MSA clause or wording needed.

[Ashland78]

7.1.5.1.1 states that statistical studies shall be conducted...when identified in the control plan.

I was thinking initially all gages needed to have MSA to prove they are capable (when working for very successful German company in the past that was our practice as that was our procedure in QMS).

Our procedure from our QMS for my current company says "each department head needs to decide what needs to be addressed annually. Not limited to what is on the control plan." No one (dept. head) has addressed this in 3 years, but we are trying to prep and fix this as it could be addressed by external auditor soon.

What I need to know is what would be good wording for gages that for instance are stand-alone equipment that measures current or voltage. Could we write that the calibration report is acceptable as this is automated equipment, or something?

If it is not even on the control plan, and we decide not to do this what is a wording that we could put in our report that we upload..."This gage is not part of the CP, the certificate of calibration is sufficient.'?

I am nearing a 'plan' for a corrective action by next week. Can anyone help me out please? Thanks!

 

[Jen Kirley]

Hello Ashland78, I am sorry for the delay in this response.

I would expect MSA for gages that measure the critical characteristics defined in pFMEA and then outlined in the Control Plan if only certain instruments would work for certain characteristics. No flowery language is needed, and nothing in the QMS needs to specifically describe this.

Other instruments could undergo MSA studies in order to understand their continued viability and/or contribution to value. Nothing prevents you from doing that. A simple note as such on the MSA report should work for making this intent clear. I would expect that is a benefit of the wording in your QMS.

I hope this helps.