Are Bias, Stability, and Linearity studies required by TS 16949 7.6.1?

M

mikenita88

#1
My company took a finding in a recent TS audit for not performing bias, stability and linearity studies. TS para 7.6.1 defers to customer manuals for which methods to use, and none of my customer supplier manuals mandates any of these 3 methods. We have never been required to submit such studies for PPAP

Do I have reason to dispute finding?
 
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R

Randy Lefferts

#2
Re: Are Bias, Stability, Linearity required

Bias, Linearity and stability are covered in MSA. Here are some links that may be helpful.

Link 1
Link 2
Link 3
MSA FAQ from AIAG

There are related threads at the bottom of this page that you may want to look at.
 

Kales Veggie

People: The Vital Few
#3
Re: Are Bias, Stability, Linearity required

My company took a finding in a recent TS audit for not performing bias, stability and linearity studies. TS para 7.6.1 defers to customer manuals for which methods to use, and none of my customer supplier manuals mandates any of these 3 methods. We have never been required to submit such studies for PPAP

Do I have reason to dispute finding?
Does your customer require compliance / implementation of the AIAG MSA manual?

7.6.1 is pretty clear about "customer reference manuals on measurement system analysis".

I doubt you will be successful in disputing, unless you have evidence in writing that your customer accepts your method.

Remember these studies are also there to protect you from shipping bad product.
 
M

mikenita88

#4
Re: Are Bias, Stability, Linearity required

None of our customer supplier manuals mandate specific requirements for B,S & L studies. No customer has ever required theses studies during PPAP. A couple of supplier manuals does make a vague reference to the MSA guidelines in general, but again no specific call out to B,S & L.
 
#5
My company took a finding in a recent TS audit for not performing bias, stability and linearity studies. TS para 7.6.1 defers to customer manuals for which methods to use, and none of my customer supplier manuals mandates any of these 3 methods. We have never been required to submit such studies for PPAP

Do I have reason to dispute finding?
How was this nc stated (exactly)? Your auditor may have been a bit over reaching. However, even if it wasn't a well worded nc, it's typically the "right thing" to do to validate your PPAP results.
 
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