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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

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120 Kit Drill

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Failure Modes & Effect AnalysisFailure Modes & Effect Analysis

Questions?Questions?Call or e-mail:

Kevin M. Treanor Bob Ollerton310-863-4182 310-332-1972/310-350-9121kevin.treanor@ngc.com robert.ollerton@ngc.com