ENS 50458
ENS Event | |
|---|---|
04:00 Aug 6, 2014 | |
| Title | Agreement State Report - Manufacturing Defect Resulting In Equipment To Not Perform As Designed |
| Event Description | The following information was provided by the Commonwealth of Massachusetts via email:
On 9/15/2014, Massachusetts Radiation Control Program (MA RCP) was notified by licensee (QSA Global, Inc.) in accordance with 105 CMR 120.142(B)(2) of manufacturing defect of a model 95020 radiographic guide tube resulting in equipment that failed to function as designed. The licensee reported that its customer (Team Industrial Services of South Roxana, Illinois) informed the licensee on 8/6/2014 that the end stop of the guide tube had come off during a radiographic exposure performed 7/25/2014, that the source was able to be returned to the shielded/stored position in the exposure device using normal retraction with the control assembly, and that there was no excessive personnel exposure related to the part failure. The licensee reported that its examination of the model 95020 assembly failed part showed that the end fitting had not been swaged to the guide tube housing as is required by the design. The licensee reported that upon learning of the part failure, it immediately performed a visual inspection of all guide tube and control assemblies accepted into stock for distribution and that there were no other instances of unswaged fitting or improper manufacture identified for accepted stock. Licensee further reported that it believes that the instance to be an isolated occurrence and that no other assemblies containing this defect remain in the field. Licensee reported that manufacturer failed to swage end stop fitting to guide tube and manufacturer failed to perform pull test of end stop fitting to guide tube and check connection for slip using inspection gauge. Licensee reported that corrective actions include changes that will be implemented in the production process to increase inspection and review of quality critical operational steps to ensure this type of manufacturing defect is not accepted and released to customers in the future. Model 95020 guide tubes are approved for use with QSA Global, Inc. model 880 series radiographic exposure devices described by Sealed Source and Device Registration No. MA-1059-D-334-S. Licensee reported that it conducted a review to determine if this type of condition had occurred previously and identified one instance from 2012 where a different model guide tube, model 48906, had not been properly swaged and tested prior to distribution to an international customer. MA RCP plans to perform inspection to include evaluation for any generic implications. |
| Where | |
|---|---|
| Qsa Global, Inc. Burlington, Massachusetts (NRC Region 1) | |
| License number: | 12-8361 |
| Organization: | Ma Radiation Control Program |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+971.2 h40.467 days <br />5.781 weeks <br />1.33 months <br />) | |
| Opened: | Joshua Daehler 15:12 Sep 15, 2014 |
| NRC Officer: | Jeff Rotton |
| Last Updated: | Sep 15, 2014 |
| 50458 - NRC Website | |
Qsa Global, Inc. with Agreement State | |
WEEKMONTHYEARENS 560302022-07-25T04:00:00025 July 2022 04:00:00
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