Failure Mode and Effective Analysis (FMEA)

For
Purified Water Generation, Storage and Distribution System

Page 1 of 17

1.0 RISK ASSESSMENT

Based on the System Level Impact Assessment the Direct / Indirect Impact system is determined. And based on FMEA
(Failure Mode Effective Analysis) various failure modes of the system components are determined and the extent of
qualification or mitigation activities are derived and documented.
The risk rating is determined based upon component failure Severity (S), frequency of Occurrence (O) and likelihood of
Detection (D).
The Severity (S) shall be rated, determined and documented (Low=1, Medium=2, High=3).
DESCRIPTION

SEVERITY (S)

No Impact on Product Quality, Overall System Performance and/or Functionality, Operator Safety,
exception or gap with respect to regulations or standards (GxP, EU, GAMP, ASTM, etc.)
Minor Impact on Product Quality, Overall System Performance and/or Functionality and Operator
Safety.
Major Impact on Product Quality, Overall System Performance and/or Functionality, Operator Safety
and Exception or gap with respect to regulations or standards (GxP, EU, GAMP, ASTM, etc.)

1
2
3

The frequency of Occurrence (O) shall be rated, determined and documented (Low=1, Medium=2, High=3).
DESCRIPTION

OCCURRENCE (O)

Occurrence is extremely rare or unlikely

Occurrence is occasionally

Occurrence is almost every time the system is used

The likelihood of Detection (D) shall be rated, determined and documented (Low=3, Medium=2, High=1).

Page 2 of 17

DESCRIPTION

DETECTION(D)

100% detection or inspection technique is in place specifically for the failure like an alarm,
interlock, and error message or system shutdown.

Detected by indirect means or by observation like indirect indication or visual inspection.

No specific detection method

RPN (Risk Priority Number) = Severity of failure (S) X frequency of Occurrence (O). X Detection (D)
The Risk level will then be based on the following table.
RATINGS
RPN 3
9 RPN > 3

RISK
Low (L)
Medium (M)

RPN > 12

High (H)

Identify the post mitigation risk level by rating S,O & D and calculate the RPN no for the same

Page 3 of 17

2.0 SYSTEM RISK ASSESSMENT MATRIX

Risk
Assessment

Risk Identification
Sr. Component
No Failure/Critic
al Process
Step Failure

Potential
Failure
Mode
(Defect)

Potential Risk
Cause

Potential
Risk/Effect/Impact
on Product
Quality/ Product
Release

Current controls
(Interlock/Alarm
arrangement)

Proposed
Additional Risk
control measure
(Mandatory for
RPN
Risk elements
having RPN>3)

Revised Risk
Classification
S

RPN

Verification
point

A. Purified Water Generation System

1.

Raw Water
Tank

2.

Raw Water

3.

NaOCl
dosing

Increased
microbial
and
particle
contaminat
ion of the
in-feed raw
water

There may be
leakage in the
Tank

Sampling
of the Raw
water is
not
possible

Sampling
point may not
be considered
in the design

NaOCl
dosing
pump fails.

Mechanical
damage of
pump

The system shall

be inefficient to
remove the
increased microbial
and particulate
contamination.
Frequent changes
of the RO
membrane
No impact on
product quality, as
raw water is not
used for process

The raw water

quality shall decide
the final purified
water quality and
the extent of the
pretreatment.
No impact on
product quality, as
raw water is not
used for process
Increase in
bioburden in raw
water.
Load on
downstream
purification
system.
No impact on
product quality as

Vent Filter is
provided for
venting to avoid
any vacuum
hazards and to
prevent any
atmospheric
contamination and
moisture from
entering the tank
The raw water
transfer piping is
provided with the
facility for adding
sodium
hypochlorite
solution on line to
raw water.
Sampling points
are provided in raw
water feed line
before Multi grade
filter

Alarm is provided in
case of malfunction
of dosing pump.
The pre-treatment
system stops in case
dosing pump
malfunction.

Routine Sampling
of the raw water
shall be carried
out as per SOP

Preventive
maintenance of
pump shall be
carried out
frequently as per
PM SOP.
A standby pump
shall be kept as
spare.

Commissioning
IQ
OQ

Commissioning
IQ
OQ
SOP for
Sampling

Commissioning
OQ
SOP for PM

Page 4 of 17

Risk
Assessment

Risk Identification
Sr. Component
No Failure/Critic
al Process
Step Failure

4.

Multi Grade
Filter

5.

Multi Grade
Filter

Potential
Failure
Mode
(Defect)

Multi
Grade
Filter not
working
properly;
filtration of
raw water
may not
take place.
Multi
Grade
Filter not
working
properly;
filtration of
raw water
may not
take place.

Potential
Risk/Effect/Impact
Potential Risk
on Product
Cause
Quality/ Product
Release
UF and RO
membranes are
installed at
downstream.
Drinking water
may go out of
microbial
specification.
Initial Filtration of
raw water may not
take place.
Downstream
Multiport valve
system may not
may not
get water for
function
processing.
properly.
No impact on
product quality, as
raw water is not
used for process.
Choking of
Initial Filtration of
Multi grade
raw water may not
Filter
take place.
Downstream
system may not
get water for
processing.
No impact on
product quality, as
raw water is not
used for process.

Current controls
(Interlock/Alarm
arrangement)

Alarm is provided
in case of
malfunctioning of
multiport valve.
Pop up is shown on
the HMI, to indicate
status of the
Multiport valve and
MGF mode i.e.
service or
backwash.
Pressure gauges
are provided to
monitor pressure
across MGF and
indicate choking.
Backwash
provision is
provided for
cleaning of MGF
and prevents
choking.

Proposed
Additional Risk
control measure
(Mandatory for
RPN
Risk elements
having RPN>3)

Multiport valve
operation shall
be verified during
commissioning.
Routine
preventive
maintenance of
the valve shall be
carried out as per
SOP.
Routine
monitoring of
pressure shall be
carried out to
check choking of
MGF.
Backwash shall
be carried out at
frequent intervals
as per SOP.
Frequency shall
be derived based
on vendor
recommendation
and on
consumption of
water.
Routine
calibration of
Pressure gauges
shall be
performed as per

Revised Risk
Classification
S

RPN

Verification
point

Commissioning
OQ
Preventive
maintenance
SOP for MGF.

Commissioning
IQ
SOP for MGF
operation &
Cleaning
Calibration
Master plan
SOP

Page 5 of 17

Risk
Assessment

Risk Identification
Sr. Component
No Failure/Critic
al Process
Step Failure

Potential
Failure
Mode
(Defect)

Potential Risk
Cause

Potential
Risk/Effect/Impact
on Product
Quality/ Product
Release

Current controls
(Interlock/Alarm
arrangement)

Proposed
Additional Risk
control measure
(Mandatory for
RPN
Risk elements
having RPN>3)

Revised Risk
Classification
S

RPN

Verification
point

calibration plan.

6.

7.

8.

Softener Unit

Softener Unit

Ultra
filtration
system

Softener
Unit not
working
properly,
removal of
ions from
the water
may not
takes place

Softener
Unit not
working
properly,
removal of
ions from
the water
may not
takes place

Colloidal
particulate
& high
molecular
weight
material
may not be
filtered
from water

Automatic
multiport
valve may not
function
properly.

Initial removal of
ions from raw
water may not take
place it may lead
to hardness &
scale formation
Downstream
system may not
get water for
further water
treatment
No impact on
product quality, as
water is not used
for process.

Regeneration
of the softener
not possible

Softener having
low OBR
Downstream may
not get water for
further water
treatment
No impact on
product quality, as
water is not used
for process

Ultra filtration
service cycle
valve not
working
properly

Increase the
colloidal
particulate & high
molecular weight
material in the
water
No impact on
product quality, as
water is not used
for process.

Alarm is provided
in case of
malfunctioning of
Automatic
multiport valve.
Pop up is shown on
the HMI, to indicate
status of the
Multiport valve and
softener unit

Brine Tank is
provided with level
switch to monitor
the level of the
brine solution
Force regeneration
can be activated
through HMI &
Manual mode as
well

Alarm is provided
in case of
malfunctioning of
Ultra filtration
service cycle
Pop up is shown on
the HMI, to indicate
status of the Ultra
filtration service
cycle valve

Automatic
Multiport valve
operation shall
be verified during
commissioning.
Routine
preventive
maintenance of
the valve shall be
carried out as per
SOP.
Routine
monitoring of
Brine tank shall
be carried out as
per defined
procedures.
Regeneration
frequency of the
Softener shall be
as per SOP.
Frequency shall
be derived based
on vendor
UF Service cycle
valve operation
shall be verified
during
commissioning.
Routine
preventive
maintenance of
the valve shall be
carried out as per
SOP.

Commissioning
OQ
Preventive
maintenance
SOP for
Softener.

Commissioning
OQ
Preventive
maintenance
SOP for
Softener.

Commissioning
OQ
Preventive
maintenance
SOP for UF.

Page 6 of 17

Risk
Assessment

Risk Identification
Sr. Component
No Failure/Critic
al Process
Step Failure

9.

Ultra
filtration
system

10.

UF permeate

11.

Activated
Carbon Filter

Potential
Failure
Mode
(Defect)

Potential Risk
Cause

Potential
Risk/Effect/Impact
on Product
Quality/ Product
Release

UF Backwash
& Fast Flush
may not takes
place

Ultra filtration may

be hampered
Lack of water to
Downstream
No impact on
product quality, as
water is not used
for process.

Level of
the UF
permeate
is not
controlled

Level switch of
the UF tank is
not working
properly

Low level of the

UF permeate tank
will lead to
damage of the
connected suction
pump
Lack of water to
downstream
No impact on
product quality, as
water is not used
for process.

High
chlorine
level & Bad
Water Odor

Activated
carbon filter
not working
properly

Choking of
the Ultra
filtration of
the system

The chlorine
content in water
shall lead to
oxidation of the RO
membrane
Odor of water may
be not good
May not affect the
final quality of the
water as SMBS

Current controls
(Interlock/Alarm
arrangement)
Centrifugal pump
with desired flow
rate is placed for
backwashing &
Fast Flushing of UF
Module
Pressure gauge is
provided at the
discharge pump to
monitor the
pressure
Popup indication in
HMI to indicate the
Backwash & Fast
Flush cycle

Alarm will appear

for high level of the
UF permeate tank
Water will recirculate in case of
the high level of
the UF permeate
tank
Connected suction
pumps will stop in
case of low level of
UF permeate tank
Activated Carbon
Filter is provided
to adsorb the free
chlorine present in
the influent water
& to improve water
bad odor
Pressure will be
monitored across
the vessel by

Proposed
Additional Risk
control measure
(Mandatory for
RPN
Risk elements
having RPN>3)

Operation of the
Backwash
centrifugal pump
shall be verified
during
commissioning
UF backwash &
Fast Flush
process shall be
verified during
commissioning
Routine
Preventive
maintenance of
the Pump shall
be as per the
SOP
Operation of the
level switches
shall be verified
during
commissioning
Routine
Preventive
maintenance of
the Pump shall
be as per the
SOP
_

Revised Risk
Classification
S

RPN

Verification
point

Commissioning
OQ
Preventive
maintenance
SOP for UF.

Commissioning
IQ & OQ
Preventive
maintenance
SOP.

Commissioning
IQ & OQ

Page 7 of 17

Risk
Assessment

Risk Identification
Sr. Component
No Failure/Critic
al Process
Step Failure

12.

13.

14.

Ultra Violate
Sterilizer

Antiscalent
Dosing
System

NaOH
Dosing
System

Potential
Failure
Mode
(Defect)

Increase
microbial
odor

Low
chemical
level in
antiscalant
dosing
tank

PH of the
PW water
not
controlled
as per the
requireme
nt

Potential Risk
Cause

Ultra violate
sterilizer not
working
properly

Antiscalent
Dosing System
not working
properly

NaOH Dosing
System not
working
properly

Potential
Risk/Effect/Impact
on Product
Quality/ Product
Release
dosing is present

Living
microorganism
grows and in a
favorable condition
for their
exponential growth
May increase the
microbial level of
the final water
Low level of
chemical will not
release antiscalant
as per the
requirement which
leads Precipitation
of silica on RO
membrane can
damage the
membrane and
reduce efficiency.
No impact on
product quality, as
water is not used
for process.
CO2 Level of the
Water may be
increase which
may affect the final
pH of the water

Current controls
(Interlock/Alarm
arrangement)

Proposed
Additional Risk
control measure
(Mandatory for
RPN
Risk elements
having RPN>3)

Revised Risk
Classification
S

RPN

Verification
point

pressure gauge
UV sterilizer is
provided with
intensity & hour
meter to check
the intensity and
working hour of the
UV lamp of UV
sterilizer
Routine Monitoring
of the UV Sterilizer
shall be checked
regularly
The Chemical
dosing system
comprises with
level switch which
will trip the dosing
pump
Alarm provision is
provided in case of
low chemical

The NaOH dosing

system comprises
with pH
Transmitter which
will monitor the pH
of the water
Alarm provision is
provided to alert
the operator

Operation of the
Chemical dosing
system shall be
verified during
commissioning
Routine checkup
of chemical
dosing shall be
performed
regularly

Operation of the
NaOH dosing
system shall be
verified during
commissioning
Routine checkup
of NaOH dosing
shall be
performed
regularly
Calibration of the
pH transmitter as

Commissioning
IQ & OQ
SOP of
Operation & PM
of the UV
Sterilizer

Commissioning
IQ & OQ
Preventive
maintenance
SOP.

Commissioning
IQ
OQ
Calibration
Master plan
SOP

Page 8 of 17

Risk
Assessment

Risk Identification
Sr. Component
No Failure/Critic
al Process
Step Failure

Potential
Failure
Mode
(Defect)

Potential Risk
Cause

Potential
Risk/Effect/Impact
on Product
Quality/ Product
Release

Current controls
(Interlock/Alarm
arrangement)

Proposed
Additional Risk
control measure
(Mandatory for
RPN
Risk elements
having RPN>3)

Revised Risk
Classification
S

RPN

Verification
point

per the SOP

15.

16.

17.

SMBS Dosing
System

ORP Sensor

Heat
Exchangers

Low
chemical
level in
SMBS
dosing
tank

Chorine
Level after
SMBS
dosing
may not be
detected

Optimum
temperatur
e of water
may not be
maintained

SMBS Dosing
System not
working
properly

ORP sensor is
not working
properly

Heat
Exchangers is
not working

Low level of
chemical will not
neutralize chlorine
as per the
requirement
The chlorine
content in water
shall lead to
oxidation of the
RO/EDI
No impact on
product quality, as
water is not used
for process.
The chlorine
content in water
shall lead to
oxidation of the RO
membrane and
hence shall affect
the final water
quality
No impact on
product quality, as
water is not used
for process.
Water temperature
will not be
adequate, which
may lead to RO
membrane
damage
No impact on
product quality, as
water is not used
for process

The Chemical
dosing system
comprises with
level switch which
will trip the dosing
pump
Alarm provision is
provided in case of
low chemical

Alarm is
provisioned for
high ORP.
Auto dump valve is
provided in case of
free chlorine level
high

Heat exchangers
are provided with
Hot and cold
arrangement
before RO inlet
Temperature
transmitters
provided to
measure the inlet
temperature of the
water before
entering to RO
membrane

Operation of the
Chemical dosing
system shall be
verified during
commissioning
Routine checkup
of chemical
dosing shall be
performed
regularly

Operation of the
ORP Sensor Shall
be Verified during
commissioning
Calibration of the
ORP Sensor as
per the SOP

Commissioning
IQ & OQ
Preventive
maintenance
SOP.

Commissioning
IQ
OQ
Calibration
Master plan
SOP

Commissioning
IQ
OQ
Preventive
maintenance
SOP.

Page 9 of 17

Risk
Assessment

Risk Identification
Sr. Component
No Failure/Critic
al Process
Step Failure

18.

Multipurpose
Storage tank

Potential
Failure
Mode
(Defect)

Storage of
water may
not be
possible
before RO

Potential Risk
Cause

Storage tank
before RO is
not working
properly

Potential
Risk/Effect/Impact
on Product
Quality/ Product
Release

Supply to RO
membrane will
hamper
No impact on
product quality, as
water is not used
for process.

19.

High
Pressure
Pump

Water
Pressure
may not
sufficient
to feed RO

High Pressure
Pump is not
functioning
properly

Filtration of the
high molecular
weight inorganic as
well organic
molecules may not
be possible which
will lead to affect
the final water
quality

20.

Heat
Sanitary RO

High
conductivit

Heat Sanitary
RO system not

Purified water out

of specification.

Current controls
(Interlock/Alarm
arrangement)
Multipurpose
storage tank is
provided with
capacitance level
transmitter which
will perform the
necessary action to
open and close the
inlet valve to avoid
the dry run of the
RO feed pump
All set points of
water level of the
storage tank shall
be controlled by
the HMI
Recirculation to UF
permeate tank in
case of the high
level of in feed
water is provided
Spray ball & vent
filter is provided to
ensure clean ability
of the tank
High pressure
pump with VFD is
provided
Pressure
Transmitter is
provided to
monitor the
Pressure of water
at RO inlet
If the Pump
discharge goes
above the set point
then pump will trip
Conductivity
transmitter is

Proposed
Additional Risk
control measure
(Mandatory for
RPN
Risk elements
having RPN>3)

Routine
calibration of

Revised Risk
Classification
S

RPN

Verification
point

Commissioning
IQ
OQ
Preventive
maintenance
SOP.

Commissioning
IQ
OQ
Preventive
maintenance
SOP.

Commissioning
OQ

Page 10 of 17

Risk
Assessment

Risk Identification
Sr. Component
No Failure/Critic
al Process
Step Failure

system

21.

22. 4

Heat
Sanitary RO
system

EDI
permeate

Potential
Failure
Mode
(Defect)

y after RO
permeate

Choking of
RO
membrane

High
conductivit
y after EDI

Potential Risk
Cause

Potential
Risk/Effect/Impact
on Product
Quality/ Product
Release

functioning
properly

Shall affect product

quality/ product
release

May be due to
high use of RO
membrane

RO membrane will
damage & shall
affect the product
quality

EDI is not
working
properly

Purified water out

of specification.
Shall affect product
quality/ product
release,

Current controls
(Interlock/Alarm
arrangement)
provided at the
downstream of RO
to check
conductivity along
with alarm provision.
High conductivity
water after RO
shall be dump by
dumping valve
Pressure at the
concentration side
and permeate side
will be monitored
and controlled by
pressure transmitter
An alarm of high
pressure will initiate
High pressure pump
will trip in case of
the high pressure
Conductivity sensor
is provided at the
downstream of EDI
to check
conductivity along
with alarm provision.
High conductivity
water after EDI shall
be diverted back to
multipurpose
storage tank
through a flow
divertor valve.

Proposed
Additional Risk
control measure
(Mandatory for
RPN
Risk elements
having RPN>3)

Revised Risk
Classification
S

RPN

conductivity
sensor shall be
performed as per
calibration plan.

Routine
calibration of
pressure
transmitter shall
be performed as
per calibration
plan.

Routine
calibration of
conductivity
sensor shall be
performed as per
calibration plan.

Verification
point

Calibration
Master Plan
SOP

Commissioning
OQ
Calibration
Master Plan
SOP

Commissioning
OQ
Calibration
Master Plan
SOP

Page 11 of 17

Risk
Assessment

Risk Identification
Sr. Component
No Failure/Critic
al Process
Step Failure

23.

RO + EDI
Sanitization

Potential
Failure
Mode
(Defect)

Bio-burden
in RO &
EDI

Potential Risk
Cause

RO + EDI
Sanitization
not possible

Potential
Risk/Effect/Impact
on Product
Quality/ Product
Release

Purified water out

of specification.
Shall affect product
quality/ product
release,

Current controls
(Interlock/Alarm
arrangement)

RO + EDI will be
heat sanitized
Hot water
sanitization will be
carried out to gather
using multipurpose
tank & heat
exchanger
Hot water
sanitization will be
3
carried out to with
the help of HMI
During Sanitization
all conductivity
interlocks will be
bypassed & EDI will
be switched off.
An Alarm message
in the HMI will
appear

Proposed
Additional Risk
control measure
(Mandatory for
RPN
Risk elements
having RPN>3)

RO+EDI
Sanitization
performance will
be verified at the
time of
commissioning
Routine
calibration of
temperature
sensor shall be
performed as per
calibration plan.

Revised Risk
Classification
S

RPN

Verification
point

Commissioning
OQ
Calibration
Master Plan
SOP

B. Purified Water Storage & Distribution System

24.

Storing of
water

25.

PW Storage
Tank

Difficulty in
catering to
simultaneo
us demand
of multiple
user
points.

Contaminatio
n of PW
possible.

No storage of
purified water
before use.

Leakage in PW
storage tank/
pipelines

The purified water

generated cannot be
stored.
The purified water may
not distributed to the
user points through
distribution loop shall
lead affect product
release

Purified water out

of specification.
Shall affect product
quality/ product
release,

The purified water

generated is stored in a
storage tank.
Storage capacity of the
storage
tank
is
sufficient.
The purified water from
the storage tank shall be
distributed to the user
points through
distribution loop and
returned back to PW
storage tank.
PW storage tank is
provided with vent
filter
to
avoid
atmospheric
contamination

12

SOP for
routine
preventive
maintenance.
Pressure
of
the
storage tank and
distribution
line

Commissioning
IQ

Commissioning
OQ
SOP of PM

Page 12 of 17

Risk
Assessment

Risk Identification
Sr. Component
No Failure/Critic
al Process
Step Failure

26.

PW Storage
Tank

27.

PW Storage
Tank

Potential
Failure
Mode
(Defect)

Cleaning of
the tank not
possible
Contaminatio
n of PW
possible.

Distribution
pumps will
run dry which
may damage
the pump and
cause loop
contamination
due to growth
of microbes

Potential Risk
Cause

Spray ball may

not functioned
properly

Low water level in

the storage tank
due to low
generation or high
usage.

Potential
Risk/Effect/Impact
on Product
Quality/ Product
Release

Purified water out

of specification.
Shall affect product
quality/ product
release,

The purified water may

not distributed to the
user points through
distribution loop shall
lead affect product
release

Current controls
(Interlock/Alarm
arrangement)

Hydrotest is conducted
for the tank at the
vendors site. Vendor
will
provide
the
certificate for the same.
For distribution pipelines,
Hydrotest/ Pressure leak
test is conducted by the
vendor on site after
installation.
The Tank is designed 3
with torispherical
top and bottom dish
to maintain full drain
ability of the water
tank
Spray ball is
provided inside the
tank which will
ensure the interior
surface of the
storage tank are
flushed continuously
to avoid the
formation of the bio
film
3
The PW storage tank is
provided with level
transmitter (with 4
levels) for monitoring
of low-low, low, high
and high-high water
level.
Discharge pump turns
off in case of low-low
level in tank.
Alarm provisioned in
case of low level and
low-low level.
The PW inlet valve
will
automatically
open in case water

Proposed
Additional Risk
control measure
(Mandatory for
RPN
Risk elements
having RPN>3)

Revised Risk
Classification
S

RPN

Verification
point

should be monitored
regularly.
Hydrotest to be
conducted at regular
intervals as per SOP.

12
Spray ball
coverage study
shall be carried
out in
commissioning
and qualification
SOP for
routine
preventive
maintenance.

12

SOP for Preventive

maintenance of PW
storage
and
Distribution system.
Routine calibration of
Level transmitter as
per SOP.

Commissioning
OQ
SOP of PM

Commissioning
OQ
SOP of PM

Page 13 of 17

Risk
Assessment

Risk Identification
Sr. Component
No Failure/Critic
al Process
Step Failure

28.

29.

30.

31.

PW
Distribution
line

PW
Distribution
line

Potential
Failure
Mode
(Defect)

Presence of
particles
inside
pipelines may
contaminate
PW. .

Increase
in
Bio burden in
Purified water
in distribution
loop
and
pumps.

PW
Distribution
line

High
conductivity
of purified
water in
distribution
line.

PW
Distribution
line

High TOC of
purified water
in distribution

Potential Risk
Cause

Pipelines may not

passivated after
welding.

Water may be
stagnant in the
distribution loop
or is held up in the
discharge pump.

PW may not used

for long duration

PW may not used

for long duration

Potential
Risk/Effect/Impact
on Product
Quality/ Product
Release

Current controls
(Interlock/Alarm
arrangement)

level inside tank goes

below high level.
Sight glass has been
provisioned in the tank.
Pipeline
shall
be
Purified water may
passivated
after
be
contaminated
welding and before
Shall
affect
being used.
product
quality/
Passivation test reports
product release,
to be provided
The water distribution
is in a closed loop
system, wherein the
water will be in
continuous flow.
Purified water out
All pipelines shall
of specification.
have drainable slope of
Shall affect product
> 1:100.
quality/ product
Discharge pump shall
release,
be self-draining type.
The dead leg in the loop
shall not be more than
1.5d. (d- diameter of the
extended part)
Conductivity sensors
are provided in the
supply and return line
along
with
alarm
provision in case of
High conductivity water
high and high high
in distribution line may
conductivity.
contaminate the fresh
Auto-dumping facility
incoming purified water
is provided in supply
to storage tank.
line in case of highhigh conductivity.
System trips in case of
continuous high-high
conductivity.
Purified water out
Online TOC analyzer is
installed at return line to
of specification.
storage tank along with
Shall affect product

Proposed
Additional Risk
control measure
(Mandatory for
RPN
Risk elements
having RPN>3)

Revised Risk
Classification
Verification
point

RPN

Commissioning
IQ

Commissioning
IQ

Routine calibration of
flow meter and
conductivity sensor as
per SOP.

Routine calibration of
TOC analyzer as per
SOP.

Commissioning
OQ
Calibration
Master Plan
SOP
2

Commissioning
OQ
Calibration

Page 14 of 17

Risk
Assessment

Risk Identification
Sr. Component
No Failure/Critic
al Process
Step Failure

Potential
Failure
Mode
(Defect)

Potential Risk
Cause

quality/ product
release,

loop.

32.

33.

Potential
Risk/Effect/Impact
on Product
Quality/ Product
Release

PW
Distribution
line

Possibility of
microbial
growth over
continuous
usage of
water.

Frequent
sanitization of PW
storage and
distribution
system not
possible

Purified water may

be contaminated
Shall affect product
quality/ product
release

MOC

Internal
surface may
react with PW
during normal
or sanitization
mode and
lead to
purified water
contamination

Internal surface/
contact parts is
not compatible
with the purified
water

Purified water may

be contaminated
Shall affect product
quality/ product
release

Current controls
(Interlock/Alarm
arrangement)
alarm provision and autodumping facility in case
of high TOC.
A suitable sanitization
process is provided in
the PLC for effective
sanitization of the PW
storage
tank
and
distribution system.
Tank is jacketed and is
provided with plant
steam
supply
for
heating
of
water
during sanitization.
Temperature sensor is
provided in the PW
storage tank and on
return line to monitor
temperature
during
sanitization.
Alarm is provisioned in
case of High/ low
temperature during
sanitization.
All Metallic critical
contact parts (PW
storage
tank,
distribution pipelines,
valves, sampling and
user valves) as well as
contact
parts
of
instruments,
level
transmitters,
valves
etc., are made of SS
316L stainless steel.
Distribution
system
pipelines are electro
polished & orbitally
welded.
Vendor to provide MOC
certificates for the same.

Proposed
Additional Risk
control measure
(Mandatory for
RPN
Risk elements
having RPN>3)

Revised Risk
Classification
S

RPN

Verification
point

Master Plan
SOP

12

Sanitization
frequency shall be
established during
qualification
and
performed routinely.
Routine calibration
of
temperature
sensors as per SOP.

Commissioning
OQ
Calibration
Master Plan
SOP

Commissioning
IQ

Page 15 of 17

Risk
Assessment

Risk Identification
Sr. Component
No Failure/Critic
al Process
Step Failure

34.

35.

Potential
Failure
Mode
(Defect)

Potential Risk
Cause

Potential
Risk/Effect/Impact
on Product
Quality/ Product
Release

Joints

Leaking
joints may
lead to
contamination
of PW.

Joints are not air

tight. Suitable
gaskets are not
provided or are
not replaceable.

Purified water may

be contaminated
Shall affect product
quality/ product
release

Calibration

Calibration
of
measuring
instrument
is not
possible

Operation
failure may
affect the
quality of the
PW.

Purified water may

be contaminated
Shall affect product
quality/ product
release

3.0

Current controls
(Interlock/Alarm
arrangement)
Suitable gaskets are
provided for air tight
triclover
connection
and
are
easily
replaceable.
Quick release Triclover
joints are recommended.
Calibration of the
instrument is done at
vendor site
Calibrated instruments
are installed

Proposed
Additional Risk
control measure
(Mandatory for
RPN
Risk elements
having RPN>3)

Regular maintenance
and replacement of
gaskets and O-rings
as per SOP

Routine calibration of
the entire measuring
instrument shall be
performed as per
SOP.

Revised Risk
Classification
Verification
point

RPN

Commissioning
IQ
SOP of PM

Commissioning
OQ
Calibration
Master Plan
SOP

APPROVALS
Function

Name

Designation

Signature/ Date

Prepared by:
IPSM Validation and
C&Q
Checked by:
IPSM Validation and
C&Q
Approved by:
J&J Facility Engineer
Approved by:
J&J Quality Assurance
Approved by:
J&J Manufacturing
Approved by:
J&J Microbiology Lab
Representative

Page 16 of 17

Function

Name

Designation

Signature/ Date

Approved by:
J&J EH & S
Representative
The words IPS or IPSM in this document will indicate Integrated Project Services Mehtalia, Mumbai and J&J will indicate
Ethicon (a Johnson & Johnson company).

Page 17 of 17