Gage RR to train operators? QS-9000 Semiconductor Supplement 4.11.4.S

[Dvansickle]

QS 9000 Semiconductor Supplement states in Section 4.11.4.S
"The supplier should repeat gage R&R studies when warranted by measurement system change (including operator) and have a systematic method to improve gaging".
My question is, "Do we have to do a study each time we get a new operator? This happens a lot, or since it says "should" instead of "shall" can we show in another way such as through SPC or other some way to satisfy this requirement.

 

[Jim Wynne]

QS 9000 Semiconductor Supplement states in Section 4.11.4.S
"The supplier should repeat gage R&R studies when warranted by measurement system change (including operator) and have a systematic method to improve gaging".
My question is, "Do we have to do a study each time we get a new operator? This happens a lot, or since it says "should" instead of "shall" can we show in another way such as through SPC or other some way to satisfy this requirement.

That's one of those sentences that only a committee could write. Because the purpose of MSA is to evaluate sources of variation in the measurement process, it stands to reason that any given analysis is only directly applicable to the operators who participated in it. I use the word "directly" advisedly, because a case can be made that if the original GR&R was done using experienced operators with the expected skills, it's not too much of a stretch to say that other operators with the same skills would produce similar results. It all depends on how critical the measurments are, and the skill and training required. You should decide for yourself when a new study is "warranted," and be prepared to defend your decision reasonably if it's questioned.

 

[Dvansickle]

"Shall" or "Should"

I know when you see the word "Shall" it means that it is required. But I'm getting different ideas at my company on the requirements when you see the word "Should". Can you help me explain the difference in these terms.

 

[Jim Wynne]

I know when you see the word "Shall" it means that it is required. But I'm getting different ideas at my company on the requirements when you see the word "Should". Can you help me explain the difference in these terms.

In essence, "should" is "shall" with wiggle room. For the "shalls" allowance is made for use of alternate methods. I don't have TS16949 handy, but QS9000 says, "The word 'should' indicates a mandatory requirement with some flexibility allowed in compliance methodology." In general practice, you "should" be able to show an auditor that the requirement has been given due deliberation and that the practice in use satisfies the spirit of the standard. In this case, the concern is that measurement system changes might render previous analyses obsolete, but if you can show that the previous results are reasonably representative of the current state of the system, there "should" be no problem.