Dave,
I was agreeing with you on the test equipment theory until your last
statement. Based on my past experience with setting up calibration programs
that satisfied both the NRC and more recently ISO, it would be my opinion
that since your rectifiers play a major role in the quality of your product,
they are not beyond the scope of ISO. While they are not part of your
test/measurement equipment they are a critical part of your process. If I
recall, section 4.9 concerns Process Control. How you chose to 'cover' your
rectifiers would depend on your plating process controls.
To over simply your rectifier example, if you monitor your plating
quality continuously with microsection analysis, you would know immediately
if your rectifiers were having a bad day. By using calibrated measuring
equipment for the analysis, you are fully compliant.
If on the other hand you depend entirely on your rectifiers to work
properly to provide consistent in-spec plating, then you would need to
demonstrate your confidence in their proper on going operation. Unless you
have an impressive song and dance routine, a documented program that
verifies their proper operation on a regular basis would be needed. A
formal preventative maintenance program with ID numbers on each piece of
equipment will go a long way toward impressing your auditor that you are
serious about producing consistent quality.
Anything that you chose to do that could be perceived as a short cut
by your assessment auditor will encourage more questions. At best, this
usually leads to excessive 'tap dancing' on your part.
Norm Dill
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From: [log in to unmask]
To: [log in to unmask]
Subject: GEN: ISO and Calibration
Date: Wednesday, January 22, 1997 10:21AM
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.
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??
Dave Pizzoferrato
Quality Assurance Manager
Centerline Circuits
- - - - - - - - - - - - - - - - - - - - - - - - - - - -
"Give me ambiguity or give me something else."
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