Loss of a Quality Record - FDA Inspection

#1
Hello Elmar Forum :)

I am looking for guidance.
We are currently going through an FDA Audit for Medical Devices and we cannot locate a CAPA from 2016. I see in 820.180 the mention of storage to minimize deterioration and to prevent loss but I do not see anywhere about what to do if you lose a record.
Currently my record retention procedure does not reflect this either.

HELP PLEASE!

Vicki
 

craiglab

Involved In Discussions
#2
Hi Vicki. The QMS is to be designed to maintain control and losing a CAPA is akin to losing control. For recreating the CAPA you might want to look at previous quality/management reviews, internal audits, places where actions already taken are documented (like an ECO), etc.). And open a CAPA to investigate and correct this deficiency in your document control process. I would not be concerned with a process to follow since this should be a rare exception - do what you can and document with a note to file.
 
#3
Hi Vicky,
If you cannot find the hard copy or the soft copy of a particular CAPA record it may be that it was cancelled. Do some research into it.
Another path to follow: talk to the IT department and retrieve a backup of 2016 QA folders. You should be able to find it if it was filled and executed.

Good luck with the audit.

Shimon
 
#4
Hi Vicki. The QMS is to be designed to maintain control and losing a CAPA is akin to losing control. For recreating the CAPA you might want to look at previous quality/management reviews, internal audits, places where actions already taken are documented (like an ECO), etc.). And open a CAPA to investigate and correct this deficiency in your document control process. I would not be concerned with a process to follow since this should be a rare exception - do what you can and document with a note to file.
Thanks craiglab, this was helpful. We were able to produce about 95% of the documents however they were not signed. He reviewed them and was ok because all of our other documents had no issues. I will take your advice and open a CAPA to address our deficiencies. Thanks again!!
 
#5
Hi Vicky,
If you cannot find the hard copy or the soft copy of a particular CAPA record it may be that it was cancelled. Do some research into it.
Another path to follow: talk to the IT department and retrieve a backup of 2016 QA folders. You should be able to find it if it was filled and executed.

Good luck with the audit.

Shimon
I had saved a lot of the information in a folder and was able to reprint. We were also able to show that it had been reviewed during a ISO audit and during our management review which saved us a 483. : )
Thanks for your help!
 

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