- Owner
- Quality Manager
- Effective date
- September 15, 2026
- Review cycle
- Every 12 months
1.Purpose
To make sure nonconformances, customer complaints and audit findings are investigated for root cause and corrected in a way that prevents recurrence, following a consistent and documented process.
2.Scope
Applies to corrective and preventive actions raised from internal audits, customer complaints, nonconforming product or service, and management review, from initiation through root cause analysis, action implementation and effectiveness verification.
Definitions
- Corrective action
- An action taken to eliminate the root cause of an existing nonconformance so it does not recur.
- Preventive action
- An action taken to reduce the risk of a similar issue occurring elsewhere, even where no nonconformance has happened yet.
- Containment
- An immediate action to limit the impact of an issue while the root cause is still being investigated.
- Effectiveness verification
- Confirming after a defined period that the corrective action actually prevented the issue from recurring.
3.Responsibilities
- CAPA Owner
- Raises the CAPA record and tracks it through to closure.
- Investigator
- Determines root cause and identifies corrective and preventive actions.
- Process Owner
- Contains the immediate issue and implements the agreed actions.
- Quality Manager
- Assigns investigations, approves actions, and verifies effectiveness before closure.
RACI matrix
| Activity | CAPA Owner | Investigator | Process Owner | Quality Manager |
|---|---|---|---|---|
| Raise the CAPA and contain the issue | R | I | R/A | I |
| Investigate and determine root cause | I | R/A | C | I |
| Approve corrective and preventive actions | I | C | C | R/A |
| Implement the actions | I | C | R/A | I |
| Verify effectiveness and close the CAPA | I | C | I | R/A |
R = Responsible, A = Accountable, C = Consulted, I = Informed
4.Materials and PPE
Materials, tools and systems
- →CAPA log or tracking system
- →Root cause analysis tools, such as five whys or fishbone templates
- →Investigation checklist
- →Affected procedure or document references
5.Procedure
- 5.1
Raise the CAPA
CAPA OwnerThe CAPA Owner raises a CAPA record for a nonconformance, a complaint trend, or an audit finding, describing the issue and where it was found.
- 5.2
Contain the immediate issue
Process OwnerThe Process Owner takes containment action to limit further impact of the issue while the root cause investigation is still underway.
Warning: Containment is not the same as a fix; do not close the CAPA once containment is in place.
- 5.3
Assign an investigator
Quality ManagerThe Quality Manager assigns an investigator to the CAPA and sets a target completion date for the investigation.
- 5.4
Investigate root cause
InvestigatorThe Investigator determines the root cause using a structured method, such as five whys or a fishbone diagram, rather than assuming the first plausible explanation.
Checkpoint: The identified root cause is supported by evidence gathered during the investigation, not just an assumption.
- 5.5
Identify the corrective action
InvestigatorThe Investigator, working with the Process Owner, identifies the corrective action needed to eliminate the confirmed root cause.
- 5.6
Identify preventive actions
InvestigatorThe Investigator, working with the Process Owner, identifies preventive actions that reduce the risk of a similar issue occurring in other areas.
- 5.7
Approve the proposed actions
Quality ManagerThe Quality Manager reviews and approves the proposed corrective and preventive actions, confirming each has a named owner and a realistic due date.
Checkpoint: Every action has a named owner and a realistic due date before it is approved.
- 5.8
Implement the actions
Process OwnerThe Process Owner implements the approved corrective and preventive actions by their due dates.
- 5.9
Update affected procedures
Process OwnerThe Process Owner updates any affected procedures, training materials or controls as a result of the corrective action.
- 5.10
Verify implementation
Quality ManagerThe Quality Manager verifies that the approved actions were actually completed as planned.
- 5.11
Verify effectiveness
Quality ManagerThe Quality Manager checks after a defined period that the original issue has not recurred, confirming the action actually worked.
- 5.12
Close or reopen the CAPA
Quality ManagerThe Quality Manager closes the CAPA once effectiveness is confirmed, or reopens it and restarts investigation if the issue recurs.
- 5.13
Report CAPA trends
CAPA OwnerThe CAPA Owner reports open and overdue CAPAs and overall trends from the CAPA log to management review.
6.Quality checks
- →Every CAPA has a documented root cause supported by evidence.
- →Corrective actions are not closed before effectiveness verification is complete.
- →Overdue CAPAs are flagged and escalated.
- →Containment actions are recorded separately from the permanent corrective action.
7.Records
- →CAPA record with investigation notes
- →Root cause analysis documentation
- →Effectiveness verification evidence
- →CAPA log and trend report
8.KPIs
- →Average time to close a CAPA
- →Percentage of CAPAs closed on time
- →Recurrence rate after CAPA closure
- →Number of open or overdue CAPAs
9.Common mistakes
- →Closing a CAPA right after implementing the fix without verifying effectiveness.
- →Treating a quick containment action as the permanent corrective action.
- →Skipping structured root cause analysis and guessing at a fix.
- →Not assigning a clear owner and due date to each action.
10.Revision history
| Revision | Date | Description | Reviewed by |
|---|---|---|---|
| 1.0 | September 15, 2026 | Initial release | Ilia Pirozhenko |
This is a template. Adapt it to your organization, equipment and local regulations before use.
