Gage Calibration non QS-9000 Section

[B. Maynard]

Good Morning,
We will be audited in Dec. 1999 for initial QS-9000 Registration. We have approximate 300 gages of which 225 are used in the mold making area which is not part of our QS-9000. We are only going for QS in the Final Product Production from the molds.
My question is !
Do we have to calibrate the gages in mold making side since it will not be involed in the QS Registration. They are highly skilled employees.
Upper management has decided that they should be labeled for referance only. The adjustment of Final Product is a Process problem and we will calibrate those gages that affect the Final Product.
I say all should be Calibrated but Management says "no".
Am I right or can we do what the Team says.
I have been through QS before and they have not.
Thanks,
The Necessary Evil 'Quality Assurance Mgr.)
Bill Maynard

 

[Debra Woodford]

Hi Bill, Well what I read in 4.11.2b identify all i,m,& t equipment that can effect product quality, and calibrate and adjust them at perscribed intervals, or prior to use yada yada yada, with the *NOTE i,m, & t equipment includes equipment in tooling departments used to qualify or maintain production tools regardless fo ownership. Sounds pretty clear to me so I'm with you however I understand the "upper management" short cut thinking. Good Luck

 

[Debra Woodford]

Hi Bill, Well what I read in 4.11.2b identify all i,m,& t equipment that can effect product quality, and calibrate and adjust them at perscribed intervals, or prior to use yada yada yada, with the *NOTE i,m, & t equipment includes equipment in tooling departments used to qualify or maintain production tools regardless fo ownership. Sounds pretty clear to me so I'm with you however I understand the "upper management" short cut thinking. Good Luck

 

[TheOtherMe]

If it's ouside your registration scope, you do not need to do anything. It is off limits to the auditors.

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On the other hand, if you take a look at the T&E Supplement to QS9000 (Second edition), you will find it says (although the AIAG will probably want to sue me for quoting verbatum from the T&E Supplement): "4.11.4 Measuring System Analysis - NOTE: All hand held variable gages that do not require setup are exempt from this requirement (e.g., micrometers, calipers and height gages). These gages still require gage identification, calibration and traceability."

So, it's saying that yes - they have to be calibrated but you don't have to do Gage R&R and such. (Duh - gage R&R and measurement studies are only appropriate for production scenarios, anyway...)

If it was me, I'd have them all calibrated and in the cal database but to me that's common sense. However - the money issue rears its ugly head. And the money issue is real. For every time someone says "That's common sense" - well, let's spend some more money. I personally am particularly sensitive to the need for calibrated M&TE and the need for preventive maintenance - they have my votes. But then there's the production folks who believe they can save some serious bucks if all the lines are upgraded with some poke-yokes here and there. And the accounting folks. And there's the design group which says it will profit 2 more SPARC stations and two more software seats so they don't have to share. I know calibration is a fixed expense (should be about the same year to year unless the business is growing rapidly) as opposed to the other examples, but I hope you catch my drift... Damn! I'm glad I'm not upper management! I guess that's why they make the big bucks - big decisions.

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Bottom line: It's outside the registratiuon scope so it doesn't matter - the auditors have no reason to even visit that area.

I have had clients who only did the QS9000 dance on automotive lines so in the same room you had some equipment which was in the scope and some not. At one client's audit, when the auditor asked about a line or piece of equipment which wasn't in the scope, we dragged out our scope statement and showed the auditor that it was not in the scope and we moved on to equipment which was listed in the scope statement. Gages not in the scope were IDed as inventory by serial number and such but the procedure read that gages with no cal sticker would not be used in QS areas. Since all the gages in the QS areas were in the system, had a cal sticker and all the rest, there was no problem.

[This message has been edited by TheOtherMe (edited 25 August 1999).]

 

[Howard Atkins]

We will be audited in Dec. 1999 for initial QS-9000 Registration. We have approximate
300 gages of which 225 are used in the mold making area which is not part of our
QS-9000. We are only going for QS in the Final Product Production from the molds.
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Do you expect to get ISO 9000 for the mold department?
I think that even if the mold department is not included i.e. the manufacture, the audit will refer to maintenance of the molds and
the interface between injection and molding. The molds are also in some case customer owned and thus have to be treated as such as per customer supplied material.
___________________________

My question is !
Do we have to calibrate the gages in mold making side since it will not be involed in
the QS Registration. They are highly skilled employees.
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I do not see the relevance of their qualifications. If they were not you would not employ them. How does their skills effect the reliability etc. of the gages.

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Upper management has decided that they should be labeled for referance only. The
adjustment of Final Product is a Process problem and we will calibrate those gages that affect the Final Product.
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IMHO calibration is necessary for gauges that are used to determine the quality of the product. If you can show that the
gauge is not a factor in the determination of final customer demands but just an aid to production I think you would not have
to calibrate them.
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I say all should be Calibrated but Management says "no".
Am I right or can we do what the Team says.
I have been through QS before and they have not.

______________________________________
The team is not necessarily right
QS9000 4.11.1 " The supplier shall ...........to demonstrate the
conformance of product to the specified requirements"