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Failure Mode and Effect Analysis

Lecture 5-1
Advanced FMEA
FMEA in Health Care
Other High-Risk Industries
References:
FMEA in Reducing Medical Errors, Thomas T. Reiley, MD, MHS, ASQ Healthcare Division
Newsletter, Winter, 2001

FMEA

Advanced FMEA

Reference:
Eubanks, C.F., Kmenta, S., Kosuka, I., Advanced Failure Mode and Effects Analysis Using
Behavior Modeling, 1997 ASME Design Engineering Technical Conference 97-DETC/DTM-02

Shortcomings of FMEA

FMEA

Three problems with traditional FMEA, in


order of importance, are:
1) FMEA is performed to late and not
used to influence design decisions.
2) FMEA does not capture many potential
failures.
3) The process for performing FMEA is
subjective and tedious.

Examples of Shortcomings

FMEA

Examples of documented shortcomings of FMEA are:


FMEA is applied too late and in such detail that it
misses key system-wide, in-service failure modes
Performing FMEA late does not affect important
design and process decisions
The analysis is often an afterthought, performed as a
box-checking exercise
Without a systematic approach, engineers produce a
subjective analysis that depends on their experience
level
FMEA is tedious and time-consuming

Systems Aspect of FMEA

FMEA

A standard FMEA is likely to miss some


failure modes because it may not account
for issues related to an items interface with
the rest of the system.
Rule of Thumb:
Always seek to optimize the next hight
level system
Helps you avoid the problem of suboptimizing
the design to a subsystem level
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Advanced FMEA

FMEA

AFMEA applies to the early stages of


design and captures failure modes
normally missed with conventional
FMEA.
AFMEA uses behavior modeling to link
desired behaviors with components,
environment and supporting systems

Approach

FMEA

Guided by the function structure


relationship, one can build a behavior
model describing the state changes of
variables expected during normal
operation.
The model qualitatively simulates
normal operation and analyzes the
effects of failures in terms of the
resulting system state.
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Advantages of Behavior ModelingFMEA


Behaviors do not rely entirely on
physical structure
Behaviors can reflect customers
desired requirements
Provides a systematic framework for
generating failure modes

Basic Concepts

FMEA

Functional Block Diagram


Ice maker

Freeze Water

Create Cubes
Create Cube Shape

Make Ice Cubes


Harvest Cubes

Each behavior is
mapped to a
specific state
transition

Behavior: deposit ice cubes in bucket


Initial State: no ice
cubes in bucket

Desired Final State:


ice cubes in bucket
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Behavior Specification

S1

BEHAVIOR

no ice
cubes in bucket

deposit
ice cubes in bucket

INITIAL STATE

(<OBJECT>,<ATTRUBUTE>,<VALUE>)
ICE BUCKET, CUBE LEVEL, NOT FULL
SWITCH , POSITION , CLOSED
COIL , STATUS , ENERGIZED
CAM , POSITION , 15 DEG

FMEA

S2

FINAL STATE
ice cubes in bucket
(<OBJECT>,<ATTRUBUTE>,<VALUE>)
ICE BUCKET, CUBE LEVEL, FULL

Behaviors can be described:


Verbally cause water flow to increase
Quantitatively flow rate increases to .03 m3/sec
Mathematically V = . . . . .
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Decompose Behaviors

FMEA

BEHAVIOR
deposit
ice cubes in bucket

Create ice cubes

deposit
ice cubes in bucket

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Function Structure Mapping


FUNCTION
Verify
cube need

Deposit
cubes in
bucket

Create
cubes

Harvest
cubes

STRUCTURE

Assess ice level


Feeler arm
Close switch
Activate harvest

Arm switch
linkage

Fill with water

Feeler arm switch

Freeze water

Ice mold

Create nom quality

Freezer system

Nominal geometry

Water delivery
system

Ice cube
level
sensor

Ice
creation
system

Ice
maker

Loosen ice
Remove ice
Mold heating sys
Sense ice level

Verify
bucket full

FMEA

Harvesting sys

Harvesting
system

open switch
De-activate harvest

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Ice Maker State Variables


Variable
V1
V2
V3
V4
V5
V6
V7
V8
V9
V10
V11
V12
V13
V14
V15
V16
V17

Object
ICE BUCKET
ICE BUCKET
TRAY
TRAY
ENVIRONMENT
WATER VALVE
WATER SWITCH
FEELER ARM SWITCH
TRAY
THERMOSTAT
HEATER
MOTOR
CAM
EJECTOR
ICE
ICE MAKER
REFRIGERATOR

FMEA

Attribute
ICE LEVEL
WATER LEVEL
WATER LEVEL
WATER STATE
TEMPERATURE
STATUS
STATUS
STATUS
TEMPERATURE
STATUS
STATUS
STATUS
ROTATION
ROTATION
INTERFACE STATE
ALIGNMENT
ALIGNMENT

Values
EMPTY, PARTIAL, FULL
NONE, XOME
EMPTY, FULL
LIQUID, SOLID
<=15, >1, >32 deg F
OPEN, CLOSED
OPEN, CLOSED
OPEN, CLOSED
<=15, >1, >32 deg F
OPEN, CLOSED
ON, OFF
ON, OFF
ON, OFF
ON, OFF
LIQUID, SOLID
NOMINAL, >=2, <-2
NOMINAL, >=0, <-4
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Behavior Model
index
1

BEHAVIOR
behavior
type
deposit cubes in
desired
bucket

mapped to
ice maker
freezer

1.1

verify cube need

desired

cube level
sensor

1.2

create cubes

desired

mold

1.3

harvest cubes

desired

mold
ice bucket
ice maker

FMEA

PRE-CONDITION SPEC
object
attribute
value
ice bucket
cube level
not full
freezer

temperature

POST-CONDITION SPEC
object
attribute
value
ice
cube level
full
bucket
freezer
temperature
>8 & <15 OF

>8 & <15 OF

ice maker

inactive

ice
maker

harvesting

active

ice bucket
mold

not full
no

mold

ice present

yes

yes

mold

ice present

no

not full
active

ice bucket

cube level

full

harvesting
status
cube level
ice cubes
present
mold
ice cubes
present
ice bucket
cube level
ice maker harvesting status

Decomposition of behavior create cubes

index
1.2
1.2.1

1.2.2

BEHAVIOR
behavior
type
create cubes
desired

mapped to
ice creation
system
fill mold with water desired water delivery
system
mold
freeze water

desired freezer system


mold

PRE-CONDITION SPEC
attribute
value
ice cubes
no
present
mold
water level
none

object
mold

mold
water

ice cubes
present
state

object
mold

POST-CONDITION SPEC
attribute
value
ice cubes present
yes

mold

water level

full

water

state

solid

mold

ice cubes present

yes

no
liquid
O

freezer

temperature

<32 F

mold

water level

full

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Identifying Failure Modes

FMEA

Failure = condition where achieved final


state does not match desired final state
3 types of failure modes:
non-behaviors
undesired behaviors
misbehaviors

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Non-behaviors

FMEA

Select a behavior for investigation


Consider it not to occur
Simulate how the system responds
Compare list of resulting final state
variable values with list of desired
values to indicate which system or
component failed

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Comparison

FMEA

Users of AFMEA claim it captures a richer set of potential failure modes


than traditional FMEA. Many failure modes can be captured which do not
necessarily relate to components., but to interaction with system
components.

Comparison of failure
modes captured by
FMEA and AFMEA

FAILURE MODE
thermostat failure
water switch failure
feeler arm damaged
power cord disconnected
high/low water pressure
bucket misplacement
refrigerator misalignment
iced gears
high freezer temperature

FMEA
yes
yes
yes
yes
no
no
no
no
no

AFMEA
yes
yes
yes
yes
yes
yes
yes
yes
yes
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FMEA

FMEA in Health Care

Reference:
FMEA in Reducing Medical Errors, Thomas T. Reiley, MD, MHS, ASQ Healthcare Division
Newsletter, Winter, 2001
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Medical Situation

FMEA
2.5 billion prescriptions dispensed from
pharmacies
3.5 billion drug administrations delivered in
a hospital setting
Medications errors in hospitalized patients
is about 2%
Increased average hospital stay 4.6 days
Increased average cost of hospitalization
$4,700 per admission (2.8 million per year
for a 700 bed teaching hospital)
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Medical Errors

FMEA

Adverse human events injuries


caused by medical management rather
than by underlying disease or patient
condition
Medical errors adverse human events
may or may not result from an error

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Human Error

FMEA

The problem of medical systems, like all


human systems, is that humans err.
Human error becomes an accident
when the preventive, error-proofing
processes within the system are
inadequate (latent system faults)
Impact on the system is often delayed

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Potential Failure Modes


Wrong drug/IV
Allergy to drug
Wrong drug for patients
disease
Incorrect administration
technique
Wrong diluent
Wrong dose
Excessive dose
Insufficient dose
Wrong concentration

FMEA

Too-rapid IV flow rate


Omitted drug
Wrong patient
Wrong time
Wrong route
Wrong procedure
Wrong test procedure
Violation of orders
Wrong label directions
Wrong preparation

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Potential Causes
Human knowledge
Chaotic work environment
Unauthorized floor stocks
Using floor stock medications
Not following policies
Verbal orders
Human performance
Lack of personnel
IV solutions that are not premixed
Unnecessary use of medications
Lack of dose verification process
Math errors
Typographical mistakes
Poor handwriting

FMEA
Acronyms
Coined names
Multidose vials
Defective packaging
Similar packaging
Lack of dose limits
Similar drug names
Borrowing medications from a
multiple-dose cart
Dangerous abbreviations (OD & QD
for once daily; U for unit)
Lack of interdisciplinary team review
of medication errors
Unnecessary use of IVs, catheters,
and nasogastric tubes
Lack of dosage check for high-risk
drugs and pediatric patients
medications
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Example

FMEA

Errors recorded during one quarter:


other
Not transcribed
calculation of dose in error
IV infiltration
drug labelling error
staff education issue
Equipment/tubing issue
oral communication error
Medication not given
Order overlooked, forgotten
Transcription error
Pharmacy misread order
0

10

20

30

40

50

60
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Severity

FMEA

Severity of Effects
noncritical illness does not improve
noncritical illness worsens
noncritical illness becomes critical
noncritical illness becomes fatal

3
6
9
10

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FMEA

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13

FMEA

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FMEA

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FMEA

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FMEA

http://www.datakel.com.au/FMEAlinks.htm

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FMEA

Other High-Risk Industries

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Heavy Industry

FMEA

Alcoa reported 1.83/100 employees


missing at least 1 day per year due to
on-the-job injuries
Industry average 5/100
Rate lowered to 0.14/100 through:
Employee incentives to report unsafe
conditions
FMEA
Root cause analysis of each incident
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Construction

FMEA

FMEA used to anticipate potential


problems in construction. Potential
problem analysis used to analyze
project plans and develop contingent
actions.
Shipbuilders (primarily US Navy) use
FMEA to improve safety for workers

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Packaging Industry

FMEA

Key environmental decisions are made during


the design of a new or modified package.
The requirements of our proprietary Package
Development Protocol include a Failure
Mode and Effects Analysis (FMEA) to make
certain the issues of package integrity are
addressed, from manufacture to retail
customer. This ensures the contents stay in
the package until opened by the customer.
R. A. Miller & Co.

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NASA

FMEA

The goal of the Failure Modes and Effects Analysis (FMEA) is to


anticipate, identify and avoid failures in the operation of a
new system while the system is still on the drawing board. The
recent occurrence of failures in some new systems in operation
has had disastrous effects on many lives. These events
prompted the author to evaluate the documented problems
and to seek improvements in FMEA procedures and their
application. The result was surprising. While a great number
of procedures exist, not one single FMEA procedure could
be found as an all encompassing document. Each FMEA
procedure was different. It is believed that the recent
disasters could have possibly been avoided if a good FMEA
procedure had been applied during development. A simple,
complete FMEA procedure is proposed.
NASA Scientific and Technical Information (STI) Program Feb.2000
http://www.sti.nasa.gov/new/fmea33.html##28
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Supply Chain

FMEA

Many organizations are training their


key suppliers in FMEA techniques
Focus is on
Process FMEA at the supplier site
Potential issues with ramp to vaolume
production
Prevention of disruption in the supply chain
Disaster prevention and contingency

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Mining Industry

FMEA

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Limitations of FMEA

FMEA

Although the FMEA methodology is highly


effective in analyzing various system failure
modes, this technique has four limitations:
Examination of human error is limited.
Focus is on single-event initiators of
problems.
Examination of external influences is
limited.
Results are dependent on the mode of
operation.
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