FMEA cycle.


Health care Failure Mode & Effect Analysis (HFMEA) - A prospective assessment that identifies and improves steps in a process thereby reasonably ensuring a safe and clinically desirable outcome. A systematic approach to identify and prevent product and process problems before they occur. [1] A failure modes and effects analysis (FMEA) is a procedure for analysis of potential failure modes within a system for classification by severity or determination of the effect of failures on the system. It is widely used in manufacturing industries in various phases of the product life cycle and is now increasingly finding use in the service industry. Failure modes are any errors or defects in a process, design, or item, especially those that affect the customer, and can be potential or actual. Effects analysis refers to studying the consequences of those failures.

Basic terms[]

Failure mode: "The manner by which a failure is observed; it generally describes the way the failure occurs."
Failure effect: Immediate consequences of a failure on operation, function or functionality, or status of some item.
Indenture levels: An identifier for item complexity. Complexity increases as levels are closer to one.
Local effect: The Failure effect as it applies to the item under analysis.
Next higher level effect: The Failure effect as it applies at the next higher indenture level.
End effect: The failure effect at the highest indenture level or total system.
Failure cause: Defects in design, process, quality, or part application, which are the underlying cause of the failure or which initiate a process which leads to failure.
Severity: "The consequences of a failure mode. Severity considers the worst potential consequence of a failure, determined by the degree of injury, property damage, or system damage that could ultimately occur."


  • Development of system requirements that minimize the likelihood of failures.
  • Development of methods to design and test systems to ensure that the failures have been eliminated.
  • Evaluation of the requirements of the customer to ensure that those do not give rise to potential failures.
  • Identification of certain design characteristics that contribute to failures, and minimize or eliminate those effects.
  • Tracking and managing potential risks in the design. This helps avoid the same failures in future projects.
  • Ensuring that any failure that could occur will not injure the customer or seriously impact a system.
  • To produce world class quality products


  • Improve the quality, reliability and safety of a product/process
  • Improve company image and competitiveness
  • Increase user satisfaction
  • Reduce system development timing and cost
  • Collect information to reduce future failures, capture engineering knowledge
  • Reduce the potential for warranty concerns
  • Early identification and elimination of potential failure modes
  • Emphasis problem prevention
  • Minimize late changes and associated cost
  • Catalyst for teamwork and idea exchange between functions
  • Reduce the possibility of same kind of failure in future

Types of FMEA[]

  • Process: analysis of manufacturing and assembly processes
  • Design: analysis of products prior to production
  • Concept: analysis of systems or subsystems in the early design concept stages
  • Equipment: analysis of machinery and equipment design before purchase
  • Service: analysis of service industry processes before they are released to impact the customer
  • System: analysis of the global system functions
  • Software: analysis of the software functions


  1. VA National Center. Safety Topics. access-date 2013.