Is Gage R&R required in a small company by ISO 9001?

[Bob_M]

Is Gage R&R required?

I understand the "need" for regular Gage R&R to ensure they measuring device and the operators are still capable of making accurate and correct measurements...

BUT does a company (small) that uses calibrated equipment (mainly digitial calipers and basic micrometers) really HAVE to perform Gage R&R in the eyes of ISO 9K2k?

Our small company (currently around 25) is currently ISO 9001:1994 (working on 9k2k upgrade) and the LAST Quality Manager wrote our ISO manual, procedures, WIs etc. He wrote a rather loose Gage R&R program (Once per year if I remeber correctly). Unfortunately at the time we had about 50 employee as a "Quality Assistant" that helped perform and enter the Gage R&R data.

When we lost her the old manager seemed to stop the Gage R&R studies. I have not had the time to start them up again.

Other than the fact that we HAVE a Gage R&R policy, do WE really HAVE to perform these R&R studies?

[Like I said I know why and the benifits of the studies, but is EVERYONE doing them? Does everyone have to?]

Side Note: Yes we use our calibrated devices to VERIFY our dimension, but since we are a metal stamping company, the only real part variations we normal get are thickness which is not usually a major factor.

Any input or comments to set me straight or did we go overboard?

Thanks Bob_M

 

[Jimmy Olson]

Hi Bob,

There is nothing in 9k2k that requires gage R&Rs to be done. I used to work in a commercial cal lab and I know of a number of companies (large and small) that don't do R&Rs. If you don't see any value or benefits to doing them, then there's no reason to worry about it. Hope that helps.

 

[JaySturgeon]

Nope.

The standard does make that requirement.

 

[Jimmy Olson]

Re: Nope.

JaySturgeon said:

The standard does make that requirement.

Where?

 

[Bob_M]

Re: Nope.

JaySturgeon said:

The standard does make that requirement.

Where?

I'd agree its IMPLIED in the plan-do-check-act cycle as far as verifying product conformance.

Anyways I just rechecked our 1994 style procedure and it states:
"a study MAY be performed at least every two years"

SO technically our BEHINDS are covered, but it may not be the BEST policy/practice in the LONG RUN.

 

[CarolX]

not needed

Hi Bob,

No, Gage R&R is not required. We are certified to the 1994 version, working toward upgrade, and the only R&R I have done was specifically requested by one customer.

Regards,
CarolX

 

[Bob_M]

Re: not needed

CarolX said:

Hi Bob,

No, Gage R&R is not required. We are certified to the 1994 version, working toward upgrade, and the only R&R I have done was specifically requested by one customer.

Regards,
CarolX

I've only done one R&R in the last 7months since I became the QA person and it was for a full blown Level 3 PPAP (on a very simple part).

We tend to take good care of our shop gages and if they don't pass calibration, we stop using them. I'm real glad were not QS!!!

 

[YKT]

There's no clear indication on the ISO9001:2000 clauses that a GRR need to be performed.
However, I believe that is a proactive approach for a company to ensure all their readings can be 'trusted' and also that it will show the actual capability of a process (with the correct discrimination to show variations).

It's just like asking yourself whether you are going to be certified ISO9001:2000 because of economic pressure (where all your competitors are certified), or you want to be proactive, cutting cost, providing better quality product ?
If you choose the later, I strongly urge you to look at any form of continuous improvement tools that help to sustain the certification in the future.

The whole approach for auditing will be slightly different now, as most auditors (having being exposed to QS9000 and ISO/Ts 16949) tend to look at 'performance-compliance' rather than 'clause-compliance'. Effectiveness and efficiency of the process implementation is the key focus.