How to Publish/Convince Stake Holders about need/utility of Risk Management Systems

v9991

Trusted Information Resource
#1
we have started implementation of risk management system...(FMEA as primary tool) and we are quite in evolving stages. the reason i say that ''évolving stages'' is that, we get to updating/documenting the risk assessment (FMEA) at the end of stages. (i.e., before manufacturing)...ideally it must be done pro-actively...(design/development to flow from FMEA to address the potential failure modes / causes)!!!

but more frequently (wittingly and seriously) we get the question of
has FMEA made any difference to product - process?

typically, regulatory industries undertake any system (especially in development) ...only if its mandated by authorities (submission requirement) and moreover ..even if it was otherwise,, the above question is legitimate...

how to answer that question;....where to start....how to establish and demonstrate the real value...
 
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v9991

Trusted Information Resource
#2
Re: how do you publish/convince stake holders about need/utility of risk managment sy

given the scenario...
"the reason i say that ''évolving stages'' is that, we get to updating/documenting the risk assessment (FMEA) at the end of stages. (i.e., before manufacturing)...ideally it must be done pro-actively...(design/development to flow from FMEA to address the potential failure modes / causes)!!!"
i have set myself two targets...
1) current & immediate set of products coming up for review ... FOCUS ON reflecting the open issues are brought forward through FMEA (of course , closed action points need also to be captured.)

2) all other project take up for review, NOW, upfront, pro-actively, such that all experimentation carried out are in support of failure modes/causes identified in risk assessment.

hope to hear your comments and corrections...

also request your thoughts & experiences on how you did handle the situation...or your recommendations..
 

sagai

Quite Involved in Discussions
#3
Re: How to Publish/Convince Stake Holders about need/utility of Risk Managment System

Forgive me for asking questions first.
Why do you think this FMEA kind of thing is needed for your company?
Does your boss see any value in this FMEA thing?
Cheers!
 

v9991

Trusted Information Resource
#4
Re: How to Publish/Convince Stake Holders about need/utility of Risk Management Syste

in the process of upgrading the system to embrace "Quality by Design" "ICH Q8" philosophy of product development, risk assessment is one of the tool/system which is implemented. (FMEA is one such tool implemented as part of risk assessment)

apart from that, the role of risk assessment in the product development is to structure the priorities of development targets and also reflect the extent&success of development efforts.

of course, boss has the buy in of the risk assessment (tool FMEA !!!)
 
A

amit_rd

#5
Re: How to Publish/Convince Stake Holders about need/utility of Risk Management Syste

As they say "seeing is believing" - The only way to convince people for the tool is by showing them the benefits.

People generally jump into conducting FMEA without having the basics clear

I recommend:

Trained moderators to be appointed - unbiased and open minded
Let people criticize the tool, just request them to experiment and ensure they see results after FMEA workshop
Train the moderator on basics of product design and development - for example - Design for manufacturing, design for assembly, difference between verification and validation and related technical jargons - special training required for asking stupid questions - politely without feeling embarrassment - These questions yield the best results in FMEAs

Last but not least – Please don't leave the world "evolve" - Its the real meaning of FMEA :)
 

Chennaiite

Never-say-die
Trusted Information Resource
#6
Re: How to Publish/Convince Stake Holders about need/utility of Risk Management Syste

but more frequently (wittingly and seriously) we get the question of
has FMEA made any difference to product - process?
IMO, FMEA is worth if it is seen and applied as an activity to manage risk in the product or process. Anyother tool for that matter makes difference if the objective is understood not just by words but in spirit. FMEA often fails in my experience because of getting too much bookish. Thats easy said than done.

If you like to demonstrate on paper, I suggest you to pick some field failures and understand how many of those products/process have FMEA in the first place and even if there is one, how many managed to address the failures atleast and then the causes. I am not trying to say all failures were supposed to find a place in FMEA, but the proportion really matters.
 

Reluctance

Involved In Discussions
#7
Re: How to Publish/Convince Stake Holders about need/utility of Risk Management Syste

If you like to demonstrate on paper, I suggest you to pick some field failures and understand how many of those products/process have FMEA in the first place and even if there is one, how many managed to address the failures atleast and then the causes. I am not trying to say all failures were supposed to find a place in FMEA, but the proportion really matters.
I agree with Chennaiite. Our company faced similar skepticism to the effectiveness and use of FMEA for design and process.

The acceptance level in our facility increased somewhat when I was able to use existing design changes or process improvements and mold them to fit the FMEA model. The only difference between them was the existing actions taken were reactionary. Using the FMEA turns that around to a more proactive approach.

It may help to look at some recent defects and how much it cost the company to react instead of prevent the defects. Then look at what it would cost to implement some of the proposed action items from your FMEA. Turning the FMEA actions into money saved versus potential money lost later often helps convert those people that do not see the value.
 
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