For The: Installation Qualification Protocol

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 manufacturers specifications and ___ ___ requirements.
This Installation Qualification will provide documented evidence that all key aspects of the Purified
Water System equipments 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
FDAs 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 predefine 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 lamps 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 m pre-filter to trap any heavy sediment before it
enters the softeners. The 1 m 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.
INSTRUMENT ID
DESCRIPTION
TEST ID
CALIBRATION
DATE/DUE DATE
COPY OF
CERTIFICATE
ATTACHED?
(YES/NO)
PERFORMED
BY/DATE
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 & IDs, 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 & IDs, etc.) does not
count as Actual Result reference
Acceptance Criteria:
Actual results match expected results as per manufacturer written specifications
IQ-01
Filter set 1A & 1B
SPEC
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
1A
Tag ID
Cartridge
Manufacturer
Cartridge Part
No.
Housing
Manufacturer
Housing
Part No.
Quantity
Tag ID
1B
Cartridge
Manufacturer
Cartridge Part
No.
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) __________
Reviewed by:
If NO, refer to Deviation # __________

Date:
IQ-01
Filter set 2A & 2B
SPEC
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
2A
Tag ID
Cartridge
Manufacturer
Cartridge Part
No.
Housing
Manufacturer
Housing
Part No.
Quantity
Tag ID
2B
Cartridge
Manufacturer
Cartridge Part
No.
Housing
Manufacturer
Housing
Part No.
Quantity
Reviewed by:

Date:
IQ-01
Filter set 3A & 3B
SPEC
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
3A
Tag ID
Cartridge
Manufacturer
Cartridge Part
No.
Housing
Manufacturer
Housing
Part No.
Quantity
Tag ID
3B
Cartridge
Manufacturer
Cartridge Part
No.
Housing
Manufacturer
Housing
Part No.
Quantity
Reviewed by:

Date:
IQ-01
Filter set 4A & 4B
SPEC
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Tag ID
4A
Cartridge
Manufacturer
Cartridge Part
No.
Housing
Manufacturer
Housing
Part No.
Quantity
Tag ID
4B
Cartridge
Manufacturer
Cartridge Part
No.
Housing
Manufacturer
Housing
Part No.
Quantity
Reviewed by:

Date:
IQ-01
Filter set 5A & 5 B
SPEC
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Tag ID
5A
Cartridge
Manufacturer
Cartridge Part
No.
Housing
Manufacturer
Housing
Part No.
Quantity
Tag ID
5B
Cartridge
Manufacturer
Cartridge Part
No.
Housing
Manufacturer
Housing
Part No.
Quantity
Reviewed by:

Date:
IQ-01
Ozone Generator
SPEC
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Tag ID
Manufacturer
Model
Serial No.
Booster pump
Tag ID
Manufacturer
Model
Recirculation pump
Serial No.
Tag ID
Manufacturer
Model
Serial No.
Reviewed by:

Date:
IQ-01
Ozone Destructor
SPEC
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Tag ID
Manufacturer
Model
Serial No.
UV light
Tag ID
Manufacturer
Model
Serial No.
Reviewed by:

Date:
IQ-01
Dual Softener unit
SPEC
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Unit A
Tag ID
Manufacturer
Model
Serial No.
Unit B
Tag ID
Manufacturer
Model
Resin
Control Panel
Serial No.
Manufacturer
Model
Type
Reviewed by:

Date:
IQ-01
Dual Softener unit (Brine Tank)

SPEC
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Tag ID
Manufacturer
Model
Serial No.
Reviewed by:

Date:
IQ-01
6,000 Gal. Tank
SPEC
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Tag ID
Manufacturer
Description
Vent Filter
Cartridge
Manufacturer
Cartridge
Part No.
Housing
Manufacturer
Housing
Part No.
Level
Manufacturer
Part No.
Reviewed by:

Date:
IQ-01
Distribution Pumps (1A, 1B)
SPEC
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Tag ID
1A
Manufacturer
Model
Serial No.
Tag ID
2A
Manufacturer
Model
Serial No.
Reviewed by:

Date:
IQ-01
8,000 Gal. Tank
SPEC
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Tag ID
Manufacturer
Description
Vent Filter
Cartridge
Manufacturer
Cartridge
Part No.
Housing
Manufacturer
Housing
Part No.
Level
Manufacturer
Part No.
Reviewed by:

Date:
IQ-01
SPEC
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Tag ID
2A
Manufacturer
Model
Serial No.
Tag ID
2B
Manufacturer
Model
Serial No.
Reviewed by:

Date:
IQ-01
UV lamps (1A, 1B)
SPEC
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Tag ID
1A
Manufacturer
Model
Serial No.
Tag ID
1B
Manufacturer
Model
Serial No.
Reviewed by:

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

Date:
IQ-01
Dual Reverse Osmosis (Service unit A)

SPEC
EXPECTED RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Tag ID
Manufacturer
Model
Serial No.
Feed Pump
Tag ID
Manufacturer
Model
Control Panel
Antiscalant Dosing System
Serial No.
Tag ID
Manufacturer
Model
Serial No.
Manufacturer
Model
Reviewed by:

Date:
IQ-01
Dual Reverse Osmosis (Service unit B)

SPEC
EXPECTED RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Tag ID
Manufacturer
Model
Serial No.
Feed Pump
Tag ID
Manufacturer
Model
Control Panel
Antiscalant Dosing System
Serial No.
Tag ID
Manufacturer
Model
Serial No.
Manufacturer
Model
Reviewed by:

Date:
IQ-01
Dual R.O. unit (Cleaning Skid)

SPEC
EXPECTED RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Tag ID
Manufacturer
Model
Serial No.
Cleaning Pump
Tag ID
Manufacturer
Model
Serial No.
Reviewed by:

Date:
IQ-01
De-gasification unit
SPEC
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Tag ID
Manufacturer
Model
Serial No.
Pump
Tag ID
Manufacturer
Model
Serial No.
Reviewed by:

Date:
IQ-01
Dual Mixed Bed unit
SPEC
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Tag ID
Unit A
Manufacturer
Model
Serial No.
Tag ID
Unit B
Manufacturer
Model
Serial No.
Acid &
Caustic
Control Panel
Manufacturer
Model
Type
Reviewed by:

Date:
IQ-01
Microza ultra filtration filters

SPEC
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
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
Manufacturers Documentation - Installation and Operational Manuals, Wiring Diagrams, Spare

Parts List, P & IDs, etc.
Vendors 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
IQ-02
Filter set 1A & 1B

DOCUMENT
TYPE
DOCUMENT INFO
(DOC #, TITLE, REV., LOCATION)
DOCUMENT STORAGE
(LOCATION)
PERFORMED
BY/DATE
Installation and
Operation
Manual
Purchase Order
Drawings
P & IDs
Other
Documents
Acceptance Criteria met? (YES/NO) ________
Reviewed by:
Date:
IQ-02
Filter set 2A & 2B

DOCUMENT
TYPE
DOCUMENT INFO
DOCUMENT STORAGE
(LOCATION)
PERFORMED
BY/DATE
Installation and
Operation
Manual
Purchase Order
Drawings
P & IDs
Other
Documents
Reviewed by:
Date:
IQ-02
Filter set 3A & 3B

DOCUMENT
TYPE
DOCUMENT INFO
DOCUMENT STORAGE
(LOCATION)
PERFORMED
BY/DATE
Installation and
Operation
Manual
Purchase Order
Drawings
P & IDs
Other
Documents
Reviewed by:
Date:
IQ-02
Filter set 3A & 3B

DOCUMENT
TYPE
DOCUMENT INFO
DOCUMENT STORAGE
(LOCATION)
PERFORMED
BY/DATE
Installation and
Operation
Manual
Purchase Order
Drawings
P & IDs
Other
Documents
Reviewed by:
Date:
IQ-02
Filter set 4A & 4B

DOCUMENT
TYPE
DOCUMENT INFO
DOCUMENT STORAGE
(LOCATION)
PERFORMED
BY/DATE
Installation and
Operation
Manual
Purchase Order
Drawings
P & IDs
Other
Documents
Reviewed by:
Date:
IQ-02
Filter set 5A & 5B

DOCUMENT
TYPE
DOCUMENT INFO
DOCUMENT STORAGE
(LOCATION)
PERFORMED
BY/DATE
Installation and
Operation
Manual
Purchase Order
Drawings
P & IDs
Other
Documents
Reviewed by:
Date:
IQ-02
Dual Softener unit

DOCUMENT
TYPE
DOCUMENT INFO
DOCUMENT STORAGE
(LOCATION)
PERFORMED
BY/DATE
Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
Mechanical
Drawings
P & IDs
PLC Software
Backup &
Report
MSDS
Other
Documents
Reviewed by:
Date:
IQ-02
6,000 Gal. Tank
DOCUMENT
TYPE
DOCUMENT INFO
DOCUMENT STORAGE
(LOCATION)
PERFORMED
BY/DATE
Installation and
Operation
Manual
Purchase Order
Drawings
P & IDs
Other
Documents
Reviewed by:
Date:
IQ-02

DOCUMENT
TYPE
DOCUMENT INFO
DOCUMENT STORAGE
(LOCATION)
PERFORMED
BY/DATE
Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
Mechanical
Drawings
P & IDs
Other
Documents
Reviewed by:
Date:
IQ-02
8,000 Gal. Tank
DOCUMENT
TYPE
DOCUMENT INFO
DOCUMENT STORAGE
(LOCATION)
PERFORMED
BY/DATE
Installation and
Operation
Manual
Purchase Order
Drawings
P & IDs
Other
Documents
Reviewed by:
Date:
IQ-02

DOCUMENT
TYPE
DOCUMENT INFO
DOCUMENT STORAGE
(LOCATION)
PERFORMED
BY/DATE
Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
Mechanical
Drawings
P & IDs
Other
Documents
Reviewed by:
Date:
IQ-02
Ozone Generator
DOCUMENT
TYPE
DOCUMENT INFO
DOCUMENT STORAGE
(LOCATION)
PERFORMED
BY/DATE
Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
Mechanical
Drawings
P & IDs
PLC Software
Backup &
Report
Other
Documents
Reviewed by:
Date:
IQ-02
Ozone Destructor
DOCUMENT
TYPE
DOCUMENT INFO
DOCUMENT STORAGE
(LOCATION)
PERFORMED
BY/DATE
Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
P & IDs
PLC Software
Backup &
Report
Other
Documents
Reviewed by:
Date:
IQ-02
UV lamps (1A, 1B, 2A, 2B)

DOCUMENT
TYPE
DOCUMENT INFO
DOCUMENT STORAGE
(LOCATION)
PERFORMED
BY/DATE
Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
P & IDs
Other
Documents
Reviewed by:
Date:
IQ-02

DOCUMENT
TYPE
DOCUMENT INFO
DOCUMENT STORAGE
(LOCATION)
PERFORMED
BY/DATE
Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
Mechanical
Drawing
P & IDs
PLC Software
Backup &
Report
MSDS
Other
Documents
Reviewed by:
Date:
IQ-02
Degasification unit
DOCUMENT
TYPE
DOCUMENT INFO
DOCUMENT STORAGE
(LOCATION)
PERFORMED
BY/DATE
Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
Mechanical
Drawings
P & IDs
Other
Documents
Reviewed by:
Date:
IQ-02
Dual Mixed Bed unit

DOCUMENT
TYPE
DOCUMENT INFO
DOCUMENT STORAGE
(LOCATION)
PERFORMED
BY/DATE
Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
P & IDs
PLC Software
Backup &
Report
Other
Documents
Reviewed by:
Date:
IQ-02

DOCUMENT
TYPE
DOCUMENT INFO
DOCUMENT STORAGE
(LOCATION)
PERFORMED
BY/DATE
Installation and
Operation
Manual
Purchase Order
Electrical
Drawings
P & IDs
Other
Documents
Reviewed by:
Date:
DRAWING VERIFICATION
IQ-03
Objective:
Assure concordance between drawings (P & I Ds 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 Ds)
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
IQ-03
Sheet ______ of ______
Use additional pages as necessary
DRAWING
TYPE & ID
TITLE & REVISION
REDLINED?
(YES/NO)
UPDATE?
(DWG, FLD, NA)
PERFORMED
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 & IDs
Material Safety Data Sheets
Chemical Analysis Sheets
Actual results match expected results as per Purified Water specifications

SPEC
EXPECTED RESULT
Feed water
The raw water source supplied to

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

capable of performing Deionization
and Reverse Osmosis or
Distillation.
IQ-04
ACTUAL RESULT
PASS/FAIL
Piping will provide constant

circulation of Purified water.
Piping
Contact
material
Piping does not have an unused

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

non-reactive to Purified Water.
Reviewed by:

Date:
PERFORMED
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
IQ-05
SKID #1 - Filter Set 1A, 1B
SPEC
EXPECTED RESULT
Position
The equipment shall

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

placed on direct
sunlight or other
sources of heat.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-05
SKID #2 - Filter set 2A, 2B
SPEC
EXPECTED RESULT
Position
The equipment shall

type waste drains.
Environment

placed on direct
sunlight or other
sources of heat.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-05
SKID #3 - Distribution Pumps 1A, 1B; UV lamps 1A, 1B & Filter set 3A, 3B
SPEC
EXPECTED RESULT
Position
The equipment shall

type waste drains.
Environment

placed on direct
sunlight or other
sources of heat.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-05
SKID #4 - R. O. Piping/Valves
SPEC
EXPECTED RESULT
Position
The equipment shall

type waste drains.
Environment

placed on direct
sunlight or other
sources of heat.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-05
SKID 5 - Pumps 2A, 2B
SPEC
EXPECTED RESULT
Position
The equipment shall

type waste drains.
Environment

placed on direct
sunlight or other
sources of heat.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-05
SKID 6 - UV lamps 2A, 2B & Filter 4A, 4B
SPEC
EXPECTED RESULT
Position
The equipment shall

type waste drains.
Environment

placed on direct
sunlight or other
sources of heat.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-05
SKID 7 - Filter set 5A, 5B
SPEC
EXPECTED RESULT
Position
The equipment shall

type waste drains.
Environment

placed on direct
sunlight or other
sources of heat.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-05
Water Softener Skid

SPEC
EXPECTED RESULT
Position
The equipment shall

type waste drains.
Environment

placed on direct
sunlight or other
sources of heat.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-05
Ozone Generator Skid

SPEC
EXPECTED RESULT
Position
The equipment shall

type waste drains.
Environment

placed on direct
sunlight or other
sources of heat.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-05
Ozone Destructor Skid
SPEC
EXPECTED RESULT
Position
The equipment shall

type waste drains.
Environment

placed on direct
sunlight or other
sources of heat.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-05
R.O. Skid
SPEC
EXPECTED RESULT
Position
The equipment shall

type waste drains.
Environment

placed on direct
sunlight or other
sources of heat.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-05
R.O. Cleaning Skid

SPEC
EXPECTED RESULT
Position
The equipment shall

type waste drains.
Environment

placed on direct
sunlight or other
sources of heat.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:
UTILITY VERIFICATION
Objective:

Date:
IQ-06
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 Electricians license and ensure it is up to date
Note: All readings will apply a 10% tolerance
Test Instruments calibration certificates
Copy of Electricians license
Utilities comply with expected results (manufacturer specifications)
All calibrations/certifications are up to date
IQ-06
Dual Softener unit
ELECTRICAL
SPECS
EXPECTED RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
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: ____________________________
OTHER SPECS
EXPECTED RESULT
License Number: ____________________________
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Compressed Air
Chemical
Reviewed by:

Date:
IQ-06
Transformer
P-OZ2
P-OZ1
OZ-1
Ozone Generator
ELECTRICAL
SPECS
Voltage
Phase
Amperage
Frequency
Panel ID
Voltage
Phase
Amperage
Frequency
Panel ID
Voltage
Phase
Amperage
Frequency
Panel ID
Voltage
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Phase
Amperage
Frequency
Panel ID

Electrician signature: ___________________________
OTHER SPECS
EXPECTED
RESULT
Compressed Air
90-110 psig
License Number: ___________________________
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-06
Ozone Destructor
ELECTRICAL
SPECS
EXPECTED RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Voltage
Phase
Amperage
Frequency
Panel ID
Bulb installation

License Number: ____________________________
Reviewed by:

Date:
IQ-06
UV lamps (1A, 1B)
ELECTRICAL
SPECS
EXPECTED RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Voltage
Phase
Amperage
Frequency
Panel ID
Bulb installation

License Number: ____________________________
Reviewed by:

Date:
IQ-06
UV lamps (2A, 2B)
ELECTRICAL
SPECS
EXPECTED RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Voltage
Phase
Amperage
Frequency
Panel ID
Bulb installation

License Number: ___________________________
Reviewed by:

Date:
IQ-06
ELECTRICAL
SPECS
EXPECTED RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Voltage
Phase
Amperage
Frequency
Panel ID

License Number: ___________________________
Reviewed by:

Date:
IQ-06
ELECTRICAL
SPECS
EXPECTED RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Voltage
Phase
Amperage
Frequency
Panel ID

License Number: ___________________________
Reviewed by:

Date:
IQ-06
ELECTRICAL
SPECS
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Voltage
Voltage
Unit A
Phase
Phase
Amperage
Amperage
Frequency
Panel ID
1
Voltage
Voltage
Unit B
Phase
Phase
Amperage
Amperage
Frequency
Panel ID

OTHER SPECS
EXPECTED RESULT
Compressed Air
80-110 psig
License Number: _____________________________
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Assembly power to assembly panel (PLC)

2
Plant power to assembly power
Reviewed by:

Date:
IQ-06
Dual Reverse Osmosis unit (Cleaning Skid)
ELECTRICAL
SPECS
EXPECTED RESULT
ACTUAL RESULT
PASS/FAIL
PERFORME
D BY/DATE
Voltage
Phase
Amperage
Frequency
Panel ID

OTHER SPECS
EXPECTED RESULT
License Number: _________________________
ACTUAL RESULT
PASS/FAIL
PERFORME
D BY/DATE
Chemicals
Reviewed by:

Date:
IQ-06
Dual Reverse Osmosis unit (pumps)
ELECTRICAL
SPECS
EXPECTED RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
R.O Feed Pump
Voltage
Phase
Amperage
Frequency
Panel ID
R.O. Cleaning
Pump
Voltage
Phase
Amperage
Frequency
Panel ID
ADS Pump
Voltage
Phase
Amperage
Frequency
Panel ID

License Number: ____________________________
Reviewed by:

Date:
IQ-06
Degasification unit
ELECTRICAL
SPECS
EXPECTED
RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Degas Panel
Voltage
Phase
Amperage
Frequency
Panel ID
Vacuum Pump
Voltage
Phase
Amperage
Frequency
Panel ID

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

Date:
IQ-06
Dual Mixed Bed unit
ELECTRICAL
SPECS
EXPECTED RESULT
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Voltage
Phase
Amperage
Frequency
Panel ID

OTHER SPECS
EXPECTED RESULT
License Number: ____________________________
ACTUAL RESULT
PASS/FAIL
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
IQ-07
Sheet ______ of ______
Use additional pages as necessary
INSTRUMENT ID
INSTRUMENT
TYPE
IT IS CURRENTLY
CALIBRATED?
(YES/NO/NA)
CALIBRATION
DUE DATE
PERFORMED
BY/DATE
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
IQ-08
Filter set 1A &1B
SPEC
EXPECTED RESULT
PMP
A PM checklist,
schedule or similar is
available as evidence
of inclusion into the
PM program.
Spare
Parts
Spare parts inventory

is available for the
equipment.
Lubricants
Lubricants inventory is
available for the
equipment.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-08
Filter set 2A & 2B
SPEC
EXPECTED RESULT
PMP
A PM checklist,
PM program.
Spare
Parts

equipment.
Lubricants
available for the
equipment.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-08
Filter set 3A & 3B
SPEC
EXPECTED RESULT
PMP
A PM checklist,
PM program.
Spare
Parts

equipment.
Lubricants
available for the
equipment.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-08
Filter set 4A & 4B
SPEC
EXPECTED RESULT
PMP
A PM checklist,
PM program.
Spare
Parts

equipment.
Lubricants
available for the
equipment.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-08
Filter set 5A & 5B
SPEC
EXPECTED RESULT
PMP
A PM checklist,
PM program.
Spare
Parts

equipment.
Lubricants
available for the
equipment.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-08
Dual Softener unit
SPEC
EXPECTED RESULT
PMP
A PM checklist,
PM program.
Spare
Parts

equipment.
Lubricants
available for the
equipment.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-08
Ozone Generator
SPEC
EXPECTED RESULT
PMP
A PM checklist,
PM program.
Spare
Parts

equipment.
Lubricants
available for the
equipment.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-08
Ozone Destructor
SPEC
EXPECTED RESULT
PMP
A PM checklist,
PM program.
Spare
Parts

equipment.
Lubricants
available for the
equipment.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-08
6,000 Gal. Tank
SPEC
EXPECTED RESULT
PMP
A PM checklist,
PM program.
Spare
Parts

equipment.
Lubricants
available for the
equipment.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-08
8,000 Gal. Tank
SPEC
EXPECTED RESULT
PMP
A PM checklist,
PM program.
Spare
Parts

equipment.
Lubricants
available for the
equipment.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-08
SPEC
EXPECTED RESULT
PMP
A PM checklist,
PM program.
Spare
Parts

equipment.
Lubricants
available for the
equipment.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-08

SPEC
EXPECTED RESULT
PMP
A PM checklist,
PM program.
Spare
Parts

equipment.
Lubricants
available for the
equipment.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-08
UV lamps (1A, 1B)

SPEC
EXPECTED RESULT
PMP
A PM checklist,
PM program.
Spare
Parts

equipment.
Lubricants
available for the
equipment.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-08
UV lamps (2A, 2B)
SPEC
EXPECTED RESULT
PMP
A PM checklist,
PM program.
Spare
Parts

equipment.
Lubricants
available for the
equipment.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-08
SPEC
EXPECTED RESULT
PMP
A PM checklist,
PM program.
Spare
Parts

equipment.
Lubricants
available for the
equipment.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-08
De-gasification unit
SPEC
EXPECTED RESULT
PMP
A PM checklist,
PM program.
Spare
Parts

equipment.
Lubricants
available for the
equipment.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-08
Dual Mixed Bed unit
SPEC
EXPECTED RESULT
PMP
A PM checklist,
PM program.
Spare
Parts

equipment.
Lubricants
available for the
equipment.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-08
SPEC
EXPECTED RESULT
PMP
A PM checklist,
PM program.
Spare
Parts

equipment.
Lubricants
available for the
equipment.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
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

SPEC
EXPECTED
RESULT
IQ-09
ACTUAL RESULT
PASS/FAIL
PERFORMED
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
SOPs (at least in DRAFT form)
Draft procedures are available for each main component of the Purified Water System.
IQ-10
Filter set 1A & 1B
SOP
EXPECTED
RESULT
Operating
Procedure
A procedure
exists at least in
Draft form.
Maintenance
Procedure
A procedure
exists at least in
Draft form.
ACTUAL RESULT
(DOC. NO., REV. NO., TITLE, STATUS)
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-10
Filter 2A & 2B
SOP
EXPECTED
RESULT
Operating
Procedure
A procedure
exists at least in
Draft form.
Maintenance
Procedure
A procedure
exists at least in
Draft form.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-10
Filter set 3A & 3B
SOP
EXPECTED
RESULT
Operating
Procedure
A procedure
exists at least in
Draft form.
Maintenance
Procedure
A procedure
exists at least in
Draft form.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-10
Filter set 4A & 4B
SOP
EXPECTED
RESULT
Operating
Procedure
A procedure
exists at least in
Draft form.
Maintenance
Procedure
A procedure
exists at least in
Draft form.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-10
Filter set 5A & 5B
SOP
EXPECTED
RESULT
Operating
Procedure
A procedure
exists at least in
Draft form.
Maintenance
Procedure
A procedure
exists at least in
Draft form.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-10
Dual Softener unit
SOP
EXPECTED
RESULT
Operating
Procedure
A procedure
exists at least in
Draft form.
Maintenance
Procedure
A procedure
exists at least in
Draft form.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-10
Ozone Generator
SOP
EXPECTED
RESULT
Operating
Procedure
A procedure
exists at least in
Draft form.
Maintenance
Procedure
A procedure
exists at least in
Draft form.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-10
Ozone Destructor
SOP
EXPECTED
RESULT
Operating
Procedure
A procedure
exists at least in
Draft form.
Maintenance
Procedure
A procedure
exists at least in
Draft form.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-10
SOP
EXPECTED
RESULT
Operating
Procedure
A procedure
exists at least in
Draft form.
Maintenance
Procedure
A procedure
exists at least in
Draft form.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-10
SOP
EXPECTED
RESULT
Operating
Procedure
A procedure
exists at least in
Draft form.
Maintenance
Procedure
A procedure
exists at least in
Draft form.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-10
8,000 Gal. Tank
SOP
EXPECTED
RESULT
Operating
Procedure
A procedure
exists at least in
Draft form.
Maintenance
Procedure
A procedure
exists at least in
Draft form.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-10
6,000 Gal. Tank
SOP
EXPECTED
RESULT
Operating
Procedure
A procedure
exists at least in
Draft form.
Maintenance
Procedure
A procedure
exists at least in
Draft form.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-10
UV lamps (1A, 1B, 2A, 2B)
SOP
EXPECTED
RESULT
Operating
Procedure
A procedure
exists at least in
Draft form.
Maintenance
Procedure
A procedure
exists at least in
Draft form.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-10
SOP
EXPECTED
RESULT
Operating
Procedure
A procedure
exists at least in
Draft form.
Maintenance
Procedure
A procedure
exists at least in
Draft form.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-10
Degasification unit
SOP
EXPECTED
RESULT
Operating
Procedure
A procedure
exists at least in
Draft form.
Maintenance
Procedure
A procedure
exists at least in
Draft form.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-10
Dual Mixed Bed unit

SOP
EXPECTED
RESULT
Operating
Procedure
A procedure
exists at least in
Draft form.
Maintenance
Procedure
A procedure
exists at least in
Draft form.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ-10
SOP
EXPECTED
RESULT
Operating
Procedure
A procedure
exists at least in
Draft form.
Maintenance
Procedure
A procedure
exists at least in
Draft form.
ACTUAL RESULT
PASS/FAIL
PERFORMED
BY/DATE
Reviewed by:

Date:
IQ CHECKLIST VERIFICATION
Verify each of the respective IQ tests and document completion and status.
TEST
NUMBER
TEST TITLE
TEST
EXECUTED
(YES/NO)
IQ-01
EQUIPMENT VERIFICATION
IQ-02
DOCUMENT INVENTORY
VERIFICATION
IQ-03
IQ-04
IQ-05
IQ-06
IQ-07
IQ-08
IQ-09
SAFETY AND ERGONOMICS

VERIFICATION
IQ-10
Performed by:
ACCEPTANCE
CRITERIA
MET?
(YES/NO)
Date:
DEVIATION
NUMBER
(if applies)
DEVIATION
SOLVED
(YES/NO)

For The: Installation Qualification Protocol

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INSTALLATION QUALIFICATION PROTOCOL

PURPOSE AND OBJECTIVE(S) .................................................................................................................................... 4

Validation Specialist ................................................................................................................................................... 5

Quality Dept. ............................................................................................................................................................... 5

Facility Dept. ............................................................................................................................................................... 5

Verification Data Sheet ............................................................................................................................................... 6

Deviation Report ......................................................................................................................................................... 6

Signature Log Sheet ................................................................................................................................................... 6

Test Instruments Calibration ....................................................................................................................................... 6

EQUIPMENT/PROCESS DESCRIPTION ....................................................................................................................... 7

Water Softener ........................................................................................................................................................... 7

Ozone Generator ........................................................................................................................................................ 7

Reverse Osmosis ....................................................................................................................................................... 7

Ozone Destructor ....................................................................................................................................................... 7

APPENDIX I: DEVIATION REPORT .......................................................................................................................................... 11

1.0 PURPOSE AND OBJECTIVE(S)

7.0 EQUIPMENT/PROCESS DESCRIPTION

6, 000 and 8, 000 Gal. Tanks

Distribution Pumps (4)

0.2 um filters (4)

Dual Reverse Osmosis unit

Dual Softener unit

Dual Mix Bed unit

Microza filters (18)

7.1 Water Softener

As per United States Pharmacopeia (USP) standards

APPENDIX I: DEVIATION REPORT

I/Q O/Q P/Q

Deviation reported by:_________________________________

Attach additional pages, if necessary

CORRECTIVE / PREVENTIVE ACTION

Evaluation performed by:____________________________________

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

APPENDIX II: SIGNATURE IDENTIFICATION LOG SHEET

APPENDIX III: TESTING INSTRUMENTS LOG SHEET

VERIFICATION DATA SHEETS

MAIN COMPONENT VERIFICATION

Actual results match expected results as per manufacturer written specifications

MAIN COMPONENT VERIFICATION

If NO, refer to Deviation # __________

MAIN COMPONENT VERIFICATION

If NO, refer to Deviation # __________

MAIN COMPONENT VERIFICATION

If NO, refer to Deviation # __________

MAIN COMPONENT VERIFICATION

If NO, refer to Deviation # __________

MAIN COMPONENT VERIFICATION

If NO, refer to Deviation # __________

MAIN COMPONENT VERIFICATION

If NO, refer to Deviation # __________

MAIN COMPONENT VERIFICATION

If NO, refer to Deviation # __________

MAIN COMPONENT VERIFICATION

If NO, refer to Deviation # __________

MAIN COMPONENT VERIFICATION

Dual Softener unit (Brine Tank)

If NO, refer to Deviation # __________

MAIN COMPONENT VERIFICATION

If NO, refer to Deviation # __________

MAIN COMPONENT VERIFICATION

If NO, refer to Deviation # __________

MAIN COMPONENT VERIFICATION