FMEA is a systematic, bottom-up, inductive method for identifying potential failure modes in a system, product, or process. For each failure mode, it assesses the potential effects or consequences, their severity, likelihood of occurrence, and the ability to detect them. The goal is to prioritize and mitigate high-risk failure modes before they occur.
Analisi delle modalità e degli effetti dei guasti (FMEA)
FMEA is one of the first structured reliability analysis techniques. It involves a cross-functional team brainstorming all conceivable ways a component or process step could fail (the failure modes). For each mode, the team identifies the potential effects on the system, the customer, or the environment. Three factors are then typically rated on a scale (e.g., 1 to 10): Severity (S) of the effect, Occurrence (O) likelihood of the cause, and Detection (D) probability of finding the failure before it reaches the customer.
These three scores are multiplied to calculate a Risk Priority Number (RPN), where [latex]RPN = S \times O \times D[/latex]. A high RPN indicates a high-risk failure mode that requires immediate attention. The team then develops and implements corrective actions to reduce the RPN, typically by improving the design to lower the Occurrence or by adding controls to improve Detection.
A key variant is the Failure Mode, Effects, and Criticality Analysis (FMECA), which extends FMEA by including a quantitative criticality analysis based on the probability of the failure mode and the severity of its consequences. FMEA is a living document, continuously updated as designs change, new data becomes available, or processes are improved.
Tipo
Disruption
Utilizzo
Precursors
- u.s. military’s need for improved reliability of munitions in the 1940s
- early quality control techniques from Shewhart and Deming
- brainstorming techniques
- root cause analysis methods
Applicazioni
- automotive industry for design and manufacturing process improvement (sae j1739)
- aerospace design to prevent catastrophic failures
- dispositivo medico development to ensure patient safety
- food industry to identify and control potential hazards (haccp)
Brevetti:
Potential Innovations Ideas
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Integrazione di componenti elettronici in plastica e metallo, progettazione in base ai costi, GMP, ergonomia, dispositivi e materiali di consumo di medio-alto volume, settori regolamentati, CE e FDA, CAD, Solidworks, Lean Sigma Black Belt, ISO 13485 in ambito medico
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Analisi delle modalità e degli effetti dei guasti (FMEA)
(if date is unknown or not relevant, e.g. "fluid mechanics", a rounded estimation of its notable emergence is provided)
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