ML24261B892

Pearts - Procurement Engineering and Related Topics Symposium

ML24261B892
Person / Time
Issue date:	08/08/2024
From:	Aaron Armstrong NRC/NRR/DRO/IQVB
To:
References
Download: ML24261B892 (23)

Text

NRC Update PeARTS - Procurement engineering And Related Topics Symposium August 6-8, 2024 Charlotte, NC Aaron Armstrong Quality Assurance & Vendor Inspection Branch Office of Nuclear Reactor Regulation

Topics 2

NRC Vendor Inspection Results Update NRCs Graded Approach to Quality ASME Code Case N-883 Update 9th Vendor Workshop on Vendor Oversight Questions

NRC Vendor Inspection Results Update 3

Since the January 2024 meeting, the NRC has completed and issued reports for 11 vendor inspections:

Paragon Energy Solutions, Fort Worth, TX

ASCO L.P., Aiken, SC

Doosan Enerbility, Changwon, Gyeongnam, Korea

Westinghouse Electric Company, Cranberry Township, PA

TE Connectivity, Fuquay-Varina, NC

Integrated Power Services, Shreveport, LA

Westinghouse Electric Company, Hopkins, SC

NuScale Power, LLC., Corvallis, OR (QA implementation)

Consolidated Power Supply, Birmingham, AL

Hanna Cylinders, Pleasant Prairie, WI

Korea Hydro & Nuclear Power Co, Vienna, VA

NRC Vendor Inspection Results Update 4

Completed Inspections, but report not issued yet:

Energy Steel and Supply Company, Rochester Hills, MI Upcoming Inspections:

Bentley Systems, Incorporated, San Diego, CA Analysis & Measurement Services Corporation, Knoxville, TN Fisher Controls International, LLC, Marshalltown, IA Framatome Fuel Facility, Richland, WA

NRC Vendor Inspection Results Update 5

There were 13 findings of significance identified during the above inspections in the areas of:

Part 21.31,Procurement Documents

(2) Criterion II, Quality Assurance Program

Criterion III, Design Control

Criterion V, Instructions, Procedures, and Drawings

(3) Criterion VII, Control of Purchased Material, Equipment, and Services

Criterion IX, Control of Special Processes

Criterion XII, Control of Measuring and Test Equipment

(3) Criterion XVI, Corrective Action

NRC Vendor Inspection Results Update 6

Hanna Cylinders Inspection Report 99902119/2024-201:

Criterion II, Quality Assurance Program 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, states in part, that the program shall provide for indoctrination and training of personnel performing activities affecting quality as necessary to assure that suitable proficiency is achieved and maintained.

Contrary to the above, as of January 12, 2024, Hanna failed to provide for indoctrination and training of personnel performing activities affecting quality as necessary to assure that suitable proficiency is achieved and maintained.

Specifically, Hanna failed to provide objective evidence that personnel performing activities affecting quality were adequately indoctrinated and trained. Hanna was unable to provide indoctrination and refresher training records from 2020 to present.

NRC Vendor Inspection Results Update 7

Hanna Cylinders Inspection Report 99902119/2024-201:

Criterion VII Control of Purchased Material, Equipment, & Services, of Appendix B to 10 CFR Part 50, states in part, that measures shall be established to assure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents. These measures shall include provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery. The effectiveness of the control of quality by contractors and subcontractors shall be assessed by the applicant or designee at intervals consistent with the importance, complexity, and quantity of the product or services.

Contrary to the above, as of January 12, 2024, Hanna failed to assure that purchased materials and services conform to procurement documents through source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery. Specifically, (1) Safety related services were procured from a supplier to perform internal audits for 2022 and 2023, however there was no objective evidence that the supplier had been audited prior to adding them to the Approved Supplier List (ASL).

(2) At least three commercial suppliers were added to the ASL without Hanna performing a survey and qualification of the suppliers.

(3) Hanna procured parts from at least two suppliers that were not on the ASL and Hanna did not take measures to control the items under its quality assurance program.

NRC Vendor Inspection Results Update 8

Hanna Cylinders Inspection Report 99902119/2024-201:

Criterion XII Control of Measuring and Test Equipment, of Appendix B to 10 CFR Part 50, states in part, that measures shall be established to assure that tools, gages, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specific periods to maintain accuracy within necessary limits.

Contrary to the above, as of January 12, 2024, Hanna failed to assure that gages used in activities affecting quality are properly controlled. Specifically, Hanna failed to adequately control measuring and test equipment (M&TE) and perform an extent of condition review for M&TE that was found to be out of calibration or tolerance, as described by the following examples:

Two ring gages (TR-309 & 340) were found to be out-of-tolerance in June 2023; however, Hanna did not perform an extent of condition review to ensure that these gages were not used to measure or test safety-related material. The NRC inspection team identified that TR-340 was used for a safety-related job that Hanna shipped in July 2022.

One vernier caliper (VNR-76) could not be found. No extent of condition review was performed.

Two plug gauges (PG713 & PG714) were not being controlled on the M&TE Log.

One vernier caliper (VNR-190) was past its calibration due date and in a segregation area on the floor but not tagged.

NRC Vendor Inspection Results Update 9

Hanna Cylinders Inspection Report 99902119/2024-201:

Criterion XVI Corrective Action, of Appendix B to 10 CFR Part 50 states, in part, that measures shall be established to assure that conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations, defective material and equipment, and nonconformances are promptly identified and corrected.

Contrary to the above, as of January 12, 2024, Hanna failed to promptly identify and correct conditions adverse to quality. Specifically, Corrective Action Reports (CARs) 2023-31, 32, 33 were issued on May 25, 2023, and remained open; CAR 2023-30 was closed without completing the corrective action to develop a procedure for controlling items with a shelf-life; at least three CARs between April 2023 and August 2023 had open effectiveness reviews beyond the established 30-day follow-up period; and CARs 2023-34, 35, 36 were issued in June of 2023, subsequently closed, and had no evaluation of the effectiveness of the CARs.

NRC Vendor Inspection Results Update 10 Consolidated Power Supply Inspection Report 99901263/2024-201-01:

Criterion III, Design Control, 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, states, in part, that Measures shall also be established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions for the structures, systems and components.

Criterion VII, Control of Purchased Material, Equipment, and Services, of Appendix B to 10 CFR Part 50, states, in part, that measures shall include provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery.

Contrary to the above, as of February 2, 2024, CPS failed to ensure the selection and review for the suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems, and components (SSC). Further, CPS failed to ensure provisions for examination of products upon delivery. Specifically, as part of the commercial-grade dedication for bar stock, channel strut, and beam materials; CPS failed to verify that certain dimensional critical characteristics such as camber, sweep, flatness, waviness, out of square, end out of square, and length of the item, conformed to the requirements in American Society for Testing and Materials (ASTM) A6, Standard Specification for General Requirements for Rolled Structural Steel Bars, Plates, Shapes, and Sheet Piling. CPS did not perform a physical measurement to verify compliance with the applicable tolerances and only performed a visual inspection to verify these critical characteristics. Adequate verification of all the critical characteristics provides reasonable assurance that the components the materials will be used for will perform their intended safety function.

NRC Vendor Inspection Results Update 11 NuScale Power, LLC (QA Licensing Inspection)

Inspection Report 05200050/2024-201-01 :

Criterion V, Instruction, Procedures, and Drawings, 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, states that Activities affecting quality shall be prescribed by documented instructions, procedures, or drawings, of a type appropriate to the circumstances and shall be accomplished in accordance with these instructions, procedures, or drawings.

Section 2.5, Instructions, Procedures, and Drawings, of NuScales Quality Assurance Program Description (QAPD), states that NuScale has established the necessary measures and governing procedures to ensure that activities affecting quality are prescribed by, and performed in accordance with, instructions, procedures, or drawings of a type appropriate to the circumstances and which, where applicable, include quantitative or qualitative acceptance criteria to implement the QAP as described in this document.

Section 5.2.2 of Engineering Procedure (EP)-0303-2109, Classification of Structures, Systems, and Components, Revision 11, dated August 30, 2023, states that the subject matter expert will review the system functions, design basis events, and functional categorization that have been identified for the SSCs systems and documented in the system function report.

Section 5.1 of LP-102185, 10 CFR 50.46 Reporting, Revision 1, dated October 5, 2023, requires the screening of any change to or error in the Emergency Core Cooling System (ECCS) evaluation model or in the application of the model using 10 CFR 50.46 Screening Form, FM-102395 and report the results to the RM (Responsible Manager). Instruction for Form FM-102395 are included in Appendix A of this procedures.

Contrary to the above, as of March 1, 2024, NuScale failed to perform activities affecting quality in accordance with prescribed instructions, procedures, or drawings. Specifically, NuScale did not adequately adhere to prescribed procedures, EP-0303-2109 and LP-102185, in the following instances:

NuScale failed to appropriately classify engineering calculation (EC) 101197, DHRS Thermal Hydraulic Calculation for the NPM-20, in accordance with EP-0303-2109. EP- 0303-2109 defines safety-related SSCs as those structures, systems and components that are relied upon to remain functional during and following design-basis events to assurethe capability to shut down the reactor and maintain it in a safe shutdown condition. EC-101197 was classified as Non-Safety Related and treated as non-safety-related calculation during NuScales design verification process when its stated scope is, in part, to assess the decay heat removal systems ability to perform its safety-related function to achieve and maintain safe shutdown.

NuScale failed to adhere to the process defined in LP-102185 to perform a screening under 10 CFR 50.46, Acceptance criteria for emergency core cooling systems for light-water nuclear power reactors, of an error in accordance with LP-102185. NuScale did not assess whether combustible gas control accumulation in the reactor coolant system may be an error in the NuScale Design Certification ECCS evaluation model, which must be evaluated against reporting thresholds, as required by 10 CFR 50.46(a)(3).

NRC Vendor Inspection Results Update 12 TE Connectivity Inspection Report 99902123/2024-201:

Criterion VII, Control of Purchased Material, Equipment, and Services, 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, states, in part, that Measures shall be established to assure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents.

Contrary to the above, as of April 12, 2024, TEC failed to establish adequate measures for source evaluation and selection to verify the effectiveness of the control of quality by contractors and subcontractors to assure that purchased products conform to the procurement documents. Specifically, TEC has not performed a commercial-grade survey of the commercial suppliers of spring clamps, ground braid, grease, and insulation covers to verify that the commercial suppliers had established adequate homogeneity and traceability controls (e.g., heat traceability, lot and batch control) and that these controls were being effectively implemented to support TECs selected sample plans. The adequate verification and implementation of a commercial suppliers homogeneity and traceability controls for the control of the critical characteristics is necessary to provide reasonable assurance that commercial-grade items to be used as basic components will perform their intended safety function.

NRC Vendor Inspection Results Update 13 TE Connectivity Inspection Report 99902123/2024-201:

Criterion XVI, Corrective Action, of Appendix B to Title 10 CFR Part 50, states, in part, that Measures shall be established to assure that conditions adverse to quality such as failures, malfunctions, deficiencies, deviations, defective material and equipment, and nonconformances are promptly identified and corrected.

Contrary to the above, as of April 12, 2024, TEC failed to assure that conditions adverse to quality such as failures, malfunctions, deficiencies, deviations, defective material and equipment, and nonconformances are promptly identified and corrected. Specifically, TEC closed several TE Complaint Handling System (TECHS) reports without adequately implementing corrective actions and kept one TECHS report opened without taking any corrections actions to assure that conditions adverse to quality are promptly identified and corrected.

NRC Vendor Inspection Results Update 14 Westinghouse Electric Company (Cranberry Township )

Inspection Report 99900404/2024-201-01:

Criterion VII, Control of Purchased Material, Equipment, and Services, of Appendix B,

Quality Assurance Program Criteria for Nuclear Power Plants and Fuel Reprocessing Plants to Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities, states in part, that Measures shall be established to assure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents. These measures shall include provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery.

Contrary to the above, as of May 10, 2024, WEC failed to ensure that purchased material, equipment, and services from Liberty Electronics conform to the purchase order (PO) requirements. Specifically, WEC did not provide sufficient objective evidence to demonstrate that the requirements imposed in PO 4500858963 for procured calibration services and recording of inspection, measurement and test equipment used were satisfied.

NRC Vendor Inspection Results Update 15 Westinghouse Electric Company (Cranberry Township)

Inspection Report 99900404/2024-201-01:

Criterion XVI, Corrective Action, of Appendix B to 10 CFR Part 50, states in part, that Measures shall be established to assure that conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations, defective material and equipment, and nonconformances are promptly identified and corrected.

Contrary to the above, as of May 10, 2024, WEC failed to correct conditions adverse to quality. Specifically, WEC closed Corrective Action Program-Issue Report (CAP-IR)- 2023-3864 and CAP-IR-2023-11754 without adequately correcting the conditions adverse to quality identified in these CAP-IRs.

NRC Vendor Inspection Results Update 16 Doosan Enerbility, Ltd.

Inspection Report 99901373/2024-201:

Section 21.31, Procurement documents, of Title 10 of the Code of Federal Regulations (10 CFR) Part 21, requires that Each individual, corporation, partnership, dedicating entity, or other entity subject to the regulations in this part shall ensure that each procurement document for a facility, or a basic component issued by him, her or it on or after January 6, 1978, specifies, when applicable, that the provisions of 10 CFR Part 21 apply.

Contrary to the above, as of May 24, 2024, Doosan failed to specify in procurement documents for suppliers of safety-related services and important to safety materials to be procured as basic components that the provisions of 10 CFR Part 21 apply. Specifically, for the procurement of safety-related machining services, Doosan invoked in the purchase orders (POs) that suppliers meet purchase specification No. CF-MPS-001, General Requirements (for foreign company), Revision 17, dated January 20, 2023, rather than imposing the applicable requirements of 10 CFR Part 21. Doosan developed CF-MPS-001 to address the fact that Doosans suppliers of machining services do not implement a program that meets the requirements of 10 CFR Part 21. This procedure relieves Doosans machining suppliers from their responsibilities under 10 CFR Part 21 and requires the suppliers to notify Doosan of any nonconformances identified in the machining services supplied to Doosan. In addition, for the procurement of important to safety materials for a vertical concrete cask, Doosan did not invoke the requirements of 10 CFR Part 21 in the POs.

NRC Vendor Inspection Results Update 17 ASCO L.P.

Inspection Report 99901054/2024-201:

Criterion II, Quality Assurance Program, 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, The program shall provide for the indoctrination and training of personnel performing activities affecting quality as necessary to assure that suitable proficiency is achieved and maintained.

Contrary to the above, as of May 10, 2024, ASCO failed to provide for the training of personnel performing manufacturing and special process activities as necessary to assure that suitable proficiency is achieved and maintained. Specifically, ASCO failed to establish adequate training requirements for personnel performing manufacturing activities and special processes activities and adequately document training for those personnel performing activities affecting quality. ASCO could not provide objective evidence that soldering, and laser welding personnel were adequately qualified to perform these activities.

NRC Vendor Inspection Results Update 18 ASCO L.P.

Inspection Report 99901054/2024-201:

Criterion IX, Control of Special Processes, of Appendix B to 10 CFR Part 50 states that Measures shall be established to assure that special processes, including welding, heat treating, and nondestructive testing, are controlled and accomplished by qualified personnel using qualified procedures in accordance with applicable codes, standards, specifications, criteria, and other special requirements.

Contrary to the above, as of May 10, 2024, ASCO failed to assure that special processes were controlled and accomplished by qualified personnel using qualified procedures in accordance with applicable standards, specifications, criteria, and other special requirements. Specifically, ASCO did not perform the minimum three weekly in-process audits of the laser welding process. Furthermore, ASCO did not perform the required dimensional measurements, and axial load and leakage testing on the laser welded joints for valve SBSA 432910 to ensure they met the required engineering specifications.

NRCs Graded Approach to Quality 19 The NRCs Graded Approach will allow users to identify the structures, systems, and components that should be covered by the QA program. In addition, it will allow users to establish major organizations that will participate in this program and allow the user to designate the function of these organizations.

This QA program is required to provide control over activities affecting quality for the identified structures, systems, and components, to an extent consistent with their importance to safety.

The user must meet the following requirements:

The Graded Approach must be documented.

Graded Approach Users can identify the component and services to be covered.

Graded Approach Users should establish organizations and assign responsibilities to those organizations for the activities affecting quality.

Graded Approach User controls should be consistent with the component or services importance to safety.

NRCs Graded Approach to Quality 20 Surprise, The NRC Graded Approach is 10 CFR Part 50, Appendix B!

Criterion II, Quality Assurance Program, states in part, This program shall be documented by written policies, procedures, or instructions and shall be carried out throughout plant life in accordance with those policies, procedures, or instructions The applicant shall identify the structures, systems, and components to be covered by the quality assurance program and the major organizations participating in the program, together with the designated functions of these organizations The quality assurance program shall provide control over activities affecting the quality of the identified structures, systems, and components, to an extent consistent with their importance to safety..

ASME Code Case N-883 Update 21 The NRC held a public meeting on ASME Code Case N-883 on May 8 and June 11, 2024.

The NRC is evaluating public feedback based on these meeting.

The public meeting slides are available in ADAMS (ML24128A072).

Status of 10 CFR 50.55(a) Issuance 22 Process: Once the NRC receives approval, The NRC will move forward with the publication process (NRC Management signs the rule, the Commission has a 2-week review period, then its sent to the Office of the Federal Register(OFR) and they can take up to 5 days to publish the document)

The ASME Code Cases and Update Frequency final rule was published on July 17, 2024. (https://www.federalregister.gov/documents/2024/07/17/2024-15288/american-society-of-mechanical-engineers-code-cases-and-update-frequency)

The ASME 2021-2022 Code Editions final rule was approved by NRR. We are waiting for approval from OFR to incorporate the codes into 50.55a.

Should be out very soon!

23 Aaron Armstrong Reactor Operations Engineer (301) 415-8396 Aaron.Armstrong@nrc.gov