IR 07100943/2023201
| ML23264A113 | |
| Person / Time | |
|---|---|
| Site: | 07100943 |
| Issue date: | 09/29/2023 |
| From: | Natreon Jordan NRC/NMSS/DFM/IOB |
| To: | Wolfe J Best Theratronics, Ltd |
| References | |
| IR 2023201 | |
| Download: ML23264A113 (16) | |
Text
September 29, 2023
SUBJECT:
BEST THERATRONICS - U.S. NUCLEAR REGULATORY COMMISSION INSPECTION REPORT NO. 710943/2023201
Dear Jessica Wolfe:
This letter refers to the inspection conducted by the U.S. Nuclear Regulatory Commission (NRC) on June 21-23, 2023, at the Best Theratronics Limited (BTL) facility near Ottawa, Canada. The inspection team continued the inspection activities with an inoffice review and held an exit meeting on July 28, 2023, with you and other members from BTL. The purpose of the inspection was to verify and assess the adequacy of BTLs activities associated with the transportation of radioactive material and determine if BTL performed those activities in accordance with the requirements of Title 10 of the Code of Federal Regulations (10 CFR) Part 71, Packaging and Transportation of Radioactive Material, and BTLs NRC approved certificate of compliances (CoC) and quality assurance program (QAP). The enclosed report presents the results of this inspection.
The inspection examined activities conducted under your NRC approved QAP as they relate to public health and safety, and whether those activities conformed and complied with the Commissions rules and regulations and with the conditions of your applicable CoCs. Within these areas, the inspection consisted of selected examination of procedures and representative records, observations of activities, and interviews with personnel.
Based on the results of this inspection, the NRC has determined that one Severity Level IV violation of NRC requirements occurred because BTL did not carry out a comprehensive system of planned and periodic audits to verify compliance with all aspects of the quality assurance program. Since BTL initiated corrective actions to address this issue, the NRC is treating this violation as a Non-Cited Violation (NCV), which is consistent with section 2.3.2 of the Enforcement Policy. The NRC inspection team describes this NCV in the enclosed inspection report. If you contest the violation or significance of this NCV, you should provide a response within 30 days of the date of this inspection report, with the basis for your denial, to the U.S.
Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington DC 205550001, with copies to: (1) the Director, Office of Nuclear Material Safety and Safeguards; and (2) the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 205550001. In accordance with 10 CFR Part 2 of the NRCs Agency Rules of Practice and Procedure, a copy of this letter, its enclosure, and your response, if you choose to provide one, will be made available electronically for public inspection in the NRC Public Document Room (PDR) or from Publicly Available Records component of the NRC's 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 1-800-397-4209 or 301-415-4737, 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, Rivera-Varona, Aida signing on behalf of Jordan, Natreon on 09/29/23 Natreon Jordan, Acting Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards Docket No. 710943
Enclosure:
Inspection Report No. 710943/2023201
Inspection Report
Docket No.: 710943 Report No.: 710943/2023201 Enterprise Identifier: I-2023-201-0035 Certificate Holder: Best Theratronics, Ltd.
Location: Best Theratronics, Ltd.
413 March Road Ottawa, Ontario, Canada K2K 0E4 Inspection Dates: June 21 - July 28, 2023 Inspectors: Matthew Learn, Senior Transportation and Storage Safety Inspector, Team Leader Marlone Davis, Senior Transportation and Storage Safety Inspector Azmi Djapari, Transportation and Storage Safety Inspector (Trainee)
Approved by: Natreon Jordan, Acting Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards Enclosure
EXECUTIVE SUMMARY
Best Theratronics, Ltd.
NRC Inspection Report 710943/2023201 On June 21, 2023, through June 23, 2023, the U.S. Nuclear Regulatory Commission (NRC)performed an announced inspection of Best Theratronics, Ltd. (BTL), at its office near Ottawa,
Canada. The team inspected BTLs activities associated with transportation of radioactive material to determine if they executed the requirements in accordance with 10 CFR Parts 21 and 71, certificates of compliances (CoCs), safety analysis reports (SARs), and BTLs NRC-approved quality assurance program (QAP). The team inspected BTLs following the requirements and guidance of inspection procedure (IP) 86001 titled Design, Fabrication,
Testing, and Maintenance of Transportation Packagings. The inspection summary of the results are as follows:
Quality Assurance Program The team determined that overall BTL generally had adequate quality assurance (QA)controls and implemented a graded approach, as defined in the QAP. (section 1.1)
Design Control The team determined that for the items sampled for review, BTL had implemented adequate design control measures. The procurement/fabrication specifications were consistent with the design commitments and requirements documented in the Safety Analysis Report for Packaging (SARP) for the F-430, F-431, and F-423 transportation packages. (section 1.2)
Fabrication and Maintenance Control The team determined that materials and components received by BTL met the procurement specifications, and the specifications conform to the design commitments and requirements contained in the SARPs and CoCs. There were no ongoing fabrication activities during the inspection. (section 1.3)
Assembly and Testing The team determined, for the items selected for observation and review, that BTL performed maintenance and testing in accordance with their approved SARP, written procedures, and specifications, as applicable (section 1.4).
Procurement Control The team determined that materials and components received by the fabricator met the procurement specifications, and the specifications conform to the design commitments and requirements contained in the SARP and CoC. (section 1.5)
Personnel Training and Oversight The team determined that overall, BTL had trained and qualified individuals performing activities affecting quality and that management provided appropriate oversight of quality related activities, as applicable. (section 1.6)
Part 21, Non-Conformance, and Corrective Actions The team concluded that BTL effectively implemented its nonconformance control and corrective and preventive action program and had adequate procedures in place to ensure compliance with the applicable regulations and QAP requirements. (section 1.7)
Audits The team determined for the most part that BTL performed internal and external audits of their QAP for the transportation packagings and resolved deficiencies if identified in a timely manner. However, BTL did not carry out a comprehensive system of planned and periodic audits to verify compliance with all aspects of the quality assurance program as scheduled and in accordance with written procedures. (section 1.8)
REPORT DETAILS
1.0 Design, Fabrication, Testing, and Maintenance of Transportation Packagings (Inspection Procedure (IP) 86001)1.1 Quality Assurance Program 1.1.1 Inspection Scope The team reviewed 5.05-QA-03, Part 71 QA Program, revision B and implementing procedures to assess the adequacy and effectiveness of BTLs QAP implementation.
The team conducted reviews of BTLs quality program, policies, and procedures, to determine whether activities subject to 10 CFR Part 71 were adequately controlled and implemented under BTL's NRC approved QAP. The team also reviewed the QAP to determine if changes were made and if so, were performed in accordance with the requirements of 10 CFR 71.106, as applicable.
The team reviewed the QAP authorities and responsibilities to determine if they were clearly defined and documented, and the QA organization functioned as an independent group.
Additionally, the team reviewed BTLs graded approach to quality as documented in the QAP to verify that BTL identified important-tosafety (ITS) components in its packaging designs in a graded approach as described.
1.1.2 Observation and Findings The team assessed that BTL had a QA program and implementing procedures in place that were generally effective in conducting activities in accordance with BTLs NRC-approved QAP and CoCs as well as Part 71 requirements. The team verified that the QA organization operated in a manner sufficiently independent from cost and schedule, when opposed to safety considerations. The team determined that no changes to the NRC-approved QAP occurred since the last NRC inspection in 2018.
The team found that BTL used a graded approach to categorize components important-tosafety in its packaging designs. The team reviewed the adequacy of the categorizations as a part of the design control review documented in section 2.0 of this report. The team noted that BTL does not currently implement a commercial grade dedication program for parts or services.
No findings of significance were identified.
1.1.3 Conclusions The team determined that overall, the QA controls at BTL were generally adequate and implemented in a graded approach, as defined in the QAP.
1.2 Design Control 1.2.1 Inspection Scope The team interviewed selected personnel and reviewed the procurement/fabrication specifications and fabrication drawings against the engineering and licensing drawings to determine if BTL had implemented adequate design controls. Specifically, the team focused on the translation of design commitments and requirements for the ITS Category A, B, and C components of the F-430, F-431, and F-423 and the design specifications, including associated licensing and fabrication drawings. The team reviewed the following documents:
5.00-QA-04, Design Control, Revision F 5.05-QA-04, F430, F431 and F423 Transport Packages Components Grading Evaluation in Conformance with Title 10 of Code of Federal Regulations (10CFR)
Part 71 Packaging and Transportation of Radioactive Material, Revision B IN/TR 1489 F423/GC220, Safety Analysis Report for the F-423/GC220 Transport Package, Revision 2a IN/TS 1262 F423, Technical Specification for the F-423 Overpack, Revision 7 IN/DS 2190 F423, Design, Manufacturing and Operating Specification for the F-423 Transport Package, Revision 4 Drawing F642301-001, F-423/GC-220 Transportation Package Information Drawing, Sheet 1, Revision G 1.2.2 Observation and Findings Based on the teams review, there were no unexplained discrepancies between the design and fabrication activities including the engineering and fabrication drawings. The team had observations regarding the safety classifications of nuts and bolts being excluded from BTLs grading evaluation document. BTL had addressed the observation and put it into their corrective action program.
No findings of significance were identified.
1.2.3 Conclusions The team determined that for the items sampled for review, BTL had implemented adequate design control measures. The procurement/fabrication specifications were consistent with the design commitments and requirements documented in the safety analysis reports for the F-430, F-431, and F-423 transportation packages.
1.3 Fabrication and Maintenance Control 1.3.1 Inspection Scope The team reviewed selected drawings and records, and interviewed personnel to verify that the procurement specifications for fabrication and maintenance materials, equipment, and services met applicable design requirements. The team evaluated the fabrication process to ensure that BTL controlled and verified the process from the onset of design through the completion of the manufacturing process. The team reviewed BTLs fabrication and procurement controls to verify that BTL controlled and implemented all fabrication and procurement activities for the transportation packagings in accordance with their NRC-approved QAP, SARPs and CoCs. The team inspected fabrication controls for the purchase order (PO) specifications, and receipt inspections.
The team reviewed the fabrication and procurement controls for gaskets, bolts, and seals applicable to the F-430, F-431, and F-423 transportation packagings. The team reviewed the procurement records, material traceability documents, drawings and procedures, shelf life of the components, and the receipt inspection program. This review included activities concerning fabrication travelers, special processes including welding, assembly, cleaning, and storage. The assessment of test and inspection activities included the review of inspection requirements, acceptance criteria, test conditions, test documentation, nondestructive examination controls, and QA hold points. The team reviewed the following documents:
5.00-QA-12, Final Inspection / Final Product Inspection, Revision D F643101-001, F-431/GC-1000/3000 Transportation Package Information Drawing, Sheet 1, Revision K and Sheet 2, Revision F PO No. 30276763 - Bolts PO No. 3027719 - Gaskets 1.3.1 Observation and Findings Overall, the team assessed that BTL had adequate control of materials and ITS components received for maintenance and fabrication of their transportation packaging.
The team verified that the procurement records, material traceability documents, drawings and procedures, shelf life of the components, and the receipt inspection program were consistent with design requirements and implementing procedures. There were no ongoing fabrication activities during the inspection to observe.
No findings of significance were identified.
1.3.2 Conclusions The team determined that materials and components received by BTL met the procurement specifications for fabrication and maintenance activities, and the PO reviewed conform to the design commitments and requirements contained in the SARPs and CoCs.
1.4 Assembly and Testing 1.4.1 Inspection Scope The team reviewed selected records and interviewed personnel to verify that BTL effectively implemented a maintenance control program in accordance with their NRC approved QAP, the applicable SARPs, and the requirements of 10 CFR Part 71 for the transportation of radioactive material. The team performed a review on maintenance activities related to the F-430 and F-431 radioactive transportation packaging for the last three maintenance cycles. The team reviewed annual maintenance records conducted at the BTL facility near Ottawa, Canada since there was no ongoing fabrication or testing at the time of the inspection. The team reviewed the maintenance requirements identified in the SARP, maintenance procedures, completed maintenance records, and personnel and qualification training records.
The team reviewed the following maintenance implementing procedures:
5.00-QA-09, Inspection and Test Status, Revision H IN/IM 2548 F000, Transport Package Maintenance Overview Procedure, Revision IN/TR 1913, Safety Analysis Report for the F-431 Transport Package, Revision H, IN/TR 6133, Safety Analysis Report for the F-430/GC40 Transport Package, Revision B Training records for maintenance technicians T21, T8, and T11 WO No. 234826 IN/PP 1961 F431, Preparation for shipment of the F-430 and F-431 Transport Packages, Revision L IN/PP 1554 F423/GC220, Instructions for Modifications and Preparation for Shipment of Gammacell-220 in F423 OP Assembly, Revision E 1.4.2 Observation and Findings Based on a review of the maintenance records and procedures, the team assessed that BTL used appropriate maintenance materials, tools, and equipment to conduct the required maintenance activities for the radioactive material transport packagings. The team verified that the inspections met acceptance criteria for tests identified in the container management system. The team also verified that maintenance personnel and technicians recorded the proper information on the applicable forms and data sheets as defined and required in BTLs verification checklist and maintenance procedures. The team assessed that the maintenance conducted satisfied the requirements identified in the SARP and CoC.
No findings of significance were identified.
1.4.3 Conclusions The team determined, for the items selected for observation and review that BTL performed maintenance and testing in accordance with approved SARP, written procedures, and specifications, as applicable.
1.5 Procurement Control 1.5.1 Inspection Scope The team reviewed BTL's processes and procedures that addressed procurement, including receipt inspection, traceability of material, and commercial grade dedication, as applicable. The team reviewed selected drawings and records and interviewed personnel to verify that BTLs procurement specification for materials, fabrication, and inspection met design commitments and requirements contained in the SARPs and CoCs. The team reviewed quality system procedures, receipt inspection records, and sampled POs. The team reviewed the following documents:
5.00-QA-07, Procurement, Revision K 5.00-QA-10, Incoming Inspection, Revision D 5.00-QA-13, Identification and Traceability, Revision C PO No. 3023182 - Sealed Source IN/TS 2578 C000, Technical Specifications for Sealed Sources IN/TS 2714 C000, Technical Specifications for Sealed Sources Containing Cs-137 1.5.2 Observation and Findings Overall, the team assessed that the fabricator had adequate control of the procurement process for the ITS components selected and reviewed. The team determined that the fabricator procured ITS components consistent with design requirements and their QA implementing procedures and purchased and applied controls over sub-contractors and vendors currently on the approved suppliers list. The fabricators material traceability, procurement, and receipt inspection controls were adequate. The team assessed that the POs were adequate and specified the applicable criteria and requirements including Part 21. The material ordered and received at the fabricators facility met the design requirements, the critical characteristics for dedicated material. Additionally, the fabricator verified and maintained the traceability throughout the procurement and receipt process.
No findings of significance were identified.
1.5.3 Conclusions The team determined that materials and components received by the fabricator met the procurement specifications, and the specifications conform to the design commitments and requirements contained in the SARP and CoC.
1.6 Personnel Training and Oversight 1.6.1 Inspection Scope The team reviewed selected records and procedures, interviewed selected personnel, and observed selected activities affecting the safety aspects of the packaging to verify that BTL properly trained and qualified individuals performing activities affecting quality and that the management and the quality assurance staff provided appropriate oversight. The team also reviewed the following training document for the overall program 5.00-QA-23, Training, Revision J.
1.6.2 Observations and Findings The team assessed that BTL had trained and qualified individuals who performed activities affecting quality and in accordance with written quality procedures. The team assessed BTL training and qualifications as a part of each applicable section of this inspection report see sections 1.4 (Assembly and Testing) and 1.8 (Audits).
No findings of significance were identified.
1.6.3 Conclusions The team determined that overall, BTL had trained and qualified individuals performing activities affecting quality and that management provided appropriate oversight of quality related activities, as applicable.
1.7 Part 21, Nonconformance, and Corrective Actions 1.7.1 Inspection Scope The team reviewed a sample of BTL's nonconformance reports (NCRs) and corrective and preventive action (CAPA) reports and interviewed selected personnel to verify that BTL effectively implemented their nonconformance control and CAPA program. The review included an evaluation of how BTLs nonconformance control program and CAPA 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 BTL quality procedures and work instructions:
5.00-QA-19, Non-Conformance, Revision K 5.03-AA-57, Risk Assessment Procedure, Revision B 5.00-QA-24, Customer Feedback, Complaint Handling, and Post Market Surveillance, Revision Q The team reviewed NCRs and CAPAs since the last NRC inspection in 2018 and reviewed CAPAs written because of issues identified during the 2018 inspection. The team discussed the nonconformances and corrective actions with the BTL staff to understand the process. The team focused the NCR review on use-asis and repair type dispositions to evaluate how BTL technically justified the NCRs reviewed. The CAPAs were reviewed to determine whether BTL completed corrective actions for identified deficiencies in a technically sound and timely manner. The team also toured the BTL facility to review the controls in place for control of nonconforming items and verified items with open NCRs were adequately controlled. In addition, the team requested a list of Part 21 evaluations and notifications associated with the BTL transportation packagings.
1.7.2 Observation and Findings The team found that BTL had adequate procedures and controls in place for identifying, writing, and dispositioning NCRs and for reporting defects that could cause a substantial safety hazard. The team noted that there were no Part 21 reports issued since the previous inspection.
The team assessed that BTL had adequate procedures and controls in place for identifying and writing CAPA reports, documenting corrective action(s) taken, performing causal analyses as necessary, documenting corrective actions and actions taken to prevent recurrence as applicable, and performing CAPA closure verification.
No findings of significance were identified.
1.7.3 Conclusions The team concluded that BTL effectively implemented its nonconformance control and CAPA program and had adequate procedures in place to ensure compliance with the applicable regulations and QAP requirements.
1.8 Audits 1.8.1 Inspection Scope The team reviewed the audit programs to verify that BTL scheduled, planned, and performed audits in accordance with their NRC approved QAP and implementing procedures. The team reviewed the audit results to determine if BTL identified deficiencies and addressed these deficiencies within their CAPA program. The team also reviewed external audits for suppliers of ITS materials, equipment, and services.
The team selected a sample of audits and interviewed personnel to verify that BTL effectively implemented their audit program for internal and external audits from 2018 to the present. This sample included a review of lead auditor certifications and qualifications. In addition, the team reviewed the last two management reviews of the QAP to determine whether BTL management performed the reviews as required and if the reviews were an effective tool to use to evaluate the overall health of the program.
The team reviewed the following quality standard procedures:
5.05-QA-03, Part 71 QAP, Revision B 5.00-QA-08, Internal Quality Audits, Revision K 5.00-QA-28, Management Review Team, Revision N 3.13-AA-01, Supplier Qualification Program, Revision G 1.8.2 Observation and Findings The team assessed that for the audits sampled that BTL conducted audits with qualified and certified personnel, scheduled and evaluated applicable quality elements of their QA program. Furthermore, BTL had developed checklists and in most cases identified issues and implemented corrective actions in a time frame commensurate with their safety significance if identified during the audits. However, the team noted that BTL did not complete periodic audits to verify compliance with all aspects of the quality assurance program as scheduled and in accordance with written procedures. The team noted that BTL did not perform external audits for two external audits (suppliers) in 2021 and 2022 as scheduled and performed some of the audits at later dates. The team noted that this was not in accordance with their supplier qualification program procedure. The team determined that this was a violation of 10 CFR 71.137, Audits.
As required by 10 CFR 71.137 it states, in part, that the certificate holder shall carry out 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. The audits must be performed in accordance with written procedures or checklists by appropriately trained personnel not having direct responsibilities in the areas being audited.
Contrary to, as of July 28, 2023, the certificate holder (BTL) did not carry out a comprehensive system of planned and periodic audits to verify compliance with all aspects of the quality assurance program that determined the effectiveness of the program. Additionally, BTL did not perform the audits in accordance with written procedures. Specifically, BTL missed performing audits and did not complete audits as scheduled in accordance with written procedures.
The team assessed the significance of the violation using the NRC Enforcement Policy and Enforcement Manual. 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 because it was like an example contained in Inspection Manual chapter 0617, Vendor and Quality Assurance Implementation Inspection Reports, appendix E, Minor Examples of Vendor and QA Implementation Findings, example 8.b. The team characterized the violation as a Severity Level IV violation in accordance with the NRCs Enforcement Policy. BTL entered the issue into its corrective action program (CAP) under CAPA numbers 230601 and 230602. The team assessed that because this violation was of low safety significance and was entered into the BTLs CAP, and the issue was not repetitive or willful, it is being treated as an NCV, consistent with section 2.3.2.a of the Enforcement Policy (71-0943/2023-201).
1.8.3 Conclusions The team determined for the most part that BTL performed internal and external audits of their QAP for the transportation packagings and resolved deficiencies if identified in a timely manner. However, BTL did not carry out a comprehensive system of planned and periodic audits to verify compliance with all aspects of the quality assurance program as scheduled and in accordance with written procedures.
2.0 Entrance and Exit Meeting On June 21, 2023, the NRC inspection team discussed the scope of the inspection during an entrance meeting with the BTL staff. On June 23, 2023, the NRC inspection team presented the inspection results and observations during an onsite debrief. On July 28, 2023, the NRC inspection team conducted a final telephone conference exit with Matthew Efseaff and other members of the BTL staff. Section 1 of the attachment to this report shows the attendance for the entrance and exit meetings.
ATTACHMENT
1. ENTRANCE/EXIT MEETING ATTENDEES AND INDIVIDUALS INTERVIEWED
Name Title Affiliation Entrance Onsite Exit Debrief Matthew Learn Inspection Team Leader NRC X X X Marlone Davis Safety Inspector NRC X X Azmi Djapari Safety Inspector (Trainee) NRC X X X Jessica Wolfe Regulatory Manager & BTL X X X Assistant RSO Matthew Efseaff Radiation Safety Officer BTL X X X Andrei Ciresianu Director - Engineering BTL X Marilee Jackson Radiation Safety Specialist BTL X Jacob Schankula Manager, Production BTL X Planning
2. INSPECTION PROCEDURES AND OTHER NRC DOCUMENTS USED
IP 86001 Design, Fabrication, Testing, and Maintenance of Transportation Packagings NUREG/CR6407 Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety NUREG/CR6314 Quality Assurance Inspections for Shipping and Storage Containers
3. LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED
Item Number Status Type Description 710943/2023201-01 Opened and Closed NCV Failure to perform audits in accordance with QAP
4. LIST OF ACRONYMS USED
ADAMS Agencywide Documents Access and Management System BTL Best Theratronics Limited CAP Corrective Action Program CAPA Corrective and Preventive Action CFR Code of Federal Regulations CoC Certificate of Compliance DFM Division of Fuel Management IP Inspection Procedure ITS Important-toSafety M&TE Measuring and Test Equipment NCR Nonconformance Report NCV Non-Cited Violation NMSS Office of Nuclear Materials Safety and Safeguards NRC Nuclear Regulatory Commission PDR Public Document Room PO Purchase Order WO Work Order QA Quality Assurance QAP Quality Assurance Program SAR Safety Analysis Report SARP Safety Analysis Report for Packaging
5.
DOCUMENTS REVIEWED
Certificate holder documents reviewed during the inspection were specifically identified in the
report details above.
2