Concept

What is CAPA?

Corrective and Preventive Action

In 30 seconds

CAPA (Corrective and Preventive Action) is the systematic process of finding and eliminating the causes of nonconformities and potential nonconformities. It is an established term especially in regulated industries such as medical devices and pharmaceuticals.

How does it work?

  • Inputs are gathered: complaints, internal nonconformities, audit findings, trend data.
  • The problem is defined, the risk assessed and the root cause analysed.
  • Corrective and/or preventive actions are planned, implemented and verified for effectiveness.

Often confused with

CAPA and 8D

CAPA is an organisational process and term; 8D is a structured problem-solving method used to run it. A CAPA record can be worked through with 8D.

Common mistakes

  • Opening a CAPA for every small issue and clogging the system; not prioritising by risk.
  • Closing a CAPA once the action list is done, without verifying effectiveness.

From a QWorks perspective

In QWorks Complaint, CAPA runs on the same case with its source, owner, deadlines and effectiveness evidence.

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