3. Warning - Limitations

Although widely used, it would be totally inaccurate to claim that FMECA is a universal tool. Let's look at some of the method's limitations:

• the quality of a FMEA depends entirely on the quality of the studies carried out upstream, and in particular the functional analysis. It also depends on the quality of communication within the working group;

• As a matter of principle, failure mode analysis tends towards exhaustiveness, which is why it is important to specify the limits of the study;

• the method is admittedly somewhat cumbersome, both in terms of the volume of documentation required and the time spent on analysis (a day's analysis is required for a device comprising between 10 and 15 components and/or organs);

• In all cases, it is best to...