Annual Validation as a detection mode on a PFMEA?

[Tonette Bogner]

Just wondering if anyone has used "annual validation" as a detection mode on a PFMEA? If so what types of failure modes did you apply it to?

 

[Jim Wynne]

"Detection" is a control, not a mode. You seem to be going about this backwards. First, for each operation, you identify potential failure modes, then the types of controls used.

 

[optomist1]

PFMEA aside, why wait for an annual validation or layout to gain insight into where the process is or headed? More to the point, an annual layout, for the "customer's benefit", should be a confirmation of what a supplier already knows...

 

[Tonette Bogner]

Thanks - sorry poor choice of words. I should have asked if you have used "Annual Validation" as a control for a failure mode. We were running though an PFMEA and the team was listing Annual Validation as a detection control for a failure mode. I do not really understand how you could use annual validation as it is a snap shot in time and not a ongoing way to monitor compliance to a requirement. Sorry for any confusion!

 

[John Predmore]

My state requires annual safety inspections of automobiles on the road as a method to detect and correct deficiencies that might otherwise be overlooked. My customer requires annual calibration as a method to detect and correct measurement deficiencies that might otherwise be overlooked. My company requires annual preventative maintenance checks to reduce the occurrence of equipment breakdowns.
Annual validation can be used as detection, but compared to other methods, it depends on how expensive, how noticeable, how gradual and how frequent are the deficiencies you check for.

 

[Bev D]

John’s point is well taken. Annual validation can be an effective control - in fact it’s required for some industries.
Of course it often isn’t the only control for most failure modes. For example, failure modes for special processes are difficult and/or expensive to test for frequently. So controls are put in place for the inputs or ‘causes’ of failure modes. In addition, field performance/warranty/maintenance monitoring are also used to detect failures. After the fact of course but better to know sooner than later. I think the thing to understand is that most failure modes need multiple controls.