What is the difference between a correction and a corrective action?

A correction eliminates the detected nonconformity, for example by rework. A corrective action eliminates the cause so that it does not recur.

How long may a CAPA take?

The standard does not set a deadline. Define deadlines by severity – for example containment within 24 hours for critical cases – and monitor compliance.

Do I need a CAPA for every deviation?

No. Assess whether eliminating the cause is necessary. Recurring or serious deviations should always lead to a CAPA.

CAPA Checklist: Close Corrective Actions with Confidence

When to use this checklist

Use the checklist when approving CAPA action plans and before closing a CAPA. Closure is the critical point: many CAPAs are closed as soon as the action is implemented – without checking whether the problem has actually stopped recurring. That is exactly what ISO 9001 clause 10.2.1 d) requires with the review of effectiveness.

The full flow is explained in our guide to the CAPA process; methods for finding causes are covered in root cause analysis.

Checkpoints

Intake and problem statement

The problem is described specifically: what, where, when, how often, which product or process?
The source is documented (complaint, audit, deviation, inspection, risk analysis).
Severity is rated against defined criteria.
An owner and deadlines are defined.

Immediate action and containment

Affected products, batches or customers are identified.
Containment actions are implemented and documented (e.g. quarantine, sorting).
It has been checked whether similar products or processes are also affected.
Customers or authorities are informed where required.

Root cause analysis

A suitable method is used (e.g. 5 Whys, Ishikawa).
The root cause is evidenced, not just assumed.
The cause of occurrence is distinguished from the cause of non-detection.
A cross-functional team took part in the analysis.

Action plan

Every action addresses an evidenced cause.
Actions have owners and deadlines.
Impacts on documents, training, risks and processes have been checked.
The action plan is approved.

Implementation and verification

Implementation of each action is evidenced (e.g. new document version, training record).
Changed documents are approved and distributed.
Affected employees have been trained.
Risk analyses and FMEAs are updated.

Effectiveness check and closure

The criterion and timing of the effectiveness check are defined in advance.
The check takes place after sufficient time and with a sufficient data basis.
The result is documented: effective, partially effective or not effective.
If it is not effective, the CAPA is reopened.
Lessons learned are transferred to similar processes or sites.
Closure is approved by an authorised person.

CAPA in docxpert

CAPA management in docxpert guides you through nine phases from intake to closure, with deadlines by severity, 5 Whys and Ishikawa analysis, actions and an effectiveness check. Deviations from deviation management can be linked to a CAPA directly.

CAPA board with columns for intake, triage, root cause analysis and action plan — CAPA board with phases and deadlines · Screenshot with sample data

CAPA Checklist

When to use this checklist

Checkpoints

Intake and problem statement

Immediate action and containment

Root cause analysis

Action plan

Implementation and verification

Effectiveness check and closure

CAPA in docxpert

Download the checklist as PDF

Frequently asked questions

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