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!
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!