FMEA - Failure Modes and Effects Analysis

FMEA is a structured approach to

• identifying the ways in which a product or process can fail
• estimating the risk of specific causes with regard to these failures
• prioritizing the actions that should be taken to reduce the chanceof failure
• evaluating the design validation plan (Product) or the currentcontrol plan (Process) for preventing these failures from occurring

Purpose

• identify potential failure modes and rate the severity of their effects
• to rank order potential deficiencies
• to help focus on prevention