IQ Purified Water

INSTALLATION QUALIFICATION PROTOCOL
For the
NEW PURIFIED WATER SYSTEM
Prepared by
____________________________________
TABLE OF CONTENTS
1.0 PURPOSE AND OBJECTIVE(S) .................................................................................................................................... 4
2.0 BACKGROUND .............................................................................................................................................................. 4
3.0 SCOPE ........................................................................................................................................................................... 4
4.0 REFERENCES ............................................................................................................................................................... 4
5.0 RESPONSABILITIES ...................................................................................................................................................... 5
5.1 Validation Specialist ................................................................................................................................................... 5
5.2 Quality Dept. ............................................................................................................................................................... 5
5.3 Facility Dept. ............................................................................................................................................................... 5
6.0 METHODOLOGY............................................................................................................................................................ 6
6.1 Verification Data Sheet ............................................................................................................................................... 6
6.2 Deviation Report ......................................................................................................................................................... 6
6.3 Signature Log Sheet ................................................................................................................................................... 6
6.4 Test Instruments Calibration ....................................................................................................................................... 6
7.0 EQUIPMENT/PROCESS DESCRIPTION ....................................................................................................................... 7
7.1 Water Softener ........................................................................................................................................................... 7
7.2 Ozone Generator ........................................................................................................................................................ 7
7.3 Reverse Osmosis ....................................................................................................................................................... 7
7.4 Mixed Bed................................................................................................................................................................... 7
7.5 Ozone Destructor ....................................................................................................................................................... 7
7.6 De-gasifier .................................................................................................................................................................. 8
7.7 UV light ....................................................................................................................................................................... 8
7.8 Filter ........................................................................................................................................................................... 8
APPENDIX I: DEVIATION REPORT .......................................................................................................................................... 11
APPENDIX II: SIGNATURE IDENTIFICATION LOG SHEET .................................................................................................... 12
APPENDIX III: TESTING INSTRUMENTS LOG SHEET ........................................................................................................... 13
IQ-01 EQUIPMENT VERIFICATION .......................................................................................................................................... 15
IQ-02 DOCUMENT INVENTORY VERIFICATION .................................................................................................................... 37
IQ-03 DRAWING VERIFICATION .............................................................................................................................................. 56
IQ-04 SYSTEM DESIGN VERIFICATION.................................................................................................................................. 58
IQ-05 PLACEMENT VERIFICATION ......................................................................................................................................... 60
IQ-06 UTILITY VERIFICATION .................................................................................................................................................. 67
IQ-07 INSTRUMENTATION VERIFICATION ............................................................................................................................. 86
IQ-08 MAINTENANCE VERIFICATION ..................................................................................................................................... 88
IQ-09 SAFETY & ERGONOMICS VERIFICATION .................................................................................................................. 107
IQ-10 PROCEDURE VERIFICATION ...................................................................................................................................... 109
IQ CHECKLIST VERIFICATION .............................................................................................................................................. 127
REVISION HISTORY
Revision Description of change Date

1.0 PURPOSE AND OBJECTIVE(S)
This protocol (___) intends to provide documented evidence that the new Purified Water System
was installed according to manufacturer’s specifications and ___ ___ requirements.
This Installation Qualification will provide documented evidence that all key aspects of the Purified
Water System equipment’s assembly and its auxiliary systems is as intended by manufacturer
design and in accordance to ___’s requirements.
At the end of the execution activities, a final report will be developed with a summary of the
executed tests results and the recommendation(s) necessary for the Installation Qualification.
Potential risks involved with the new Purified Water System installation when connected to the
manufacturing processes has already being evaluated by Risk Assessment PLS 0410.
2.0 BACKGROUND
In order to meet the new purified water utility demands at ___ I in ___ ___, ___ ___, a new purified
water system was purchased to replace the existing system. It is expected that this new purified
water system will increase the supply to up to 100 GPM. Additionally, it is intended to produce a
water quality that meets or exceeds current Purified Water USP and EP standards.
3.0 SCOPE
This protocol applies to the new equipment and auxiliary components that constitute the Purified
Water System, installed at ___ in ___ ___, ___ ___
4.0 REFERENCES
• FDA’s Office of Regulatory Affairs: “Guide To Inspections of High Purity Water Systems”
5.0 RESPONSABILITIES
5.1 Validation Specialist
• Prepare the documents that are applicable to the Validation exercise
• Coordinate efforts and resources, along with Facilities Dept., to perform the Validation
exercise
• Execute and collect the verification data for the Validation protocol
• Verify data against Acceptance Criteria and initiate deviation, as applicable
• Investigate, justify, and correct any deviation encountered during Validation execution
• Prepare validation Final Report
5.2 Quality Dept.
• Evaluate with the originator the extent of the validation required
• Review and approve documents for the validation exercise
• Review and approve validation activities for compliance and adherence to ___’s policies,
practices, and procedures
• Check that the collected data meets the acceptance criteria and that all the deviations (if
applicable) are properly resolved
• Once executed, review any deviations generated to confirm that investigation and
resolutions are complete
• Cooperate with Validation Specialist to investigate, justify, and correct any deviation
encountered during Validation execution
• Review and approve Final Report
• Maintain original validation documentation, except for drawings and equipment manuals
that will remain in the equipment information files
• Store the Validation Package in a designated filing area
5.3 Facility Dept.
• Review and approve documents for the validation exercise
• Coordinate efforts and resources to perform the validation activities
• Supply documentation and tools needed for the protocol execution
• Provide training in this protocol to all employees involved (internal and external) during the
execution of this protocol and ensure that all signatures are collected on Signature Log
Sheet
• Assist to document, investigate, justify, and correct any deviation encountered during the
IQ protocol execution
• Review and approve validation Final Report
• Provide technical support for trouble shooting during the execution
6.0 METHODOLOGY
6.1 Verification Data Sheet
All data resulting from test execution will be entered in Verification Data Sheets that will pre-
define the objective(s) to be attained with the verification, the procedure that will be followed
to reach such objective(s), the reference material to be used, and the criteria to evaluate as
to accept or not the testing results. All data entry will be properly signed and dated by the
executor in the “Performed By” and “Date” spaces. In cases where a Field Verification is
requested, a “Fail” condition will be applied to unverifiable information.
The comments/observations section included in each Data Collection Form will be used to
describe any additional information considered of importance for describing the validated
condition and/or discrepancies and resolution activities produced during the execution. The
comments/observations included must be signed or initialed and dated.
When the test execution is finished, a subject matter expert will sign and date on the
“Reviewed by” and “Date” spaces respectively, to state the completeness and correctness of
the data.
6.2 Deviation Report
The following deviations must be documented using the Deviation Report Form attached to
this protocol:
• Results invalidated and/or not in compliance with their pre-established Acceptance Criteria
• Testing procedure and/or sampling plan not followed or that could not be completed as
planned
These deviations will be handled as per ___ ___ PR
The investigation process due to deviated sampling results will be handled by contract
laboratory, following their own investigation procedures. These incidents will be informed to
who oversees the validation project in ___ ___, ___ PR, which in turn will open a deviation
report to follow the lifecycle of the investigation and to implement any possible changes due
to investigation resolution.
Typographic, text edit and syntax errors will be documented as such in the “Comments”
section under the corresponding test script, and considered as a minor issue that may not
invalidate a test or become cause for writing a deviation report. These will be explained in the
Final Report.
6.3 Signature Log Sheet
Each individual who signs or initials any page included in this protocol shall be identified
using the Signature Log Sheet by type/printed name, full signature, written initials and
department represented.
6.4 Test Instruments Calibration
All testing equipment used during for the execution shall be currently calibrated with
documented evidence of its “up to date” calibration status. Copies of the calibration
certificates shall be attached to the protocol and referred to the applicable test script.
7.0 EQUIPMENT/PROCESS DESCRIPTION
Purified Water▲ is water obtained by distillation, ion-exchange treatment, reverse osmosis, and
other suitable processes. It is prepared from water complying with the regulations of U.S.
Environmental Protection Agency (EPA) with respect to drinking water. It contains no added
substances.
The Purified Water system includes the following equipment, along with associated components:
• 30 um filters (2) • 6, 000 and 8, 000 Gal. Tanks

• 1 um filters (4) • Distribution Pumps (4)
• 0.2 um filters (4) • Dual Reverse Osmosis unit
• Dual Softener unit • Dual Mix Bed unit
• Ozone Generator • UV lamps (4)
• Ozone Destructor • Degasification unit
• Microza filters (18)
7.1 Water Softener

The Water Softener reduces the levels of calcium and other scale creating elements from the
process stream. Water softeners also remove aluminum, copper and other trace metals. The
removal process occurs by ion exchange. The softener vessel is filled with sodium form cation
resin. The calcium, magnesium, barium, strontium, and other ions removed by the resin are
replaced with sodium ions. The cation resin has a fixed capacity for ion removal and must be
regenerated when that capacity has been exhausted.
7.2 Ozone Generator
The Ozone Generator is employed to produce the Ozone used to sanitize the Softened Water
that passes through to the 6,000 Gallon Tank.
7.3 Reverse Osmosis
The Reverse Osmosis unit processes water by means of semi-permeable membranes, which
allow pressurized water to freely pass through the membranes, but almost totally reject
dissolved and suspended substances in the feed water.
7.4 Mixed Bed
The Mixed Bed de-mineralizes water by using the ion exchange process. The influent water
passes through a bed of Cation and Anion resin that are intimately mixed. The mixed bed
configuration functions similarly to a two-bed configuration in regards to the ion exchange
process; however, it is much more efficient and therefore produces water of much greater
purity.
7.5 Ozone Destructor
The Ozone Destructor employs ultraviolet light to reduce the ozone level to a safe preset level
before exiting the skid to the Service Points of Use. Ozone reduction is done by breakage of
the O3 bonds at the ultraviolet spectrum.
▲
As per United States Pharmacopeia (USP) standards
7.6 De-gasifier
De-gasifier membranes are employed to reduce the oxygen level of the water. Membrane
contactors make it possible to transfer gas from an aqueous stream without dispersion. By
virtue of surface tension, the water on one side of the membrane is exposed to the gas side of
the membrane with no liquid transfer, providing a large surface area for gas/liquid contact and
transfer. Dissolved O2 passes from the water surface into the gas side by diffusion and is
swept out by a combined vacuum/air flow.
7.7 UV lights
Ultraviolet lamps produce UV-C (germicidal UV), which is a radiation that when harmful
microbes are exposed to the UV rays, scrambles the DNA structure of the organism,
rendering it sterile and can no longer reproduce.
Almost all of a UV lamp’s output is concentrated in the 254 nanometers (nm) region in order to
take full advantage of the germicidal properties of this wavelength. The lamp is mounted such
that water passing through a flow chamber is exposed to the UV-C light rays.
7.8 Filters
At the first stage, the raw water enters a 30 µm pre-filter to trap any heavy sediment before it
enters the softeners. The 1 µm filters will act as a resin trap and removes suspended from the
softeners. The absolute 0.2 micron rated filters significantly enhances the water quality with its
capacity to remove the majority of microorganisms. The Microza ultra filters that are at the end
of the purified water system uses fiber hollow technology that will remove endotoxins and
viruses.
7.9 Distribution Pumps
Two pairs of distribution pumps will provide constant flow of the processed water throughout
the Purified Water System pipelines. Although its functionality will not contribute directly to the
processing of Purified Water, by providing a constant flow will indeed significantly reduce the
chances of microbial growth due to stagnant water.
7.10 Tanks
Two storage tanks will provide storage capacity to the Purified Water System. A 6,000 gallon
tank will store ozone-treated softened water that will supply constant feed to the dual R.O.
unit, while an 8,000 gallon tank will store water post reverse osmosis and de-ozonization
treatment, which will supply constant feed to the main loop.
With this configuration in place, a Purified Water (USP, EP) quality is intended to be achieved through the following processes:
• Filtration (by means of 30 um filters, 1 um filters, 0.2 um filters, and R.O. Unit, and “Microza” filters)
• Ion exchange (by means of Softener and Mix Bed)
• Sanitation (by means of Ozone Injection and UV light radiation)
• Degasification (by means of a de-gasifier unit)
APPENDICES
DEVIATION DESCRIPTION
APPENDIX I: DEVIATION REPORT
Deviation Number: _________________

Test Description/Test Number:
Deviation Area: □ I/Q □ O/Q □ P/Q
Deviation reported by:_________________________________ Date: _________________
ENGINEERING INVESTIGATION
Attach additional pages, if necessary
Root Cause: □Manpower □Methods □Equipment □ Materials □Environment
CORRECTIVE / PREVENTIVE ACTION
Evaluation performed by:____________________________________ Date: _________________
Testing required after Corrective action implemented? (YES/NO) ______________
Test results (PASS/FAIL/NA) ________________
Performed by: _______________________________________ Date: _______________________
Comments:
Reviewed by ______________________________________ Date: ____________________________

APPENDIX II: SIGNATURE IDENTIFICATION LOG SHEET
This sheet is intended to record each individual who takes part of the execution process and is not
included in the front page. The scope of this sheet applies to anyone who signs or initials any page
included in the attached qualification documents. Each person shall be identified by typed or printed
name, full signature, written initials, and department represented.
NAME SIGNATURE INITIALS DEPARTMENT

APPENDIX III: TESTING INSTRUMENTS LOG SHEET
This sheet is intended to record all field test instrument that assists in the execution process.
COPY OF
CALIBRATION CERTIFICATE PERFORMED
INSTRUMENT ID DESCRIPTION TEST ID
DATE/DUE DATE ATTACHED? BY/DATE
(YES/NO)
VERIFICATION DATA SHEETS
INSTALLATION QUALIFICATION
MAIN COMPONENT VERIFICATION IQ-01
Objective:
• Assure that all main and auxiliary components of the Purified Water System are as per
manufacturer/vendor specifications (Manuals, Spec sheets, P & ID’s, etc.)
Procedure:
a. Per equipment, collect and document the required information thru physical inspection (tag,
engrave, plate, sticker, etc)
b. Evaluate findings against specifications
References Required:
• Note: Vendor/Manufacturer documentation (Manuals, Spec sheets, P & ID’s, etc.) does not
count as “Actual Result” reference
Acceptance Criteria:
• Actual results match expected results as per manufacturer written specifications

Filter set 1A & 1B
EXPECTED PERFORMED
SPEC ACTUAL RESULT PASS/FAIL
RESULT BY/DATE
Tag ID
Cartridge
Manufacturer
Cartridge Part
No.
1A
Housing
Manufacturer
Housing
Part No.
Quantity
Tag ID
Cartridge
Manufacturer
Cartridge Part
No.
1B
Housing
Manufacturer
Housing
Part No.
Quantity
Comments/Observations:
Conformance to the acceptance criteria was evaluated and the final determination is as follows:
Acceptance Criteria met? (YES/NO) __________ If NO, refer to Deviation # __________
Reviewed by: Date:

Filter set 2A & 2B
EXPECTED PERFORMED
RESULT BY/DATE
Tag ID
Cartridge
Manufacturer
Cartridge Part
No.
2A
Housing
Manufacturer
Housing
Part No.
Quantity
Tag ID
Cartridge
Manufacturer
Cartridge Part
No.
2B
Housing
Manufacturer
Housing
Part No.
Quantity
Reviewed by: Date:

Filter set 3A & 3B
EXPECTED PERFORMED
RESULT BY/DATE
Tag ID
Cartridge
Manufacturer
Cartridge Part
No.
3A
Housing
Manufacturer
Housing
Part No.
Quantity
Tag ID
Cartridge
Manufacturer
Cartridge Part
No.
3B
Housing
Manufacturer
Housing
Part No.
Quantity
Reviewed by: Date:

Filter set 4A & 4B
EXPECTED PERFORMED
RESULT BY/DATE
Tag ID
Cartridge
Manufacturer
Cartridge Part
No.
4A
Housing
Manufacturer
Housing
Part No.
Quantity
Tag ID
Cartridge
Manufacturer
Cartridge Part
No.
4B
Housing
Manufacturer
Housing
Part No.
Quantity
Reviewed by: Date:

Filter set 5A & 5 B
EXPECTED PERFORMED
RESULT BY/DATE
Tag ID
Cartridge
Manufacturer
Cartridge Part
No.
5A
Housing
Manufacturer
Housing
Part No.
Quantity
Tag ID
Cartridge
Manufacturer
Cartridge Part
No.
5B
Housing
Manufacturer
Housing
Part No.
Quantity
Reviewed by: Date:

Ozone Generator
EXPECTED PERFORMED
RESULT BY/DATE
Tag ID
Manufacturer
Model
Serial No.
Tag ID
Booster pump
Manufacturer
Model
Serial No.
Tag ID
Recirculation pump
Manufacturer
Model
Serial No.
Reviewed by: Date:

Ozone Destructor
EXPECTED PERFORMED
RESULT BY/DATE
Tag ID
Manufacturer
Model
Serial No.
Tag ID
Manufacturer
UV light
Model
Serial No.
Reviewed by: Date:

Dual Softener unit
EXPECTED PERFORMED
RESULT BY/DATE
Tag ID
Manufacturer
Unit A
Model
Serial No.
Tag ID
Manufacturer
Unit B
Model
Serial No.
Manufacturer
Control Panel
Model
Resin
Type
Reviewed by: Date:

Dual Softener unit (Brine Tank)
EXPECTED PERFORMED
RESULT BY/DATE
Tag ID
Manufacturer
Model
Serial No.
Reviewed by: Date:

6,000 Gal. Tank
EXPECTED PERFORMED
RESULT BY/DATE
Tag ID
Manufacturer
Description
Cartridge
Manufacturer
Cartridge
Vent Filter
Part No.
Housing
Manufacturer
Housing
Part No.
Manufacturer
Level
Part No.
Reviewed by: Date:

Distribution Pumps (1A, 1B)
EXPECTED PERFORMED
RESULT BY/DATE
Tag ID
Manufacturer
1A
Model
Serial No.
Tag ID
Manufacturer
2A
Model
Serial No.
Reviewed by: Date:

8,000 Gal. Tank
EXPECTED PERFORMED
RESULT BY/DATE
Tag ID
Manufacturer
Description
Cartridge
Manufacturer
Cartridge
Vent Filter
Part No.
Housing
Manufacturer
Housing
Part No.
Manufacturer
Level
Part No.
Reviewed by: Date:

EXPECTED PERFORMED
RESULT BY/DATE
Tag ID
Manufacturer
2A
Model
Serial No.
Tag ID
Manufacturer
2B
Model
Serial No.
Reviewed by: Date:

UV lamps (1A, 1B)
EXPECTED PERFORMED
RESULT BY/DATE
Tag ID
Manufacturer
1A
Model
Serial No.
Tag ID
Manufacturer
1B
Model
Serial No.
Reviewed by: Date:

EQUIPMENT VERIFICATION IQ-01
UV lamps (2A, 2B)
EXPECTED PERFORMED
RESULT BY/DATE
Tag ID
Manufacturer
2A
Model
Serial No.
Tag ID
Manufacturer
2B
Model
Serial No.
Reviewed by: Date:

Dual Reverse Osmosis (Service unit A)
PERFORMED
SPEC EXPECTED RESULT ACTUAL RESULT PASS/FAIL
BY/DATE
Tag ID
Manufacturer
Model
Serial No.
Tag ID
Feed Pump
Manufacturer
Model
Serial No.
Antiscalant Dosing System
Tag ID
Manufacturer
Model
Serial No.
Control Panel
Manufacturer
Model
Reviewed by: Date:

Dual Reverse Osmosis (Service unit B)
PERFORMED
BY/DATE
Tag ID
Manufacturer
Model
Serial No.
Tag ID
Feed Pump
Manufacturer
Model
Serial No.
Antiscalant Dosing System
Tag ID
Manufacturer
Model
Serial No.
Control Panel
Manufacturer
Model
Reviewed by: Date:

Dual R.O. unit (Cleaning Skid)
PERFORMED
BY/DATE
Tag ID
Manufacturer
Model
Serial No.
Tag ID
Cleaning Pump
Manufacturer
Model
Serial No.
Reviewed by: Date:

De-gasification unit
EXPECTED PERFORMED
RESULT BY/DATE
Tag ID
Manufacturer
Model
Serial No.
Tag ID
Manufacturer
Pump
Model
Serial No.
Reviewed by: Date:

Dual Mixed Bed unit
EXPECTED PERFORMED
RESULT BY/DATE
Tag ID
Manufacturer
Unit A
Model
Serial No.
Tag ID
Manufacturer
Unit B
Model
Serial No.
Manufacturer
Control Panel
Model
Caustic
Acid &
Type
Reviewed by: Date:

Microza “ultra filtration” filters
EXPECTED PERFORMED
RESULT BY/DATE
Tag ID
Manufacturer
Part No.
Serial No.
Reviewed by: Date:

DOCUMENT INVENTORY VERIFICATION IQ-02
Objective:
• Assure that all the basic literature required for the system operation/maintenance of the Purified
Water system is available and properly stored
Procedure:
a. Per equipment, collect all related documentation
b. Document all relevant information according to “Document Info” column
c. If any of the “document type” is not applicable, write an Not Apply to the “Document Info”
column and explain in the “Comments/Observations” section
• Manufacturer’s Documentation - Installation and Operational Manuals, Wiring Diagrams, Spare

Parts List, P & ID’s, etc.
• Vendor’s Documentation - Purchase Order, etc.

• At least the basic literature (see document type) was found for all equipment and was found to
be properly stored
• “Not applicable” document type was properly explained

Filter set 1A & 1B
DOCUMENT DOCUMENT INFO DOCUMENT STORAGE PERFORMED

TYPE (DOC #, TITLE, REV., LOCATION) (LOCATION) BY/DATE
Installation and
Operation
Manual
Purchase Order
Drawings
P & ID’s
Other
Documents
Acceptance Criteria met? (YES/NO) ________ If NO, refer to Deviation # __________
Reviewed by: Date:

Filter set 2A & 2B

Installation and
Operation
Manual
Purchase Order
Drawings
P & ID’s
Other
Documents
Reviewed by: Date:

Filter set 3A & 3B

Installation and
Operation
Manual
Purchase Order
Drawings
P & ID’s
Other
Documents
Reviewed by: Date:

Filter set 3A & 3B

Installation and
Operation
Manual
Purchase Order
Drawings
P & ID’s
Other
Documents
Reviewed by: Date:

Filter set 4A & 4B

Installation and
Operation
Manual
Purchase Order
Drawings
P & ID’s
Other
Documents
Reviewed by: Date:

Filter set 5A & 5B

Installation and
Operation
Manual
Purchase Order
Drawings
P & ID’s
Other
Documents
Reviewed by: Date:

Dual Softener unit

Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
Mechanical
Drawings
P & ID’s
PLC Software
Backup &
Report
MSDS
Other
Documents
Reviewed by: Date:

6,000 Gal. Tank

Installation and
Operation
Manual
Purchase Order
Drawings
P & ID’s
Other
Documents
Reviewed by: Date:


Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
Mechanical
Drawings
P & ID’s
Other
Documents
Reviewed by: Date:

8,000 Gal. Tank

Installation and
Operation
Manual
Purchase Order
Drawings
P & ID’s
Other
Documents
Reviewed by: Date:


Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
Mechanical
Drawings
P & ID’s
Other
Documents
Reviewed by: Date:

Ozone Generator

Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
Mechanical
Drawings
P & ID’s
PLC Software
Backup &
Report
Other
Documents
Reviewed by: Date:

Ozone Destructor

Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
P & ID’s
PLC Software
Backup &
Report
Other
Documents
Reviewed by: Date:

UV lamps (1A, 1B, 2A, 2B)

Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
P & ID’s
Other
Documents
Reviewed by: Date:

Dual Reverse Osmosis unit

Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
Mechanical
Drawing
P & ID’s
PLC Software
Backup &
Report
MSDS
Other
Documents
Reviewed by: Date:

Degasification unit

Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
Mechanical
Drawings
P & ID’s
Other
Documents
Reviewed by: Date:

Dual Mixed Bed unit

Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
P & ID’s
PLC Software
Backup &
Report
Other
Documents
Reviewed by: Date:


Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
P & ID’s
Other
Documents
Reviewed by: Date:

DRAWING VERIFICATION IQ-03
Objective:
• Assure concordance between drawings (P & I D’s and Electrical Schematics, etc.) and field
installation of the Purified Water System
Procedure:
a. Collect and document the drawings found thru IQ - 02: “Document Inventory Verification”
b. Verify against field installation by performing a physical inspection and redline drawings, if
discrepancy occurs
c. Sign, date & submit discrepancies to Facilities Dept. for review
d. Upon review, determine if drawings and/or field installation needs to be updated
e. Attach verified drawings to this protocol
• Process and Instrument Diagrams (P & I D’s)
• Electrical Schematics
• Drawings match field installation and vice versa
• Discrepancies between drawings and field installation were satisfactorily resolved by submitting
changes and updating drawings and/or field installation
DRAWING VERIFICATION IQ-03
Sheet ______ of ______
Use additional pages as necessary
DRAWING REDLINED? UPDATE? PERFORMED
TITLE & REVISION
TYPE & ID (YES/NO) (DWG, FLD, NA) BY/DATE
Reviewed by: Date:

SYSTEM DESIGN VERIFICATION IQ-04
Objective:
• Assure that the installation design is in compliance with the specified requirements for systems
capable of producing Purified Water
Procedure:
• Verify system installation as per specifications by performing a physical verification and/or

providing documented evidence
• Document findings and evaluate against expected results

Note: This verification is best performed during “Drawing Verification”
• P & ID’s
• Material Safety Data Sheets
• Chemical Analysis Sheets
• Actual results match expected results as per Purified Water specifications

SYSTEM DESIGN VERIFICATION IQ-04
PERFORMED
BY/DATE
The raw water source supplied to

Feed water the system must be from Well or
City Water
The system contains equipment

capable of performing Deionization
Processing and Reverse Osmosis or
Distillation.
Piping will provide constant

circulation of Purified water.
Piping does not have an unused

Piping portion greater in length than six
diameters of the unused pipe
measured from the axis of the pipe
in use (dead leg).
Contact All material in direct contact shall be

material non-reactive to Purified Water.
Reviewed by: Date:

PLACEMENT VERIFICATION IQ-05
Objective:
• Assure that the equipments have the appropriate conditions to perform setup and maintenance
and to operate accordingly.
Procedure:
• Per equipment, verify field conditions by performing a physical inspection as per expected
results
• Document and evaluate findings against expected results

• Skid Drawings
• Actual results match expected results as per ___ requirements

SKID #1 - Filter Set 1A, 1B
PERFORMED
BY/DATE
The equipment shall

Position be located along open
type waste drains.
The equipment is not

placed on direct
Environment sunlight or other
sources of heat.
Reviewed by: Date:

SKID #2 - Filter set 2A, 2B
PERFORMED
BY/DATE
The equipment shall

type waste drains.

placed on direct
sources of heat.
Reviewed by: Date:

SKID #3 - Distribution Pumps 1A, 1B; UV lamps 1A, 1B & Filter set 3A, 3B
PERFORMED
BY/DATE
The equipment shall

type waste drains.

placed on direct
sources of heat.
Reviewed by: Date:

SKID #4 - R. O. Piping/Valves
PERFORMED
BY/DATE
The equipment shall

type waste drains.

placed on direct
sources of heat.
Reviewed by: Date:

SKID 5 - Pumps 2A, 2B
PERFORMED
BY/DATE
The equipment shall

type waste drains.

placed on direct
sources of heat.
Reviewed by: Date:

SKID 6 - UV lamps 2A, 2B & Filter 4A, 4B
PERFORMED
BY/DATE
The equipment shall

type waste drains.

placed on direct
sources of heat.
Reviewed by: Date:

SKID 7 - Filter set 5A, 5B
PERFORMED
BY/DATE
The equipment shall

type waste drains.

placed on direct
sources of heat.
Reviewed by: Date:

Water Softener Skid
PERFORMED
BY/DATE
The equipment shall

type waste drains.

placed on direct
sources of heat.
Reviewed by: Date:

Ozone Generator Skid
PERFORMED
BY/DATE
The equipment shall

type waste drains.

placed on direct
sources of heat.
Reviewed by: Date:

Ozone Destructor Skid
PERFORMED
BY/DATE
The equipment shall

type waste drains.

placed on direct
sources of heat.
Reviewed by: Date:

R.O. Skid
PERFORMED
BY/DATE
The equipment shall

type waste drains.

placed on direct
sources of heat.
Reviewed by: Date:

R.O. Cleaning Skid
PERFORMED
BY/DATE
The equipment shall

type waste drains.

placed on direct
sources of heat.
Reviewed by: Date:
UTILITY VERIFICATION IQ-06

Objective:
• Assure that the installed utility meets the Purified Water System requirements
Procedure:
• Utility Verification
a. Per equipment, perform utility verification as per expected results by using a calibrated test
instrument (when required), and document results
b. Attach copy of instrument calibration certificate and ensure it is up to date
c. Ensure that each utility connection is properly labeled
• Electrical Verification
a. Perform verification as per Utility Verification thru a certified electrician

b. Attach copy of Electrician’s license and ensure it is up to date
Note: All readings will apply a ±10% tolerance
• Test Instruments calibration certificates
• Copy of Electrician’s license

• Utilities comply with expected results (manufacturer specifications)
• All calibrations/certifications are up to date

Dual Softener unit
ELECTRICAL PERFORMED
EXPECTED RESULT ACTUAL RESULT PASS/FAIL
SPECS BY/DATE
Voltage
Phase
Amperage
Frequency
Panel ID
To be filled by a licensed electrician or electrical engineer with PE license

Does electrical installation comply with NEC standards? (YES/NO) _______________
Electrician signature: ____________________________ License Number: ____________________________
PERFORMED
OTHER SPECS EXPECTED RESULT ACTUAL RESULT PASS/FAIL
BY/DATE
Compressed Air
Chemical
Reviewed by: Date:

Ozone Generator
ELECTRICAL EXPECTED PERFORMED

ACTUAL RESULT PASS/FAIL
SPECS RESULT BY/DATE
Voltage
Phase
OZ-1
Amperage
Frequency
Panel ID
Voltage
Phase
P-OZ1
Amperage
Frequency
Panel ID
Voltage
Phase
P-OZ2
Amperage
Frequency
Panel ID
Voltage
Transformer
Phase
Amperage
Frequency
Panel ID
Electrician signature: ___________________________ License Number: ___________________________

EXPECTED PERFORMED
OTHER SPECS ACTUAL RESULT PASS/FAIL
RESULT BY/DATE
Compressed Air 90-110 psig

Reviewed by: Date:

Ozone Destructor
SPECS BY/DATE
Voltage
Phase
Amperage
Frequency
Panel ID
Bulb installation

Reviewed by: Date:

UV lamps (1A, 1B)
SPECS BY/DATE
Voltage
Phase
Amperage
Frequency
Panel ID
Bulb installation

Reviewed by: Date:

UV lamps (2A, 2B)
SPECS BY/DATE
Voltage
Phase
Amperage
Frequency
Panel ID
Bulb installation
Electrician signature: ____________________________ License Number: ___________________________
Reviewed by: Date:

SPECS BY/DATE
Voltage
Phase
Amperage
Frequency
Panel ID

Reviewed by: Date:

SPECS BY/DATE
Voltage
Phase
Amperage
Frequency
Panel ID

Reviewed by: Date:


1
Voltage
2
Voltage
1
Phase
2
Unit A
Phase
1
Amperage
2
Amperage
Frequency
Panel ID
1
Voltage
2
Voltage
1
Phase
Unit B
2
Phase
1
Amperage
2
Amperage
Frequency
Panel ID
Electrician signature: ____________________________ License Number: _____________________________

PERFORMED
BY/DATE
Compressed Air 80-110 psig

1
Comments/Observations: Assembly power to assembly panel (PLC)
2
Plant power to assembly power
Reviewed by: Date:

Dual Reverse Osmosis unit (Cleaning Skid)
ELECTRICAL PERFORME
SPECS D BY/DATE
Voltage
Phase
Amperage
Frequency
Panel ID
Electrician signature: ____________________________ License Number: _________________________

PERFORME
D BY/DATE
Chemicals
Reviewed by: Date:

Dual Reverse Osmosis unit (pumps)
SPECS BY/DATE
Voltage
R.O Feed Pump
Phase
Amperage
Frequency
Panel ID
Voltage
R.O. Cleaning
Phase
Pump
Amperage
Frequency
Panel ID
Voltage
ADS Pump
Phase
Amperage
Frequency
Panel ID

Reviewed by: Date:

Degasification unit

Voltage
Degas Panel
Phase
Amperage
Frequency
Panel ID
Voltage
Vacuum Pump
Phase
Amperage
Frequency
Panel ID

Electrician signature: ___________________________ License Number: _____________________________
EXPECTED PERFORMED
OTHER SPECS ACTUAL RESULT PASS/FAIL
RESULT BY/DATE
Compressed Air
Reviewed by: Date:

Dual Mixed Bed unit
SPECS BY/DATE
Voltage
Phase
Amperage
Frequency
Panel ID
Electrician signature: ___________________________ License Number: ____________________________

PERFORMED
BY/DATE
Compressed Air
(control panel)
Clean Compressed
Air
(MB column)
Chemicals
Reviewed by: Date:

INSTRUMENTATION VERIFICATION IQ-07
Objective:
• Assure that all the instrumentation installed in the Purified Water System that requires
calibration are added to a calibration program
Procedure:
a. Inspect all instruments evaluated with the “Calibration Program Addition Form” and verify that all
instruments installed at the Purified Water System were included
b. Record instruments (ID & type) that requires calibration according to the “Calibration Program
Addition Form”
c. Verify if the instrument that requires calibration is currently calibrated and record finding
d. Attach calibration certificate of all calibrated instruments
• Instruments that required calibration were included in site calibration program
• Instruments are currently calibrated

INSTRUMENTATION VERIFICATION IQ-07
Sheet ______ of ______
Use additional pages as necessary
IT IS CURRENTLY
INSTRUMENT CALIBRATION PERFORMED
INSTRUMENT ID CALIBRATED?
TYPE DUE DATE BY/DATE
(YES/NO/NA)
Reviewed by: Date:

MAINTENANCE VERIFICATION IQ-08
Objective:
• Assure that the Purified Water System is included in a Preventive Maintenance Program and a
spare parts list exists
Procedure:
a. Per equipment, verify and document the required information by collecting documented
evidence (i.e. PM checklist, PM schedule) of the inclusion of the Purified Water System
components into ___’s Preventive Maintenance Program
b. Collect the Spare Parts list; verify & document the required information
c. Collect the Lubricants list; verify & document the required information
d. If lubricant specifications is not applicable, write a Not Apply to the “Actual Result” column and
explain in the “Comments/Observations” section
• Evidence of PMP inclusion - PM checklist, PM schedule, PM program printouts, etc.
• Spare Parts list
• Lubricants list
• FOP 4.1 “Scheduled Preventive Maintenance”

• All equipment is included in a PM schedule
• All equipment has spare part list
• “Not applicable” lubricant requirements were properly explained

Filter set 1A &1B
PERFORMED
BY/DATE
A PM checklist,
schedule or similar is
PMP available as evidence
of inclusion into the
PM program.
Spare parts inventory

Spare
is available for the
Parts
equipment.
Lubricants inventory is
Lubricants available for the
equipment.
Reviewed by: Date:

Filter set 2A & 2B
PERFORMED
BY/DATE
A PM checklist,
PM program.

Spare
Parts
equipment.
equipment.
Reviewed by: Date:

Filter set 3A & 3B
PERFORMED
BY/DATE
A PM checklist,
PM program.

Spare
Parts
equipment.
equipment.
Reviewed by: Date:

Filter set 4A & 4B
PERFORMED
BY/DATE
A PM checklist,
PM program.

Spare
Parts
equipment.
equipment.
Reviewed by: Date:

Filter set 5A & 5B
PERFORMED
BY/DATE
A PM checklist,
PM program.

Spare
Parts
equipment.
equipment.
Reviewed by: Date:

Dual Softener unit
PERFORMED
BY/DATE
A PM checklist,
PM program.

Spare
Parts
equipment.
equipment.
Reviewed by: Date:

Ozone Generator
PERFORMED
BY/DATE
A PM checklist,
PM program.

Spare
Parts
equipment.
equipment.
Reviewed by: Date:

Ozone Destructor
PERFORMED
BY/DATE
A PM checklist,
PM program.

Spare
Parts
equipment.
equipment.
Reviewed by: Date:

6,000 Gal. Tank
PERFORMED
BY/DATE
A PM checklist,
PM program.

Spare
Parts
equipment.
equipment.
Reviewed by: Date:

8,000 Gal. Tank
PERFORMED
BY/DATE
A PM checklist,
PM program.

Spare
Parts
equipment.
equipment.
Reviewed by: Date:

PERFORMED
BY/DATE
A PM checklist,
PM program.

Spare
Parts
equipment.
equipment.
Reviewed by: Date:

PERFORMED
BY/DATE
A PM checklist,
PM program.

Spare
Parts
equipment.
equipment.
Reviewed by: Date:

UV lamps (1A, 1B)
PERFORMED
BY/DATE
A PM checklist,
PM program.

Spare
Parts
equipment.
equipment.
Reviewed by: Date:

UV lamps (2A, 2B)
PERFORMED
BY/DATE
A PM checklist,
PM program.

Spare
Parts
equipment.
equipment.
Reviewed by: Date:

PERFORMED
BY/DATE
A PM checklist,
PM program.

Spare
Parts
equipment.
equipment.
Reviewed by: Date:

De-gasification unit
PERFORMED
BY/DATE
A PM checklist,
PM program.

Spare
Parts
equipment.
equipment.
Reviewed by: Date:

Dual Mixed Bed unit
PERFORMED
BY/DATE
A PM checklist,
PM program.

Spare
Parts
equipment.
equipment.
Reviewed by: Date:

PERFORMED
BY/DATE
A PM checklist,
PM program.

Spare
Parts
equipment.
equipment.
Reviewed by: Date:

SAFETY & ERGONOMICS VERIFICATION IQ-09
Objective:
• Assure that the Purified Water System complies with ___’s EHS Safety and Ergonomics
requirements
Procedure:
• Collect documented evidence (i.e. EHS checklist) of EHS evaluation of the Purified Water
System
• Document evaluation results and compare against expected results

• Evidence of EHS evaluation - EHS checklist, etc.

• EHS checklist is approved by EHS representative

SAFETY & ERGONOMICS VERIFICATION IQ-09
EXPECTED PERFORMED
RESULT BY/DATE
EHS Change
Management
AWO column
checklist was
completed and
approved.
PWS Safety &
Ergonomics
Compliance
EHS found
Purified Water
System to be in
compliance.
Reviewed by: Date:

PROCEDURE VERIFICATION IQ-10
Objective:
• Assure written procedures for the operation and maintenance of the Purified Water System
Procedure:
a. Per equipment, collect and evaluate written procedures (i.e. operating, maintenance, cleaning)
and document findings
b. If any of the specifications is not applicable, write a Not Apply to the “Actual Result” column and
explain in the “Comments/Observations” section
c. Evaluate findings against expected results

• SOP’s (at least in DRAFT form)

• Draft procedures are available for each main component of the Purified Water System.
Filter set 1A & 1B
EXPECTED ACTUAL RESULT PERFORMED

SOP PASS/FAIL
RESULT (DOC. NO., REV. NO., TITLE, STATUS) BY/DATE
A procedure
Operating
exists at least in
Procedure
Draft form.
A procedure
Maintenance
exists at least in
Procedure
Draft form.
Reviewed by: Date:

Filter 2A & 2B

SOP PASS/FAIL
A procedure
Operating
exists at least in
Procedure
Draft form.
A procedure
Maintenance
exists at least in
Procedure
Draft form.
Reviewed by: Date:

Filter set 3A & 3B

SOP PASS/FAIL
A procedure
Operating
exists at least in
Procedure
Draft form.
A procedure
Maintenance
exists at least in
Procedure
Draft form.
Reviewed by: Date:

Filter set 4A & 4B

SOP PASS/FAIL
A procedure
Operating
exists at least in
Procedure
Draft form.
A procedure
Maintenance
exists at least in
Procedure
Draft form.
Reviewed by: Date:

Filter set 5A & 5B

SOP PASS/FAIL
A procedure
Operating
exists at least in
Procedure
Draft form.
A procedure
Maintenance
exists at least in
Procedure
Draft form.
Reviewed by: Date:

Dual Softener unit

SOP PASS/FAIL
A procedure
Operating
exists at least in
Procedure
Draft form.
A procedure
Maintenance
exists at least in
Procedure
Draft form.
Reviewed by: Date:

Ozone Generator

SOP PASS/FAIL
A procedure
Operating
exists at least in
Procedure
Draft form.
A procedure
Maintenance
exists at least in
Procedure
Draft form.
Reviewed by: Date:

Ozone Destructor

SOP PASS/FAIL
A procedure
Operating
exists at least in
Procedure
Draft form.
A procedure
Maintenance
exists at least in
Procedure
Draft form.
Reviewed by: Date:


SOP PASS/FAIL
A procedure
Operating
exists at least in
Procedure
Draft form.
A procedure
Maintenance
exists at least in
Procedure
Draft form.
Reviewed by: Date:


SOP PASS/FAIL
A procedure
Operating
exists at least in
Procedure
Draft form.
A procedure
Maintenance
exists at least in
Procedure
Draft form.
Reviewed by: Date:

8,000 Gal. Tank

SOP PASS/FAIL
A procedure
Operating
exists at least in
Procedure
Draft form.
A procedure
Maintenance
exists at least in
Procedure
Draft form.
Reviewed by: Date:

6,000 Gal. Tank

SOP PASS/FAIL
A procedure
Operating
exists at least in
Procedure
Draft form.
A procedure
Maintenance
exists at least in
Procedure
Draft form.
Reviewed by: Date:

UV lamps (1A, 1B, 2A, 2B)

SOP PASS/FAIL
A procedure
Operating
exists at least in
Procedure
Draft form.
A procedure
Maintenance
exists at least in
Procedure
Draft form.
Reviewed by: Date:


SOP PASS/FAIL
A procedure
Operating
exists at least in
Procedure
Draft form.
A procedure
Maintenance
exists at least in
Procedure
Draft form.
Reviewed by: Date:

Degasification unit

SOP PASS/FAIL
A procedure
Operating
exists at least in
Procedure
Draft form.
A procedure
Maintenance
exists at least in
Procedure
Draft form.
Reviewed by: Date:

Dual Mixed Bed unit

SOP PASS/FAIL
A procedure
Operating
exists at least in
Procedure
Draft form.
A procedure
Maintenance
exists at least in
Procedure
Draft form.
Reviewed by: Date:


SOP PASS/FAIL
A procedure
Operating
exists at least in
Procedure
Draft form.
A procedure
Maintenance
exists at least in
Procedure
Draft form.
Reviewed by: Date:

IQ CHECKLIST VERIFICATION
Verify each of the respective IQ tests and document completion and status.
ACCEPTANCE
TEST DEVIATION DEVIATION
TEST CRITERIA
TEST TITLE EXECUTED NUMBER SOLVED
NUMBER MET?
(YES/NO) (if applies) (YES/NO)
(YES/NO)
IQ-01 EQUIPMENT VERIFICATION
DOCUMENT INVENTORY
IQ-02
VERIFICATION
IQ-03 DRAWING VERIFICATION
IQ-04 SYSTEM DESIGN VERIFICATION
IQ-05 PLACEMENT VERIFICATION
IQ-06 UTILITY VERIFICATION
IQ-07 INSTRUMENTATION VERIFICATION
IQ-08 MAINTENANCE VERIFICATION
SAFETY AND ERGONOMICS

IQ-09
VERIFICATION
IQ-10 PROCEDURE VERIFICATION
Performed by: Date:

IQ Purified Water

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INSTALLATION QUALIFICATION PROTOCOL

NEW PURIFIED WATER SYSTEM

Revision Description of change Date

• 30 um filters (2) • 6, 000 and 8, 000 Gal. Tanks

7.1 Water Softener

APPENDIX I: DEVIATION REPORT

Deviation Number: _________________

Deviation reported by:_________________________________ Date: _________________

Attach additional pages, if necessary

Root Cause: □Manpower □Methods □Equipment □ Materials □Environment

CORRECTIVE / PREVENTIVE ACTION

Evaluation performed by:____________________________________ Date: _________________

Testing required after Corrective action implemented? (YES/NO) ______________

Test results (PASS/FAIL/NA) ________________

Performed by: _______________________________________ Date: _______________________

Reviewed by ______________________________________ Date: ____________________________

NAME SIGNATURE INITIALS DEPARTMENT

• Actual results match expected results as per manufacturer written specifications

Reviewed by: Date:

Reviewed by: Date:

Reviewed by: Date:

Reviewed by: Date:

Reviewed by: Date:

Reviewed by: Date:

Reviewed by: Date:

Reviewed by: Date:

Reviewed by: Date:

Reviewed by: Date:

Reviewed by: Date:

Reviewed by: Date:

Reviewed by: Date:

Reviewed by: Date:

Reviewed by: Date:

Dual Reverse Osmosis (Service unit A)

Reviewed by: Date:

Reviewed by: Date:

Reviewed by: Date:

Reviewed by: Date:

Reviewed by: Date:

Reviewed by: Date:

• Manufacturer’s Documentation - Installation and Operational Manuals, Wiring Diagrams, Spare

• Vendor’s Documentation - Purchase Order, etc.

• “Not applicable” document type was properly explained

DOCUMENT DOCUMENT INFO DOCUMENT STORAGE PERFORMED

Reviewed by: Date:

DOCUMENT DOCUMENT INFO DOCUMENT STORAGE PERFORMED

Reviewed by: Date:

DOCUMENT DOCUMENT INFO DOCUMENT STORAGE PERFORMED

Reviewed by: Date:

DOCUMENT DOCUMENT INFO DOCUMENT STORAGE PERFORMED

Reviewed by: Date:

DOCUMENT INVENTORY VERIFICATION IQ-02

DOCUMENT DOCUMENT INFO DOCUMENT STORAGE PERFORMED

Reviewed by: Date:

DOCUMENT INVENTORY VERIFICATION IQ-02

DOCUMENT DOCUMENT INFO DOCUMENT STORAGE PERFORMED

Reviewed by: Date:

DOCUMENT DOCUMENT INFO DOCUMENT STORAGE PERFORMED

Reviewed by: Date:

DOCUMENT DOCUMENT INFO DOCUMENT STORAGE PERFORMED

Reviewed by: Date:

DOCUMENT DOCUMENT INFO DOCUMENT STORAGE PERFORMED

Reviewed by: Date:

DOCUMENT DOCUMENT INFO DOCUMENT STORAGE PERFORMED

Deviation reported by:_________________ Date: _

Evaluation performed by:____________________ Date: _

Performed by: _________________ Date: _

Reviewed by __________ Date: