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:
Component:

Item Function or
Purpose

Potential Potential
Failure Mode Effect of
Failure

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

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/downl
oad/6>