Slide 36 of 241
Notes:
Understand there are different ways companies address FMEAs (and control plans, etc.). Some take a generic approach for a product family (in the case of Design FMEAs) and process (machine) specific Process FMEAs. Other companies have product specific FMEAs.
The above diagram represents a product specific approach where each product has its own FMEA. It is probable that when a new contract is agreed to the control plan from the similar product will simply be copied. Changes driven by engineering changes (often in response to an 8-D investigation / customer complaint) up to that point will probably have addressed all known issues. Note that one of the failures or downsides in a product specific system like this is that typically a change to the FMEA in response to a customer problem have to be addressed in the FMEAs for similar products. The problem is the trigger for a change in one to cause other FMEAs for similar products to be appropriately updated.
In the case of part family DFMEAs and machine specific PFMEAs, the same FMEA is used for a ‘new’ product . **Control plans will almost always change because of ‘slight’ product differences. On the other hand I have seen control plans which were relatively static because the company used a matrix which defined specific tolerances (for example). The control plan process / product specification / tolerance column referenced the matrix.
Product Specific FMEA Approach
Process FMEA
Brand spanking new, never before product.
Production Life
Year 1
Process FMEA
Copy of process FMEA from a similar product
Year 1
I do NOT recommend product specific FMEAs unless you really cannot segregate your products into families for some reason.
FMEA revised in response to an 8-D investigation
Year 2002 - “Q” Body
Year 2003 - “Q” Body
Year 2
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