> CAPA checklist: checkpoints from problem statement, containment and root cause analysis to the effectiveness check under ISO 9001 clause 10.2 – online and PDF.

Source: [https://docxpert.io/en/checklists/capa](https://docxpert.io/en/checklists/capa)

# CAPA Checklist: Close Corrective Actions with Confidence

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## 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](https://docxpert.io/en/guides/capa-process); methods for finding causes are covered in [root cause analysis](https://docxpert.io/en/guides/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](https://docxpert.io/en/features/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](https://docxpert.io/en/features/deviation-management) can be linked to a CAPA directly.

CAPA board with phases and deadlines · Screenshot with sample data

## Download the checklist as PDF

Print-ready with tick boxes – ideal for your next audit or team meeting. Free; we also email you the link.

## Frequently asked questions

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.

## Read next

[CAPA processFrom report to effectiveness check: the CAPA process in nine steps.Learn more](https://docxpert.io/en/guides/capa-process) [Root cause analysis5 Whys, Ishikawa and more: which method fits when.Learn more](https://docxpert.io/en/guides/root-cause-analysis) [8D reportThe eight disciplines explained – with an example and common mistakes.Learn more](https://docxpert.io/en/guides/8d-report) [CAPA managementCorrective and preventive actions in nine phases – with 5 Whys, Ishikawa, deadlines and effectiveness checks.Learn more](https://docxpert.io/en/features/capa-management)

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