process failure mode effect analysis northrop grumman corporation integrated systems ca/pa-rca :...
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HEADER / FOOTER INFORMATION (SUCH AS PRIVATE / CONFIDENTIAL)
Process Failure Mode Effect
Analysis
Northrop Grumman CorporationIntegrated Systems
CA/PA-RCA : Advanced Tool
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Overview Objective
Failure Mode Effect Analysis (FMEA) – Provide a Basic familiarization with a tool that aids in quantifying severity, occurrences and detection of failures, and guides the creation of corrective action, process improvement and risk mitigation plans.
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Agenda
FMEA History What IS FMEA
Definitions What it Can Do For You
Types of FMEA Team Members Roles FMEA Terminology Getting Started with an FMEA The Worksheet FMEA Scoring
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Agenda Why does it always Why does it always seem we have plenty seem we have plenty
of time to fix our of time to fix our problems, but never problems, but never
enough time to enough time to prevent the prevent the
problems by doing it problems by doing it right the first time?right the first time?
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FMEA HistoryFMEA History
This This “type” “type” of thinking has been around of thinking has been around for hundreds of years. It was first for hundreds of years. It was first formalized in the aerospace industry formalized in the aerospace industry during the Apollo program in the 1960’s.during the Apollo program in the 1960’s.
Initial automotive adoption in the 1970’s.Initial automotive adoption in the 1970’s.
Potential serious & frequent safety issues.Potential serious & frequent safety issues.
Required by QS-9000 & Advanced Product Quality Planning Process Required by QS-9000 & Advanced Product Quality Planning Process in 1994.in 1994.
Now adopted by many other industries.Now adopted by many other industries.
For all automotive suppliers.For all automotive suppliers.
Potential serious & frequent safety issues or loyalty issues.Potential serious & frequent safety issues or loyalty issues.
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What is FMEA ?What is FMEA ?
Cause & effect, Root Cause Analysis, Cause & effect, Root Cause Analysis, Fishbone Diagram EtcFishbone Diagram Etc
Failure Mode Effect AnalysisFailure Mode Effect Analysis
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What is FMEA ?What is FMEA ?
Definition: Definition: FMEA is an Engineering “Reliability Tool” FMEA is an Engineering “Reliability Tool” That:That: Helps define, identify, prioritize, and eliminate known and/or Helps define, identify, prioritize, and eliminate known and/or potential failures of the system, design, or manufacturing potential failures of the system, design, or manufacturing process before they reach the customer. The goal is to process before they reach the customer. The goal is to eliminate the Failure Modes and reduce their risks.eliminate the Failure Modes and reduce their risks. Provides structure for a Cross Functional Critique of a Provides structure for a Cross Functional Critique of a design or a Processdesign or a Process
Facilitates inter-departmental dialog.Facilitates inter-departmental dialog.
Is a mental discipline “great” engineering teams go Is a mental discipline “great” engineering teams go through, when critiquing what might go wrong with the through, when critiquing what might go wrong with the product or process.product or process.
Is a living document which ultimately helps prevent, and not reactIs a living document which ultimately helps prevent, and not react to problems.to problems.
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What is FMEA ?What is FMEA ?
What it can do for you!What it can do for you!
1.) Identifies Design or process related 1.) Identifies Design or process related Failure ModesFailure Modes before they happen.before they happen.
2.) Determines the 2.) Determines the Effect & SeverityEffect & Severity of these failure modes. of these failure modes.
3.) Identifies the 3.) Identifies the CausesCauses and probability of and probability of OccurrenceOccurrence of of the Failure Modes.the Failure Modes.
4.) Identifies the 4.) Identifies the ControlsControls and their and their EffectivenessEffectiveness..
5.) Quantifies and prioritizes the 5.) Quantifies and prioritizes the Risks Risks associated associated with the Failure Modes.with the Failure Modes.
6.) Develops & documents Action Plans that will 6.) Develops & documents Action Plans that will occur to reduce risk.occur to reduce risk.
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Types of FMEAs ?Types of FMEAs ?
System/Concept “S/CFMEA”-System/Concept “S/CFMEA”- (Driven by System (Driven by System functions) functions) A system is a organized set of parts or A system is a organized set of parts or subsystems to accomplish one or more functions. System subsystems to accomplish one or more functions. System FMEAs are typically very early, before specific hardware has FMEAs are typically very early, before specific hardware has been determined.been determined.Design “DFMEA”-Design “DFMEA”- (Driven by part or component (Driven by part or component functions) functions) A Design / Part is a unit of physical hardware A Design / Part is a unit of physical hardware that is considered a single replaceable part with respect that is considered a single replaceable part with respect to repair. Design FMEAs are typically done later in the to repair. Design FMEAs are typically done later in the development process when specific hardware has been development process when specific hardware has been determined. determined. Process “PFMEA”-Process “PFMEA”- (Driven by process functions & (Driven by process functions & partpart characteristics)characteristics) A Process is a sequence of tasks A Process is a sequence of tasks that is organized to produce a product or provide a that is organized to produce a product or provide a service. A Process FMEA can involve fabrication, service. A Process FMEA can involve fabrication, assembly, transactions or services.assembly, transactions or services.
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Types of FMEAs ?Types of FMEAs ?
System/Concept “S/CFMEA”-System/Concept “S/CFMEA”- (Driven by System (Driven by System functions) functions) A system is a organized set of parts or A system is a organized set of parts or subsystems to accomplish one or more functions. System subsystems to accomplish one or more functions. System FMEAs are typically very early, before specific hardware has FMEAs are typically very early, before specific hardware has been determined.been determined.Design “DFMEA”-Design “DFMEA”- (Driven by part or component (Driven by part or component functions) functions) A Design / Part is a unit of physical hardware A Design / Part is a unit of physical hardware that is considered a single replaceable part with respect that is considered a single replaceable part with respect to repair. Design FMEAs are typically done later in the to repair. Design FMEAs are typically done later in the development process when specific hardware has been development process when specific hardware has been determined. determined. Process “PFMEA”-Process “PFMEA”- (Driven by process functions & (Driven by process functions & partpart characteristics)characteristics) A Process is a sequence of tasks A Process is a sequence of tasks that is organized to produce a product or provide a that is organized to produce a product or provide a service. A Process FMEA can involve fabrication, service. A Process FMEA can involve fabrication, assembly, transactions or services.assembly, transactions or services.
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The FMEA Team RolesThe FMEA Team Roles
FMEA Core TeamFMEA Core Team4 – 6 Members4 – 6 Members
Expertise in Product / ProcessExpertise in Product / ProcessCross functionalCross functional
Honest CommunicationHonest CommunicationActive participationActive participation
Positive attitudePositive attitudeRespects other opinionsRespects other opinions
Participates in team decisionsParticipates in team decisions
FMEA Core TeamFMEA Core Team4 – 6 Members4 – 6 Members
Expertise in Product / ProcessExpertise in Product / ProcessCross functionalCross functional
Honest CommunicationHonest CommunicationActive participationActive participation
Positive attitudePositive attitudeRespects other opinionsRespects other opinions
Participates in team decisionsParticipates in team decisions
Champion / SponsorChampion / SponsorProvides resources & supportProvides resources & support
Attends some meetingsAttends some meetingsPromotes team effortsPromotes team efforts
Shares authority / power with teamShares authority / power with teamKicks off teamKicks off team
Implements recommendationsImplements recommendations
Champion / SponsorChampion / SponsorProvides resources & supportProvides resources & support
Attends some meetingsAttends some meetingsPromotes team effortsPromotes team efforts
Shares authority / power with teamShares authority / power with teamKicks off teamKicks off team
Implements recommendationsImplements recommendations
RecorderRecorderKeeps documentation of teams effortsKeeps documentation of teams efforts
FMEA chart keeperFMEA chart keeperCoordinates meeting rooms/timeCoordinates meeting rooms/time
Distributes meeting rooms & agendasDistributes meeting rooms & agendas
RecorderRecorderKeeps documentation of teams effortsKeeps documentation of teams efforts
FMEA chart keeperFMEA chart keeperCoordinates meeting rooms/timeCoordinates meeting rooms/time
Distributes meeting rooms & agendasDistributes meeting rooms & agendas
FacilitatorFacilitator““Watchdog“ of the processWatchdog“ of the process
Keeps team on trackKeeps team on trackFMEA Process expertiseFMEA Process expertise
Encourages / develops team dynamicsEncourages / develops team dynamicsCommunicates assertivelyCommunicates assertively
Ensures everyone participatesEnsures everyone participates
Team LeaderTeam Leader““Watchdog” of the projectWatchdog” of the project
Good leadership skillsGood leadership skillsRespected & relaxedRespected & relaxed
Leads but doesn’t dominateLeads but doesn’t dominateMaintains full team participationMaintains full team participation
Typically lead engineerTypically lead engineer
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FMEA TerminologyFMEA Terminology
1.) 1.) Failure Modes:Failure Modes: (Specific loss of a function) is a (Specific loss of a function) is a concise concise
description of how a part , system, or manufacturing description of how a part , system, or manufacturing process may potentially fail to perform its functions.process may potentially fail to perform its functions.
2.) 2.) Failure ModeFailure Mode““Effect”:Effect”: A description of the consequence or A description of the consequence or Ramification of a system or part failure. A typical failure mode may Ramification of a system or part failure. A typical failure mode may have several have several “effects” “effects” depending on which customer you consider.depending on which customer you consider.
3.) 3.) Severity Rating:Severity Rating: (Seriousness of the Effect) Severity is the (Seriousness of the Effect) Severity is thenumerical rating of the impact numerical rating of the impact on customerson customers..
When multiple effects exist for a given failure mode, enter the worstWhen multiple effects exist for a given failure mode, enter the worst case severity on the worksheet to calculate risk.case severity on the worksheet to calculate risk.
4.) 4.) Failure ModeFailure Mode“Causes”:“Causes”: A description of the design or process A description of the design or processdeficiency (global cause or root level cause) that results deficiency (global cause or root level cause) that results in the failure mode .in the failure mode .
You must look at the causes not the symptoms of the failure. Most failureYou must look at the causes not the symptoms of the failure. Most failureModes have more than one Modes have more than one Cause.Cause.
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FMEA Terminology (continued)FMEA Terminology (continued)
5.) 5.) Occurrence Rating:Occurrence Rating: Is an estimate number of Is an estimate number of frequencies or cumulative number of failures (based on frequencies or cumulative number of failures (based on experience) that will occur (in our design concept) for a experience) that will occur (in our design concept) for a given cause over the intended “life of the design”.given cause over the intended “life of the design”.
6.) 6.) Failure ModeFailure Mode““Controls”:Controls”: The mechanisms, The mechanisms, methods, tests, methods, tests, procedures, or controls that we have in place to procedures, or controls that we have in place to PREVENT PREVENT the Cause of the Failure Mode or the Cause of the Failure Mode or DETECT DETECT the Failure the Failure Mode or Cause should it occur .Mode or Cause should it occur .Design Controls prevent or detect the Failure Mode prior to engineering Design Controls prevent or detect the Failure Mode prior to engineering releaserelease
7.) 7.) Detection Rating: Detection Rating: A numerical rating of the probability that a given A numerical rating of the probability that a given set of controls set of controls WILL DISCOVERWILL DISCOVER a specific Cause of Failure Mode to a specific Cause of Failure Mode to prevent bad parts leaving the facility or getting to the ultimate customer.prevent bad parts leaving the facility or getting to the ultimate customer.
Assuming that the cause of the failure did occur, assess the capabilities of the Assuming that the cause of the failure did occur, assess the capabilities of the controls to find the design flaw.controls to find the design flaw...
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FMEA Terminology (continued)FMEA Terminology (continued)
8.) 8.) Risk Priority Number (RPN): Risk Priority Number (RPN): Is the product of Is the product of Severity, Occurrence, & DetectionSeverity, Occurrence, & Detection. Risk= . Risk= RPN= S x O x RPN= S x O x DDOften the RPN’s are sorted from high to low for consideration in the action planning Often the RPN’s are sorted from high to low for consideration in the action planning
step (Caution, RPN’s can be misleading- you must look for patterns).step (Caution, RPN’s can be misleading- you must look for patterns).
9.) 9.) Action Planning: Action Planning: A thoroughly thought out and well A thoroughly thought out and well developed FMEA With High Risk Patterns that is not developed FMEA With High Risk Patterns that is not followed with corrective actions has little or no value, other followed with corrective actions has little or no value, other than having a chart for an auditthan having a chart for an auditAction plans should be taken very seriously.Action plans should be taken very seriously.If ignored, you have probably wasted much of your valuable time.If ignored, you have probably wasted much of your valuable time.Based on the FMEA analysis, strategies to reduce risk are focused Based on the FMEA analysis, strategies to reduce risk are focused on:on:
Reducing theReducing the Severity Rating.Severity Rating.Reducing theReducing the Occurrence Rating.Occurrence Rating.Reducing theReducing the detection Rating.detection Rating.
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DetermineDetermine““Controls”Controls”
Detection RatingDetection Rating
DetermineDetermine““Effects” ofEffects” ofThe FailureThe Failure
ModeModeSeverity RatingSeverity Rating
Getting Started on FMEAGetting Started on FMEA
What Must be done before FMEA Begins!
DetermineDetermine““Causes” ofCauses” ofThe FailureThe Failure
ModeModeOccurrence RatingOccurrence Rating
DetermineDetermineProduct orProduct or ProcessProcess
FunctionsFunctions
DetermineDetermine Failure ModesFailure Modes
of Functionof Function
Understand yourUnderstand yourCustomer Customer
NeedsNeeds
Develop & EvaluateDevelop & EvaluateProduct/ProcessProduct/Process
ConceptsConcepts
Create Create an Effective an Effective FMEA TeamFMEA Team
Develop andDevelop andDriveDrive
Action PlanAction Plan
Ready?Ready?
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33
22 44 66
=QFD=QFD
=Brain Storming=Brain Storming
=4 to 6 Consensus Based Multi=4 to 6 Consensus Based MultiLevel ExpertsLevel Experts
= What we = What we are and are are and are not workingnot working
Define the FMEADefine the FMEAScopeScope
55Calculate &Calculate &Assess RiskAssess Risk
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77
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The FMEA WorksheetThe FMEA Worksheet
Product or
Process
Failure Mode
Failure Effects
SEV
CausesOCC
ControlsDET
RPN
Actions / Plans
Resp. & Target
Complete Date
pSEV
pOCC
pDET
pRPN
1 62 3 4 5 7
DetermineProduct or Process
Functions
Determine Failure Modes
of Function
Determine“Effects” ofThe Failure
ModeSeverity Rating
Determine“Causes” ofThe Failure
ModeOccurrence
Rating
Determine“Controls”Detection
Rating
Calculate &
Assess Risk
Develop and
DriveAction Plan
If an FMEA was created during the Design Phase of the Program, USE IT!Create an Action Plan for YOUR ROOT CAUSE
and Re-Evaluate the RPN Accordingly
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FMEA ScoringFMEA ScoringSeveritySeverity
Severity of EffectSeverity of Effect Rating
May endanger machine or operator. Hazardous without warning 1010
May endanger machine or operator. Hazardous with warning 99
Major disruption to production line. Loss of primary function, 100% scrap. Possible jig lock and Major loss of Takt Time 88
Reduced primary function performance. Product requires repair or Major Variance. Noticeable loss of Takt Time 77
Medium disruption of production. Possible scrap. Noticeable loss of takt time. Loss of secondary function performance. Requires repair or Minor Variance 66
Minor disruption to production. Product must be repaired. Reduced secondary function performance. 55
Minor defect, product repaired or "Use-As-Is" disposition. 44Fit & Finish item. Minor defect, may be reprocessed on-line. 33
Minor Nonconformance, may be reprocessed on-line. 22
Non
eN
one
No effect 11
Ext
rem
eE
xtre
me
Hig
hH
igh
Mod
erat
eM
oder
ate
Low
Low
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FMEA ScoringFMEA ScoringOccurrenceOccurrence
Likelihood of OccurrenceFailureRate
Capability(Cpk) Rating
1 in 2 < .33 1010
1 in 3 > .33 99
1 in 8 > .51 88
1 in 20 > .67 77
1 in 80 > .83 66
1 in 400 > 1.00 55
1 in 2000 > 1.17 44
Process is in statistical control. 1 in 15k > 1.33 33
Low
Low Process is in statistical control. Only isolated
failures associated with almost identical processes.1 in 150k > 1.50 22
Rem
ote
Rem
ote
Failure is unlikely. No known failures associatedwith almost identical processes. 1 in 1.5M > 1.67 11
Failure is almost inevitable
Process is not in statistical control.Similar processes have experienced problems.
Process is in statistical control but with isolated failures.Previous processes have experienced occasional
failures or out-of-control conditions.
Ver
y H
igh
Ver
y H
igh
Hig
hH
igh
Mod
erat
eM
oder
ate
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FMEA ScoringFMEA ScoringDetectionDetection
Likelihood that control will detect failure RatingV
ery
Low
Ver
y L
ow
No known control(s) available to detect failure mode. 1010
99
88
77
66
55
44
33
22
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The process automatically detects failure.Controls will almost certainly detect the existence ofa failure.
Controls have a good chance of detecting the existenceof a failure
Low
Low
Mod
erat
eM
oder
ate
Hig
hH
igh
Ver
y H
igh
Ver
y H
igh
Controls have a remote chance of detecting the failure.
Controls may detect the existence of a failure
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FMEA ScoringFMEA ScoringRPN or Risk Priority NumberRPN or Risk Priority Number
SSeverity x everity x OOccurrence x ccurrence x DDetection= etection=
RPNRPN
The Calculation !The Calculation !
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Failure Modes & Effect AnalysisFailure Modes & Effect Analysis(FMEA) Part or Process Improvement FMEA is a technique utilized to define, identify, and eliminate
known or potential failures or errors from a product or a process. Identify each candidate Part or Process, list likely failure
mode, causes, and current controls Prioritize risk by using a ranking scale for severity,
occurrence, and detection Mitigate risk – Can controls be added to reduce risk?
Recalculate RPN. Characteristics with high Risk Priority Numbers should be
selected for Improvement and Action Plans Created Recalculate RPN After Completion of Action Plans to Validate
ImprovementsProduct
or Process
Failure Mode
Failure Effects
SEV
CausesOCC
ControlsDET
RPN
Actions / Plans
Resp. & Target
Complete Date
pSEV
pOCC
pDET
pRPN
Hole Drilling
Oversize Hole
Unable toInstall BPFastener
WrongDrill Bit
Used
Ball GageVisual Insp5 8 3
120
120 Kit Drill
Bits010103 5 11 55
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Failure Modes & Effect AnalysisFailure Modes & Effect Analysis
Questions?Questions?Call or e-mail:
Kevin M. Treanor Bob Ollerton310-863-4182 310-332-1972/[email protected] [email protected]