Академический Документы
Профессиональный Документы
Культура Документы
For
Purified Water Generation, Storage and Distribution System
Page 1 of 17
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 occasionally
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.
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
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
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
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
Level of
the UF
permeate
is not
controlled
Level switch of
the UF tank is
not working
properly
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
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
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
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
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
May be due to
high use of RO
membrane
RO membrane will
damage & shall
affect the product
quality
EDI is not
working
properly
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
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
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
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
Potential
Risk/Effect/Impact
on Product
Quality/ 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
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
Water may be
stagnant in the
distribution loop
or is held up in the
discharge pump.
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
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
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
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.
Calibration
Calibration
of
measuring
instrument
is not
possible
Operation
failure may
affect the
quality of the
PW.
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