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
– Assign a Risk Priority Number
• Update the FMEA as action is
taken
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: Model Number:
Design Responsibility:
Component: Completion Date:
FMEA Number:
Prepared By: Action Results
Item Function or Potential Potential S C Potential O Current D R Recom- Responsibility Actions S O D R
Purpose Failure Mode Effect of e l Cause of c Controls e P mended & Completion Taken e c e P
Failure v a Failure c t N Action Date v c t N
s u
s r
r
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.npd-
solutions.com/fmea.html>
• FMECA.COM. Kentic, LLC: 1998-
2001. <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>