Re: validation
- From: Gregg <nospam123gcrume@xxxxxxxxxxxxxxx>
- Date: Sat, 17 Feb 2007 12:44:23 GMT
Uncle Al wrote:
tancho wrote:ISO 9000x - Do what you say and say what you do - that's it
For a customer we made a NaCl 10% in water, he asks now to validate
this process, can I do this with a design of expiriments ? Who can
help me ?
ISO 900x, Six Sigma... oh boy are you in for a ride! Bear in mind
that none of the foregoing bears on the quality of the product, only
its production documentation and reproduciblity. You might start by
asking theme exactly what they want - reply to be received on their
corporate stationery, signed and dated. Save the envelope.
If they do not know at they want, don't volunteer possiblities.
Stick a calibrated (concentration and temp) ion-sensing electrode in
it. If you're worried about stuff other than NaCl being in there...
you'll need a whole exra building of analytical chemists to avoid
massive legal liability. That probably includes a floor for
microbiology.
Can you say "limulus amoebocyte lysate assay?" Uncle A knew you
could! Can you afford it?
- Use calibrated equipment for measurement.....
You could write a procedure for someone taking a dump into a mixer as a binder component and be ISO certified.
As far as specs......
Don't ask the customer what he wants unless you have a good working relationship or you really need the business....
- Think about the end use - do you even want to sell into that market?
Then use your calibrated electrode or whatever and state - our solution meets the following specification ........That's it! - Do not imply any more than that!
How you use the product is your responsibility!
As far as validation goes - look in the ISO spec for guidance - If they have any
It may be a case of making a couple lots and meeting specifications.. - again - what's the end use of your product?
I became heavily involved when 2 companies I worked for (on two separate occasions) geared up and got their ISO certification.
If done right - it can provide a lot of political protection for R&D types -
It can protect the company (and the fall out R&D gets) from marketing types coming into the lab and saying - this is HUGE - drop everything and work on this Six months later you find out your designing a product to the wrong specifications. Or worse yet - you send a proto type to a customer and he say's - what the hell is this? - this isn't what I wanted! - Then the finger pointing begins
After that company became ISO compliant - I could get they file - look at the design specification and say - you guys screwed up - We designed to the targets specified right here - why the hell don't you let us talk to the customer and find out what they want?
On the other hand - ISO certification - in my opinion - can be worthless - A company can put a lot of paper and processes in place for show and wind up bogging everything down and wasting a lot of resources.
I have (do?) worked for ISO certified companies that had (based on my past training and experience as an internal auditor) lousy quality systems, but they paid the money....and have paper work for show
OR - you can come up with a quality system that will insure everybody does their job and has clear cut areas of responsibility.
I worked for a small company that had an excellent quality system. Everything was concentrated on constant improvement with systems in place to insure the company kept quality high waste down and was smart about it's R&D and marketing efforts. They were audited all the time because they were NOT ISO certified -They would have had to pay $10,000's of dollars to get certification and have some auditor come in and tell them how to run their business. - All their systems were in place and they were ISO compliant. That was a clear cut case of using the spirit of ISO and the hell with paying money to get certified.
Gregg
.
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- From: tancho
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