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Risk Priority Number : ウィキペディア英語版
Failure mode and effects analysis
Failure mode and effects analysis (FMEA)—also "failure modes," plural, in many publications—was one of the first systematic techniques for failure analysis. It was developed by reliability engineers in the late 1950s to study problems that might arise from malfunctions of military systems. A FMEA is often the first step of a system reliability study. It involves reviewing as many components, assemblies, and subsystems as possible to identify failure modes, and their causes and effects. For each component, the failure modes and their resulting effects on the rest of the system are recorded in a specific FMEA worksheet. There are numerous variations of such worksheets. A FMEA can be a qualitative analysis,〔System Reliability Theory: Models, Statistical Methods, and Applications, Marvin Rausand & Arnljot Hoylan, Wiley Series in probability and statistics - second edition 2004, page 88〕 but may be put on a quantitative basis when mathematical failure rate models are combined with a statistical failure mode ratio database.
A few different types of FMEA analyses exist, such as
* Functional
* Design, and
* Process FMEA.
Sometimes FMEA is extended to FMECA to indicate that criticality analysis is performed too.
FMEA is an inductive reasoning (forward logic) single point of failure analysis and is a core task in reliability engineering, safety engineering and quality engineering. Quality engineering is specially concerned with the "Process" (Manufacturing and Assembly) type of FMEA.
A successful FMEA activity helps to identify potential failure modes based on experience with similar products and processes - or based on common physics of failure logic. It is widely used in development and manufacturing industries in various phases of the product life cycle. ''Effects analysis'' refers to studying the consequences of those failures on different system levels.
Functional analyses are needed as an input to determine correct failure modes, at all system levels, both for functional FMEA or Piece-Part (hardware) FMEA. A FMEA is used to structure Mitigation for Risk reduction based on either failure (mode) effect severity reduction or based on lowering the probability of failure or both. The FMEA is in principle a full inductive (forward logic) analysis, however the failure probability can only be estimated or reduced by understanding the ''failure mechanism''. Ideally this probability shall be lowered to "impossible to occur" by eliminating the ''(root) causes''. It is therefore important to include in the FMEA an appropriate depth of information on the causes of failure (deductive analysis).
== Introduction ==
The FME(C)A is a design tool used to systematically analyze postulated component failures and identify the resultant effects on system operations. The analysis is sometimes characterized as consisting of two sub-analyses, the first being the failure modes and effects analysis (FMEA), and the second, the criticality analysis (CA). Successful development of an FMEA requires that the analyst include all significant failure modes for each contributing element or part in the system. FMEAs can be performed at the system, subsystem, assembly, subassembly or part level. The FMECA should be a living document during development of a hardware design. It should be scheduled and completed concurrently with the design. If completed in a timely manner, the FMECA can help guide design decisions. The usefulness of the FMECA as a design tool and in the decision-making process is dependent on the effectiveness and timeliness with which design problems are identified. Timeliness is probably the most important consideration. In the extreme case, the FMECA would be of little value to the design decision process if the analysis is performed after the hardware is built. While the FMECA identifies all part failure modes, its primary benefit is the early identification of all critical and catastrophic subsystem or system failure modes so they can be eliminated or minimized through design modification at the earliest point in the development effort; therefore, the FMECA should be performed at the system level as soon as preliminary design information is available and extended to the lower levels as the detail design progresses.
Remark: For more complete scenario modelling another type of Reliability analysis may be considered, for example fault tree analysis(FTA); a ''deductive'' (backward logic) failure analysis that may handle multiple failures within the item and/or external to the item including maintenance and logistics. It starts at higher functional / system level. An FTA may use the basic failure mode FMEA records or an effect summary as one of its inputs (the basic events). Interface hazard analysis, Human error analysis and others may be added for completion in scenario modelling.

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