During the time a facility is establishing new processor operating levels (typically done by performing a five-day data plot average): A) does the facility continue to plot the data on the processor chart?; B) Is the facility exempt from having to stay within the old processor action limits during the five-day averaging period?
While establishing new processor operating levels (during which time the facility can continue to process mammograms), the facility must continue to perform the daily processor QC tests and should plot the data in the same manner it usually does. This may be done on the same graph as the previous data or on a different graph. In either event, this new data should be clearly identified as being derived during the establishment of the new operating levels, so that both the facility and the inspector are aware of the origins of this data. Because no operating level has yet been established, the facility is exempt from having to stay within any processor action limits during this five-day averaging period. FDA recommends that during the five-day averaging period, the facility daily perform and evaluate a phantom image as a means of monitoring image quality. Because phantom optical densities may also vary during this time period, the facility may limit its evaluation of the phantom image to the fiber/speck/mass scores. If the facility follows this recommendation and the scores fall below the minimum requirement, the facility must cease performing mammography until the problem has been corrected. 21 C.F.R. 900.12(e)(8)(ii)(A).