FMEA Definition

An FMEA can be described as a systemized group of activities intended to:
a. recognize and evaluate the potential failure of a product/process and its
effects,
b. identify actions which could eliminate or reduce the chance of the
potential failure occurring, and
c. document the process. It is complementary to the process of defining
what a design or process must do to satisfy the customer.


FMEAs identify potential and confirm Critical and Significant
Characteristics to be addressed by design changes, process changes,
or inclusion in Process Control Plans.
FMEAs evaluate the adequacy of proposed controls and the need to
mitigate risk by changes to the Design Verification Plan or the
Manufacturing Control Plan. The intent of the evaluation and the
proposed actions is to prevent failures from reaching the customers,
improving customer satisfaction.