AdvancedPFMEA

8/3/2019 AdvancedPFMEA

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Process FailureMode Effect

Analysis

Northrop Grumman CorporationIntegrated Systems

CA/PA-RCA : Advanced Tool



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Overview Objective

Failure Mode Effect Analysis (FMEA) ± Provide a Basicfamiliarization with a tool that aids in quantifyingseverity, occurrences and detection of failures, andguides the creation of corrective action, processimprovement 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 alwaysWhy does it alwaysseem we have plenty ofseem we have plenty of

time to fix ourtime to fix our

problems, but neverproblems, but neverenough time to preventenough time to preventthe problems by doingthe problems by doingit right the first time?it right the first time?



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FMEA HistoryFMEA History

ThisThis type type of thinking has been around forof thinking has been around forhundreds of years. It was first formalized inhundreds of years. It was first formalized inthe aerospace industry during the Apollothe aerospace industry during the Apolloprogram in the 1960s.program in the 1960s.

Initial automotive adoption in the 1970s.Initial automotive adoption in the 1970s.

Potential serious & frequent safety issues.Potential serious & frequent safety issues.

Required by QSRequired by QS--9000 & Advanced Product Quality Planning Process9000 & Advanced Product Quality Planning Processin 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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Definition:Definition: FMEA is an Engineering Reliability Tool That:FMEA is an Engineering Reliability Tool That: Helps define, identify, prioritize, and eliminate known and/orHelps define, identify, prioritize, and eliminate known and/orpotential failures of the system, design, or manufacturing processpotential failures of the system, design, or manufacturing processbefore they reach the customer. The goal is to eliminate the Failurebefore they reach the customer. The goal is to eliminate the FailureModes and reduce their risks.Modes and reduce their risks.

Provides structure for a Cross Functional Critique of a design or aProvides structure for a Cross Functional Critique of a design or aProcessProcess

Facilitates interFacilitates inter--departmental dialog.departmental dialog.

Is a mental discipline great engineering teams go through, whenIs a mental discipline great engineering teams go through, when

critiquing what might go wrong with the product or process.critiquing what might go wrong with the product or process.

Is a living document which ultimately helps prevent, and not react Is a living document which ultimately helps prevent, and not react to problems.to problems.



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What it can do for you!What it can do for you!1.) Identifies Design or process related1.) Identifies Design or process related Failure ModesFailure Modes beforebeforethey happen.they happen.

2.) Determines the2.) Determines the Effect & SeverityEffect & Severity of these failure modes.of these failure modes.

3.) Identifies the3.) Identifies the CausesCauses and probability of and probability of OccurrenceOccurrence of theof theFailure Modes.Failure Modes.

4.) Identifies the4.) Identifies the ControlsControls and theirand their EffectivenessEffectiveness..

5.) Quantifies and prioritizes the5.) Quantifies and prioritizes the RisksRisks associated withassociated withthe Failure Modes.the Failure Modes.

6.) Develops & documents Action Plans that will occur to6.) Develops & documents Action Plans that will occur toreduce risk.reduce risk.



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Types of FMEAs ?Types of FMEAs ?

System/Concept S/CFMEASystem/Concept S/CFMEA-- (Driven by System functions)(Driven by System functions) A Asystem is a organized set of parts or subsystems to accomplish onesystem is a organized set of parts or subsystems to accomplish oneor more functions. System FMEAs are typically very early, beforeor more functions. System FMEAs are typically very early, beforespecific hardware has been determined.specific hardware has been determined.

Design DFMEADesign DFMEA-- (Driven by part or component functions)(Driven by part or component functions) A ADesign / Part is a unit of physical hardware that is considered aDesign / Part is a unit of physical hardware that is considered asingle replaceable part with respect to repair. Design FMEAs aresingle replaceable part with respect to repair. Design FMEAs aretypically done later in the development process when specifictypically done later in the development process when specifichardware has been determined.hardware has been determined.

Process PFMEAProcess PFMEA-- (Driven by process functions & part (Driven by process functions & part characteristics)characteristics) A Process is a sequence of tasks that is A Process is a sequence of tasks that isorganized to produce a product or provide a service. Aorganized to produce a product or provide a service. AProcess FMEA can involve fabrication, assembly, transactionsProcess FMEA can involve fabrication, assembly, transactionsor services.or services.



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Types of FMEAs ?Types of FMEAs ?

System/Concept S/CFMEASystem/Concept S/CFMEA-- (Driven by System functions)(Driven by System functions) A Asystem is a organized set of parts or subsystems to accomplish onesystem is a organized set of parts or subsystems to accomplish oneor more functions. System FMEAs are typically very early, beforeor more functions. System FMEAs are typically very early, beforespecific hardware has been determined.specific hardware has been determined.

Design DFMEADesign DFMEA-- (Driven by part or component functions)(Driven by part or component functions) A ADesign / Part is a unit of physical hardware that is considered aDesign / Part is a unit of physical hardware that is considered asingle replaceable part with respect to repair. Design FMEAs aresingle replaceable part with respect to repair. Design FMEAs aretypically done later in the development process when specifictypically done later in the development process when specifichardware has been determined.hardware has been determined.

Process PFMEAProcess PFMEA-- (Driven by process functions & part (Driven by process functions & part characteristics)characteristics) A Process is a sequence of tasks that is A Process is a sequence of tasks that isorganized to produce a product or provide a service. Aorganized to produce a product or provide a service. AProcess FMEA can involve fabrication, assembly, transactionsProcess FMEA can involve fabrication, assembly, transactionsor services.or services.



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The FMEA Team RolesThe FMEA Team Roles

FMEA Core TeamFMEA Core Team44 6 Members6 Members

Expertise in Product / ProcessExpertise in Product / ProcessCross functionalCross functional

Honest CommunicationHonest Communication Active participation Active participation

Positive attitudePositive attitudeRespects other opinionsRespects other opinions

Participates in team decisionsParticipates in team decisions

Champion / SponsorChampion / SponsorProvides resources & support Provides resources & support

Attends some meetings Attends 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

FacilitatorFacilitator Watchdog of the process Watchdog 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 project Watchdog of the project

Good leadership skillsGood leadership skillsRespected & relaxedRespected & relaxed

Leads but doesnt dominateLeads but doesnt 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 concise(Specific loss of a function) is a concise

description of how a part , system, or manufacturing process maydescription of how a part , system, or manufacturing process maypotentially fail to perform its functions.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 mayRamification of a system or part failure. A typical failure mode mayhave severalhave 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 worst When 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 ModeCauses: Causes: A description of the design or process A description of the design or processdeficiency (global cause or root level cause) that resultsdeficiency (global cause or root level cause) that resultsin the failure mode .in the failure mode .

Y ou must look at the causes not the symptoms of the failure. Most failure Y ou must look at the causes not the symptoms of the failure. Most failureModes have more than oneModes 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 frequencies orIs an estimate number of frequencies orcumulative number of failures (based on experience) that willcumulative number of failures (based on experience) that willoccur (in our design concept) for a given cause over the intendedoccur (in our design concept) for a given cause over the intended

life of the design. life of the design.

6.)6.) Failure ModeFailure Mode Controls:Controls: The mechanisms, methods, tests,The mechanisms, methods, tests,procedures, or controls that we have in place toprocedures, or controls that we have in place to PREVENTPREVENT thetheCause of the Failure Mode orCause of the Failure Mode or DETECTDETECT the Failure Mode or Causethe Failure Mode or Causeshould it occur .should it occur .

Design Controls prevent or detect the Failure Mode prior to engineeringDesign Controls prevent or detect the Failure Mode prior to engineeringreleaserelease

7.)7.) Detection Rating:Detection Rating: A numerical rating of the probability that a given A numerical rating of the probability that a givenset of controlsset of controls WILL DISCOVERWILL DISCOVER a specific Cause of Failure Mode toa specific Cause of Failure Mode toprevent 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 thecontrols 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 Severity,Is the product of Severity,

Occurrence, & DetectionOccurrence, & Detection. Risk=. Risk= RPN= S x O x DRPN= S x O x DOften the RPNs are sorted from high to low for consideration in the action planningOften the RPNs are sorted from high to low for consideration in the action planningstep (Caution, RPNs can be misleadingstep (Caution, RPNs can be misleading-- you must look for patterns).you must look for patterns).

9.)9.) Action Planning: Action Planning: A thoroughly thought out and well developed A thoroughly thought out and well developedFMEA With High Risk Patterns that is not followed with correctiveFMEA With High Risk Patterns that is not followed with correctiveactions has little or no value, other than having a chart for an audit actions has little or no value, other than having a chart for an audit

Action 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 on:Based on the FMEA analysis, strategies to reduce risk are focused 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 of Effects ofThe FailureThe Failure

ModeMode

Severity RatingSeverity Rating

Getting Started on FMEAGetting Started on FMEA

What Must be done before FMEA Begins!

DetermineDetermine Causes of Causes ofThe FailureThe Failure

ModeModeOccurrence RatingOccurrence Rating

DetermineDetermineProduct orProduct or

ProcessProcessFunctionsFunctions

DetermineDetermineFailure ModesFailure Modes

of Functionof Function

Understand yourUnderstand yourCustomerCustomer

NeedsNeeds

Develop & EvaluateDevelop & EvaluateProduct/ProcessProduct/Process

ConceptsConcepts

CreateCreatean Effectivean EffectiveFMEA TeamFMEA Team

Develop andDevelop andDriveDrive

Action Plan Action 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 weare and areare and are

not workingnot working

Define the FMEADefine the FMEA

ScopeScope

55Calculate &Calculate &

Assess Risk Assess Risk

66

77



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The FMEA WorksheetThe FMEA Worksheet

Product

or

Process

Failure

Mode

Failure

Effects

S

E

V

Causes

O

C

C

Controls

D

E

T

R

P

N

Actions

/ Plans

Resp. &

Target

Complete

Date

p

S

E

V

p

O

C

C

p

D

E

T

p

R

P

N

1 62 3 4 5 7

DetermineProduct or

ProcessFunctions

DetermineFailureModes

of Function

Determine Effects ofThe Failure

ModeSeverityRating

Determine Causes ofThe Failure

ModeOccurrence

Rating

Determine ControlsDetection

Rating

Calculate&

AssessRisk

Developand

Drive Action 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 Scoring

SeveritySeveritySeverity 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

Maj or loss of Takt Time 88

R educed primary function performance. Product requires repair or Major Variance.

N oticeabl e loss of Takt Time 77

Medium disruption of production. Possible scrap. Noticeable loss of takt time.

Loss of secondary function performance. R equires repair or Minor Variance 66

Minor disruption to production. Product must be repaired.

R educed 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

N o n e

N o n e

No effect 11

E x t r e m e

E x t r e m e

H i g h

H i g h

M

o d e r a t e

M

o d e r a t e

L o w

L o w



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OccurrenceOccurrence

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

L o w L o w

Process is in statistical control. Only isolatedfailures associated with almost identical processes. 1 in 150k > 1.50 22

R e m o t e

R e m o t e

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.

V e r y H i g h

V e r y H i g h

H i g h

H i g h

M o d e r a t e

M o d e r a t e



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DetectionDetectionLikelihood that control will detect failure Rating

V e r y L o w

V e r y L o w

No known control(s) available to detect failure mode. 1010

99

88

77

66

55

44

33

22

11

The process automatically detects failure.

Controls will almost certainly detect the existence of a failure.

Controls have a good chance of detecting the existenceof a failure

L o w L o w

M o d e r a t e

M o d e r a t e

H i g h H i g h

V e r y H i g h

V e r y H i g h

Controls have a remote chance of detecting the failure.

Controls may detect the existence of a failure





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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 orpotential 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, anddetection

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 ValidateImprovements

Productor

Process

FailureMode

FailureEffects

SE

V

Causes

O

C

C

Controls DE

T

RP

N

Actions / Plans

Resp. &

TargetComplete

Date

p

SE

V

p

O

C

C

p

DE

T

p

RP

N

Hole

Drilling

Oversize

Hole

Unable to

Install BP

Fastener

Wrong

Drill Bit

Used

Ball Gage

Visual Insp5 8 3

1 2 0

1 2 0

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 Ollerton

310-

863-

4182 310-

332-

1972/310-

350-

9121

[email protected] [email protected]

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AdvancedPFMEA