Beruflich Dokumente
Kultur Dokumente
by Susanto
Background
j Quality assurance of product must be
guaranteed not only by On Line Quality
Control activity in the Production Line but
early since in the stage of design and
development. Which is call as Of Line
Quality Control
j Prediction of failure probability of product
is a part of Of Line Quality Control
Failure Mode and Effect Analysis
j Method to describe probability of failure of
a product
j How the failure can be happen
j How far severity of the failure
j What are the effect of the failure to the
user, system and environment
j How failure occurrence can be detected
Harmonized Standard
j ISO 9001 : 2000 ; Quality Management
System
j ISO 13485 : 1996; Quality System Medical
Devices - Particular requirements for
application of ISO 9001
j EN 1441 :1997 ; Medical Devices - Risk
Analysis
j 93/42/EEC Medical Devices Directive
PROSEDUR FMEA
Identified and analyze
Function
Of theof system
the system
Is risk acceptable ?
6
M odification data
M odification
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Risk Priority Number (RPN)
j RPN is Degree of Failure Risk
j RPN = Rating of Severity x Rating of
Occurrence x Rating of Detection method
j RPN = 1 Lowest Risk
j RPN = 1000 Highest Risk
Severity Rating Table
Y
Y
Effect Rating Criteria
No effect
No Effect 1
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Detection Rating Table
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FunctionStructure
E
Patient Placing the Supporting Adjusting
patient the load position of
BED the bed Manual
force
Patient Transporting
Parking the bed
Manual Manual
force force
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Supporting Load
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Transporting The Bed
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Castor Testing
Result of Castor Testing
Y
Y
Type Castor Testing Result Remark
time
(minute)
0.5 good
1 Yield Wheel out begin to loose from wheel in
one side
Castor
2 Yield
Haibam
two side
6 Broken Wheel out broken and loose from wheel
in. Life ability = 6*255=1530m
<11 Good
20 Begin Temperature of wheel out rise and
damage wheel out begin to soft
Castor TPU
Wheel out begin to yield, temperature
30 Broken rise significantly wheel out to hot. Live
ability = 30 * 255 =7650m
Y
Y
Y
!
Type Castor time Result Remark
(minute)
Castor 2 Broken Wheel out yield and loose from wheel
Haibam in
100 Good Wheel out and all the structure of
Castor TPU Castor steel in good condition. Life
ability >100*255=25500 m=25.5 km
Castor Haibam
Castor TPU
Result of Bed Testing
Mode test Load (N) Result
Crash testing 1700 There is no shape change and deformation after crash
Pull and push force 900 The bed can moved by 150 N Forces
Head & foot panel 450 Head & foot capable receive load
Impactor 250 The mattress platform capable receive impact load without shape
change and deformation
Loading pad 880 The bed capable receive load without deformation
Static testing 4000 The bed loaded for 1 hour, when loaded there is any static deformation
in the bed, but after load release the bed back to original position.
Conclusion and Recommendation
From the risk analysis and testing result the most risky
mode of failure are failure of castor and spindle pair for
high-low motion.
The potential effect of the failure is make user very
dissatisfied and the system inoperable. There is no
injury risk to the user or sudden failure to the system.
Suggested to used Castor TPU to change Castor
Haibam
As soon as possible to take action for take corrective
action to improve spindle pair for hi-low motion.