RISK MANAGEMENT TOOLS - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 38

TABLE 2.5 Risk Ranking of the Previous FMEA Example

“After”
Action Taken

Item or Potential Potential

Process Failure Failure Potential Current Recommended Target

Step Mode Effect(s) Cause(s) Controls Action Responsible Date

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

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 /1422 6

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 /1822 2

3 Overfill of

reaction
vessel

Possible
overfill of
Tank XX i f
vessel is

2 HMI location and
controls for PW
are located on
media prep

2 None 8 32 None 0