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U.S. Department of Health and Human Services

Radiation-Emitting Products

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What quality assurance (QA) records must be maintained and for how long?

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The facility must maintain quality assurance (QA) records that show:

1) Personnel Responsibilities: qualified mammography personnel assigned appropriate QA tasks

2) Technique Charts/Tables: the mammography techniques and procedures used in conducting mammograms

3) Quality Control (QC) test Records: including QC test procedures, test performance and monitoring, data analysis and timely corrective actions for each.

4) Procedures for safety and protection of patients and personnel.

These records must be maintained until the next annual inspection that would verify compliance or until an individual test has been performed two additional times at the required frequency, whichever is longer. Verifying compliance implies that if QC records for a given test were found to be deficient and the facility was cited during an annual inspection, these records must be kept until the facility corrects the problem to FDA’s satisfaction. This also means that records for semi-annual tests may have to be kept longer than the period between two successive annual inspections, and records for annual tests must include the most recent two.

While the test result records must be maintained as described above, FDA realizes that maintaining a large number of QC test images may be overly burdensome. Therefore the QC test images need 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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