Fmea Pw System-1

Failure Mode and Effective Analysis (FMEA) For

Purified Water Generation, Storage and Distribution System

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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.) 1

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 Exception or gap with respect to regulations or standards (GxP, EU, GAMP, ASTM, etc.) 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 1Occurrence is occasionally 2Occurrence 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).

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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. 1

Detected by indirect means or by observation like indirect indication or visual inspection. 2No 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 RISKRPN 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

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2.0 SYSTEM RISK ASSESSMENT MATRIX

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Risk IdentificationCurrent controls (Interlock/Alarm arrangement)

Risk Assessment Proposed

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

Revised Risk Classification

Verification point

Component Failure/Critic

al Process Step Failure

Potential Failure Mode

(Defect)

Potential Risk Cause

Potential Risk/Effect/Impact

on Product Quality/ Product

Release

S O D RPN S O D RPN

A. Purified Water Generation System

1. Raw Water Tank

Increased microbial and particle contamination of the in-feed raw water

There may be leakage in the Tank

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

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.

3 1 1 3 _ _ _ _ _ Commissioning IQ OQ

2. Raw Water

Sampling of the Raw water is not possible

Sampling point may not be considered in the design

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

Sampling points are provided in raw water feed line before Multi grade filter 3 1 1 3

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

3 1 1 3

Commissioning IQ OQ SOP for

Sampling

3. NaOCl dosing

NaOCl dosing pump fails.

Mechanical damage of pump

Increase in bioburden in raw water.

Load on downstream purification system.

No impact on product quality as UF and RO

Alarm is provided in case of malfunction of dosing pump.

The pre-treatment system stops in case dosing pump malfunction.

3 2 1 6 Preventive maintenance of pump shall be carried out frequently as per PM SOP.

A standby pump shall be kept as spare.

3 1 1 3 Commissioning OQ SOP for PM

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membranes are installed at downstream.

Drinking water may go out of microbial specification.

4. Multi Grade Filter

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

Multiport valve may not function properly.

Initial Filtration of raw water may not take place. Downstream system may not get water for processing.

No impact on product quality, as raw water is not used for process.

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.

2 2 1 4

Multiport valve operation shall be verified during commissioning.

Routine preventive maintenance of the valve shall be carried out as per SOP.

2 1 1 2

Commissioning OQ Preventive

maintenance SOP for MGF.

5. Multi Grade Filter

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

Choking of Multi grade Filter

Initial Filtration of raw water may not take place.

Downstream system may not get water for processing.

No impact on product quality, as raw water is not used for process.

Pressure gauges are provided to monitor pressure across MGF and indicate choking.

Backwash provision is provided for cleaning of MGF and prevents choking.

2 3 1 6

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 calibration plan.

2 1 1 2

Commissioning IQ SOP for MGF

operation & Cleaning

Calibration Master plan SOP

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6. Softener Unit

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

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.

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

2 2 1 4

Automatic Multiport valve operation shall be verified during commissioning.


2 1 1 2


maintenance SOP for Softener.

7. Softener Unit

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

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

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

2 3 1 6

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

2 1 1 2


maintenance SOP for Softener.

8.Ultra filtration system

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

Ultra filtration service cycle valve not working properly

Increase the colloidal particulate & high molecular weight material in the water


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

2 2 1 4

UF Service cycle valve operation shall be verified during commissioning.


2 1 1 2


maintenance SOP for UF.

9. Ultra filtration system

Choking of the Ultra

filtration of

UF Backwash & Fast Flush

may not takes

Ultra filtration may be hampered

Lack of water to

Centrifugal pump with desired flow rate is placed for

2 2 1 4 Operation of the Backwash centrifugal pump

2 1 1 2 Commissioning OQ Preventive

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the system place

Downstream No impact on

product quality, as water is not used for process.

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

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

maintenance SOP for UF.

10. UF permeate

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


Alarm will appear for high level of the UF permeate tank

Water will re-circulate 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

2 2 1 4

Operation of the level switches shall be verified during commissioning

Routine Preventive maintenance of the Pump shall be as per the SOP

2 1 1 2

Commissioning IQ & OQ Preventive

maintenance SOP.

11. Activated Carbon Filter

High chlorine

level & Bad Water Odor

Activated carbon filter not working

properly

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 dosing is present

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 pressure gauge

2 1 1 2 _ _ _ _ _ Commissioning IQ & OQ

12. Ultra Violate Sterilizer

Increase microbial

Ultra violate sterilizer not

Living microorganism

UV sterilizer is provided with 3 1 1 3 _ _ _ _ _ Commissioning

IQ & OQ

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odor working properly

grows and in a favorable condition for their exponential growth

May increase the microbial level of the final water

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

SOP of Operation & PM of the UV Sterilizer

13.Antiscalent Dosing System

Low chemical level in antiscalant dosing tank

Antiscalent Dosing System

not working properly

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.


The Chemical dosing system comprises with level switch which will trip the dosing pump

Alarm provision is provided in case of low chemical

3 2 1 6

Operation of the Chemical dosing system shall be verified during commissioning

Routine checkup of chemical dosing shall be performed regularly

2 1 1 2

Commissioning IQ & OQ Preventive

maintenance SOP.

14.NaOH Dosing System

PH of the PW water not controlled as per the requirement

NaOH Dosing System not

working properly

CO2 Level of the Water may be increase which may affect the final pH of the water

The NaOH dosing system comprises with pH Transmitter which will monitor the pH of the water

Alarm provision is provided to alert the operator

3 2 1 6

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 per the SOP

2 1 1 2

Commissioning IQ OQ Calibration

Master plan SOP

15. SMBS Dosing System

Low chemical level in SMBS

SMBS Dosing System not

working properly

Low level of chemical will not neutralize chlorine as per the

The Chemical dosing system comprises with level switch which

3 2 1 6 Operation of the Chemical dosing system shall be verified during

2 1 1 2 Commissioning IQ & OQ Preventive

maintenance

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dosing tank

requirement The chlorine

content in water shall lead to oxidation of the RO/EDI


will trip the dosing pump

Alarm provision is provided in case of low chemical

commissioning Routine checkup

of chemical dosing shall be performed regularly

SOP.

16. ORP Sensor

Chorine Level after SMBS dosing may not be detected

ORP sensor is not working

properly

The chlorine content in water shall lead to oxidation of the RO membrane and hence shall affect the final water quality


Alarm is provisioned for high ORP.

Auto dump valve is provided in case of free chlorine level high 3 2 1 6

Operation of the ORP Sensor Shall be Verified during commissioning

Calibration of the ORP Sensor as per the SOP

2 1 1 2

Commissioning IQ OQ Calibration

Master plan SOP

17. Heat Exchangers

Optimum temperature of water may not be maintained

Heat Exchangers is not working

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

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

3 1 1 3 _ _ _ _ _

Commissioning IQ OQ Preventive

maintenance SOP.

18. Multipurpose Storage tank

Storage of water may not be possible before RO

Storage tank before RO is not working

properly

Supply to RO membrane will hamper


Multipurpose storage tank is provided with capacitance level transmitter which will perform the necessary action to

3 1 1 3 _ _ _ _ _ Commissioning IQ OQ Preventive

maintenance SOP.

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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

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

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

3 1 1 3 _ _ _ _ _

Commissioning IQ OQ Preventive

maintenance SOP.

20. Heat Sanitary RO system

High conductivity after RO permeate

Heat Sanitary RO system not

functioning properly

Purified water out of specification. Shall affect product quality/ product release

Conductivity transmitter is provided at the downstream of RO to check conductivity along with alarm provision.

High conductivity water after RO shall be dump by

3 1 1 3 Routine calibration of conductivity sensor shall be performed as per calibration plan.

2 1 1 2 Commissioning OQ Calibration

Master Plan SOP

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dumping valve

21.Heat Sanitary RO system

Choking of RO membrane

May be due to high use of RO membrane

RO membrane will damage & shall affect the product quality

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

3 1 1 3

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

2 1 1 2

Commissioning OQ Calibration

Master Plan SOP

22.4

EDI permeate

High conductivity after EDI

EDI is not working properly

Purified water out of specification. Shall affect product quality/ product release,

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.

3 1 1 3

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

2 1 1 2


Master Plan SOP

23. RO + EDI Sanitization

Bio-burden in RO & EDI

RO + EDI Sanitization not possible


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 carried out to with the help of HMI

During Sanitization all conductivity interlocks will be

3 2 1 6 RO+EDI Sanitization performance will be verified at the time of commissioning

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


Master Plan SOP

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bypassed & EDI will be switched off.

An Alarm message in the HMI will appear

B. Purified Water Storage & Distribution System

24. Storing of water

Difficulty in catering to simultaneous demand of multiple user points.

No storage of purified water before use.

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

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.

3 1 1 3 _ _ _ _ _ Commissioning IQ

25. PW Storage Tank

Contamination of PW possible.

Leakage in PW storage tank/ pipelines


PW storage tank is provided with vent filter to avoid atmospheric contamination

Hydrotest is conducted for the tank at the vendor’s 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.

3 2 2 12

SOP for routine preventive maintenance.

Pressure of the storage tank and distribution line should be monitored regularly.

Hydrotest to be conducted at regular intervals as per SOP.

2 1 1 2 Commissioning OQ SOP of PM

26. PW Storage Tank

Cleaning of the tank not possible Contamination of PW possible.

Spray ball may not functioned properly


The Tank is designed with torispherical top and bottom dish to maintain full drain ability of the water

3 2 2 12 Spray ball coverage study shall be carried out in commissioning and qualification


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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

SOP for routine preventive maintenance.

27. PW Storage Tank

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

Low water level in the storage tank due to low generation or high usage.

The purified water may not distributed to the user points through distribution loop shall lead affect product release

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 level inside tank goes below high level.

Sight glass has been provisioned in the tank.

3 2 2 12

SOP for Preventive maintenance of PW storage and Distribution system.

Routine calibration of Level transmitter as per SOP.


28.PW Distribution line

Presence of particles inside pipelines may contaminate PW. .

Pipelines may not passivated after welding.

Purified water may be contaminated Shall affect product quality/ product release,

Pipeline shall be passivated after welding and before being used.

Passivation test reports to be provided


29. PW Distribution line

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

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


The water distribution is in a closed loop system, wherein the water will be in continuous flow.

All pipelines shall


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have drainable slope of > 1:100.

Discharge pump shall be self-draining type.

The dead leg in the loop shall not be more than 1.5d. (d- diameter of the extended part)


High conductivity of purified water in distribution line.

PW may not used for long duration

High conductivity water in distribution line may contaminate the fresh incoming purified water to storage tank.

Conductivity sensors are provided in the supply and return line along with alarm provision in case of 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 conductivity.

3 1 1 3

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

2 1 1 2


Master Plan SOP


High TOC of purified water in distribution loop.

PW may not used for long duration


Online TOC analyzer is installed at return line to storage tank along with alarm provision and auto-dumping facility in case of high TOC.

3 1 1 3Routine calibration of TOC analyzer as per SOP.

2 1 1 2


Master Plan SOP

32. 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

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

3 2 2 12 Sanitization frequency shall be established during qualification and performed routinely.

Routine calibration of temperature sensors as per SOP.


Master Plan SOP

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temperature during sanitization.

Alarm is provisioned in case of High/ low temperature during sanitization.

33. 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


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.


34. Joints

Leaking joints may lead to contamination of PW.

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


Suitable gaskets are provided for air tight triclover connection and are easily replaceable.

Quick release Triclover joints are recommended.

3 2 1 6

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

2 1 1 2 Commissioning IQ SOP of PM

35. Calibration

Calibration of measuring instrument is not possible

Operation failure may affect the quality of the PW.


Calibration of the instrument is done at vendor site

Calibrated instruments are installed

3 2 1 6

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

2 1 1 2


Master Plan SOP

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3.0 APPROVALS

Function Name Designation Signature/ DatePrepared by:IPSM – Validation and C&QChecked by: IPSM – Validation and C&QApproved by:J&J – Facility EngineerApproved by:J&J – Quality AssuranceApproved by:J&J – Manufacturing Approved by:J&J – Microbiology Lab RepresentativeApproved 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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Fmea Pw System-1

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