| ISO 13485:2016 Section | Document Section |
|---|---|
| 8.5.2 | (All) |
| 8.5.3 | (All) |
Summary
This list contains all of our Corrective and Preventive Actions (CAPAs).
List of CAPAs
- “Adverse Implications”: Verifying that the corrective / preventive action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device.
- “Verification”: Documenting proof of implementation of actions taken.
- “Effectiveness”: Review of the effectiveness of corrective / preventive actions taken.
- “Root Cause”: Analyzing the underlying cause that led to the event. Different methodologies can be used, e.g. 5 Why’s (asking 5 times Why? in a row) or Ishakawa/Fishbone Diagram (identifying cause categories and sub-causes in a diagram).
| Input Category | CAPA ID | Date Created | CAPA Description | Root Cause | Date Root Cause Analysis Completed | Action (Corrective / Preventive) | Date Actions Defined | Potentially Adverse Implications | Verification | Date of Verification | Effectiveness Evaluation | Date Closed |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Usability feedback | 1 | 01-01-2022 | No contact details provided as part of product information | Missing Test Case for Product Information | 02-01-2022 | New product release incl. contact details; update test cases | 03-01-2022 | Release of product version and test case update | Number of future complaints related to this issue; review of technical information by Notified Body for completeness |
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