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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
Examples of Shortcomings
FMEA
FMEA
Advanced FMEA
FMEA
Approach
FMEA
Basic Concepts
FMEA
Freeze Water
Create Cubes
Create Cube Shape
Each behavior is
mapped to a
specific state
transition
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
Decompose Behaviors
FMEA
BEHAVIOR
deposit
ice cubes in bucket
deposit
ice cubes in bucket
11
Deposit
cubes in
bucket
Create
cubes
Harvest
cubes
STRUCTURE
Arm switch
linkage
Freeze water
Ice mold
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
12
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
13
Behavior Model
index
1
BEHAVIOR
behavior
type
deposit cubes in
desired
bucket
mapped to
ice maker
freezer
1.1
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
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
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
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
yes
no
liquid
O
freezer
temperature
<32 F
mold
water level
full
14
FMEA
15
Non-behaviors
FMEA
16
Comparison
FMEA
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
17
FMEA
Reference:
FMEA in Reducing Medical Errors, Thomas T. Reiley, MD, MHS, ASQ Healthcare Division
Newsletter, Winter, 2001
18
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)
19
Medical Errors
FMEA
20
10
Human Error
FMEA
21
FMEA
22
11
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
23
Example
FMEA
10
20
30
40
50
60
24
12
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
25
FMEA
26
13
FMEA
27
FMEA
28
14
FMEA
29
FMEA
http://www.datakel.com.au/FMEAlinks.htm
30
15
FMEA
31
Heavy Industry
FMEA
16
Construction
FMEA
33
Packaging Industry
FMEA
34
17
NASA
FMEA
Supply Chain
FMEA
36
18
Mining Industry
FMEA
37
Limitations of FMEA
FMEA
19