Hi Everyone,
I recently had an ISO 13485 Audit and the auditor gave me a Cat 3 finding (opportunity for improvement) that "The firm does not keep a traditional CAPA Log, but there is evidence of active tracking of CAPA performance both at management reviews and in Quarterly Data Analysis Reports."
This is true of us, we do track CAPAs and other type of reports in a quarterly meeting and the meeting notes, but we dont keep traditional logs. I was wondering, which documents do you keep traditional logs of?
Our auditor recommended at least:
(1) CAPAs
(2) Engineering Change requests
(3) Maintenance events
(4) Customer complaints
I am trying to consider what is useful to implement and what would just be a pain in the ass. Can someone give me their input on which logs they find useful and which are just more work and reporting than necessary? Is there anything you'd add or subtract to that list?
Thanks
I recently had an ISO 13485 Audit and the auditor gave me a Cat 3 finding (opportunity for improvement) that "The firm does not keep a traditional CAPA Log, but there is evidence of active tracking of CAPA performance both at management reviews and in Quarterly Data Analysis Reports."
This is true of us, we do track CAPAs and other type of reports in a quarterly meeting and the meeting notes, but we dont keep traditional logs. I was wondering, which documents do you keep traditional logs of?
Our auditor recommended at least:
(1) CAPAs
(2) Engineering Change requests
(3) Maintenance events
(4) Customer complaints
I am trying to consider what is useful to implement and what would just be a pain in the ass. Can someone give me their input on which logs they find useful and which are just more work and reporting than necessary? Is there anything you'd add or subtract to that list?
Thanks