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What do you think about Remote Audit during COVID 19?

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by ValeriaGar, Dec 22, 2020.

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  1. ValeriaGar

    ValeriaGar Member

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    Due to the current situation, we all switched to remote work, audit, etc. How effective do you think this way of auditing is? We know that the jobs of the future are remote jobs, but how efficient is that and do you think there will be many consequences related to Quality?
     
    ValeriaGar, Dec 22, 2020
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    To be very honest, from what I've seen of Certification audits over the passed few years, I'd say (in the US market) not much difference. Let's not overlook that many auditors never get out of a meeting room, so you could say they were already doing remote audits! However, since this is a medical device forum, things might be a little different and, given that the whole idea of remote audits is based on risk, some client site won't be allowed to be remotely audited.

    You mention the word "efficient" and I'd suggest that remote audits are very efficient. However, you probably mean effective and that they are NOT...
     
    Last edited: Dec 23, 2020
    Andy Nichols, Dec 23, 2020
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  3. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @ValeriaGar ;
    I've been doing some remote auditing recently. While there is certainly benefit still gained from remote auditing, from my experiences I would offer an educated guess that remote auditing is approximately 30% less effective than on-site.

    The reason for this is that ...
    - The amount of information (how long and deep an individual talks) that I receive from individuals is generally less.
    - I don't have the visual opportunity to view an individual/process and ask "describe what he/she is doing over there".
    - I don't have the same visual opportunity to see "books", posted documents, etc...and inquire as to ask "describe what this is...describe how it is used".
    - etc....

    My opinion only based on my experiences.

    Hope this helps.
    Be well.
     
    John C. Abnet, Dec 23, 2020
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  4. ValeriaGar

    ValeriaGar Member

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    Hello John.
    I thought similarly to you, but I wanted to hear someone else's opinion. However, 30% is a pretty big percentage which I didn’t expect. It is important that the quality does not lose its meaning and becomes part of the formality. Even today, it is difficult to explain to companies how important it really is for themselves in the first place.
    If audit work turns into completely Remote work, the question is whether it will really be a real Quality.
     
    ValeriaGar, Dec 28, 2020
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  5. Lennart Ljungh

    Lennart Ljungh Member

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    After almost a year with remote audits my experience is that parts of the audits can be as effective as on site. However the implementation part of the audit doesn't reach the level I think is required to tell that the management system is effective and fully implemented. In my opinion is that the part of the audit where you actually can see the processes is essential to verify the system.

    Certificates issued only by remote audit should have some on site follow up requirement...
     
    Lennart Ljungh, Dec 29, 2020
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  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Good point, Lennart! I'd offer that, remote audits or not, most CB auditors don't know what it means to have an effective QMS...
     
    Andy Nichols, Dec 29, 2020
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  7. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Remote auditing is not new, but certainly our present circumstances are more pressing than other scenarios, for which the ISO 9001 Auditing Practices Group published IAF MD 4 guidance for including "technology" in audits. In 2020 they published APG Guidance on Remote Audits. I have had required audit time increased based on the slowdown that remote auditing entails. That is, being able to observe only what someone's cell phone camera shows me and having to say "Can we come closer to XYZ please? Can you read me/Can you zoom in to the number on that tool/machine/hoist?" as well as the occasional cell phone battery dying and loss of connectivity... Performing audits remotely are at least as challenging as doing them in person. IAF MD 4 calls out for auditor competence to use technology, but success also depends on the client and the registrar is overall responsible for preparing us to perform with this medium for the entire audit. Lots of us look forward to things getting back to normal, but I have a sense this won't be our last go-around so we had better develop some skill at it.
     
    Jennifer Kirley, Dec 31, 2020
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