Score the risk of an issue when you open a CAPA, then score it again once the corrective action has been done — so the record shows whether the risk actually came down.
What we are aiming at:
  • Severity, occurrence and detectability scored on a scale your organisation sets, producing a single risk number
  • An initial score at CAPA opening and a re-score at effectiveness verification, with the change shown on the record
  • Both scores included in what gets signed, so the numbers are part of the signed record rather than editable afterwards
  • Risk scores that can be trended across your whole CAPA programme, not just read one record at a time
Why this matters: quality managers tell us that an effectiveness check written as a paragraph asks an auditor to take your word for it, while a before-and-after score shows the improvement as a measurement. It also makes effectiveness something you can trend across a programme rather than something you re-read case by case.