We are a supplier of electronics systems where we do the D-FMEA on system level (our product defined as a system). Some times we do a System
FMEA with the customer as well.
When starting the develpment of this product we start out with a specification but since we are a development partner to our customers the specification is never complete when we start, we always work together on finalizing it.
Here we need the special or critical characteristics as input to our D-FEMA work. If the product has saftety features it's simple they become Special characteristics but if you do not have safety of regulatory requirements on the product and the customer has not pointed out any SC's and on top of that no high severities comes out of the D-FMEA work.
What it really comes down to would an external auditor approve of an D-FEMA without andy special characteristics if above can be proven?
I'll check about SC's but does not req's comes from the TS16949?!
Thanks Mikael