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FMEA. By Andy Klimes. Outline. 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:

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By Andy Klimes

  • What is FMEA?
  • History
  • Benefits
  • Applications
  • Procedure
  • Sample Worksheet
  • Patient Safety Standards
  • Exercise
  • Summary
what is fmea
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
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
What are the Benefits?
  • Improvements in:
    • Safety
    • Quality
    • Reliability
benefits cont
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
FMEA Procedure
  • Assign a label to each system component
  • Describe the functions of each part
  • Identify potential failures for each function
procedure cont
Procedure cont.
  • Determine the effects of the failures
  • Estimate the severity of the failure
  • Estimate the probability of occurrence
procedure cont10
Procedure cont.
  • Determine the likelihood of detecting the failure
  • Determine which risks take priority
  • Address the highest risks
    • Assign a Risk Priority Number
  • Update the FMEA as action is taken
fmea flow chart
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 for patient safety standards
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
Patient Safety Standards
  • Medication Use Processes
    • Selection
    • Procurement
    • Ordering
    • Transcribing
    • Preparing
    • Dispensing
    • Administration
    • Monitoring
  • Conduct a FMEA
patient safety standards15
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 standards16
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 standards17
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
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 cont20
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 cont21
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: 1998-2001. <>
references cont
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. <>