Quality & standardsCorrective and Preventive Action

What is CAPA?

CAPA (Corrective and Preventive Action) is the quality system’s process for handling deviations: corrective actions remove the root cause of an error that has occurred, so it doesn’t recur; preventive actions remove the risk before the error occurs.

A CAPA is not firefighting with a case number. The chain is: contain and fix immediately (correction), find the root cause (5 Whys, fishbone), implement the countermeasure, and verify the effect over time. Without verification, the CAPA is only a claim.

The most frequent CAPA problem in practice: 80% of actions are “employee re-instructed” — a human cause without a system change. It rarely passes an audit and never prevents the recurrence.

Related concepts

Root cause analysis

Root cause analysis is a structured investigation that finds the underlying cause of a problem — the cause that, if removed, prevents recurrence. Symptom treatment removes the effect temporarily; root-cause treatment removes the problem permanently.

5 Whys

5 Whys is a root-cause technique where you ask “why?” repeatedly — typically around five times — until you get from the symptom to the underlying cause that can be removed, so the problem doesn’t return.

ISO 9001

ISO 9001 is the world’s most widespread management standard: it sets requirements for a quality management system that ensures the organisation consistently delivers products and services meeting customer and regulatory requirements — and improves continuously.

FMEA

FMEA (Failure Mode and Effects Analysis) is a systematic risk analysis that, before the failure occurs, identifies possible failure modes in a product or process, assesses severity, occurrence and detectability, and prioritises preventive actions.

From concept to practice

The methods only work when they are anchored in daily routines and leadership behaviour. The operations check shows in 4 minutes where your operations stand — and what the next step is.

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