failure mode effects analysis effects analysis risk identification fmea risk identification fmea

FFailure ailure MModeode

EEffects ffects AAnalysisnalysis

Risk IdentificationRisk Identification

FMEAFMEA

Failure at 30,000 feetFailure at 30,000 feet

Jeff PrahstJeff Prahst Quality SolutionsQuality Solutions 22

Risks of Failure in both Design and ProcessIdentified risks for customers, the business, our personnel

and the environment, etc.

Tool to help identify and prioritize risks

Types of FMEA:• Design FMEA – DFMEA• Process FMEA - PFMEA• Implementation FMEAs (for starting new processes)• Special PFMEA (used as a specific problem solving tool)

FMEA Tool Identifies RisksFMEA Tool Identifies Risks

Quality SolutionsQuality Solutions 77

WhatWhat in the process in the process can go wrongcan go wrong??– Potential Failure Modes

WhenWhen failure happens what is failure happens what is the effectthe effect on the customer and on the customer and how badhow bad is ailure? is ailure?

– Effect and Severity

WhyWhy does it happen and does it happen and how oftenhow often??– Causes and Occurrence

How will failure be detectedHow will failure be detected and and corrected before it leaves the process?corrected before it leaves the process?

– Controls and Detection

PFMEA - Critical Questions PFMEA - Critical Questions


Risk IdentificationRisk IdentificationProcess Failure Mode and Effect AnalysisProcess Failure Mode and Effect Analysis

Function: Process Step

Failure ModeEffectsSeverity

(1-10)

CausesOccurrence

(1-10)

ControlsDetectability

(1-10)

RPN =Risk Priority NumberRPN = S x O x D = 1 to 1000

RPN =Risk Priority NumberRPN = S x O x D = 1 to 1000

Quality SolutionsQuality Solutions 99

PFMEA FormPFMEA Form

#

ProcessFunction or Step Requirements

PotentialFailureMode

PotentialEffect ofFailure S

ever

ity

Cla

ss

PotentialCause/

Mechanismof Failure O

ccu

rren

ce

Detection Prevention Det

ecti

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Cri

tica

lity

RP

N

0 0

0 0

0 0

0 0

Current ControlsCausesProcess Failures

1010

Quality by DesignQuality by Design

DFMEADFMEA DDesign esign FFailure ailure MModeode

and and EEffects ffects AAnalysisnalysis


Design - DFMEA FormatDesign - DFMEA Format


BenefitsBenefits - - Design FMEADesign FMEA

AidsAids in design to reduce risks.in design to reduce risks.

EvaluatesEvaluates design requirements / alternatives.design requirements / alternatives.

IdentifiesIdentifies how a product may fail to meet its how a product may fail to meet its

intended function.intended function.

ExaminesExamines potential consequences of failure.potential consequences of failure.

PrioritizesPrioritizes corrective corrective actions needed.actions needed.


Information SourceInformation Source

BoundariesBoundaries for Customer change notificationfor Customer change notification

IdentifiesIdentifies special characteristics for PFMEAspecial characteristics for PFMEA

RanksRanks potential failure modes according to their potential failure modes according to their

effect on the customeeffect on the custome

PrioritizesPrioritizes risks & improvement opportunitiesrisks & improvement opportunities

Problem Solving ToolProblem Solving Tool when analyzing when analyzing

customer product concernscustomer product concerns


Team Requirement ?Team Requirement ?

Team ActivityTeam Activity• Team Leader / FacilitatorTeam Leader / Facilitator• Design and Development EngineersDesign and Development Engineers• Process EngineersProcess Engineers• Manufacturing Supervisors and OperatorsManufacturing Supervisors and Operators

Others Participate as NeededOthers Participate as Needed• Quality AssuranceQuality Assurance• Quality EngineersQuality Engineers• Customers of ProductCustomers of Product• Suppliers of Raw Materials and EquipmentSuppliers of Raw Materials and Equipment


Function, Expectation, FailureFunction, Expectation, Failure

1. List Product Functions1. List Product Functions• Appearance, Performance, Processability, ...Appearance, Performance, Processability, ...

2. List Customer Expectations2. List Customer Expectations• AppearanceAppearance – – Looks Good; Clean; Shiny; No defects...Looks Good; Clean; Shiny; No defects...• PerformancePerformance – – Resistant to damage; Starts and runs ...Resistant to damage; Starts and runs ...• ProcessabilityProcessability – – Easy to use & Easy to make...Easy to use & Easy to make...

3. Translate into Failure Modes3. Translate into Failure Modes• Looks GoodLooks Good – – Not shiny; Dirty; Not at expectations ... Not shiny; Dirty; Not at expectations ... • No DefectsNo Defects – – Scratches; Dents; Broken parts ...Scratches; Dents; Broken parts ...• Starts EasyStarts Easy – – Will not start; Hard to start...Will not start; Hard to start...


Functions & Failure ModesFunctions & Failure Modes


Effects or ConsequencesEffects or Consequences

Identify Identify Effects Effects as perceived by Customer.as perceived by Customer. What could be the What could be the result of failureresult of failure mode? mode? Describe in terms of what the customer Describe in terms of what the customer

might experience or notice.might experience or notice.– Customer DissatisfactionCustomer Dissatisfaction– Warranty Costs and Production Line ReworkWarranty Costs and Production Line Rework

Consider Consider “Customer”“Customer” to also be to also be “internal customers”“internal customers” as well as final as well as final or ultimate end users.or ultimate end users.


Severity RatingsSeverity Ratings


Design MatrixDesign Matrix

Materials and PartsMaterials and Parts

Select Materials, Parts and Quantity LevelsSelect Materials, Parts and Quantity Levels– Material - Failure under 47% to over 58% by WeightMaterial - Failure under 47% to over 58% by Weight

– Part - Failure under X % to over Z %Part - Failure under X % to over Z %

Material and Part Characteristics Material and Part Characteristics

Establish Material and Part SpecificationsEstablish Material and Part SpecificationsIdentify significant properties which have a major Identify significant properties which have a major impact on final product performanceimpact on final product performance– Material: Failure under or over amounts usedMaterial: Failure under or over amounts used– Part : Failure to meet specification (under/over )Part : Failure to meet specification (under/over )



Product CharacteristicsProduct CharacteristicsSelect tests and specifications which determine Select tests and specifications which determine the ultimate performance of the product.the ultimate performance of the product.

– Time to Temp.: Failure under or over specificationTime to Temp.: Failure under or over specification– Solids - Failure under 65% to over 73% by weightSolids - Failure under 65% to over 73% by weight– Pressure Test: Failure @ 5 psiPressure Test: Failure @ 5 psi

Process ConstraintsProcess ConstraintsIdentify significant manufacturing constraintsIdentify significant manufacturing constraints

– Equipment Required: Stainless, special toolsEquipment Required: Stainless, special tools– Space and Line Requirements: Sq Footage; heightSpace and Line Requirements: Sq Footage; height



Conditions for UseConditions for Use

Identify significant constraints in the conditionsIdentify significant constraints in the conditions

involved when the Customer uses of the product.involved when the Customer uses of the product.– Film Build - Failure under 2.0 mils.Film Build - Failure under 2.0 mils.

– Bake Time @ 350°F - Failure under 20 minutes.Bake Time @ 350°F - Failure under 20 minutes.

– Bake Temperature @ 20 min. - Failure under 350°F.Bake Temperature @ 20 min. - Failure under 350°F.

– Shelf Life - Failure after Six MonthShelf Life - Failure after Six Month

– Storage Temperature - Failure over 70°F.Storage Temperature - Failure over 70°F.

– Humidity - Failure over 60% relative humidityHumidity - Failure over 60% relative humidity

– Temperature (paint): Failure under 50°F to over 120°FTemperature (paint): Failure under 50°F to over 120°FJeff PrahstJeff Prahst Quality SolutionsQuality Solutions 2222

Design Matrix -Design Matrix -


Occurrence TableOccurrence Table


DFMEA FormDFMEA Form


Design ControlsDesign Controls

Identify Design ControlsIdentify Design Controls Designed Experiments (DOE) Designed Experiments (DOE)

Customer Validation Tests, Trial RunsCustomer Validation Tests, Trial Runs

Test Protocols, Test MethodsTest Protocols, Test Methods

Subcontractor Third Party TestingSubcontractor Third Party Testing

Engineering General Practice RangesEngineering General Practice Ranges


DetectionDetection - - Chance of EscapeChance of Escape

How likely will design failures escape through How likely will design failures escape through our controls to customer?our controls to customer?

• High likelihood = High numberHigh likelihood = High number

• Low likelihood = Low numberLow likelihood = Low number

Will current Design Controls detect and stop Will current Design Controls detect and stop the causes of failure.the causes of failure.

• Designed Experiments (DOE) Designed Experiments (DOE)

• MSA and Gage R&R resultsMSA and Gage R&R results


Design - Detection TableDesign - Detection Table


Improvement Action PlanImprovement Action Plan

Recommended Action(s)Recommended Action(s) Responsibility & Target DatesResponsibility & Target Dates Actions TakenActions Taken Resulting Risk AnalysisResulting Risk Analysis

• SeveritySeverity• OccurrenceOccurrence• DetectionDetection• RPNRPN


““Living Document” Living Document”

Select Areas for Improvement.Select Areas for Improvement. (high risk) (high risk)• Formulate plans for corrective actions.Formulate plans for corrective actions.

• Implement additional corrective actions.Implement additional corrective actions.

• Re-compute the risk assessment (RPN).Re-compute the risk assessment (RPN).

Up-Date and MaintainUp-Date and Maintain• Update as new information is available.Update as new information is available.

• Record all changes made to Product or Process.Record all changes made to Product or Process.

• Revise as experience grows.Revise as experience grows.


Importance of PrioritizationImportance of Prioritization


Priority and PracticalityPriority and Practicality


DFMEA – Cup of CoffeeDFMEA – Cup of Coffee


DFMEA for Making CoffeeDFMEA for Making Coffee


Functions & Failure ModesFunctions & Failure Modes


Design Matrix -Design Matrix -


Design FMEADesign FMEA


failure mode effects analysis effects analysis risk identification fmea risk identification fmea

Documents

risks of failure

pfmea n

potential failure modes

severity n

occurrence n

operators n

custome n

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