Problem with organization

Tintypographer

Starting to get Involved
I've posted on this before:

The medical device company I work for is very lean in staffing. The products barely sell enough revenue to cover the costs of the manufacturing and employment contracts. The labs are very thin and the development and QC scientists double as manufacturing. They've all been frustrated for a while. We have our audit coming up in two months with 7 CAPAs from the last one under development by me. The staff of the R&D and manufacturing team quit this morning in mass. All 7 employees quit with leaving their laptops at the office along with their badges and letters.

This was the only group related to the science and research staff and the entire technical knowledge. My calls to them have been forwarded to voice mail. The executive leadership has asked me to do what I can but I'm unsure without their knowledge that our deficiencies in biocompatibility, sterilization validation and risk analysis can be completed without a staff. The departure included the VP of R&D and all of the lab scientists.


Has this ever happened to anyone?
 

yodon

Leader
Super Moderator
executive leadership has asked me to do what I can
Um, follow the exodus?

without their knowledge that our deficiencies in biocompatibility, sterilization validation and risk analysis can be completed
It can't! It boils down to management providing sufficient and adequate resources.

Irrespective of your ISO cert (which is undoubtedly in jeopardy) Is there really any hope that the company can survive? Sure sounds like a bad business.

I guess there's something gallant about going down with the ship, but I don't think I would?
 

Tintypographer

Starting to get Involved
The product has approval and ce mark but very poor reimbursement, barely covering manufacturing costs. Development and manufacturing staff are overworked and had almoar no time between emergencies for support of the quality system in the first place. I recommended a few things to.senior management. The quality system is all paper and binders. They sell only a few hundred units per quarter now which makes tracking adverse events easy but showing statistical improvement impossible; they don't have any sales.

I figure I'll look for a new role and close our what I can.
 

Golfman25

Trusted Information Resource
I've posted on this before:

The medical device company I work for is very lean in staffing. The products barely sell enough revenue to cover the costs of the manufacturing and employment contracts. The labs are very thin and the development and QC scientists double as manufacturing. They've all been frustrated for a while. We have our audit coming up in two months with 7 CAPAs from the last one under development by me. The staff of the R&D and manufacturing team quit this morning in mass. All 7 employees quit with leaving their laptops at the office along with their badges and letters.

This was the only group related to the science and research staff and the entire technical knowledge. My calls to them have been forwarded to voice mail. The executive leadership has asked me to do what I can but I'm unsure without their knowledge that our deficiencies in biocompatibility, sterilization validation and risk analysis can be completed without a staff. The departure included the VP of R&D and all of the lab scientists.


Has this ever happened to anyone?
This is something for your management to solve. They need to figure it all out -- Are they subject to legal contracts? Maybe have to pay a few of the X employees to put everything in order. Frankly, with 7 leaving at the same time they are likely setting up or working for a competitor.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
the standard(s) requires the management team to provide adequate resources to achieve the objectives of the business following the standard.

A loss of staffing almost seems like you need to execute your business disaster and recovery plan.
 

DallasThomasIQVIA

IQVIA Medical Device-Pharmaceutical FDA Consultant
The management may need some consultants to fill the gap of the subject matter expertise. This is a tough situation. If Management and Ownership are open to it we can provide a free consultation. However this experience rings of the mantra "It's better to prepare and prevent, than to have to repair and repent". Is the upcoming audit a CE Mark Audit with the notified body? Or is it for another external regulatory body?
 

John Broomfield

Leader
Super Moderator
By now you should have issued a corrective action request for acceptance by. the chief executive to fix and to stop recurrence of this problem.

Naturally you may offer to help but your colleagues must also see their leader calling for action.

Failure of your leader and colleagues to take up this challenge will tell you what you should do.
 

Golfman25

Trusted Information Resource
By now you should have issued a corrective action request for acceptance by. the chief executive to fix and to stop recurrence of this problem.

Naturally you may offer to help but your colleagues must also see their leader calling for action.

Failure of your leader and colleagues to take up this challenge will tell you what you should do.
Right. Bold strategy Cotton.

They are knee deep in "stuff." The last thing they want to see is some excess paperwork. :)
 

Sidney Vianna

Post Responsibly
Leader
Admin
By now you should have issued a corrective action request for acceptance by. the chief executive to fix and to stop recurrence of this problem.
This is like issuing a corrective action request to the captain of the Titanic when they realized there were not enough life boats for all the passengers and crew onboard the sinking vessel.
 

normzone

Trusted Information Resource
Oh, a meme! I watch so little video that I'm always behind the times, but with the power of the internet (a connected series of pipes) I figured it out. Yeah, I feel for the OP, but these things happen. You can jump overboard and swim now, or stay on as long as the paychecks keep clearing just so you can watch the show.

Unfortunately, you are now one of the stars of the show in the season ending finale.
 
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