Audit by Skype?

J

jeyaraj

Hi guys, it's great to be back after a long while! :bigwave:

I'm in a Quality Assurance team with around 12 contractors to manage. We are required to carry out audits to gauge if the contractors' QMS is sufficient for the project we are working on. Since it is based on ISO 9001:2008, it's all pretty routine. Majority of the contractors are based locally, so it was just a matter of getting to the contractor's project office for the audit, and carry out the audit in the usual manner (i.e. interviews, viewing objective evidence, etc.)

Here's where it gets interesting! One of the contractors is based in Europe, without a local project office (I'm in Malaysia, Truly Asia! :D). We did not have the budget to travel to Europe for the audit (it's OK for top management to go on several unproductive 'visits', but not us auditors. Still, that's a different rant for a different day!), so I proposed that the audit be carried out via Skype. What we have planned is for me to send out our audit checklist to the contractor in advance (about 2 weeks +) so they understand what we are looking at, & get them to fill in their responses, referencing their evidences. For the next week, we will look through the responses to see if we can close out the straightforward ones. For those that need more details, we shall ask for clarification or further evidence.

On the stipulated audit days, we will be in touch via Skype, having the opening & closing meetings, asking questions that require face-to-face explanation, & some demonstration of the actual processes in place, factual evidence, etc.

While this sounds all hunky dory, I have a concern if this practice is acceptable from a Standards point of view. I mean, I couldn't find anything in ISO 19011 that said I can't do it, but in your expert opinions, do you think that is acceptable to do this? Please reply ASAP as I've got only slightly more than a week to go before the audit date proper.

Thanks in advance, guys. Really appreciate it.:thanks::thanx:
 
K

keres

In accordance with the recommendations of ISO 19011 performing remote audit is acceptable. I think Skype + camera will be OK.
 

sagai

Quite Involved in Discussions
I think it should be okay.
The think I would add is to assess any potential risk that you can think of due to this remote audit and than it could be fool proof.
Cheers!
 
We did not have the budget to travel to Europe for the audit (it's OK for top management to go on several unproductive 'visits', but not us auditors
Ah... I see :rolleyes:

While this sounds all hunky dory, I have a concern if this practice is acceptable from a Standards point of view. I mean, I couldn't find anything in ISO 19011 that said I can't do it, but in your expert opinions, do you think that is acceptable to do this? Please reply ASAP as I've got only slightly more than a week to go before the audit date proper.
I understand your concern, as this kind of practice is typically frowned upon, but then again, I find nothing that spells out that you cannot do it. Apart from a bit of tunnel vision, I don't suppose there is much difference between watching things with the naked eye or via a camera, and new technique or technique used in novel ways will always be frowned upon until somebody proves that it can be made to work.

Opinions, anyone?

/Claes
 

TWA - not the airline

Trusted Information Resource
When during some audits the auditor never leaves the audit room and only looks at the documents the auditee feeds him/her, then an audit via Skype should be o.K. While you can audit their QMS up-front by requesting their handbook and procedures, the real question is: Is this real or just the paper? (If they are certified then I?d bet you won?t find much there unless you are determined to construe something and as I read it you want to really know whether they are a good supplier or not?)
Possible areas of concern would be the following:
- You cannot check original documents, so you cannot verify that the copies you get match the original documents (you?d typically do this with a statistical sampling approach). And (at least for medical devices) you should check device history records not with copies
- You cannot check whether the gruff day-to-day reality matches the glossy paperwork. Is the facility neat and tidy? How do people handle products? Do operators seem to know their job? Are work instructions at hand, is the equipment in a state of control?
- CAPA, internal audits, NCs: Does the system really work and ensure quality. Does the company really live the system, do people understand about quality and do they care (especially management)?
- (Again medical device) Any hint that you did not do what needed to be done just because management did not supply the resources will earn you an observation?

In all, if you feel confident about that approach and your QMS (or other applicable regulations for your industry) does not have requirements you can?t match with it, I?d say it?s a go. Maybe you want to document how you arrived at the conclusion that this way is acceptable (just in case?).
Best, TWA
 
As TWA indicates, I would want to see the things you normally have a look at during audits, and as long as someone is prepared to carry the camera (separate cam, laptop, Ipad or whatever) around and point it towards what or whom I ask for, I would be ok with that.

I would not be able to actually touch anything (or literally smell a rat) of course, but I believe sight and sound would be enough. ;)

/Claes
 
T

t.PoN

ISO 19011:2011 clause B.1 allow you to conduct a remote assessment.

its very common these days, and its acceptable.

However, the scope of audit should not include witnessing or observing an operation. this will be problematic.

if the scope doesn't include witnessing or observing, then go ahead but be careful about one more thing: The sampling method.

you should be clear in how the sample is selected. and you should report it.

many remote auditors allow the auditee to select the sample of documents, records ....etc to be audited and don't even mention in it in the report.
 
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