Medical Device Risk Analysis - FMEA vs ALARP (As Low As Reasonably Possible)

J

Jerome

#1
Hello to you all,

I'm working at a company that makes Class IIa medical devices. By the Medical Device Directive we are obliged to do a Risk analysis of each product (classified as MD). I've been hired (since a short period) to improve the technical documentation and while doing so I found out that FMEA is widely recognized. :read:
Though my colleague did some earlier work using the ALARP (as low as reasonably possible) principe. He likes that way and wants to stick to it.
I'm not yet that convinced and haven't got that much experience (yet) in this area.
Since 1. I'm fairly new to this form of risk analysis and 2. I'm the 'new' guy at work, and nobody likes the new guy to tell you how to do your work (stubburn old colleague), I was wordering if anybody has experience with changing from ALARP or even using ALARP. I like to make a good case defending FMEA in my next duscussion ( :argue: ) or maybe even merging both FMEA and ALARP.

Who can help me out here :truce:

Kind regards :thanx: ,

Jerome
 
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Jim Wynne

Staff member
Admin
#2
I don't think ALARP (As Low As Reasonably Practicable) is a technique as much as it is a concept; the goal of FMEA is to evaluate risk and reduce it in ALARP fashion. So it becomes a question as to how one arrives at the conclusion that risk has been reduced to its lowest practical level, and in my mind the FMEA process is a good starting point. So it's not an either/or question. Here's a good general overview of the ALARP concept: Wikipedia: ALARP
 

Caster

An Early Cover
Trusted Information Resource
#3
Ilike Alarp

JSW05 said:
Here's a good general overview of the ALARP concept: Wikipedia: ALARP
I love the Cove, 'cause I always learn new things...I never heard of ALARP before now.

One of the links says:


ALARP (As Low As Reasonably Practicable)


The two key levels seem to lie around road death statistics and the chances of being struck by lightning.

In simple terms, it seems that if we believe something is more dangerous than driving a car then the risk is unacceptable (about one chance in 10,000 per year), but if it is about as likely as being struck by lightning (about one chance in 10 million per year), then it is probably so low that we don't expect anyone to do anything about it.

In the range between these two figures cost benefit studies to reduce the risk to As Low As Reasonably Practicable (ALARP) is appropriate.

I find it interesting how poorly people perceive risk. People will seek shelter during a thunderstorm on a golf course, yet have not a care in the world getting in their car to drive home.

Shouldn’t we be 1,000 times more afraid to drive than to stand in a thunderstorm?



And dare I say it, why am I so afraid of becoming a victim of a terrorist attack sitting here with a cigarette in my hand?


I think a lot of interesting work has been done showing that the perception of control influences how we feel about risk. I am driving my car, but someone else is piloting the airplane and I am not in control, thus it seems much riskier.
 

Jim Wynne

Staff member
Admin
#4
Caster said:
I find it interesting how poorly people perceive risk. People will seek shelter during a thunderstorm on a golf course, yet have not a care in the world getting in their car to drive home.

Shouldn’t we be 1,000 times more afraid to drive than to stand in a thunderstorm?
You're much more likely than the general population to be struck by lightening if you stand in the middle of a fairway in a thunderstorm holding a putter over your head. By the same token, if you lie down in the middle of a busy street, you're more likely to be struck by a car than someone who is sitting nearby in a gin mill drinking beer and smoking a big nasty cigar. That doesn't mean that the latter behavior is more healthful in terms of the general population, though.
 
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