Calibration 'Requirements' under ISO? Design and Development Laboratory M&TE

[BubbaDog56]

We have just went through our yearly rounds of test and measurement (T&M) equipment cals, conducted on-site by an outside vendor. Having been with the company just a few months and tasked with this project, I wanted to do a comprehensive sweep of the facility looking for stragglers not included on the existing cal list. What I found was that the majority of the T&M gear in our engineering and design labs was not included in the cal list. In trying to get listings of equipment from these groups, I received constant resistance and questioning as to why their T&M stuff needed to be on the program as it was not used in the production or production testing of assemblies. This attitude was shared by upper management as not being value-added. My personal feelings are that T&M performed during research and design is just as critical (if not more so) as any T&M performed during production. However, ISO Secs. 7.6 and 8.2.4 appear vague in clearly defining where calibrated T&M equipment is required.

Though we are not currently ISO certified (or compliant), we have been tasked with moving towards that goal. What ammo or arguments can I give to convince them that this is necessary as part of an overall quality management system? I would like to think it's common sense to understand this, but common sense appears to be lacking. Any suggestions?

 

[CarolX]

Just me thoughts on the subject, and others may and will disagree….



I have always excluded equipment used by engineering used for design and evaluation purposes. My thinking is…if the measurement is THAT important, give it to the pro to measure.

 

[Al Rosen]

Just me thoughts on the subject, and others may and will disagree….

I have always excluded equipment used by engineering used for design and evaluation purposes. My thinking is…if the measurement is THAT important, give it to the pro to measure.

I do disagree. The reason is in this thread Out of Calibration Microscope Used for Development Work.

 

[BubbaDog56]

Carol,

I've always worked with the assumption (perhaps misguided) that the folks in research and design engineering were the pros. My thoughts are that they are doing the initial T&M to assure conformance to design specs before releasing to production and as such need to make sure they've got good numbers. I am more than happy to be convinced otherwise or proven wrong (wouldn't be the first time ), as it would definitely save us a major chunk of change. Our last go-round for cals of electrical and mechanical T&M stuff came out to about $25K, I know if we added all the lab stuff we'd be up around $30K. But I keep coming back to a quote I saw recently:

"Does it matter if the measurement result is wrong?
If it does, then calibrate the instrument.
If it doesn't matter, then why are you making the measurement?"
- P. G. Stein, 2000


B'Dog

 

[BubbaDog56]

Al,

An extremely valid point, thanks for pointing me at the thread. Often a published spec is 'backed into' by first designing and then measuring something at the lab level, rather than defining the specs first and then designing and validating around them. Then when it hits the shop floor (or the customer's door) and is checked with 'good' T&M gear, it fails to meet the published spec.

B'Dog

 

[Al Rosen]

In the thread I referenced in my prervious post, the company spent two years develping a specification with an uncalibrated microscope. It turned out that the spec, they developed was incorrect. Was it worth it to save a few $s?

 

[Marc]

Design and Development equipment is, in my opinion, even more important than production measuring and test equipment.

As an extreme example, would you want a drug or a safety device designed and validated using 'out of calibration' equipment?

 

[cncmarine]

I agree with you Mark. But the question is regarding ISO.


When it comes to 9001:2000 the scope is gaging used to verify conformance to the speciifed requirments


So I also agree with Carol (in terms of ISO)

 

[CarolX]

And it definitly matters what industry you are in and what the equipment is for. Al's thread reference was excellent, but not along the line's I was thinking. That company was devloping the "specification". I would certainly agree that a M&TE be calibrated under that enviroment.


But if you have an engineer doing reverserve engineering on a cabinet made from sheet metal, who will really care if the tips of his calipers are worn .010.

There is no right or wrong on this...but you do have to decide if it is worth it.

 

[Hershal]

Some points to consider, from someone who has fought the same fight......

If the R&D stuff is not cal'd, then the R&D have no idea if their specified measurements are being met, until the item is handed off. That may well result in much revision to drawings and prototypes. If the R&D group says they do know, but have uncal'd equipment, then what is their basis to know? they can't prove the knowledge and so must wait on production to tell them if they are right or wrong.

Most Engineers do not want production to have the say as to whether they are right or wrong.

as for 9K, how can a product be realized, if one does not know whether the measurements are correct?

Hershal