Failure Mode and Effective Analysis (FMEA)

For
Purified Water Generation, Storage and Distribution System

Page 1 of 15
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 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

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

Page 2 of 15
 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 15
2.0 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 atmospheric
microbial and
microbial contamination and
particulate  Commissioning
and particle There may be moisture from
Raw Water contamination.  IQ
1. Tank
contaminati leakage in the
 Frequent changes of entering the tank ( 3 1 1 3 _ _ _ _ _
on of the in- Tank  OQ
feed raw
the RO membrane  The raw water
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
3. NaOCl dosing NaOCl Mechanical  Increase in bioburden  Alarm is provided in 3 2 1 6  Preventive 3 1 1 3  Commissioning
dosing damage of in raw water. case of malfunction of maintenance of  OQ
pump fails. pump  Load on downstream dosing pump. pump shall be  SOP for PM
purification system.  The pre-treatment carried out
 No impact on system stops in case frequently as per
product quality as UF dosing pump PM SOP.
and RO membranes malfunction.  A standby pump
are installed at shall be kept as
downstream. spare.
 Drinking water may
go out of microbial

Page 4 of 15
 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
specification.
 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
provided to monitor  Commissioning
Filter not take place. as per SOP.
pressure across MGF  IQ
working  Downstream system  Frequency shall be
Choking of and indicate choking.  SOP for MGF
Multi Grade properly; may not get water for derived based on
5. Multi grade 2 3 1 6 2 1 1 2 operation &
Filter filtration of
Filter
processing.  Backwash provision vendor
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
SOP.

Page 5 of 15
 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
 No impact on
product quality, as
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.
9. Ultra filtration Choking of UF Backwash &  Ultra filtration may  Centrifugal pump 2 2 1 4  Operation of the 2 1 1 2  Commissioning
system the Ultra Fast Flush may be hampered with desired flow rate Backwash  OQ
filtration of not takes place  Lack of water to is placed for centrifugal pump  Preventive
the system Downstream backwashing & Fast shall be verified maintenance SOP
 No impact on Flushing of UF during for UF.
product quality, as Module commissioning
water is not used for  Pressure gauge is  UF backwash &
process. provided at the Fast Flush process
discharge pump to shall be verified
monitor the pressure during
 Popup indication in commissioning
HMI to indicate the  Routine Preventive
Backwash & Fast maintenance of the
Flush cycle Pump shall be as

Page 6 of 15
 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
per the SOP

 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  Commissioning
Level of the Level switch of circulate in case of the
pump commissioning  IQ & OQ
UF permeate the UF tank is high level of the UF
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 maintenance
controlled properly  Connected suction
 No impact on Pump shall be as SOP.
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
13. Antiscalent Low Antiscalent  Low level of chemical  The Chemical dosing 3 2 1 6  Operation of the 2 1 1 2  Commissioning
Dosing System chemical Dosing System will not release system comprises Chemical dosing  IQ & OQ
level in not working antiscalant as per the with level switch system shall be  Preventive
antiscalant properly requirement which which will trip the verified during maintenance
dosing tank leads Precipitation of dosing pump commissioning SOP.

Page 7 of 15
 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
silica on RO  Alarm provision is
membrane can provided in case of
damage the low chemical
 Routine checkup of
membrane and
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  Commissioning
SMBS Dosing  The chlorine content dosing pump
chemical verified during  IQ & OQ
SMBS Dosing System not in water shall lead to  Alarm provision is
15. System
level in
working oxidation of the provided in case of
3 2 1 6 commissioning 2 1 1 2  Preventive
SMBS  Routine checkup of maintenance
properly RO/EDI low chemical
dosing tank chemical dosing SOP.
 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
dosing may membrane and hence provided in case of commissioning  Calibration
not be shall affect the final free chlorine level  Calibration of the Master plan SOP
detected water quality high ORP Sensor as per
 No impact on the SOP
product quality, as

Page 8 of 15
 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.
 Heat exchangers are
 Water temperature
provided with Hot
will not be adequate,  Commissioning
and cold arrangement
Optimum which may lead to  IQ
before RO inlet
temperature RO membrane  OQ
Heat Heat Exchangers  Temperature
17. Exchangers
of water
is not working
damage
transmitters provided
3 1 1 3 _ _ _ _ _  Preventive
may not be  No impact on maintenance
to measure the inlet
maintained product quality, as SOP.
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  Commissioning
feed pump
Storage of membrane will  IQ
Storage tank  All set points of water
water may hamper  OQ
Multipurpose before RO is not level of the storage
18. Storage tank
not be
working
 No impact on
tank shall be
3 1 1 3 _ _ _ _ _  Preventive
possible product quality, as maintenance
properly controlled by the
before RO water is not used for SOP.
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
19. High Pressure Water High Pressure Filtration of the high  High pressure pump 3 1 1 3 _ _ _ _ _  Commissioning
Pump Pressure Pump is not molecular weight with VFD is provided  IQ
may not functioning inorganic as well  Pressure Transmitter  OQ
sufficient to properly organic molecules is provided to  Preventive
feed RO may not be possible monitor the Pressure maintenance

Page 9 of 15
 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
of water at RO inlet
 If the Pump discharge
which will lead to
goes above the set SOP.
affect the final water
point then pump will
quality
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

 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
22. provision.  OQ
EDI permeate conductivity working affect product 3 1 1 3 sensor shall be 2 1 1 2
4 after EDI properly quality/ product
 High conductivity
performed as per
 Calibration
water after EDI shall be Master Plan SOP
release, calibration plan.
diverted back to
multipurpose storage
tank through a flow
divertor valve.
23. RO + EDI Bio-burden RO + EDI Purified water out of  RO + EDI will be heat 3 2 1 6  RO+EDI 2 1 1 2  Commissioning

Page 10 of 15
 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
sanitized
 Hot water sanitization
will be carried out to
gather using Sanitization
multipurpose tank & performance will be
heat exchanger verified at the time
specification. Shall
 Hot water sanitization of commissioning  OQ
Sanitization not affect product
Sanitization in RO & EDI will be carried out to  Routine calibration  Calibration
possible quality/ product
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

 The purified water
generated is stored in a
 The purified water storage tank.
Difficulty in generated cannot be  Storage capacity of the
catering to stored. storage tank is
 The purified water may  Commissioning
simultaneou No storage of sufficient.
Storing of not distributed to the  IQ
24. water
s demand of purified water
user points through  The purified water from 3 1 1 3 _ _ _ _ _
multiple before use. the storage tank shall be
distribution loop shall
user points. distributed to the user
lead affect product
release points through
distribution loop and
returned back to PW
storage tank.
25. PW Storage Contaminatio Leakage in PW Purified water out of 3 2 2 12  SOP for routine 2 1 1 2  Commissioning
Tank n of PW storage tank/ specification. Shall  PW storage tank is preventive  OQ
possible. pipelines affect product provided with vent maintenance.  SOP of PM
quality/ product filter to avoid  Pressure of the
release, atmospheric storage tank and
contamination distribution line
 Hydrotest is conducted should be monitored
for the tank at the regularly.
vendor’s site. Vendor  Hydrotest to be
will provide the conducted at regular
certificate for the same. intervals as per SOP.

Page 11 of 15
 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
 For distribution pipelines,
Hydrotest/ Pressure leak
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
 The PW storage tank
is provided with level
transmitter (with 4
levels) for monitoring
of low-low, low, high
and high-high water
Distribution level.
pumps will The purified water may  SOP for Preventive
Low water level in  Discharge pump turns
run dry which not distributed to the maintenance of PW
the storage tank off in case of low-low  Commissioning
may damage user points through storage and
PW Storage due to low level in tank.
27. Tank
the pump and
generation or high
distribution loop shall
 Alarm provisioned in
3 2 2 12 Distribution system. 2 1 1 2  OQ
cause loop
usage.
lead affect product  Routine calibration of  SOP of PM
case of low level and
contamination release Level transmitter as
low-low level.
due to growth per SOP.
of microbes  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.
PW Presence of Pipelines may not Purified water may  Pipeline shall be  Commissioning
28. Distribution particles passivated after be contaminated passivated after 3 1 1 3 _ _ _ _ _
 IQ

Page 12 of 15
 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
inside welding and before
Shall affect product
pipelines may being used.
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  All pipelines shall
PW Purified water stagnant in the specification. Shall have drainable slope of  Commissioning
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  Discharge pump shall
pumps. 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)
 Conductivity sensors
are provided in the
supply and return line
along with alarm
High provision in case of
High conductivity water
PW conductivity
in distribution line may
high and high – high  Routine calibration of  Commissioning
of purified PW may not used conductivity. flow meter and  OQ
30. Distribution contaminate the fresh
 Auto-dumping facility
3 1 1 3 2 1 1 2
line
water in for long duration
incoming purified water conductivity sensor as  Calibration
distribution is provided in supply per SOP. Master Plan SOP
to storage tank.
line. line in case of high-
high conductivity.
 System trips in case of
continuous high-high
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.
32. PW Possibility of Frequent Purified water may be  A suitable sanitization 3 2 2 12  Sanitization 2 1 1 2  Commissioning
Distribution microbial sanitization of PW contaminated Shall process is provided in frequency shall be  OQ
line growth over storage and affect product the PLC for effective established during  Calibration
continuous distribution quality/ product sanitization of the PW qualification and Master Plan SOP

Page 13 of 15
 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
storage tank and
distribution system.
 Tank is jacketed and is
provided with plant
steam supply for
heating of water
during sanitization.
 Temperature sensor is performed routinely.
usage of system not provided in the PW  Routine calibration
release
water. possible storage tank and on of temperature
return line to monitor sensors as per SOP.
temperature during
sanitization.
 Alarm is provisioned in
case of High/ low
temperature during
sanitization.
 All Metallic critical
contact parts (PW
storage tank,
distribution pipelines,
Internal valves, sampling and
surface may user valves) as well as
react with PW Internal surface/ Purified water may be contact parts of
during normal contact parts is contaminated Shall instruments, level  Commissioning
33. MOC or sanitization not compatible affect product transmitters, valves 3 1 1 3 _ _ _ _ _  IQ
mode and with the purified quality/ product etc., are made of SS
lead to water release 316L stainless steel.
purified water  Distribution system
contamination pipelines are electro
polished & orbitally
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 triclover connection  Regular maintenance  Commissioning
joints may tight. Suitable
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.
35. Calibration Calibration Operation Purified water may be  Calibration of the 3 2 1 6 Routine calibration of 2 1 1 2  Commissioning

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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
of instrument is done at
contaminated Shall the entire measuring
measuring failure may vendor site  OQ
affect product instrument shall be
instrument affect the quality  Calibrated instruments  Calibration
quality/ product performed as per
is not of the PW. are installed Master Plan SOP
release SOP.
possible

3.0 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
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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