ABSTRACT
Failure mode effects and analysis (FMEA) is not a new concept. It is a well-worn tool commonly used during new product introduction to prepare control plans for potential product and process failures. This chapter will discuss the history of FMEA, starting as a military document for use in weaponry system designs, to the latest industry application in health care. Different historical perspectives on the process and its intentions will also be discussed. This will include controversial aspects, such as the distinction between risk assessment and criticality analysis, the difficulty of team-based completion, and common problems encountered while doing risk assessment. How this helps toward the completion of FMEA for social responsibility will conclude the chapter.
