Ignoring a Failed Gage R&R and upcoming external audit

[UncleFester]

Hi JohnH, it looks like you're trying to maintain your certification, but as you say - you're "being told to flatout ignore the 2018 failed gauge R&R / do nothing to correct it and present the 2006 Gauge R&R."

To me, it's the culture of the organisation that's really at fault if that's the attitude of your seniors. If this is just one instance I'm sure there could be more.

As it's been written before, "Culture eats strategy for breakfast".

 

[Judegu]

If I found that your measurement system did not pass. rather than ask you why you are hiding it, I would consider to check for your deviation and containment processes.

Hi, sir. Here is one question. In this case, only variable Gage R&R failed. Is it necessary to implement a containment process?

 

[Mr.Ruiz]

Hi, sir. Here is one question. In this case, only variable Gage R&R failed. Is it necessary to implement a containment process?

Hi Judegu, if your Gage R&R study failed, a common containment action is to segregate the device used for the study from your production process, since the GR&R shows that is not a reliable equipment, but, you cannot leave the manufacturing process without an equipment to perform those measures (process controls). That's where a deviation process should be consider as defined in 8.5.6.1.1 sub-clause.

per 7.1.5.2 at the bottom of the clause states:

"The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary."

Most of the companies already have those "containment actions" in place, but, for some of them this is just a knowledge acquired thru experience, and has never been consider to be documented.

Sometimes, we use to perform this Gage R&R studies just to cover some sort of requirement, but we are losing the primary intention of it. Remember that a failed Gage R&R could be just a formal notice that something is not going according to the plan. (Page 128 MSA 4ed).

 

[Golfman25]

I would not get hung up on the "failure" of the gage R&R. What does "failure" mean anyway? Not reaching 10% -- which may be impossible or unnecessary in many applications. You really need to dig deeper into what is going on before taking all sorts of actions. Start with why the G R&R turned out differently and work from there.

 

[Judegu]

Hi Judegu, if your Gage R&R study failed, a common containment action is to segregate the device used for the study from your production process, since the GR&R shows that is not a reliable equipment, but, you cannot leave the manufacturing process without an equipment to perform those measures (process controls). That's where a deviation process should be consider as defined in 8.5.6.1.1 sub-clause.

per 7.1.5.2 at the bottom of the clause states:

"The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary."

Most of the companies already have those "containment actions" in place, but, for some of them this is just a knowledge acquired thru experience, and has never been consider to be documented.

Sometimes, we use to perform this Gage R&R studies just to cover some sort of requirement, but we are losing the primary intention of it. Remember that a failed Gage R&R could be just a formal notice that something is not going according to the plan. (Page 128 MSA 4ed).

Hi Ruiz. I think when Gage R＆R failes, the "bad" machine is only one of the possible causes, right? If we identify it is the machine which causes the fail, we should pull it out of the production. If we find out it is the inspector' being lack of training, we can keep the machine in the line, and train the incompetent inspector instead, right?

 

[Mr.Ruiz]

Hi Ruiz. I think when Gage R＆R failes, the "bad" machine is only one of the possible causes, right? If we identify it is the machine which causes the fail, we should pull it out of the production. If we find out it is the inspector' being lack of training, we can keep the machine in the line, and train the incompetent inspector instead, right?

Hi Judegu,

Yes, it is possible, however, two things should be carried out prior to letting the equipment in production floor.

1-a new analysis to make sure that the cause was the measurement taken by the operator and not the equipment, and;
2-Limit its use until new analysis.

 

[ezekieltemple]

It seems you need to get to the root cause of the difference in Gauge R&Rs... (AFTER that we can offer helpful/informed advice...)

Additionally, regarding to "having to repeat"a gauge R&R study... There are many threads discussing that Gauge R&Rs do not "HAVE" to be done more than once (if done correctly) - although it can be for a variety of reasons... (did your auditor see operators that needed training and suggest the Gage R&R to help you realize that...?)

REFERENCED THREADS:
Re: Gauge R&R studies - How often do you have to repeat a gage R&R study?

The fact is a correctly performed gage R&R never needs to be redone. There is no time function to gage R&R. It has one fundamental function: determine if the gage is the correct gage for the job. The portions of MSA that have a time function are calibration, stability, etc. They verify the gage system is still working correctly.

Often customers will ask for annual gage R&R's. They do it for one of three reasons -1. they believe they were not performed correctly the first time, 2. they think you likely changed the gage system and did not report it or 3. they have very little understanding of gage R&R themselves. However, those anomalies themselves do not justify multiple, ongoing gage R&Rs.

Re: Gauge R&R studies - How often do you have to repeat a gage R&R study?

Ever read through a thread as an outsider and see clearly that people are talking about two different topics? This seems to be the case here (though Bob and Bev are trying well to point this out too).

Gage R&R is a test to see if a measurement method (Gage and use of that gage) is appropriate for measuring a particular feature/characteristic.
It either is appropriate or is not appropriate...period.
Three years of waiting will not chage its appropriateness. Heavy use will not change its appropriateness.
A new customer will not change its appropriateness.
Based on this alone, Gage R&R is a one time proof.

When operators change, it may be worthwhile to verify that the new ones are using the same method. This does not require Gage R&R, though you may choose to use that tool.

When a gage is used heavily and may drift, it may be worthwhile to verify that the gage is still accurate and repeatable. This does not require Gage R&R, though you may choose to use that tool.

Bottom line is that Gage R&R does not have to be run again...the test method is appropriate for that which is being tested.
You may choose to run it again for some other purpose...but there is no need to check for appropriateness again.

 

[Judegu]

Bottom line is that Gage R&R does not have to be run again

Hi ezekietemple, your opinion is quite new to me. IMO, manafaturing process does not always stay unchanged. If the manufacturing pocess has been improved significantly, the variation of its output i.e. products would be largely decreased. In this case, though the gage is still in its good condition, the result of Gage R & R would not stay the same, the result would get worse. And the gage may not be suitable to measure this improved process. Moreover it is possible that the operators who use this gage would be also changed. In order to know whether this measuring system works well or not, the Gage R＆R should be run again, right?

 

[Miner]

Hi ezekietemple, your opinion is quite new to me. IMO, manafaturing process does not always stay unchanged. If the manufacturing pocess has been improved significantly, the variation of its output i.e. products would be largely decreased. In this case, though the gage is still in its good condition, the result of Gage R & R would not stay the same, the result would get worse. And the gage may not be suitable to measure this improved process. Moreover it is possible that the operators who use this gage would be also changed. In order to know whether this measuring system works well or not, the Gage R＆R should be run again, right?

Your example raises a valid point, but you would not have to repeat the entire study. You could take the original study, substitute the new process variation and calculate the revised metrics. One scenario that I can think of that would make it advisable to repeat the entire study would be a process change that impacts the variation in form in such a way that it would affect how the gage measures. However, the gage would be more sensitive to a deterioration in the process than to an improvement.

 

[Judegu]

ou could take the original study, substitute the new process variation and calculate the revised metrics.

Hi Miner. Would you please give me an example which could show me how to do it. I myself still have troubles in fully understanding the whole mechanism of Gage R & R. The easy way for me to perform the Gage R ＆ R is via Minitab.

However, the gage would be more sensitive to a deterioration in the process than to an improvement.

Yes, I totally agree. In practice, improvement is much harder to achieved than deterioration is. What is more, even the result of the gage R＆R got worse due to this kind of process improvement, there would be still low risk for the customer if we do nothing about the gage.