3 What is FMEA
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What is FMEA (Failure Modes and Effects Analysis)? • Identify ways the product or process can fail • Plan how to prevent those failures How does FMEA work? • Identify potential failure modes and rate the severity of their defect • Evaluate objectively the probability of occurrence of causes and the ability to detect the cause when it occurs • Rank order potential product and process deficienci es • Focus on eliminating product and process concerns and help prevent problems from occurring Definition – FMEA • A structured approach to: • identifying the ways in which a process can fail to meet critical customer requirements • estimating the risk of specific causes with regard to these failures • evaluating the current control plan for preventing these failures from occurring • prioritizing the actions that should be taken to improve the process Concept: Identify ways the product or process can fail. Then plan to prevent those failures Purposes & Benefits of FMEA • Improves the quality, reliability, and safety of products. • Helps to increase customer satisfaction. • Reduces product development timing and cost. • Documents and tracks actions taken to reduce risk. Types of FMEA • System FMEA: is used to analyze systems and subsystems in the early concept and design stages. Focuses on potential failure modes associated with the functions of a system caused by design. • Design FMEA: is used to analyze products before they are released to production. • Process FMEA: is used to analyze manufacturing, assembly and transactional processes. When will an FMEA start?
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What is FMEA (Failure Modes and Effects Analysis)?• Identify ways the product or process can fail• Plan how to prevent those failures
How does FMEA work?
• Identify potential failure modes and rate the severity of their defect• Evaluate objectively the probability of occurrence of causes and the
ability to detect the cause when it occurs
• Rank order potential product and process deficiencies• Focus on eliminating product and process concerns and help prevent
problems from occurring
Definition – FMEA• A structured approach to:
• identifying the ways in which a process can fail to meet criticalcustomer requirements
• estimating the risk of specific causes with regard to these failures
• evaluating the current control plan for preventing these failures from occurring
• prioritizing the actions that should be taken to improve the process
Concept: Identify ways the product or process can fail. Then plan to prevent those failures
Purposes & Benefits of FMEA • Improves the quality, reliability, and safety of products.• Helps to increase customer satisfaction.• Reduces product development timing and cost.• Documents and tracks actions taken to reduce risk.
Types of FMEA• System FMEA: is used to analyze systems and subsystems in the
early concept and design stages Focuses on potential failure modes
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• When new systems, products, and processes are being designed.• When existing designs or processes are being changed.
• When carryover designs/processes will be used in new applications,or new environments.
• After completing a Problem Solving Study (to prevent recurrence ofproblem)
• For a System FMEA, after System functions are defined, but beforespecific hardware is selected.
• For a Design FMEA, after product functions are defined, but beforethe design is approved and released to manufacturing.
• For a Process FMEA, when preliminary drawings of the product areavailable.
Steps in the FMEA Process
Continuing with the FMEA discussion, the jargon related to FMEA is discussedbelow:
Failure Mode
The manner in which a part or process can fail to meet specification
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Potential causes are sources of Variability associated with Key Process Input Variables
Potential Effect
Impact on Customer if Failure Mode is not prevented or correctedCustomer can be downstream or the ultimate customer
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The following template can be used to put all the discussion and material prepared on FMEA together in a meaningful,
practical way which results in action items for the process owners/operations persons.
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ProcessorProductName:
Prepared by:Page ____ of ____
Responsible:FMEA Date (Orig) ______________ (Rev) _____________
ProcessStep
Key ProcessInput
PotentialFailureMode
PotentialFailure Effects
S E
V E RI T Y
PotentialCauses
O C
C URA N C E
Current Controls
DE
T E C T I O N
RP
N
ActionsRecommended
Resp. ActionsTaken
S E
V
O C
C
DE
T
RP
N
What istheprocessstep
Whatis theKey ProcessInput?
In what waysdoes theKey Input go wrong?
What is theimpact on theKey Output Variables(CustomerRequirements)
or internalrequirements?
How Severe isthe effectto thecusotmer?
Whatcausesthe Key Input togo wrong?
How oftendoescauseor FMoccur?
What are the existing controls andprocedures (inspection and test)that prevent eith the cause or theFailure Mode? Should include anSOP number.
How wellcan youdetectcause orFM?
What are theactions forreducing theoccurrance of the Cause, orimproving
detection?Should haveactions only on high RPN'sor easy fixes.
WhoseResponsiblefor therecommendedaction?
What arethecompletedactionstaken withthe
recalculatedRPN? Besure toincludecompletionmonth/year
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