We recently had a continious assessment from KPMG and the auditor gave us a minor nonconformance for not including Accuracy, Linearity and stability studies along with a GR&R in a PPAP submission. Our question is , are all of these statistical studies required? or are they optional.
Any help to clear up the confusion would be helpful.

The PPAP manual does not detail what is actual required in terms of documentation.
I think that the demand for the additional data is "harsh".
The PPAP was approved as submitted and this should be the test. If you fulfilled the customer requirements to his satisfaction I do not see how the Registrar can fault this.

I haven't seen them required in a PPAP package before.

Refer to 4.11.4. It appears that your auditor may be referring to this para. to determine analysis content for the GR&R.

The auditor may have been peeling back one layer, and was simply asking how do you prove to your customer that your GR&R accurately reflects your true measurement capabilities.
The statistical tests for bias, stability, and linearity show the impact of the environment on the measurment system. When these are shown to have a neglible effect upon the measurements taken, then the GR&R results more accurately reflect the system's capabilities.

Depending on what your measuring, where you're measuring it, and the tolerances you're measuring to should drive what type of statistical testing you do for your measurement system analysis, as well as any stated customer requirements.

But, with all that said and done, Howard and Marc are right, these tests aren't specific stated requirements for PPAP. It's not against the rules to question your auditor, and ask him or her clarify or to point out the source of the nonconformance.

5 years ago the question was pretty much "Are you calibrating appropriate equipment?" The evolution has been to a holistic and 'educated' approach (not many people even heard of 'Uncertainty' 5 years ago and even now few auditors understand it). Howard, Mike and Sam are right, I believe. You have to show evidence - but as an actual part of the PPAP package - well, I haven't heard that specific info requested.

Thank's guys, That is what we wanted to hear, Please keep the answers flying this way, I'll post the results of the review when we get it back.

weel in my understod you will be define a procedure or work instruction if it says you will be used YOU MAY BE HAVE IT.

I´M WRONG ?

I'm not exactly sure what you're saying. But if you are saying that you have to do it if you write it in a work instruction, yes - you say you have to do it you have to do it.

Hi guys!
I had an aditor tell me that the PPAP hsould include a Gage R&R for each piece of measuring equipment stated on the control plan. In this particular case the control plan stated use of a go, no-go gage, however there was not a Gage R&R sent with the PPAP. When I was questioned by the auditor, I simply went to the Gage R&R book & found a Gage R&R for a pin gage, which seemed to satisfy him. Hope that is of some help!
By the way......
Does anyone else's NCAA brackets look messed up??????

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