Failure Mode Effect Analysis on Anticoagulation Across the Continuum
Failure Mode and Effect Analysis
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Transcript of Failure Mode and Effect Analysis
Failure Mode and Effect Analysis
Failure Mode and Effect Analysis
Jackie Harris, Josh Agusti, and Natasha Sommer
Jackie Harris, Josh Agusti, and Natasha Sommer
ObjectivesObjectives
What is FMEA?Why is an FMEA important?History of FMEABenefits of FMEALimitations of FMEAHow to conduct an FMEA?
What is FMEA?Why is an FMEA important?History of FMEABenefits of FMEALimitations of FMEAHow to conduct an FMEA?
Who is in Attendance?Who is in Attendance?
Anyone conducted an FMEA before?
Anyone completed a Risk Analysis Procedure?
Anyone conducted an FMEA before?
Anyone completed a Risk Analysis Procedure?
What is FMEA?What is FMEA?
A systemized group of activities designed to:▪ recognize and evaluate the potential failure of a product/process and its effects▪ identify actions which could eliminate or reduce the chance of potential failure▪ document the process
A systemized group of activities designed to:▪ recognize and evaluate the potential failure of a product/process and its effects▪ identify actions which could eliminate or reduce the chance of potential failure▪ document the process
Failure Mode and Effect Analysis
Failure Mode and Effect Analysis
Failure Mode and Effect Analysis
Simply put FMEA is:a process that identifies all the possible types of failures that could happen to a product and potential consequences of those failures.
Simply put FMEA is:a process that identifies all the possible types of failures that could happen to a product and potential consequences of those failures.
FMEA TermsFMEA Terms
Failure mode - the way in which something might fail
Effects analysis – studying the consequences of the various failure modes to determine their severity to the customer.
Failure mode - the way in which something might fail
Effects analysis – studying the consequences of the various failure modes to determine their severity to the customer.
Why do an FMEA?Why do an FMEA?
Preventing problems is cheaper and easier than cleaning them up.
Some things are too risky or costly to incur mistakes.
Preventing problems is cheaper and easier than cleaning them up.
Some things are too risky or costly to incur mistakes.
The Reasons for FMEAThe Reasons for FMEA
Get it right the first time Indentifies any inadequacies in the
development of the product Tests and trials may be limited to a few
products Regulatory reasons Continuous improvement Preventive approach Team building Required procedures
Get it right the first time Indentifies any inadequacies in the
development of the product Tests and trials may be limited to a few
products Regulatory reasons Continuous improvement Preventive approach Team building Required procedures
FMEA Provides the Potential to:
FMEA Provides the Potential to:
Reduce the likelihood of customer complaints
Reduce the likelihood of campaign changes
Reduce maintenance and warranty costs
Reduce the possibility of safety failures
Reduce the possibility of extended life or reliability failures
Reduce the likelihood of product liability claims
Reduce the likelihood of customer complaints
Reduce the likelihood of campaign changes
Reduce maintenance and warranty costs
Reduce the possibility of safety failures
Reduce the possibility of extended life or reliability failures
Reduce the likelihood of product liability claims
BenefitsBenefits
Identify potential and known failures
Reduce the number of engineering changes
Reduce product development timeLower start-up costsGreater customer satisfaction Increased cooperation and
teamwork between various functions
Continuous improvement
Identify potential and known failures
Reduce the number of engineering changes
Reduce product development timeLower start-up costsGreater customer satisfaction Increased cooperation and
teamwork between various functions
Continuous improvement
HistoryHistory
An offshoot of Military Procedure MIL-P-1629, titled Procedures for Performing a Failure Mode, Effects and Criticality Analysis, dated November 9, 1949.
Used as a reliability evaluation technique to determine the effect of system and equipment failures.
Failures were classified according to their impact on mission success and personnel/equipment safety.
Formally developed and applied by NASA in the 1960’s to improve and verify reliability of space program hardware.
An offshoot of Military Procedure MIL-P-1629, titled Procedures for Performing a Failure Mode, Effects and Criticality Analysis, dated November 9, 1949.
Used as a reliability evaluation technique to determine the effect of system and equipment failures.
Failures were classified according to their impact on mission success and personnel/equipment safety.
Formally developed and applied by NASA in the 1960’s to improve and verify reliability of space program hardware.
Concept FMEAConcept FMEA
Used to analyze concepts in the early stages before hardware is defined (most often at system and subsystem)
Focuses on potential failure modes associated with the proposed functions of a concept proposal
Includes the interaction of multiple systems and interaction between the elements of a system at the concept stages.
Used to analyze concepts in the early stages before hardware is defined (most often at system and subsystem)
Focuses on potential failure modes associated with the proposed functions of a concept proposal
Includes the interaction of multiple systems and interaction between the elements of a system at the concept stages.
Design FMEADesign FMEA
Aid in the objective evaluation of design requirements and design alternatives
Aid in the initial design for manufacturing and assembly
Increase the probability that potential failure modes have been considered
Provide additional information to aid in the planning of efficient design testing
Aid in the objective evaluation of design requirements and design alternatives
Aid in the initial design for manufacturing and assembly
Increase the probability that potential failure modes have been considered
Provide additional information to aid in the planning of efficient design testing
Process FMEAProcess FMEA
Indentify potential product related process failure modes
Assess the potential customer effects of the failures
Indentify the potential manufacturing causes on which to focus on
Develop a ranked list of potential failure modes
Document the results of the manufacturing
Indentify potential product related process failure modes
Assess the potential customer effects of the failures
Indentify the potential manufacturing causes on which to focus on
Develop a ranked list of potential failure modes
Document the results of the manufacturing
Types of FMEATypes of FMEA
Resources NeededResources Needed
Commitment of top managementKnowledgeable individuals Individuals attentive to FMEA
timelinesPeople resources may be internal
or external to the business or a combination of both
Commitment of top managementKnowledgeable individuals Individuals attentive to FMEA
timelinesPeople resources may be internal
or external to the business or a combination of both
FMEA TimingFMEA Timing
FMEA should be updated:▪at the conceptual stage▪when changes are made to the design▪when new regulations are instituted▪when customer feedback indicates a problem
FMEA should be updated:▪at the conceptual stage▪when changes are made to the design▪when new regulations are instituted▪when customer feedback indicates a problem
AdvantagesAdvantages
Enhance design and manufacturing efficiencies
Alleviate late change crisesMinimize exposure to product
failuresAugment business records Improve “bottom line” resultsAdd to customer satisfaction
Enhance design and manufacturing efficiencies
Alleviate late change crisesMinimize exposure to product
failuresAugment business records Improve “bottom line” resultsAdd to customer satisfaction
LimitationsLimitations
Employee training requirements Initial impact on product and
manufacturing schedulesFinancial impact required to
upgrade design, manufacturing, and process equipment and tools
▪These limitations should be recognized and treated as short term and minimal interruptions to a business.
Employee training requirements Initial impact on product and
manufacturing schedulesFinancial impact required to
upgrade design, manufacturing, and process equipment and tools
▪These limitations should be recognized and treated as short term and minimal interruptions to a business.
Risk Assessment FactorsRisk Assessment Factors
Severity (S): A number from 1 to 5, depending on the severity of the potential failure mode’s effect 1 = no effect5 = maximum severity
Probability of occurrence (O): A number from 1 to 5, depending on the likelihood of the failure mode’s occurrence1 = very unlikely to occur5 = almost certain to occur
Severity (S): A number from 1 to 5, depending on the severity of the potential failure mode’s effect 1 = no effect5 = maximum severity
Probability of occurrence (O): A number from 1 to 5, depending on the likelihood of the failure mode’s occurrence1 = very unlikely to occur5 = almost certain to occur
Risk Assessment FactorsRisk Assessment Factors
Probability of detection (D): A number from 1 to 5, depending on how unlikely it is that the fault will be detected by the system responsible (design control process, quality testing, etc.)1 = nearly certain detention5 = impossible to detect
Risk Priority Number (RPN): The failure mode’s risk is found by the formula RPN = S x O x D. RPN = Severity x Probability of Occurrence x Probability of Detection. RPN will be a number between 1 (virtually no risk) and 125 (extreme risk).
Probability of detection (D): A number from 1 to 5, depending on how unlikely it is that the fault will be detected by the system responsible (design control process, quality testing, etc.)1 = nearly certain detention5 = impossible to detect
Risk Priority Number (RPN): The failure mode’s risk is found by the formula RPN = S x O x D. RPN = Severity x Probability of Occurrence x Probability of Detection. RPN will be a number between 1 (virtually no risk) and 125 (extreme risk).
Risk Priority NumberRisk Priority Number
Procedures for FMEAProcedures for FMEA
Necessity
“Process
Function”
Problem
“Failure Mode”
Effects How bad is it?
“Severity”
Causes How Likely?
“Occurrence”
Score Steps to
Prevent
Procedures for FMEAProcedures for FMEA
Necessity
“Process
Function”
Problem
“Failure Mode”
Effects How bad is it?
“Severity”
Causes How Likely?
“Occurrence”
Score Steps to
Prevent
Put PB on bread
Procedures for FMEAProcedures for FMEA
Necessity
“Process
Function”
Problem
“Failure Mode”
Effects How bad is it?
“Severity”
Causes How Likely?
“Occurrence”
Score Steps to
Prevent
Put PB on bread
No PB
Procedures for FMEAProcedures for FMEA
Necessity
“Process
Function”
Problem
“Failure Mode”
Effects How bad is it?
“Severity”
Causes How Likely?
“Occurrence”
Score Steps to
Prevent
Put PB on bread
No PB Jelly Sandwich
Procedures for FMEAProcedures for FMEA
Necessity
“Process
Function”
Problem
“Failure Mode”
Effects How bad is it?
“Severity”
Causes How Likely?
“Occurrence”
Score Steps to
Prevent
Put PB on bread
No PB Jelly Sandwich
5/5
Procedures for FMEAProcedures for FMEA
Necessity
“Process
Function”
Problem
“Failure Mode”
Effects How bad is it?
“Severity”
Causes How Likely?
“Occurrence”
Score Steps to
Prevent
Put PB on bread
No PB Jelly Sandwich
5/5 Out of Stock
Past Expiration
Procedures for FMEAProcedures for FMEA
Necessity
“Process
Function”
Problem
“Failure Mode”
Effects How bad is it?
“Severity”
Causes How Likely?
“Occurrence”
Score Steps to
Prevent
Put PB on bread
No PB Jelly Sandwich
5/5 Out of Stock
Past Expiration
2/5
Procedures for FMEAProcedures for FMEA
Necessity
“Process
Function”
Problem
“Failure Mode”
Effects How bad is it?
“Severity”
Causes How Likely?
“Occurrence”
Score Steps to
Prevent
Put PB on bread
No PB Jelly Sandwich
5/5 Out of Stock
Past Expiration
2/5 10
Procedures for FMEAProcedures for FMEA
Necessity
“Process
Function”
Problem
“Failure Mode”
Effects How bad is it?
“Severity”
Causes How Likely?
“Occurrence”
Score Steps to
Prevent
Put PB on bread
No PB Jelly Sandwich
5/5 Out of Stock
Past Expiration
2/5 10 Check Pantry
Check Expiration Date
Conduct an FMEAConduct an FMEA
Conduct a process FMEA on a paper airplane
Build a paper airplaneConduct a design FMEA on your
paper airplanePaper Airplane Competition
Conduct a process FMEA on a paper airplane
Build a paper airplaneConduct a design FMEA on your
paper airplanePaper Airplane Competition
ConclusionConclusion
What is FMEA?Why is an FMEA important?History of FMEABenefits of FMEALimitations of FMEAHow to conduct an FMEA?
What is FMEA?Why is an FMEA important?History of FMEABenefits of FMEALimitations of FMEAHow to conduct an FMEA?
ReferencesReferences
Lean Six Sigma - http://www.leansixsigma.com/
Stunell Technology - http://www.stunell.com/images/fmea.jpg
Lean Six Sigma - http://www.leansixsigma.com/
Stunell Technology - http://www.stunell.com/images/fmea.jpg