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:
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

Applications
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

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

Exercise
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

Summary
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

References
Crow, Kenneth. Failure Modes and Effects Analysis (FMEA). DRM Associates: 2002. <http://www.npdsolutions.com/fmea.html> FMECA.COM. Kentic, LLC: 19982001. <http://www.fmeca.com/>

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. <http://www.fmeainfocentre.com/dow nload/6>