List of CAPAs
Contents
List of CAPAs#
ISO 13485:2018 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 |