Radiation-Emitting Products

What does it mean to be under the direct supervision of a qualified medical physicist?

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For the physics survey and/or mammography equipment evaluation, direct supervision means that the supervising medical physicist must have qualified under the Master’s or higher pathway 21 C.F.R. 900.12(a)(3)(i)(B)(3). and be present to observe and correct, as needed, the performance of the supervisee. This requires that the supervisor be in the room during the performance of the individual equipment tests to assure that any mistakes made by the supervisee are corrected before the test is completed. The supervisor must review any calculations made from, and any conclusions drawn from the test results, before those results are provided to the facility.

Furthermore, when conducting a physics survey, the supervisor and supervisee must jointly review the QC program records. The supervisor does not have to be present when the supervisee initially reviews the QC program records. However, the supervisor must review, discuss, confirm, and if necessary, correct the findings made by the supervisee prior to either the initial or final survey report being issued. 21 C.F.R. 900.12(e)(9).

The goal of direct supervision is to provide reasonable assurance that any mistakes made by the supervisee are corrected before the QC program review or tests are completed.

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Page Last Updated: 08/12/2014
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