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 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 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.

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 & 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


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:



SPEC

EXPECTED RESULT

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE

2A


2B






SPEC

EXPECTED RESULT

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE

3A


3B






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





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





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. Comments/Observations:




IQ-01 Ozone Destructor

SPEC

EXPECTED RESULT

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE


UV light

Tag ID Manufacturer Model Serial No. Comments/Observations:




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

Comments/Observations:




IQ-01

Dual Softener unit (Brine Tank) SPEC

EXPECTED RESULT

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE

Tag ID

Manufacturer

Model

Serial No. Comments/Observations:




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. Comments/Observations:




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






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. Comments/Observations:





SPEC

EXPECTED RESULT

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE

Tag ID

2A

Manufacturer

Model

Serial No.

Tag ID

2B

Manufacturer

Model





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




EQUIPMENT VERIFICATION


SPEC

EXPECTED RESULT

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE

Tag ID

2A

Manufacturer

Model

Serial No.

Tag ID

2B

Manufacturer

Model





IQ-01

Dual Reverse Osmosis (Service unit A) SPEC

EXPECTED RESULT

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE


Feed Pump


Control Panel

Antiscalant Dosing System

Serial No. Tag ID Manufacturer Model Serial No. Manufacturer Model





IQ-01

Dual Reverse Osmosis (Service unit B) SPEC

EXPECTED RESULT

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE


Feed Pump


Control Panel

Antiscalant Dosing System

Serial No. Tag ID Manufacturer Model Serial No. Manufacturer Model





IQ-01

Dual R.O. unit (Cleaning Skid) SPEC

EXPECTED RESULT

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE


Cleaning Pump





IQ-01 De-gasification unit

SPEC

EXPECTED RESULT

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE

Tag ID

Manufacturer

Model

Serial No.

Pump





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





IQ-01

Microza “ultra filtration” filters SPEC

EXPECTED RESULT

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE

Tag ID

Manufacturer

Part No.




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 References Required: •

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


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 & ID’s

Other Documents


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:


IQ-02




PERFORMED BY/DATE


Purchase Order

Drawings

P & ID’s

Other Documents



Date:


IQ-02




PERFORMED BY/DATE


Purchase Order

Drawings

P & ID’s

Other Documents



Date:


IQ-02




PERFORMED BY/DATE


Purchase Order

Drawings

P & ID’s

Other Documents




Date:

IQ-02




PERFORMED BY/DATE


Purchase Order

Drawings

P & ID’s

Other Documents




Date:

IQ-02




PERFORMED BY/DATE


Purchase Order

Drawings

P & ID’s

Other Documents



Date:


IQ-02

Dual Softener unit DOCUMENT TYPE



PERFORMED BY/DATE

Installation and Operation Manual Purchase Order

Electrical Drawings Mechanical Drawings

P & ID’s PLC Software Backup & Report MSDS

Other Documents Comments/Observations:


Date:



DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Drawings

P & ID’s

Other Documents



Date:


IQ-02

Distribution Pumps (1A, 1B) DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Electrical Drawings

Mechanical Drawings

P & ID’s

Other Documents



Date:



DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Drawings

P & ID’s

Other Documents



Date:


IQ-02

Distribution Pumps (2A, 2B) DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Electrical Drawings

Mechanical Drawings

P & ID’s

Other Documents



Date:


IQ-02

Ozone Generator DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Electrical Drawings

Mechanical Drawings

P & ID’s

PLC Software Backup & Report



Date:


IQ-02

Ozone Destructor DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Electrical Drawings

P & ID’s


Other Documents



Date:


IQ-02

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



PERFORMED BY/DATE


Purchase Order

Electrical Drawings

P & ID’s

Other Documents



Date:


IQ-02

Dual Reverse Osmosis unit DOCUMENT TYPE



PERFORMED BY/DATE

Installation and Operation Manual Purchase Order

Electrical Drawings Mechanical Drawing

P & ID’s PLC Software Backup & Report MSDS



Date:


IQ-02

Degasification unit DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Electrical Drawings

Mechanical Drawings

P & ID’s



Date:


IQ-02

Dual Mixed Bed unit DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Electrical Drawings

P & ID’s


Other Documents



Date:


IQ-02

Microza “ultra filtration” filters DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Electrical Drawings

P & ID’s

Other Documents



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 References Required: •

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


IQ-03 Sheet ______ of ______ Use additional pages as necessary

DRAWING TYPE & ID

TITLE & REVISION

REDLINED? (YES/NO)

UPDATE? (DWG, FLD, NA)

PERFORMED 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” References Required: • • •

P & ID’s Material Safety Data Sheets Chemical Analysis Sheets


Actual results match expected results as per Purified Water specifications

SYSTEM DESIGN VERIFICATION 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.




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

References Required: •

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





IQ-05 SKID #2 - Filter set 2A, 2B

SPEC

EXPECTED RESULT

Position


Environment


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE





IQ-05

SKID #3 - Distribution Pumps 1A, 1B; UV lamps 1A, 1B & Filter set 3A, 3B SPEC

EXPECTED RESULT

Position


Environment


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE





IQ-05 SKID #4 - R. O. Piping/Valves

SPEC

EXPECTED RESULT

Position


Environment


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE





IQ-05 SKID 5 - Pumps 2A, 2B

SPEC

EXPECTED RESULT

Position


Environment


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE





IQ-05 SKID 6 - UV lamps 2A, 2B & Filter 4A, 4B

SPEC

EXPECTED RESULT

Position


Environment


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE





IQ-05 SKID 7 - Filter set 5A, 5B

SPEC

EXPECTED RESULT

Position


Environment


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE





IQ-05

Water Softener Skid SPEC

EXPECTED RESULT

Position


Environment


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE





IQ-05

Ozone Generator Skid SPEC

EXPECTED RESULT

Position


Environment


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE





IQ-05 Ozone Destructor Skid

SPEC

EXPECTED RESULT

Position


Environment


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE





IQ-05

R.O. Skid SPEC

EXPECTED RESULT

Position


Environment


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE





IQ-05

R.O. Cleaning Skid SPEC

EXPECTED RESULT

Position


Environment


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE



UTILITY VERIFICATION Objective:


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 Electrician’s license and ensure it is up to date Note: All readings will apply a ±10% tolerance References Required: •

Test Instruments calibration certificates

•

Copy of Electrician’s license


Utilities comply with expected results (manufacturer specifications)

•

All calibrations/certifications are up to date

UTILITY VERIFICATION


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 Comments/Observations:




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

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

Compressed Air

90-110 psig

License Number: ___________________________

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE






ELECTRICAL SPECS

EXPECTED RESULT

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE

Voltage Phase Amperage Frequency Panel ID Bulb installation To be filled by a licensed electrician or electrical engineer with PE license


License Number: ____________________________






ELECTRICAL SPECS

EXPECTED RESULT

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE



License Number: ____________________________






ELECTRICAL SPECS

EXPECTED RESULT

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE



License Number: ___________________________






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


License Number: ___________________________






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


License Number: ___________________________





IQ-06 Dual Reverse Osmosis unit

ELECTRICAL SPECS

EXPECTED RESULT

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE

1

Voltage

2

Voltage

1

Unit A

Phase

2

Phase

1

Amperage

2

Amperage

Frequency Panel ID 1

Voltage

2

Voltage

1

Unit B

Phase

2

Phase

1

Amperage

2

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

Compressed Air

80-110 psig


License Number: _____________________________

ACTUAL RESULT

1

PASS/FAIL

PERFORMED BY/DATE

Assembly power to assembly panel (PLC) 2 Plant power to assembly power




IQ-06 Dual Reverse Osmosis unit (Cleaning Skid)

ELECTRICAL SPECS

EXPECTED RESULT

ACTUAL RESULT

PASS/FAIL

PERFORME D BY/DATE


Does electrical installation comply with NEC standards? (YES/NO) _______________ Electrician signature: ____________________________ OTHER SPECS

EXPECTED RESULT

License Number: _________________________

ACTUAL RESULT

PASS/FAIL

PERFORME D BY/DATE

Chemicals Comments/Observations:




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


ADS Pump



License Number: ____________________________





IQ-06

Degasification unit ELECTRICAL SPECS

EXPECTED RESULT

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE

Degas Panel


Vacuum Pump



EXPECTED RESULT

License Number: _____________________________

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE

Compressed Air Comments/Observations:





ELECTRICAL SPECS

EXPECTED RESULT

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE



EXPECTED RESULT

License Number: ____________________________

ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE

Compressed Air (control panel)

Clean Compressed Air (MB column)

Chemicals Comments/Observations:



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 References Required: Acceptance Criteria: •

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




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 References Required: •

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






SPEC

EXPECTED RESULT

PMP


Spare Parts


Lubricants


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE






SPEC

EXPECTED RESULT

PMP


Spare Parts


Lubricants


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE






SPEC

EXPECTED RESULT

PMP


Spare Parts


Lubricants


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE






SPEC

EXPECTED RESULT

PMP


Spare Parts


Lubricants


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE






SPEC

EXPECTED RESULT

PMP


Spare Parts


Lubricants


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE






SPEC

EXPECTED RESULT

PMP


Spare Parts


Lubricants


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE






SPEC

EXPECTED RESULT

PMP


Spare Parts


Lubricants


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE






SPEC

EXPECTED RESULT

PMP


Spare Parts


Lubricants


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE






SPEC

EXPECTED RESULT

PMP


Spare Parts


Lubricants


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE






SPEC

EXPECTED RESULT

PMP


Spare Parts


Lubricants


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE





IQ-08

Distribution Pumps (2A, 2B) SPEC

EXPECTED RESULT

PMP


Spare Parts


Lubricants


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE





IQ-08

UV lamps (1A, 1B) SPEC

EXPECTED RESULT

PMP


Spare Parts


Lubricants


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE






SPEC

EXPECTED RESULT

PMP


Spare Parts


Lubricants


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE






SPEC

EXPECTED RESULT

PMP


Spare Parts


Lubricants


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE





IQ-08 De-gasification unit

SPEC

EXPECTED RESULT

PMP


Spare Parts


Lubricants


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE






SPEC

EXPECTED RESULT

PMP


Spare Parts


Lubricants


ACTUAL RESULT

PASS/FAIL

PERFORMED BY/DATE





IQ-08 Microza “ultra filtration” filters

SPEC

EXPECTED RESULT

PMP


Spare Parts


Lubricants


ACTUAL RESULT

PASS/FAIL

PERFORMED 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

References Required: •

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.




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 References Required: •

SOP’s (at least in DRAFT form)


Draft procedures are available for each main component of the Purified Water System.



SOP

EXPECTED RESULT

Operating Procedure

A procedure exists at least in Draft form.

Maintenance Procedure


ACTUAL RESULT (DOC. NO., REV. NO., TITLE, STATUS)

PASS/FAIL

PERFORMED BY/DATE





IQ-10 Filter 2A & 2B

SOP

EXPECTED RESULT

Operating Procedure





PASS/FAIL

PERFORMED BY/DATE






SOP

EXPECTED RESULT

Operating Procedure





PASS/FAIL

PERFORMED BY/DATE






SOP

EXPECTED RESULT

Operating Procedure





PASS/FAIL

PERFORMED BY/DATE






SOP

EXPECTED RESULT

Operating Procedure





PASS/FAIL

PERFORMED BY/DATE






SOP

EXPECTED RESULT

Operating Procedure





PASS/FAIL

PERFORMED BY/DATE






SOP

EXPECTED RESULT

Operating Procedure





PASS/FAIL

PERFORMED BY/DATE






SOP

EXPECTED RESULT

Operating Procedure





PASS/FAIL

PERFORMED BY/DATE






SOP

EXPECTED RESULT

Operating Procedure





PASS/FAIL

PERFORMED BY/DATE






SOP

EXPECTED RESULT

Operating Procedure





PASS/FAIL

PERFORMED BY/DATE






SOP

EXPECTED RESULT

Operating Procedure





PASS/FAIL

PERFORMED BY/DATE






SOP

EXPECTED RESULT

Operating Procedure





PASS/FAIL

PERFORMED BY/DATE





IQ-10 UV lamps (1A, 1B, 2A, 2B)

SOP

EXPECTED RESULT

Operating Procedure





PASS/FAIL

PERFORMED BY/DATE






SOP

EXPECTED RESULT

Operating Procedure





PASS/FAIL

PERFORMED BY/DATE





IQ-10 Degasification unit

SOP

EXPECTED RESULT

Operating Procedure





PASS/FAIL

PERFORMED BY/DATE





IQ-10

Dual Mixed Bed unit SOP

EXPECTED RESULT

Operating Procedure





PASS/FAIL

PERFORMED BY/DATE





IQ-10 Microza “ultra filtration” filters

SOP

EXPECTED RESULT

Operating Procedure





PASS/FAIL

PERFORMED 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


IQ-03


IQ-04

SYSTEM DESIGN VERIFICATION

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)

IQ Purified Water

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