Module24 April 20265 min read
Module spotlight: CAPA Management
CAPA is where a quality system proves it can learn. Corrective and preventive action turns a problem into a root cause, a fix, and the evidence that the fix worked.
By MoniDoseQMS Team
Every quality system finds problems. The good ones learn from them. CAPA — corrective and preventive action — is the engine that turns a deviation, complaint, or audit finding into a root-cause investigation, a corrective action, and proof that the action actually worked.
What you can do
- Raise CAPAs from deviations, non-conformances, complaints, or audit findings
- Classify as corrective, preventive, improvement, or combined
- Document root-cause analysis, action plans, and effectiveness checks
- Apply electronic signatures and link to the change control that follows
Why it matters
ISO 13485 §8.5.2 requires corrective action that addresses root cause and verifies effectiveness. Keeping CAPA linked to what triggered it and what change it produced means problems close for real — not just on paper.