astudent said:
I know little about
FMEA. Hope someone can help me.
If I have, say, 100 product and each of them has his own bill of materials (for ex. on the average 10 items per product), how many
PFMEA have I to write?
Looking at your problem another way, take a step back and consider the following.
What has happened that you now need to prepare PFMEA's for your existing processes? Are you planning for TS accreditation? What benefit will completing the FMEA’s in retrospect give you?
In my opinion their are two options available to you.
1) Review your processes and determine families for legacy / generic FMEA's based on similar processes (i.e. injection moulding, progression stamping, spot welding). Create the generics then refer to the generics where required from product specific FMEA's
For unique assembly / manufacturing processes you would still need to prepare a specific PFMEA.
2) Place a line in the sand with your current processes and determine that new products and processes entering the factory be subject to D/PFMEA. For your existing products you could perform mini PFMEA reviews based upon future customer and internal concerns. This would mean that you are reviewing the process in an FMEA format but as more of a corrective than preventative action. However the information you get could be used to help new projects. If you are looking for accreditation your registrar may be able to clarify if he would accept this approach. My opinion is that most are OK with it.
At this moment in time you should know the issues with your products and processes and therefore the PFMEA is an “after the event” exercise and may not prove an efficient use of time.
I would consider option 2 above, but at the same time look to develop generic FMEA’s based upon common manufacturing processes. IMHO I would always look to have an FMEA for each product but refer to a generic. This way you save work in document creation but can review product specific concerns against a specific FMEA.
I hope this is of some help.