Biomedical Engineering Reference
In-Depth Information
TABLE 2.3 Example FMEA/FMECA Worksheet
“After”
Action Taken
Item or
Potential
Potential
Process
Failure
Failure
Potential
Current
Recommended
Target
Step
Mode
Effect(s)
Cause(s)
Controls
Action
Responsible Date
1
Overpressure
of reaction
vessel
Possible
overpressure
of Vessel YY
with popping
of rupture
disk to floor
4 Level indicator fails
on tank causing
valve to be left
open too far
4 None
8 128 Change
supplier,
100%
inspection of
level
indicators
AB1
8/1
4
2
2
16
2
Loss of lot
due to
filling line
failure
Inability to
transfer
material to
tank
10 Process control
valve fails closed
or block valve
closed or set too
far closed
4 None
4 160 Add process
flow meter
JD1
8/1
10
2
2
40
3
Overfill of
reaction
vessel
Possible
overfill of
Tank XX i f
vessel is
overfilled
2 HMI location and
controls for PW
are located on
media prep
2 None
8 32 None
0
4
Loss of lot
due to
temperature
excursion
Inaccurate
reading from
temperature
gauge
8 Gauge not correctly
calibrated
2 Calibration
every 2
yrs
8 128 Calibrate
quarterly
AW2
7/1
8
2
2
32
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