Raise and Close a Corrective Action (CAPA)
Who / when: Chika or Dr. Bello — both can do this — when a QC run rejects or a turnaround target breaches and the lab needs a documented fix. A CAPA (Corrective And Preventive Action) is the record of a problem and how it was put right. Raising and closing one is what turns a noted problem into the kind of defensible, audited evidence accreditation depends on, because the close carries an electronic signature.
We’ll follow Chika raising a corrective action after a QC reject, and Dr. Bello closing it.
- Lab Scientist — open Labs → Corrective Actions. This is the CAPA register. Press “Raise Corrective Action”.
- Lab Scientist — choose the trigger — a QC violation, a TAT breach, or Other — and describe what happened. Save it. The corrective action gets a CAPA number and starts as Open.
- Lab Scientist — work it: record the root cause and the action, and you can set an owner. As work proceeds the status moves from Open to In Progress.
- Lab Admin — to close it, press “Close Corrective Action”. Enter the final root cause, the action taken, and your 6-digit eSign PIN (your electronic signature, separate from your password). The PIN is verified before anything is saved. The CAPA then becomes Closed.
What happens next
Section titled “What happens next”A closed corrective action is a permanent, signed entry in the register, ready to show an accreditor as evidence the lab finds problems and fixes them. The triggers that feed it — QC rejects on the dashboard and breaches on the TAT monitor — are where the next ones come from, so the quality programme is a loop: detect, raise, fix, sign, close.