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Nonconformance about MSA (Measurement Systems Analysis) in ISO/TS16949:2009

B

berseak

#1
I got an NC for MSA.

I implemented only GR&R variable. But auditor gave NC. Comment is: "Shall implement GR&R attribute, bias, linearity and stability. Refer MSA Manual 4th ed.

What do you think about this?
 
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qusys

Trusted Information Resource
#2
Re: NC about MSA in ISO/TS16949:2009

I got an NC for MSA.

I implemented only GR&R variable. But auditor gave NC. Comment is: "Shall implement GR&R attribute, bias, linearity and stability. Refer MSA Manual 4th ed.

What do you think about this?
If formulated in this way, it can be questionable or have more details.
I do not know what you have agreed with your customer based upon 7.6.1.
Statistical studies shall be done for measurement equipment and test recalled in the control plan.

I do not know how you proceed in your calibration system but if you have a regular calibration program with demonstrable results, together with GR&Rs variable done, you should be ok
:bigwave:
 
#3
I got an NC for MSA.

I implemented only GR&R variable. But auditor gave NC. Comment is: "Shall implement GR&R attribute, bias, linearity and stability. Refer MSA Manual 4th ed.

What do you think about this?
I've had a similar experience where all 3 studies were expected! My understanding is that not all 3 are appropriate to all equipment, all of the time.

What equipment type was the subject of the GR&R study? What types of study had you performed?
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#4
I got an NC for MSA.

I implemented only GR&R variable. But auditor gave NC. Comment is: "Shall implement GR&R attribute, bias, linearity and stability. Refer MSA Manual 4th ed.

What do you think about this?
They are pretty much are quoting TS 16949:2009 7.6.1, and yes, they state studies SHALL be conducted per and conform to the REFERENCE manual, which suddenly makes the reference manual a standard. :rolleyes: Bias and linearity are calibration, and even the basic ISO standard requires that.
 

Jim Wynne

Staff member
Admin
#5
They are pretty much are quoting TS 16949:2009 7.6.1, and yes, they state studies SHALL be conducted per and conform to the REFERENCE manual, which suddenly makes the reference manual a standard. :rolleyes: Bias and linearity are calibration, and even the basic ISO standard requires that.
It sounds to me like the auditor is quoting the PPAP manual, not 16949. PPAP 4th Edition, page 6: "The organization shall have applicable Measurement System Analysis studies, e.g., gage R&R, bias, linearity, stability..."

That "e.g." means "for example," and is not prescriptive in all cases. The key word is "applicable." Studies should be appropriate to the device and system.

Note 1 says, "Gage R&R acceptability criteria are defined in the Measurement Systems Analysis reference manual." (Emphasis in the original)

So the only reference to the manual is for GR&R acceptance criteria, which is the weakest part of the manual.
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#6
It sounds to me like the auditor is quoting the PPAP manual, not 16949. PPAP 4th Edition, page 6: "The organization shall have applicable Measurement System Analysis studies, e.g., gage R&R, bias, linearity, stability..."

That "e.g." means "for example," and is not prescriptive in all cases. The key word is "applicable." Studies should be appropriate to the device and system.

Note 1 says, "Gage R&R acceptability criteria are defined in the Measurement Systems Analysis reference manual." (Emphasis in the original)

So the only reference to the manual is for GR&R acceptance criteria, which is the weakest part of the manual.
Since the standard states "The analytical methods and acceptance criteria used shall conform to those in customer reference manuals on measurement systems analysis, " so you can include any applicable manual, including the CSRs which can be even more prescriptive. At the AIAG MSA rollout, their warning is NOT to make it a requirement in your own QM, or you can be held to it. Some customers have done that to you anyway. IATF holds no further clarification in their guide...so they think it is pretty clear (to them).

But, you always have the option to have the auditor clarify specifically what in the standard they are referring to.
 
Q

QualityQ

#7
Does any of you, use any statistical methods for destructive measurement systems, such as burst test?
I've read the chapter IV of the MSA manual, forth edition. As far as I understood, I can follow the cpk+cp and if the process is under control, etc.
As the total sigma is a function of measurement system's sigma and the process sigma, this method seems ok to me?
I really think that standard GRR study is not applicable in this case.
What do you think?
 
B

berseak

#8
Thank you for all comment.

Actually I refer customer manual. In manual request only GR&R veriable.

(I show auditor already both manual and 7.6.1
The analytical methods and acceptance criteria used shall conform to those in customer reference manuals on measurement systems analysis​
) But it's waste.

What ever will be will be.
 
B

berseak

#9
. (4) GRR (attribute) for visual inspection (deformation) did not include Kappa, miss rate and false alarm rate.

I copy some wording from CB auditor. I disagree with Kappa. He said because refer MSA 4th edition shall implement.

really?
 

JuneFoo

Starting to get Involved
#10
Hi, berseak,

To share an audit experience during my TS2 audit July this year, we did conduct Kappa study but customer reference manual did not specific type of GRR shall conduct, the CB advise us to get customer agree on our MSA method during PPAP submission, then the issue is solve. Cause the TS clause ask everything's refer to customer manual, not AIAG manual.
 
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