During a customer audit we were asked if we ranked the severity our defects I said well that’s what our PFMEA is for (ranking potential process or product failures). They were referring to non-conforming material. Something about risk to the customer.

I’m confused. Does anyone do this and how is this different than what a PFMEA is used for? I realize that a PFMEA does not cover all NCM conditions but I’m not sure what the benefit would be.

Can anyone give some insight to this or tell me if this is common.

I have not seen a formal ranking of Severity of a nonconformance, but possibly your auditor may have been looking for how you process nonconforming material. Is there a process to ensure that nonconforming product does not get to the customer?
I hope this helps,
Phil

If nonconformances are counted and sorted by severity, corrective action can be rather quickly planned for solving the problems resulting in the nonconformances. My experience with FMEAs is that they do not in themselves prevent nonconformances; they are analysis and planning tools for the controls.

The PFMEA can then be updated, as I am guessing that the nonconformance is due to something the PFMEA did not address. Lessons learned are then recorded and hopefully shared with likely beneficiaries.

If the PFMEA already states a control to avoid the nonconformance(s) but it was not followed, that's a different issue unless the control was impractical. The the PFMEA could be examined and updated then too.

Your customer may be interested in how you do this.

Yes - nonconformities should be classified since your corrective action should be based on severity and $$. Every "critical" nonconformity which relates to safety should have corrective action while many nonconformities may not.

The Process FMEA is a great tool (if used properly) as a preventive system to address potential product defects prior to actually making them. It also increases the appropriateness of the Control Plan but it must be a collective meeting not a 1 person team just before sample submission to satisfy a Customer requirement. About 40% of the Process FMEAs are still "fakers" but keep a Customer happy.

A long time ago and far, far away, I worked in QC for a major company that we implemented ranking of non-conformances, These were defined as Critical, Major, Minor, Incidental, and noted same on the inspection reports. The purpose was to prioritize corrective actions and timing of corrections.
Critical=Safety related
Major=Functional related
Minor=reason for NC of out of tolerence but will not affect safety,function or fit, or class A surface NC
Incedental=cosmetic, or visual NC on a class B, or C surface, which will not affect

Ralph,

Thank you for your response. Do happen to remember how the response time went along with the severity rankings? I can see where safety related issues should require immediate response, probably within 24 hours but how do the rest go and do you get into an audit nightmare with this type of NCM ranking system?


Jerry