ML24261B890
| ML24261B890 | |
| Person / Time | |
|---|---|
| Issue date: | 01/25/2024 |
| From: | Aaron Armstrong, Odunayo Ayegbusi NRC/NRR/DRO/IQVB |
| To: | |
| References | |
| Download: ML24261B890 (21) | |
Text
NRC Update PeARTS - Procurement engineering And Related Topics Symposium January 23-25, 2024 Clearwater, FL Aaron Armstrong & Odunayo Ayegbusi Quality Assurance & Vendor Inspection Branch Office of Nuclear Reactor Regulation / Office of Nuclear Reactor Regulation
Topics 2
Update on Mistras Services Inspection and Investigation NRC Vendor Inspection Results Update Update on Draft Regulatory Information Summary Requiring Assessment of DOE Labs, Draft Regulatory Guide (RG) 1415 and Draft RG 1416 NRC position on ASME Code Case N-883 Questions
Mistras Services Findings Update 3
Vendor Inspection performed March 6-10, 2023 Evaluated nondestructive examination services provided for safety-related equipment Inspection Report (ML23151A458)
Resulting enforcement actions included:
Two Violations (SL IV) for Part 21 Notifications One Nonconformance against Criteria I - Organization Department of Justice (DOJ) Prosecution of Mistras Personnel On October 18, 2023, DOJ issued a press release announcing that two men pled guilty for their roles in creating false calibration certificates in a matter within the jurisdiction of the NRC.
Both helped create and transmit final testing reports to the owners of the plants which, among other things, contained calibration certificates for the equipment used.
Both created numerous false calibration certificates for AE testing equipment, and 15 of these false certificates were sent a total of 29 times to nuclear plant owners as part of final testing reports required by the NRC. The falsified calibration certificates were discovered in 2021 during an NUPIC audit.
Both are scheduled to be sentenced on Jan. 25, 2024. Each faces a maximum penalty of five years in prison.
Mistras Services Findings Update 4
Office of Investigation Report 1-2022-003 (ML23340A106) -
December 2023 Resulting enforcement action - 1 apparent violation:
10 CFR 50.5(a)(2) Deliberate misconduct Criterion XVII Quality Assurance Records Criterion XII Control of Measuring and Test Equipment Mistras has requested Alternative Dispute Resolution (ADR)
NRC Vendor Inspection Results Update 5
Since the August 2023 meeting, the NRC has completed and issued reports for 7 vendor inspections:
Fluor, Greenville, SC ANSYS, Canonsburg, PA Velan Inc., Montreal, Canada Westinghouse Electric Company, Cranberry Township, PA Namco Controls, Elizabethtown, NC Thermo Fisher Scientific, Oakwood Village, OH Henry Pratt Company, Kimball, TN
NRC Vendor Inspection Results Update 6
Vendor Inspections completed, but inspection reports not issued:
Hanna Cylinders, Pleasant Prairie, WI Upcoming:
KHNP - Safeguards Information Consolidated Power Supply Westinghouse Columbia Fuel Cycle Facility NuScale Standard Design Approval Application QA Implementation
NRC Vendor Inspection Results Update 7
There were 7 findings of significance and 1 Unresolved Item(URI) identified during the above inspections in the areas of:
Criterion II, Quality Assurance Program (2)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 (2) Criterion XVI, Corrective Action Criterion IV and Criterion VII, Procurement Document Control and Control of Purchased Material, Equipment, and Services URI - Part 21.51, Maintenance and Inspection of Records
NRC Vendor Inspection Results Update 8
Ansys Corporation Inspection Report 99902113/2023-201:
Criterion II, Quality Assurance Program
Ansys Quality Manual and its referenced documents do not include provisions for ensuring that measures are established to assure that applicable regulatory requirements and the design basis for those Ansys products that Appendix B to 10 CFR Part 50 applies to are correctly translated into specifications. The Ansys Quality Manual and referenced procedures do not provide consistent definitions of what constitutes design specifications or requirements. Ansys Quality Manual and referenced procedures do not have provisions to establish controls for traceability from specifications and requirements to software design and code.
Ansys Quality Manual does not include provisions for establishing measures for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems and components and establishment of provisions to assure that purchased material, equipment, and services conform to the procurement documents, when applied to the use of third-party software. Third party software includes open source and freeware software integrated into Ansys products.
Ansys Quality Manual does not include provisions for ensuring activities affecting quality are prescribed by documented instructions, procedures, or drawings, of a type appropriate to the circumstances and are accomplished in accordance with these instructions, procedures, or drawings.
Ansys Quality Manual references specific policies, procedures, and work instructions, but does not specify the adherence to these documents for accomplishing specific requirements within the Quality Manual. In addition, instructions, procedures, or drawings do not specify appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished.
Ansys Quality Manual and its referenced procedures do not include requirements for the prompt identification and resolution of conditions adverse to quality. Specifically, Ansys Quality Manual and procedure QP-14, Corrective and Preventive Actions, Revision 12, do not specify that conditions adverse to quality must be promptly identified and corrected.
NRC Vendor Inspection Results Update 9
Ansys Corporation Inspection Report 99902113/2023-201:
10 CFR Part 21.21, Notification of failure to comply or existence of a defect and its evaluation, Paragraph (a)(1)
Ansys failed to adopt appropriate procedures to evaluate deviations and failures to comply and identify defects as soon as practicable.
Ansys implementing procedure for 10 CFR Part 21 only requires reporting of Class 3 errors to purchasers of its products in lieu of reporting any departures from technical requirements included in a procurement document, per the definition of a deviation in 10 CFR 21.3.
As a result, Ansys failed to perform an adequate evaluation of a deviation in its products to determine a defect exists, or notify Ansys customers of all deviations (e.g., non-class 3 errors) so that they may evaluate the deviations, pursuant to
§ 21.21(a).
NRC Vendor Inspection Results Update 10 Ansys Corporation Inspection Report 99902113/2023-201:
10 CFR Part 21.21, Notification of failure to comply or existence of a defect and its evaluation, Paragraph (b)
Ansys failed to inform its customers or purchasers within five working days of determining that Ansys does not have the capability to perform an evaluation of a deviation to determine if a defect exists.
Specifically, Class 3 error reports 2022-013, 2022-016, 2022-108, and 2023-059, were sent to Ansys customers 21 to 65 days from Ansys classification of these errors as Class 3.
NRC Vendor Inspection Results Update 11 Ansys Corporation Inspection Report 99902113/2023-201:
Criterion XVI, Corrective Action Ansys failed to correct conditions adverse to quality. Ansys closed two Corrective Action Reports (CARs) without adequately correcting the conditions adverse to quality identified in these CARs.
ANSYS Vendor Inspection 12 Vendor Inspection performed June 26-30, 2023.
Evaluated software development and support services provided for safety-related services.
Inspection Report documents (ML23237B258):
Inadequate Part 21 procedures and actions related to notification to the Commission and Purchasers.
Company failed to establish a quality assurance program that met the applicable provisions of Appendix B to 10 CFR Part 50. Specifically, procedures failed to document the policies, procedures, and instructions of a quality assurance program which complies with Appendix B.
Resulting enforcement actions included:
Two Violations (SL IV) for Part 21 Notifications Two Nonconformances against Criteria II & XVI NRC received a response from ANSYS on October 10, 2023 (ML23285A168), in which ANSYS stated that they are a provider of commercial grade software products and does not accept any responsibility for Part 21 reporting.
NUPIC led a team of nuclear industry organizations in a meeting with ANSYS on November 17, 2023.
NRC is awaiting a revised response from ANSYS.
NRC Vendor Inspection Results Update 13 Namco Controls Inspection Report 99901470/2023-201:
Corrective actions implemented by Namco to address two of the four findings in the 2016 NRC inspection report (No.
99901470/2016-202), dated August 29, 2016 (ADAMS Accession No. ML16238A509) were not effective to prevent recurrence.
Namco failed to provide objective evidence that nonconforming items dispositioned as re-work were re-inspected to original specification requirements, as required by Namco Standard Procedure 60-0004 Processing Nonconforming Material, Parts, Components and Services.
This issue was previously identified as part of NON 99901470/2016-202-02.
Namco failed to ensure that for mandatory hold points specified in procedures, the work did not proceed beyond such hold points until the required inspections were complete. This issue was previously identified as part of NON 99901470/2016-202- 04.
NRC Vendor Inspection Results Update 14 Henry Pratt Company LLC (HPCO), Kimball, TN.
Inspection Report 99902116/2023-201:
Criterion IV, Procurement Document Control, and Criterion VII, Control of Purchased Material, Equipment, and Services HPCO failed to assess the effectiveness of the control of quality by contractors and subcontractors.
HPCO did not invoke the applicable requirements in the procurement documents for protective coating on safety-related valves, procurement of water testing services to ensure the water meets the chemistry requirements used in hydrostatic testing and cleaning of safety-related valves.
HPCO did not perform an assessment of the paint supplier and the water testing suppliers to verify the adequate implementation of their quality controls associated with the manufacturing of the paint and the supply of water testing services.
NRC Vendor Inspection Results Update 15 Henry Pratt Company LLC (HPCO), Kimball, TN.
Inspection Report 99902116/2023-201:
Unresolved Item (URI) - 10 CFR 21.51(a)(1)
HPCO was unable to provide objective evidence that Part 21 evaluations over the last five years were retained. HPCO started its search for the objective evidence necessary to demonstrate that it had retained the 10 CFR Part 21 evaluations as required, however, at the conclusion of the inspection, HPCO had not completed its investigation.
The NRC inspection team concluded that more information is required to determine if a violation of the requirements of 10 CFR 21.51(a)(1) has occurred.
The NRC inspection team identified this issue as Unresolved Item (URI) 99902116/2023-201-02, pending HPCOs investigation on whether it had appropriately retained Part 21 evaluations for the last five years.
NRC Vendor Inspection Results Update 16 Thermo Fisher Scientific, Oakwood Village, OH.
Inspection Report 99901460/2023-201:
10 CFR Part 21.21, Notification of failure to comply or existence of a defect and its evaluation, Paragraph Section (a)(1) requires in part that entities subject to Part 21, evaluate deviations and failures to comply to identify defects and failures to comply associated with substantial safety hazards as soon as practicable.
TFS failed to evaluate a deviation to identify defects associated with substantial safety hazards as soon as practicable. Specifically, TFS received information from an NRC licensee that a screw was missing on the base/back panel of a safety-related power supply, No. 201401-101, Serial Number 514, Revision T. Upon further inspection, TFS also discovered that a wrong base/back panel was installed and mislabeled. The part installed was No.
201458-101 and mislabeled as 201458-102. TFS failed to evaluate the reported deviation and document the actions in the material review board evaluation form in order to determine if a reportable defect exists that could create a substantial safety hazard.
Draft Regulatory Issue Summary - Required Assessment of DOE Labs 17 Developed a Regulatory Issue Summary (RIS)
(ML22080A051) to clarify the agencys regulatory position on the required assessment of U.S.
Department of Energy Laboratories by licensees, applicants, and suppliers.
60 days public comment period closed on December 5, 2023.
No comments received.
Currently working to issue document by Spring 2024.
Revisions to RG 1.164 and RG 1.234 18 The NRC staff proposed changes (DG-1415) to RG 1.164, Dedication of Commercial Grade Items for use in Nuclear Power Plants, Revisions 0 and (DG-1416) RG 1.234, Evaluating Deviations and Reporting Defects and Noncompliance under 10 CFR Part 21, Revision 0, to provide additional clarification on the NRCs definition of counterfeit, fraudulent, and suspect items (CFSI).
This update was in response to the Office of Inspector Generals report OIG-22-A-06, Audit of the Nuclear Regulatory Commission's Oversight of Counterfeit, Fraudulent, and Suspect Items at Nuclear Power Reactors.
NRC staff understands CFSI to mean:
Items that are intentionally manufactured or altered to imitate a legitimate product without the legal right to do so (Counterfeit);
intentionally misrepresented with the intent to deceive (Fraudulent);
or reasonably suspected of being Counterfeit or Fraudulent (Suspect)
ASME Code Case N-883 Update 19 The NRC is working with a Task Group from Section III, Subgroup General Requirements (SGGR), to address issues that would impact a future licensee when it goes to use the code case.
Concerns shared with the Task Group include:
How will owners responsibilities will be fulfilled?
Independence of inspections Regulatory oversight of the ASME Certificate Holders manufacturing the components
9th Vendor Workshop on Vendor Oversight 20 The workshop provides an open forum to exchange information regarding the oversight of components and materials supplied to new and operating nuclear power plants.
Scheduled for Thursday June 13, 2024, in Baltimore, MD.
Coordinating presentation topics and presenters with NUPIC/industry. If you have any suggestions, please contact Michael Fitzgerald.
Michael.Fitzgerald@nrc.gov (301) 415-0420
21 Odunayo Ayegbusi Reactor Operations Engineer (301) 415-8107 Odunayo.Ayegbusi@nrc.gov Aaron Armstrong Reactor Operations Engineer (301) 415-8396 Aaron.Armstrong@nrc.gov