List of CAPAs
|ISO 13485:2018 Section||Document Section|
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|
Template Copyright openregulatory.com. See template license.
Please don’t remove this notice even if you’ve modified contents of this template.