FAIRSpectra - Enabling the FAIRification of Analytical Science
Overview of FMEA
1. FAILURE MODE & EFFECTS ANALYSIS
(FMEA)
By Fahmi Ramadhan Putra
QC/Lab Supervisor
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2. WHY PERFORM FMEA ?
Effective at identifying and correcting
process failure early on
Multiple choices for mitigating the risk
Lower cost solution
etc
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3. WHAT IS FMEA ?
FMEA proactive tool & quality method
that enables the identification & prevention
of process or product errors before they
occur
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4. BENEFITS OF FMEA
Early identification & elimination of process failure
Improve product / process quality, reliability & safety
Provides cutomer satisfaction
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5. PROCEDURE TO MAKE FMEA SHEET
Identify the functions
of your scope
Identify the failure
mode
Identify the
consequences on
the process /
system
Give severity rating
for the
consequences
scale from ( 1 – 10)
Determine the
potential root
cause
Determine the
occurrence rating
for the cause scale
from (1-10)
Identify current
process control
Determine the
detection rating
scale from (1-10)
Calculate the risk
priority number
(RPN = Severity x
Occurrence x
Detection)
Make recommended
actions
As actions are
completed, make
new RPN
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Source : http://asq.org/learn-
about-quality/process-analysis-
tools/overview/fmea.html
6. EXAMPLE OF FMEA
Item : Cool the compound using cold water
Core Team : Production & QC Team
Responsibility : Production / Mixing Operator
Prepared by : QC Supervisor
FMEA Number : 654321
FMEA Date : December 16th 2016
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Valve position is
opened ( normal)
Valve position is closed
( potential failure)
7. EXAMPLE OF FMEA (CONTINUED)
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PROCESS
FUNCTION
FAILURE MODE
POTENTIAL
IMPACT
SEVERITY POTENTIAL
CAUSE
OCCURENCE
DETECTION
MODE
DETECTION
Cool the
compound
using cold water
Cooling Water
Valve is not
opened
Compound is
not cooled
low mooney /
low viscosity
10
Operator forget
to open the
cooling water
valve
5
QC Inspector
check the valve
position
1
RPN
RECOMMENDED
ACTION
RESPONSIBILITY
ACTION RESULT
SEVERITY OCCURENCE DETECTION RPN
50
Provide
preliminary check
sheet before
process
Mixing Operator 1 2 1 2