Failure Mode and Effective Analysis (FMEA)

For
Purified Water Generation, Storage and Distribution System

Page 1 of 16
1 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 1
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. 2
Major Impact on Product Quality, Overall System Performance and/or Functionality, Operator Safety and 3
Exception or gap with respect to regulations or standards (GxP, EU, GAMP, ASTM, etc.)

 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 1
Occurrence is occasionally 2
Occurrence is almost every time the system is used 3

Page 2 of 16
 The likelihood of Detection (D) shall be rated, determined and documented (Low=3, Medium=2, High=1).
DESCRIPTION DETECTION(D)
100% detection or inspection technique is in place specifically for the failure like an alarm, interlock, and 1
error message or system shutdown.
Detected by indirect means or by observation like indirect indication or visual inspection. 2

No specific detection method 3

 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 RISK
RPN  3 Low (L)
9 ≥ RPN > 3 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 16
 2 SYSTEM RISK ASSESSMENT MATRIX
Revised Risk
Risk Identification Risk Assessment Proposed Additional Classification
Current controls Risk control measure
Sr. Component Potential
Potential (Interlock/Alarm (Mandatory for Risk Verification point
No Failure/Critical Potential Risk Risk/Effect/Impact on
Failure Mode arrangement) S O D RPN elements having S O D RPN
Process Step Cause Product Quality/
(Defect) RPN>3)
Failure Product Release

A. Purified Water Generation System

 Vent Filter is
provided for venting
 The system shall be to avoid any vacuum
inefficient to remove hazards and to
the increased prevent any
Increased
microbial and atmospheric
microbial
particulate contamination and  Commissioning
and particle There may be
Raw Water contamination. moisture from  IQ
1. Tank
contaminati leakage in the
 Frequent changes of entering the tank
3 1 1 3 _ _ _ _ _
on of the in- Tank  OQ
the RO membrane  The raw water
feed raw
water  No impact on transfer piping is
product quality, as provided with the
raw water is not used facility for adding
for process sodium hypochlorite
solution on line to
raw water.
 The raw water quality Sampling points are
shall decide the final provided in raw
purified water quality water feed line before
Sampling of Sampling point Routine Sampling  Commissioning
and the extent of the Multi grade filter
the Raw may not be of the raw water  IQ
2. Raw Water
water is not considered in
pretreatment. 3 1 1 3
shall be carried out
3 1 1 3
 OQ
 No impact on
possible the design as per SOP  SOP for Sampling
product quality, as
raw water is not used
for process
NaOCl  Increase in bioburden  Alarm is provided in
dosing in raw water. case of malfunction of
pump fails.  Preventive
 Load on downstream dosing pump.
maintenance of
purification system.  The pre-treatment
pump shall be
 No impact on system stops in case
Mechanical carried out  Commissioning
product quality as UF dosing pump
3. NaOCl dosing damage of
and RO membranes malfunction.
3 2 1 6 frequently as per 3 1 1 3  OQ
pump PM SOP.  SOP for PM
are installed at
 A standby pump
downstream.
shall be kept as
 Drinking water may
spare.
go out of microbial
specification.

Page 4 of 16
 Revised Risk
Risk Identification Risk Assessment Proposed Additional Classification
Current controls Risk control measure
Sr. Component Potential
Potential (Interlock/Alarm (Mandatory for Risk Verification point
No Failure/Critical Potential Risk Risk/Effect/Impact on
Failure Mode arrangement) S O D RPN elements having S O D RPN
Process Step Cause Product Quality/
(Defect) RPN>3)
Failure Product Release
 Initial Filtration of  Alarm is provided in
 Multiport valve
Multi Grade raw water may not case of
operation shall be
Filter not take place. malfunctioning of
verified during  Commissioning
working Multiport valve Downstream system multiport valve.
commissioning.  OQ
Multi Grade properly; may not may not get water for  Pop up is shown on
4. Filter filtration of function processing. the HMI, to indicate
2 2 1 4  Routine preventive 2 1 1 2  Preventive
maintenance of the maintenance SOP
raw water properly.  No impact on status of the
valve shall be for MGF.
may not product quality, as Multiport valve and
carried out as per
take place. raw water is not used MGF mode i.e.
SOP.
for process. service or backwash.
 Routine monitoring
of pressure shall be
carried out to check
choking of MGF.
 Backwash shall be
 Initial Filtration of carried out at
Multi Grade raw water may not  Pressure gauges are frequent intervals
 Commissioning
Filter not take place. provided to monitor as per SOP.
 IQ
working  Downstream system pressure across MGF  Frequency shall be
Choking of  SOP for MGF
Multi Grade properly; may not get water for and indicate choking. derived based on
5. Filter filtration of
Multi grade
processing.  Backwash provision
2 3 1 6
vendor
2 1 1 2 operation &
Filter Cleaning
raw water  No impact on is provided for recommendation
may not  Calibration
product quality, as cleaning of MGF and and on
take place. Master plan SOP
raw water is not used prevents choking. consumption of
for process. water.
 Routine calibration
of Pressure gauges
shall be performed
as per calibration
plan.
6. Softener Unit Softener Automatic  Initial removal of ions  Alarm is provided in 2 2 1 4  Automatic 2 1 1 2  Commissioning
Unit not multiport valve from raw water may case of Multiport valve  OQ
working may not not take place it may malfunctioning of operation shall be  Preventive
properly, function lead to hardness & Automatic multiport verified during maintenance SOP
removal of properly. scale formation valve. commissioning. for Softener.
ions from  Downstream system  Pop up is shown on the  Routine preventive
the water may not get water for HMI, to indicate status maintenance of the
may not further water of the Multiport valve valve shall be
takes place treatment and softener unit carried out as per
 No impact on SOP.
product quality, as

Page 5 of 16
 Revised Risk
Risk Identification Risk Assessment Proposed Additional Classification
Current controls Risk control measure
Sr. Component Potential
Potential (Interlock/Alarm (Mandatory for Risk Verification point
No Failure/Critical Potential Risk Risk/Effect/Impact on
Failure Mode arrangement) S O D RPN elements having S O D RPN
Process Step Cause Product Quality/
(Defect) RPN>3)
Failure Product Release
water is not used for
process.
Softener  Brine Tank is  Routine monitoring
Unit not provided with level of Brine tank shall
 Softener having low
working switch to monitor the be carried out as
OBR
properly, level of the brine per defined
 Downstream may not  Commissioning
removal of solution procedures.
ions from Regeneration of get water for further  OQ
 Force regeneration  Regeneration
7. Softener Unit the water the softener not water treatment
can be activated
2 3 1 6
frequency of the
2 1 1 2  Preventive
may not possible  No impact on maintenance SOP
through HMI & Softener shall be as
takes place product quality, as for Softener.
Manual mode as well per SOP.
water is not used for
 Frequency shall be
process
derived based on
vendor
Colloidal  Alarm is provided in  UF Service cycle
particulate  Increase the colloidal case of valve operation
& high particulate & high malfunctioning of shall be verified
Ultra filtration  Commissioning
molecular molecular weight Ultra filtration service during
service cycle  OQ
Ultra filtration weight material in the water cycle commissioning.
8. system material
valve not
 No impact on  Pop up is shown on
2 2 1 4
 Routine preventive
2 1 1 2  Preventive
working maintenance SOP
may not be product quality, as the HMI, to indicate maintenance of the
properly for UF.
filtered from water is not used for status of the Ultra valve shall be
water process. filtration service cycle carried out as per
valve SOP.
 Centrifugal pump  Operation of the
with desired flow rate Backwash
is placed for centrifugal pump
backwashing & Fast shall be verified
 Ultra filtration may Flushing of UF during
be hampered Module commissioning
 Commissioning
Choking of  Lack of water to  Pressure gauge is  UF backwash &
UF Backwash &  OQ
Ultra filtration the Ultra Downstream provided at the Fast Flush process
9. system filtration of
Fast Flush may
discharge pump to
2 2 1 4
shall be verified
2 1 1 2  Preventive
not takes place  No impact on
the system maintenance SOP
product quality, as monitor the pressure during
for UF.
water is not used for  Popup indication in commissioning
process. HMI to indicate the  Routine Preventive
Backwash & Fast maintenance of the
Flush cycle Pump shall be as
per the SOP

Page 6 of 16
 Revised Risk
Risk Identification Risk Assessment Proposed Additional Classification
Current controls Risk control measure
Sr. Component Potential
Potential (Interlock/Alarm (Mandatory for Risk Verification point
No Failure/Critical Potential Risk Risk/Effect/Impact on
Failure Mode arrangement) S O D RPN elements having S O D RPN
Process Step Cause Product Quality/
(Defect) RPN>3)
Failure Product Release
 Alarm will appear for
 Low level of the UF
high level of the UF
permeate tank will  Operation of the
permeate tank
lead to damage of the level switches shall
 Water will re-
connected suction be verified during
Level of the Level switch of circulate in case of the  Commissioning
pump commissioning
UF permeate the UF tank is high level of the UF  IQ & OQ
10. UF permeate
is not not working
 Lack of water to
permeate tank
2 2 1 4  Routine Preventive 2 1 1 2
 Preventive
downstream maintenance of the
controlled properly  Connected suction maintenance SOP.
 No impact on Pump shall be as
pumps will stop in
product quality, as per the SOP
case of low level of
water is not used for
UF permeate tank
process.
 The chlorine content  Activated Carbon
in water shall lead to Filter is provided to
oxidation of the RO adsorb the free
membrane chlorine present in
High Activated
 Odor of water may be the influent water &  Commissioning
Activated chlorine carbon filter not
11. Carbon Filter level & Bad working
not good to improve water bad 2 1 1 2 _ _ _ _ _  IQ & OQ
 May not affect the odor
Water Odor properly
final quality of the  Pressure will be
water as SMBS monitored across the
dosing is present vessel by pressure
gauge
 UV sterilizer is
provided with
 Living
intensity & hour
microorganism grows  Commissioning
meter to check the
Ultra violate and in a favorable  IQ & OQ
Increase intensity and working
Ultra Violate sterilizer not condition for their  SOP of Operation
12. Sterilizer
microbial
working exponential growth
hour of the UV lamp 3 1 1 3 _ _ _ _ _
odor of UV sterilizer & PM of the UV
properly  May increase the Sterilizer
 Routine Monitoring
microbial level of the
of the UV Sterilizer
final water
shall be checked
regularly

Page 7 of 16
 Revised Risk
Risk Identification Risk Assessment Proposed Additional Classification
Current controls Risk control measure
Sr. Component Potential
Potential (Interlock/Alarm (Mandatory for Risk Verification point
No Failure/Critical Potential Risk Risk/Effect/Impact on
Failure Mode arrangement) S O D RPN elements having S O D RPN
Process Step Cause Product Quality/
(Defect) RPN>3)
Failure Product Release
 Low level of chemical  The Chemical dosing
will not release system comprises
antiscalant as per the with level switch
 Operation of the
requirement which which will trip the
Chemical dosing
leads Precipitation of dosing pump
Low system shall be
Antiscalent silica on RO  Alarm provision is  Commissioning
chemical verified during
Antiscalent Dosing System membrane can provided in case of  IQ & OQ
13. Dosing System
level in
not working damage the
3 2 1 6 commissioning 2 1 1 2
antiscalant
low chemical  Preventive
 Routine checkup of
properly membrane and maintenance SOP.
dosing tank chemical dosing
reduce efficiency.
shall be performed
 No impact on
regularly
product quality, as
water is not used for
process.
 The NaOH dosing  Operation of the
system comprises NaOH dosing
with pH Transmitter system shall be
PH of the which will monitor verified during
CO2 Level of the  Commissioning
PW water NaOH Dosing the pH of the water commissioning
Water may be  IQ
NaOH Dosing not System not  Alarm provision is  Routine checkup of
14. System controlled as working
increase which may
provided to alert the
3 2 1 6
NaOH dosing shall
2 1 1 2  OQ
affect the final pH of  Calibration
per the properly operator be performed
the water Master plan SOP
requirement regularly
 Calibration of the
pH transmitter as
per the SOP
 Low level of chemical  The Chemical dosing
will not neutralize system comprises
 Operation of the
chlorine as per the with level switch
Chemical dosing
requirement which will trip the
Low system shall be
SMBS Dosing  The chlorine content dosing pump  Commissioning
chemical verified during
SMBS Dosing System not in water shall lead to  Alarm provision is  IQ & OQ
15. System
level in
working oxidation of the provided in case of
3 2 1 6 commissioning 2 1 1 2
SMBS  Preventive
 Routine checkup of
properly RO/EDI low chemical maintenance SOP.
dosing tank chemical dosing
 No impact on
shall be performed
product quality, as
regularly
water is not used for
process.
16. ORP Sensor Chorine ORP sensor is  The chlorine content  Alarm is provisioned 3 2 1 6  Operation of the 2 1 1 2  Commissioning
Level after not working in water shall lead to for high ORP. ORP Sensor Shall  IQ
SMBS properly oxidation of the RO  Auto dump valve is be Verified during  OQ

Page 8 of 16
 Revised Risk
Risk Identification Risk Assessment Proposed Additional Classification
Current controls Risk control measure
Sr. Component Potential
Potential (Interlock/Alarm (Mandatory for Risk Verification point
No Failure/Critical Potential Risk Risk/Effect/Impact on
Failure Mode arrangement) S O D RPN elements having S O D RPN
Process Step Cause Product Quality/
(Defect) RPN>3)
Failure Product Release
membrane and hence provided in case of
shall affect the final free chlorine level
commissioning
dosing may water quality high
 Calibration of the  Calibration
not be  No impact on
ORP Sensor as per Master plan SOP
detected product quality, as
the SOP
water is not used for
process.
 Heat exchangers are
 Water temperature
provided with Hot
will not be adequate,
and cold arrangement  Commissioning
Optimum which may lead to
before RO inlet  IQ
temperature RO membrane
Heat Heat Exchangers  Temperature  OQ
17. Exchangers
of water
is not working
damage
transmitters provided
3 1 1 3 _ _ _ _ _
may not be  Preventive
 No impact on
to measure the inlet maintenance SOP.
maintained product quality, as
temperature of the
water is not used for
water before entering
process
to RO membrane
 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
 Supply to RO
feed pump  Commissioning
Storage of membrane will
Storage tank  All set points of water  IQ
water may hamper
Multipurpose before RO is not level of the storage  OQ
18. Storage tank
not be
working
 No impact on
tank shall be
3 1 1 3 _ _ _ _ _
possible  Preventive
product quality, as
properly controlled by the maintenance SOP.
before RO water is not used for
HMI
process.
 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

Page 9 of 16
 Revised Risk
Risk Identification Risk Assessment Proposed Additional Classification
Current controls Risk control measure
Sr. Component Potential
Potential (Interlock/Alarm (Mandatory for Risk Verification point
No Failure/Critical Potential Risk Risk/Effect/Impact on
Failure Mode arrangement) S O D RPN elements having S O D RPN
Process Step Cause Product Quality/
(Defect) RPN>3)
Failure Product Release
 High pressure pump
with VFD is provided
Filtration of the high
 Pressure Transmitter  Commissioning
molecular weight
Water is provided to
High Pressure inorganic as well  IQ
Pressure monitor the Pressure
High Pressure Pump is not organic molecules  OQ
19. Pump
may not
functioning may not be possible
of water at RO inlet 3 1 1 3 _ _ _ _ _
sufficient to  Preventive
properly which will lead to  If the Pump discharge
feed RO maintenance SOP.
affect the final water goes above the set
quality point then pump will
trip

 Conductivity
transmitter is provided
at the downstream of
Purified water out of  Routine calibration
High Heat Sanitary RO to check  Commissioning
specification. Shall of conductivity
Heat Sanitary conductivity RO system not conductivity along  OQ
20. RO system after RO functioning
affect product
with alarm provision.
3 1 1 3 sensor shall be 2 1 1 2
quality/ product  Calibration
performed as per
permeate properly  High conductivity Master Plan SOP
release calibration plan.
water after RO shall
be dump by dumping
valve
 Pressure at the
concentration side and
permeate side will be
monitored and
 Routine calibration
controlled by pressure  Commissioning
Choking of May be due to RO membrane will of pressure
Heat Sanitary transmitter  OQ
21. RO system
RO high use of RO damage & shall affect
 An alarm of high
3 1 1 3 transmitter shall be 2 1 1 2
membrane membrane the product quality  Calibration
performed as per
pressure will initiate Master Plan SOP
calibration plan.
 High pressure pump
will trip in case of the
high pressure

Page 10 of 16
 Revised Risk
Risk Identification Risk Assessment Proposed Additional Classification
Current controls Risk control measure
Sr. Component Potential
Potential (Interlock/Alarm (Mandatory for Risk Verification point
No Failure/Critical Potential Risk Risk/Effect/Impact on
Failure Mode arrangement) S O D RPN elements having S O D RPN
Process Step Cause Product Quality/
(Defect) RPN>3)
Failure Product Release
 Conductivity sensor is
provided at the
downstream of EDI to
check conductivity
Purified water out of  Routine calibration
along with alarm  Commissioning
High EDI is not specification. Shall of conductivity
provision.  OQ
22. 4 EDI permeate conductivity working affect product
 High conductivity
3 1 1 3 sensor shall be 2 1 1 2
after EDI properly quality/ product  Calibration
performed as per
water after EDI shall be Master Plan SOP
release, calibration plan.
diverted back to
multipurpose storage
tank through a flow
divertor valve.
 RO + EDI will be heat
sanitized
 Hot water sanitization
will be carried out to  RO+EDI
gather using Sanitization
multipurpose tank & performance will be
Purified water out of
heat exchanger verified at the time  Commissioning
RO + EDI specification. Shall
RO + EDI Bio-burden  Hot water sanitization of commissioning  OQ
23. Sanitization in RO & EDI
Sanitization not affect product
will be carried out to
3 2 1 6
 Routine calibration
2 1 1 2
possible quality/ product  Calibration
with the help of HMI of temperature Master Plan SOP
release,
 During Sanitization all sensor shall be
conductivity interlocks performed as per
will be bypassed & EDI calibration plan.
will be switched off.
 An Alarm message in
the HMI will appear

B. Purified Water Storage & Distribution System

24. Storing of Difficulty in No storage of  The purified water  The purified water 3 1 1 3 _ _ _ _ _  Commissioning
water catering to purified water generated cannot be generated is stored in a  IQ
simultaneou before use. stored. storage tank.
s demand of  The purified water may  Storage capacity of the
multiple not distributed to the storage tank is
user points. user points through sufficient.
distribution loop shall  The purified water from
lead affect product the storage tank shall be
release distributed to the user
points through
distribution loop and

Page 11 of 16
 Revised Risk
Risk Identification Risk Assessment Proposed Additional Classification
Current controls Risk control measure
Sr. Component Potential
Potential (Interlock/Alarm (Mandatory for Risk Verification point
No Failure/Critical Potential Risk Risk/Effect/Impact on
Failure Mode arrangement) S O D RPN elements having S O D RPN
Process Step Cause Product Quality/
(Defect) RPN>3)
Failure Product Release
returned back to PW
storage tank.

 PW storage tank is
provided with vent
 SOP for routine
filter to avoid
preventive
atmospheric
maintenance.
Purified water out of contamination
 Pressure of the
Contaminatio specification. Shall  Hydrotest is conducted  Commissioning
Leakage in PW storage tank and
PW Storage n of PW for the tank at the
25. Tank possible.
storage tank/ affect product
vendor’s site. Vendor
3 2 2 12 distribution line 2 1 1 2  OQ
pipelines quality/ product should be monitored  SOP of PM
will provide the
release, regularly.
certificate for the same.
 Hydrotest to be
 For distribution pipelines,
conducted at regular
Hydrotest/ Pressure leak
intervals as per SOP.
test is conducted by the
vendor on site after
installation.
 The Tank is designed
with torispherical top
and bottom dish to
maintain full drain  Spray ball coverage
Cleaning of ability of the water study shall be
the tank not Purified water out of tank carried out in
possible Spray ball may specification. Shall  Spray ball is provided commissioning and  Commissioning
PW Storage
26. Tank
Contaminatio not functioned affect product inside the tank which 3 2 2 12 qualification 2 1 1 2  OQ
n of PW properly quality/ product will ensure the interior  SOP for routine  SOP of PM
possible. release, preventive
surface of the storage
tank are flushed maintenance.
continuously to avoid
the formation of the bio
film
27. PW Storage Distribution Low water level in The purified water may  The PW storage tank is 3 2 2 12  SOP for Preventive 2 1 1 2  Commissioning
Tank pumps will the storage tank not distributed to the provided with level maintenance of PW  OQ
run dry which due to low user points through transmitter (with 4 storage and  SOP of PM
may damage generation or high distribution loop shall levels) for monitoring Distribution system.
the pump and usage. lead affect product of low-low, low, high  Routine calibration of
cause loop release and high-high water Level transmitter as
contamination level. per SOP.
due to growth  Discharge pump turns
of microbes off in case of low-low
level in tank.

Page 12 of 16
 Revised Risk
Risk Identification Risk Assessment Proposed Additional Classification
Current controls Risk control measure
Sr. Component Potential
Potential (Interlock/Alarm (Mandatory for Risk Verification point
No Failure/Critical Potential Risk Risk/Effect/Impact on
Failure Mode arrangement) S O D RPN elements having S O D RPN
Process Step Cause Product Quality/
(Defect) RPN>3)
Failure Product Release
 Alarm provisioned in
case of low level and
low-low level.
 The PW inlet valve
will automatically
open in case water
level inside tank goes
below high level.
 Sight glass has been
provisioned in the tank.
Presence of Purified water may  Pipeline shall be
PW particles be contaminated passivated after  Commissioning
Pipelines may not
inside welding and before
28. Distribution
pipelines may
passivated after Shall affect product
being used.
3 1 1 3 _ _ _ _ _  IQ
line welding. quality/ product
contaminate  Passivation test reports
release,
PW. . to be provided
 The water distribution
is in a closed loop
system, wherein the
water will be in
Increase in
continuous flow.
Bio burden in Water may be Purified water out of
PW specification. Shall  All pipelines shall  Commissioning
Purified water stagnant in the
have drainable slope of
29. Distribution in distribution distribution loop affect product
> 1:100.
3 1 1 3 _ _ _ _ _  IQ
line loop and or is held up in the quality/ product
pumps.  Discharge pump shall
discharge pump. release,
be self-draining type.
 The dead leg in the loop
shall not be more than
1.5d. (d- diameter of the
extended part)
30. PW High PW may not used High conductivity water  Conductivity sensors 3 1 1 3  Routine calibration of 2 1 1 2  Commissioning
Distribution conductivity for long duration in distribution line may are provided in the flow meter and  OQ
line of purified contaminate the fresh supply and return line conductivity sensor as  Calibration
water in incoming purified water along with alarm per SOP. Master Plan SOP
distribution to storage tank. provision in case of
line. high and high – high
conductivity.
 Auto-dumping facility
is provided in supply
line in case of high-
high conductivity.
 System trips in case of
continuous high-high

Page 13 of 16
 Revised Risk
Risk Identification Risk Assessment Proposed Additional Classification
Current controls Risk control measure
Sr. Component Potential
Potential (Interlock/Alarm (Mandatory for Risk Verification point
No Failure/Critical Potential Risk Risk/Effect/Impact on
Failure Mode arrangement) S O D RPN elements having S O D RPN
Process Step Cause Product Quality/
(Defect) RPN>3)
Failure Product Release
conductivity.

Purified water out of Online TOC analyzer is

High TOC of installed at return line to  Commissioning
PW specification. Shall Routine calibration of
purified water PW may not used storage tank along with  OQ
31. Distribution affect product 3 1 1 3 TOC analyzer as per 2 1 1 2
line
in distribution for long duration
quality/ product
alarm provision and auto-
SOP.  Calibration
loop. dumping facility in case Master Plan SOP
release,
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
 Sanitization
provided with plant
Possibility of Frequent Purified water may be frequency shall be
steam supply for  Commissioning
PW microbial sanitization of PW contaminated Shall established during
heating of water
growth over storage and qualification and  OQ
32. Distribution affect product during sanitization. 3 2 2 12 2 1 1 2
line
continuous distribution
quality/ product
performed routinely.  Calibration
 Temperature sensor is
usage of system not  Routine calibration Master Plan SOP
release provided in the PW
water. possible of temperature
storage tank and on
sensors as per SOP.
return line to monitor
temperature during
sanitization.
 Alarm is provisioned in
case of High/ low
temperature during
sanitization.
33. MOC Internal Internal surface/ Purified water may be  All Metallic critical 3 1 1 3 _ _ _ _ _  Commissioning
surface may contact parts is contaminated Shall contact parts (PW  IQ
react with PW not compatible affect product storage tank,
during normal with the purified quality/ product distribution pipelines,
or sanitization water release valves, sampling and
mode and user valves) as well as
lead to contact parts of
purified water instruments, level
contamination transmitters, valves
etc., are made of SS
316L stainless steel.
 Distribution system
pipelines are electro
polished & orbitally

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 Revised Risk
Risk Identification Risk Assessment Proposed Additional Classification
Current controls Risk control measure
Sr. Component Potential
Potential (Interlock/Alarm (Mandatory for Risk Verification point
No Failure/Critical Potential Risk Risk/Effect/Impact on
Failure Mode arrangement) S O D RPN elements having S O D RPN
Process Step Cause Product Quality/
(Defect) RPN>3)
Failure Product Release
welded.
 Vendor to provide MOC
certificates for the same.
 Suitable gaskets are
Leaking Joints are not air Purified water may be provided for air tight
contaminated Shall  Regular maintenance  Commissioning
joints may tight. Suitable triclover connection
and replacement of
34. Joints lead to gaskets are not affect product and are easily 3 2 1 6
gaskets and O-rings
2 1 1 2  IQ
contamination provided or are quality/ product replaceable.  SOP of PM
as per SOP
of PW. not replaceable. release  Quick release Triclover
joints are recommended.
Calibration  Calibration of the
Purified water may be Routine calibration of
of Operation instrument is done at  Commissioning
contaminated Shall the entire measuring
measuring failure may vendor site  OQ
35. Calibration
instrument affect the quality
affect product
 Calibrated instruments
3 2 1 6 instrument shall be 2 1 1 2
quality/ product performed as per  Calibration
is not of the PW. are installed Master Plan SOP
release SOP.
possible

3 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

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 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).

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