At 08:21 AM 1/22/97 -0700, you wrote:
>Hello,
>
>I am looking for opinions and interpretations of the calibration
>requirement for section 4.11, Control of Measuring and Test Equipment, of
>ISO 9002. I contend, that by the strictest interpretation of the standard,
>(not necesarily best practice) that as a manufacturer of PCBs, we need only
>control and calibrate measuring and test equipment used to measure or test
>product.
>
>Example: Calipers must be calibrated because they are used to measure
>product to demonstrate conformance to specifications, Plating tank
>rectifiers need not be calibrated because they are not used to measure
>product conformance.
***************
This is where the crux of the matter lays.  If you are involved in a
Continuous Process Improvement program using, among other tools, SPC, and
have used your program as cause to change your sample frequency, test
method, etc.....
then the measuring device, IMHO, does require calibration/verification.  If
you wish to continue to do large amounts of product testing instead of
process control, you are free to use "meets minimum requirements" a.k.a
"schlok" instead of "best business practices".

I firmly believe that the framers of documents such as ISO 9000 and / or IPC
documents such as J-001 are trying to provide real financial encouragement
to take a proactive approach in their operations.  I see the areas of test
and inspection as non-value added functions where most of the real cost
savings can be had today.  But those savings can only be had when real
progress has been made in deveoloping bullet proof processes with automatic
controls and automatic system calibration or verification.  Ease of
calibration continues to be a significant factor in my equipment choices.
**************
>
>And, paragraph one of section 4.11 reads as follows:
>" The supplier shall establish and maintain documented procedures to
>control, calibrate and maintain inspection, measuring and test equipment
>(including test software) used by the supplier to demonstrate the
>conformance of product to the specified requirements...."
>
>Now, dont get me wrong, we do calibrate our rectifiers (best practice) and
>like equipment. I simply contend that the calibration of equipment, other
>than equipment that is used to demonstrate PRODUCT conformance, is beyond
>the scope of the requirement (ISO 9002).
>
>Sooooo, opinions anyone??
>
**********
One last shot.
If I had a choice between two shops, and one had a QA manager empowered to
shut down the shop while the other had a Process Engineering Manager
empowered to shut down the shop, where do you think I want to do
business.......................
**********
>Dave Pizzoferrato
>Quality Assurance Manager
>Centerline Circuits
>
>- - - - - - - - - - - - - - - - - - - - - - - - - - - -
>"Give me ambiguity or give me something else."
>
>
Thanks for the chance to soapbox once again, Dave
and once again, these opinions are not endorsed by those who feed me.
Steve Mikell
SCI Systems, Government Division

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