FAIL MODE ANLS DES
FAIL MODE ANLS DES ETM 5291
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This 0 page Class Notes was uploaded by Xander Quitzon III on Sunday November 1, 2015. The Class Notes belongs to ETM 5291 at Oklahoma State University taught by Staff in Fall. Since its upload, it has received 21 views. For similar materials see /class/232770/etm-5291-oklahoma-state-university in Electronics Technology at Oklahoma State University.
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Date Created: 11/01/15
Failure Mode and Effect Analysis Lecture 51 Advanced FMEA FMEA in Health Care Other HighRisk Industries References FMEA in Reducing Medical Errors Thomas T Reiley MD MHS ASQ Healthcare Divin39on Newsletter Winter 200 FMEA Advanced FM EA Reference Eubanks CF Kmenta S Kosuka 1 Advanced Failure Mode and Effects Analysis Using Behavior Modeling 1997 ASME Design Engineering Technical Conference 97DETC DTM02 Shortcomings of FMEA FMEA Three problems with traditional FMEA in order of importance are 1 FMEA is performed to late and not used to influence design decisions 2 FMEA does not capture many potential failures 3 The process for performing FMEA is subjective and tedious Examples of Shortcomings FMEA Examples of documented shortcomings of FMEA are c FMEA is applied too late and in such detail that it misses key systemwide inservice failure modes 0 Performing FMEA late does not affect important design and process decisions 0 The analysis is often an afterthought performed as a boxchecking exercise 0 V thout a systematic approach engineers produce a subjective analysis that depends on their experience level 0 FMEA is tedious and timeconsuming Systems Aspect of FM EA FMEA A standard FMEA is likely to miss some failure modes because it may not account for issues related to an item s interface with the rest of the system Rule of Thumb Always seek to optimize the next hight level system Helps you avoid the problem of suboptimizing the design to a subsystem level Advanced FM EA FMEA AFMEA applies to the early stages of design and captures failure modes normally missed with conventional FMEA AFMEA uses behavior modeling to link desired behaviors with components environment and supporting systems Approach FMEA Guided by the function structure relationship one can build a behavior model describing the state changes of variables expected during normal operation The model qualitatively simulates normal operation and analyzes the effects of failures in terms of the resulting system state Advantages of Behavior ModelingMEA Behaviors do not rely entirely on physical structure Behaviors can reflect customer s desired requirements Provides a systematic framework for generating failure modes Basic Concepts FMEA Functional Block Diagram Ice maker quot7 I Make Ice Cubes Eachbehavioris mapped to 3 Initial State no ice Desired Final State SpeCI C state cubes in bucket t ice cubes in bucket transition 39 9 Behavior Specification FMEA 1 BEHAVIOR 2 INITIAL STATE FINAL STATE deP0539t ice cubes in bucket no ice cubes in bucket ice cubes in bucket l l ltOBJECTgtltATTRUBUTEgtltVALUEgt ltOBJECTgtltATTRUBUTEgtltVALUEgt ICE BUCKET CUBE LEVEL NOT FULL ICE BUCKET CUBE LEVEL FULL SWITCH POSITION CLOSED COIL STATUS ENERGIZED CAM POSITION 15 DEG Behaviors can be described Verbally cause water flow to increase Quantitativer ow rate increases to 03 m3sec Mathematically V Decompose Behaviors FMEA BEHAVIOR deposit ice cubes in bucket deposit create Ice CUbeS ice cubes in bucket l Function Structure Mapping FMEA FUNCTION Assessicelml STRUCTURE Feeler arm ver39fy Close swrtch Ice cube cube need Arm swrtch level ActIvate harvest IInkage sensor Fl wnh water Feeler arm swnch create Freeze water Ice mom Ice CUbes Freezer 5 stem creation Deposquot Create nom quaIIty Y t ce cubes in sys em maker b k t Nomlnal geometry Water deIIvery quot 3 e system Harvest Loosen Ice cubes Remove Ice Mold heatlng sys Harvesting Sense Ice level V HarvestIng sys yStem el39l bucket full Wequot SWquot h 12 DeractIvate harvest Ice Maker State Variables FMEA Behavior Model Identifying Failure Modes FMEA Failure condition where achieved final state does not match desired final state 3 types of failure modes nonbehaviors undesired behaviors misbehaviors Nonbehaviors FMEA Select a behavior for investigation Consider it not to occur Simulate how the system responds Compare list of resulting final state variable values with list of desired values to indicate which system or component failed Comparison FMEA Users ofAFMEA claim it captures a richer set of potential failure modes than traditional FMEA Many failure modes can be captured which do not necessarily relate to components but to interaction with system components FAILURE MODE FMEA AFMEA thermostat failure Comparison of faiure water switch failure yes yes modes captured by feeler arm damaged yes yes power cord disconnected yes yes FMEA and AFMEA highlow water pressure no yes bucket misplacement no yes refrigerator misalignment no yes iced gears no yes high freezer temperature no yes 17 FMEA FMEA in Health Care Reference FMEA in Reducing Medical Errors Thomas T Reiley MD MHS ASQ Healthcare Divin39on Newxletter Winter 2001 18 Medical Situation FMEA 25 billion prescriptions dispensed from pharmacies 35 billion drug administrations delivered in a hospital setting Medications errors in hospitalized patients is about 2 Increased average hospital stay 46 days Increased average cost of hospitalization 4700 per admission 28 million per year for a 700 bed teaching hospital Medical Errors FMEA Adverse human events injuries caused by medical management rather than by underlying disease or patient condition Medical errors adverse human events may or may not result from an error Human Error FMEA The problem of medical systems like all human systems is that humans err Human error becomes an accident when the preventive errorproofing processes within the system are inadequate latent system faults Impact on the system is often delayed Potential Failure Modes FMEA Wrong drugIV Toorapid IV ow rate Allergy to drug Omitted drug Wrong drug for patient s Wrong patient disease Wrong time Incorrect administration Wrong route teChnique Wrong procedure wrong diluent Wrong test procedure Wrong dose Violation of orders Wrong label directions Wrong preparation Excessive dose Insuf cient dose Wrong concentration Potential Causes FMEA Human knowledge Chaotic work environment Unauthorized floor stocks Using floor stock medications Not following policies Verbal orders Human performance Lack of personnel lV solutions that are not premixed Unnecessary use of medications Lack of dose verification process Math errors Typographical mistakes Poor handwriting Example Acronyms Coined names Multidose vials Defective packaging Similar packaging Lack of dose limits Similar drug names Borrowing medications from a multipledose cart Dangerous abbreviations OD amp QD for once daily U for unit Lack of interdisciplinary team review of medication errors Unnecessary use of IVs catheters and nasogastric tubes Lack of dosage check for highrisk drugs and pediatric patients medications 23 FMEA Errors recorded during one quarter other Not transcribed calculation of close in error IV infiltration drug labelling error staff education issue Equipmenttubing issue oral communication error Medication not given Order overlooked forgotten e I39I39OI39 Pharmacy misread order Severity FMEA Severity of Effects noncritical illness does not improve noncritical illness worsens noncritical illness becomes critical noncritical illness becomes fatal 1 00030 25 Figure 1 Heallhcare FMEA Process Steps 1 and 2 Slap 1 preduel to be sludled Slap 2 Assemble lhe Team FMEA Number Dale smell Date Compleleel Team Members l 4 2 5 a 5 Team Leader Are all alfecmd areas vepvesenled YES no Are differenl levels and types ol knowledge represenled on me team vzs No 26 Figure 2 Healthcare FMEA Worksheet 27 Figure 3 Severity Rating 4 39 r PalHIE 7 Failure Evamahun and 28 Figure 4 Probability Ra ng 39MEA Frequent leely nu occur mmsedrmety or wunin a short penuu may happen several Hmes m one year Occasional Probably wru ucwr may happen several llmes n 1 m 2 years Uncommon Possmre to occur may happen somerime in 2 lo 5 years Remote Unhkely IO OLur y r 10 30 years Figure 5 Hazard Scoring Matrix Prohalal my Hypothetical Failure Mode and 15mm Analysis mm Anymm MANmm mmmym Pu r r m mm yummy mmsazmskmmm Mum mm mm lineman yr 11 n am Mon new H mhahca Hypmhahca y Eaus lsl r we Mechamsmls Eomv atmn Ammns Yaken mm Data mam wun mm mmdhymsm mhwm Vusmn 1 n http www datakel com auFMEAlinkshtm may Assumes W FMEA Other HighRisk Industries Heavy Industry FMEA Alcoa reported 183100 employees missing at least 1 day per year due to onthejob injuries Industry average 5100 Rate lowered to 014100 through Employee incentives to report unsafe conditions FMEA Root cause analysis of each incident Construction FMEA FMEA used to anticipate potential problems in construction Potential problem analysis used to analyze project plans and develop contingent actions Shipbuilders primarily US Navy use FMEA to improve safety for workers Packaging Industry FMEA Key environmental decisions are made during the design of a new or modified package The requirements of our proprietary Package Development Protoco include a Failure Mode and Effects Analysis FMEA to make certain the issues of package integrity are addressed from manufacture to retail customer This ensures the contents stay in the package until opened by the customer R A Miller amp Co NASA FMEA o The goal of the Failure Modes and Effects Analysis FMEA is to anticipate identify and avoid failures in the operation of a new system while the system is still on the drawing board The recent occurrence of failures in some new systems in operation has had disastrous effects on many lives These events prompted the author to evaluate the documented problems and to seek improvements in FMEA procedures and their application The result was surprising While a great number of procedures exist not one single FMEA procedure could be found as an all encompassing document Each FMEA procedure was different It is believed that the recent disasters could have possibly been avoided if a good FMEA procedure had been applied during development A simple complete FMEA procedure is proposed NASA Scientific and Technical Information STI Program Feb2000 httpwwwsti nasagovneWfmea33 htm128 Supply Chain FMEA Many organizations are training their key suppliers in FMEA techniques Focus is on Process FM EA at the supplier site Potential issues with ramp to vaolume production Prevention of disruption in the supply chain Disaster prevention and contingency Mining Industry FMEA CauseConsequence Diagrams Potential Failure Intermediate Conseguences Component Events 7 Isolation at Isolation at Plplng 10 minutes Small release Valves Medium release Flanges etc Large release Time Fault Tree Event Tree Limitations of FMEA FMEA Although the FMEA methodology is highly effective in analyzing various system failure modes this technique has four limitations Examination of human error is limited Focus is on singleevent initiators of problems Examination of external influences is limited Results are dependent on the mode of operation