ML18267A038
| ML18267A038 | |
| Person / Time | |
|---|---|
| Site: | 07100943, 07109290, 07109299, 07109310 |
| Issue date: | 08/13/2018 |
| From: | Jon Woodfield NRC/NMSS/DSFM/IOB |
| To: | Best Theratronics, Ltd |
| Woodfield J | |
| References | |
| IR 2018201 | |
| Download: ML18267A038 (7) | |
Text
NRC FORM 591S PART 1 _.. ***.*,\ U.S. NUCLEAR REGULATORY COMMISSION (10-2013) f :.'l:.z,:I ,
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SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION 1 CERTIFICATE/QUALITY ASSURANCE PROGRAM (OAP) HOLDER* 2 NRG/REGIONAL OFFICE Best Theratronics, Ltd. Headquarters 4 13 March Road U. S. Nuclear Regulatory Commission Ottawa, Ontario, Canada K2K OE4 Mail Stop TWFN 48-34 Washington, DC 20555-000 I REPORT NUMBER(S) 07I-0943/2018-201 3 CERTIFICATE/OAP DOCKET NUMBER(S) 4. INSPECTION LOCATION 5 DATE(S) OF INSPECTION QAP 71-0943, CoC 71-9290, Coe 71-9299, Best Theratronics, Ltd. (Best)
August 13-14, 2018 CoC 71-9310 Ottawa, Ontario, Canada CERTIFICATEJQUALITY ASSURANCE PROGRAM HOLDER:
The inspection was an examination of the activities conducted under your OAP as they relale to compliance with the Nuclear Regulatory Commission (NRC) rules and regulations and the conditions of your OAP Approval and/or Certificate(s) of Compliance. The inspection consisted of selective examinations of procedures and representative records, interviews with personnel. and observations by the inspector The inspection findings are as follows:
Based on the inspection findings, no violations were identified.
Previous violatlon(s) closed.
The violations(s), specifically described to you by the inspector as non-cited violations. are not being cited because they were self-identified.
non-repetitive, and corrective action was or Is being taken. and the remaining criteria in the NRG Enforcement Policy, to exercise discretion, were satisfied.
(
Non-cited violation s) was/were discussed involving the following requirement(s) and Corrective Actions(s)
During this inspection, certain of you, activities. as described below and/or attached, were in violation of NRG requirements and are being cited in accordance with NRG Enforcement Policy This form is a NOTICE OF VIOLATION. which may be subject to posting in accordance with 10CFR 1911 (Violations and Corrective Actions)
Statement of Corrective Actions I hereby state that. within 30 days. the actions described by me to the Inspector will be taken to correct the violations identified This statement of corrective actions is made in accordance with the requirements of 10 CFR 2.201 (corrective steps already taken. corrective steps which will be taken.
date when full compliance will be achieved) I understand that no further written response to NRC will be required. unless specifically requested TITLE PRINTED NAME /l /) SIGNATURE DATE CERTIFICATE/OAP Mojgan Soleimani, Quality and Regulatory REPRESENTATIVE Manager 610 NRC INSPECTOR Jon N. Woodfield BRANCH CHIEF Patricia Silva NRC FORM 591S PART 1 (10-2013)
INSPECTOR NOTES COVER SHEET Licensee/Certificate Holder Best Theratronics, Ltd. (Best)
(name and address) 413 March Road Ottawa, Ontario Canada K2K OE4 Licensee/Certificate Holder Mojgan Soleimani, Quality and Regulatory Manager contacts and hone number 613-591-2100 extension 2766 Office Docket No. 71-0943 Inspection Report No. 71-0943/2018-201 Inspection Date(s) August 13-14,2018 Inspection Location(s) Best Theratronics, Ltd; Ottawa, Ontario, Canada Inspectors Jon Woodfield, Team Leader, Safety Inspector Marlene Davis, Senior Safety Inspector Jerem Ta , Safet Ins ector Summary of Findings and This inspection was a non-routine limited scope inspection to Actions follow-up on Best's corrective actions taken to address four Notice of Violations (NOVs) from the previous September 20-22, 2016 routine periodic inspection assessment of Best's Quality Assurance Program (QAP) implementation.
Best responded to the four NOVs in a letter dated November 30, 2016 with four attached Corrective and Preventive Action (CAPA) documents, one for each violation. The letter contained commitment dates for the completion of the corrective actions.
The violations were related to Certificates of Compliance 71-9290 (F-430), 71-9299 (F-423), and 71-9310 (F-431).
The team reviewed Best's corrective actions taken to address the violations, Best's completion and close out of those actions, and all supporting documentation.
The team assessed that Best was adequately implementing their 10 CFR Part 71 NRC approved QAP with regard to taking effective corrective actions to address the four NOVs.
There was one minor violation against regulation 10 CFR 71.91, "Records," for Best storing Quality Records in paper boxes directly under a fire sprinkler nozzle. The team also determined that Best needed to perform an engineering evaluation of the safety classification of its sealed sources and revise a containment boundary evaluation. Best captured the need for the new and revised evaluations in a CAPA.
Lead Inspector Jon N. Woodfield Signature/Date Inspector Notes Approval Patricia Silva Branch Chief Signature/Date Page 1 of 6
Inspection History From September 20 through 22 , 2016, the NRC conducted the last programmatic inspection of Best Theratronics, Ltd. (Best) at its offices in Ottawa, Ontario, Canada. The purpose of the inspection was to review Best's activities associated with the transportation of radioactive material and to determine if they were executed in accordance with the requirements of 10 CFR Parts 21 and 71 , Certificates of Compliance (CoCs) , Safety Analysis Reports , and Best's NRC-approved Quality Assurance Program (QAP). The team inspected Best's management, design, maintenance, and fabrication controls .
The NRC inspection team assessed that, overall , Best's OAP and procedures were marginal in meeting the QA requirements of 10 CFR Part 71 and 10 CFR Part 21 . The team identified examples where recordswere not properly maintained , measures were not established for the selection and suitability of materials, activities affecting quality were not prescribed in documented procedures, and the effectiveness of the control of quality by contractors was not assessed at intervals consistent with the importance, complexity, and quality of the service.
Therefore, the NRC decided to maintain Best on an increased inspection frequency and thus the need for this just completed inspection.
Based on the results of the 2016 inspection , the NRC determined that four Severity Level IV Violations (some with multiple examples) of NRC requirements occurred . Details are provided in the 2016 inspection report (ML16312A007).
Inspection Purpose The specific purpose of this inspection was to follow-up on Best's corrective actions taken to address the four violations from the September 2016 inspection documented in Inspection Report 71-0943/2016-201 and Notice of Violation (NOV). Best responded to the NOV in a letter dated November 30 , 2016 (ML16347A012) with four attached Corrective and Preventive Action (CAPA) documents, one written for each violation . The letter response contained comm itment dates for completion of corrective actions. The inspection team was to determine that all corrective actions had been completed and closed out with supporting documentation.
Primary Inspection Procedures/Guidance Documents IP-86001, "Design, Fabrication , Testing , and Maintenance of Transportation Packagings" NUREG/CR-6407, "Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety" NUREG/CR-6314, "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" Page 2 of 6
INSPECTOR NOTES: THE 2016 NOTICE OF VIOLATION IDENTIFIED THE FOUR VIOLATIONS AS A THROUGH D. THE RESULTS OF THE REVIEW OF BEST'S CORRECTIVE ACTIONS FOR EACH NOV ARE THEREFORE DOCUMENTED BELOW A THROUGH D.
Violation A The team reviewed Best's corrective actions associated with the violation of 10 CFR 71.91, "Records," identified during the 2016 inspection to verify they were completed as described in the November 30, 2016 response letter to the violation. Specifically, the violation of 10 CFR 71.91 was that Best, as the holder of CoC 9290 for transportation packaging model F-430, had failed to maintain sufficient written records to furnish evidence of the quality of five packaging units. At the time of the 2016 inspection, Best could only demonstrate that it had maintained between 50 and 70 percent of the original F-430 fabrication records for unit serial numbers 5, 6, 7, 8, and 9.
The team reviewed the CAPA 160905 associated with this violation whose primary resolution was to find the missing quality records. However, as part of the CAPA, Best undertook a project to scan all their transportation packaging and gamma cell quality fabrication records and store them electronically besides in hard copy. Best stated they are now committed to electronic storage for historic records and newly developed records; however, completion of the project is long term due to budget and work scheduling constraints.
The team noted that Best closed CAPA 160905 July 25, 2018, which was after the date of April 30, 2017 committed to for completion in Best's November 30, 2016 letter response to the NOV.
The team asked Best how they could close the CAPA if the scanning of paper quality records to electronic records project was still in progress. Best stated that the CAPA, although closed, has a date for performing an effectiveness check on it (January 30, 2019) which is tracked so that Best will revisit the CAPA to monitor the progress of the electronic records project for completion as required by the CAPA resolution.
CAPA 160905 in its resolution stated that the missing fabrication quality records for the F-430 transportation packaging units had been found. Best presented a box of F-430 hard copy fabrication records to the team for its review. The team reviewed the documentation and determined that the quality records were adequate for all F-430 transportation packaging units.
The team noted that the records were old and not up to current standards with bulk material purchases and certifications that could not be traced to specific units. However, the team determined the records to be overall effective and adequate to verify quality materials were used and quality fabrication performed in producing the F-430 units.
The team requested Best to demonstrate how it was controlling the filing and ability to retrieve quality records within its electronic records system in accordance with procedure 5.00-QA-18, "Quality Records." Best personnel demonstrated from a computer terminal how its electronic database was set up with folders and files to retrieve quality records. The team requested a Page 3 of 6
retrieval demonstration of a sampling of randomly selected quality records of its choosing and Best was able to quickly find them in the electronic records system.
The 2016 inspection report had documented that Best was not properly maintaining its records for the fabrication of its medical equipment which becomes part of the transportation packaging during shipment. The older fabrication records were in paper form and not electronically scanned. The storage of the paper records were in folders on open storage shelves. In 2016 the storage area had inadequate fire protection against record loss from fire. This was cited as a minor violation during the 2016 inspection since at the time none of the records had been lost or damaged. Therefore, since the Best electronic records project was ongoing, the team requested to observe how yet to be scanned paper quality records were being stored at the time of the current inspection. The team determined that the remaining to be scanned historic quality records had been moved to an area that had fire sprinklers with the majority of the records stored in metal file cabinets. However, the team observed some paper records stored in paper boxes directly under sprinkler nozzles. These records could be damaged from water if the sprinklers went off. This is a continuation of the violation against properly maintaining records from the 2016 inspection but again identified as a minor violation since currently none of the records have been lost or damaged. The team made Best aware of this minor violation.
The team determined the Best corrective actions to find the F-430 missing quality records in response to Violation A were adequate and the violation is closed. The team determined the associated long term corrective action to CAPA 160905 to make all historic quality records (along with new quality records) electronic with electronic backup to be a major improvement in Best's records management.
Violation B The team reviewed Best's corrective actions associated with the violation of 10 CFR 71.107, "Package design control ," identified during the 2016 inspection to verify they were completed as described in the November 30, 2016 response letter to the violation. Specifically, the violation of 10 CFR 71.107 was that Best did not perform engineering evaluations for transportation packaging components to determine their important to safety level/category to ensure Best applied a graded approach to quality assurance and design control. Also, another concern associated with not performing the component safety category evaluations was that Best did not have a Commercial Grade Dedication procedure for commercially purchased components or materials used in important to safety applications for its packagings.
The team reviewed CAPA 160906 associated with this violation which included the development of a new quality assurance procedure, 5.05-QA-04, "F430, F431 and F423 Transport Packages Components Grading Evaluation in Conformance with 10 CFR Part 71 Packaging and Transportation of Radioactive Material," Revision A The team evaluated the effectiveness of Best's corrective actions and assessed the results of the engineering evaluations performed for the F430, F431, and F423 transportation packaging components using the new procedure. The team noted that Best completed the corrective actions just prior to the follow-up inspection, Page 4 of 6
which was after the date of April 30, 2017 committed to for completion in Best's November 30, 2016 letter response to the NOV. The team determined for the most part that Best conducted an adequate review and evaluation of the components using the new graded approach procedure except for containment of the sealed sources. In reviewing 5.05-QA-04, the team discovered that Best excluded the content from the graded approach evaluation. The team noted that the package as defined in 10 CFR 71.4, is the packaging together with its radioactive contents. Therefore, the team determined that the package description and evaluation included the content. In this case, the radioactive contents in either special form or non-special form sealed sources provide the containment. The team noted that these items are critical to safe operation whose failure could directly result in a condition adversely affecting public health and safety. The team assessed that the fabrication of the sealed sources is a part of the packaging design control and quality assurance program . Also, for the F-423 the team determined the evaluation of the containment boundary to be improper. Best entered these issues of concern into their CAPA program as CAPA number 180801 to perform an engineering evaluation of the sealed sources to determine their important to safety level/category and revise the containment boundary evaluation. After reviewing the transportation packaging component safety category evaluations, it was determined by the team in agreement with Best that a Commercial Grade Dedication procedure was not required since there were no Category A components or materials commercially procured for the packagings by Best.
The team determined the corrective actions in response to Violation B were adequate and will be fully completed under CAPA 180801 and the violation is considered closed .
Violation C The team reviewed Best's corrective actions associated with the violation of 10 CFR 71 .111 ,
"Instructions, procedures, and drawings," identified during the 2016 inspection to verify they were completed as described in the November 30, 2016 response letter to the violation.
Specifically, the violation cited Best's failure to incorporate three maintenance program activities described in the F-430 and F-431 Safety Analysis Reports , Section 8.2.3, into the Best maintenance procedure IN/IM 2548 FOOO. CAPA 160908, dated September 26, 2016 documented Best's corrective actions for this violation . The team determined that Best incorporated the three maintenance requirements in IN/IM 2548 FOOO and the applicable work orders , as appropriate. These actions were performed as described in Best's response to the violation . The team noted that the actions were completed and full compliance achieved by the stated date of November 11 , 2016 in the Best NOV response letter.
The team determined the corrective actions in response to Violation C were adequate and the violation is closed .
Violation D The team reviewed Best's corrective actions associated with the violation of 10 CFR 71.115, "Control of purchased material, equipment, and services ," identified during the 2016 inspection Page 5 of 6
to verify they were completed as described in the November 30, 2016 response letter to the violation. Specifically, the violation cited two examples of Best's failure to perform external audits of contractor Nordion for their sealed source receipt inspection and package maintenance programs. CAPA 160907, dated September 26, 2016, documented Best's corrective actions for this violation. The team assessed that Best identified the cause for the violation to be supplier qualification procedure, 5.03-AA-54, "Control of Products and Services Obtained from Suppliers," being less than adequate and not requiring formal on-site audits of suppliers. Best revised the procedure to require an annual review of Class A suppliers and an on-site audit every 3 years using checklists developed from US industry standards such as Nuclear Procurement Issues Committee (NUPIC) or Nuclear Industry Assessment Committee (NIAC) checklists. This action was performed as described in Best's response to the violation. The team noted that the action was completed and full compliance achieved by October 25, 2017, which was after the date of April 30, 2017 committed to for completion in Best's letter response to the NOV. However, the team determined that the corrective actions were completed in a reasonable timeframe commensurate with the current schedule for required external audits of Class A suppliers.
Additionally, the team noted that no additional external audits of Nordion were performed as part of Best's corrective actions. The team determined and agreed that no additional audits were necessary as the maintenance activities Nordion performed for Best did not include work or inspection of any Class A components, and the sealed source receipt inspection program at Nordion was only used as a secondary verification of the receipt inspection activities Best performed on the sealed sources from supplier Mayak.
The team determined the corrective actions in response to Violation D were adequate and the violation is closed.
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