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What Is CAPA?

CAPA stands for Corrective and Preventive Action. It is the discipline of treating a problem properly: recording what went wrong, finding out why it went wrong, doing something that stops it recurring, and proving afterwards that it worked.

Fixing the symptom is not a CAPA. A CAPA is complete when the cause has been addressed and the effectiveness of that action has been demonstrated.

The three record types​

Every record in the module is one of three types, chosen when it is opened:

TypeOpened whenQuestion it answers
CorrectiveSomething has already gone wrong.Why did this happen, and how do we stop it happening again?
PreventiveSomething has not gone wrong yet, but could.What would cause this, and how do we remove that possibility?
ImprovementNothing is wrong.This works, but it could work better β€” what would make it better?

The type does not change the workflow; it changes how the record is reported on and how it is judged at closure.

Why the workflow has so many stages​

A nonconformity walks through a multi-stage lifecycle rather than a simple open/closed switch, because each stage answers a different question and each one has a different owner:

  1. Draft β€” what happened? Recorded by whoever detected it.
  2. Open approval β€” is this genuinely a nonconformity, and who should handle it?
  3. Progress report β€” what do we know so far, and does this need root cause analysis at all?
  4. Root cause and action plan β€” why did it happen, and what will we do?
  5. Close progress report β€” what did we actually do, and what was the result?
  6. Close approval β€” is that good enough to close?
  7. Closed β€” with the closing person and date stamped automatically.

Each stage gates what you are allowed to edit. You cannot add a root cause while the record is still waiting for open approval, and you cannot rewrite the root cause after the action plan has moved on.

Root cause analysis methods​

The module supports three ways of working:

  • Standard β€” a free-text cause description with no structure.
  • 5 Why β€” a chain of "why?" questions drilling from the symptom to the cause.
  • Fishbone β€” a cause-and-effect tree grouped by category.

The method is chosen on the progress report, and it decides what the root cause screen expects from you.

What you need before you start​

  1. Nonconformity sources β€” where records come from (audit, customer complaint, internal observation…).
  2. Nonconformity categories β€” how records are classified. Categories drive task assignment, so this list matters more than it looks.
  3. Root cause definitions β€” the reusable catalogue of known causes.

Continue with Purpose of This Guide or go straight to Nonconformity Records.