Crucial Personnel Resignation and Transfer of Responsibilities (medical device)

kapinka

Starting to get Involved
#1
Hello everyone,
I was searching if I can find some thread for absence of crucial personnel, but I couldn't find any.
We are a medical device factory certified according to ISO: 13485 and we are facing an audit from the Certified Body in September, but without Production Manager (he resigned 4 months ago) and yet we can not find someone appropriate!!
We have issued preventive action according to which all the responsibilities "were transffered to the Plant Manager" (officially :)). But neithter Plant Manager, nor someone else in the factory has appropriate education/training.

I'm wondering can this be a problem which can end up with NC from the Certified Body?

Thanks in advance!
 
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yodon

Staff member
Super Moderator
#2
If the auditor determines that the Plant Manager is not qualified to do the job, then yes, I can see justification for an NC. To me, it sounds like your PA is insufficient. If the responsibilities were permanently transferred, then, by your own admission, this may cause a problem since that person is not qualified.

You can't stop such a situation from occurring, but you can take measures to ensure quality isn't compromised. What are the possible impacts that could happen by not having a qualified Plant Manager? I would suggest that you do additional analysis and possibly include some temporary measures (additional approvals / checkpoints, additional / more frequent in-process inspections, etc.) to address any of those risks.

Show that you are being pro-active in ensuring that the situation remains in control and quality is not compromised and I would think you should be fine. Just transferring responsibility to an unqualified person, though, sounds pretty risky - both from a compliance perspective, but more important, from a business perspective.
 

Wes Bucey

Quite Involved in Discussions
#3
FWIW:
When I create [draw? invent?] organization "trees" [charts] with lists of functions for each job title, I add in an omnibus [CYA] note to the effect:
"in the event of disability or absence of any member of the organization, the highest ranking remaining member on the chart shall have the right, power, and authority to allocate the functions of that member to some other member or members of the organization on a temporary or permanent basis."

If you don't have such an omnibus clause in your business management plan now, perhaps you might consider adding one.

Above all, don't paint the organization into a corner by getting too detailed such as requiring that ONE individual be named to replace the missing John Doe. I have often seen organizations create an "office of the Chief Executive" comprised of several top officers and Board Members who each take on a part of the functions the former CEO performed when the executive dies or becomes disabled or otherwise unable to perform his duties.
 
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