Risk analysis can be a pain – one way to reduce this pain is by using ISO 14971 risk management for medical devices

You may recall I mentioned the terms Hazard and Harm in my last post.

These are terms from the risk management standard ISO 14971 and can help explain why there are things You need not be concerned about.

Many companies by default choose FMEA as their tool for risk analysis, but there are many other ways to do a risk analysis.

There are many good things to say about FMEA but on thing that strikes me is that quite often it grows extensively large. Everyone in the team is eager to bring something to the table, everyone is worried that some possible event is not considered and therefore the list of possible perils seems to be endless.

This is very good since You will cover (almost) any risk, but at the same time You introduce a risk that something important “drowns” in all the other input.

Wouldn’t it be nice to reduce this amount of possible event to relatively few but significant issues?

ISO 14971 may very well be a way to do just that.

First of all because ISO14971 investigates the actual damage that can happen FMEA looks all the possible ways that some event could lead to a possibility that something might happen but not so dangerous after all……

In FMEA terms: With this failure the user gets slightly hurt. It has a low severity, is easy to detect, and with a low occurrence. We have all seen this on the FMEA list, we have all spent time discussing if the severity was 1 or 2 or something in between, when we all knew it was not important at all.

The ISO 14971 approach is the other way around; “Can my product harm the user?” If it can, then ask yourself how and if it is a likely event at all. If chances are slim (the risk is low) then You may not need to spend so much time to mitigate just that risk and You can focus on more important issues.

This is where the terms Harm and Hazard comes in.

The Harm is what actually can happen to the user (or bystander). E.g.: Her leg disappears.

The Hazard is what can cause this kind of harm. E.g.: A great white Shark

And then You ask yourself – “but are there any sharks in these waters?”

Even though there is a hazard, no harm will come if there is no hazardous situation. E.g. She is swimming in the North Sea where there are no great white sharks.

There is only a significant risk if the is a probability that a hazard occurs in a situation where it will cause harm.

In these dire times it can be translated to:

The Hazard is COVID,

but it can only cause Harm (illness)

if the Hazardous situation (being close to an infected person) occurs.

For more information please contact EpsilonPlus here.

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