Dear the Cove friends,
Regarding QS-9000 requirement clause 4.9.4 and definition of setup verification in glossary of tem, I would like to ask for some help to clarify this one for me.
One internal auditor of us just raised one NC for our production section that he couldn’t see evidence that on SPC chart have the first plot according to setup verification data.
To explain more little bit: SPC chart gathering data of pilot hole dimension from CNC machine. Auditees can show evidence of setup result, however, most of them do not know that they have to plot setup result on control chart. Is my auditor correct?
In my understanding, I think he (the auditor) is probable right, but how can we satisfy this requirement?
Do we have to follow completely as the definition of “Setup Verification” in page 132 of Quality System Requirements QS-9000 book.

Finally, I would like to express all the best to everyone participate in this forum. Merry Christmas and Happy New Year

QSMSO
:)

I don't have it in front of me, but I thought SPC was a 'preferred' method - or a should, not a shall.

Regardless of 'requirements' it makes good sense to verify job set-ups with a statistically relevant sample run, not just based on the measurement of the first piece off of the machine, as that one piece could have come from anywhere in the 'distribution' of the process.

I guess one question you have to ask is "is SPC applicable on this job"? If not the standard does not require it, plain and simple.

Qsmo - The definition on page 162 is as Laura said, only a suggestion. You don't need to do SPC for verification although it is good way to verify set-up. There are other accepted ways such as first piece inspection, "last off / first off", measurement, etc.

The way you verify set-up is up to you (and sometimes your customer) and needs to assure you the process will produce good parts. The criticality of the product should determine how you do the verification.

If your current procedure for set-up verification states you will plot it on an SPC chart, the auditor is right. You are not following your procedures. If the auditor is referring to page 162 of the QS manual and it is not in your procedures to do verifications that way, he is wrong.

Write your procedures stating what you do then train your employees to follow the procedure. As Laura pointed out, you need to follow the "shalls" but you have options with the "shoulds".

Dave