Failure Mode and Effects Analysis

E555154

Failure Mode and Effects Analysis is a systematic, proactive method for identifying potential failures in a process, product, or system and evaluating their causes and effects to prioritize and mitigate risk.

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Statements (77)

Predicate Object
instanceOf engineering methodology
quality management tool
reliability analysis technique
risk analysis method
abbreviation FMEA
FMECA NERFINISHED
RPN
alsoKnownAs Failure Mode, Effects and Criticality Analysis
Failure Modes and Effects Analysis
appliesTo processes
products
systems
calculates Risk Priority Number
commonlyUsedIn aerospace industry
automotive industry
chemical process industry
electronics industry
manufacturing industry
medical device industry
extendsTo Failure Mode, Effects and Criticality Analysis
hasPurpose evaluate effects of failures
identify potential failure modes
improve quality
improve reliability
improve safety
mitigate risk
prioritize risks
hasVariant Design FMEA
FMECA NERFINISHED
Process FMEA NERFINISHED
Service FMEA NERFINISHED
System FMEA
includesStep assess current controls
calculate risk priority numbers
define and implement actions
define scope and boundaries
determine causes of each failure mode
determine effects of each failure mode
identify functions and requirements
identify potential failure modes
prioritize failure modes
rate severity occurrence and detection
reassess risk after actions
isApproachType bottom-up
proactive
systematic
keyConcept Risk Priority Number
detection
failure cause
failure effect
failure mode
occurrence
severity
originatedIn aerospace industry
military applications
relatedTo Fault Tree Analysis NERFINISHED
Hazard Analysis and Critical Control Points NERFINISHED
Hazard and Operability Study NERFINISHED
root cause analysis
requires multidisciplinary team
RPNFormula RPN = Severity × Occurrence × Detection
standardizedIn MIL-STD-1629A NERFINISHED
supports continuous improvement
design for reliability
design for safety
preventive quality planning
usedFor documentation of potential failures
early identification of risk
maintenance planning
process development
product development
regulatory compliance
usedInStandard AIAG FMEA Handbook NERFINISHED
IATF 16949 NERFINISHED
IEC 60812 NERFINISHED
ISO 14971 NERFINISHED
SAE J1739 NERFINISHED

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ICH Q9 Quality Risk Management mentionsTool Failure Mode and Effects Analysis