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By Andy Klimes

• • • • • • • • • What is FMEA? History Benefits Applications Procedure Sample Worksheet Patient Safety Standards Exercise Summary

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

History of FMEA
• Created by the aerospace industry in the 1960s. • Ford began using FMEA in 1972. • Incorporated by the “Big Three” in 1988. • Automotive Industry Action Group and American Society for Quality Control copyright standards in 1993.

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

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

• • • • • Concept Design Process Service Equipment

FMEA Procedure
• Assign a label to each system component • Describe the functions of each part • Identify potential failures for each function

Procedure cont.
• Determine the effects of the failures • Estimate the severity of the failure • Estimate the probability of occurrence

Procedure cont.
• Determine the likelihood of detecting the failure • Determine which risks take priority • Address the highest risks

• Update the FMEA as action is taken

– Assign a Risk Priority Number

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

FMEA Worksheet
Failure Mode and Effects Analysis
Product or Process Name: Component: Model Number: Design Responsibility: Completion Date: FMEA Number: Prepared By: S C Potential O Current e l Cause of c Controls v a Failure c s u s r r

Action Results
D R Recom- Responsibility Actions e P mended & Completion Taken t N Action Date S O D R e c e P v c t N

Item Function or Purpose

Potential Potential Failure Mode Effect of Failure

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 process
– – Medication use Restraint use

Patient Safety Standards
• Medication Use Processes
– – – – – – – – Selection Procurement Ordering Transcribing Preparing Dispensing Administration Monitoring

• Conduct a FMEA

Patient Safety Standards
• Flow Chart Requirement • Determine which steps can fail
– – – – Physician Order completion Transcription Look-alike drug

• Determine effects of the failures

Patient Safety Standards
• Assign a rank for each effect:
– – – Occurrence of Failure Severity of Failure Probability of Failure

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

Patient Safety Standards
• Rich is advocating the use of FMEA to:

– Enhance patient satisfaction – Prevent potential hazardous drug interaction – Prevent incorrect dosages from being administered to patients

• You are the owner of a lawn mowing service.

– Use FMEA to analyze the failure modes associated with mowing a lawn.

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

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

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

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

• Crow, Kenneth. Failure Modes and Effects Analysis (FMEA). DRM Associates: 2002. <> • FMECA.COM. Kentic, LLC: 19982001. <>

References Cont.
• 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. < nload/6>