ML25175A273
| ML25175A273 | |
| Person / Time | |
|---|---|
| Site: | 07100254 |
| Issue date: | 06/27/2025 |
| From: | Gerond George NRC/NMSS/DFM/IOB |
| To: | Neely B GE Hitachi Nuclear Energy Americas |
| References | |
| IR 2025201 | |
| Download: ML25175A273 (1) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 205550001 Brian Neely, Quality Leader GE Hitachi Nuclear Energy Americas, LLC 3901 Castle Hayne Road Wilmington, NC 28402
SUBJECT:
GE Hitachi Nuclear Energy Americas, LLC - U.S. NUCLEAR REGULATORY COMMISSION INSPECTION REPORT NO. 7100254/2025-201
Dear Brian Neely:
On May 13, through May 15, 2025, the U.S. Nuclear Regulatory Commission (NRC) staff conducted an announced onsite inspection at the GE Hitachi Nuclear Energy Americas, LLC.,
(GEH) and Global Nuclear Fuel - Americas (GEH/GNF-A) corporate office in Wilmington, North Carolina, to verify and assess GEH/GNF-A compliance with Title 10 of the Code of Federal Regulations (10 CFR) Part 71, Packaging and Transportation of Radioactive Material, and 10 CFR Part 21, Reporting of Defects and Noncompliance.
The purpose of the inspection was to verify and assess the adequacy of GEH/GNF-A implementation and compliance with the NRC requirements for the design, modification, fabrication, assembly, testing, procurement, repair and maintenance of transportation packaging(s) to determine if GEH/GNF-A performed these activities in accordance with the requirements of 10 CFR Part 71, Packaging and Transportation of Radioactive Material, and selected portions of 10 CFR Part 21, Reporting of Defects and Noncompliance. GEH is the certificate of compliance (CoC) holder of the New Powder Container, RAJ-II and model 2000 transportation packagings. In addition, GEH is a registered user of model 702, NPI-20WC-6 MKII, NAC-LWT, and model 2000 and GNF-A is a registered user of CoCs UX-30 overpack, TNF-XI, SP-1 and SP-3, BW-2901 and DN30 packages.
The inspection scope included review of records, observations of maintenance activities, documentation reviews, and interviews with personnel to determine whether GEH/GNF-A design, fabricated and maintained the transportation packagings, in accordance with the commitments and requirements specified in the applicable safety analysis reports for packaging, the NRCs corresponding safety evaluation report, CoC and NRC-approved quality assurance program requirements. The enclosed report presents the results of this inspection, which were discussed with you and other GEH/GNF-A representatives on May 15, 2025.
Based on the results of this inspection, the NRC inspection team determined that one Severity Level IV, Non-Cited violation of NRC requirements occurred. The violation was evaluated in accordance with the NRC Enforcement Policy. The current Enforcement Policy is included on the NRC's website at (http://www.nrc.gov/about nrc/regulatory/enforcement/enforce pol.html).
Because GEH/GNF-A initiated corrective actions to address this violation, this violation is being treated as a Non-Cited Violation (NCV), consistent with Section 2.3.2 of the Enforcement Policy.
The NRC inspection team described this NCV in the subject inspection report.
June 27, 2025
B. Neely 2
If you contest this violation, you should provide a response within 30 days of the date of this inspection report, with the basis for your denial, to the Nuclear Regulatory Commission, ATTN:
Document Control Desk, Washington DC 20555-0001, with copies to: (1) the Director, Office of Nuclear Materials Safety and Safeguards; and (2) the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.
In accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding, a copy of this letter, its enclosure, and your response (if any) will be available electronically for public inspection in the NRC Public Document Room (PDR) or from the Publicly Available Records component of the NRCs Agencywide Documents Access and Management System (ADAMS). ADAMS is accessible from the NRC website at http://www.nrc.gov/reading-rm/adams.html. The PDR is open by appointment. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 18003974209 or 3014154737, between 8 a.m. and 4 p.m. eastern time (ET), Monday through Friday, except Federal holidays.
To the extent possible, your response should not include any personal privacy or proprietary information so that it can be made available to the public without redaction.
Sincerely, Gerond George, Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards Docket No. 7100254
Enclosure:
NRC Inspection Report No.
7100254/2025201 Signed by George, Gerond on 06/27/25
ML25175A273 OFFICE NMSS/DFM NMSS/DFM NMSS/DFM NAME RPatel SFigueroa GGeorge DATE 6/24/2025 6/25/2025 6/27/2025
Enclosure U.S. NUCLEAR REGULATORY COMMISSION Office of Nuclear Material Safety and Safeguards Division of Fuel Management Docket:
7100254 Report.:
7100254/2025201 Enterprise Identifier: I20252010021 Certificate Holder:
GE Hitachi Nuclear Energy Americas, LLC (GEH)
Facility:
Corporate Location:
Wilmington, NC Inspection Dates:
May 13-15, 2025 Inspection Team:
Raju Patel, Transportation and Storage Safety Inspector, Team Leader Jeremy Tapp, Senior Transportation and Storage Safety Inspector Azmi Djapari, Transportation and Storage Safety Inspector Gabriel Witter, General Engineer (Trainee)
Approved By:
Gerond George, Branch Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards
2 U.S. NUCLEAR REGULATORY COMMISSION Office of Nuclear Material Safety and Safeguards Division of Fuel Management EXECUTIVE
SUMMARY
GE Hitachi Nuclear Energy Americas, LLC NRC Inspection Report 7100254/2025201 On May 13, through May 15, 2025, the U.S. Nuclear Regulatory Commission (NRC) staff conducted an announced onsite inspection at GE Hitachi Nuclear Energy Americas, LLC (GEH) and Global Nuclear Fuel - Americas (GNF-A) corporate office in Wilmington, North Carolina.
The staff held an exit meeting on May 15, 2025.
The purpose of the inspection was to verify and assess the adequacy of GEH/GNF-A radioactive material transportation activities to determine if they were performed in accordance with the requirements of Title 10 of the Code of Federal Regulations (10 CFR) Part 71, Packaging and Transportation of Radioactive Material, 10 CFR Part 21, Reporting of Defects and Noncompliance, the Certificates of Compliance (CoCs) and Safety Analysis Reports for packagings (SARPs) used by GEH/GNF-A and NRC-approved 10 CFR Part 71 transportation Quality Assurance Program (QAP).
Quality Assurance Program The team identified GEH/GNF-As quality assurance records program as an area for improvement as evidence by the issue identified and described in this report. The team identified one Severity Level IV Non-Cited Violation of 10 CFR Part 71.91(d), Records, and its CoC, with one example for GEH/GNF-As failure to maintain records of model 2000 transportation packagings for retaining records for 3 years after the life of the packaging to which they apply. Specifically, GEH/GNF-A could not furnish design, fabrication, test and maintenance records for model 2000 transportation packagings (NRC CoC USA/9228/B(U)F-96, revision 29), during the week of NRC inspection. Further, after GEH and GNF-A got merged, the model 2000 transportation packagings was sold to NorthStar Vallecitos, LLC, GEH/GNF-A but failed to maintain sufficient written records to furnish evidence of the quality of packaging.
(section 1.1) 10 CFR Part 21 The team determined that provisions are in place for reporting defects which could cause a substantial safety hazard for transportation packaging activities, and GEH/GNF-A personnel were familiar with the reporting requirements of 10 CFR Part 21. (section 1.2)
Design Control The team determined the items selected for review and the personnel interviewed that GEH/GNF-A implemented an adequate design control program in accordance with their approved CoC and SARP, written procedures, and design specifications, as applicable. (section 1.3)
3 Fabrication, Testing and Maintenance The team determined, for the items selected for observation and review that GEH/GNF-A performed maintenance and testing in accordance with the approved SARP, written procedures, and specifications, as applicable. (section 1.4)
Procurement The team concluded that GEH/GNF-A implemented its procurement document control and supplier oversight programs in accordance with the applicable regulatory requirements of 10 CFR Part 71, Subpart H. Based on the limited sample of documents reviewed, the team determined that GEH/GNF-A implemented its procedures associated with the procurement document control and supplier oversight programs.(section 1.5)
Nonconformance and Corrective Action The team determined that GEH/GNF-A implemented its nonconformance control and corrective action program (CAP). The team determined that GEH/GNF-A had adequate procedures in place to ensure compliance with the applicable regulations and QA requirements. (section 1.6).
Personnel Training and Quality Assurance Oversight The team determined that GEH/GNF-A had trained and qualified individuals performing activities affecting quality. The team determined that GEH/GNF-A management provided appropriate oversight of quality related activities, as applicable. (section 1.7)
Audit Program The team concluded that GEH/GNF-A had an adequate internal audit program in place to schedule, evaluate and document the results. The team determined that GEH/GNF-A appropriately identified issues, documented them in the CAP, as required, and resolved them in a timely manner. (section 1.8)
4 REPORT DETAILS 1.0 Applicable portions of Inspection Procedure 86001 - Design, Fabrication, Testing, and Maintenance of Transportation Packagings 1.1 Quality Assurance Program 1.1.1 Inspection Scope The team reviewed GEH/GNF-A quality assurance program description and implementing procedures to verify how GEH/GNF-A conducted 10 CFR Part 71 activities in accordance with their Quality Assurance Program (QAP). The team reviewed GEH/GNF-As NDEO-11209A, GE Hitachi Nuclear Energy Quality Assurance Program Description, revision 17. The team reviewed GEH/GNF-As graded approach for identifying Important-to-Safety (ITS) components for their radioactive material transportation packagings model RAJ II (No. 9309, revision 14, dated July 24, 2023) and model New Powder Container (NPC), (No. 9294, revision 9, dated June 19, 2020). The team conducted a high-level review of the program and implementing procedures to evaluate the quality program authorities, responsibilities and functions.
The team also reviewed the previous two revisions of the QAP to determine if changes made without prior NRC review and approval were performed in accordance with the requirements of 10 CFR 71.106, as applicable.
1.1.2 Observations and Findings Overall, the team assessed that GEH/GNF-A had an adequate QAP that included implementing procedures in place to conduct effective quality activities in accordance with the CoCs for the NPC (CoC No. 71-9294) and RAJ-II (CoC No. 71-9309) radioactive material transportation package models. The team verified that the QA organization operated in a manner independent from cost and schedule, when opposed to safety considerations. The team also assessed that GEH/GNF-As RAJ-II component safety classification and quality classification list for the NPC appropriately identified and classified those components used to maintain and refurbish packaging components in accordance with implementing procedures.
Upon request for QA records for model 2000 transportation packagings, GEH/GNF-A management informed the team that the records were not available at the facility but were at GEH Vallecitos, California facility. GEH/GNF-A management informed the team that after the merger of GEH and GNF-A, the model 2000 transportation packagings was sold to NorthStar Vallecitos, LLC, transferring all the records associated with model 2000. The team was informed that the last shipment of model 2000 transportation packagings was made in 2020 from Hatch Nuclear Power Station to Oak Ridge Laboratory. Based on the information, the team determined that GEH/GNF-A did not maintain QA records for model 2000 transportation packagings for a period of 3 years after the life of the packaging to which they apply, records identifying the packaging by model number, serial number, and date of manufacture furnish QA records. Specifically, GEH/GNF-A could not furnish records associated with the design, fabrication, test and maintenance activities for model 2000 transportation packagings (NRC CoC
5 USA/9228/B(U)F-96, revision 29) beyond 3 years after the life of the packaging to which they apply.
The team assessed this issue as a Severity Level IV, Non-Cited Violation of NRC requirements. The team determined that a violation of 10 CFR 71.91(d), Records, occurred in that GEH/GNF-A did not retain design, fabrication, test and maintenance records for model 2000 transportation packagings for 3 years beyond the date it sold and transferred records to NorthStar Vallecitos, LLC.
As required by 10 CFR 71.91(d), Records, states, in part that, licensee, certificate holder, and applicant for a CoC shall maintain sufficient written records to furnish evidence of the quality of packaging. The records to be maintained include results of the determinations required by 10 CFR 71.85, design, fabrication, and assembly records; results of overviews, inspections, tests, and audits; results of monitoring work performance and materials analyses; the results of maintenance, modification, and repair activities. These records must be retained for 3 years after the life of the packaging to which they apply.
Contrary to the above, as of May 15, 2025, GEH/GNF-A failed to maintain quality records for model 2000 transportation packagings that prescribe the activities affecting quality for 3 years beyond when GEH/GNF-A last engaged in the quality activities.
Specifically, at the time of the inspection, GEH/GNF-A did not retain records associated with the design, fabrication, test and maintenance activities for the model 2000 transportation packagings when it was sold to NorthStar Vallecitos, LLC. GEH/GNF-A documented this issue as condition report number 49360 in its corrective action program.
The team dispositioned the violation using the traditional enforcement process in Section 2.3 of the Enforcement Policy. The team determined that the violation was of more than-minor safety significance in accordance with Inspection Manual Chapter 0617, Vendor and Quality Assurance Implementation Inspection Reports, Appendix E, Minor Examples of Vendor and QA Implementation Findings. The team utilized example 17.a, as GEH/GNF-A could not retrieve the QA records nor easily re-create the QA records with reasonable assurance of their accuracy during the week of NRC inspection.
In accordance with NRC Enforcement Policy Section 6.8, Transportation, the team determined the significance of this violation as Severity Level IV violation. In accordance with the NRC Enforcement Policy Section 2.3.2.a, the violation was a Non-Cited violation, because the violation was entered into the corrective action program as condition report 49360.
1.1.3 Conclusions The team concluded that GEH/GNF-A had adequate QAP and implementing procedures. However, the team identified GEH/GNF-As QA records program as an area of improvement as evidenced by one example where GEH/GNF-A failed to retain records associated with the design, fabrication, test and maintenance activities for the model 2000 transportation packagings for 3 years after it was sold to NorthStar Vallecitos, LLC as well as failed to retain maintenance records for 3 years beyond
6 GEH/GNF-As last shipment made in 2020. The team identified this example of inadequate maintenance of QA records as a violation of 10 CFR 71.135, Quality Assurance Records, requirements.
1.2 10 CFR Part 21 1.2.1 Inspection Scope The team reviewed selected records and interviewed personnel to verify that GEH/GNF-A effectively implemented a nonconformance control program in accordance with their NRC-approved QAP and the requirements of 10 CFR Part 21. The team reviewed the GEH/GNF-A implementing procedure WI-16-108-07, Reporting of Defects and Noncompliance Under 10 CFR Part 21, revision 17, to verify if provisions were in place for reporting defects that could cause a substantial safety hazard from the nonconformance reports (NCRs), and quality issues identified. The team requested a list of 10 CFR Part 21 evaluations and notifications associated with any transportation activities and interviewed personnel to verify if they were familiar with the implementing work instruction W-16-108-07. This review also included an assessment for compliance with 10 CFR 71.95, Reports, as applicable.
1.2.2 Observation and Findings The team assessed that GEH/GNF-A had provisions in place for evaluating deviations and reporting defects that could cause a substantial safety hazard, as required by 10 CFR Part 21. The team noted that the 10 CFR Part 21 posting at GEH/GNF-As receiving, fabrication, and maintenance area met the applicable requirements of 10 CFR Part 21. The team also assessed that GEH/GNF-A employees are knowledgeable of reporting requirements and training have been performed to GEH/GNF-A Part 21 work instruction. The team noted that GEH/GNF-A did not have any Part 21 reports within the last 5 years.
No findings of significance were identified.
1.2.3 Conclusions The team determined that the provisions of 10 CFR Part 21 were implemented that GEH/GNF-A personnel were familiar with the reporting requirements of 10 CFR Part 21 and GEH/GNF-A complied with 10 CFR 21.6, "Posting requirements."
1.3 Design Control 1.3.1 Inspection Scope The team interviewed selected personnel and reviewed selected design documentation to determine that adequate design controls are implemented. The team focused its review in the areas of design modifications, quality classification evaluation for ITS, review and control of design calculations, and verification of commercially available computer programs. The team specifically reviewed GEH/GNF-A design activities related to CoC No. 71-9309 for the RAJ-II packaging. The team reviewed the following
7 GEH/GNF-A implementing procedures, work instructions, and guidance associated with design control to verify the documents were adequate and followed as required:
CP-03-100, Design Control, revision 11 WI-03-100-30, Design Verification, revision 6 CP-03-100-G330, Technical Reviews, revision 9 CP-03-113, Engineering Change Control, revision 7 CP-23-400, Engineering Software, revision 5 WI-23-400-12, Engineering Software Acquisition, revision 1.0 WI-23-400-13, Problem Reporting, Notifications, and Corrective Actions, revision 1 Specifically, the team reviewed the design documentation related to the latest amendment submitted to the NRC for the RAJ-II transportation packaging. The team reviewed the project work plan and work authorization that defined the work request and authorized work for the CoC revision. The team reviewed design-basis records that were developed for the RAJ-II modification work. These records included the technical justification for the changes including associated calculations. In addition, the team reviewed design verification documentation to ensure independent reviews were performed and verified the adequacy of the design changes in accordance with quality procedures.
The team also reviewed the computer software used to perform some of the design work for the RAJ-II CoC revision. The team verified the software used was qualified and validated for use in the intended application as required by GEH/GNF-A quality procedures. The team also verified that GEH/GNF-A had a mechanism in place in their quality program to ensure that error or anomaly reporting was received for externally procured software, and evaluated for any potential issues that could negatively affect the calculations performed by GEH/GNF-A.
Lastly, the team reviewed the ITS classifications of selected components of the RAJ-II packaging to verify the designated category was appropriately justified.
1.3.2 Observation and Findings The team assessed that overall, GEH/GNF-A effectively implemented its design control procedures as demonstrated through the review of the RAJ-II design change. The team found that GEH/GNF-A developed and processed the engineering quality documents reviewed in accordance with applicable procedures and design documents received the proper independent verification reviews and approvals.
No findings of significance were identified.
1.3.3 Conclusions The team concluded that GEH/GNF-A effectively implemented its design control program and has adequate procedures in place to ensure compliance with the applicable regulations and QAP requirements.
8 1.4 Fabrication, Assembly, Maintenance and Testing 1.4.1 Inspection Scope The team reviewed selected records and interviewed personnel to verify that GEH/GNF-A effectively implemented a fabrication, testing, and maintenance control program in accordance with their NRC-approved QAP, the applicable SARP and the requirements of 10 CFR Part 71 for the transportation of radioactive materials. During the inspection there was no ongoing fabrication or assembly of the GEH/GNF-As transportation packaging. However, the team was able to observe maintenance activities on the RAJ-II transportation packagings. The team observed the maintenance activities to verify that GEH/GNF-A performed in these activities in accordance with approved methods, procedures, and specifications that met the SARP design commitments and requirements documented in the CoC. The team also reviewed the maintenance requirements identified in the SARP, maintenance procedures, completed maintenance records, and personnel and qualification training records.
The team reviewed the following documents:
Operational Procedure (OP)-2000.03, RAJ-II Inner Container Refurbishing, revision 46 OP-2000.02, RAJ-II Outer Container Refurbishing, revision 47 Log Sheet (LS)-2000.02.16, Refurbishing of RAJ-II Inner Container Signoff Sheet LS for refurbishment of RAJ-II Inner Container S/N RB-1078, dated 1/20/25 Measuring and Test Equipment The team reviewed the control of measuring and test equipment (M&TE) control program to evaluate how GEH identified, specified, and controlled tools and equipment in accordance with applicable standards and regulatory requirements. The team reviewed the following documents:
CP-12-101, Calibration Control Program, revision 10 GIS-A-04, Standard M&TE Inspection Cycle, Tolerances, and Special Requirements, revision 44.0 GIS-A-04-L01, M&TE Calibration Frequency List, revision 8.0 GIS-B-13, Calibration of Dial and Vernier Calipers, revision 5.1 GIS-B-65, Calibration of Torque Wrenches and Torque Meters, revision 7.0 GIS A-12, Calibration Stickers, revision 3.0 GIS-B-81, Procedure for Supplier Calibrated Gages, revision 22.0 The team reviewed a sample of M&TE used during maintenance activities, including 20 ft-lb torque wrenches, a digital 6-inch caliper, a Shore A durometer, and gage blocks.
The team reviewed calibration records to verify calibration dates, the standards used, and traceability of the equipment.
1.4.2 Observation and Findings The team assessed that GEH/GNF-A performed maintenance activities on the RAJ-II package in accordance with established procedures. These activities included the
9 refurbishment of the inner and outer containers of the RAJ-II package. The team verified that damaged parts and nonconforming items were promptly segregated and removed upon identification during the maintenance process. The team also reviewed training and qualification records of four maintenance technicians to ensure that personnel performing the maintenance activities were appropriately trained and qualified.
The team assessed that GEH/GNF-A established adequate control of M&TE used during maintenance activities, in accordance with their approved quality assurance procedures and applicable regulatory requirements. The team verified that M&TE was used within rated capacities and sensitivities as documented in calibration records, and that calibration services were performed by accredited laboratories using reference standards traceable to the national standards. The team noted that the sample of M&TE reviewed were properly labeled with unique identifiers, calibration dates, and due dates.
No findings of significance were identified.
1.4.3. Conclusion The team concluded that GEH/GNF-A effectively implemented its maintenance program through use of adequate qualified procedures, personnel and calibrated measuring and test equipment to ensure compliance with the applicable regulations and QAP requirements.
1.5 Procurement 1.5.1 Inspection Scope The team reviewed procedures and processes that addressed procurement. Those procedures and processes include receipt inspection, traceability of materials, and commercial-grade dedication. The team reviewed a sample of records and drawings to verify procurement specifications for materials, fabrication, and inspection that met design commitments and requirements contain in SARPs and CoCs. The team reviewed quality procedures, receipt inspection records, and sampled purchase orders (POs). The team reviewed ITS Category A and Category B procurement items associated with the inspection and maintenance of the NPC and RAJ-II transportation packagings. The team reviewed the following documents:
CP-04-105, Purchase Order Receiving, revision 9 CP-07-104, Customer Purchase Order Technical Evaluation and Dedication of Commercial Grade Items and Services, revision 7 CP-04-107, GEH/GNF-A Order Placement, revision 20 CP 07-106, Receiving Inspection Procedure and Routines, revision 2 CP-07-107, Deviation Disposition Requests from Suppliers, revision 10 PO 137101831 PO 437128386 PO 437135803 PO 437137549 PO# 900691461, revision 2
10 The team reviewed the GEH/GNF-As supplier audit program to determine if GEH/GNF-A scheduled, planned, and performed supplier audits in accordance with their implementing procedures, reference standards, and guidance documents.
CP-07-02, Supplier Approval, revision 40 CP-07-04, Supplier Surveillance, revision 4.0 CP-18-02, Supplier Audits and Commercial Grade Surveys, revision 23 1.5.2 Observation and Findings The team reviewed a sample of purchased materials, equipment, and services, including band clamps, band clamp nuts, Helicoils, lid bolts, and calibration services. The band clamps, band clamp nuts, and calibration services were procured as commercial grade items and dedicated for ITS Category A use under GEH/GNF-As commercial-grade dedication (CGD) program. The team found that the CGD packages clearly defined the required material grades, dimensions, and other critical characteristics, as well as the verification activities performed to ensure these requirements were met. Supporting documentation such as receipt inspection reports, test results, and traceability records demonstrated that these items met the applicable technical and quality requirements for important to safety use.
No findings of significance were identified.
1.5.3 Conclusions The team determined materials and components procured and received by GEH/GNF-A for fabrication, and maintenance activities met procurement specification, as applicable, and that the specifications conformed to the design commitments and requirements contained in the SARP and CoC. The team concluded that GEH/GNF-A has implemented its procurement control program in accordance with the requirements of regulations and QAP.
1.6 Nonconformance and Corrective Action Programs 1.6.1 Inspection Scope The team reviewed sample of GEH/GNF-As NCRs and condition reports (CRs) and interviewed selected personnel to verify that GEH/GNF-A effectively implemented a nonconformance control program and CAP in which personnel completed corrective actions for identified deficiencies in a technically sound and timely manner. The review included an evaluation of how GEH/GNF-A nonconformance control program and CAP addressed materials, parts, and components that do not conform to requirements and identified quality deficiencies. The team also reviewed provisions for reporting defects that could cause a substantial safety hazard. The team reviewed the following GEH/GNF-A quality procedures:
CP-15-07, Stop Work Notice, revision 7.2 CP-15-100, Control of Nonconforming Items, revision 5 CP-15-101, Control and Disposition of Supplier Provided Nonconforming Items, revision 15.0
11 CP-16-108, Corrective Action Program, revision 20 CP-16-202, Common Cause Analysis, revision 6.0 The team reviewed a list of nonconformances, and corrective action reports from the last 5 years. Additionally, the team reviewed and assessed the corrective action from the previous NCV (Agencywide Document Access and Management System [ADAMS]
Accession Number ML20077L220) identified by the NRC during the 2020 inspection.
Additionally, the team reviewed and assessed a sample of 10 CFR 71.95 60-day reports and CRs associated with RAJ-II, dated January 5, 2024, DN30 dated May 11, 2022, NPC dated December 8, 2022, RAJ-II dated October 5, 2021 and DN30 dated September 16, 2021 to verify GEH/GNF-A took adequate corrective actions and performed 10 CFR Part 21 evaluation to determine if the condition could create a substantial safety hazard. The team discussed the nonconformances and corrective actions with the GEH/GNF-A staff including the previous NCV. The team focused the NCR review on use-asis and repair type dispositions to evaluate how GEH/GNF-A technically justified the approved dispositions.
1.6.2 Observation and Findings Overall, the team found that GEH/GNF-A had an adequate nonconformance and corrective action program in place to resolve deficiencies. GEH/GNF-A addressed concerns from previous NCV, and the corrective actions addressed the deficiencies identified and GEH/GNF-A resolved those items in a timely manner.
No issues of significance were identified.
1.6.3 Conclusions The team concluded that GEH/GNF-A effectively implemented its nonconformance control program and CAP and had adequate procedures in place to ensure compliance with the applicable regulations and QAP requirements.
1.7 Personnel Training and Certifications 1.7.1 Inspection Scope The team reviewed selected records and procedures and interviewed selected personnel to verify that individuals performing activities affecting quality are properly trained and qualified, and to verify that management and QA staff are cognizant and provide appropriate oversight. The team reviewed the following GEH/GNF-A implementing procedures:
CP-20-103, Nuclear Safety Training, revision 4 CP-20-303, Transportation of Hazardous Materials Training, revision 3 CP-18-03, Lead Auditor Certification and Audit Team Training Requirements, revision 6 Specifically, the team reviewed the indoctrination and training records for selected GEH/GNF-A employees that have performed design engineering activities to verify the training was adequate. The team reviewed records for two quality control inspectors that
12 had performed quality related inspection activities on sample annual inspection/maintenance reports for NRC-approved CoC cask packages. The team reviewed the qualifications and training for selected lead auditors to determine if they met the requirements stated in the QAP. In addition, the team reviewed training records of a random selection of employees in quality related positions to determine if they received the required indoctrination to and familiarization with the QAP.
1.7.2 Observation and Findings The team found that sample of GEH/GNF-A staff members records reviewed, each had completed the required QA indoctrination and training and attained the applicable qualifications to perform their duties.
The team also found that sample of GEH/GNF-A lead auditor personnel, each was qualified, and their qualification records were current in accordance with GEH/GNF-A CP-18-03.
No findings of significance were identified.
1.7.3 Conclusions The team concluded that GEH/GNF-A had trained and qualified individuals performing activities affecting quality and that GEH/GNF-A management provided appropriate oversight of quality related activities, as applicable.
1.8 Audit Program 1.8.1 Inspection Scope The team reviewed GEH/GNF-A audit program to determine whether GEH/GNF-A scheduled, planned, and performed internal audits in accordance with approved implementing procedures and QAP requirements. The team also reviewed the qualification records of lead auditors to determine if they met the QAP and procedure requirements. The team reviewed the following GEH/GNF-A quality procedures:
CP-18-100, Quality Assurance Internal Audit Requirements, revision 9.3 CP-18-03, Lead Auditor Certification and Audit Team Training Requirements, revision 6 CP-07-02, Supplier Approval, revision 40 CP-07-04, Supplier Surveillance, revision 4.0 CP-18-02, Supplier Audits and Commercial Grade Surveys, revision 23 The team selected internal audits from the last 5 years, particularly related to transportation activities. The team reviewed and assessed internal audits to determine if they were performed in accordance with quality procedures, performed by qualified lead auditors independent of the areas being reviewed, and determine if GEH/GNF-A identified deficiencies and addressed these deficiencies within their CAP.
13 The team also reviewed a sample of surveillances performed by QA personnel since the previous NRC inspection to verify the adequacy of the assessment and that they were performed in accordance with the implementing procedure.
1.8.2 Observation and Findings Overall, the team assessed that for the internal audits sampled, GEH/GNF-A conducted activities with qualified and certified personnel, were comprehensive in nature, and covered a representative sample of GEH/GNF-A activities in the area being audited.
No findings of significance were identified.
1.8.3 Conclusions The team concluded that GEH/GNF-A had an adequate internal audit program in place to schedule, evaluate, and document the results. The team determined that GEH/GNF-A appropriately identified issues and documented them in the CAP as required.
2.0 Entrance and Exit Meeting On May 13, 2025, the NRC inspection team discussed the scope of the inspection during an entrance meeting with the GEH/GNF-A staff. On May 15, 2025, the NRC inspection team held an exit meeting with GEH/GNF-A management and staff informing them about the inspection results and a potential inspection finding.
Attachment ATTACHMENT 1.
ENTRANCE/EXIT MEETING ATTENDEES AND INDIVIDUALS INTERVIEWED Name Title Affiliation Entrance Debrief Exit Raju Patel Inspection Team Leader NRC X
X X
Jeremy Tapp Inspector NRC X
X X
Azmi Djapari Inspector NRC X
X X
Gabriel Witter General Engineer NRC X
X X
Brian Neely GNF Quality Leader GEH/GNF-A X
X X
Don Hartsock Container Asset Manager GEH/GNF-A X
X X
Michael Conner Logistics Manager GEH/GNF-A X
X X
Brian Eber GEH Fuel Design Manager GEH/GNF-A X
X James Mathews GNF-A Logistics Team Leader GEH/GNF-A X
X X
Brad Boyette GEH Fuel Design Technical Leader GEH/GNF-A X
X X
Justin Brown GEH Fuel Design Engineer GEH/GNF-A X
X X
Thomas Ware GEH Logistics Designer GEH/GNF-A X
X X
Chandra Del Vecchio Lead Manufacturing Specialist GEH/GNF-A X
X X
Michael Torbit Lead Auditor GEH/GNF-A X
2.
INSPECTION PROCEDURES USED Inspection Procedure 86001 Design, Fabrication, Testing, and Maintenance of Transportation Packagings NUREG/CR6314 Quality Assurance Inspections for Shipping and Storage Containers Regulatory Guide 7.10 Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material 3.
LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED Item Number Status Type Description None None None None
2 4.
LIST OF ACRONYMS USED 10 CFR Title 10 of the Code of Federal Regulations ADAMS Agencywide Documents Access and Management System CAP Corrective Action Program CAR Corrective Action Report CGD Commercial-Grade Dedication CoC Certificate of Compliance CR Condition Report DBR Design Basis Record GEH GE Hitachi Nuclear Energy Americas LLC GNF-A Global Nuclear Fuels - Americas LLC ITS Important-to-Safety M&TE measuring and test equipment NCR Nonconformance Report NPC New Powder Container NRC U.S. Nuclear Regulatory Commission PDR Public Document Room PO Purchase Order QA Quality Assurance QAP Quality Assurance Program SAR Safety Analysis Report SARP Safety Analysis Report for Package 5.
DOCUMENTS REVIEWED:
In addition to the documents listed below, licensee documents reviewed during the inspection are specifically identified in the Report Details above.
Design Documents:
001N1316, Software Methods Qualification for KENO601P, revision 3 001N2140, Design Notes for KENO601P Software Methods Qualification Document, revision 2 51-5053410-00, Safety Classification and Quality Categories for RAJ-II Container Components CA-00029145, revision 0 CR-46451, dated July 12, 2024 CR-3635, dated March 2, 2021 Design Basis Record (DBR)-0043728, RAJ-II Aluminum Honeycomb Licensing Evaluation, revision 0 DBR-0067749, Technical Justification for Changes to Chapters 1 and 7 of the RAJ-II SAR to Create Rev. 11., revision 0 DBR-0060960, Technical Justification for Changes to Chapters 2, 3 and 8 of the RAJ-II SAR to Create Rev. 11, revision 0 DBR-0060711, Technical Justification for Changes to RAJ-II Licensing Drawings for SAR Rev. 11, revision 0 Technical Review Report, RAJ-II Aluminum Honeycomb Replacement, dated August 6, 2019 Work Authorization No.: ZZZ21E001, ATF Program - Phase 2C (Feb. 2021 - Jan. 2025) -
LEU+/HBU, IronClad and other R&D, revision 0
3 Condition Reports:
34688, 34689, 35296, 36924, 41283, 41284, 41285, 41286, 41291, 44166, 46451, 47244, 47423, 45501 10 CFR 71.95 Reports:
M240003, 10 CFR 71.95 - 60 Day Report-RAJ-II Certificate Condition of Approval Not Observed, dated 1/5/2024, CR # 44166 M220039, 10 CFR 71.95 - 60 Day Report - DN30 Condition of Approval not Observed, dated 3/11/2022 M220160, 10 CFR 71.95 - 60 Day Report - NPC Certificate Condition of Approval Not Observed, dated 12/8/2022, CR# 40767 M210118 10 CFR 71.95 - 60 Day Report - RAJ-II Certificate Condition Not Observed, dated 10/5/2021, CR# 37520 M210109, 10 CFR 71.95 - 60 Day Report - DN30 Certificate Condition Not Followed, dated 9/16/2021