Download as pdf or txt
Download as pdf or txt
You are on page 1of 1

Applicability of FMEA

There are three basic cases for which FMEA process is to be applied, each with a different
scope or focus:

Case 1: New designs, new technology, or new process.


The scope of the FMEA is the complete design, technology, or process.

Case 2: Modifications to existing design or process.


The scope of the FMEA should focus on the modification to design or process, possible
interactions due to the modification, and field history. This can include changes in regulatory
requirements.

Case 3: Use of an existing design or process in a new environment, location, application, or


usage profile.
The scope of the FMEA should focus on the impact of the new environment, location, or
application usage on the existing design or process (including duty cycle, regulatory
requirements, etc.).

12

You might also like