What is defined as a Laboratory? Supplier Laboratory Requirements - QS-9000 4.10.6

L

Lyndon Diong

#1
What is defined as a Laboratory? Supplier Laboratory Requirements - Clause 4.10.6

What is defined as a laboratory? We do titration in a lab to the find the acidity of a chemical. Does this mean that 4.10.6 applies? We can easily perform the titration outside a lab too.
We calibrate thermometers using the comparison method. A std thermocouple and the thermocouple for calibration are both used to measure the heater block temp. The results are compared. This is done at room temp and humidity. Is this acceptable?
 
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G

Ganesh Chidambarakrishnan

#2
Laboratory is not a place bound by four walls, but a place where testing is performed. If titration is performed outside the four walls of the place called "laboratory", the place where titration is doen becomes the laboratory as per QS9000 definition.

Calibrating a thermocouple or thermometer using a standard thermocouple is acceptable, as long as "traceability to national or international standards" is maintained. Necessary systems to ensure that the said calibration is done corretcly must be documented.

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J

Joe Ptak

#4
More 4.10.6 Supplier Lab Requirements


Thanks Dan for posting the AIAG link, that helps to clear things up a little. Additionally, I recently attended a 3rd edition upgrade seminar and was advised that 4.10.6 is concerned about labs that do product development, failure analysis, specialized tests that require lab techs, or in other words, tests that are clearly OFF-LINE and not a normal function of in-process testing.

And so, I have another applicability question for the board. We are a metal stamper and we perform traditional in-process dimensional tests by the operator and a QC auditor, also rockwell tests, plating thickness tests, etc. Pretty basic stuff. We also have a CMM which we use to perform more complex dimensionsal testing and calibration services. It is our opinion that the CMM is really the only equipment performing "tests" that would need to be covered by 4.10.6, all the other are in-process tests.

Am I interpreting all of this info correctly or should our scope be expanded to cover other areas? Any info would be greatly appreciated.
 
R

Roger Eastin

#5
This is another QS gray area to me. I think there is some merit to the opinion that this requirement applies only to off-line lab tests. However, unless my eyes deceive me (which happens all too often), I don't see this in the text. We have, what I consider, in-line lab tests that operate on a sampling basis. IMHO, this requirement applies to those tests. Off-line, to me, does not just include physical location of the lab facility, but also that production is not necessarily waiting for the results to allow the product to proceed to the next step.
 
B

Bryon C Simmons

#6
Gotta agree with Roger on this one...isnt your rockwell testing (which I have some limited experience with)a form of failure analysis? It surely is non-destructive testing....which is gonna fall into the 4.10.6 thing. I think you will have a hard time convincing your registrar that your testing scope falls outside the requirement as it is stated. My advice is to keep it simple, and be pragmatic about it....

Good luck
 
M

Mkrickel

#7
Supplier Lab Requirements

Could someone please send me a sample of a Lab scope and related procedures. I am almost complete with our documentation system, but am stuck on this one. I would greatly appreciate it.

Thankyou
MK

e-mail [email protected]
 
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