The CAPA that never actually worked.

The FDA investigator asks to see CAPA-2023-047. Opened fourteen months ago after a sterility failure. Corrective action: additional training for aseptic technique. CAPA closed after training records were collected.

Then the investigator pulls up your deviation log. Three sterility failures in the past six months—all in the same suite, all with operators who completed that training. The CAPA is closed. The problem isn't fixed.

483 observation: "inadequate CAPA."

The checkbox that lies

"Effectiveness verification complete." Click it and the CAPA closes. No evidence required. No criteria defined. No waiting period to see if the fix actually worked.

In Seal, effectiveness verification is a gate. When you open a CAPA, you define specific criteria: "Zero recurrence in the next 100 batches." You define the verification method: batch record review. You define the timeline: after 100 batches.

The CAPA cannot close until verification is complete and evidence is attached.

When the fix doesn't work

When verification fails, the CAPA reopens automatically. Your root cause analysis was wrong. Go deeper. The cycle continues until the fix actually works.

Finding the real root cause

"Operator error" isn't a root cause. Why did the operator err? Were they trained? Was the procedure clear? Was the equipment functioning?

5-Why analysis: Why did the operator skip the step? The step was unclear. Why unclear? The SOP was poorly written. Why poorly written? Never peer-reviewed. Why not reviewed? No review process exists.

Now you have something you can fix.

40 symptoms, one disease

40% of your CAPAs involve training gaps. You've been treating them as 40 individual problems. But it's one problem: your training program doesn't work. Fix the system, prevent 40% of future CAPAs.