How to Document CAPA Effectiveness for FDA Inspection

If this question was asked in your next FDA inspection:

"How did you determine this CAPA was effective — and who authorized that conclusion?"

Could your team produce that record in under five minutes?

Most organizations cannot. Not because the CAPA failed — but because the authorization record does not exist.

Personal Exposure Check

Can you identify who evaluated CAPA effectiveness?
Can you show what evidence they reviewed at the time of the decision?
Can you produce the criteria used to define "effective"?

If any answer requires reconstruction, you have inspection exposure.

Produce the CAPA Effectiveness Authorization Record now — before the question is asked

Inspector Reality

The investigator does not explore your process.

They isolate a decision and ask:

"How was this CAPA determined to be effective?"

Then they wait.

At that moment, your team either produces the record — or begins reconstructing it under observation.

If this inspection happened tomorrow:

You could produce the authorization record immediately or
You would need to reconstruct the decision under inspection

There is no third outcome.

Authorization Gap

The CAPA record documents what was done.

It does not document:

Who authorized the effectiveness conclusion
What evidence was evaluated at the time of the decision
What regulatory standard governed that conclusion

That is the gap.

The effectiveness decision exists.
The authorization record does not.

Case File Preview

Investigator Question: "How was CAPA effectiveness determined and who authorized the conclusion?"

What Exists

CAPA record
Action completion evidence
Closure signature

What Doesn't Exist

Defined effectiveness criteria
Evidence evaluation at decision point
Authorization record tied to regulatory expectation

Result: The decision is correct. The evidence exists.

The authorization record does not.

The investigator expects it to already exist.

Most teams only realize this gap during inspection. By then, it is too late to create the record.

Produce the CAPA Effectiveness Authorization Record now — before the question is asked

Before you write the record

Test one CAPA decision against the eight reconstruction domains an investigator applies. The audit names which elements of that decision cannot be reconstructed from your current record — and which of those a record can close.

Audit one CAPA decision →