CAP - TRM. 44970 Radiation Dose (...Quality Control Program for the indicator system)

[Keith]

We just recently had a CAP inspection and were cited for non compliance for this checklist. Specifically the inspector cited that we did not QC the new lot of the irradiation indicators when received? How do you perform the QC? Any suggestion will be appreciated. Furthermore, if you can share your Quality Control Program for the indicator system will also be appreciated. Thanks.

[adiescast]

We have a computer attached to our irradiator that tracks lot number and exposure for indicators. We use that to document that the new lot worked. If you do not have that, you could document on a form with the first use of each lot that the indicator behaved as expected.