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Transform variable data into attribute data

John Predmore

Trusted Information Resource
#11
Our instrument system is not capable to find the variation after the cutting press process
I agree with the others, it sounds like there is no problem except your Cpk looks suspicious. It might be easier to temporarily adopt a one-time approach than to get the auditor to change his mind, now that he has dug his heels in. If you could measure samples to thousandths of an inch, you would see variation in the data. You told us you don't have the equipment, but maybe a business associate or a supplier has an optical device. Have him measure a few dozen parts as a favor to you.

Another idea of mine to interject variation into the data, instead of measuring your parts with a 10-foot tape measure, measure with a single 12-inch ruler. By downgrading to a less-capable measure device and introducing reproducability variation, you will see more variation in measurements. As long as your die-cutter is plenty capable, a compromised measurement does not reduce your process capability in reality, it only makes a stellar result look less suspicious. This is simply a suggestion to make the ignorant auditor happy, so he goes away without a fight.
 
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Bev D

Heretical Statistician
Staff member
Super Moderator
#12
It might be easier to temporarily adopt a one-time approach than to get the auditor to change his mind, now that he has dug his heels in. This is simply a suggestion to make the ignorant auditor happy, so he goes away without a fight.
:unsure: not a dig at you John, just a general commentary on the state of the quality profession as it is practiced by far too many people. When did we become the enablers of ignorance? When did we decide that it was easier to waste time and effort on placating ignorant bullies than to fight for real quality engineering? That auditor won't 'go away'. They will not only come back with an emboldened state of ignorance to bully this company even more, they will continue to spread their ignorance and waste at other companies. Science and math matter. That's what all of these standards purport to be about...Without the courage to stand up to ignorance we are on the return path to the dark ages. (and yes I know that some operations are so lacking in their understanding and commitment to quality that they see placating the auditor as the best way to keep a useless certification in place, that they will demand that their engineers and quality managers placate the auditor...but shouldn't our first response be to help the OP fight the good fight and only when they have no choice suggest unscientifically sound and statistically silly approaches to 'get out of it'?
 

Kid006

Starting to get Involved
#14
What prevents you from explaining the facts to the auditor? Why are you trying to do a capability study to begin with?
I do not made this validation, im in charge of this finding.
The capability study was performed by an exemployee, looking through the data i found that they were manipulated, the 32 samples were 9.0; if all samples are equal minitab do not perform de capability study instead the program throws a warning saying that there is no enough variation among the data
I already try to explain to the auditor the fact that since we are using a verified die cut the output will be same since our measurement instrument does not have enough resolution to verify that milimetric/micrometric variation among the product, that cpk shouldnt be calculated since all samples were equal and her response was "the equipment is not adequately validated"
 

Jim Wynne

Staff member
Admin
#15
I do not made this validation, im in charge of this finding.
This doesn't mean that you can't find out why the validation is being done in the way that it's being done. It should be a fairly simple thing to determine that the process is "capable" without doing a lot of voodoo math.
The capability study was performed by an exemployee, looking through the data i found that they were manipulated, the 32 samples were 9.0; if all samples are equal minitab do not perform de capability study instead the program throws a warning saying that there is no enough variation among the data
If 9.0 is what's needed and is consistently produced (regardless of the measurement method) you know what you need to know.
I already try to explain to the auditor the fact that since we are using a verified die cut the output will be same since our measurement instrument does not have enough resolution to verify that milimetric/micrometric variation among the product, that cpk shouldnt be calculated since all samples were equal and her response was "the equipment is not adequately validated"
Did she explain what she would consider "adequate" validation?
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#16
what do you mean the data were "manipulated"?

What part of the standard is she quoting to say that the equipment is not adequately validated? What does the standard say is adequate validation?
 

Kid006

Starting to get Involved
#17
what do you mean the data were "manipulated"?

What part of the standard is she quoting to say that the equipment is not adequately validated? What does the standard say is adequate validation?
they add an extra point/sample to the data so minitab could made the capability study (six pack)
21CFR 820.75
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#18
OK - that's not really manipulating the data. It's just a means to trick 'minitab'.
what does 21CFR 820.75 say? sorry many people here are not familiar with the CFR standards and even then we don't have each paragraph and section memorized. plus it is important for you to read the section and understand what it actually says.
 

Jim Wynne

Staff member
Admin
#19
they add an extra point/sample to the data so minitab could made the capability study (six pack)
21CFR 820.75
The (a) section of 21 CFR 820.75 says:
Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.
Why is validation considered necessary?
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#20
This is a 'special process' clause that has nothing to do with a Cpk value, normal distribution, etc. 'special process' examples are those like welding. the only way to test for the integrity of the weld is through a destruct test - which can't be done on 100% o fall welds on all product. a die cut process that creates a feature or dimension can be verified on 100% of the parts, so this clause doesn't seem to apply to your situation at all. What does you quality manager say about this?
What do your procedures say about qualifying 'special processes'?
 
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