Template: CAPA List

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ISO 13485:2016 SectionDocument 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 CategoryCAPA IDDate CreatedCAPA DescriptionRoot CauseDate Root Cause Analysis CompletedAction (Corrective / Preventive)Date Actions DefinedPotentially Adverse ImplicationsVerificationDate of VerificationEffectiveness EvaluationDate Closed
Usability feedback101-01-2022No contact details provided as part of product informationMissing Test Case for Product Information02-01-2022New product release incl. contact details; update test cases03-01-2022Release of product version and test case updateNumber of future complaints related to this issue; review of technical information by Notified Body for completeness

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