Can anyone give some examples of "Defined requirements for determining potential nonconformities and their causes"?

Is the standard asking for actual instructions to do this and do they need to be documented in the Preventive action procedure?

Thanks
Paula:bigwave:

Any contemporary comments?

I don't know if I'm fully awake yet this morning but Paula's first line just "screams" PFMEA to me. As to the second question, I suppose a blurb mentioning PFMEA and any other risk analysis methodology employed could be in the PA procedure.

As I reread this, it came to me that a Feasibility Analysis should also be included which would incorporate more of the "service" departments into the PA process.

Good Stuff

The most important thing to remember is that the system needs to be documented and have defined requirements for closure.