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Remote Audits for ISO 9001 (or any other standard)

mpfizer

Involved In Discussions
#21
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.

We are based in India and have been audited by a prestigious UK NB by their office based in India for more than three years for ISO 13485 .Our surveillance audit is due in March 21 .

The NB has informed us that we have to pay full amount but they will not be able to certify us unless their management allows them to visit our site and that may happen only after a few more months because of pandemic ...time not specified .

They also informed us that if we do not agree our certificate would be cancelled !!

what do we do till then ?? remain without a certificate ?

what are the options ?

Any help would be highly appreciated

Thanks

Michelle
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#22
Michelle, March 21 is very nearly here and I do not expect to see drastic changes in travel policies before then.

My employer has had ISO 13485 audit done remotely, so it is not about the accrediting body allowing it. I am guessing the registrar is not comfortable with remote auditing. However, my understanding is that accrediting bodies are not allowing extensions on certificates. I could be wrong about that but it seems to me like a good time to contact a different registrar. Certainly I would not wait. The discussion is free and you could get better information about your options.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#23
As to the overall question:

I am not auditing full time anymore, but I have done audits on two chemical plants plus a warehouse for ISO 9001 and Responsible Care. I expect the same compensation as before, and can say that although my legs were not as tired at the end of the day I found remote auditing to be as least as challenging and tiring as being there in person. There is always the nervous feeling that I may be missing something, because while in person my head swivels like an Owl's as I observe all manner of quality, environmental, safety and security details.

Added time for using technology to review that which I would ordinarily just observe is to be expected, in fact audits were made longer. One client was better prepared than the other; more efficient handoffs with Teams meetings as well as plans to use personnel's phone cameras to observe the spaces. I needed to ask "Let's approach that waste can. Can we look inside it?" and "Can I see that fire extinguisher's tag? No, the other one over there to the right, in the corner" and so on. People's phone batteries were drained in very short periods of time while we did this. And yes, there is always the chance that something is being hidden from me.

Overall though, I was grateful that the option existed and I could still do the work. The clients were grateful too. Actually my Responsible Care client was quite pleased at the thoroughness the team managed to maintain.
 

Randy

Super Moderator
#24
As to the overall question:

I am not auditing full time anymore, but I have done audits on two chemical plants plus a warehouse for ISO 9001 and Responsible Care. I expect the same compensation as before, and can say that although my legs were not as tired at the end of the day I found remote auditing to be as least as challenging and tiring as being there in person. There is always the nervous feeling that I may be missing something, because while in person my head swivels like an Owl's as I observe all manner of quality, environmental, safety and security details.

Added time for using technology to review that which I would ordinarily just observe is to be expected, in fact audits were made longer. One client was better prepared than the other; more efficient handoffs with Teams meetings as well as plans to use personnel's phone cameras to observe the spaces. I needed to ask "Let's approach that waste can. Can we look inside it?" and "Can I see that fire extinguisher's tag? No, the other one over there to the right, in the corner" and so on. People's phone batteries were drained in very short periods of time while we did this. And yes, there is always the chance that something is being hidden from me.

Overall though, I was grateful that the option existed and I could still do the work. The clients were grateful too. Actually my Responsible Care client was quite pleased at the thoroughness the team managed to maintain.
Experienced most of the same (except for last week.......I wanted to ##$2!1(*&.

The remote audit rules and guidance being applied by AB's (such as ANAB) towards CB's and then from the ISO "groups" like the one Sidney gave us a heads-up on are becoming a hodge-podge of "Who hit John?, Where's Waldo? and Who's on 1st" and one of the few thinks I haven't seen prescribed is swinging a dead cat over your head, in a cemetery, during the dark of the moon, on a Friday the 13th.

As for physically demanding....By the end of an audit day I'm finding myself trashed in mind and body. Your brain is fried trying to put everything in place, trying to make sure you're covering everything, and trying to keep up, let alone with staying ahead of the curve. Physical exhaustion is almost the norm, you've spent 8-10 hours sitting, looking into a screen bent over, and as tense as if you were doing isometric exercises the entire time. The lack of real personal contact is horrendous to work with, and everything, everything is channelized like you are entering a dark tunnel while only using a straw for a visual aid to navigate with. I did 5 remote days last week, and I've got 4.5 remote days next week, followed by another 2 days remote, and then a 5 day onsite.

Back to Michelle.............Odds are it's not your NB/CB behind everything, they have to follow rules as well for every aspect of issuing and managing your certificate, and right now it's less than easy for the entire industry.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#25
You're not responsible for the auditor's actions. If your team holds that against you, that's on them.

Why did they have to be in the conference room? Why not have them join virtually?
As the QA rep, I ALWAYS want the person being interviewed as close to me as possible. There are several reasons for this.... I have had bad results leaving talkative engineers to their own habits.
 
#26
As the QA rep, I ALWAYS want the person being interviewed as close to me as possible. There are several reasons for this.... I have had bad results leaving talkative engineers to their own habits.
I have mixed feelings when I read this response. As an auditor I wonder if the person being interviewed had been trained well enough about the requirements of the standard regarding their application of the standard.

As a consultant I can't help but wonder what could happen with an auditor who didn't truly explain himself or try to make the interviewee at ease. I remember spending three hours training the production crew (eight individuals who's first language wasn't English although they were able to converse pretty well) on the quality policy and quality objectives. During the registration audit the Management Representative was distracted with some urgent customer business and the auditor asked one of those well trained individuals if he knew the quality policy and became nervous and didn't respond well. When the Management Representative returned and tried to explain to the auditor that he did know and only needed to be set at ease, the auditor wouldn't have any of it and wrote a nonconformance.

So train well but also stay nearby.
 

mpfizer

Involved In Discussions
#27
Michelle, March 21 is very nearly here and I do not expect to see drastic changes in travel policies before then.

My employer has had ISO 13485 audit done remotely, so it is not about the accrediting body allowing it. I am guessing the registrar is not comfortable with remote auditing. However, my understanding is that accrediting bodies are not allowing extensions on certificates. I could be wrong about that but it seems to me like a good time to contact a different registrar. Certainly I would not wait. The discussion is free and you could get better information about your options.
Hi,

Is there any SOP for remote audit which NB / CB's have to follow ?
I see that many are getting remote audits done for ISO 13485 ,while our NB says its just not possible , there should be some uniformity

Michelle
 
#28
If you compare your senior managers to a bunch of criminals, maybe you have bigger problems than audit methodology.

I'm not sure I understand your position. If your company truly wanted to "get something" from the audit as you say would you purposefully try to hide problems from the auditor?

Covid made us do things differently, virtual audits vs. in-person is one of those things. But in either case, if you know you have problems and you hide them from the auditor, the results are the same.

I'm sorry that you totally misunderstood the intended humour - i have no intention of hiding anything from anyone!! this is my point it is not up to us to bring problems to the auditor - where is the value in that " by the way Mr Auditor - I found an issue on the shop floor (which you didn't as you were not there) - please write that in your report as a NC and also please invoice me £1500 for me telling you what to tell me "" - What a value add that is !!


You have made one hell of an assumption in your lazy post - "whining about getting no value?" The reason I am raising it is clearly because we get more value ourselves than have someone sipping coffee in their kitchen - I would suggest anyone who says they are getting value out of having someone who a) does not know the business and b) is not even there - is not doing the things you are mentioning (internal audits and closing corrective actions down) - its not rocket science that if I am living and breathing the standard whilst being emerged in manufacturing - then I am better placed to identify issues that someone remote who has about 6 hours ??
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#29
Hi,

Is there any SOP for remote audit which NB / CB's have to follow ?
I see that many are getting remote audits done for ISO 13485 ,while our NB says its just not possible , there should be some uniformity

Michelle
I didn't have a SOP for remote auditing, but training has been increasingly available within CBs for 3rd party auditors, as well as Exemplar Global.

My employer was recently audited remotely to ISO 13485 by TUV. If your NB says it is just not possible, I have to wonder if they really mean it is not possible for them?
 
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