Corrections not allowed during audit

#1
My company was recently going through a ISO 13485 surveillance audit. During the audit, the lead auditor would not allow/accept corrections to documents where errors were discovered. We were told that all corrections would need to go through the third party process with an Action Plan, Root Cause and Corrective Action written and approved by the audit team. This is the first time in +20 years in the medical device industry that I have not been allowed to make corrections. My question is, has anyone one else experienced this?
 
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Tidge

Trusted Information Resource
#2
Is it possible that this policy is to keep the audit on track and on schedule?

I've typically observed auditors (in the field of medical device manufacturing) allow for some level of corrections during audits, but I've also seen this sort of thing get out-of-hand where lots of time that is supposed to be spent on a new area (e.g. day 2) ends up being consumed by re-review of earlier material, plus a bonus assessment of implementation of all sorts of areas that may not have been in the scope of area where the corrections needed to be made (NCR, Change Control, Doc Control, CA/PA) from day 1.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
My question is, has anyone one else experienced this?
That is (or should be) a standard practice. If the auditor identifies meaningful nonconformities, you don't want to rush the process and apply a band aid (correction). The organization needs to delve into root cause analysis (what takes time and effort, if done properly) and the review to be done by the CB for corrective action implementation and effectiveness also takes time and effort.

Further, you should ask yourself: how come a CB auditor, who pays you a visit every 6 or 12 months is able to identify so many (?) errors? If that is the case, you know that you have a poor internal review process.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Welcome SHiggins!

I'm with Sidney. For all of my years my associates and I were exhorted to not allow corrections during the audit, as it tends to invite a sense of "Let's just move on now" when they want the issue investigated and resolved in a robust way.

And just as Sidney said, part of that robust approach is detection. Your internal audit process is your secret weapon. I encourage you to review its effectiveness.
 
#5
It was well over 10 years ago that accepting responses during the audit were no longer permitted. At the time it was explained that it interrupted the audit process (taking up audit time), and rushing to resolve the issue resulted in very poor responses with inadequate root cause analysis.

Maybe you had a lenient certification body and a lenient auditor. Looks like your party is over.
 

Billy Milly

Involved In Discussions
#6
I agree with the above, this kind of approach is a standard practice. In our case(s), corrections on documents or records were accepted only if performed or at least detected and recorded before audit (for example, mentioned and evaluated in some kind of periodic report or meeting record). If not, NC.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#7
Was there an observer to the audit? Perhaps the audit was being monitored?
 

Billy Milly

Involved In Discussions
#8
If you are asking me - in all cases. Auditor without monitoring, with monitoring, with trainee, two auditors... Doesn't matter. Our NB is one of the big 3.
 
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