How to Manage Corrective & Preventive Actions (CAPA)

This guide explains how to raise, investigate, and close Corrective and Preventive Action (CAPA) records — required by ISO 9001:2015 §10.2 (Corrective Action) and §6.1 (Preventive Action / Risk-Based Thinking).

What Is a CAPA?

• Corrective Action (CA) addresses the root cause of a nonconformance that has already occurred, to prevent it from recurring.
• Preventive Action (PA) addresses a potential failure before it happens.

A well-documented CAPA includes the problem, the root cause analysis, the corrective action taken, and evidence that the action was effective.

Prerequisites

• Any logged-in user can raise a CAPA
• Only a superuser (admin) can add root cause analysis, close a CAPA, and record effectiveness

Navigating to CAPA

Click CAPA in the navigation bar, or go to /corrective-actions.

The table shows all CAPAs with status:

Status	Meaning
Open	Raised, not yet assigned or in progress
In Progress	Under investigation or implementation
Closed	Actions implemented, pending effectiveness check
Verified	Effectiveness confirmed — fully resolved

Raising a CAPA

1. Click Raise CAPA
2. Fill in the fields:

Field	Description	Required
NCR Reference	Link to the triggering Nonconformance Report (if applicable)
Part Number	Part affected
Problem Description	Clear statement of the problem or risk	Yes
Assigned To	Person responsible for the investigation
Due Date	Target completion date

3. Click Save — CAPA is created with status Open

Tip: Link the CAPA to an NCR whenever possible. This connects the symptom (nonconformance) to the systemic fix (corrective action).

Completing Root Cause Analysis (Admin)

1. Open the CAPA and click Edit
2. Fill in the investigation fields:

Field	Description
Root Cause	What fundamental condition caused the problem? Use a structured technique such as 5-Why, Fishbone (Ishikawa), or Fault Tree.
Corrective Action	What was changed, implemented, or controlled to eliminate the root cause?
Preventive Action	What additional step will prevent similar issues in other products or processes?

3. Update Status to In Progress or Closed as applicable
4. Click Save

Recording Effectiveness Review

After enough time has passed to observe results, a superuser records whether the actions worked:

1. Open the CAPA and click Edit
2. Fill in Effectiveness Review: describe the evidence that the problem has not recurred (e.g. "No further bore OOT on P/N 4045 over 60 lots since tooling change — effective")
3. Set Status to Verified
4. Click Save

Note: ISO 9001 §10.2.1(f) requires reviewing the effectiveness of actions taken. An auditor will look for this field to be populated before accepting a CAPA as closed.

CAPA Best Practices

• Five-Why example: "Bore was oversize → drill worn beyond limit → no tool-life tracking → no tooling PM procedure → procedure gap." The root cause is the procedure gap, not the worn drill.
• Avoid go-back-and-check solutions. "Operator will be more careful" is not a corrective action — it does not remove the cause.
• Set realistic due dates. An overdue CAPA is worse than no CAPA when an auditor reviews the system.

⚠️ Warning: Closing a CAPA without an effectiveness review is a common minor finding in ISO 9001 audits. Always document evidence of effectiveness before setting status to Verified.