Ratio of Quality vs. Manufacturing Staff in Medical Device Industry

[Vincnet]

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.

[Marc]

I see some people are responding. Any comments to go with your 'vote'?

[Vincnet]

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]

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]

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!

[suziwann]

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.

[fireonce]

In our company it's 8%.

[Claes Gefvenberg]

I am not in the MD industry... Still, I would like to suggest a look in the following threads, where the same question was asked. Some of the comments should have a bearing on this thread as well:

Number of Quality Personnel - How many quality personnel does your company employ?
QA (Quality Assurance) Staff Personnel Ratios

/Claes