Managing CAPA in a Digital Quality System
The short answer
Separate immediate correction from root-cause action. Assign owner, due date, implementation evidence and an effectiveness method. Closing a task does not prove recurrence was prevented.
Three actions to take
- Define the problem with reviewable evidence.
- Connect each action to a defined cause.
- Review effectiveness after a suitable period.
Start with the real scope
Separate immediate correction from root-cause action. Assign owner, due date, implementation evidence and an effectiveness method. Closing a task does not prove recurrence was prevented.
- Define the problem with reviewable evidence.
- Connect each action to a defined cause.
Review the points that change the decision
Turning a finding into containment, cause analysis, action and effectiveness review rather than closing it with a written response. Record assumptions clearly and separate confirmed data from items that need checking against the official source or actual operation.
- Connect each action to a defined cause.
- Review effectiveness after a suitable period.
Turn the review into a usable output
Finish with an owner, version, date and follow-up indicator. This keeps the file useful after delivery and allows it to change with the activity, product or system.
- Define the problem with reviewable evidence.
- Review effectiveness after a suitable period.
Need to apply this to your facility?
Share the activity, city and current stage, and we can help define an appropriate work scope.
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