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

v9991

Trusted Information Resource
#1
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 :frust: &interested :read: to get insights into kind of "failure modes" and "causes" considered at each of stages

thanks in advance,
 
Elsmar Forum Sponsor

qusys

Trusted Information Resource
#2
Re: Examples of Risk Assessment (FMEA) through the Life Cycle of the Product Developm

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 :frust: &interested :read: 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.:bigwave:
 

yodon

Staff member
Super Moderator
#3
Re: Examples of Risk Assessment (FMEA) through the Life Cycle of the Product Developm

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

Inactive Registered Visitor
#4
Re: Examples of Risk Assessment (FMEA) through the Life Cycle of the Product Developm

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.php?p=346920&postcount=12
 

v9991

Trusted Information Resource
#5
Re: Examples of Risk Assessment (FMEA) through the Life Cycle of the Product Developm

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

Trusted Information Resource
#6
Re: Examples of Risk Assessment (FMEA) through the Life Cycle of the Product Developm

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.)
 

Avraham Harris

Involved In Discussions
#7
Re: Examples of Risk Assessment (FMEA) through the Life Cycle of the Product Developm

Though this is an old post.......
perhaps this would be helpful to some.

What I do at early stages of a project, as well as later stages, is to use a risk matrix scoring method combined with an FMECA-like table to record, per row, each identified hazardous situations leading to hazard, leading to harm. Then I score simply based on severity of harm and its probability of occurrence. They are not multiplied, nor is detection directly figured in. Therefore it is not FMECA.
Instead Risk matrices are created as follows: one for performing risk evaluation - i.e., determining a "risk level". The second is for determining "acceptability".
For compliance with the content deviations in the Z annexes of EN ISO 14971:2012 one could define acceptable as any case where there is no residual risk, and use the second matrix to define what is and what is not considered residual risk. For example: one may decide that if the initial risk was in the "negligible zone" and risk control reduced the probability, then the post-mitigation risk is considered as non-existent and therefore not defined as residual risk.
This is only one suggestion. A template of the risk matrices, and overall risk analysis report is attached. I hope it is useful.
Please note : this has been used with General class IVDs and has not been reviewed by any NB. Use at your own risk!
all the best,
Avraham
 

Attachments

W

wrodnigg

#8
Re: Examples of Risk Assessment (FMEA) through the Life Cycle of the Product Developm

My suggestion is to KISS (keep it simple, stupid).

Instead of a FMEA ist is often more useful to make an Ishikawa analysis (for each life cycle phase).

And most of the "FMEA" I have seen during the last ten years were just brainstorming filled "FMEA tables" (FMEA without FMEA).
 

Avraham Harris

Involved In Discussions
#9
Re: Examples of Risk Assessment (FMEA) through the Life Cycle of the Product Developm

Wrodnigg,
thank you for this suggestion.
Can you elaborate on possible practice:
1) are the factors / hazards listed repeated at each lifecycle stage with additions or deletions made, but the same basic template, or is it a completely new analysis ignoring the previous stages diagram?
2) how do you use this to perform risk evaluation and estimation? i.e., do you calculate risk using the diagram or a separate method?

thanks,
Avraham
 

Jim Wynne

Staff member
Admin
#10
Re: Examples of Risk Assessment (FMEA) through the Life Cycle of the Product Developm

Wrodnigg,
thank you for this suggestion.
Can you elaborate on possible practice:
1) are the factors / hazards listed repeated at each lifecycle stage with additions or deletions made, but the same basic template, or is it a completely new analysis ignoring the previous stages diagram?
You should consider each stage independently of the previous stages. Concentrate on the unique risks for each stage. Presumably, previous stages have been evaluated already, including risks that might be passed on to subsequent stages.

2) how do you use this to perform risk evaluation and estimation? i.e., do you calculate risk using the diagram or a separate method?
Unless you have actual data to aid in estimating risks, there might be no calculations that can be done. Sometimes you have to use a best guess, which can perhaps be adjusted later when there is actual data.
 
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