| ISO 13485:2016 Section | Document Section |
|---|---|
| 8.5.2 | (All) |
| 8.5.3 | (All) |
Overview
This document provides a comprehensive record of all Corrective and Preventive Actions (CAPAs).
CAPA Details
- Adverse Implications: Ensuring that corrective or preventive actions do not negatively impact compliance with regulatory requirements or compromise the safety and performance of the medical device.
- Verification: Providing evidence that the implemented actions have been carried out.
- Effectiveness: Assessing the success of the corrective or preventive actions taken.
- Root Cause: Investigating the primary cause of the issue. Common methods include:
- 5 Whys: Asking “Why?” repeatedly to identify the root cause.
- Ishikawa/Fishbone Diagram: Categorizing causes and sub-causes visually.
| Input Category | CAPA ID | Date Created | Description | Root Cause | Root Cause Analysis Completion Date | Action (Corrective / Preventive) | Action Definition Date | Potential Adverse Implications | Verification | Verification Date | Effectiveness Evaluation | Date Closed |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Usability Feedback | 1 | 01-01-2022 | No contact details included in product information | Missing Test Case for Product Info | 02-01-2022 | New product release with contact details added; update test cases | 03-01-2022 | Product version release and test case update | Monitoring complaint trends; Notified Body review of info completeness |