Failure Mode and Effects Analysis

HFEMA infusion pump example

About

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.

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."

Uses of FMEA

• 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

Advantages

These are some examples of its benefits:

• 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
• Emphasize 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