Remote Audits for ISO 9001 (or any other standard)

#1
Good Afternoon all.

What are you thoughts on remote audits for ISO 9001 (or any other standard)

We had ours last week:

a) I totally appreciate the need for this under the current COVID restrictions
b) I've been a QM for 20 years so handled dozens of audits and appreciate that certain elements work ok this way

I got the bill today and have to say if it were my money I would not be happy. To be brutally honest we didn't get anything from the audit - it almost feels like paying to keep the certification which goes against the grain for me.

Having someone on the end of a call trying to audit a manufacturing plant is surely an impossible task.

I know some will say there may be ways around this - virtual tours and other IT solutions but it doesn't seem right that the company would have to spend time and energy on doing this - the certifying body in my mind needs to come up with a solution, particulary when this one actually stated that this is the future and many will be done this way after the pandemic - otherwise surely people will leave them?
 
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Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#2
FDA seems to agree with you. They are under heat for not doing remote audits. We had our remote ISO 13485 audit a few months ago. It's tedious.
 
#3
thanks for the quick response - it was getting a little embarressing while senior managers were all over the shop floor taking photos of pallet tickets to show the auditor?

A bit like the police working from home and using a bunch of criminals to investigate their own crime.... no wonder we passed?
 

indubioush

Quite Involved in Discussions
#4
I agree that remote audits are not ideal. There are certain aspects that can be audited remotely without taking away from the audit, but other aspects such as production, equipment controls, facility, just cannot be audited remotely. Also, there are many nuances during in-person auditing that indicate to an auditor that some thread should be pulled so to speak. These nuances cannot be picked up in a remote audit.
 

John Broomfield

Staff member
Super Moderator
#5
How about the management rep wearing an earpiece, microphone and a headcam to investigate per the audit plan and the requests of your remote auditor who is watching a monitor linked via the world wide web?

Sampling would be determined by the auditor as would be the questions while the auditor listens carefully to the answers; clarifying facts as the audit progresses.

Provide a wider view of the workplace to give the auditor the opportunity to look for whatever may need further investigation.

Evidence of nonconformity would be agreed after asking for contrary evidence.

Then allow the auditor an hour to prepare the report for each day of audit.

Management rep then invites the auditor to the closing meeting via Zoom or equivalent to present the audit report and obtain commitment to any required corrective action.

This procedure would be pre-agreed with remedies for any technical hitches or a failure to cooperate.
 

Miner

Forum Moderator
Staff member
Admin
#6
Our external auditor performs the audit using MS Teams. Our local management rep has Teams open on an iPad and takes it out to all the locations so the auditor can talk directly to the same people they would normally interview. The auditor can see the process using the iPad camera. We also use Vuforia Chalk, so the auditor can flag specific items that they want to more closely examine. So far it has been very successful, and our internal auditors are using the same approach when necessary.
 

blackholequasar

The Cheerful Diabetic
#7
We did our ISO 9001 audit remotely using GoToMeeting and an FTP for document transfer. I felt that it was not nearly as effective, however given the circumstances last fall it was our safest alternative. I had planned out a method to tour the production floor in real-time using an iPad on GoToMeeting with my Bluetooth headphones as a direct connection to the conversation but our auditor did not feel that was needed.

And then we got the bill - nearly the same price as a physical on-site audit. I wasn't thrilled with that, as I'm sure was the case for our upper management.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#8
We used GoToMeeting and no method for sharing documents like a cloud service; instead, the auditor would ask to see a procedure, we would share our screen and literally tab down little by little as he read it. Some documents were 40 pages long. We let our NB this was not a good use of anyone's time.
 
#9
As the guy on the other end of the line I'll start by admitting I'm not fond of virtual audits, but they can work if the auditee is properly prepared. Keep in mind that the auditor needs to keep control of the sample. Planning out a tour for him doesn't keep the auditor in control of the sample. You need to have the cameras (tablet, laptop, or phone) that have the capability (wifi or phone signal) strong enough to go wherever the auditor needs to go with him in control. Document sharing on Go To Meeting or Zoom only works if the auditee can bring it up on the screen he is using for the call. Emailing documents to the auditor slows down the time considerably. The use of headsets cuts down on unwanted audio feedback. If the auditee cannot provide what was mentioned, there should not be a virtual audit. Hybrid audits are available so that parts can be done virtually and parts on site.

As for the cost. Do you think the auditors or the certification bodies should be paid less? I don't think so. There is just as much work for the auditor and just as much administration on the part of the certification body. And don't forget that there would be no travel expenses.

My biggest concern about the quality of the audit is that if an auditee wants to cheat, he is much more able to hide things. The opportunities for cheating are much greater.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#10
Big Jim, The auditor, and the NB need to have the technical training done beforehand. I do not want to teach the auditor how to use their or our remote tools; that's not part of the budget. The auditor should have a strong command of the technology they utilize going in. We spend 30 minutes or so each day resolving his issues.
 
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