Nine reasons why FMEA is difficult

Lack of management support – People sense this in spite of what management might say and the result is less participation.

Low interest level – My experience with engineers is that they like to design things. Meetings to challenge the design do not command their attention. Maybe things are different in labs.

Poor facilitator – FMEA meetings require a leader. If the leadership is poor, the results will suffer.

Wrong level of granularity – The level of detail in examining process steps could either be not detailed enough or too detailed.

Process is challenged – The person who developed parts of the process may be in the FMEA meeting, which can create an adversarial situation.

The existing process is simply documented – but it is never challenged.

Meeting is too adversarial – A legitimate challenge to the process can become adversarial.

The FMEA process is seen as being imposed from outside of the department (which often is true).

Good results are uninspiring – To say, “You know that event that could kill patients that has never happened? We’ve just changed our process to make that event even less likely.” Not a very compelling thing for management to hear.

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