Regarding ISO13485 and FDA 21cfr part 820 is it within compliance for the QA Manager to report to the VP of Manufacturing with dotted line to the VP of quality? I would think it should be the other way around. It would be hard to request intervention by the VP of Quality during a conflict without expecting possible repercussions from the VP of Manufaturing who ultimatley controls the Quality Manager's employment status.
Send to friendSign In to get started!
Comments
forrestbreyfogle 8/31/2004
INITIAL POSTING: On RTY, Pyzdek advocates the use of DPMO. You recommend the use of DPU. While I agree with you, I would be interested in your comments on the use of DPMO in a RTY calculation. Is Pyzdek flat out wrong?
RESPONSE: John, as you know I am big on metrics that make sense and lead to the right activities. I am sure that Tom (Pyzdek) would agree with that. I have concerns that when Six Sigma deployments force the determinination of "opportunities for failure" for ALL projects they can be spending a lot of effort "counting things", which, in addition, can lead to the wrong activities. For example, I am not sure what an appropriate "opportunity for failure" unit would be for a Lean Six Sigma project where someone is to reduce cycle time or inventory.
I suggest using dpmo and RTY calculations when it makes sense for a project. I think that someone could use either dpmo or dpu metrics for a RTY calculation, depending upon what is most appropriate for the situation (i.e., leads to the "right" activity with the least amount of effort).
Forrest Breyfogle
forrest@smartersolutions.com
www.smartersolutions.com
512-918-0280