Radiation-Emitting Products

How should a facility document the corrective actions that have been taken in response to quality control tests that fall outside the action limits and how should it document the effectiveness of those actions?

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The corrective actions taken should be documented by the individual who took the actions. The documentation can be in the form of a service report or any other document that lists the actions taken.

The documentation required on the effectiveness of the corrective actions depends upon their nature. For corrective actions involving major repairs, the facility's medical physicist must perform an equipment evaluation after completion of the corrective actions. The report of that evaluation showing that the equipment now meets the requirements will serve as documentation that the corrective actions were effective.

For corrective actions that did not require a major repair, the facility must document that the failed tests were repeated following the corrective actions and that the test results are now within the action limits. In this case, the test may be performed by any person with adequate training, not just the medical physicist.

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Page Last Updated: 07/18/2014
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