ML23221A382
| ML23221A382 | |
| Person / Time | |
|---|---|
| Issue date: | 08/03/2023 |
| From: | Aaron Armstrong NRC/NRR/DRO/IQVB |
| To: | |
| References | |
| Download: ML23221A382 (1) | |
Text
Regulatory Update PeARTS - Procurement engineering And Related Topics Symposium August 3, 2023 Clearwater, FL Aaron Armstrong, Odunayo Ayegbusi and Rebecca Romero-Devore Quality Assurance & Vendor Inspection Branch / Office of Nuclear Reactor Regulation
Topics 2
NRC Vendor Inspection Results Update NRC position on Code Cases and ASME Code Case N-883 Sampling in Commercial-Grade Dedication & Vendor Inspection Procedure Expectations Current status of Regulatory Guide 1.28, Revision 6 Questions
NRC Vendor Inspection Results Update 3
Since the March 2023 meeting, the NRC has completed and issued reports for 10 vendor inspections:
Curtiss-Wright - EMS - Target Rock, Farmingdale, NY Fluke Biomedical Company, Solon, OH Curtiss-Wright, QualTech NP, Cincinnati, OH MPR Associates, Inc., Alexandria, VA Ultra Energy, Round Rock, TX Global Nuclear Fuel - Americas, LLCs (GNF-A)
Wilmington, NC Nutherm International, Inc, Mount Vernon, IL Mistras Services, Trainer, PA Valcor Engineering Corporation, Springfield, NJ Prysmian Group, Willimantic, CT
NRC Vendor Inspection Results Update 4
Vendor Inspections completed, but inspection reports not issued:
ANSYS, Canonsburg, PA Fluor, Greenville, SC
NRC Vendor Inspection Results Update 5
There were 7 findings of significance identified during the above inspections:
Criterion I, Organization 10 CFR 21.21(a)(1), Notification of failure to comply or existence of a defect and its evaluation 10 CFR 21.21(b), Notification of failure to comply or existence of a defect and its evaluation Criterion VII, Control of Purchased Material, Equipment, and Services Criterion X, Inspection Criterion XVI, Corrective Action Criterion XVIII, Audits
NRC Vendor Inspection Results Update 6
Mistras Services Inspection Report 99902109/2023-201:
Criterion I, Quality Assurance Program The NRC inspection team identified that the Mistras Quality Manager: (1) delegated QA functions to individuals within Mistras that did not have sufficient independence from cost and schedule to perform the QA functions, and (2) failed to retain responsibility of the QA functions as required by the Quality Assurance Program.
Mistras failed to ensure reports for Acoustic Emission (AE) inspection of reactor head and internals lift rigs at nuclear power plants were reviewed by individuals who did not perform or supervise the AE inspections contrary to the requirements of the Mistras QA Manual.
NRC Vendor Inspection Results Update 7
Mistras Services Inspection Report 99902109/2023-201:
Two Apparent Part 21 violations for Notification of failure to comply or existence of a defect and its evaluation The two 10 CFR Part 21 findings cited in the inspection report were discussed with Mistras during a Pre-decisional Enforcement Conference held on July 11, 2023.
Enforcement of these potential findings are being finalized.
NRC Vendor Inspection Results Update 8
Prysmian Inspection Report 99900227/2023-201:
Criterion VII, Control of Purchased Material, Equipment, and Services, Prysmian 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 services conform to the procurement documents.
Specifically, Prysmian did not perform an on-site commercial-grade survey of a supplier of calibration services to determine the adequacy of the suppliers quality controls to ensure the critical characteristics of the calibration services continue to be acceptable. Instead, Prysmian performed a fully remote commercial-grade survey of the calibration supplier.
NRC Vendor Inspection Results Update 9
Global Nuclear Fuel - America (GNF-A)
Inspection Report 99901376/2023-201:
Criterion X, Inspection GNF-A failed to ensure that inspections were performed by individuals who do not report to the supervisors responsible for the work being inspected. GNF-A removed the requirement for Quality Inspectors to perform quality inspection activities, such as confirming the proper orientation of the water rod, as a result of a change to a Temporary Operating Procedure.
As a result, the inspection of the water rods proper orientation was performed by shop operations personnel who shared the same first line supervisor and contributed to several water control rods having an incorrect operation that were not identified by the shop operations personnel.
NRC Vendor Inspection Results Update 10 Curtis-Wright - EMS - Target Rock (Target Rock)
Inspection Report 99900060/2023-201:
Criterion XVI, Corrective Action NRC inspection team identified that Target Rock closed corrective action reports without adequately implementing corrective actions to assure that conditions adverse to quality were promptly identified and corrected.
The NRC inspection team identified two corrective action reports (CARs) related to internal audits that were closed.
In both cases, the corrective and preventative action failed to prevent reoccurrence.
Target Rock failed to prevent the reoccurrence of cases where audit reports were issued more than 30 days from a Post-Audit conference or perform internal audits in accordance with a revised audit schedule.
NRC Vendor Inspection Results Update 11 Global Nuclear Fuel - America (GNF-A)
Inspection Report 99901376/2023-201:
Criterion XVIII, Audits The NRC inspection team identified that GNF-A failed to implement a comprehensive system of planned and periodic audits to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program.
As a result, in 2022, GNF-A did not schedule or perform an internal audit of its Fuel Manufacturing Organization (FMO) - Bundle Assembly and, an annual evaluation was not performed. Additionally, supplemental audits were not performed when conditions indicated that the quality of an item was in jeopardy due to deficiencies in the QA program.
Regulatory Process for Codes and Standards 12 10 CFR 50.55a, Codes and Standards, incorporates by reference the ASME B&PV Code.
Lists the Editions and Addenda, Regulatory Guides (RG), and Code Cases that have been approved by the NRC and incorporated by reference in the regulation.
Regulatory Process for Codes and Standards 13 RG 1.84, Design, Fabrication, and Materials Code Case Acceptability, ASME Section III, Revision 39, December 2021 RG 1.147, Inservice Inspection Code Case Acceptability, ASME Section XI, Division 1, Revision 20, dated December 2021 RG 1.192, Operation and Maintenance Code Case Acceptability, ASME OM Code, Revision 4, December 2021 RG 1.193, ASME Code Cases Not Approved for Use, Revision 7, dated December 2021
Regulatory Process for Codes and Standards 14 RG 1.84, identifies Code Cases the NRC has determined to be acceptable alternatives to applicable parts of Section III of the ASME B&PV Code.
10 CFR 50.55a(z) allows the use of alternatives to Code requirements in 10 CFR 50.55a provided that the alternatives:
- Provide an acceptable level of quality and safety, or
- Compliance will result in hardship or unusual difficulty without a compensating increase in the level of quality and safety.
Regulatory Process for Codes and Standards 15 NRC-approved Code Cases provide an acceptable voluntary alternative to the mandatory ASME B&PV Code provisions.
Users of Code Cases are responsible for ensuring it does not conflict with the licensees commitments or regulatory requirements.
NRC position on Code Cases and ASME Code Case N-883 16 What is the purpose of a Code Case?
To clarify the intent of existing requirements.
To allow early implementation of an approved Code revision.
To provide, when there is an urgent need, rules for materials or construction not covered by existing Code rules.
ASME Code Case N-883 17 Code Case N-883 Construction of Items Prior to the Establishment of a Section III, Division 1 Owner
- Approved in RG 1.84, Revision 39 with the following condition:
This Code Case may only be used for the construction of items by a holder of a construction permit, operating license, or combined license under 10 CFR Part 50 or Part 52. This Code Case may not be used by a holder of a manufacturing license or standard design approval or by a design certification applicant.
ASME Code Case N-883 18 Code Case N-883 would allow Certificate Holders to construct components prior to the establishment of an Owner.
NRC concerned with not being able to provide regulatory oversight of the ASME Certificate Holders manufacturing the components:
Not consistent with the requirements in Appendix B to 10 CFR Part 50 and in 10 CFR 50.55a for a basic component
Next Step 19 NRC staff provided feedback to ASME B&PV Code committees to enhance Code Case N-883, specifically to address how owners responsibilities will be fulfilled and the independence of inspections.
NRC is working on different regulatory approaches to consider incorporating the premise of Code Case N-883 into the regulatory framework.
Sampling in the CGD Process 20 What is the goal of commercial-grade dedication?
Acceptance process that provides reasonable assurance that a commercial-grade item to be used as a basic component will perform its intended safety function.
Sampling in the CGD Process 21 Sampling as part of CGD is a way to verify the critical characteristics on a representative statistical sample of commercial-grade items, so you dont have to do 100% verification testing.
Sample plans should be established in accordance with nationally recognized industry standards.
Sample plans should have an adequate documented technical basis.
Sampling in the CGD Process 22 NQA-1, Part II, Subpart 2.14 states:
Sampling plans utilized to select items for special test(s), inspection(s), and/or analyses shall be based upon standard statistical methods with supporting engineering justification and shall consider lot/batch traceability, homogeneity, and the complexity of the item.
Regulatory & Industry Guidance 23 NRC Inspection Procedure (IP) 43004, Inspection of Commercial-Grade Dedication Programs, dated February 10, 2023.
Appendix A, Dedication Issues Basis For The Selection and Verification of Critical Characteristics Regulatory Guide 1.164, Dedication of Commercial-Grade Items for Use in Nuclear Power Plants, Revision 0, dated June 2017.
Electric Power Research Institute (EPRI) 3002002982, Revision 1 to EPRI 5652 and TR 102260, Plant Engineering: Guidelines for the Acceptance of Commercial-Grade Items in Nuclear Safety-Related Applications, dated September 2014.
EPRI 3002002982 refers to EPRI TR-017218-R1, Guideline for Sampling in the Commercial-Grade Item Acceptance Process, dated January 1999.
Regulatory & Industry Guidance 24 Section D.2.9 of EPRI 3002002982 states: Basis for selection of sampling plans. When sampling is used, document the sampling plan selected for each critical characteristic and the basis/factors considered when selecting the sampling plan.
Section 1.4.5 of EPRI TR-017218-R1 states: The commercial grade item acceptance sampling process and the bases for sampling plan selection and application should be adequately documented. Documentation should address such factors as lot formation, complexity of the item, adequacy of supplier control as appropriate, safety function, test methodology, product performance, acceptance history of a supplier, item performance history, and other qualitative factors.
The NRC has not endorsed EPRI TR-017218-R1 or any other sampling method.
Sampling in the CGD Process 25 What does the NRC look for when inspecting sampling as part of CGD? The staff uses IP 43004 to evaluate if there is a:
Documented technical basis and/or engineering justification for the sample plan selected.
Engineering involvement in the selection of the sampling plan.
Documentation should address the factors considered in the selection of the sampling plan (e.g., lot traceability/homogeneity, complexity of the item, performance history, supplier controls, etc.)
Sampling in the CGD Process 26 What is traceability?
The ability to verify history, location, or application of an item by means of recorded identification. (IP 43004)
What is lot/batch control?
Units of product of a single type, grade, class, size, and composition, manufactured essentially under the same conditions and at the same time. (IP 43004)
Current status of Regulatory Guide 1.28, Revision 6 27 The NRC staff has completed its review of NQA-1-2017, NQA-1-2019, and NQA-1-2022; and has initiated the concurrence process for Draft Regulatory Guide 1403, (Proposed Revision 6 of Regulatory Guide 1.28). DG-1403 will endorse parts I and II of NQA-1-2017, 2019, and 2022. The DG will also endorse NEI 14-05A, Revision 1.
The staff is proposing one clarification and two additional regulatory positions:
Now includes Revision 1 to NEI 14-05A for the use of the ILAC alternative.
Part II, Subpart 2.2 - Etching shall not be used on nickel alloys, weld areas, or sensitized areas of stainless steel.
Part II, Subpart 2.5 - Codes and standards are referenced or invoked throughout Subpart 2.5. When the referenced or invoked code or standard becomes superseded or canceled, licensees or applicants need to submit their proposed alternative for NRC review and approval, as appropriate, for continued use of the code or standard or a proposed alternative.
Draft Guide 1403 was published for public comment and the public comment period ended on June 2nd.
No comments requiring resolution were received and the document is going through concurrence for publishing as RG 1.28, Revision 6.
Questions 28