MSA for gaging which specifies process parameters and 7.6.1

[Roberticus]

Good morning to all. We are working through a minor NC from our TS audit, and a few related questions. I want to ask this specifically regarding the TS expectations, as most of my experience is under medical device standards.

MSA "shall apply to measurement systems referenced in the control plan". What about gaging which verifies process parameters? (i.e. specific gravity, humidity, temperature) as opposed to product characteristics.

If we refer to these in our control plan, must we perform GR&R?

Of course in all cases this gaging is calibrated & routinely verified. In my general experience this is all which would be required, but I don't want to leave us open for further trouble down the road...

Thanks,
Rob

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!

 

[Roberticus]

Please allow me to "bump" this question one more time, which is really more about the expectations under the TS 16949 standard, but any help I can get this would be greatly appreciated, as we have a follow-up meeting on the topic this afternoon...

 

[Jim Wynne]

The standard is pretty clear. If a measurement device is cited in the control plan, MSA requirements apply. Sometimes MSA isn't practical and/or doesn't add any value and calibration is enough. This is an area of the standard that's always been controversial, and if you have an inflexible auditor it can be a real pain. My advice is to either get explicit waivers from customers or remove the things from control plans.

 

[MWR4QA]

Another aspect of this is when you are visually inspecting a product for acceptance/rejection. Often, the inspector is comparing the production to some type of acceptance criteria, usually a set of physical samples that contain examples of the appearance characteristic to be evaluated. One would show the acceptable condition, one would show the reject condition and one would show the all-important, "no worse than this" condition. In such cases, an attribute agreement analysis may be required.