RISK ANALYSIS USING AN ENHANCED FMEA

Well after reading this article several questions will come to your mind such as :

Let us consider a general example:

My company has been asked to provide training for a medical device company on risk analysis (or risk management) and FMEA. We have on staff a medical device expert who knows risk analysis inside and out, and I have been asked to team with her and focus on the FMEA training.

My background in FMEA comes from years in automotive and aerospace companies. Of course, we'll be getting together to prepare for this, but I'd like some help from all of you cove-dwelling brainiacs to get me up to speed on the finer points of applying this to a medical device company.

In the reading that I've done recently, my impression is that FMEA and risk analysis are very similar. My questions are these:

What does risk analysis (or risk management) require over and above FMEA?Are there things in FMEA that are not normally part of risk analysis? Is FMEA commonly used in the medical device industry?

The answer to these questions after reading the article is:-

FMEA is a Risk Analysis tool. There are several tools that can be used by an organization to perform risk analysis, and the FMEA/FMECA may be the most widely used tool. Your experience with process in the Automotive industry should serve you well.

In the Medical Device industry, the two most broadly used tools for risk assessment are Hazards Analysis and FMEAs. Often times, I've heard it expressed that Hazards Analysis is a top-down approach at risk analysis while the FMEA/FMECA is a bottom-up approach. Either way, its about risk mitigation or how you plan to manage risk.

Design and Process FMEAs are the most widely used approaches in medical device as far as FMEAs go. However, I would do a Systems FMEA also. I can say that while they may have been used by many medical device manufacturers in the past, recent experience indicates a growing movement towards their inclusion into the Design and Design Transfer activities.

In my mind, FMEAs just make good sense no matter what industry you find yourself in. I would even go further to say that folks should be creative in how to apply this Risk Analysis tool. For example, if folks challenged the need to create a procedure/form using this tool, I think many folks out there would have far fewer docs to manage in their Doc Control activities.