ISO 13485 reassessment audit and passed with no NCs and 2 OFIs

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J

Julius

#22
Doug, Congratulations. Did your Registrar audit you using "Process Audit" techniques or "Element Auditing"? Did the Registrar strictly audit ISO 13485:03 or did the Lead Auditor also look at the Regulatory and Statutory Requirements? Example: 21 CFR 820? Thank you.:rolleyes:
 
R

Roland Cooke

#24
I'll be interested in seeing Doug's response, this one can certainly be contentious.

For myself, I like to see a formal system - whatever form that takes* - to review our non-NCR audit findings (aka Observations, OFIs, feedback, commentary, etc etc).
After all, the requirement in 5.6.2 (a) is "results of audits". It doesn't say "review of NCRs".


Now maybe the OFI is reviewed and it is considered that no action needs to be taken. Or perhaps that it's a great idea - but that the company can't dedicate the resources to it this year.
Or maybe even that the auditor is talking complete rubbish. :notme:


But to have no evidence that the OFIs have been reviewed at all? I don't like that.
Is it an automatic Minor CAR against 5.6.2 (a)? Clearly not, it depends on the situation.


*that can perhaps be a post-audit review meeting, part of Management Review, all OFIs automatically entered into the CAPA programme...whatever the company likes.

Obviously if action (probably preventive action) needs to be taken, then that should be managed, resourced and evaluated for effectiveness like any other project.


But, like I said, this one can be contentious. :)
 
P

Phil Fields

#25
Our registrar (SGS) practices this method. All nonconformance’s and OFI are reviewed and addressed in some manner. I am not sure of all of the nuances, this is an area that my boss the Director of QA/RA addresses.

Phil
 
A

arios

#26
I work as a contract third party auditor for ISO 13485 and I don't raise OFI to NC's unless a true NC exists. It is up to the company to consider OFI's
 
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A

arios

#27
Thanks for your reply Doug,

If you ever need help during audits in Nuevo Laredo Mexico or another local town please let me know. I work as a contract auditor for two registrars, mostly doing Medical Device assessments.

Take care
A. Rios
 
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Doug Tropf

Quite Involved in Discussions
#28
Doug, Congratulations. Did your Registrar audit you using "Process Audit" techniques or "Element Auditing"? Did the Registrar strictly audit ISO 13485:03 or did the Lead Auditor also look at the Regulatory and Statutory Requirements? Example: 21 CFR 820? Thank you.:rolleyes:
The audit was conducted using the process technique for the most part. In addition to auditing ISO 13485:03, ISO 11135-01:2007 was also covered.
 

Doug Tropf

Quite Involved in Discussions
#29
Doug,
Does your auditor look at OFIs during the next audit, if no action was taken, then consider them a nonconformance?

Phil
Phil, These were the first OFIs we have received from this particular auditor so I'm not sure what actions he will take at our next audit. Although we do not have a formal procedure for addressing audit OFIs, we do always evaluate their merits and act accordingly.
 
R

Roland Cooke

#30
I work as a contract third party auditor for ISO 13485 and I don't raise OFI to NC's unless a true NC exists. It is up to the company to consider OFI's
Ola Alberto, que pasa? Long time no speak!

I don't think anyone is arguing that NCs should be written as OFIs. (Disclaimer - occasionally a client will fix a NC whilst I'm onsite, including addressing the root cause. In those circumstances I will often raise a comment to that effect, just for completeness.)


However, my question to you is: if the company hasn't considered the OFIs...what do you do?
Do you spend your time tracking down the previous issues to see if an NC now exists?
Or is it an automatic NC that they haven't reviewed feedback on the status on the quality management system? (e.g. against 8.5.1, failure to analyse data)
Or something else?


(As a devious sort, I can probably argue it coherently from all sides :lmao:)
 
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