posted 10 October 1998 09:54 AM               

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Subject: Re: Q: Cal of Design Instruments/Woodley/Kleinpaste/Perdue
Date: Wed, 30 Sep 1998 11:27:42 -0600
From: ISO Standards Discussion

From: Jon Perdue
Subject: RE: Q: Cal of Design Instruments/Woodley/Kleinpaste/Perdue

I respectfully disagree. The company I am the Management Rep. for builds "Hard Tools" for metal stamping. Our customer gives us a blueprint for the part they want the tool to produce. They tell us they want it to be able to produce "X" amount of parts per hour, and they expect the product life to be "X" amount of parts. We design the tool based on that input. Hard Tool designs can take into account many variables, and with minor changes from one lot to another in material hardness, tensile strength, and the "chaos" factor, it is an inexact science (tool designers may disagree, but for the sake of argument, let's continue) . The First Article report generated from measurements taken from an actual part that has been produced by the hard tool. The First Article measurements are made using calibrated equipment. The acceptance of our hard tool is based on the First Article report.

So, the measuring and test equipment of the hard tool designers and the people making the hard tool is not calibrated. The tools (4.11.1) "used by the supplier to demonstrate the conformance of product to the specified requirements" are calibrated.

Obviously, one can question if it makes good business sense to not calibrate the toolmakers measuring equipment, but since they don't use them for final approval of the hard tool...

This application of this interpretation has passed ISO9001 scrutiny (so far).

OK, take aim and let me have it.
Jon Perdue
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

>From: "Kleinpaste, Marcia E"

Yes! We are principally a design firm with no manufacturing at this point. Underwriter's Laboratories has required calibration records, i.e. certificates, recall data, etc. on all instruments, including a tape measure. Our technicians and design engineers must keep accurate records of calibration.

posted 10 October 1998 09:59 AM               

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Subject: Re: Q: Calibration of Design Instruments/Woodley/Randall
Date: Wed, 30 Sep 1998 11:32:00 -0600
From: ISO Standards Discussion

From: [email protected]
Subject: Re: Q: Calibration of Design Instruments/Woodley/Randall

> From: Craig Woodley <[email protected]>
>
> Do instruments (gen. calipers, rulers, thickness gauges) that are used by
> Design Engineers in the development of a design need to be a part of the
> calibration program?

During the ISO 9001 audits I perform, I expect to see all instrumentation used for Design verification and Design validation under calibration control. Remember that ISO 9001 addresses design, NOT research and development.

> 4.11.1 says "used by the supplier to demonstrate the conformance of
> product to the specified requirements"
>
> The design function is at a different site than the manufacturing function.

If this function is included in your scope of registration, then all of ISO 9001 requirements apply to that site regardless of its location.

> The equipment would be used to measure the customer supplied part to
> determine the design for packaging around the customer's product. The
> designs are then done in a CAD system and a die built from that data.

I would expect to see instruments used to "verify" customer supplied product (parts) under calibration control. On a personal note, it seems to me that since you are collecting design input from your own measurements that you would want to be certain that those measurements were accurate regardless of any ISO 9001 requirements.

> Our output is the actual packaging, which is verified at manufacture. The
> customer signs off on the design and pre-production sample.

If the packaging (the final output) is not verified (validated) until manufacture, doesn't that defeat (or at least impede) the purpose of design verification and design validation? (Assuming that that the product (packaging) you develop is mass produced) Calibration, in this instance, appears to be a means of preventive action. If design input data is not accurate, causing production of incorrect packaging, couldn't that potentially create a tremendous unnecessary expense?

I understand that one argument in this area is that there may have never been any defective product manufactured - even though "uncalibrated" instrumentation has always been used. This is because many instruments calibrated by the manufacturer retain their accuracy for several years (even though a yearly calibration cycle may be recommended by the manufacturer). This argument is a great basis for extending calibration cycles, not for debating whether a calibration system is needed or not.

I hope that this helps,