Failure Mode and Effects Analysis (FMEA)

Failure Mode and Effects Analysis (FMEA) is a structured risk assessment method used to identify how a product, process, system or service could fail, evaluate the potential effects of those failures, and determine actions to reduce the associated risks.

FMEA is a preventative approach, aiming to identify potential problems before they result in defects, safety incidents, customer complaints or operational disruption. It typically considers the potential failure mode, its effect, possible causes, existing controls and the level of risk associated with the failure.

Traditional FMEA methods assess factors such as the severity of the effect, the likelihood of occurrence, and the ability to detect the failure before it reaches the customer or causes harm. These assessments help organisations prioritise improvement and risk-reduction activities.

Common forms include Design FMEA (DFMEA), which considers risks associated with product or system design, and Process FMEA (PFMEA), which considers risks arising from manufacturing or operational processes.

FMEA is widely used in automotive, aerospace, manufacturing, engineering and quality management and can support risk-based thinking within management systems such as ISO 9001 and IATF 16949.