAR No. 14-CAR-09 for Nonconformance 99900779/2014-201-04. The NRC inspection team verified that Nutherm developed a standard format component dedication plan for EMI and RFI testing services and Nutherm trained its affected staff about the dedication of services. Additionally, all EMI and RFI testing services are currently procured as a safety-related service.
The NRC inspection team determined that Nutherms corrective actions were adequately implemented to address Nonconformances 99900779/2014-201-01 through 99900779/2014-201-04. Based on its review, the NRC inspection team closed Nonconformances 99900779/2014-201-01 through 99900779/2014-201-04. No findings of significance were identified.
c. Conclusion
The NRC inspection team concluded that Nutherm is implementing its nonconformance and corrective action programs in accordance with the regulatory requirements of Criterion XV and Criterion XVI of Appendix B to 10 CFR Part 50. Based on the limited sample of documents reviewed, the NRC inspection team also determined that Nutherm is implementing its policies and procedures associated with its nonconformance and corrective action programs. No findings of significance were identified.
7 3.
Design Control and Qualification a.
Inspection Scope The NRC inspection team reviewed Nutherms policies and procedures that govern the implementation of its design control program to verify compliance with the requirements of Criterion III, Design Control, of Appendix B to 10 CFR Part 50. The NRC inspection team selected a sample of Nutherms qualification reports provided to U.S. nuclear power plants and reviewed relevant POs, design reports, customer specifications, drawings, test procedures, and engineering design changes. Nutherm is the original equipment manufacturer (OEM) for limited items and indicated that there were no original design activities underway for safety-related items.
The NRC inspection team reviewed a design package for a Nutherm 120 VAC / 24 VDC Power Supply Model No. 55320, to verify that the documents included the correct technical and regulatory requirements per the customer specifications, Nutherms procedures, and the applicable IEEE requirements. The NRC inspection team reviewed engineering design changes to the Nutherm 120 VAC / 24 VDC Power Supply Model No.
55320 to verify that it incorporated the flexible location of the power supply components.
The NRC inspection team verified that Nutherms design control process effectively translated the design change request into the affected Nutherm documentation.
The NRC inspection team reviewed the engineering evaluations and associated test reports to support the acceptability of a Square D Nutherm Model No. 9036DW31-NM294 Float Switch Assembly, including the thermal aging calculation of the switchs Rynite 530 material. The NRC inspection team verified that any activation energies used in the thermal aging analysis had a proper reference and were appropriate for the characteristic most associated with the safety function of the component.
The NRC inspection team also discussed the design control program with Nutherms management and technical staff. The attachment to this inspection report lists the documents reviewed and personnel interviewed by the NRC inspection team.
b.
Observations and Findings No findings of significance were identified.
c.
Conclusion The NRC inspection team concluded that Nutherm is implementing its design control program in accordance with the regulatory requirements of Criterion III of Appendix B to 10 CFR Part 50. Based on the limited sample of documents reviewed, the NRC inspection team also determined that Nutherm is implementing its policies and procedures associated with the design control program. No findings of significance were identified.
8 4.
Commercial-Grade Dedication a.
Inspection Scope The NRC inspection team reviewed Nutherms policies and implementing procedures that govern the implementation of its commercial-grade dedication (CGD) program to verify compliance with the regulatory requirements of Criterion III and Criterion VII, Control of Purchased Material, Equipment, and Services, of Appendix B to 10 CFR Part 50.
The NRC inspection team reviewed a sample of CGD documents associated with the CGD of the following items: (1) solenoid valve; (2) temperature switch; (3) circuit breakers; (4) integrated circuit chips; (5) silicone fluid; (6) contactor; (7) auxiliary contact blocks; (8) indicating light; and (9) relays. The CGD documents reviewed included, as applicable: (1) CGD plans; (2) technical evaluations; (3) failure modes and effect analysis (FMEA); (4) receiving inspection reports; (5) component dedication planners; (6) equivalency evaluations; (7) lot homogeneity comparison sheets; and (8) project travelers.
The NRC inspection team evaluated the criteria for the identification of the safety functions, FMEA, selection of critical characteristics and acceptance criteria, selection of verification methods, and the justification provided for the of the sampling methodologies, as applicable, to verify effective implementation of Nutherms CGD process. The NRC inspection team confirmed that Nutherms CGD process provides reasonable assurance that the items and services being dedicated will perform their intended safety function.
The NRC inspection team also observed the verification of a sample of critical characteristics as part of the CGD of an auxiliary contact block. The NRC inspection team verified that Nutherms laboratory technician was adequately following the testing plan and documenting the inspection results. In addition, the NRC inspection team confirmed the laboratory technician was using calibrated measuring and testing equipment (M&TE) to take the appropriate measurements. Furthermore, the NRC inspection team reviewed the training and qualification records of the laboratory technician and confirmed he had completed all the required training and had maintained the applicable qualification and certification in accordance with Nutherms policies and procedures.
The NRC inspection team also discussed the CGD programs with Nutherms management and technical staff. The attachment to this inspection report lists the documents reviewed and personnel interviewed by the NRC inspection team.
b.
Observations and Findings No findings of significance were identified.
c.
Conclusion The NRC inspection team concluded that Nutherm is implementing its CGD program 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, the NRC inspection team determined that Nutherm is implementing its policies and procedures associated with the CGD program. No findings of significance were identified.
9 5.
Procurement Document Control and Oversight of Contracted Activities a.
Inspection Scope The NRC inspection team reviewed Nutherms policies and implementing procedures that govern the implementation of its procurement document control and supplier oversight programs to verify compliance with the regulatory requirements of Criterion IV, Procurement Document Control, and Criterion VII of Appendix B to 10 CFR Part 50.
The NRC inspection team reviewed Nutherms approved supplier list (ASL), and a sample of POs, supplier audits, job travelers, and receipt inspection records. For the sample of POs reviewed, the NRC inspection team verified that the POs included, as appropriate: scope of work, right of access to the suppliers facilities, and conditions and restrictions imposed to sub-suppliers. The NRC inspection team confirmed that the POs adequately invoked the applicable technical, regulatory, and quality requirements. In addition, the NRC inspection team verified that for the sample of receipt inspection records reviewed (e.g., receipt inspection reports, Certificates of Compliance, and Certificate of Calibration), these records were (1) reviewed by Nutherm for compliance with the requirements of the POs, (2) approved by qualified individuals, and (3) the records contained the applicable technical and regulatory information. The NRC inspection team performed a walkdown of the receipt and quality control inspection areas.
The NRC inspection team selected a sample of suppliers from the ASL to review the methodology for conducting and documenting audits to verify adequate evaluation of the suppliers controls for meeting the applicable requirements of Appendix B to 10 CFR Part
- 50. For the sample of supplier audits reviewed, the NRC inspection team verified the following: the audit reports included an audit plan; audits were performed according to established frequency; audit reports included adequate documented objective evidence of compliance with the applicable requirements; and audit documentation was reviewed by Nutherms responsible management. The NRC inspection team also verified that audits performed by the Nuclear Industry Assessment Committee were evaluated by Nutherm in accordance with its written procedures for applicability to its scope of activities.
The NRC inspection team also discussed the procurement document control and supplier oversight programs with Nutherms management and technical staff. The attachment to this inspection report lists the documents reviewed and personnel interviewed by the NRC inspection team.
b.
Observations and Findings No findings of significance were identified.
c.
Conclusion The NRC inspection team concluded that Nutherm is implementing its procurement document control and supplier oversight programs in accordance with the regulatory requirements of Criterion IV and Criterion VII of Appendix B to 10 CFR Part 50. Based on the limited sample of documents reviewed, the NRC inspection team determined that Nutherm is adequately implementing its policies and procedures associated with the
10 procurement document control and supplier oversight programs. No findings of significance were identified.
6.
Identification and Control of Materials, Parts, and Components a.
Inspection Scope The NRC inspection team reviewed Nutherms policies and implementing procedures that govern the implementation of its material identification and control program to verify compliance with the regulatory requirements of Criterion VIII, Identification and Control of Materials, Parts, and Components, of Appendix B to 10 CFR Part 50.
The NRC inspection team performed a walk-down of Nutherms facility and verified that components were identified with a traceability number that is attached with a label to the component. The traceability number is based on Nutherms PO number. The NRC inspection team also noted that the traceability number is included in all the documentation associated with the component, as applicable.
The NRC inspection team observed the receipt inspection of six low voltage coils to be used in a contactor. The NRC inspection team observed the receipt inspector use calibrated M&TE to perform the inspection in accordance with Nutherms policies and procedures. In addition, the NRC inspection team observed the receipt inspector generated a traceability number and used a label to attach it to the coils. The traceability number was also recorded on the receiving inspection report.
The NRC inspection team discussed the material identification and control program with Nutherms management and technical staff. The attachment to this inspection report lists the documents reviewed and personnel interviewed by the NRC inspection team.
b.
Observations and Findings No findings of significance were identified.
c.
Conclusion The NRC inspection team concluded that Nutherm is implementing its material identification and control program in accordance with the regulatory requirements of Criterion VIII of Appendix B to 10 CFR Part 50. Based on the limited sample of documents reviewed and direct observation of material control practices in Nutherms facility, the NRC inspection team determined that Nutherm is adequately implementing its policies and procedures associated with the material identification and control program.
No findings of significance were identified.
7.
Control of Measuring and Test Equipment a.
Inspection Scope The NRC inspection team reviewed Nutherms policies and implementing procedures that govern the implementation of its M&TE program to verify compliance with the requirements of Criterion XII, Control of Measuring and Test Equipment, of Appendix B to 10 CFR Part 50.
11 For a sample of M&TE, the NRC inspection team determined that the M&TE had the appropriate calibration stickers and current calibration dates, including the calibration due date. The NRC inspection team also verified that the M&TE had been calibrated, adjusted, and maintained at prescribed intervals prior to use. In addition, the calibration records reviewed by the NRC inspection team indicated the as-found or as-left conditions, accuracy required, calibration results, calibration dates, and the due date for recalibration. Furthermore, the NRC inspection team verified that the selected M&TE used in the CGD of the auxiliary contact block was calibrated and labeled, and the associated certificate of calibration stated the traceability to a nationally recognized standard.
The NRC inspection team confirmed that when M&TE equipment is found to be out of calibration, an NCR is initiated, and an evaluation is performed to determine if the M&TE was previously used. The NRC inspection team performed a walk-down of Nutherms calibration laboratory to observe that M&TE were labeled, handled, and stored in a manner that indicated the calibration status of the instrument and ensured its traceability to calibration test data.
The NRC inspection team discussed the control of M&TE with Nutherms management and technical staff. The attachment to this inspection report lists the documents reviewed and personnel interviewed by the NRC inspection team.
b.
Observations and Findings No findings of significance were identified.
c.
Conclusion The NRC inspection team concluded that Nutherm is implementing its M&TE program in accordance with the regulatory requirements of Criterion XII of Appendix B to 10 CFR Part 50. Based on the limited sample of documents reviewed, the NRC inspection team also determined that Nutherm is implementing its policies and procedures associated with the M&TE program. No findings of significance were identified.
8.
Internal Audits a.
Inspection Scope The NRC inspection team reviewed Nutherms policies and implementing procedures that govern its internal audit program to verify compliance with the requirements of Criterion XVIII, Audits of Appendix B to 10 CFR Part 50.
The NRC inspection team reviewed Nutherms internal audit plans, internal audit reports, and CARs generated during internal audits when applicable. The NRC inspection team verified that the audit documents reviewed were adequately completed and that Nutherm adequately corrected the conditions identified in CARs generated during internal audits.
The NRC inspection team verified that Nutherms procedures described the scope and purpose of audits to be performed, the frequency, audit criteria, and corrective actions when required. The NRC inspection team verified that the audit teams consisted of
12 qualified auditors and that they were not auditing their own work. The NRC inspection team verified that internal audits were performed using checklists.
The NRC inspection team discussed the internal audits program with Nutherms management and technical staff. The attachment to this inspection report lists the documents reviewed and personnel interviewed by the NRC inspection team.
b.
Observations and Findings No findings of significance were identified.
c.
Conclusion The NRC inspection team concluded that Nutherm is implementing its internal audits program in accordance with the regulatory requirements of Criterion XVIII of Appendix B to 10 CFR Part 50. Based on the limited sample of documents reviewed, the NRC inspection team determined that Nutherm is adequately implementing its policies and procedures associated with the internal audit program. No findings of significance were identified.
9.
Entrance and Exit Meetings On April 24, 2023, the NRC inspection team presented the inspection scope during an entrance meeting with Mr. Tom Sterbis, Nutherms President, and other members of Nutherms management and technical staff. On April 28, 2023, the NRC inspection team presented the inspection results to Mr. Sterbis and other members of Nutherms 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-1 ATTACHMENT 1.
ENTRANCE/EXIT MEETING ATTENDEES Name Position Affiliation Entrance Exit Interviewed Adrienne Smith Quality Assurance Manager Nutherm International, Inc.
(Nutherm)
X X
X Tom Sterbis President Nutherm X
X Wade Bowlin Vice President Nutherm X
X Roger Edwards Engineering Manager Nutherm X
X X
Kyle Mitchell Assistant Engineering Manager Nutherm X
X Eric Cermak Equipment Qualification Manager Nutherm X
X X
Jack Burton Laboratory Production Manager Nutherm X
X X
Aaron Evrard Quality Control Inspector Nutherm X
X Dennis Miller Receipt Inspector Nutherm X
X Louis Mines Laboratory Technician Level II Nutherm X
Odunayo Ayegbusi Inspection Team Leader Nuclear Regulatory Commission (NRC)
X X
Dong Park Inspector NRC X
X Yamir Diaz-Castillo Inspector NRC X
X Michael Fitzgerald Inspector NRC X
X Eva Brown Acting Branch Chief NRC X
Att-2 2.
INSPECTION PROCEDURES USED:
Inspection Procedure (IP) 43002, Routine Inspections of Nuclear Vendors, dated February 10, 2023
IP 43004, Inspection of Commercial-Grade Dedication Programs, dated February 10, 2023
IP 36100, Inspection of 10 CFR Part 21 and Programs for Reporting of Defects and Noncompliance, dated February 10, 2023 3.
LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED Item Number Status Type Description 99900779/2014-201-01 CLOSED Nonconformance Criterion III 99900779/2014-201-02 CLOSED Nonconformance Criterion III 99900779/2014-201-03 CLOSED Nonconformance Criterion III 99900779/2014-201-04 CLOSED Nonconformance Criterion III 4.
DOCUMENTS REVIEWED Quality Assurance Procedures (QAP)
QA-N-10179-5, Quality Assurance Manual, Revision 6, dated November 4, 2019
QAP 1.00.00, Organization, Revision 8, dated March 26, 2015
QAP 2.0.00, Terms and Definitions, Revision 4, dated October 7, 2019
QAP 2.0.01, Qualification and Certification of Audit Personnel, Revision 5, dated January 13, 2023
QAP 2.0.03, Management Review of the Quality Assurance Program, Revision 3, dated March 26, 2015
QAP 2.7.02, Personnel Training, Revision 8, dated October 7, 2019
QAP 2.7.04, Qualification and Certification of Inspection, Examination and Testing Personnel, Revision 6, dated October 7, 2019
QAP 3.0.00, Design Control, Revision 15, dated October 7, 2019
QAP 3.0.01, Project Management, Revision 10, dated March 6, 2019
QAP 3.0.02, Preparation, Review and Approval of Calculations, Revision 5, dated September 22, 2005
QAP 4.0.00, Procurement Control, Revision 14, dated June 3, 2020
QAP 5.0.00, Instructions, Procedures and Drawings, Revision 8, dated October 11, 2018
QAP 6.0.00, Document Control, Revision 11, dated October 7, 2019
QAP 6.0.01, Control of Quality Related Forms, Revision 6, dated September 22, 2005
QAP 7.0.01, Supplier Evaluation, Revision 7, October 7, 2019
QAP 7.1.00, Control of Purchased Items and Services, Revision 23, dated October 7,
Att-3 2019
QAP 8.1.00, Identification and Control of Items, Revision 0, dated October 7, 2019
QAP 8.2.00, Identification and Control of Electrical Wire, Revision 2, dated September 22, 2005
QAP 8.2.01, Identification and Control of Metal, Revision 7, dated September 22, 2005
QAP 9.7.6.03, Equipment Qualification, Revision 8, dated October 13, 2014
QAP 9.7.6.03, Equipment Qualification, IPCN No.: 1, Revision 8, dated April 10, 2023
QAP 9.7.10.19, Dedication of Commercial Grade Items, Revision 21, dated January 16, 2023
QAP 12.2.00, Control of Calibrated Measuring and Test Equipment, Revision 15, dated October 7, 2019
QAP 13.2.00, Storage of Items, Revision 8, dated October 7, 2019
QAP 15.0.00, Control of Nonconforming Items, Revision 11, dated October 7, 2019
QAP 16.1.00, Corrective Action, Revision 10, dated October 7, 2019
QAP 16.1.00, Corrective Action, IPCN 1, dated January 16, 2023
QAP 17.1.00, Collection, Storage, and Maintenance of Quality Assurance Records, Revision 12, dated October 7, 2019
QAP 18.1.00, Audit System, Revision 13, dated October 7, 2019
QAP 19.0.00, Trending, Revision 4, dated March 26, 2015
QAP 19.1.00, Reporting of Defects, Revision 9, dated October 29, 2010
QCI 18.0.00, Evaluation of Third-Party Assessment Reports, Revision 2, January 31, 2019
Measuring and Test Equipment (M&TE) Procedure Index No. 2021-07-30
Quality Control Inspection (QCI) No. 4.0.00, Planning, Performing, and Reporting Source Activities, Revision 2, dated July 28, 2014
QCI No. 18.1.00, Supplemental Guideline for Commercial Grade Survey Activities, Revision 0, dated January 5, 2010
Technical Procedure, Contact Resistance Measurements, Revision 1, dated May 26, 2011 Design Documents
Drawing No: 71572, Sheets 1-8, Nutherm 120 VAC / 24 VDC Power Supply Model
- 55320, Revision O
Project Traveler No.15392-01, Nutherm Power Supply Model 55320 S/N 15392-01
Bill of Materials, Drawing No. 71573, Revision R
EGC-14888R, Nutherm Qualification Report - Square D/Nutherm Model 9036DW31-NM294 Float Switch Assembly for R.E. Ginna Nuclear Plant, Revision 0, dated April 14, 2022
EGC-14888P, Nutherm Qualification Test Plan - Square D/Nutherm Model 9036DW31-NM294 Float Switch Assembly for R.E. Ginna Nuclear Plant, Revision 2, dated December 16, 2021
Nutherm Qualification Report CWE-8598R, Revision 1
Nutherm International, Inc., Interim Procedure Change Notice, Equipment Qualification, IPCN No.: 1, dated April 10, 2023
EQ Drawing Revision Evaluation Sheet, Nutherm Ref. No.: CEG-15566, Drawing/Rev.:
71572 Revision O
ROD-1197, Reviews of Discrepancy, Revision 3
Memorandum,
Subject:
FT-IR Analysis Specimen Selection Revised 07/22/2014
Att-4 Commercial Grade Dedication Packages (CGD) and Critical Characteristics Attribute and Verification sheets
Commercial Grade Item Dedication Technical Evaluation 1002-TE-01, Revision 5
Commercial Grade Item Dedication Technical Evaluation 1002-TE-06, Revision 1
Certificate of Conformance No. CC-15670 for a solenoid valve, Revision 0, dated February 14, 2023
Certificate of Conformance No. CC-15661-1 for a temperature switch, Revision 0, dated March 24, 2023
Certificate of Conformance No. CC-15619-1 for a circuit breaker, Revision 0, dated October 6, 2022
Certificate of Conformance No. CC-15209-1 for integrated circuit components and chips, Revision 0, dated August 3, 2022
Certificate of Conformance No. CC-15564-1 for silicone fluid, Revision 0, dated November 8, 2022
Comparison of NTL and NQI for Nutherm Project No. CEG-15728, Item 1 (right side contactor only), dated April 20, 2023
Comparison of NTL and NQI for Nutherm Project No. CEG-15728, Item 2 (coil only),
dated April 24, 2023
Comparison of NTL and NQI for Nutherm Project No. TBA-15670, Item 1, (valve only),
dated January 19, 2023
Comparison of NTL and NQAI for Nutherm Project No. PSE-15661, Item 1, dated January 3, 2023
Comparison of NTL and NQAI for Nutherm Project No. CEG-15716, Item 1, dated April 11, 2023
Commercial Grade Item Dedication Technical Evaluation No. 1068-TE-01, General Electric/ABB/Nutherm Contactor with Low Voltage Coil, P/N: CR305C002-NM203, Revision 3, dated July 29, 2022
Commercial Grade Item Dedication Technical Evaluation No. 1096-TE-01, Parker Hannifin Solenoid Valve, P/N: 73212BN52N00N0C222C8, Revision 1, dated February 3, 2023
Commercial Grade Item Dedication Technical Evaluation No. 1328-TE-01, United Electric Temperature Switch, P/N: B402-120, Revision 2, dated March 17, 2023
Commercial Grade Item Dedication Technical Evaluation No. 1479-TE-01, Eaton Circuit Breaker, P/N: EHD2060, Revision 0, dated September 2, 2022
Commercial Grade Item Dedication Technical Evaluation No. 1462-TE-01, Harris Semiconductor 555 Timer, P/N: CA55T, Revision 1, dated May 10, 2022
Commercial Grade Item Dedication Technical Evaluation No. 1176-TE-01, Silicone Transformer Fluid, P/N: SF97-50 or Clearco STO-50, Revision 1, dated February 17, 2022
Commercial Grade Item Dedication Technical Evaluation No. 1499-TE-01, General Electric Indicating Light, P/N: 116B6708G3, Revision 1, dated April 24, 2023
Commercial Grade Item Dedication Technical Evaluation No. 1002-TE-06, General Electric (GE)/ABB Auxiliary Contact Block, P/N: CR305X100E, Revision 1, April 18, 2023
Commercial Grade Item Dedication Technical Evaluation No. 1002-TE-01, General Electric (GE)/ABB Auxiliary Contact Block, P/N: CR305X Series, Revision 5, dated April 19, 2023
Commercial Grade Item Dedication Technical Evaluation No. 1040-TE-01,
Att-5 Eaton/Nutherm Relays, P/N: D26MRD22A1, Revision 4, dated October 24, 2022
Component Dedication Planner (CDP) No. 15728-01 for a contactor, NEMA Size 2, 600VAC, 27A Continuous, with Low Voltage Coil, Revision 0, dated April 20, 2023
CDP No. 15670-01 for a solenoid valve, 5-300 PSI, 240V coil, Revision 1, dated February 2, 2023
CDP No. 15661-01 for a temperature switch, 0-225 F, 2-SPDT, complete with mounting bracket, Revision 0, dated March 3, 2023
CDP No. 15619-01 for a circuit breaker, thermal magnetic, 60A, 2 pole, 480VAC, 250VDC, Revision 0, dated September 8, 2022
CDP No. 15209-01 for a 555 timer, 4.5-18V, 8 pin, metal can, Revision 0, dated May 10, 2022
CDP No. 15209-02 for a dual op-amp, +/- 22V supply, +/- 30 V differential input voltage, 10 pin, metal can, Revision 0, dated June 21, 2022
CDP No. 15664-01 for silicone transformer fluid, polydimethysiloxane, Revision 0, dated October 13, 2022
CDP N0. 15728-01 for a contactor, NEMA size 1, 600VAC, 27A continuous with low voltage coil, Revision 0, dated April 20, 2023
CDP No. 15716-01 for an auxiliary contact adder block, 1 NC, size 0-9, Revision 1, dated April 19, 2023
CDP No. 15689-01 for an indicating light, no color cap, 125 VDC, Revision 0, dated April 25, 2023
Dedication Plan No. 15619-DP-01, Dedication Plan for Eaton Circuit Breaker P/N:
EHD2060, Revision 0, dated September 2, 2022
Dedication Plan No. 15209-DP-01, Harris Semiconductor 555 Timer, P/N: CA555T, Revision 0, dated April 25, 2022
Engineering Instruction No. 15716-EI-01, Contact Loading and Operation Test, Revision 0, dated April 10, 2023
Dedication Plan No. 15209-DP-02, Texas Instruments Dual OP-AMP, P/N: LM747H, Revision 0, dated May 16, 2022
Dedication Plan No. 15689-DP-01, Indicating Light, P/N: 116B6708G3, Revision 1, dated April 24, 2023
Failure Modes and Effects Analysis (FMEA) No. 6008-FMEA, Contactor, Revision 0, dated June 15, 2016
FMEA No. 6046-FMEA, Solenoid Valve, Revision 0, dated March 2, 2017
FMEA No. 6058-FMEA, Thermal Cutout/Temperature Controller/Temperature Switch, Revision 1, dated May 30, 2018
FMEA No. 6015-FMEA, Molded Case Circuit Breaker, Revision 0, dated March 31, 2022FMEA No. 6140-FMEA, Integrated Circuit Chip, Revision 0, dated April 18, 2022
FMEA No. 6071-FMEA, Transformer Dielectric Fluid, Revision 0, dated December 14, 2017
FMEA No. 6003-FMEA, Auxiliary Contact Block, Revision 0, dated June 10, 2016
FMEA No. 6014-FMEA, Indicating Light, Revision 0, dated July 8, 2016
Lot Homogeneity Comparison Sheet for Nutherm Project No. CEG-15728, Purchase Order (PO) No. 15728-001, Item 1, dated April 20, 2023
Lot Homogeneity Comparison Sheet for Nutherm Project No. CEG-15728, PO No.
15728-001, Item 2, dated April 24, 2023
Lot Homogeneity Comparison Sheet for Nutherm Project No. PSE-15661, PO No. 15661-001, Item 1, dated January 3, 2023
Lot Homogeneity Comparison Sheet for Nutherm Project No. ENS-15619, PO No. 15619-
Att-6 001, Item 1, dated August 29, 2022
Lot Homogeneity Comparison Sheet for Nutherm project No. CEG-15209, PO No.
MRA102974, Item 1, dated March 3, 2022
Lot Homogeneity Comparison Sheet for Nutherm Project No. CEG-15209, PO No.
MRA102974, Item 2, dated March 3, 2022
Lot Homogeneity Comparison Sheet for Nutherm Project No. CEG-15716, PO NO.
15716-001, Item 1, dated April 11, 2023Material Analysis Report (MAR) No. MAR-708, United Electric Temperature Switch, Revision 0, dated February 8, 2023
MAR No. MAR-702, Clearco Dielectric Fluid, P/N: STO-50, Revision 0, dated November 3, 2022
Memorandum to Engineering and EQ Departments from Roger Edwards, FT-IR Analysis Specimen Selection Revised 07/22/2014, dated July 22, 2014
Memorandum to TVA-15670 from Kyle Mitchell, Inspector Critical Characteristics Acceptance Criteria Verification, dated February 6, 2023
Memorandum to ENS-15619 from Tiffany Kluck, Inspector Critical Characteristics Acceptance Criteria Verification, dated October 5, 2022
Memorandum to Project File PSE-15661 from Eric Cermak, Materials Memo, dated March 17, 2023
Memorandum to PSE-15661 from Tyler Garlock, Inspector Critical Characteristics Acceptance Criteria Verification, dated March 17, 2023
Project Traveler No. 15670-01 for TVA-15670, Revision 1, dated February 13, 2023
Project Traveler No. 15661-01 for PSE-15661, Revision 0, dated January 9, 2023
Project Traveler No. 15619-01 for ENS-15619, Revision 0, dated September 8, 2022
Project Traveler No. 15209-01 for CEG-15209, Revision 0, dated May 10, 2022
Project Traveler No. 15209-02 for CEG-15209, Revision 0, dated June 1, 2022
Project Traveler No. 15689-01 for XLE-15689, Revision 0, dated April 25, 2023
Project Traveler No. 15716 for CEG 15716, Revision 0, dated April 10, 2023
Project Traveler No. 15689-01 for XLE-15689, Revision 0, dated April 25, 2023
Record of Dedication (ROD)-900 for a contactor and reversing starter, test specimens No. NTL-6683, 6675, 6676, and 6677, dated May 16, 2022
ROD No. ROD-1344 for a coil, test specimen No. NTL-6380, Revision 0, dated March 15, 2015
ROD No. ROD-1650 for a circuit breaker, various test specimen, Revision 1, dated November 18, 2019
Review of Discrepancy No. ROD-1623 for a solenoid valve, test specimen No. NTL-6380, Revision 1, dated January 27, 2023
Review of Discrepancy No. ROD-1698 for a temperature switch, test specimen NTL-7171, Revision 1, dated February 8, 2023
Review of Discrepancy No. ROD-1712 for a temperature switch, test specimen NTL-7170/7171, Revision 1, dated February 9, 2023
Review of Discrepancy No. ROD-1197 for an auxiliary contact block, test specimens NTL-6678, 6679, and 6680, Revision 3, dated November 30, 2022
Receiving Inspection Report (RIR) No. 19697 for six contactors, PO No. 15728-001, dated April 19, 2023
RIR No. 19646 for one solenoid valve, PO No. 15670-001, dated January 18, 2023
RIR No. 19700 for six coils, PO No. 15728-001, dated April 24, 2023
RIR No. 19632 for two temperature switches, PO No. 15661-001, dated January 3, 2023
RIR No. 19552 for five circuit breakers, PO No. 15619-001, dated August 26, 2022
RIR No. 19689 for an indicating light, PO No. 15689-001, dated April 3, 2023
Att-7
RIR No. 19693 for an auxiliary contact, PO No. 15716-001, dated April 11, 2023
Test Specification No. TPG-0103, Contact Resistance Measurements, Revision 1, dated April 3, 2023
Test Specification No. TPG-0304, Indicator Light Testing, Revision 1, dated April 25, 2023 Audit/Survey
23-01-INT, Nutherm International Intern Audit, dated February 17, 2023
Third Party Assessment Evaluation of the Nuclear Industry Assessment Committee (NIAC) Audit, Inc, dated August 24, 2021
Nutherms Third Party Assessment Evaluation of NIACs Audit at, Inc, dated March 14, 2023
Nutherms External Audit, dated November 23, 2021 Purchase Orders
PO No. 14953-006, Revision 1, dated April 6, 2020
PO No. 00819681, Revision 2, dated April 27, 2021
PO No. 01389049, Revision 2, dated March 20, 2023
PO No. 2022-027, Revision 0, dated June 15, 2022
PO No. 2022-041, Revision 0, dated August 19, 2022
PO No. 2022-052, Revision 0, dated November 7, 2022
PO No. 2022-056, Revision 1, dated December 5, 2022
PO No. 2023-007, Revision 0, dated February 8, 2023
PO No. 15728-001 for six General Electronic/ABB contactors and six General Electronic/ABB coils, Revision 0, dated April 13, 2023
PO No. 15670-001 for one skinner solenoid valve, Revision 0, dated December 21, 2022
PO No. 15661-001 for two temperature switches, Revision 0, dated December 16, 2022
PO No. 15619-001 for five circuit breakers, Revision 0, dated August 23, 2022
PO No. 15564-001 for silicone fluid, Revision 0, dated May 6, 2022
PO No. 15664-004 for chemical testing services, Revision 0, dated October 5, 2022
PO No. 1589-001 for an indicating light, Revision 0, dated March 9, 2023
PO No. 01391386 from Constellation Energy for four contactors Revision 2, dated April 17, 2023
PO No. 7403335 from Tennessee Valley Authority for a skinner solenoid valve, Revision 1, dated January 12, 2023
PO No. 4501224262 from Public Service Electric and Gas Company for a temperature switch, Revision 1, dated March 4, 2023
PO No. 10677555 from Entergy for circuit breakers, Revision 1, dated October 4, 2022
PO No. 01349750 from Constellation Energy for integrated circuit components and chips, Revision 1, dated March 1, 2022
PO No. 01366616 from Constellation Energy for capacitors, Revision 0, dated August 30, 2022
PO No. 01355174 from Constellation Energy for silicone fluid, Revision 1, dated May 2, 2022
PO No. 01391386 from Constellation Energy for a motor starter contactor with low voltage coil, Revision 2, dated April 17, 2023
Att-8
PO No. 4000029057 from Xcel Energy for an indicating light, Revision 0, dated March 1, 2023
PO No. 00723498, Revision 0, dated March 1, 2023
PO No. 00654922, Revision 5, dated March 4, 2021
PO No. 00613475, Revision 12, dated October 24, 2022
PO No. 00819681, Revision 2, dated April 27, 2021 Measuring and Test Equipment Documents
Certificate of Calibration No. 1327597 for power system timer, dated January 24, 2022
Certificate of Calibration No. 3329659 for 0-6-inch caliper, dated January 18, 2023
Certificate of Calibration No. 3300269 for 0-12-inch caliper, dated December 12, 2022
Certificate of Calibration No. 3200439 for 10-lb weight, dated July 29, 2022
Certificate of Calibration No. 3359651 for thermometer, dated March 21, 2023
Certificate of Calibration No. 3329661 for digital multimeter, dated January 18, 2023
Certificate of Calibration No. 3329660 for digital multimeter, dated January 18, 2023
Certificate of Calibration No. 3272518 for digital multimeter, dated October 20, 2022
Certificate of Calibration No. 3329659 for digital multimeter, dated January 18, 2023
Certificate of Calibration No. NI-594, for weigh scale, dated January 18, 2023
Certificate of Calibration No. Nl-676 Stanley Tape Measure, Model 33-425, dated April 6, 2023 Nonconformance Reports (NCRs)
NCRs 7076 - 7123 (2020)
NCRs 7124 - 7200 (2021)
NCRs 7201 - 7207, 7211 - 7283 (2022)
NCRs 7284 - 7298, 7302, 7305, 7306 (2023)
Corrective Action Reports (CARs) Reviewed During the NRC Inspection:
14-CAR-01
14-CAR-03
14-CAR-04
14-CAR-05
14-CAR-06
14-CAR-07
14-CAR-08
14-CAR-09
20-CAR-01
20-CAR-02
20-CAR-03
21-CAR-01
21-CAR-02
22-CAR-01
22-CAR-02
22-CAR-03
22-CAR-04
23-CAR-01
Att-9 10 CFR Part 21 Records
20-CAR-01
20-CAR-02 (2020-29)
22-CAR-01 (2022-08)
22-CAR-02 (2022-21)
Training Records
Lead Auditor Qualifications and Certification Record of Frances Faulkenberg
Lead Auditor Qualifications and Certification Record of Adrienne Smith
Training and Qualification Records of Dennis Miller, Aaron Evrard, and Louie Mines Miscellaneous
2022 Annual Trending Report, dated February 14, 2023
2022 Annual QA Program Review, dated February 15, 2023
Form 56564-13, Quality Assurance Program Requirements for Nuclear Vendors, Revision 13