1. FMEA By Andy Klimes

2. Outline What is FMEA?What is FMEA? HistoryHistory BenefitsBenefits ApplicationsApplications ProcedureProcedure Sample WorksheetSample Worksheet Patient Safety StandardsPatient Safety Standards ExerciseExercise SummarySummary

3. What is FMEA? FMEA is an acronym that stands for Failure Modes and Effects AnalysisFMEA is an acronym that stands for Failure Modes and Effects Analysis Methodology of FMEA: Methodology of FMEA: –Identify the potential failure of a system and its effects –Assess the failures to determine actions that would eliminate the chance of occurrence –Document the potential failures

4. History of FMEA Created by the aerospace industry in the 1960s.Created by the aerospace industry in the 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 American Society for Quality Control copyright standards in 1993.Automotive Industry Action Group and American Society for Quality Control copyright standards in 1993.

5. What are the Benefits? Improvements in:Improvements in: –Safety –Quality –Reliability

6. Benefits cont. What other potential benefits can be identified?What other potential benefits can be identified? –Company image –User satisfaction –Lower development costs –Presence of a historical record

7. Applications ConceptConcept DesignDesign ProcessProcess ServiceService EquipmentEquipment

8. FMEA Procedure Assign a label to each system componentAssign a label to each system component Describe the functions of each partDescribe the functions of each part Identify potential failures for each functionIdentify potential failures for each function

9. Procedure cont. Determine the effects of the failuresDetermine the effects of the failures Estimate the severity of the failureEstimate the severity of the failure Estimate the probability of occurrenceEstimate the probability of occurrence

10. Procedure cont. Determine the likelihood of detecting the failureDetermine the likelihood of detecting the failure Determine which risks take priorityDetermine which risks take priority Address the highest risksAddress the highest risks –Assign a Risk Priority Number Update the FMEA as action is takenUpdate the FMEA as action is taken

11. FMEA 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

12. FMEA Worksheet

13. FMEA for Patient Safety Standards Darryl S. Rich, Pharm. D., M.B.A., FASHP, advocates using FMEA in the pharmacy industry Annually select at least one high-risk processAnnually select at least one high-risk process –Medication use –Restraint use

14. Patient Safety Standards Medication Use ProcessesMedication Use Processes –Selection –Procurement –Ordering –Transcribing –Preparing –Dispensing –Administration –Monitoring Conduct a FMEAConduct a FMEA

15. Patient Safety Standards Flow Chart RequirementFlow Chart Requirement Determine which steps can failDetermine which steps can fail –Physician –Order completion –Transcription –Look-alike drug Determine effects of the failuresDetermine effects of the failures

16. Patient Safety Standards Assign a rank for each effect:Assign a rank for each effect: –Occurrence of Failure –Severity of Failure –Probability of Failure Compute the Risk Probability numberCompute the Risk Probability number –Find the root cause of the most critical effects

17. Patient Safety Standards Rich is advocating the use of FMEA to:Rich is advocating the use of FMEA to: –Enhance patient satisfaction –Prevent potential hazardous drug interaction –Prevent incorrect dosages from being administered to patients

18. Exercise You are the owner of a lawn mowing service.You are the owner of a lawn mowing service. –Use FMEA to analyze the failure modes associated with mowing a lawn.

19. Exercise cont. Brainstorm for possible failures that can occur while mowing a lawnBrainstorm for possible failures that can occur while mowing a lawn Determine the effects of the failureDetermine the effects of the failure Assign rankings to each failureAssign rankings to each failure Determine the RPNDetermine the RPN

20. Exercise cont. List the current controls over the process of lawn mowingList the current controls over the process of lawn mowing List the recommended actions to reduce severity, detection, and occurrenceList the recommended actions to reduce severity, detection, and occurrence Assign responsibility and completion dates for each actionAssign responsibility and completion dates for each action

21. Exercise cont. List actions takenList actions taken After actions have been taken, estimate the new rankings and calculate the new RPNAfter actions have been taken, estimate the new rankings and calculate the new RPN

22. Summary FMEA is a procedure designed to identify and prevent potential failuresFMEA is a procedure designed to identify and prevent potential failures Provides cost savings and quality enhancing benefitsProvides cost savings and quality enhancing benefits Should be used for all business aspects in both manufacturing and servicesShould be used for all business aspects in both manufacturing and services

23. References Crow, Kenneth. Failure Modes and Effects Analysis (FMEA). DRM Associates: 2002. Crow, Kenneth. Failure Modes and Effects Analysis (FMEA). DRM Associates: 2002. FMECA.COM. Kentic, LLC: 1998- 2001. FMECA.COM. Kentic, LLC: 1998- 2001.

24. References Cont. Foster, S. Thomas. Managing Quality: An Integrative Approach. Upper Saddle River, New Jersey: Prentice Hall, 2001.Foster, S. Thomas. Managing Quality: An Integrative Approach. Upper Saddle River, New Jersey: Prentice Hall, 2001. Rich, Darryl S. Complying with the FMEA Requirements of the New Patient Safety Standard. JCAHO: 2001. Rich, Darryl S. Complying with the FMEA Requirements of the New Patient Safety Standard. JCAHO: 2001.