FMEA, FEMA, & FAME€¦ ·  · 2008-04-08Ø FMEA was used by NASA on the 1960s Apollo space missions. Ø FMEA was further developed by the aerospace ... Ø FMEA use in healthcare

FMEA, FEMA, & FAMEFMEA, FEMA, & FAME

Would Mike Would Mike BrownBrown be be famousfamous todaytodayif if FEMAFEMA had used had used FMEAFMEA??

ASQ North JerseyASQ North JerseyDinner MeetingDinner Meeting

Wednesday, November 15, 2006Wednesday, November 15, 2006

Presented by Ed May,Presented by Ed May, ASQ CSSBBASQ CSSBB

Overview of PresentationOverview of Presentation

ØØ IntroductionIntroductionØØ FEMAFEMA, Mike , Mike BrownBrown, Hurricane , Hurricane KatrinaKatrinaØØ FFailure ailure MMode & ode & EEffects ffects AAnalysisnalysisØØ FMEAFMEA ExamplesExamplesØØ FMEAFMEA ExerciseExerciseØØ ConclusionsConclusionsØØ Q & AQ & A

FMEA ?FMEA ?

ØØ FFlorida lorida MMusic usic EEducators ducators AAssociation ?ssociation ?ØØ FFlorida lorida MMunicipal unicipal EElectric lectric AAssociation ?ssociation ?ØØ FFreshwater and reshwater and MMarine arine EEcosystems in cosystems in AAfrica ?frica ?ØØ FFederal ederal EEmergency mergency MManagement anagement AAgency !?gency !?

Federal Emergency Management AgencyFederal Emergency Management Agency

ØØ FEMAFEMAØØ 500 C Street SW, Washington, D.C. 20472500 C Street SW, Washington, D.C. 20472

Disaster Assistance: Disaster Assistance: (800) 621(800) 621--FEMA, TTY (800) 462FEMA, TTY (800) 462--75857585

ØØ U.S. Department of Homeland SecurityU.S. Department of Homeland SecurityØØ www.fema.govwww.fema.gov

FEMA AdviceFEMA Advice

ØØ Before a Hurricane take the following measures:Before a Hurricane take the following measures:ll Make plans to secure your property. Permanent storm Make plans to secure your property. Permanent storm

shutters offer the best protection for windows. A second shutters offer the best protection for windows. A second option is to board up windows with 5/8option is to board up windows with 5/8”” marine plywood, marine plywood, cut to fit and ready to install. Tape does not prevent cut to fit and ready to install. Tape does not prevent windows from breaking.windows from breaking.

ll Install straps or additional clips to securely fasten your roof Install straps or additional clips to securely fasten your roof to the frame structure. This will reduce roof damage.to the frame structure. This will reduce roof damage.

ll Be sure trees and shrubs around your home are trimmed.Be sure trees and shrubs around your home are trimmed.ll Clear loose and clogged rain gutters and downspouts.Clear loose and clogged rain gutters and downspouts.ll Determine how and where to secure your boat.Determine how and where to secure your boat.ll Consider building a safe room.Consider building a safe room.

FEMAFEMAAcronyms, Abbreviations & TermsAcronyms, Abbreviations & Terms

ØØ The The FAATFAAT ListList is a handy reference for the myriad of is a handy reference for the myriad of acronyms and abbreviations used within the federal acronyms and abbreviations used within the federal government, emergency management and the first government, emergency management and the first response community. response community.

ØØ This year's new edition, which further reflects the This year's new edition, which further reflects the establishment of the U.S. Department of Homeland establishment of the U.S. Department of Homeland Security, contains nearly 600 new entries and other Security, contains nearly 600 new entries and other addadd--ons bringing the total to over ons bringing the total to over 4,200 acronyms4,200 acronymsand abbreviations. and abbreviations.

ØØ Some organizations and terms listed are obsolete, Some organizations and terms listed are obsolete, but they are included because they may still appear but they are included because they may still appear in publications and correspondence.in publications and correspondence.

Mike Mike BrownBrownExpert in Failure Mode ?Expert in Failure Mode ?

Hurricane Hurricane KatrinaKatrina

ØØ KatrinaKatrina was one of the most devastating was one of the most devastating hurricanes in United States history. hurricanes in United States history. ll KatrinaKatrina was the deadliest hurricane to strike was the deadliest hurricane to strike

the United States since 1928. the United States since 1928. ll Katrina Katrina was the costliest hurricane ever was the costliest hurricane ever

recorded in North America. recorded in North America. ll KatrinaKatrina produced damage estimated at produced damage estimated at

$75,000,000,000 in the New Orleans area $75,000,000,000 in the New Orleans area and along the Mississippi coast. and along the Mississippi coast.

KatrinaKatrina was devastatingwas devastating

ØØ KatrinaKatrina was responsible for approximately 1200 reported was responsible for approximately 1200 reported deaths, in Louisiana and Mississippi. deaths, in Louisiana and Mississippi.

ØØ KatrinaKatrina caused catastrophic damage in southeastern caused catastrophic damage in southeastern Louisiana and southern Mississippi. Louisiana and southern Mississippi.

ØØ Storm surge along the Mississippi coast caused total Storm surge along the Mississippi coast caused total destruction of many structures, with the surge damage destruction of many structures, with the surge damage extending several miles inland. extending several miles inland.

ØØ Similar damage occurred in portions of southeastern Similar damage occurred in portions of southeastern Louisiana southeast of New Orleans. Louisiana southeast of New Orleans.

ØØ The surge overtopped and breached levees in the New The surge overtopped and breached levees in the New Orleans metropolitan area, resulting in the inundation of Orleans metropolitan area, resulting in the inundation of much of the city and its eastern suburbs. much of the city and its eastern suburbs.

KatrinaKatrina was predictedwas predicted

ØØTHE BIG ONETHE BIG ONEØØBy Mark By Mark SchleifsteinSchleifstein & John & John McQuaidMcQuaid

ØØ A major hurricane could decimate New A major hurricane could decimate New Orleans, but flooding from even a moderate Orleans, but flooding from even a moderate storm could kill thousands. storm could kill thousands.

ØØ It's just a matter of time.It's just a matter of time.

KatrinaKatrina was predictedwas predictedØØ KEEPING ITS HEAD ABOVE WATERKEEPING ITS HEAD ABOVE WATER

New Orleans faces doomsday scenarioNew Orleans faces doomsday scenarioBBy ERIC BERGERy ERIC BERGER

ØØ It's been 36 years since It's been 36 years since Hurricane BetsyHurricane Betsy buried New Orleans 8 feet deep. buried New Orleans 8 feet deep.

ØØ Since then a deteriorating ecosystem and increased development hSince then a deteriorating ecosystem and increased development have left the ave left the city in an ever more precarious position. city in an ever more precarious position.

ØØ The problem went unaddressed for decades by a laissezThe problem went unaddressed for decades by a laissez--faire government, faire government, experts said.experts said.

ØØ"To some extent, I think we've been lulled to sleep," said Marc "To some extent, I think we've been lulled to sleep," said Marc LevitanLevitan, , director of Louisiana State University's hurricane center.director of Louisiana State University's hurricane center.

HistoryHistory was bound to Repeatwas bound to Repeat

ØØ In September 1998 the debris along New Orleans' In September 1998 the debris along New Orleans' lakefront levees marked the wake of lakefront levees marked the wake of Hurricane GeorgesHurricane Georges. .

ØØ It also measured the slender margin separating the city It also measured the slender margin separating the city from mass destruction.from mass destruction.

ØØ The debris, showed that Georges, a Category 2 storm The debris, showed that Georges, a Category 2 storm that only grazed New Orleans, had pushed waves to that only grazed New Orleans, had pushed waves to within a foot of the top of the levees. within a foot of the top of the levees.

ØØ A stronger storm on a different course could have realized A stronger storm on a different course could have realized emergency officials' worstemergency officials' worst--case scenario.case scenario.ll Billions of gallons of lake water pouring over the levees into aBillions of gallons of lake water pouring over the levees into an n

area 5 feet below sea level with no natural means of drainage. area 5 feet below sea level with no natural means of drainage.

Computer ModelsComputer Models

ØØ With computer modeling of hurricanes and storm With computer modeling of hurricanes and storm surges, disaster experts had developed a surges, disaster experts had developed a detailed picture of how a storm could push detailed picture of how a storm could push Lake Lake PontchartrainPontchartrain over the levees and into New over the levees and into New Orleans, tOrleans, the worst case being a hurricane moving in he worst case being a hurricane moving in from due south. from due south.

ØØ That scenario would turn the city into a lake 30 feet That scenario would turn the city into a lake 30 feet deep, fouled with chemicals and waste from ruined deep, fouled with chemicals and waste from ruined septic systems, businesses and homes, trapping septic systems, businesses and homes, trapping thousands of people in buildings and vehicles.thousands of people in buildings and vehicles.

More detailMore detail

ØØ The scene has been played out for years in The scene has been played out for years in computer models and emergencycomputer models and emergency--operations operations simulations.simulations. Officials at the local, state and Officials at the local, state and national level are convinced the risk is genuine national level are convinced the risk is genuine and are devising plans for alleviating the and are devising plans for alleviating the aftermath of a disaster that could leave the city aftermath of a disaster that could leave the city uninhabitable for six months or more. The uninhabitable for six months or more. The Army Army Corps of EngineersCorps of Engineers has begun a study to see has begun a study to see whether the levees should be raised to counter whether the levees should be raised to counter the threat. But officials said that right now, the threat. But officials said that right now, nothing can stop "the big one."nothing can stop "the big one."

Filling the BowlFilling the Bowl

ØØ New Orleans lies in a low, flat coastal area/New Orleans lies in a low, flat coastal area/ØØ New Orleans has hurricane levees that create a New Orleans has hurricane levees that create a

bowl with the bottom dipping lower than the bowl with the bottom dipping lower than the bottom of Lake bottom of Lake PontchartrainPontchartrain. .

ØØ Though providing protection from weaker Though providing protection from weaker storms, the levees also trap any water that gets storms, the levees also trap any water that gets inside inside ---- by breach, overtopping or torrential by breach, overtopping or torrential downpour downpour ---- in a catastrophic storm. in a catastrophic storm.

ØØ "Filling the bowl" was the worst potential scenario "Filling the bowl" was the worst potential scenario for a natural disaster in the United States.for a natural disaster in the United States.

Play By PlayPlay By PlayØØ The The hurricanehurricane approaches from the south. approaches from the south. ØØ People People hopehope that hurricanethat hurricane--protection system protection system ““worksworks””. . ØØ Water is Water is pumpedpumped into Lake into Lake PontchartrainPontchartrain..ØØ The 20 foot deep lake becomes The 20 foot deep lake becomes 30 feet deep30 feet deep..ØØ Water flows through the Water flows through the gapsgaps around the lake. around the lake. ØØ The The eyeeye of the hurricane continues to move north.of the hurricane continues to move north.ØØ The The windswinds over the lake start to come from the north. over the lake start to come from the north. ØØ The winds blow south at The winds blow south at 100 mph100 mph..ØØ The water moves The water moves southsouth..ØØ The winds generate 10 foot high The winds generate 10 foot high waveswaves..ØØ The waves breaking and crash along the The waves breaking and crash along the sea wallsea wall. . ØØ The waves start breaking over the The waves start breaking over the levees.levees.ØØ The levee acts like a The levee acts like a weir,weir, as water pours over the top.as water pours over the top.ØØ The water The water floodsfloods the lakefront, filling up lowthe lakefront, filling up low--lying areas.lying areas.ØØ Pumping Pumping systems are overwhelmed and submerged in a matter of hours. systems are overwhelmed and submerged in a matter of hours. ØØ Parts of the levee Parts of the levee failfail as erosion occurs.as erosion occurs.ØØ Water flows through the city stopping only when it reaches the sWater flows through the city stopping only when it reaches the south louth leveeevee. .

FEMAFEMA lost a Gamblelost a Gamble

ØØ The projected death and destruction eclipsed any natural The projected death and destruction eclipsed any natural disaster that emergency officials had disaster that emergency officials had dremptdrempt up. up.

ØØ The risks were significant for New Orleans.The risks were significant for New Orleans.ØØ In a given year, the Army Corps of Engineers said that In a given year, the Army Corps of Engineers said that

the risk of the lakefront levees being topped was less the risk of the lakefront levees being topped was less than 1 in 300. than 1 in 300.

ØØ But over 30 years, that risk approached 10 percent. But over 30 years, that risk approached 10 percent. ØØ Federal Emergency Management Agency officials had Federal Emergency Management Agency officials had

begun working with state and local agencies to devise begun working with state and local agencies to devise plans on what to do plans on what to do ifif a Category 5 hurricane struck. a Category 5 hurricane struck.

After The Fact After The Fact ……

ØØ The LSU Hurricane Center was appointed by The LSU Hurricane Center was appointed by the State of Louisiana to lead the state's the State of Louisiana to lead the state's forensic investigation of the Hurricaneforensic investigation of the HurricaneKatrinaKatrina levee failureslevee failures. .

ØØ Dr. Dr. IvorIvor van van HeerdenHeerden leads a team of leads a team of engineers and coastal scientists conducting engineers and coastal scientists conducting analysis of the storm surge levels, levee analysis of the storm surge levels, levee construction, and levee failure mechanisms. construction, and levee failure mechanisms.

ØØ Known as Team Louisiana, this group Known as Team Louisiana, this group consists of LSU engineers, scientists, and consists of LSU engineers, scientists, and several wellseveral well--known local geotechnical known local geotechnical engineering experts. engineering experts.

I contacted the Hurricane CenterI contacted the Hurricane Center

ØØ HiHiØØ

ØØ My name is Ed May. I am preparing a talk for my local chapter My name is Ed May. I am preparing a talk for my local chapter of the American Society for Qualityof the American Society for Quality about a technique called about a technique called Failure Modes and Effects Analysis (FMEA). IFailure Modes and Effects Analysis (FMEA). I thought it would thought it would be interesting to find out if FEMA (Federal Emergency be interesting to find out if FEMA (Federal Emergency Management Agency) used FMEA.Management Agency) used FMEA. Since FEMA was not much Since FEMA was not much help I help I googledgoogled the internet and found your Hurricane the internet and found your Hurricane Department at LSU.Department at LSU. I would greatly appreciate finding out if I would greatly appreciate finding out if FMEA has been applied to the failure mechanisms of the dikes FMEA has been applied to the failure mechanisms of the dikes around New Orleans before Hurricane Katrinaaround New Orleans before Hurricane Katrina.. Or anything Or anything along those lines. Thanks.along those lines. Thanks.

ØØ

ØØ Prof May, ASQ CSSBBProf May, ASQ CSSBBØØ New Jersey Institute of TechnologyNew Jersey Institute of Technology

The Hurricane Center Wrote BackThe Hurricane Center Wrote Back

ØØ Prof MayProf May

ØØ I searched the entire 6,000 page IPET report so it is apparent tI searched the entire 6,000 page IPET report so it is apparent that hat the Corps is not using FMEAthe Corps is not using FMEA..

ØØ I recommend, however, that you look at Volume 9 that addresses tI recommend, however, that you look at Volume 9 that addresses the he subject of risk and probabilistic failure modeling.subject of risk and probabilistic failure modeling.

ØØ Best, PaulBest, PaulØØ

ØØ G. Paul Kemp, Ph.D.G. Paul Kemp, Ph.D.ØØ Associate Professor, ResearchAssociate Professor, ResearchØØ Director, Natural Systems Modeling GroupDirector, Natural Systems Modeling GroupØØ Louisiana State UniversityLouisiana State UniversityØØ School of the Coast and Environment & LSU Hurricane CenterSchool of the Coast and Environment & LSU Hurricane CenterØØ 1002Q Energy, Coast and Environment Bldg.1002Q Energy, Coast and Environment Bldg.ØØ Baton Rouge, Louisiana 70803Baton Rouge, Louisiana 70803

So What is So What is FMEAFMEA ??

ØØ FFailureailureØØ MMode &ode &ØØ EEffectsffectsØØ AAnalysisnalysis

HistoryHistory of FMEAof FMEAØØ The FMEA process was originally developed by the The FMEA process was originally developed by the US militaryUS military in the late in the late

19401940’’s to classify failures "according to their impact on mission sucs to classify failures "according to their impact on mission success and cess and personnel/equipment safety". personnel/equipment safety".

ØØ FMEA was used by FMEA was used by NASANASA on the 1960s Apollo space missions.on the 1960s Apollo space missions.ØØ FMEA was further developed by the FMEA was further developed by the aerospaceaerospace industry.industry.ØØ FMEA was adopted by the FMEA was adopted by the automotiveautomotive industry. industry. ØØ FMEA was used by FMEA was used by FordFord in the 1980in the 1980’’s to reduce risks after the Pinto s to reduce risks after the Pinto

suffered a fault in several vehicles causing the fuel tank to rusuffered a fault in several vehicles causing the fuel tank to rupture and burst pture and burst into flames after crashes.into flames after crashes.

ØØ FMEA use in FMEA use in healthcarehealthcare began in the early 1990s, around the time Six began in the early 1990s, around the time Six Sigma began to emerge as a viable process improvement methodologSigma began to emerge as a viable process improvement methodology.y.

ØØ Several industriesSeveral industries maintain formal FMEA standardsmaintain formal FMEA standards

FMEA around the WorldFMEA around the World

ØØ Analyse des Modes de DAnalyse des Modes de Dééfaillances de leurs Effetsfaillances de leurs Effets

ØØ FehlermFehlermööglichkeitsglichkeits -- und und EinflussanalyseEinflussanalyse

ØØ FaalFaal ToestandToestand En Effect En Effect AnalyseAnalyseØØ Effect Effect verminderdverminderd wordtwordtØØ ? ? :? ? : ? ? ? ? ?? ? ? ? ? ? ? ? ? ? ? ? ? ) ?? ? ? ? ? ? ? ? ) ?ØØ ? ?? ? ·· ? ? ?? ? ? ? ? ? ? ? ? ? ? ? ? ? ?? ? ? ? ? ? ? ? ? ? ? ?

? ? ? ? · ? ? ? ? ? ? ? ? ? ? ? ?? ? ? ? · ? ? ? ? ? ? ? ? ? ? ? ? ??

Some FMEA DefinitionsSome FMEA DefinitionsØØ Juran: Juran: ““A preventative technique for the designer to use to A preventative technique for the designer to use to

study the causes and effects of failures before the design is study the causes and effects of failures before the design is finishedfinished””. .

ØØ PyzdekPyzdek: : ““An attempt to delineate all of the possible failure An attempt to delineate all of the possible failure modes, their effect on the system, the likelihood of occurrence,modes, their effect on the system, the likelihood of occurrence,and the probability that the failure will go undetectedand the probability that the failure will go undetected””..

ØØ ““All the ways that failure can occur are examined. Action taken All the ways that failure can occur are examined. Action taken to minimize the chances of failure and the effect of failureto minimize the chances of failure and the effect of failure””..

FMEA is a stepFMEA is a step--byby--step Approachstep Approach

ØØ …… for identifying all possible failures in a design, for identifying all possible failures in a design, manufacturing / assembly process, or product / service. manufacturing / assembly process, or product / service.

ØØ ““Failure modesFailure modes”” means the ways, or modes, in which means the ways, or modes, in which something might fail. something might fail.

ØØ Failures are any errors or defects, especially ones that Failures are any errors or defects, especially ones that affect the customer.affect the customer.

ØØ Failures can be potential or actual. Failures can be potential or actual. ØØ ““Effects analysisEffects analysis”” refers to studying the consequences refers to studying the consequences

of those failures. of those failures. ØØ Failures are prioritized according to:Failures are prioritized according to:

ll how serious their consequences arehow serious their consequences arell how frequently they occur how frequently they occur ll how easily they can be detected. how easily they can be detected.

FMEA is a stepFMEA is a step--byby--step Approachstep Approach

ØØ The purpose of the FMEA is to take actions to eliminate The purpose of the FMEA is to take actions to eliminate or reduce failuresor reduce failuresll starting with the higheststarting with the highest--priority ones. priority ones.

ØØ FMEA documents current knowledge and actions about FMEA documents current knowledge and actions about the risks of failuresthe risks of failuresll for use in continuous improvement. for use in continuous improvement.

ØØ FMEA is used during design to prevent failures.FMEA is used during design to prevent failures.ØØ Later itLater it’’s used for control, before and during ongoing s used for control, before and during ongoing

operation of the process. operation of the process. ØØ FMEA begins during the earliest conceptual stages of FMEA begins during the earliest conceptual stages of

designdesignØØ FMEA continues throughout the life of the product or FMEA continues throughout the life of the product or

serviceservice. .

Types of Types of FMEAsFMEAsØØ FMECA (Failure Mode, Effects, Criticality Analysis):FMECA (Failure Mode, Effects, Criticality Analysis): Considers every possible failure mode Considers every possible failure mode

and its effect on the product/service. Goes a step above FMEA anand its effect on the product/service. Goes a step above FMEA and considers the criticality d considers the criticality of the effect and actions, which must be taken to compensate forof the effect and actions, which must be taken to compensate for this effect. (critical = loss this effect. (critical = loss of life/product). of life/product).

ØØ Design FMEADesign FMEA: Used to analyze component designs. Focuses on potential failur: Used to analyze component designs. Focuses on potential failure modes e modes associated with the functionality of a component caused by desigassociated with the functionality of a component caused by design. Failure modes may be n. Failure modes may be derived from causes identified in the System FMEA. derived from causes identified in the System FMEA.

ØØ Process FMEAProcess FMEA: Used to analyze transactional processes. Focus is on failure t: Used to analyze transactional processes. Focus is on failure to produce o produce intended requirement, a defect. Failure modes may stem from causintended requirement, a defect. Failure modes may stem from causes identified.es identified.

ØØ System FMEASystem FMEA: A specific category of Design FMEA used to analyze systems and: A specific category of Design FMEA used to analyze systems andsubsystems in the early concept and design stages. Focuses on posubsystems in the early concept and design stages. Focuses on potential failure modes tential failure modes associated with the functionality of a system caused by design.associated with the functionality of a system caused by design.

ØØ Service FMEAService FMEA-- focuses on service functions focuses on service functions

ØØ Software FMEASoftware FMEA -- focuses on software functions FMEA is most commonly applied butfocuses on software functions FMEA is most commonly applied but not not limited to design (Design FMEA) and manufacturing processes (Prolimited to design (Design FMEA) and manufacturing processes (Process FMEA).cess FMEA).

AIAG AIAG FMEAsFMEAsØØ DFMEA = Design Failure Modes Effects AnalysisDFMEA = Design Failure Modes Effects Analysis is a is a

systemized group of activities intended to:systemized group of activities intended to:ll Identify potential failures of a design before they occur. Identify potential failures of a design before they occur.

•• Establish the potential effects of the failuresEstablish the potential effects of the failuresll their causestheir causesll how often they occurhow often they occurll when they might occurwhen they might occurll their potential seriousness.their potential seriousness.

ØØ PFMEA = Process Failure Modes Effects AnalysisPFMEA = Process Failure Modes Effects Analysis is a is a systemized group of activities intended to:systemized group of activities intended to:ll Recognize the potential failure of a processRecognize the potential failure of a processll Evaluate the potential failure Evaluate the potential failure

•• Predict its effectPredict its effectll Identify actions which could eliminate or reduce the occurrenceIdentify actions which could eliminate or reduce the occurrencell or improve delectabilityor improve delectabilityll Document the processDocument the processll Track changes to process Track changes to process -- incorporated to avoid potential failures.incorporated to avoid potential failures.

FMEA & SIX SIGMAFMEA & SIX SIGMA

ØØ As a tool embedded within Six Sigma As a tool embedded within Six Sigma methodology, FMEA can help identify and methodology, FMEA can help identify and eliminate concerns early in the development of a eliminate concerns early in the development of a process or new service delivery.process or new service delivery.

ØØ It is a systematic way to examine a process It is a systematic way to examine a process prospectively for possible ways in which failure prospectively for possible ways in which failure can occur, and then to redesign the processes can occur, and then to redesign the processes so that the new model eliminates the possibility so that the new model eliminates the possibility of failure.of failure.

ØØ Properly executed, FMEA can assist in Properly executed, FMEA can assist in improving overall satisfaction and safety levels. improving overall satisfaction and safety levels.

FMEA in DMAIC / DMADV StagesFMEA in DMAIC / DMADV Stages

ØØ DesignDesignll determine high risk process activitiesdetermine high risk process activitiesll determine product featuresdetermine product features

ØØ Measure Measure ØØ Analyze Analyze

ll prioritize process activities prone to failureprioritize process activities prone to failurell prioritize product features prone to failureprioritize product features prone to failure

ØØ Improve (Design) Improve (Design) ll determine high risk process activitiesdetermine high risk process activitiesll determine high risk product featuresdetermine high risk product features

ØØ Control (Verify)Control (Verify)

ØØ Hardware approach: Hardware approach: ll DFSS projects on individual hardware items DFSS projects on individual hardware items

ØØ Functional approach:Functional approach:ll DMAIC projects to improve processes and systemsDMAIC projects to improve processes and systemsll DMADV projects to improve processes and systemsDMADV projects to improve processes and systems

FMEA Requires TeamworkFMEA Requires TeamworkØØ A cause creates a failure mode which creates an effect A cause creates a failure mode which creates an effect

on the customer. on the customer. ll Each team member must understand the process, subEach team member must understand the process, sub--

processes and interrelations.processes and interrelations.ll If people are confused in this phase, the process reflects If people are confused in this phase, the process reflects

confusion.confusion. FMEA requires teamwork: gathering information, FMEA requires teamwork: gathering information, making evaluations and implementing changes with making evaluations and implementing changes with accountability. accountability.

ll Combining Six Sigma, change management and FMEA you can Combining Six Sigma, change management and FMEA you can achieve:achieve:

•• Better qualityBetter quality•• Safer environmentSafer environment•• Greater efficiency and reduced costs Greater efficiency and reduced costs •• Stronger leadership capabilities Stronger leadership capabilities •• Increased revenue and market share Increased revenue and market share •• Optimized technology and workflowOptimized technology and workflow

Benefits of FMEABenefits of FMEA

ØØ FMEA is designed to help the team improve the quality FMEA is designed to help the team improve the quality and reliability of design. and reliability of design. ll Properly used the FMEA provides several benefits. Properly used the FMEA provides several benefits.

•• Improve product/process reliability and quality Improve product/process reliability and quality •• Increase customer satisfaction Increase customer satisfaction •• Early identification and elimination of potential Early identification and elimination of potential

product/process failure modes product/process failure modes •• Prioritize product/process deficiencies Prioritize product/process deficiencies •• Capture engineering/organization knowledge Capture engineering/organization knowledge •• Emphasizes problem prevention Emphasizes problem prevention •• Documents risk and actions taken to reduce risk Documents risk and actions taken to reduce risk •• Provide focus for improved testing and development Provide focus for improved testing and development •• Minimizes late changes and associated cost Minimizes late changes and associated cost •• Catalyst for teamwork and idea exchange between functions Catalyst for teamwork and idea exchange between functions

Another Look at FMEA BenefitsAnother Look at FMEA Benefits

ØØ Captures the collective knowledge of a team Captures the collective knowledge of a team ØØ Improves quality, reliability & safety of the process Improves quality, reliability & safety of the process ØØ Logical, structured way to ID process concerns Logical, structured way to ID process concerns ØØ Reduces process development time and cost Reduces process development time and cost ØØ Documents and tracks risk reduction activities Documents and tracks risk reduction activities ØØ Helps to identify CriticalHelps to identify Critical--ToTo--Quality characteristics Quality characteristics ØØ Provides historical records; establishes baseline Provides historical records; establishes baseline ØØ Helps increase customer satisfaction and safetyHelps increase customer satisfaction and safety

Applications of FMEAApplications of FMEAØØ FMEA / FMECA is a tool that has been adapted in many different FMEA / FMECA is a tool that has been adapted in many different

ways for many different purposes. ways for many different purposes. ØØ It can contribute to It can contribute to improved designsimproved designs for products and processes, for products and processes,

resulting in higher reliability, better quality, increased safetresulting in higher reliability, better quality, increased safety, y, enhanced customer satisfaction and reduced costs. enhanced customer satisfaction and reduced costs.

ØØ The tool can also be used to establish and optimize The tool can also be used to establish and optimize maintenance maintenance plansplans for repairable systems and/or contribute to for repairable systems and/or contribute to control planscontrol plans and and other quality assurance procedures.other quality assurance procedures.

ØØ It provides a It provides a knowledge baseknowledge base of failure mode and corrective action of failure mode and corrective action information that can be used as a resource in future troubleshooinformation that can be used as a resource in future troubleshooting ting efforts and as a training tool for new engineers.efforts and as a training tool for new engineers.

ØØ A FMEA or FMECA is often required to A FMEA or FMECA is often required to comply with safety and comply with safety and quality requirementsquality requirements, such as ISO 9001, QS 9000, ISO/TS 16949, , such as ISO 9001, QS 9000, ISO/TS 16949, Six Sigma, FDA Good Manufacturing Practices (Six Sigma, FDA Good Manufacturing Practices (GMPsGMPs), Process ), Process Safety Management Act (PSM), etc. Safety Management Act (PSM), etc.

Using Technology ToolsUsing Technology Tools

ØØ Pen and PaperPen and PaperØØWhite BoardWhite BoardØØ Flip ChartFlip ChartØØMicrosoft ExcelMicrosoft Excel®® spreadsheetspreadsheetØØMiniTabMiniTab ®®ØØ FMEA SoftwareFMEA Software

RISKRISKØØ Risk Management BasicsRisk Management Basics

Before going into the specifics of using FMEA, a brief review ofBefore going into the specifics of using FMEA, a brief review of the the risk analysis phase of risk management is in order.risk analysis phase of risk management is in order.

In analyzing risk, the first step is to identify all hazards andIn analyzing risk, the first step is to identify all hazards and harms harms associated with the device based on its characteristics and inteassociated with the device based on its characteristics and intended nded use.use. Why distinguish between hazard and harm? Because while a Why distinguish between hazard and harm? Because while a hazard is a potential source of harm, many hazards (such as hazard is a potential source of harm, many hazards (such as electrical, mechanical, or thermal energy) result in multiple foelectrical, mechanical, or thermal energy) result in multiple forms of rms of harm. It is in fact the harm that we are addressing in the risk harm. It is in fact the harm that we are addressing in the risk analysis process. Sometimes, of course, a given hazard may be analysis process. Sometimes, of course, a given hazard may be linked with a single harm. In this case, the two terms can (and linked with a single harm. In this case, the two terms can (and frequently are) used interchangeably.frequently are) used interchangeably.

RISKRISKØØ Once all hazards and harms have been identified, the analysis prOnce all hazards and harms have been identified, the analysis process is ocess is

completed by estimating the likelihood that the harm will occur completed by estimating the likelihood that the harm will occur and, in the and, in the event that it does, the severity of the resulting damage. Combinevent that it does, the severity of the resulting damage. Combining ing likelihood and severity (either graphically or mathematically) rlikelihood and severity (either graphically or mathematically) results in an esults in an expression of the risk associated with the hazard.expression of the risk associated with the hazard.

Following this analysis, the risk is evaluated. Is it necessary Following this analysis, the risk is evaluated. Is it necessary to reduce the to reduce the risk? Or is it inherently acceptable? Where the risk is not consrisk? Or is it inherently acceptable? Where the risk is not considered idered acceptable, specific actions, or mitigations, are identified to acceptable, specific actions, or mitigations, are identified to reduce, or reduce, or control, the risk.control, the risk.

After putting these controls in place, a new value for risk is eAfter putting these controls in place, a new value for risk is established for stablished for the hazard or harm. The mitigation is then evaluated to determinthe hazard or harm. The mitigation is then evaluated to determine whether e whether any new hazards or harms have been created. Then the evaluation any new hazards or harms have been created. Then the evaluation and, if and, if necessary, control processes are repeated necessary, control processes are repeated until the risk is found to be until the risk is found to be acceptable.acceptable.

FMEA FORMFMEA FORM

The basic processThe basic process

ØØ Describe the parts of a systemDescribe the parts of a systemØØ List the consequences if each part failsList the consequences if each part failsØØ Evaluate by three criteria and associated risk Evaluate by three criteria and associated risk

indices:indices:ll SS = Severity= Severityll OO or P = Probability of Occurrenceor P = Probability of Occurrencell DD = Inability of controls to detect it= Inability of controls to detect it

ØØ Each index ranges fromEach index ranges fromll 11 (lowest risk) to(lowest risk) toll 1010 (highest risk).(highest risk).

ØØ The overall risk of each failure isThe overall risk of each failure isll Risk Priority Number (RPN)Risk Priority Number (RPN)

The basic process (continued)The basic process (continued)

ØØ RPN = S RPN = S ×× O O ×× DDØØ For a failure with a:For a failure with a:ØØ severity of 6severity of 6ØØ detection of 3detection of 3ØØ occurrence of 6occurrence of 6ØØ RPN will be 108 (6 x 6 x 3 = 108). RPN will be 108 (6 x 6 x 3 = 108). ØØ The The RPN (ranging from 1 to 1000)RPN (ranging from 1 to 1000) is used to is used to

prioritize all potential failures to decide upon prioritize all potential failures to decide upon actions leading to reduce the risk, usually by actions leading to reduce the risk, usually by reducing likelihood of occurrencereducing likelihood of occurrence and and improving controls for detecting the failure.improving controls for detecting the failure.

The basic process (continued)The basic process (continued)

ØØ Since the purpose of an FMEA is to prevent Since the purpose of an FMEA is to prevent failures, actions should be taken to prevent failures, actions should be taken to prevent their occurrence.their occurrence.

ØØ The recommended preventive actions are The recommended preventive actions are generally suggested by the FMEA team generally suggested by the FMEA team during a brainstorming session. during a brainstorming session.

ØØ The reasons for failures are multifaceted; The reasons for failures are multifaceted; every failure can have several causes, so every failure can have several causes, so recommended preventive actions are better recommended preventive actions are better generated by cross functional team.generated by cross functional team.

The basic process (continued)The basic process (continued)ØØ Task ownerTask owner and projected and projected completion datecompletion dateØØ The task owner is the person or people who have been The task owner is the person or people who have been

assigned the task of mending the aspects of the product, assigned the task of mending the aspects of the product, process or design that are subject to failure. process or design that are subject to failure.

ØØ The projected completion date should also be determined to The projected completion date should also be determined to avoid procrastination and enforce accountability.avoid procrastination and enforce accountability.

ØØ Once the recommended actions are taken calculate the Once the recommended actions are taken calculate the new new RPNRPN

ØØ Here again, the Risk Priority Number will be the product of the Here again, the Risk Priority Number will be the product of the Detection, the Occurrence and the Severity. After the Detection, the Occurrence and the Severity. After the improvements have been made, the RPN is expected to be improvements have been made, the RPN is expected to be significantly lowersignificantly lower than it was beforethan it was before

Caterpillar Tractor Example Caterpillar Tractor Example

ØØ Component = springComponent = springØØ Possible Failure = brokenPossible Failure = broken

ll Cause 1Cause 1–– fatiguefatiguell Effect Effect –– lack of plate separation lack of plate separation ll Action 1Action 1–– design for lower stressdesign for lower stress

ll Cause 2Cause 2–– improper assemblyimproper assemblyll Effect Effect –– lack of plate separationlack of plate separationll Action 2Action 2–– provide assembly instructionprovide assembly instruction

FMEA / FMECA OverviewFMEA / FMECA Overview

ØØ Failure Modes, Effects and Criticality Analysis (FMEA / FMECA) Failure Modes, Effects and Criticality Analysis (FMEA / FMECA) requires the identification of the following basic information:requires the identification of the following basic information:

ØØ Item(sItem(s))ØØ Function(sFunction(s))ØØ Failure(sFailure(s))ØØ Effect(sEffect(s) of Failure) of FailureØØ Cause(sCause(s) of Failure) of FailureØØ Current Current Control(sControl(s))ØØ Recommended Recommended Action(sAction(s))ØØ Plus other relevant detailsPlus other relevant detailsØØ Most analyses of this type also include some method to assess thMost analyses of this type also include some method to assess the e

risk associated with the issues identified during the analysis arisk associated with the issues identified during the analysis and to nd to prioritize corrective actions. Two common methods include:prioritize corrective actions. Two common methods include:

ØØ Risk Priority Numbers (Risk Priority Numbers (RPNsRPNs))ØØ Criticality Analysis (FMEA with Criticality Analysis = FMECA)Criticality Analysis (FMEA with Criticality Analysis = FMECA)

Risk Priority NumbersRisk Priority NumbersØØ Risk Priority NumbersRisk Priority Numbers

To use the Risk Priority Number (RPN) method to assess risk, theTo use the Risk Priority Number (RPN) method to assess risk, theanalysis team must:analysis team must:

ØØ Rate the Rate the severityseverity of each effect of failure.of each effect of failure.ØØ Rate the likelihood of Rate the likelihood of occurrenceoccurrence for each cause of failure.for each cause of failure.ØØ Rate the likelihood of prior Rate the likelihood of prior detectiondetection for each cause of failure for each cause of failure

((i.e.i.e. the likelihood of detecting the problem before it reaches the likelihood of detecting the problem before it reaches the end user or customer).the end user or customer).

ØØ Calculate the RPN by obtaining the product of the three ratings:Calculate the RPN by obtaining the product of the three ratings:ØØ RPN = Severity x Occurrence x DetectionRPN = Severity x Occurrence x DetectionØØ The RPN can then be used to compare issues within the analysis The RPN can then be used to compare issues within the analysis

and to prioritize problems for corrective action. and to prioritize problems for corrective action.

ReducingReducing S S vsvs O O vsvs DD

ØØ Reducing Reducing SeveritySeverity Level requires a design Level requires a design change to the product or process change to the product or process –– costly or costly or impossibleimpossible

ØØ Reducing Reducing OccurrenceOccurrence Level is often the best Level is often the best approach approach –– reduction in process errors reduction in process errors ––reduces cost. reduces cost.

ØØ Reducing Reducing DetectionDetection Level increases cost Level increases cost with no improvement to quality (inspection, with no improvement to quality (inspection, etc.) etc.) –– non value added non value added –– hidden factory hidden factory --mudamuda (waste) (waste) –– costly short term solutioncostly short term solution

Severity ScaleSeverity Scale

No effectNo effect1

May noticeSlight disruption2

InconveniencedNoneMarginal Disruption3

DissatisfactionSlightMarginal Disruption4

Less ProductiveMinorSome lossMinor disruption5

ComplaintModerateSome lossModerate disruption6

Very dissatisfiedSignificantSome lossSignificant disruption7

Loss of Goodwill100% lossMajor disruption8

Potential violationSevere injury9

Violate lawLife threatening10

CustomerRemedyProduct / ServiceOperationsLegalSafetyLEVEL

SEVERITY TABLE

Example

Occurrence ScaleOccurrence Scale

>1.67< 1 in 150,000Remote1

1.501 in 150,000Very Low2

1.331 in 15,000Low3

1.171 in 2,000Moderate4

1.001 in 400Moderate5

0.831 in 80Moderate6

0.671 in 20High7

0.511 in 8Fairly High8

0.331 in 3Very High9

<.33>1 in 2~Inevitable10

ValueRateFailureLEVEL

CpkFailureProbable

OCCURRENCE

Example

Detection ScaleDetection Scale

~ 0 %Nearly certain to detect before customer1

0 to 1 %Extremely low probability of reaching customer2

1 to 5 %Very low probability of reaching customer3

5 to 20 %Likely to be detected before customer4

20 to 50 %Might be detected before customer5

50 to 70 %Unlikely to be detected before customer6

70 to 90 %Highly unlikely to be detected before customer7

90 to 95 %Poor chance of detection8

95 to 99 %Extremely poor chance of detection9

~100 %Nearly certain that failure won't be detected10

(Not to detect)(Difficulty to detect)LEVEL

ProbabilityDescription

DETECTION

Example

Worksheet exampleWorksheet example

ØØ ColumnsColumnsØØ Function = Tank overflow valveFunction = Tank overflow valveØØ Potential Failure Mode = Valve stem sticksPotential Failure Mode = Valve stem sticksØØ Potential Failure Effect = Tank overflowsPotential Failure Effect = Tank overflowsØØ Potential Causes = Packing ID undersizePotential Causes = Packing ID undersizeØØ Current Prevention Controls = Tolerance on packing ID SeverityCurrent Prevention Controls = Tolerance on packing ID SeverityØØ Current Detection Methods = Test valve after assembly Current Detection Methods = Test valve after assembly ØØ Before Severity Before Severity 99; Before Occurrence ; Before Occurrence 66; Before Detection ; Before Detection 55ØØ RPN RPN 270 270 ØØ Recommended Action Alignment Guides Recommended Action Alignment Guides ØØ Responsibility Jones Due Date 4/8/3Responsibility Jones Due Date 4/8/3ØØ Actions taken Guides addedActions taken Guides addedØØ After Severity After Severity 99; After Occurrence ; After Occurrence 11; After Detection ; After Detection 55ØØ After RPN After RPN 4545

FMEA Example in Excel (Before)FMEA Example in Excel (Before)

AssemblyID

AfterPackingUndersizeSticksValve

ValveOn IDOverflowsStemOverflow

270569TestTolerancePackingTankValveTankTank

NTCVControlsControlsCausesEffectsModesFunctionName

PECEDetectionPreventionFailureFailureFailurePartNumber

RDOSCurrentCurrentPotentialPotentialPotentialIdentifyPart

Before

FMEA Example in Excel (After)FMEA Example in Excel (After)

Installed13thGuides

GuidesOctoberPlumberAlignment

# 14a45519AlignmentFridayImaInstall

ItemNTCVTakenDateTaskedPlan

PlanPECEActionsDueIsAction

ControlRDOSWhatActionWhoMake

FMEA StepsFMEA Steps

ØØ Brainstorm all the potential failures modesBrainstorm all the potential failures modesØØ List themList themØØ Identify potential causesIdentify potential causesØØ Develop a rating scaleDevelop a rating scaleØØ Rate factors re S O DRate factors re S O DØØ S x O x D = RPNS x O x D = RPNØØ Rank by descending RPNRank by descending RPNØØ How to reduce How to reduce RPNsRPNsØØ ActionsActionsØØ New RPNNew RPN

A problem with RPN? A problem with RPN? ØØ The Six Sigma PractitionerThe Six Sigma Practitioner’’s Guide to Data Analysis by Donald Wheelers Guide to Data Analysis by Donald WheelerØØ Versus Versus RPNRPN’’ss ! ~ Only 120 RPN values! ~ Only 120 RPN valuesØØ Not uniformly spread out between 1 and 1000Not uniformly spread out between 1 and 1000ØØ 1000 different situations mapped onto 120 values in a nonlinear 1000 different situations mapped onto 120 values in a nonlinear mannermannerØØ Equivalent Equivalent RPNRPN’’ss not really equal ~ Not correct to rank by RPN !?not really equal ~ Not correct to rank by RPN !?ØØ SOD = ordinal scale dataSOD = ordinal scale dataØØ Adding and subtracting require interval scale data (degrees F oAdding and subtracting require interval scale data (degrees F or C)r C)ØØ Multiplying and dividing require ratio scale data (Absolute or Multiplying and dividing require ratio scale data (Absolute or Kelvin scales)Kelvin scales)ØØ In the Design Phase there is a rationale for doing FMEAIn the Design Phase there is a rationale for doing FMEAØØ Three scales and ranking are OK but not RPNThree scales and ranking are OK but not RPNØØ Solution: Solution:

ll Systematic overall rankingSystematic overall ranking•• use 0 to 9 plus a 3 digit code for each failure mode SOD codeuse 0 to 9 plus a 3 digit code for each failure mode SOD code•• 1000 values for 1000 situations1000 values for 1000 situations•• S then O then DS then O then D

Other Scales & GuidelinesOther Scales & Guidelines

ØØ Other Scales: Other Scales: ll 1 to 31 to 3ll 1 to 51 to 5ll 0 to 90 to 9

ØØ Other Guidelines : Other Guidelines : ØØ RPN > 100, Severity first (AIAG)RPN > 100, Severity first (AIAG)ØØ RPN > 120 (Boeing) RPN > 120 (Boeing)

FMECAFMECAØØ Criticality AnalysisCriticality Analysis

The MILThe MIL--STDSTD--1629A document describes two types of criticality analysis:1629A document describes two types of criticality analysis:

ØØ To use the To use the Quantitative Criticality Analysis MethodQuantitative Criticality Analysis Method, the analysis team must:, the analysis team must:ll Define the reliability/unreliability for each item, at a given oDefine the reliability/unreliability for each item, at a given operating time.perating time.ll Identify the portion of the itemIdentify the portion of the item’’s unreliability attributed to each potential failure mode.s unreliability attributed to each potential failure mode.ll Rate the probability of loss (or severity) that will result fromRate the probability of loss (or severity) that will result from each failure mode each failure mode ll Calculate the criticality for each potential failure mode by obtCalculate the criticality for each potential failure mode by obtaining the product of the aining the product of the

three factors:three factors:ll Mode Criticality = Item Unreliability x Mode Ratio of UnreliabilMode Criticality = Item Unreliability x Mode Ratio of Unreliability x Probability of Lossity x Probability of Lossll Calculate the criticality for each item by obtaining the sum of Calculate the criticality for each item by obtaining the sum of the criticalities for each the criticalities for each

failure mode that has been identified for the item.failure mode that has been identified for the item.ll Item Criticality = SUM of Mode CriticalitiesItem Criticality = SUM of Mode Criticalities

ØØ To use the To use the Qualitative Criticality Analysis MethodQualitative Criticality Analysis Method: the analysis team must:: the analysis team must:ll Rate the severity of the potential effects of failure.Rate the severity of the potential effects of failure.ll Rate the likelihood of occurrence for each potential failure modRate the likelihood of occurrence for each potential failure mode.e.ll Compare failure modes via a Criticality MatrixCompare failure modes via a Criticality Matrix

•• identifingidentifing severity on the horizontal axisseverity on the horizontal axis•• identifying occurrence on the vertical axis. identifying occurrence on the vertical axis.

Basic Analysis ProcedureBasic Analysis Procedurefor FMEA or FMECAfor FMEA or FMECA

ØØ AAssemble the teamssemble the teamØØ Establish the ground rulesEstablish the ground rulesØØ Gather and review relevant informationGather and review relevant informationØØ Identify the Identify the item(sitem(s) or ) or process(esprocess(es) to be analyzed) to be analyzedØØ Identify the Identify the function(sfunction(s), ), failure(sfailure(s), ), effect(seffect(s), ), cause(scause(s) )

and and control(scontrol(s) for each item or process ) for each item or process ØØ Evaluate risk associated with the issues identified Evaluate risk associated with the issues identified ØØ Prioritize and assign corrective actionsPrioritize and assign corrective actionsØØ Perform corrective actions and rePerform corrective actions and re--evaluate riskevaluate riskØØ Distribute, review, update the analysisDistribute, review, update the analysis

FMEA StandardsFMEA StandardsØØ There are a number of published guidelines and standards for theThere are a number of published guidelines and standards for the

requirements and recommended reporting format of FMEArequirements and recommended reporting format of FMEAll SAE J1739SAE J1739ll AIAG FMEAAIAG FMEA--3 3 ll MILMIL--STDSTD--1629A1629A ((criticality analysis)criticality analysis)ll MILMIL--STDSTD--882D (4 levels of severity, 22 tasks to eliminate)882D (4 levels of severity, 22 tasks to eliminate)ll 21 CFR 21 CFR §§820 (FDA GMP)820 (FDA GMP)ll JCAHO Standard Req. L.D. 5.2 JCAHO Standard Req. L.D. 5.2

ØØ In addition, a FMEA (or FMECA) is often required to comply with In addition, a FMEA (or FMECA) is often required to comply with safety and quality requirements, such as:safety and quality requirements, such as:ll ISO 14971 medical devices ISO 14971 medical devices ll EN 1441EN 1441ll IEC 60601IEC 60601--11ll IEC 60812 system reliabilityIEC 60812 system reliabilityll QS 9000 American AutomotiveQS 9000 American Automotivell ISO/TS 16949 Global AutomotiveISO/TS 16949 Global Automotivell Process Safety Management Act (PSM)Process Safety Management Act (PSM)

Related ToolsRelated ToolsØØ AFD Anticipatory Failure Determination AFD Anticipatory Failure Determination -- an an

application of Iapplication of I--TRIZ specifically designed for Failure Analysis TRIZ specifically designed for Failure Analysis and Failure Prediction.and Failure Prediction.

ØØ FTA Fault Tree Analysis FTA Fault Tree Analysis –– another method for studying another method for studying potential failures potential failures –– applied only to failures considered serious applied only to failures considered serious enough to warrant detailed analysis enough to warrant detailed analysis -- top down approach that top down approach that starts with supposing that an accident takes placestarts with supposing that an accident takes place –– then looks then looks for origins of causes for origins of causes –– then ways to avoid origins and causes. then ways to avoid origins and causes. Reverse of FMECAReverse of FMECA which starts with origins and causes and which starts with origins and causes and looks for resulting bad effects.looks for resulting bad effects.

ØØ HTA HTA Hazard Tree AnalysisHazard Tree Analysis

ØØ HAZOPHAZOP Hazard and Operability AnalysisHazard and Operability Analysis

Printed Resources forPrinted Resources forFMEA and FMECAFMEA and FMECA

ØØ International International ElectrotechnicalElectrotechnical Commission (IEC), ACommission (IEC), Analysis Techniques for nalysis Techniques for System Reliability: Procedure for Failure Mode and Effects AnalySystem Reliability: Procedure for Failure Mode and Effects Analysis (FMEA)sis (FMEA), , July 1985.July 1985.

ØØ KececiogluKececioglu, , DimitriDimitri, , Reliability Engineering Handbook Volume 2Reliability Engineering Handbook Volume 2. Prentice. Prentice--Hall Hall Inc., Englewood Cliffs, New Jersey, 1991. Pages 473Inc., Englewood Cliffs, New Jersey, 1991. Pages 473--506.506.

ØØ McDermott, Robin E., Raymond J. McDermott, Robin E., Raymond J. MikulakMikulak and Michael R. Beauregard, and Michael R. Beauregard, The The Basics of FMEABasics of FMEA. Productivity Inc., United States, 1996.. Productivity Inc., United States, 1996.

ØØ StamatisStamatis, D.H., , D.H., Failure Mode and Effect Analysis: FMEA from Theory to Failure Mode and Effect Analysis: FMEA from Theory to ExecutionExecution. American Society for Quality (ASQ), Milwaukee, Wisconsin, 1995. American Society for Quality (ASQ), Milwaukee, Wisconsin, 1995..

ØØ Society of Automotive Engineers (SAE), Society of Automotive Engineers (SAE), Aerospace Recommended Practice Aerospace Recommended Practice ARP5580: Recommended Failure Modes and Effects Analysis (FMEA) PARP5580: Recommended Failure Modes and Effects Analysis (FMEA) Practices ractices for Nonfor Non--Automobile ApplicationsAutomobile Applications, June 2000., June 2000.

ØØ Society of Automotive Engineers (SAE), Society of Automotive Engineers (SAE), Surface Vehicle Recommended Surface Vehicle Recommended Practice J1739: (R) Potential Failure Mode and Effects Analysis Practice J1739: (R) Potential Failure Mode and Effects Analysis in Design in Design (Design FMEA), Potential Failure Mode and Effects Analysis in Ma(Design FMEA), Potential Failure Mode and Effects Analysis in Manufacturing nufacturing and Assembly Processes (Process FMEA), and Potential Failure Modand Assembly Processes (Process FMEA), and Potential Failure Mode and e and Effects Analysis for Machinery (Machinery FMEA)Effects Analysis for Machinery (Machinery FMEA), June 2000., June 2000.

ØØ U.S. Department of Defense, U.S. Department of Defense, MILMIL--STDSTD--1629A: Procedures for Performing a 1629A: Procedures for Performing a Failure Mode Effects and Criticality AnalysisFailure Mode Effects and Criticality Analysis, Cancelled in November, 1984., Cancelled in November, 1984.

Other FMEA ReferencesOther FMEA ReferencesØØ Total Quality Control, 3e by Total Quality Control, 3e by FeigenbaumFeigenbaumØØ Quality Control Handbook 3e by JuranQuality Control Handbook 3e by JuranØØ JuranJuran’’ss Quality Planning & Analysis for Enterprise Quality 5e by Quality Planning & Analysis for Enterprise Quality 5e by GrynaGryna, Chua, , Chua, DeFeoDeFeo

ØØ The Six Sigma Handbook 2e by The Six Sigma Handbook 2e by PyzdekPyzdekØØ The Certified Six Sigma Black Belt Handbook by The Certified Six Sigma Black Belt Handbook by BenbowBenbow and and KubiakKubiakØØ Six Sigma Six Sigma DeMystifiedDeMystified by Keller by Keller ØØ The Six Sigma Way Team The Six Sigma Way Team FieldbookFieldbook by by PandePande, , NeumanNeuman, , CavanaghCavanaghØØ RathRath & Strong& Strong’’s Six Sigma Pocket Guide Revised Edition s Six Sigma Pocket Guide Revised Edition ØØ Six Sigma for the Millennium Six Sigma for the Millennium -- A CSSBB handbook by Kim PriesA CSSBB handbook by Kim PriesØØ Quality Council of Indiana Quality Council of Indiana -- CSSGB (2006) AND CSSBB (2001) PrimersCSSGB (2006) AND CSSBB (2001) PrimersØØ The Six Sigma PractitionerThe Six Sigma Practitioner’’s Guide to Data Analysis by Donald Wheelers Guide to Data Analysis by Donald WheelerØØ Quality Progress articles by Dan ReidQuality Progress articles by Dan Reid

INFO ON WEBINFO ON WEB

ØØ References:References:ØØ www.fmeainfocentre.comwww.fmeainfocentre.comØØ www.isixsigma.comwww.isixsigma.com

ØØ SAE InternationalSAE International:: The Society for Automotive Engineers provides the ability to puThe Society for Automotive Engineers provides the ability to purchase rchase the J1739 and ARP5580 standards, as well as the AIR4845 documentthe J1739 and ARP5580 standards, as well as the AIR4845 document..

ØØ AIAGAIAG:: The Automotive Industry Action Group provides the ability to puThe Automotive Industry Action Group provides the ability to purchase the AIAG rchase the AIAG FMEA Third Edition (FMEAFMEA Third Edition (FMEA--3) guidelines.3) guidelines.

ØØ IECIEC:: The International The International ElectrotechnicalElectrotechnical Commission provides the ability to purchase the Commission provides the ability to purchase the IEC 60812 standard.IEC 60812 standard.

ØØ ReliabilityReliability--Related Military Handbooks and Standards on Related Military Handbooks and Standards on weibull.comweibull.com:: This site provides access This site provides access to U.S. Department of Defense standards and handbooks in PDF forto U.S. Department of Defense standards and handbooks in PDF format, including the MILmat, including the MIL--STDSTD--1629A standard for Failure Modes, Effects and Criticality Analys1629A standard for Failure Modes, Effects and Criticality Analysis (FMECA) analysis.is (FMECA) analysis.

ØØ FMEA Info CenterFMEA Info Center:: This site provides information on books, publications, standardThis site provides information on books, publications, standards, s, software, consultants and other resources related to Failure Modsoftware, consultants and other resources related to Failure Mode and Effects Analysis e and Effects Analysis (FMEA). It also provides an on(FMEA). It also provides an on--line discussion list.line discussion list.

ØØ NASA STI Special Bibliography for FMEANASA STI Special Bibliography for FMEA:: NASA's Scientific and Technical Information (STI) NASA's Scientific and Technical Information (STI) program provides a "sampler bibliography" that contains abstractprogram provides a "sampler bibliography" that contains abstracts for documents related s for documents related to Failure Mode and Effects Analysis ( FMEA) and Failure Modes, to Failure Mode and Effects Analysis ( FMEA) and Failure Modes, Effects and Criticality Effects and Criticality Analysis (FMECA) in the NASA STI Database.Analysis (FMECA) in the NASA STI Database.

ConclusionsConclusions

ØØ FMEAFMEA is a useful toolis a useful tool

ØØMike Brown had his 15 minutes of Mike Brown had his 15 minutes of FAMEFAME

ØØ FEMAFEMA should have used should have used FMEAFMEA

ØØ Questions ?Questions ?

Ed May - Short BioØ Ed May is an American Society for QualityØ ‘Certified Six Sigma Black Belt’Ø who specializes in ISO 9000, Six Sigma Quality, and Lean Thinking. Ø Ed has degrees in engineering and business. Ø He held positions in management, engineering, Ø manufacturing, and quality in several manufacturingØ companies before he became a quality consultant,Ø adjunct instructor, and on-site trainer. Ø Ed is the founder of MAYplewood Consulting, Ø an Adjunct Instructor for both New Jersey InstituteØ of Technology and Union County College, andØ a quality trainer at many local companies. Ø Ed also teaches Saturday Six Sigma Classes for North Jersey ASQ.Ø Ed has been the guest speaker at many technical societyØ meetings and conferences including ASQ.

For More Info For More Info

ØØ Ed May, ASQ CSSBBEd May, ASQ CSSBBØØ www.MAYplewoodconsulting.comwww.MAYplewoodconsulting.comØØ Phone: 973.761.1774Phone: 973.761.1774ØØ Fax No: 973.761.4174Fax No: 973.761.4174ØØ [email protected]@aol.com

FMEA, FEMA, & FAMEFMEA, FEMA, & FAME

Would Mike Brown be Would Mike Brown be famousfamous todaytodayif if FEMAFEMA had used had used FMEAFMEA??

ASQ North JerseyASQ North JerseyDinner MeetingDinner Meeting

Wednesday, November 15, 2006Wednesday, November 15, 2006

Presented by Ed May,Presented by Ed May, ASQ CSSBBASQ CSSBB