FMEA Basics - Failure Mode and Effects Analysis

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FMEA Basics - Failure Mode and Effects Analysis

Neural Blog, 29th Aug 2006

FMEA Basics, FMECA Books, FMEA Information
FMEA Basics - Failure Mode and Effects Analysis
FMEA Basics - Failure Mode and Effects Analysis
FMEA Basics, FMECA Books, FMEA Information

FMEA Basics - Failure Mode and Effects Analysis

Software for FMEA and FMECA

FMEA and FMECA Analysis

FMEA and FMECA Failure Mode and Effects Criticality Analysis is a systematic approach that identifies potential failure modes in a system, product, or manufacturing / assembly

FMEA Basics - Failure Mode and Effects Analysis

The FMEA Failure Mode and Effects Analysis process is a systematic approach that identifies potential failure modes in a system, product, or manufacturing / assembly operation caused by either design or manufacturing / assembly process deficiencies.

The methodology contained within FMEA Analysis allows you to quickly and easily analyze the potential failure modes of your system and the resulting effects of those failures.

It also identifies critical or significant design or process characteristics that require special controls to prevent or detect failure modes. The FMEA process or analysis is used as a method for identifying problems and preventing them from occurring. In addition, the Food and Drug Administration (FDA) has recognized FMEA as a design verification method for Drugs and Medical Devices.(21 CFR 820)

FMEA Facilitation Services

Facilitation of Quality disciplines such as FMEA can greatly reduce the overall time necessary to capture information necessary to assess the risk of each design feature failure mode and/or process step failure mode. Once risk has been determined, an action may be necessary to reduce risk by preventing, or reducing its occurrence.

Benefits of FMEA

Improves the quality, reliability, and safety of products / services / machinery and processes
Improves company image and competitiveness
Increases customer satisfaction
Reduces product development timing and cost / support integrated product development
Documents and tracks action taken to reduce risk
Reduces potential for Warranty concerns
Integrates with Design for Manufacturing & Assy. techniques

Applications for FMEA

FMEA Process - analyze manufacturing and assembly processes.
FMEA Design - analyze products before they are released for production.
FMEA Concept - analyze systems or subsystems in the early design concept stages.
FMEA Equipment - analyze machinery and equipment design before they are purchased.
FMEA Service - analyze service industry processes before they are released to impact the customer.

FMEA and FMECA Fualt Tree / Event Tree Analysis

Widely used in system reliability and safety studies, fault tree analysis offers the ability to focus on an event of importance, such as a highly critical safety issue, and work to minimize its occurrence or consequence.

Fault tree analyses are performed using a top-down approach. Starting with a top-level event, fault tree analysis is performed by working down to evaluate all the contributing events that may ultimately lead to the occurrence of the top-level event. The resulting fault tree diagram is a graphical representation of the chain of events in your system or process, built using events and logical gate configurations. The probability of the top-level event can then be determined by using mathematical techniques.

Human Factor FMEA and FMECA Risk Analysis

Human errors account for an alarming rate of failures throughout a broad range of industries worldwide. With high failure rates and the fact that the results of human error can result in enormously costly failures, including the loss of life, the need for human error analysis and safety assessment is crucial. Methodologies for analyzing human error have been developed and adopted in several industries, with NASA being a leader in this effort. There are a few software tools based on the NASA adopted methodology to aid in the analysis of human error and corresponding risk assessment. The resulting Human Factors Risk Analysis provides a comprehensive, systematic, and streamlined approach to addressing these critical issues.



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