Examples of Risk Assessment (FMEA) through the Life Cycle of the Product Development

[v9991]

we know the FMEA (risk assessment) is continuously evolving..and is a live document.

can somebody share the document-reference/example of it during various stages of product development
viz., FMEA at feasibility/proto-type stage
FMEA at optimization/scale-up stage
FMEA at pre-commercialization or post commercialization stage.

I am confused &interested to get insights into kind of "failure modes" and "causes" considered at each of stages

thanks in advance,

[qusys]

In Reply to Parent Post by v9991

we know the FMEA (risk assessment) is continuously evolving..and is a live document.

can somebody share the document-reference/example of it during various stages of product development
viz., FMEA at feasibility/proto-type stage
FMEA at optimization/scale-up stage
FMEA at pre-commercialization or post commercialization stage.

I am confused &interested to get insights into kind of "failure modes" and "causes" considered at each of stages

thanks in advance,

I think this request is very difficult.
FMEA's are usually considered as intellectual property and they can be difficulty shared.

[yodon]

We don't create new FMEAs for each phase / stage in a product's life. We create FMEAs based on perspective (e.g., design FMEA, application / use FMEA, etc.) and then update as necessary throughout the product's life. So if, say, after initial design (and a design FMEA has been established), we find in integration testing that a new potential hazard exists or that severity is greater or whatever, we update the existing / applicable risk management documents.

[Marcelo Antunes]

we know the FMEA (risk assessment) is continuously evolving..and is a live document.

can somebody share the document-reference/example of it during various stages of product development
viz., FMEA at feasibility/proto-type stage
FMEA at optimization/scale-up stage
FMEA at pre-commercialization or post commercialization stage.

I am confused &interested to get insights into kind of "failure modes" and "causes" considered at each of stages

thanks in advance,

Maybe you are having trouble because you really need to use different techniques if you want to perform risk management thru the product lifecycle (as required by ISO 14971).

An example of different techniques in different steps/cycles is in this post - http://elsmar.com/Forums/showpost.ph...0&postcount=12

[v9991]

true, you are spot on...
what we are trying to do is, to establish a process of risk assessment by using the tool of FMEA; and we are having problems in propagating the definition of failure modes at various stages of development!!!

that is the background of my request for examples of design fmea and process fmea.

once again thank in advance if someone could be able to share the generic/non-infringing examples of same.

[v9991]

I will try to rephrase the query... or my dilemma...

what are the challenges(bottle-necks) of implementing a single tool (viz., FMEA) across the product development life cycle...?
are there any (dis)advantages...?

one argument against FMEA is that ...it requires many details (at initial stages of prod.dev..not all clarity/details are available). Now the argument can be flip both sides.
1) since you have nothing concrete/certain, pick up a tool which provides structured analysis of product at hand.(and gives you opportunity to record/assess the known & uncertain risks )
OR
2) since you have nothing concrete/certain,.. pick up a tool which simply-represents your available-uncertainty/risks (thought...at a very high level.)