How do I show a CAPA was effective?
Decide, when you plan the action, what will show that it worked, from which date you will measure and when you will check; then check against those criteria and record the result with the evidence you saw. For a CAPA opened from complaints, that evidence is often whether the same problem recurred on the affected product after the action, compared with before. ISO 13485:2016 clause 8.5.2 asks for the effectiveness of corrective action to be reviewed: closing a CAPA is not the same as showing it worked.
Set the criteria first
Write down what will show the action worked before you see the result, in terms someone else can check: for example, no complaint with the same problem code on lots built after the change, over a period long enough to have seen the problem had it continued.
Measure from when the action took effect
Start the measurement when the action reached the product, such as the first lot built after a change, not when the CAPA was approved. Compare like with like: the same product and the same problem codes, before and after.
Record the judgement
The result is a judgement against the criteria, made and signed by an authorized person, with what they saw. If the action did not work, the record says so and leads to a further action.
Where the rules ask for it
- ISO 13485:2016 clause 8.5.2 (corrective action) and clause 8.5.3 (preventive action) include reviewing the effectiveness of the action taken.
What MDARIX does
- Every CAPA that is not cancelled or rejected gets an effectiveness check, closed ones included, and you can filter the checks that are overdue, due soon or not planned.
- You plan the check: what will show the action worked, the day measurement starts and the day to check. Quality reviewers get a reminder 14 days before the check day.
- The check shows complaint recurrence on the CAPA's product and problem codes before and since the action, as observed counts, not a statistical verdict.
- An authorized person signs the result, Effective or Not effective, with what they found, their password and an authenticator code. Readiness names the CAPAs without a verified effect.