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The TheFMEA FMEAdiscipline disciplinewas wasdeveloped developedin inthe theUnited UnitedStates States
Military Militaryin in1949 1949(Military (MilitaryProcedure ProcedureMIL-P-1629, MIL-P-1629,titled titled Procedures Proceduresfor forPerforming Performinga aFailure FailureMode, Mode,Effects Effectsand and Criticality CriticalityAnalysis. Analysis.
The Thefirst firstformal formalapplication applicationof ofFMEA FMEAdiscipline disciplinewas wasused usedin in
aerospace aerospacein inmid mid60s. 60s. It Itwas wasused usedas asa areliability reliabilityevaluation evaluationtechnique techniqueto todetermine determine the theeffect effectof ofsystem systemand andequipment equipmentfailures. failures.Failures Failureswere were classified classifiedaccording accordingto totheir theirimpact impacton onmission missionsuccess successand and personnel/equipment personnel/equipmentsafety. safety.
What is FMEA?
A Astructured structuredapproach approachto to Identify Identify the the way way in in which which a a design design // process process can can fail fail to to meet meet critical critical customer customerrequirements. requirements. Estimating Estimatingthe therisk riskof ofspecific specificcauses causeswith withregard regardto tothe thefailures. failures. Evaluating Evaluatingthe theCurrent Currentcontrol controlplan planfor forpreventing preventingthe thefailures failuresfrom from occurring. occurring. Prioritizing Prioritizingthe theactions actionsthat thatshould shouldbe betaken takento toimprove improvethe thedesign/ design/ process. process.
FMEA FMEAis isvery verybeneficial beneficialto toconduct conductwhile whiledesigning designinga aproduct productor or process. process. Design DesignFMEA FMEAshould shouldbe bedone doneduring duringinitial initialdesign designof ofthe theproduct. product. Process ProcessFMEA FMEAshould shouldbe bedone doneduring duringdesign designof ofmanufacturing manufacturing process. process. Process ProcessFMEA FMEAcan canbe beperformed performedfor forlegacy legacyproducts productsand andprocesses processes also alsoififthe theprocess processcarry carryhigh highrisks risksto toproduct productquality, quality,customer, customer,safety, safety, etc. etc.
Design FMEA An analytical technique used primarily by design responsible engineer/Team to assure potential failure modes; causes and effects have been addressed for design related characteristics.
Process FMEA An analytical technique used primarily by manufacturing responsible engineer/Team to assure potential failure modes; causes and effects have been addressed for process related characteristics.
Definitions
Criticality
Severity
Severity is an assessment of how serious the Effect of the potential Failure Mode is on the Customer. The Criticality rating is the mathematical product of the Severity and Occurrence ratings. Criticality = (S) X (O). This number is used to place priority on items that require additional quality planning.
Critical Characteristics
Critical Characteristics are Special Characteristics defined by organization that affect customer safety and/or could result in noncompliance with government regulations and thus require special controls to ensure 100% compliance.
Occurrence
Occurrence is an assessment of the likelihood that a particular Cause will happen and result in the Failure Mode during the intended life and use of the product.
Detection
Detection is an assessment of the likelihood that the Current Controls (design and process) will detect the Cause of the Failure Mode or the Failure Mode itself, thus preventing it from reaching the Customer.
Definitions
Current Controls
FMEA Element Function
A Function could be any intended purpose of a product or process. FMEA functions are best described in verb-noun format with engineering specifications. FMEA elements are identified or analyzed in the FMEA process. Common examples are Functions, Failure Modes, Causes, Effects, Controls, and Actions. FMEA elements appear as column headings in the output form. Current Controls (design and process) are the mechanisms that prevent the Cause of the Failure Mode from occurring, or which detect the failure before it reaches the Customer.
Failure Mode
Failure Modes are sometimes described as categories of failure. A potential Failure Mode describes the way in which a product or process could fail to perform its desired function (design intent or performance requirements) as described by the needs, wants, and expectations of the internal and external Customers.
Cause
A Cause is the means by which a particular element of the design or process results in a Failure Mode.
Effect
An Effect is an adverse consequence that the Customer might experience. The Customer could be the next operation, subsequent operations, or the end user.
Customer
Customers are internal and external departments, people, and processes that will be adversely affected by product failure.