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PPT that describes FMEA aplication.
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Safety Through DesignSafety Through Design
Bruce W. Main, PE CSPBruce W. Main, PE CSP
design safety engineering, inc.design safety engineering, inc.
Ann Arbor, MichiganAnn Arbor, Michigan10 Sept 200310 Sept 2003
Presentation OverviewPresentation Overview
• Safety through designSafety through design
• Why you should careWhy you should care
• Risk assessment basicsRisk assessment basics
• designsafedesignsafe demonstration and hints demonstration and hints
• ExamplesExamples
Safety Through Design... Safety Through Design...
• Design - optimizing against criteriaDesign - optimizing against criteria
• Late changes in criteria - safetyLate changes in criteria - safety
• Getting it right the first time Getting it right the first time
Familiar MethodsFamiliar Methods
• Government regulations (OSHA, FDA, etc.)Government regulations (OSHA, FDA, etc.)
• Industry standardsIndustry standards
• ChecklistsChecklists
• Safety factorsSafety factors
“Recent” Advances“Recent” Advances
• FMEA FMEA
• Failure Modes & Effects AnalysisFailure Modes & Effects Analysis
• Component failuresComponent failures
• Risk assessmentRisk assessment
• People failuresPeople failures
Safety Through Design…Safety Through Design…
• Getting it right the first time Getting it right the first time
• How?How?
• Risk assessmentRisk assessment
Why you should care…Why you should care…
• Your professors think it’s a good ideaYour professors think it’s a good idea
• Your grade depends on itYour grade depends on it
Other reasons to careOther reasons to care
• Industry standards are requiring risk assessmentIndustry standards are requiring risk assessment
• Europe - CE mark requires risk assessmentEurope - CE mark requires risk assessment
• Customers are beginning to require risk assessmentCustomers are beginning to require risk assessment
• Condition of saleCondition of sale
• Lots of momentum in industry in risk assessmentLots of momentum in industry in risk assessment
• Risk assessment worksRisk assessment works
• Better, cheaper, faster, more productiveBetter, cheaper, faster, more productive
The Safety Hierarchy…
Forms the theoretical basis for design safetyForms the theoretical basis for design safety
The preferred approach to addressing hazards is:The preferred approach to addressing hazards is:
1. Eliminate the hazard by design1. Eliminate the hazard by design2. Substitute less hazardous work methods or materials2. Substitute less hazardous work methods or materials3. Incorporate safety devices (guarding systems)3. Incorporate safety devices (guarding systems)4. Provide warning systems4. Provide warning systems5. Apply administrative controls (work methods, training)5. Apply administrative controls (work methods, training)6. Provide personal protective equipment (PPE)6. Provide personal protective equipment (PPE)(Manuele: Innovations in Safety Management 2001(Manuele: Innovations in Safety Management 2001))
1. Determine the limits of the Machine
2. Hazard Identification
3. Risk Estimation
4. Risk Evaluation
5. Risk Reduction(Countermeasures)
6. Verify Implementation
7. Document Results ANSI B11 TR3ANSI B11 TR3
Hazard Analysis...Hazard Analysis...
• Identify hazardsIdentify hazards
• Task-based is a very useful approachTask-based is a very useful approach
• Focuses on what people doFocuses on what people do
• Users/tasks/hazardsUsers/tasks/hazards
• Brainstorming grounded in realityBrainstorming grounded in reality
Risk Assessment...Risk Assessment...
• Qualitative / semi-quantitative / quantitativeQualitative / semi-quantitative / quantitative
• Working to achieve acceptable riskWorking to achieve acceptable risk• risk which remains after protective measures risk which remains after protective measures
have been takenhave been taken
• risk which is accepted in a given contextrisk which is accepted in a given context
• Zero risk does not existZero risk does not exist
B11 TR3 MatrixB11 TR3 MatrixB11 TR3 MatrixB11 TR3 Matrix
NegligibleNegligibleNegligibleNegligibleLowLowLowLowRemoteRemote
NegligibleNegligibleLowLowMediumMediumMediumMediumUnlikelyUnlikely
LowLowMediumMediumHighHighHighHighLikelyLikely
MediumMediumHighHighHighHighHighHighVery LikelyVery Likely
MinorMinor
SeveritySeverity
ModerateModerate
Level ofLevel of
SeriousSeriousCatastrophicCatastrophic
Probability Probability of of
Occurrence Occurrence of Harmof Harm
MIL-STD-882D MatrixMIL-STD-882D MatrixMIL-STD-882D MatrixMIL-STD-882D Matrix
(E) IMPROBABLE(E) IMPROBABLE
( 10( 10-6 -6 > X ) > X )
(D) REMOTE(D) REMOTE
( 10( 10-3 -3 > X > 10> X > 10-6 -6 ))
(C) OCCASIONAL(C) OCCASIONAL
( 10( 10-2 -2 > X 10> X 10-3 -3 ))
(B) PROBABLE(B) PROBABLE
( 10( 10-1 -1 > X > 10 > X > 10-3 -3 ))
(A) FREQUENT(A) FREQUENT
( X > 10( X > 10-1 -1 ))
(4)(4)
NEGLIGIBLENEGLIGIBLE
(3)(3)
MARGINALMARGINAL
(2)(2)
CRITICALCRITICAL
(1)(1)
CATASTROPHICCATASTROPHIC
CATEGORY
FREQUENCY
UNACCEPTABLEUNACCEPTABLE
UNDESIRABLEUNDESIRABLE
ACCEPTABLE WITH REVIEWACCEPTABLE WITH REVIEW
ACCEPTABLE WITHOUT REVIEWACCEPTABLE WITHOUT REVIEW
R15.06 MatrixR15.06 MatrixR15.06 MatrixR15.06 Matrix
Table 2 – Risk reduction decision matrix prior to safeguard selection
R4R4A1A1 Likely Likely
R3BR3BA2 A2 Not LikelyNot LikelyE1E1 Infrequent Infrequent
exposureexposure
R3AR3AA1A1 Likely Likely
R2CR2CA2 A2 Not LikelyNot LikelyE2 E2 FrequentFrequent
exposureexposureS1S1 Slight Injury Slight Injury
First-aidFirst-aid
R2BR2BA1A1 Likely Likely
R2BR2BA2 A2 Not LikelyNot LikelyE1 E1 InfrequentInfrequent
exposureexposure
R2AR2AA1A1 Likely Likely
R1R1A2 A2 Not LikelyNot LikelyE2E2 Frequent Frequent
exposureexposureS2S2 Serious Injury Serious Injury
More thanMore than
First-aidFirst-aid
RISK REDUCTIONRISK REDUCTION
CATEGORYCATEGORYAVOIDANCEAVOIDANCEEXPOSUREEXPOSURESEVERITY OF INJURYSEVERITY OF INJURY
HFMEA Hazard Scoring MatrixHFMEA Hazard Scoring Matrix
Pro
bab
ilityP
rob
ability
Severity Severity CatastrophicCatastrophic MajorMajor ModerateModerate MinorMinor
FrequentFrequent 1616 1212 88 44
OccasionalOccasional 1212 99 66 33
UncommonUncommon 88 66 44 22
RemoteRemote 44 33 22 11
Risk Scoring SystemsRisk Scoring Systems
• Bringing structure to a subjective analysisBringing structure to a subjective analysis
• There is no one right approachThere is no one right approach
• This is subjectiveThis is subjective
• Become comfortable with subjectivityBecome comfortable with subjectivity
• The goal is acceptable riskThe goal is acceptable risk
Risk Assessment ResultsRisk Assessment Results
• New design requirements/criteria !!New design requirements/criteria !!• Assessment of risk: severity/probability ratingsAssessment of risk: severity/probability ratings• Road map for risk reduction activitiesRoad map for risk reduction activities• Framework for solutions (safety hierarchy)Framework for solutions (safety hierarchy)
• design changes, guarding systemsdesign changes, guarding systems• warnings, instructions, training, PPE requirementswarnings, instructions, training, PPE requirements
• Risk reduced to acceptable riskRisk reduced to acceptable risk
Key Points about designsafeKey Points about designsafe
• Guides you through the risk assessment Guides you through the risk assessment processprocess
• Conforms to current standardsConforms to current standards• Helps you identify hazardsHelps you identify hazards• Prompts your risk reduction effortPrompts your risk reduction effort• Creates the documentationCreates the documentation• Free demo at Free demo at www.designsafe.comwww.designsafe.com
Too Much Residual Risk? What do you do?Too Much Residual Risk? What do you do?
Reduce Reduce
TransferTransfer
AvoidAvoid
AcceptAccept
When do we accept risk?When do we accept risk?
• When it’s insignificantly low.When it’s insignificantly low.
• When we are sure it is worth it.When we are sure it is worth it.
• When we do not know it is there.When we do not know it is there.
Tips on using designsafe…Tips on using designsafe…
• It is a guide. Use your head.It is a guide. Use your head.• Keep your eye on the goal Keep your eye on the goal
• Identify hazardsIdentify hazards• Reduce risks to an acceptable levelReduce risks to an acceptable level
• Risk scoring is not a scientific exercise.Risk scoring is not a scientific exercise.• Look for effective shortcutsLook for effective shortcuts
• All users, all tasksAll users, all tasks• Cut, copy, pasteCut, copy, paste
• Make it work for you.Make it work for you.
Example – Large Oven SystemExample – Large Oven System
• Oven system to bake finish on partsOven system to bake finish on parts
• Elevated, overhead locationElevated, overhead location
• Access required from time to timeAccess required from time to time
• Service conveyor, ovenService conveyor, oven
• Retrieve fallen partsRetrieve fallen parts
ProblemsProblems
• Lighting insufficientLighting insufficient
• Access difficultAccess difficult
• Introduced hazards to the workplaceIntroduced hazards to the workplace
• Task-based risk assessment finds theseTask-based risk assessment finds these
Perishable Goods ProcessingPerishable Goods Processing
• Packaging system to extend food shelf lifePackaging system to extend food shelf life
• Automated production system in operationAutomated production system in operation
• Sales wants small, manual system Sales wants small, manual system
• customers can “try before they buy”customers can “try before they buy”
• Prototype hand-held design in developmentPrototype hand-held design in development
• Risk assessment performedRisk assessment performed
New hazards identified New hazards identified
• Electrical equipment in wet environmentElectrical equipment in wet environment• - not hard wired- not hard wired
• Complex/confusing operation Complex/confusing operation • unmarked/confusing controls unmarked/confusing controls • high probability for operator errorhigh probability for operator error• equipment damage could occur if not equipment damage could occur if not
properly doneproperly done• Hand puncture – needle stickHand puncture – needle stick
Changes MadeChanges Made
• GFI addedGFI added• Design changes to greatly simplify Design changes to greatly simplify
proceduresprocedures• Entirely eliminated need for operator to Entirely eliminated need for operator to
adjust controlsadjust controls• Improved user information – manual, Improved user information – manual,
warnings, system ‘packagewarnings, system ‘package’’
• Puncture resistant gloves addedPuncture resistant gloves added
Common ThemesCommon Themes
• Must identify hazards earlyMust identify hazards early
• Early is better, faster, cheaper and more effectiveEarly is better, faster, cheaper and more effective
• Task based risk assessment helps identify more Task based risk assessment helps identify more
hazards hazards
• Allows engineers to reduce risksAllows engineers to reduce risks
• Risk assessment helps to determineRisk assessment helps to determine
• What, why, how and how muchWhat, why, how and how much