How long must we maintain our quality assurance records for our FFDM unit?

While the test result records (documentation logs) must be maintained as described above, FDA realizes that maintaining a large number of QC test images may be overly burdensome. Therefore, similar to what is already allowed for film-screen, FDA will allow FFDM QC test images to be retained according to the following schedule:

Images produced from daily QC tests – previous 30 days

Images produced from weekly QC tests – previous 12 weeks

Images produced from monthly QC tests – until the next annual inspection has been completed and FDA has determined that the facility is in compliance with the quality assurance requirements

Images produced from quarterly QC tests – until the next annual inspection has been completed and FDA has determined that the facility is in compliance with the quality assurance requirements

Images produced from semi-annual QC tests – until the next annual inspection has been completed and FDA has determined that the facility is in compliance with the quality assurance requirements or until the test has been performed two additional times at the required frequency, whichever is longer.

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