Have a finding from Corp. Internal Audit that production performs an Inspection that is not identified in the PFMEA. It is part of a general inspection taught to all associates as a general catch all. Does it really need to be updated in the PFMEA if we have it in the Work Instruction as an "Extra" check.
Performing Additional Inspections
- Thread starter Charasou1
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I cannot speak precisely to IATF 16949, and how diligent it requires you to be as far as accounting for inspections as controls (as part of an action plan), but it is possible that inspections can also introduce failure modes... via electrostatic damage, fingerprints, etc. that I would expect to be spoken to as part of the analysis of the process where the handling occurs.
There's a school of thought wherein it's believed that inspection operations shouldn't be a part of the PFMEA process. I disagree, and think that anything that could result in failure should be considered. If the operation in question is important, and other inspection operations are included, it should be included too. Of course, when considered in the PFMEA process, it should also find itself in the control plan.
malasuerte
Quite Involved in Discussions
Short answer, yes.
I am unclear on the finding: Is the finding that the Inspection is not listed as an actual step in the PFMEA? or is it that the inspection is not listed as part of your methodology for Detection??
IF Step in PFMEA
If it is a step in the process; it should be in there if that inspection can fail (i.e. tool can fail). This is just good practice. Now, if you tell us that this "extra check" doesn't really matter, then you could probably exclude it. But then, I would ask why you have it in place if it doesn't matter?
IF Detection (in PFMEA and Control Plan)
You have that "extra check" in for some reason - maybe it is because of the FMEA and added it to reduce the Detection score. It doesn't really matter, your FMEA should provide the details of your Detection (Inspection) to reduce the score.
Currently, based on what I read in your post, the FMEA does not have this check and your DET score is XXX - right? So is the DET score with the "extra check" or without it? If it is with it, then you aren't explaining in your FMEA how you got to DET score XXX; if it is without it, then you will have an inflated RPN and should be doing something to improve it - you are with the "extra check" but not documenting it.
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The inspection is not documented on the PFMEA but is listed in the Work instruction at the assembly line and the associate is performing the extra check. Another example is the PFMEA and the Control Plan call out an inspect at start and end of shift but associate performs the check at start-up, after break and at end of shift. So an increased frequency to what is documented.
As this was an "internal audit", I want to write that you may be escaping with a relative easy observation. It sounds like the FMEA simply has a mis-alignment between the work as required (per work instruction) and the process as assessed/analyzed in the FMEA. I can imagine many reason (both from a Quality perspective and a Business perspective) why your corporate masters want to see more explicit alignment.
If I was a probing, professorial auditor... that is, someone with the attitude of wanting the process owner to think more comprehensively about the work (as directed, as performed)... I would be asking questions about this:
There are natural questions about the teaching (is it consistent? is it effective?) and questions about the method (is it effective? is it comprehensive?). Personally: I am a big believer in building user competency so that operators can be trusted to recognize when something looks wrong without explicitly being given strict directions (think "headlights" as opposed to "guardrails"), but if I were in your position I would add these "general checks" to your PFMEA but not claim that they are really doing anything (in the absence of Objective Evidence appropriate to particular failure modes).
If I was a probing, professorial auditor... that is, someone with the attitude of wanting the process owner to think more comprehensively about the work (as directed, as performed)... I would be asking questions about this:
There are natural questions about the teaching (is it consistent? is it effective?) and questions about the method (is it effective? is it comprehensive?). Personally: I am a big believer in building user competency so that operators can be trusted to recognize when something looks wrong without explicitly being given strict directions (think "headlights" as opposed to "guardrails"), but if I were in your position I would add these "general checks" to your PFMEA but not claim that they are really doing anything (in the absence of Objective Evidence appropriate to particular failure modes).
January 2001, I was on QS-9000 internal auditor training.
One of test questions was related to how auditor should evaluate observation - inspection sampling increased comparing to what is required per control plan.
Proper answer was : nonconformity.
Probably idea of reverse PFMEA is getting more popular, because it gives team opportunity to learn in reality how implemented controls look like. They ranked somehow detection, but do we control process/product according to their ranking today?
One of test questions was related to how auditor should evaluate observation - inspection sampling increased comparing to what is required per control plan.
Proper answer was : nonconformity.
Probably idea of reverse PFMEA is getting more popular, because it gives team opportunity to learn in reality how implemented controls look like. They ranked somehow detection, but do we control process/product according to their ranking today?
You question isn't quite clear. Can you rephrase, please?
What is "R-PFMEA"?