Introduction to FMEA

The Failure Mode and Effects Analysis (FMEA) is a proactive, systematic and structured technique used to identify, assess and prevent system, process or product failures before they occur. FMEA, also known as Failure Modes, Effects and Criticality Analysis (FMECA), was introduced in the late 1940s by the United States military as a reliability evaluation technique to examine the potential effects of military equipment failures. Since 1960s FMEA has been increasingly used in aerospace, nuclear, chemical, automotive, and other industries. Properly executed FMEA:

  • Identifies the ways in which a new or redesigned system, product or process can fail
  • Defines preventive and corrective actions to eliminate or reduce failures and defects
  • Reduces the likelihood that a failure mode and defect will occur
  • Improves the detection of failures and defects
  • Provides input into the design and testing requirements
  • Develops control plans and eliminates unsafe conditions that may result from a failure
  • Evaluates existing control measures for preventing failures and human errors
  • Sets risk management priorities and identifies opportunities for improvement
  • Reduces costs and shortens product development times
  • Reduces risks when an existing product is used in new applications
  • Improves reliability and overall performance of systems, products and processes
  • Documents the rationale behind various design changes
  • Improves safety and drives continuous quality improvement

The widespread use of FMEA in the healthcare sector was triggered in 2001 by the US Joint Commission on Accreditation of Healthcare Organizations (JCAHO). To further enhance patient safety, the JCAHO required its accredited hospitals to perform a proactive risk assessment such as FMEA on an annual basis. FMEA offers the apparent advantage over Root Cause Analysis (RCA) by preventing failures proactively rather than reacting to adverse events after failures have happened. FMEA helps keep the failure from reaching the patient, provides greater understanding of hazards in the system of care, makes failures more visible, and enables identification of human errors without the fear of litigation or emotional burden often associated with the actual adverse events. There are several different types of FMEA. Although the main purpose, assessment criteria and other details may vary, the basic approach and intended outcomes remain essentially the same.


Types of FMEA