QMS for Life Sciences
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Element 4.2.6.1

J
#1
Hello, I'm new to this forum. My company is in the preparation of QS 9000 certification, we have no idea of how to comply with this requirement. At present we had come out the plant layout but what is the next step. What method can we used to evaluate the effectiveness of the existing operations and process.
Any responds and ideas are most appriciated.
Thanks in advance.
 

Marc

Captain Nice
Staff member
Admin
#2
All this is saying is that you'll communicate internally and that you'll look at data and such. You probably already do most if not all of this.

Do you not plan your processes (including work flow)? Etc.

How do you check for effectiveness? Check data. What's your through-put?

Just some thoughts. Hopefully some of the folks reading through this can give you some specifics on how they 'measure effectiveness'.

The biggest thing here is to take a step back and and analyze the paragraph.

See elsmar.com/ubb/Forum1/HTML/000082.html and elsmar.com/ubb/Forum1/HTML/000101.html for a few thoughts.

How about it folks? How are YOU meeting this requirement?
 
S
#3
Para 4.2.6.1 infers "lean Manufacturing",i.e., it has all the "buzz" words.
In the past four registration audits that I have participated in not one auditor has raised a question pertaining to compliance to this requirement. Naturally, I thoughtg that kind of strange, but I wasn't about to press the issue.
At my present location we have six work stations that utilise the "Toyota Production System". So I guess for my next surveillance audit I will be OK.
 
S
#4
Para 4.2.6.1 infers "lean Manufacturing",i.e., it has all the "buzz" words.
In the past four registration audits that I have participated in not one auditor has raised a question pertaining to compliance to this requirement. Naturally, I thoughtg that kind of strange, but I wasn't about to press the issue.
At my present location we have six work stations that utilise the "Toyota Production System". So I guess for my next surveillance audit I will be OK.
 
L

Laura M

#5
In a very small facility, we handled it with maintaining a facilities list(asset inventory), and reviewing it annually as a part of the business plan and management review process. As far as evaluating the effectiveness of existing operations - this was a bit more of a challenge - due to level of knowledge in the company on how to do that. However, we looked at things like inventory levels, value added labor, cross training departments for flexibiltiy. As it turns out, they are moving their building, so we were also able to have an outside IE consultant recommend a new layout for more sychronous material flow.
 
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