CAPA · Investigations
In most systems we open, "closing a CAPA" means: the announced action was carried out, somebody signed, the record moves to closed. The regulation asks for one more step — and it is the one that is almost always missing.
Verify the effect
ISO 13485 asks you to verify that the action produced the intended effect and did not degrade device conformity. 21 CFR 820.100 requires the action to be verified or validated before implementation. Both texts aim at the same thing.
A CAPA without evidence of effectiveness is an administrative record, not a corrective action. And it shows: the recurrence indicator does not come down. That is the most reliable symptom of a system handling its deviations on the surface — more reliable, in fact, than the share of CAPAs closed on time, which mainly measures your administrative discipline.
The belief that costs you
"A good CAPA is one closed within the deadline."
That is what your dashboard measures, so that is what your organisation optimises. The result is predictable: you pick the actions that close quickly. Reinforce an instruction, add a double check, run the training again — three actions that take a few weeks, document easily, and correct almost nothing. The cause is still there.
What the regulation actually says
Not "identify who is responsible". The cause is what, once removed, prevents recurrence. If the proposed action does not remove what you wrote in the root cause field, one of the two is wrong — and it is almost always the cause.
This step explicitly allows you not to open a CAPA when the risk does not warrant it. Most organisations skip it and open by reflex. They then end up with a portfolio of actions they have no means of running seriously.
The regulation asks you to make sure the action does not degrade something else. Adding an end-of-line control lengthens cycle time, shifts attention and sometimes manufactures the next error. This check is not a formality: it is the safeguard against stacking.
With a criterion set before implementation and an observation window. "No recurrence observed" is not a criterion if nobody was watching. A properly built CAPA states at opening what it will have to demonstrate, and by when.
Our conviction
And "human error" is not a root cause: it is an observation. The question that follows is always the same — what, in the workstation, the procedure or the workload of that moment, made this error likely? No regulatory text accepts stopping before that question. We are the ones who stop, because the answer costs more than a refresher course.
What you gain
Recurrence
It is the only indicator that judges the quality of your investigations. When it falls, the backlog stops rebuilding itself and the workload drops for good.
Inspection
The heaviest findings rarely concern an isolated deviation. They concern a failing investigation system — that is, a series of CAPAs closed without evidence.
Workload
Opening fewer CAPAs and running them properly takes fewer people than opening many and handling them superficially. The trade-off happens at step 2, and it is explicitly permitted.
The turning point is nearly always the same: accepting that some deviations call for no corrective action at all, so that real time can go to the ones that do. That is a quality management decision, not a regulatory concession.
Frequently asked
Give us your history. Two days is enough to measure the real recurrence rate and to name the causes that were never addressed.
