Failure Modes and Effects Analysis (FMEA)

Failure Mode and Effects Analysis (FMEA) is a structured approach to discovering potential failures that may exist within the design of a product or process.

Failure modes are the ways in which a process can fail. Effects are the ways that these failures can lead to waste, defects or harmful outcomes for the customer. Failure Mode and Effects Analysis is designed to identify, prioritize and limit these failure modes.

FMEA is not a substitute for good engineering. Rather, it enhances good engineering by applying the knowledge and experience of a Cross Functional Team (CFT) to review the design progress of a product or process by assessing its risk of failure.

There are two broad categories of FMEA, Design FMEA (DFMEA) and Process FMEA (PFMEA).

Design FMEA (DFMEA) explores the possibility of product malfunctions, reduced product life, and safety and regulatory concerns derived from:

●       Material Properties

●       Geometry

●       Tolerances

●       Interfaces with other components and/or systems

●       Engineering Noise: environments, user profile, degradation, systems interactions

Process FMEA (PFMEA) discovers failure that impacts product quality, reduced reliability of the process, customer dissatisfaction, and safety or environmental hazards derived from:

●       Human Factors

●       Methods followed while processing

●       Materials used

●       Machines utilized

●       Measurement systems impact on acceptance

●       Environment Factors on process performance