To be a CAPA or not be a CAPA that is the question.

  1. Verify that CAPA System procedure(s) address the requirements of the quality system regulation are defined, documented and uptodate.
  2. Determine appropriate sources of product and quality problems as input in the CAPA System
  3. Confirm that data from these sources are analysed to identify existing product and quality problems that may require corrective action.
  4. Challenge the quality data information system. Verify that the data received by the CAPA System are complete, accurate and timely.
  5. Define a process of reviewing and analysing the data with appropriate documentation.

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