Quality Assurance Records
Citation:
900.12(d)(2): Quality assurance records. The lead interpreting physician, quality control technologist, and medical physicist shall ensure that records concerning mammography technique and procedures, quality control (including monitoring data, problems detected by analysis of that data, corrective actions, and the effectiveness of the corrective actions), safety, protection, and employee qualifications to meet assigned quality assurance tasks, are properly maintained and updated. These quality control records shall be kept for each test specified in paragraphs (e) and (f) of this section 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.
Questions:
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What quality assurance (QA) records must be maintained and for how long?
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How long must we maintain our quality assurance records for our FFDM unit?
- Can a facility digitize (scan) its paper QC records, MEE and annual physics survey reports, and personnel documentation, keep the digital data in a retrievable format, and then discard the original paper records?