Closing a finding before closing meeting

[Nishith Neema]

When you present to the auditor the evidence against the observation before the closing meeting and the auditor has accepted it then he/she can not write this as an audit observation. Thou in the closing meeting verbally he/she can mention it along with the closer by the auditee.

 

[ChrisM]

^
I beg to differ. the auditor can write it in the report as an observation but also qualify it by including wording that says that it was addressed during the audit, with a summary of how it was addressed - assuming that the auditor also had the time to verify the response before writing up the report. I've had this happen somewhere that I worked. The auditor should include it for reference, not leave it out as if it didn't happen. They could choose to leave it out, but that is up to them

 

[Randy]

Are you talking "Observation" or "Non-conformance"? 2 totally different things, one is a duck and the other an apple.

I'm an auditor and right off the top I don't care if you do anything with "Observations" because there's no requirement that you do so. Observations are for the most part opinions and my opinion doesn't count squat.

Next, a Non-conformance requires corrective action, and effective corrective action is a time based process. For effective corrective action you've got to review the problem, come up with some type of cause determination, apply some type of short term fix, develop a long term fix, implement the fix, and verify that the fix works over time.......while at the same time checking to see if you have any other similar problems that need fixing.............and you ain't honestly going to do that between 8:30am and 5:00pm. Regardless, fixing it or not during the audit, it's going into the report and to do otherwise is dishonest.

 

[Bev D]

As a reminder the OP stated that it was an observation not a non-conformance

 

[Ed Panek]

I've seen it vary depending on severity. Our 13485 auditor might accept a fix on something minor like a missing reference on an SOP to some ISO standard but for a systemic finding like not doing MR on schedule probably not.

Remember the auditor is also being audited so not having any findings compared to peers may stand out.

 

[YellowQCPro]

I've seen it go both ways. I would guess that the impact of the non-conformity on the overall QMS could drive their determination of whether or not to issue the NC, officially. I have been able to correct things mid-audit without NC, but I have also had some instances where the ink had already dried and they were not willing to just record an observation. Could be the auditor, too.