Effectives Check

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1

Hi All,

We are having a bit of a discussion around the compliance of the CAR systems. When we close a car here we would have to manually put in an effectiveness check that the change has worked or not. An effectiveness check is part of our compliance to ISO 13485 and so having it in overt form is beneficial when it come to audit time.

How have others managed this process? or any suggestions in the mangagnment of this.

Thanks
Joe @ DML

2

We do something similar after we close a CAR the effectiveness is reviewed at our next Management Team meeting. We have handled this by using the Resolutions. So our options here are Action Items Assigned - Waiting for Completion, Closed - all action items completed, and Effectiveness Verified by Management. It allows us to filter out all of the Corrective Actions in each category. You can add the details in the Resolution Comments as to when the check was completed, who verified it, etc. You can have both fields displayed up as columns when you search so you can show your auditor that you are tracking that stage of the process and the details of the check.

3

Hi Robin,

Thanks for the help. Sounds like a good way to monitor the CAR’s and be able to filter them also. :grin:

Thanks
Joe