ML24281A194

Nuclear Regulatory Commission Vendor Inspection Report of Fisher Controls International No. 99900105/2024-201

ML24281A194
Person / Time
Site:	99900105
Issue date:	10/23/2024
From:	Kerri Kavanagh, Frankie Vega NRC/NRR/DRO/IQVB
To:	Hoeger C Fisher Controls International
References
EPID I-2024-201-0045 IR 2024201
Download: ML24281A194 (1)

Text

Ms. Catherine Hoeger Quality Manager Fisher Controls International, LLC 1702 South 12th Avenue Marshalltown, IA 50158

SUBJECT:

NUCLEAR REGULATORY COMMISSION INSPECTION REPORT OF FISHER CONTROLS INTERNATIONAL, LLC NO. 99900105/2024-201

Dear Ms. Hoeger:

On September 9 - 13, 2024, the U.S. Nuclear Regulatory Commission (NRC) staff conducted an inspection at the Fisher Controls International, LLC facility (hereafter referred to as Fisher) in Marshalltown, IA. The purpose of this limited-scope routine inspection was to assess Fishers compliance with the 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 Fishers implementation of quality activities associated with the design, fabrication, and testing of safety-related components (e.g.,

valves, actuators, actuator accessories, replacement parts and/or appurtenances, etc.) being supplied to U.S. nuclear power plants. In addition, the NRC inspection team evaluated Fishers closure of the inspection findings documented in inspection report No. 99900105/2019-201, dated January 8, 2020 (Agencywide Documents Access and Management System (ADAMS)

Accession No. (ML19339F625). The enclosed report presents the results of this inspection. This NRC inspection report does not constitute NRCs endorsement of Fishers 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, of the NRCs Rules of Practice, a copy of this letter, its enclosure(s), and your response will be October 23, 2024

C. Hoeger 2

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/readingrm/adams.html.

Sincerely, Kerri A. Kavanagh, Chief Quality Assurance and Vendor Inspection Branch Division of Reactor Oversight Office of Nuclear Reactor Regulation Docket No.:

99900105 EPID No.:

I-2024-201-0045

Enclosures:

1. Inspection Report No. 99900105/2024-201 and Attachment Signed by Kavanagh, Kerri on 10/23/24

ML24281A194 NRR-106 OFFICE NRR/DRO/IQVB NRR/DRO/IQVB NRR/DRO/IQVB NAME FVega DPark YLaw DATE 10/8/2024 10/8/2024 10/8/2024 OFFICE NRR/ DRO/IQVB NRR/DRO/IQVB NAME MFitzgerald KKavanagh DATE 10/8/2024 10/23/2024

Enclosure U.S. NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR REACTOR REGULATION DIVISION OF REACTOR OVERSIGHT VENDOR INSPECTION REPORT Docket No.:

99900105 Report No.:

99900105/2024-201 Vendor:

Fisher Controls International, LLC 1702 South 12th Avenue Marshalltown, IA 50158 Vendor

Contact:

Ms. Catherine Hoeger Quality Manager Email: Catherine.Hoeger@Emerson.com Phone: (641) 754-3210 Nuclear Industry Activity:

Fisher Controls International, LLC (hereafter referred to as Fisher) is an American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code N (nuclear components) and NPT (nuclear parts) Certificate Holder. Fishers scope of supply includes design, manufacturing, maintenance, repairs and replacement of ASME and non-ASME safety-related control valves, including spare/replacement parts and components and associated engineering for NRCs regulated facilities.

Inspection Dates:

September 9-13, 2024 Inspectors:

Frankie Vega NRR/DRO/IQVB Team Leader Dong Park NRR/DRO/IQVB Yiu Law NRR/DRO/IQVB Remote Michael Fitzgerald NRR/DRO/IQVB Approved by:

Kerri A. Kavanagh, Chief Quality Assurance and Vendor Inspection Branch Division of Reactor Oversight Office of Nuclear Reactor Regulation

2 EXECUTIVE

SUMMARY

Fisher Controls International, LLC 99900105/2024-201 The U.S. Nuclear Regulatory Commission (NRC) staff conducted a limited-scope routine vendor inspection at the Fisher Controls International, LLC (hereafter referred to as Fisher) facility in Marshalltown, IA, to verify that 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. Furthermore, the NRC inspection verified that Fisher had implemented a program in accordance with the applicable requirements of Section III, Rules for Construction of Nuclear Facility Components,Section V, Nondestructive Examination, and Section IX, Welding and Brazing Qualification, of the American Society of Mechanical Engineers Boiler and Pressure Vessel Code, and the American Society for Nondestructive Testing SNT-TC-1A, Personnel Qualification and Certification in Nondestructive Testing. The NRC inspection team conducted this inspection on-site the week of September 9-13, 2024. This was the fourth NRC inspection of Fisher at the Marshalltown facility.

This technically-focused inspection specifically evaluated Fishers implementation of quality activities associated with the design, fabrication, and testing of safety-related components (e.g.,

valves, actuators, actuator accessories, replacement parts, and/or appurtenances) being supplied to U.S. nuclear power plants. In addition, the NRC inspection team evaluated Fishers closure of the inspection findings documented in inspection report (IR) No. 99900105/2019-201, dated January 8, 2020 (Agencywide Documents Access and Management System (ADAMS)

Accession No. ML19339F625).

Specific activities observed by the NRC inspection team included:

1.

Commercial-grade dedication inspection and test activities for a bearing race thrust, taper pin, and a Type 67C series regulator 2.

Hydrostatic testing and seat leakage testing of a 6-inch butterfly valve 3.

Receipt inspection for a box of ten 67-CFR-NUC pressure regulators 4.

Gas tungsten arc welding (GTAW) of a yoke/lower casing 5.

Fluorescent liquid penetrant testing on a 3/4 inch round bar These 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 Defects and Noncompliance, dated February 10, 2023.

3 Inspection Areas The NRC inspection team determined that Fisher established its programs for design control, commercial-grade dedication, procurement document control and oversight of contracted activities, material traceability, manufacturing control, test control, control of measuring and test equipment, and nonconforming materials, parts, or components, corrective action, 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 Fisher is implementing its policies and procedures associated with these programs. In addition, the NRC inspection team determined that Fisher is implementing its 10 CFR Part 21 program for evaluating deviations and reporting defects that could create a substantial safety hazard in accordance with the applicable regulatory requirements. No findings of significance were identified in these areas.

4 REPORT DETAILS 1.

10 CFR Part 21 Program a.

Inspection Scope The NRC inspection team reviewed Fisher Controls International, LLC (hereafter referred to as Fisher) 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. In addition, the NRC inspection team evaluated the 10 CFR Part 21 postings and a sample of Fishers Purchase Orders (POs) for compliance with the requirements of 10 CFR 21.6, Posting requirements, and 10 CFR 21.31, Procurement documents, respectively.

Furthermore, for a sample of 10 CFR Part 21 evaluations performed by Fisher, the NRC inspection team verified that Fisher 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 Fishers 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 Fisher 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 Fisher is implementing its policies and procedures associated with the 10 CFR Part 21 program. No findings of significance were identified.

2.

Design Control a.

Inspection Scope The NRC inspection team reviewed Fishers policies and implementing procedures that govern the implementation of its design control program to verify compliance with the regulatory requirements of Criterion III, Design Control, of Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities.

The NRC inspection team reviewed Fishers procedures related to requirements identification and design activities. The NRC inspection team reviewed design documentation related to a 6-inch butterfly valve, valve body, and plug and stem assembly to ensure that adequate design control measures were applied, verification of

5 American Society of Mechanical Engineers (ASME) Boiler & Pressure Vessel (B&PV)

Code requirements were met, and requirements were correctly and accurately verified.

The NRC inspection team verified the qualifications and documentation of Fishers Certifying Engineers. The NRC inspection team concluded that: (1) Fishers design control process was being adequately implemented in accordance with the applicable regulatory requirements; (2) Fisher had correctly translated the design information into the applicable specifications, drawings, procedures, and instructions; and that (3) design activities were effectively controlled by documented instructions and procedures.

The NRC inspection team also discussed the design control program with Fishers 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 Fisher 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 Fisher is implementing its policies and procedures associated with the design control program. No findings of significance were identified.

3.

Commercial-Grade Dedication

a. Inspection Scope The NRC inspection team reviewed Fishers policies and implementing procedures that govern the implementation of its commercial-grade dedication (CGD) program to verify their 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 six CGD packages for the following components:

bearing race thrust - 1 1/2, pin, taper, type 67C series regulator, yoke, yoke casing and t-ring. Within these CGD packages, the NRC inspection team reviewed: (1) POs; (2) technical evaluations; (3) inspection and test reports; and (4) Certificates of Conformance (CoCs). The NRC inspection team evaluated the criteria for the identification of item functions, credible failure mechanisms/modes, selection of critical characteristics and acceptance criteria, identification of verification methods and justification of the sampling methodologies, as applicable. The NRC inspection team observed inspection and testing (CGD Method 1) activities for the bearing race thrust, taper pin and type 67C series regulator.

The NRC inspection team reviewed 14 commercial-grade survey packages and verified that commercial-grade surveys contained the objective evidence necessary to demonstrate the commercial vendors have adequate controls of the critical characteristics identified by Fisher. The NRC inspection team verified the qualifications of inspectors performing inspection and test activities.

6 The NRC inspection team reviewed Fishers measures for using the International Laboratory Accreditation Cooperation accreditation process in lieu of performing commercial-grade surveys for the procurement of calibration and testing services as part of the CGD process. Fisher implements this process as described in the Nuclear Energy Institute document No.14-05A, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, Revision 1, dated September 2020, which was recognized for use by the NRC in a safety evaluation dated November 23, 2020 (Agencywide Documents Access Management System Accession (ADAMS) No. ML20322A019).

The NRC inspection team also discussed the CGD program with Fishers 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 Fisher 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 also determined that Fisher is implementing its policies and procedures associated with the CGD program. No findings of significance were identified.

4.

Procurement Document Control and Supplier Oversight a.

Inspection Scope The NRC inspection team reviewed Fishers policies and implementing procedures that govern the implementation of its supplier oversight program to verify compliance with the requirements of Criterion IV, Procurement Document Control, and Criterion VII of Appendix B to 10 CFR Part 50.

The NRC inspection team reviewed a sample of POs, Fishers Nuclear Approved Supplier List (NASL), supplier audit reports, and annual evaluations. For the review of the sample of POs, the NRC inspection team verified the POs included, as applicable:

(1) the scope of work; (2) right of access to the suppliers facilities; (3) extension of contractual requirements to sub-suppliers; (4) and the applicable technical, regulatory, and quality requirements.

The NRC inspection team selected a sample of suppliers from the NASL 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 that the audits reports included, as applicable: (1) an audit plan; (2) any findings identified and the associated corrective actions; (3) adequate documented objective evidence of compliance with the applicable requirements; and (4) a documented review by Fishers responsible management. For the review of the annual evaluations, the NRC

7 inspection team confirmed they included the information required by Fishers policies and procedures. In addition, the NRC inspection team also verified that the audits were performed in accordance with the established frequency and by qualified lead auditors and auditors. Furthermore, the NRC inspection team reviewed the training and qualification records of lead auditors and auditors and confirmed that auditing personnel had completed all the required training and had maintained the applicable qualification and certification in accordance with Fishers policies and procedures.

The NRC inspection team also discussed the procurement document control and supplier oversight programs with Fishers 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 Fisher 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 also determined that Fisher is implementing its policies and procedures associated with the procurement document control and supplier oversight programs. No findings of significance were identified.

5.

Material Traceability a.

Inspection Scope The NRC inspection team reviewed Fishers policies and implementing procedures that govern the implementation of its material traceability 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 walkdown of the receipt inspection, nonconforming material, and weld filler material storage areas. The NRC inspection team confirmed that materials were adequately identified with Fishers unique identification code, which is traceable to the POs and vendor certification reports.

The NRC inspection team observed the receipt inspection for a box of ten 67-CFR-NUC pressure regulators. These pressure regulators were commercial-grade items that would be stored in inventory to undergo a CGD process. The NRC inspection team verified that receipt inspection records were reviewed by Fisher for compliance with the requirements of the POs and approved by qualified individuals. The NRC inspection team discussed the receipt inspection process with Fishers quality control inspector.

The NRC inspection team inspected the welding material storage area and reviewed how Fisher documents the use of a new batch of welding material when an old batch is exhausted. The NRC inspection team reviewed a sample of job order-routing trackers associated with the plug/stem assembly and the yoke/lower casing. The NRC inspection

8 team confirmed that only specified and accepted items are used, and that markings are applied using materials and methods that provide a clear and legible identification and do not adversely affect the function or service life of the item.

The NRC inspection team also discussed the material traceability program with Fishers management and technical staff. 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 Fisher is implementing its material traceability 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, the NRC inspection team also determined that Fisher is adequately implementing its policies and procedures associated with the material traceability program. No findings of significance were identified.

6.

Manufacturing Control a.

Inspection Scope The NRC inspection team reviewed Fishers policies and implementing procedures that govern the implementation of its manufacturing control program to verify compliance with the regulatory requirements of Criterion IX, Control of Special Processes, of Appendix B to 10 CFR Part 50, and with the applicable requirements of Section III, Rules for Construction of Nuclear Facility Components,Section V, Nondestructive Examination, and Section IX, Welding and Brazing Qualification, of the ASME B&PV Code, and the American Society for Nondestructive Testing (ASNT) SNT-TC-1A, Personnel Qualification and Certification in Nondestructive Testing.

The NRC inspection team observed the gas tungsten arc welding (GTAW) of a yoke/lower casing, and the fluorescent liquid penetrant testing on a plug/stem assembly 3/4 inch round bar. The NRC inspection team reviewed the following documentation associated with these activities: (1) a sample of work order travelers; (2) test reports; (3) weld certificates; and (4) calibration certificates of the measuring and test equipment (M&TE) used. The NRC inspection team reviewed Fishers procedures for the certification and qualification of welders and nondestructive testing personnel and confirmed they were consistent with the latest revision of the American Society for Nondestructive Testing Recommended Practice SNT-TC-1A and Section III of the ASME B&PV Code. The NRC inspection team performed a walkdown of the weld filler material storage and weld filler material issue areas and verified that welding material was adequately controlled to prevent degradation, inadvertent use, or loss of traceability. The NRC inspection team also reviewed the logs used for issuing weld rods and confirmed that the weld rods were properly issued to the welder. The NRC inspection team confirmed that ovens in the weld electrodes area were held at specified temperatures to control moisture, as applicable, in accordance with the requirements of Section IX of the ASME B&PV Code.

9 The NRC inspection team also discussed the manufacturing control program with Fishers management and technical staff. The attachment to this inspection report lists the documents reviewed by the NRC inspection team.

b.

Observation and Findings No findings of significance were identified.

c.

Conclusion The NRC inspection team concluded that Fisher is implementing its manufacturing control program in accordance with the regulatory requirements of Criterion IX of Appendix B to 10 CFR Part 50. Based on the limited sample of documents reviewed, the NRC inspection team also determined that Fisher is implementing its policies and procedures associated with the manufacturing control program. No findings of significance were identified.

7.

Test Control a.

Inspection Scope The NRC inspection team reviewed Fishers policies and implementing procedures that govern the implementation of its test control program to verify compliance with the requirements of Criterion XI, Test Control, of Appendix B to 10 CFR Part 50.

The NRC inspection team observed hydrostatic testing and seat leakage testing of a 6-inch butterfly valve. The NRC inspection team witnessed Fishers processes for preparing the testing sample, setting up testing equipment and performing the hydrostatic testing and seat leakage testing, and recording the test results. The NRC inspection team discussed the process with the test and laboratory technicians and confirmed that these activities were performed following Fishers procedures. The NRC inspection team reviewed testing documentation pertaining to the 6-inch butterfly valve and Fisher 546 series transducer. The NRC inspection confirmed that the following testing elements were satisfied, verified, and recorded, as appropriate: (1) test parameters and initial conditions; (2) test acceptance criteria; (3) test prerequisites; (4) test instrument range, accuracy, and uncertainty appropriate for the test; (5) current calibration; and (6) any deviations documented and evaluated. The NRC inspection team also reviewed the test records for the completed tests and confirmed that all the test requirements had been met. The NRC inspection team reviewed qualifications of personnel supporting testing activities and confirmed that testing personnel had completed all the required training and had maintained the applicable qualification and certification in accordance with Fishers policies and procedures.

The NRC inspection team discussed the test control program with Fishers management and technical 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.

10 c.

Conclusion The NRC inspection team concluded that Fisher is implementing its test control program in accordance with the regulatory requirements of Criterion XI of Appendix B to 10 CFR Part 50. Based on the limited sample of documents reviewed, the NRC inspection team also determined that Fisher is adequately implementing its policies and procedures associated with the test control program. No findings of significance were identified.

8.

Control of Measuring and Test Equipment a.

Inspection Scope The NRC inspection team reviewed Fishers 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.

The NRC inspection team inspected Fishers Gage Center and interviewed the calibration technician. The NRC inspection team reviewed the calibration records for the M&TE used in activities observed through the inspection week, e.g., welding, liquid penetrant examination, welding material control, hydrostatic test and dedication. The NRC inspection team observed that the M&TE was calibrated, labeled, tagged, handled, stored, or otherwise controlled to indicate the calibration status and its traceability to nationally recognized standards. In addition, the NRC inspection team confirmed that when M&TE is found to be out of calibration, Fisher initiates a nonconformance report and performs an evaluation to determine the extent of condition.

The NRC inspection team also discussed the M&TE program with Fishers 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 Fisher 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 Fisher is adequately implementing its policies and procedures associated with the M&TE program. No findings of significance were identified.

9.

Nonconforming Materials, Parts, or Components and Corrective Action a.

Inspection Scope The NRC inspection team reviewed Fishers policies and implementing procedures that govern the implementation of its nonconforming materials, parts, or components and

11 corrective action program to verify compliance with the requirements of Criterion XV, Nonconforming Materials, Parts, or Components, and Criterion XVI, Corrective Action, of Appendix B to 10 CFR Part 50.

The NRC inspection team reviewed a sample of Nonconformance Reports (NRs) and verified that Fisher: (1) dispositioned the NRs in accordance with applicable procedures; (2) documented an appropriate technical justification for the selected disposition; and (3) took adequate corrective action regarding the nonconforming items, as applicable.

The NRC inspection team also reviewed a sample of Corrective Action Reports (CARs) and verified that the CARs contained, as applicable: (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.

The NRC inspection team also reviewed Fishers corrective actions initiated in response to Nonconformances 99900105/2019-201-01 and 99900105/2019-201-02, identified in the NRCs Inspection Report (IR) No. 99900105/2019-201, dated January 8, 2020 ADAMS Accession No. ML19339F625).

The NRC inspection team also discussed the nonconforming materials, parts, or components and corrective action programs with Fishers 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 Corrective Actions Associated with Nonconformances 99900105/2019-201-01 and 99900105/2019-201-02 Following the November 2019 inspection of Fisher, the NRC issued Nonconformances 99900105/2019-201-01 and 99900105/2019-201-02 for Fishers failure to ensure the suitability of equipment supplied to the nuclear industry. Specifically, in Nonconformance 99900105/2019-201-01, Fisher was cited for its failure to adequately seismically qualify the design of the 546NS electro-pneumatic transducers through suitable qualification testing to verify the adequacy of the design. In Nonconformance 99900105/2019-201-02, Fisher was cited for its failure to adequately environmentally qualify the design of the 546NS electro-pneumatic transducers through suitable qualification testing under the most adverse design conditions to verify the adequacy of the design.

In its response to Nonconformances 99900105/2019-201-01 and 99900105/2019-201-02, dated October 21, 2020 (ADAMS Accession No. ML20300A320), Fisher committed to update their nuclear order processing procedure and processing forms to include a requirement for an alignment meeting with the Application Engineering group when processing nuclear orders. The purpose of this meeting is to define and communicate order scope, schedule, objectives, specifications and requirements to the internal stakeholders who have contribution to the execution of orders and would provide its Application Engineering group greater involvement in the procurement process. Fisher

12 also committed to conduct formal training on responsibilities and changes made to the nuclear order processing procedure and associated forms. Finally, Fisher committed to review all current 546NS Fisher qualification reports (FQRs) and orders to ensure compliance with individual order requirements.

The NRC inspection team reviewed documentation that provided objective evidence for the completion of the corrective actions, including a review of CARs 1924 and 1925. The NRC inspection team verified that Fisher has updated its procedure and forms to include an internal alignment meeting with the Application Engineering group to increase its involvement in the procurement process. The NRC inspection team reviewed meeting summaries of these internal alignment meetings to ensure that these meetings are now part of Fishers regular procurement process. The NRC inspection team also reviewed quality project (QP) report No. 19QP009, 546 Certification to IEEE 323-1983, Revision A, dated October 6, 2020; which was created as part of the corrective actions to address the nonconformances. QP 19QP009 documents the evaluation performed by Fisher on the qualification of the Type 546NS transducers to address the specific technical issues identified in the nonconformances and justify the adequacy of the FQRs. In addition, the NRC inspection team reviewed the updates made to FQR-82, IPEEE 323/344 Qualification Fisher Nuclear Service Type 546 NS I/P Transducer, Revision B, dated July 27, 2022, to ensure these updates addressed the technical concerns in the areas of environmental and seismic qualifications of the 546NS transducer, as identified in the nonconformances. The NRC inspection team noted that Revision B of FQR-82 provides a clear description of the qualification testing performed on the 546NS transducers and this will allow each individual Fisher customer to determine where and how the component could be used within their own facilities. Finally, CARs 1924 and 1925 also described the communications that occurred between Fisher and its customers to ensure the customer had a clear understanding of the qualification issues identified by the NRC and the evaluations performed by Fisher regarding the test sequences and results associated with the specific FQR. Fisher agreed to update CARs 1924 and 1925 to reference QP 19QP009 and therefore described all the corrective actions taken to address the nonconformances.

The NRC inspection team determined that Fishers corrective actions were adequately implemented to address Nonconformances 99900105/2019-01 and 99900105/2019-201-

02. Based on its review, the NRC inspection team closed Nonconformances 99900105/2019-01 and 99900105/2019-201-02.

c.

Conclusion The NRC inspection team concluded that Fisher is implementing its nonconforming materials, parts, or components 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 Fisher is implementing its policies and procedures associated with its nonconforming materials, parts, or components and corrective action programs. No findings of significance were identified.

13

10. Internal Audits a.

Inspection Scope The NRC inspection team reviewed Fishers policies and implementing procedures that govern the implementation of its internal audits program to verify compliance with the requirements of Criterion XVIII, Audits, of Appendix B to 10 CFR Part 50.

The NRC inspection team verified that Fishers procedures described the scope and purpose of audits to be performed, the frequency, audit criteria, and corrective actions when required. For the sample of internal audits reviewed, the NRC inspection team verified that the audit reports included: (1) audit plan; (2) audit results; (3) adequately documented objective evidence with the applicable requirements; and (4) a review by Fishers responsible management. The NRC inspection team verified that the internal audits were performed by qualified auditors who were not auditing their own work and that the internal audits were performed using the appropriate checklists. The NRC inspection team also verified that Fisher adequately initiated and corrected any findings identified during the internal audits.

The NRC inspection team also discussed the internal audits program with Fishers 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 Fisher 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 also determined that Fisher is implementing its policies and procedures associated with the internal audits program. No findings of significance were identified.

11. Entrance and Exit Meetings On September 9, 2024, the NRC inspection team discussed the scope of the inspection with Stephanie Bauder, Vice-President of Operations, Ms. Catherine Hoeger, Quality Manager, and other members of Fishers management and technical staff. On September 13, 2024, the NRC inspection team presented the inspection results and observations during an exit meeting with Ms. Bauder, Ms. Hoeger and other members of Fishers 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.

Att1 ATTACHMENT 1.

ENTRANCE/EXIT MEETING ATTENDEES Name Title Affiliation Entrance Exit Interviewed Catherine Hoeger Quality Manager Emerson x

x x

Alison Clark Quality Engineering Manager Emerson x

x x

Barry Hurst Director Quality Americas Emerson x

x Ben Ahrens Global Quality Director Emerson x

x Brian Sink Quality Engineer Emerson x

x x

Deric Bracy Quality Supervisor Emerson x

x x

Jason Russell Quality Engineer Emerson x

x x

Darrin Nuese Operations Manager Emerson x

Jason Bowers Welding Manager Emerson x

x Edwin Schreuder Global Nuclear Quality & Europe Quality Director Emerson x

Matt Anson Design Qualification Engineer Emerson x

x x

Thomas Steven Nuclear Value Stream Manager Emerson x

June DelGrosso North America Nuclear Director Emerson x

Rande Jones Director of Operations Emerson x

Keith Sink Plant Manager Emerson x

Stephanie Bauder Vice-President, Nuclear Manufacturing &

Service Operations Emerson x

x James Love Quality Control Inspector Emerson x

Tom Leaper Quality Control Inspector Emerson x

Att1 Name Title Affiliation Entrance Exit Interviewed Alexis Tobias Quality Control Inspector Emerson x

Scott Ellis Nuclear Assembler Emerson x

Christopher Brown Quality Control Inspector Emerson x

James Doonan Laboratory Supervisor Emerson x

Shawn Beckham Welding Supervisor Emerson x

John Brones QC Technician Emerson x

Tim Bell Nuclear Inspector Emerson x

Frankie Vega Inspection Team Leader Nuclear Regulatory Commission (NRC) x x

Kerri Kavanagh Branch Chief NRC x

Dong Park Inspector NRC x

x Yiu Law (remote)

Inspector NRC x

x Michael Fitzgerald Inspector NRC x

x 2.

INSPECTION PROCEDURES USED Inspection Procedure (IP) 36100, Inspection of 10 CFR Part 21 and Programs for Reporting Defects and Noncompliance, dated February 10, 2023 IP 43002, Routine Inspections of Nuclear Vendors, dated February 10, 2023 IP 43004, Inspection of Commercial-Grade Dedication Programs, dated February 10, 2023 3.

LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED Item Number Status Type Description 99900105/2019-201-01 CLOSED NON Criterion III 99900105/2019-201-02 CLOSED NON Criterion III

Att1 4.

DOCUMENTS REVIEWED Policies and Procedures Fisher Controls Internationals Nuclear Quality Assurance Manual, Revision 1, dated December 20, 2023 Engineering Practice (EP) 9, A Guide to Nuclear Qualification, Revision B, dated January 29, 1997 Engineering Standard (ES) ES 93, Nuclear Valve Design Reports - ASME Boiler and Pressure ES 94, Design Review Committee, Revision AH, dated June 11, 2004 ES 118, Design Verification Requirements for Valve Components, Revision Q, dated April 2, 2023 ES 119, Design Control Requirements, Revision AE, dated May 1, 2023 ES 121, Control and Maintenance Procedures for Emerson Automation Solutions -

Flow Controls Business Analytical Computer Programs and Databased, Revision V, dated April 24, 2018 ES 142, Identification of Essential-to-Function Parts or Assemblies for Use in Nuclear Safety Related Applications, Revision P, dated July 10, 2018 ES 192, Engineering Change Request Procedure, Revision AH, dated January 22, 2021 ES 206, Laboratory Report Procedures, Revision E, dated May 22, 2019 ES 238, Technical Assessment Process, Revision T, dated April 27, 2023 ES 239, Product Field Evaluation, Revision F, dated July 22, 2009 ES 242, Controlled Documents and Data, Revision T, dated May 4, 2023 ES 243, Control Standard for Calibration and Use of Research and Engineering Lab Test and Measuring Equipment, Revision G, dated October 25, 2016 ES 245, Authorized Signature Requirement, Revision B, dated October 8, 2021 ES 256, Code and Specification Reconciliation for Nuclear Service Replacement Parts and Components, Revision C, dated August 25, 2008 ES 266, Commercial Grade Dedication Requirements for Fisher Manufactured Instruments and Accessories, Revision C, dated March 21, 2024 ES 269, Instrument Engineering Product Development Process, Revision C, dated May 4, 2023 Fisher General Specification (FGS) FGS4L1, Hydrostatic Testing, Revision BA, dated August 17, 2023 FGS4L5, Seat Leak Test for Control Valves, Revision AS, dated April 12, 2022 FGS4L6, Seat Leak Tests for Single and Double-Offset HPBVs, Revision G, dated January 3, 2017 FGS 15B13.2, Supplier Evaluation, Revision N, dated May 13, 2024 Fisher Manufacturing Procedure (FMP) 0E3 Nuclear Purchasing & Unqualified source Revision 4, dated December 15, 2023 FMP20A11, Engineering Change Request Notification (ECRN) Process, Revision 4 dated December 9, 2016

Att1

• FMP12B3, Deionized Water-Testing & Control in Compliance with ASME NQA-1-2017, Revision 9, dated September 24, 2020 FGS 15B 15.9 Auditor/Lead auditor Qualification Revision B, dated November 15, 2017 FGS 15B 13.0 Supplier Quality Procedure, Revision C, dated January 12, 2024 FMP 2H2, Procedure for Control and Calibration of Gauges, Measurement Equipment and Examination Equipment, Revision 65, dated April 21, 2021 FMP 2J3 Qualification of Auditors/Audit Programs, Revision 21, dated February 16, 2024 FMP 2K9, Procedure for Corrective Action, Revision 35, dated April 8, 2024 FMP2K27, Control of Commercial Grade Items to be Dedicated for Use in Nuclear Safety-Related Applications, Revision 29, dated October 10, 2022 FMP 2K29, Processing of Nonconforming Materials and Items, Revision 23, dated February 20, 2024 FMP 2K37 Supplier Evaluation - 10 CFR Part 50, Revision 9, March 10, 2022 FMP 2K41 Requirements for Performing and Reporting Results of Internal Audits for NQAM, QMSM, ATEX and PED Revision 12, dated April 8, 2024 FMP 2K43.1.1 Supplier Evaluation - Accreditation-Calibration Services, Revision 8, dated December 18, 2023 FMP 2K43 Supplier Evaluation - Commercial Grade Survey, Revision 6, dated April 18, 2021 FMP 2K46 Supplier Evaluations-Audits, Survey (Code) and Commercial Grade Surveys, Revision 22, dated April 8, 2024 FMP 2K47 Supplier Qualification and Control Revision 5, dated May 3, 2021 FMP 2K48 Annual Evaluation and Performance Assessment (NASL), Revision 5, dated December 15, 2023 FMP 2Q11 Nuclear Order Processing System - Order Receipt Processing, Revision 7, dated April 30, 2019 FMP 2Q14, Nuclear Order Processing System - Processing of Manufacturing Documentation, Revision 8, dated April 10, 2015 ES 269, Instrument Engineering Product Development Process, Revision C, dated May 4, 2023 General Practice (GP) 1, New Product Development Process, Revision L, dated May 1, 2023 Quality Project (QP) 23QP01 9200 T-Ring, Revision A, dated February 21, 2024 World Manufacturing Procedure (WMP) 7A6, Chloride Testing of Aqueous Manufacturing Solution, Revision E, dated August 20, 2024 Commercial-Grade Dedication Packages 003-T10013580, dated April 7, 2023 Bearing Race, Thrust - 16A0875X042 Pin, Taper - G14178X0072 Type 67C Series Instrument - 63276977 Yoke - AB073637 Diaphragm Casing - AB081430 T-Ring - 24B5041 T-Ring - K14292

Att1 Welding and Nondestructive Examination (NDE) Records Liquid Penetrant Test Report #: PT00028233 Liquid Penetrant Test Report #: PT00028234 Liquid Penetrant Test Report #: PT00028236 Weld Order Card for Job Order No. 39257942 Weld Certificate Control No. 3632 FCI Inspection and Test Report (Form 3126Q), Serial No. AB082066 Purchase Orders (POs), Audit Reports, and Annual Evaluations PO 4780845703, Revision 0, dated June 11, 2024 PO 4780877651, Revision 0, dated September 6, 2024 PO 4780875749, Revision 0, September 3, 2024 PO 4780877652, Revision 0, September 6, 2024 PO 02385926, Revision 6, dated November 28, 2018 PO 02440519, Revision 4, dated January 3, 2023 PO 4780759800, Revision 0, dated October 20, 2023 PO 4780810675, Revision 0, dated March 14, 2024 PO 4780114664, Revision 0, February 11, 2019 PO 4780764317, Revision 0, October 30, 2023 PO 4780299193, Revision 0, April 20, 2020 PO 4780676000, Revision 0, March 20, 2023 PO 4780776518, Revision 0, December 6, 2023 External Audit Report, dated February 26, 2024 External Audit Report, dated June 22, 2023 External Audit Report, dated October 28, 2022 External Audit Report, dated February 28, 2024 Annual Supplier Evaluation, dated April 28, 2024 Annual Supplier Evaluation, dated April 2026, 2024 Annual Supplier Evaluation, dated November 19, 2022 Annual Supplier Evaluation, dated November 19, 2022 Commercial-Grade Surveys 150056816, dated August 24, 2022 50015834, dated December 16, 2021 150031970, dated December 14, 2021 6314, dated September 16, 2022 150044992, dated January 20, 2022 150020803, dated January 17, 2024 150026110, dated January 18, 2023 150007850, dated February 8, 2022 150024620, dated May 25, 2022 5227, dated April 28, 2022

Att1

• Y520, dated February 3, 2022 150002035, dated February 2, 2022 742D, dated November 15, 2022 297D, dated March 27, 2024 Calibration, Inspection, and Test Records Calibration Report #:391629335151747, dated August 28, 2024 Calibration Report #:399389475039211, dated August 28, 2024 Calibration Certificate Number 2024000638, dated April 4, 2024 Calibration Certificate Number WAMO40734-B, dated May 8, 2024 Calibration Certificate Number 1500363175, dated October 6, 2023 Calibration Certificate Number 1500363221, dated October 6, 2023 Calibration Certificate Number 1500363147, dated October 5, 2023 Calibration Certificate Number 1500363163, dated October 5, 2023 Calibration Certificate Number 202396105, dated December 12, 2023 Calibration Certificate Number 5523631030584870, dated December 29, 2023 Calibration Report for 7692675, Stopwatch Calibration Report for PG01712, Pressure Gage Calibration Report for PG26751, Pressure Transducer Calibration Report for PG26752, Pressure Transducer Calibration Report for G10019-0010, Inside Micrometer Calibration Report for G10053-0006, Thread Gage Calibration Report for G10052-0042, Thread Gage Calibration Report for G14447-0005, Outside Diameter Micrometer Calibration Report for G17313-0028, Digital Caliper Calibration Report for G17313-0031, Digital Caliper Calibration Report for G17976-0001, Rockwell Hardness Tester Calibration Report for G18035-0014, Dot Scale Calibration Report for G18045-0017 Caliper Material Traceability Records Certificates of Conformance for PO 4780114664, issued February 11, 2019 CMTR for 3/32x36 LINCOLN ER70S, Lot: 1162Z Nuclear Safety Related Commercial-Grade Item Dedication Inspection Report CGID Plan No: 1481 Traveler for Work Order #39257942 Traveler for Work Order #37945624 Manufacturing Records Routing for Job Order #39257942 Routing for Job Order #37945624

Att1 Internal Audits Reports 2022 Internal Audit report, audit dates April 11-13, 2022 2023 Internal Audit report, audit dates May 1-5, 2023 2024 Internal audit report, audit dates February 5-9, 2024 Nonconformance Reports NC000481301 NC000450867 NC000434062 NC000433948 NC000514859 DISP000335774 NC000514875 DISP000336177 NC000514505 DISP000335777 NC000514425 DISP000335554 NC000514307 DISP000335675 NC000518893 DISP000338857 NC000519448 DISP000339104 Corrective Action Reports CAR #2021, dated February 9, 2024 CAR #2004, dated April 5, 2023 CAR #2005, dated April 5, 2023 CAR# 2026, dated March 7, 2024 CAR #1893, dated December 6, 2019 CAR #1894, dated November 25, 2019 CAR #1896, dated February 12, 2020 CAR #1924, dated November 23, 2020 CAR #1925, dated October 12, 2020 CAR #1963, dated February 7, 2022 CAR #1993, dated April 4, 2023 CAR #1994, dated April 3, 2023 CAR #2011, dated September 3, 2024 CAR #2024, dated May 8, 2024 CAR #2029, dated May 22, 2024 CAR #2036, dated August 26, 2024

Att1 Corrective Action Reports Opened During the NRC Inspection CAR #2052 CAR #2053 CAR #2054 Part 21 Fisher Information Notice FIN 2023-01, Post Weld Heat Treat for PV14 DS102 and DS114, dated August 28, 2023 Training and Qualification Records Brian Sink, Lead Auditor Geremy Neisess Dan Zuelke James Love Tom Leaper Alexis Tobias Christopher Brown James Hogan Zachary Mailahn Steven Smith Matt Hala Additional Documentation FMP2Q11 form for PO 02440519 FMP2Q12 form for PO 02440519 Declaration of Compliance for PO 02440519 NA-23, Vibration and Environmental Testing Report - Type 546 Transducer, dated July 16, 2013 24QN02-CC-01, Type 546NS Transducer Certificate of Conformance for Florida Power

& Light Company, dated November 8, 2023 M20170026, Seismic Testing of the Fisher 546NS Electro-Pneumatic Transducer in Support of 10 CFR Part 21 Investigation, dated February 2017 19QP008, 546 Certification to IEEE-323 - 1974 vs 1983, dated August 9, 2019 19QN66-TC-01, Technical Correspondence - 546 Environmental Qualification to IEEE-323, dated August 7, 2019 FQR-82, Rev. A, Qualification Report IEEE 323/344 Qualification Fisher Nuclear Service Type 546NS I/P Transducer, dated August 24, 2006 19QP009, 546 Certification to IEEE-323 - 1983, dated July 25, 2022 19QP09-TC-01, Summary and Finding Thermodyne Report 4F-3-1-2 Critique, dated October 6, 2020 19QP09-TC-02, Type 546 Qualification Test Program Supplemental Details -

Response to NRC NON 99900105/2019-201-01 and NON 99900105/2019-201-02, dated October 6,2020

Att1

• FQR-82, Rev. B, Qualification Report IEEE 323/344 Qualification Fisher Nuclear Service Type 546NS I/P Transducer, dated July 27, 2022