Ratio of Quality vs. Manufacturing Staff in Medical Device Industry

What is the ratio of Quality staff vs Production staff in your company ?


  • Total voters
    15
V

Vincnet

#1
Ratio of Quality versus Manufacturing staff in MD industry

Dear Fellows,

In your companies what is the ratio of QM versus Production Staff ?
1 for 10 ?
1 for 20 ?
1 for 50 ?
1 for 100?
compare to the company size ?

In my case for we are 1.5 Quality for 18 Production + R&D in with 25 staff altogether.
 
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V

Vincnet

#3
:agree1: Good point Marc,

I shall start, I openned this poll because I spend too much time arguing with my CEO about Quality staff ressources in the company. We are a fairly young company (4 years old) designing, manufacturing and distributing IVDs. I started my job as Quality and Regulatory Affairs Manager 2 years ago. As I allready said we are 1.5 FTE working in quality, and I feel it's **** because things are not going fast enough or well enough.
When I ask for more ressources my CEO repplies that he will never have more than 3 staff in the Quality dep. So I oppened the poll to get some feedback from other Cove fellows on how it is in their own companies. I should perhaps have asked my question on the money side what is the cost of Quality in your company as a percent of all expenses !

Feel free to comment extensively my babbling.

Vincnet
 

Cari Spears

Super Moderator
Leader
Super Moderator
#4
We have 65 employess. About 45 of them are machinists and benchhands and there are 2 inspectors and me (the QA Manager) - so 3 total for the inspection department.

Oops - we're not in the medical device industry.
 

Statistical Steven

Statistician
Leader
Super Moderator
#5
Mr

The answer is "it depends". There are many Class I medical device manufacturers that have just a QC department and use consultants for the QA piece. Does your company anticipate regulatory filings? If not, the number of quality personnel will be reduced...like I said...it all depends!
 
S

suziwann

#6
I have worked with medical devices where there were

Two QM for 50+ production.
One QM for 50+ production.
One QM for 50+ production.

In comparison I have also worked where there is one QM in >5000 staff, but not sure how many of these exactly were production staff. This was in defence aerospace.
 
F

fireonce

#7
Re: Ratio of Quality versus Manufacturing staff in MD industry

In our company it's 8%.
 
J

John Nabors - 2009

#9
Vincnet-

(Disclaimer- like Cari and Claes, we're not in the medical device industry)

The correct answer should be, "everyone in any organization is part of the quality program"

Whew!! I gotta slow down on these energy drinks!! OK, back to reality.

My department consists of me, two full time inspectors, one part time assistant for them, and backup from the crew in Performance Testing if needed. We audit supplier quality and perform in-process and final inspection for our manufacturing processes. 300+ employees total, basically 3.5 QA employees and backup as needed, call it 2%.

That is for dimensional, 'fit, form and function' type stuff. There is a separate sort of sub-department, Performance Testing, that does the 'how much water is this pump gonna shoot out and how high?' type stuff. They are in kind of a grey area between Quality and R&D. If we put them in the mix it would be 6.5 employees in Quality total among, at last count, 312 overall.

If I'm not making sense please forgive me. I was recently in a fairly violent auto accident (flipped my truck four times on I-95 and there was nothing left of the truck but a debris field), I'm at work at 7:30am on a Saturday, and the ibuprofen hasn't kicked in yet.

Regards -John
 
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