ML18267A038: Difference between revisions

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{{#Wiki_filter: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 t o determ i ne 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 approved Quality Assurance Program (QAP). The team inspected Best's management , design , maintenance , and fabrication controls. The NRC inspect i on 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 determ i ned that four Severity Level IV Violations (some with multiple examples) of NRC requirements occurred. Details are provided in the 2016 inspection report (ML 16312A007). Inspection Purpose The specific purpose of th i s inspection was to follow-up on Best's correct i ve 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 (ML 16347 A012) with four attached Corrective and Preventive Action (CAPA) documents , one written for each violation. The letter response contained comm i tment 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 , " Establish i ng Quality Assurance Programs for Packaging Used in the Transport of Rad i oactive Material" Page 2 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 1 O 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 1 O 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 prog r am 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 1 O CFR 71.115 , " Control of purchased material , equipment , and services ," identified during the 2016 inspection Page 5 of 6}}

Revision as of 09:29, 1 October 2018

Theratronics, Ltd (Best), Ottawa, Ontario, Canada, NRC Form 591S Part 1, Inspection Report 07100943/2018-201. with Inspector Notes Cover Sheet
ML18267A038
Person / Time
Site: 07100943, 07109290, 07109299, 07109310
Issue date: 08/13/2018
From: Woodfield J N
NRC/NMSS/DSFM/IOB
To:
Best Theratronics, Ltd
Woodfield J N
References
IR 2018201
Download: ML18267A038 (7)
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