I hate Risk Management. There, I said it. And I am not the only one actually. Many of us are thinking that the Risk management is terrible!
Please note that Risk Management is integral part of medical device and nobody can do away with this, so it needs t be embraced. With feeling of hate it will be difficult to implement this process with true potential. This system, no doubt is slightly complex and requires some training and in-depth knowledge for its application. Once done then life becomes easy.
It is confusing and lengthy to induce through. you have got no real idea if you’ve covered everything or if you would like to stay going further. And once you get into probabilities and severities, it seems like you are just guessing. Though this is true but once mind change happens and you start using the same you learn a lot. Couple of guideline documents are available. ISO standard 14971-2019 is latest standard on this which also describes a lot about what is risk assessment.
Once understood and applied it gives you in-depth understanding of your product and risk associated with it. Once you know risk, you very well know to what level you can mitigate it.
Please note that Risk management is associated with various tools like FMEA and one misunderstand that as main risk assessment and start getting different feeling.
That is because I want to be during a mindset that risk management meant FMEA which I had to try to it all alone first, before we met as a team to review and discuss. And it appeared to be a never-ending argument as against a true discussion.
Now, I enjoy risk management and that I like helping convert others to a replacement way of thinking about risk.
Want to enjoy risk management too? Here are following things stop doing today.
1. Stop using FMEAS. It is one of the tools and not risk management itself.
2. Stop Thinking that Risk must be made zero to put medical device into market. Risk will always be there, and risk benefit analysis is important. Benefit must be higher than risk otherwise the very purpose is defeated.
3. Stop thinking about risk so late in the project. If done so you may have to go back to correct.
4. Stop assigning probabilities to events. This is greatest mistake people do. Take for example air accident on mid air and aircraft falls all die so it is not like car accident on road. However, probability of occurring car accident is high while that of air is very very low that is why many of us travel in air without fear. Same is car accident where probability of accident is high, but severity is not like certain death like air accident. That is why we use road vehicles also.

In fact, we always do risk assessment unknowingly and unorganised manner in most of our day-to-day steps. E.g., If there is a forecast of heavy storm, we would avoid going out while if there is medical emergency then we will go out for medical help even when storm is on. Our decision is based on risk assessment but as part of daily routine.
So, risk assessment is not new just do it in organised manner with documentation.