FMEAFMEA

By Andy KlimesBy Andy Klimes

OutlineOutline

• What is FMEA?What is FMEA?• History History • BenefitsBenefits• ApplicationsApplications• ProcedureProcedure• Sample WorksheetSample Worksheet• Patient Safety StandardsPatient Safety Standards• ExerciseExercise• SummarySummary

What is FMEA?What is FMEA?

• FMEA is an acronym that stands for FMEA is an acronym that stands for Failure Modes and Effects AnalysisFailure Modes and Effects Analysis

• Methodology of FMEA:Methodology of FMEA:– Identify the potential failure of a system and Identify the potential failure of a system and

its effectsits effects– Assess the failures to determine actions that Assess the failures to determine actions that

would eliminate the chance of occurrencewould eliminate the chance of occurrence– Document the potential failuresDocument the potential failures

History of FMEAHistory of FMEA

• Created by the aerospace industry in the Created by the aerospace industry in the 1960s.1960s.

• Ford began using FMEA in 1972.Ford began using FMEA in 1972.• Incorporated by the “Big Three” in 1988.Incorporated by the “Big Three” in 1988.• Automotive Industry Action Group and Automotive Industry Action Group and

American Society for Quality Control American Society for Quality Control copyright standards in 1993.copyright standards in 1993.

What are the Benefits?What are the Benefits?

• Improvements in:Improvements in:– SafetySafety– QualityQuality– ReliabilityReliability

Benefits cont.Benefits cont.

• What other potential benefits can What other potential benefits can be identified?be identified?– Company imageCompany image– User satisfactionUser satisfaction– Lower development costsLower development costs– Presence of a historical recordPresence of a historical record

ApplicationsApplications

• ConceptConcept• DesignDesign• ProcessProcess• ServiceService• EquipmentEquipment

FMEA ProcedureFMEA Procedure

• Assign a label to each system Assign a label to each system componentcomponent

• Describe the functions of each partDescribe the functions of each part• Identify potential failures for each Identify potential failures for each

functionfunction

Procedure cont.Procedure cont.

• Determine the effects of the Determine the effects of the failuresfailures

• Estimate the severity of the failureEstimate the severity of the failure• Estimate the probability of Estimate the probability of

occurrenceoccurrence

Procedure cont.Procedure cont.

• Determine the likelihood of Determine the likelihood of detecting the failuredetecting the failure

• Determine which risks take priorityDetermine which risks take priority• Address the highest risksAddress the highest risks

– Assign a Risk Priority NumberAssign a Risk Priority Number• Update the FMEA as action is takenUpdate the FMEA as action is taken

FMEA Flow ChartFMEA Flow Chart

Assign a label to each process or system component

List the function of each component

List potential failure modes

Describe effects of the failures

Determine failure severity

Determine probability of failure

Determine detection rate of failure

Assign RPN

Take action to reduce the highest risk

FMEA WorksheetFMEA Worksheet

FMEA for Patient Safety FMEA for Patient Safety StandardsStandards

Darryl S. Rich, Pharm. D., M.B.A.,Darryl S. Rich, Pharm. D., M.B.A.,

FASHP, advocates using FMEA in the FASHP, advocates using FMEA in the pharmacy industrypharmacy industry

• Annually select at least one high-Annually select at least one high-risk processrisk process– Medication useMedication use– Restraint useRestraint use

Patient Safety StandardsPatient Safety Standards

• Medication Use ProcessesMedication Use Processes– SelectionSelection– ProcurementProcurement– OrderingOrdering– TranscribingTranscribing– PreparingPreparing– DispensingDispensing– AdministrationAdministration– MonitoringMonitoring

• Conduct a FMEAConduct a FMEA

Patient Safety StandardsPatient Safety Standards

• Flow Chart RequirementFlow Chart Requirement• Determine which steps can failDetermine which steps can fail

– PhysicianPhysician– Order completionOrder completion– TranscriptionTranscription– Look-alike drugLook-alike drug

• Determine effects of the failuresDetermine effects of the failures

Patient Safety StandardsPatient Safety Standards

• Assign a rank for each effect:Assign a rank for each effect:– Occurrence of FailureOccurrence of Failure– Severity of FailureSeverity of Failure– Probability of FailureProbability of Failure

• Compute the Risk Probability Compute the Risk Probability numbernumber– Find the root cause of the most critical Find the root cause of the most critical

effectseffects

Patient Safety StandardsPatient Safety Standards

• Rich is advocating the use of FMEA Rich is advocating the use of FMEA to:to:– Enhance patient satisfactionEnhance patient satisfaction– Prevent potential hazardous drug Prevent potential hazardous drug

interactioninteraction– Prevent incorrect dosages from being Prevent incorrect dosages from being

administered to patientsadministered to patients

ExerciseExercise

• You are the owner of a lawn You are the owner of a lawn mowing service. mowing service. – Use FMEA to analyze the failure Use FMEA to analyze the failure

modes associated with mowing a modes associated with mowing a lawn.lawn.

Exercise cont.Exercise cont.

• Brainstorm for possible failures that Brainstorm for possible failures that can occur while mowing a lawncan occur while mowing a lawn

• Determine the effects of the failureDetermine the effects of the failure• Assign rankings to each failure Assign rankings to each failure • Determine the RPNDetermine the RPN

Exercise cont.Exercise cont.

• List the current controls over the List the current controls over the process of lawn mowingprocess of lawn mowing

• List the recommended actions to List the recommended actions to reduce severity, detection, and reduce severity, detection, and occurrenceoccurrence

• Assign responsibility and Assign responsibility and completion dates for each actioncompletion dates for each action

Exercise cont.Exercise cont.

• List actions takenList actions taken• After actions have been taken, After actions have been taken,

estimate the new rankings and estimate the new rankings and calculate the new RPNcalculate the new RPN

SummarySummary

• FMEA is a procedure designed to FMEA is a procedure designed to identify and prevent potential identify and prevent potential failuresfailures

• Provides cost savings and quality Provides cost savings and quality enhancing benefitsenhancing benefits

• Should be used for all business Should be used for all business aspects in both manufacturing and aspects in both manufacturing and servicesservices

ReferencesReferences

• Crow, Kenneth. Crow, Kenneth. Failure Modes and Failure Modes and Effects Analysis (FMEA)Effects Analysis (FMEA). DRM . DRM Associates: 2002. Associates: 2002. <http://www.npd-solutions.com/fm<http://www.npd-solutions.com/fmea.html>ea.html>

• FMECA.COM. Kentic, LLC: 1998-FMECA.COM. Kentic, LLC: 1998-2001. <http://www.fmeca.com/>2001. <http://www.fmeca.com/>

References Cont.References Cont.

• Foster, S. Thomas. Foster, S. Thomas. Managing Quality: An Managing Quality: An Integrative ApproachIntegrative Approach. Upper Saddle . Upper Saddle River, New Jersey: Prentice Hall, 2001.River, New Jersey: Prentice Hall, 2001.

• Rich, Darryl S. Rich, Darryl S. Complying with the FMEA Complying with the FMEA Requirements of the New Patient Safety Requirements of the New Patient Safety StandardStandard. JCAHO: 2001. . JCAHO: 2001. <http://www.fmeainfocentre.com/downl<http://www.fmeainfocentre.com/download/6>oad/6>