| ISO 13485:2016 Section | Document Section |
|---|---|
| 8.5.1 | All |
| 8.5.2 | All |
| 8.5.3 | All |
Overview
This SOP outlines the procedures for initiating, implementing, and tracking CAPAs.
| Process Owner | \ |
| Key Performance Indicators | \ |
Process Steps
1. CAPA Inputs
CAPAs may be initiated due to a variety of events, such as:
- Non-conformities in the product or QMS
- Customer complaints
- Internal bug reports (e.g., from developers)
- Audit findings
- Post-market surveillance data or trends
- Management review findings or trends
Inputs for CAPA can originate from anyone within or outside the organization. The QMO is responsible for creating and monitoring the resolution of CAPAs, which are recorded in the CAPA list.
| Participants |
|---|
| QMO |
| Input | Output |
|---|---|
| Non-conformity, complaint, etc. | CAPA is created |
2. Determining Immediate Actions and Next Steps
If urgent action is required (e.g., field safety corrective action or regulatory notifications per SOP Vigilance), the QMO consults the Person Responsible for Regulatory Compliance. Immediate action must be initiated promptly, as stipulated in ISO 13485 section 8.5.2.
Subsequently, the QMO collaborates with the person closest to the issue (e.g., Head of Software Development for software-related problems) to decide on further steps.
| Participants |
|---|
| QMO |
| Medical Device Safety Officer/Person Responsible for Regulatory Compliance (if required) |
| Input | Output |
|---|---|
| CAPA | CAPA updated with actions |
3. Root Cause Analysis
The QMO facilitates a root cause analysis in partnership with the individual most familiar with the issue. The preferred methodology is the “Five Whys” technique. Results of the analysis are added to the CAPA record.
| Participants |
|---|
| QMO |
| Other relevant team members (if needed) |
| Input | Output |
|---|---|
| CAPA | CAPA updated with root cause data |
4. Action Implementation
The QMO oversees the definition and execution of corrective and preventive actions. Care is taken to ensure that actions do not negatively affect compliance with regulatory requirements or the safety and performance of the medical device. All actions are documented in the CAPA list.
| Participants |
|---|
| QMO |
| Other relevant team members (if needed) |
| Input | Output |
|---|---|
| CAPA | CAPA updated with an action plan |
5. Verification and Effectiveness Review
The QMO verifies and evaluates the effectiveness of the implemented actions. These steps are defined as:
- Verification: Confirming that actions have been implemented as planned.
- Effectiveness: Reviewing whether the actions successfully resolved the issue.
Once these reviews are completed, the QMO formally closes the CAPA.
| Participants |
|---|
| QMO |
| Input | Output |
|---|---|
| CAPA | CAPA updated with verification, effectiveness review, and closure date |