iq purified water

INSTALLATION QUALIFICATION PROTOCOL

For the

NEW PURIFIED WATER SYSTEM

Prepared by

____________________________________

TABLE OF CONTENTS 1.0 PURPOSE AND OBJECTIVE(S) .................................................................................................................................... 4

2.0 BACKGROUND .............................................................................................................................................................. 4

3.0 SCOPE ........................................................................................................................................................................... 4

4.0 REFERENCES ............................................................................................................................................................... 4

5.0 RESPONSABILITIES ...................................................................................................................................................... 5

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

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

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

6.0 METHODOLOGY ............................................................................................................................................................ 6

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

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

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

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

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

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

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

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

7.4 Mixed Bed................................................................................................................................................................... 7

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

7.6 De-gasifier .................................................................................................................................................................. 8

7.7 UV light ....................................................................................................................................................................... 8

7.8 Filter ........................................................................................................................................................................... 8

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

APPENDIX II: SIGNATURE IDENTIFICATION LOG SHEET .................................................................................................... 12

APPENDIX III: TESTING INSTRUMENTS LOG SHEET ........................................................................................................... 13

IQ-01 EQUIPMENT VERIFICATION .......................................................................................................................................... 15

IQ-02 DOCUMENT INVENTORY VERIFICATION .................................................................................................................... 37

IQ-03 DRAWING VERIFICATION .............................................................................................................................................. 56

IQ-04 SYSTEM DESIGN VERIFICATION .................................................................................................................................. 58

IQ-05 PLACEMENT VERIFICATION ......................................................................................................................................... 60

IQ-06 UTILITY VERIFICATION .................................................................................................................................................. 67

IQ-07 INSTRUMENTATION VERIFICATION ............................................................................................................................. 86

IQ-08 MAINTENANCE VERIFICATION ..................................................................................................................................... 88

IQ-09 SAFETY & ERGONOMICS VERIFICATION .................................................................................................................. 107

IQ-10 PROCEDURE VERIFICATION ...................................................................................................................................... 109

IQ CHECKLIST VERIFICATION .............................................................................................................................................. 127

REVISION HISTORY

Revision Description of change Date

1.0 PURPOSE AND OBJECTIVE(S) This protocol (___) intends to provide documented evidence that the new Purified Water System was installed according to manufacturer’s specifications and ___ ___ requirements.

This Installation Qualification will provide documented evidence that all key aspects of the Purified Water System equipment’s assembly and its auxiliary systems is as intended by manufacturer design and in accordance to ___’s requirements.

At the end of the execution activities, a final report will be developed with a summary of the executed tests results and the recommendation(s) necessary for the Installation Qualification.

Potential risks involved with the new Purified Water System installation when connected to the manufacturing processes has already being evaluated by Risk Assessment PLS 0410.

2.0 BACKGROUND In order to meet the new purified water utility demands at ___ I in ___ ___, ___ ___, a new purified water system was purchased to replace the existing system. It is expected that this new purified water system will increase the supply to up to 100 GPM. Additionally, it is intended to produce a water quality that meets or exceeds current Purified Water USP and EP standards.

3.0 SCOPE This protocol applies to the new equipment and auxiliary components that constitute the Purified Water System, installed at ___ in ___ ___, ___ ___

4.0 REFERENCES

• FDA’s Office of Regulatory Affairs: “Guide To Inspections of High Purity Water Systems”

5.0 RESPONSABILITIES 5.1 Validation Specialist

• Prepare the documents that are applicable to the Validation exercise • Coordinate efforts and resources, along with Facilities Dept., to perform the Validation

exercise • Execute and collect the verification data for the Validation protocol • Verify data against Acceptance Criteria and initiate deviation, as applicable • Investigate, justify, and correct any deviation encountered during Validation execution • Prepare validation Final Report

5.2 Quality Dept. • Evaluate with the originator the extent of the validation required • Review and approve documents for the validation exercise • Review and approve validation activities for compliance and adherence to ___’s policies,

practices, and procedures • Check that the collected data meets the acceptance criteria and that all the deviations (if

applicable) are properly resolved • Once executed, review any deviations generated to confirm that investigation and

resolutions are complete • Cooperate with Validation Specialist to investigate, justify, and correct any deviation

encountered during Validation execution • Review and approve Final Report • Maintain original validation documentation, except for drawings and equipment manuals

that will remain in the equipment information files • Store the Validation Package in a designated filing area

5.3 Facility Dept. • Review and approve documents for the validation exercise • Coordinate efforts and resources to perform the validation activities • Supply documentation and tools needed for the protocol execution • Provide training in this protocol to all employees involved (internal and external) during the

execution of this protocol and ensure that all signatures are collected on Signature Log Sheet

• Assist to document, investigate, justify, and correct any deviation encountered during the IQ protocol execution

• Review and approve validation Final Report • Provide technical support for trouble shooting during the execution

6.0 METHODOLOGY 6.1 Verification Data Sheet

All data resulting from test execution will be entered in Verification Data Sheets that will pre-define the objective(s) to be attained with the verification, the procedure that will be followed to reach such objective(s), the reference material to be used, and the criteria to evaluate as to accept or not the testing results. All data entry will be properly signed and dated by the executor in the “Performed By” and “Date” spaces. In cases where a Field Verification is requested, a “Fail” condition will be applied to unverifiable information. The comments/observations section included in each Data Collection Form will be used to describe any additional information considered of importance for describing the validated condition and/or discrepancies and resolution activities produced during the execution. The comments/observations included must be signed or initialed and dated. When the test execution is finished, a subject matter expert will sign and date on the “Reviewed by” and “Date” spaces respectively, to state the completeness and correctness of the data.

6.2 Deviation Report The following deviations must be documented using the Deviation Report Form attached to this protocol: • Results invalidated and/or not in compliance with their pre-established Acceptance Criteria • Testing procedure and/or sampling plan not followed or that could not be completed as

planned These deviations will be handled as per ___ ___ PR

The investigation process due to deviated sampling results will be handled by contract laboratory, following their own investigation procedures. These incidents will be informed to who oversees the validation project in ___ ___, ___ PR, which in turn will open a deviation report to follow the lifecycle of the investigation and to implement any possible changes due to investigation resolution. Typographic, text edit and syntax errors will be documented as such in the “Comments” section under the corresponding test script, and considered as a minor issue that may not invalidate a test or become cause for writing a deviation report. These will be explained in the Final Report.

6.3 Signature Log Sheet Each individual who signs or initials any page included in this protocol shall be identified using the Signature Log Sheet by type/printed name, full signature, written initials and department represented.

6.4 Test Instruments Calibration All testing equipment used during for the execution shall be currently calibrated with documented evidence of its “up to date” calibration status. Copies of the calibration certificates shall be attached to the protocol and referred to the applicable test script.

7.0 EQUIPMENT/PROCESS DESCRIPTION Purified Water▲ is water obtained by distillation, ion-exchange treatment, reverse osmosis, and other suitable processes. It is prepared from water complying with the regulations of U.S. Environmental Protection Agency (EPA) with respect to drinking water. It contains no added substances.

The Purified Water system includes the following equipment, along with associated components:

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

• 1 um filters (4) • Distribution Pumps (4)

• 0.2 um filters (4) • Dual Reverse Osmosis unit

• Dual Softener unit • Dual Mix Bed unit

• Ozone Generator • UV lamps (4)

• Ozone Destructor • Degasification unit

• Microza filters (18)

7.1 Water Softener The Water Softener reduces the levels of calcium and other scale creating elements from the process stream. Water softeners also remove aluminum, copper and other trace metals. The removal process occurs by ion exchange. The softener vessel is filled with sodium form cation resin. The calcium, magnesium, barium, strontium, and other ions removed by the resin are replaced with sodium ions. The cation resin has a fixed capacity for ion removal and must be regenerated when that capacity has been exhausted.

7.2 Ozone Generator The Ozone Generator is employed to produce the Ozone used to sanitize the Softened Water that passes through to the 6,000 Gallon Tank.

7.3 Reverse Osmosis The Reverse Osmosis unit processes water by means of semi-permeable membranes, which allow pressurized water to freely pass through the membranes, but almost totally reject dissolved and suspended substances in the feed water.

7.4 Mixed Bed The Mixed Bed de-mineralizes water by using the ion exchange process. The influent water passes through a bed of Cation and Anion resin that are intimately mixed. The mixed bed configuration functions similarly to a two-bed configuration in regards to the ion exchange process; however, it is much more efficient and therefore produces water of much greater purity.

7.5 Ozone Destructor The Ozone Destructor employs ultraviolet light to reduce the ozone level to a safe preset level before exiting the skid to the Service Points of Use. Ozone reduction is done by breakage of the O3 bonds at the ultraviolet spectrum.

▲As per United States Pharmacopeia (USP) standards

7.6 De-gasifier De-gasifier membranes are employed to reduce the oxygen level of the water. Membrane contactors make it possible to transfer gas from an aqueous stream without dispersion. By virtue of surface tension, the water on one side of the membrane is exposed to the gas side of the membrane with no liquid transfer, providing a large surface area for gas/liquid contact and transfer. Dissolved O2 passes from the water surface into the gas side by diffusion and is swept out by a combined vacuum/air flow.

7.7 UV lights Ultraviolet lamps produce UV-C (germicidal UV), which is a radiation that when harmful microbes are exposed to the UV rays, scrambles the DNA structure of the organism, rendering it sterile and can no longer reproduce. Almost all of a UV lamp’s output is concentrated in the 254 nanometers (nm) region in order to take full advantage of the germicidal properties of this wavelength. The lamp is mounted such that water passing through a flow chamber is exposed to the UV-C light rays.

7.8 Filters At the first stage, the raw water enters a 30 µm pre-filter to trap any heavy sediment before it enters the softeners. The 1 µm filters will act as a resin trap and removes suspended from the softeners. The absolute 0.2 micron rated filters significantly enhances the water quality with its capacity to remove the majority of microorganisms. The Microza ultra filters that are at the end of the purified water system uses fiber hollow technology that will remove endotoxins and viruses.

7.9 Distribution Pumps Two pairs of distribution pumps will provide constant flow of the processed water throughout the Purified Water System pipelines. Although its functionality will not contribute directly to the processing of Purified Water, by providing a constant flow will indeed significantly reduce the chances of microbial growth due to stagnant water.

7.10 Tanks Two storage tanks will provide storage capacity to the Purified Water System. A 6,000 gallon tank will store ozone-treated softened water that will supply constant feed to the dual R.O. unit, while an 8,000 gallon tank will store water post reverse osmosis and de-ozonization treatment, which will supply constant feed to the main loop.

With this configuration in place, a Purified Water (USP, EP) quality is intended to be achieved through the following processes: • Filtration (by means of 30 um filters, 1 um filters, 0.2 um filters, and R.O. Unit, and “Microza” filters) • Ion exchange (by means of Softener and Mix Bed) • Sanitation (by means of Ozone Injection and UV light radiation) • Degasification (by means of a de-gasifier unit)

APPENDICES

DEVIATION DESCRIPTION

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 I: DEVIATION REPORT

Deviation Number: _________________

Test Description/Test Number:

Deviation Area: □ I/Q □ O/Q □ P/Q

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.)

Pr

a. Per equipment, collect and document the required information thru physical inspection (tag, engrave, plate, sticker, etc)

ocedure:

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

MAIN COMPONENT VERIFICATION 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

1B

Tag ID


Cartridge Part No.


Housing Part No.

Quantity

Comments/Observations:

Conformance to the acceptance criteria was evaluated and the final determination is as follows: Acceptance Criteria met? (YES/NO) __________ If NO, refer to Deviation # __________

Reviewed by: Date:


Filter set 2A & 2B


BY/DATE

2A

Tag ID


Cartridge Part No.


Housing Part No.

Quantity

2B

Tag ID


Cartridge Part No.


Housing Part No.

Quantity



Reviewed by: Date:


Filter set 3A & 3B


BY/DATE

3A

Tag ID


Cartridge Part No.


Housing Part No.

Quantity

3B

Tag ID


Cartridge Part No.


Housing Part No.

Quantity



Reviewed by: Date:


Filter set 4A & 4B


BY/DATE

4A

Tag ID


Cartridge Part No.


Housing Part No.

Quantity

4B

Tag ID


Cartridge Part No.


Housing Part No.

Quantity



Reviewed by: Date:


Filter set 5A & 5 B


BY/DATE

5A

Tag ID


Cartridge Part No.


Housing Part No.

Quantity

5B

Tag ID


Cartridge Part No.


Housing Part No.

Quantity



Reviewed by: Date:


Ozone Generator


BY/DATE

Tag ID

Manufacturer

Model

Serial No.

Boo

ster

pum

p

Tag ID

Manufacturer

Model

Serial No.

Rec

ircul

atio

n pu

mp Tag ID

Manufacturer

Model

Serial No.



Reviewed by: Date:


Ozone Destructor


BY/DATE

Tag ID

Manufacturer

Model

Serial No.

UV

light

Tag ID

Manufacturer

Model

Serial No.



Reviewed by: Date:


Dual Softener unit


BY/DATE

Uni

t A

Tag ID

Manufacturer

Model

Serial No.

Uni

t B

Tag ID

Manufacturer

Model

Serial No.

Con

trol

Pan

el Manufacturer

Model

Res

in

Type



Reviewed by: Date:


Dual Softener unit (Brine Tank)


BY/DATE

Tag ID

Manufacturer

Model

Serial No.



Reviewed by: Date:


6,000 Gal. Tank


BY/DATE

Tag ID

Manufacturer

Description

Vent

Filt

er


Cartridge Part No.


Housing Part No.

Leve

l Manufacturer

Part No.



Reviewed by: Date:


Distribution Pumps (1A, 1B)


BY/DATE

1A

Tag ID

Manufacturer

Model

Serial No.

2A

Tag ID

Manufacturer

Model

Serial No.



Reviewed by: Date:


8,000 Gal. Tank


BY/DATE

Tag ID

Manufacturer

Description

Vent

Filt

er


Cartridge Part No.


Housing Part No.

Leve

l Manufacturer

Part No.



Reviewed by: Date:




BY/DATE

2A

Tag ID

Manufacturer

Model

Serial No.

2B

Tag ID

Manufacturer

Model

Serial No.



Reviewed by: Date:


UV lamps (1A, 1B)


BY/DATE

1A

Tag ID

Manufacturer

Model

Serial No.

1B

Tag ID

Manufacturer

Model

Serial No.



Reviewed by: Date:

EQUIPMENT VERIFICATION IQ-01

UV lamps (2A, 2B)


BY/DATE

2A

Tag ID

Manufacturer

Model

Serial No.

2B

Tag ID

Manufacturer

Model

Serial No.



Reviewed by: Date:


Dual Reverse Osmosis (Service unit A)

SPEC EXPECTED RESULT ACTUAL RESULT PASS/FAIL PERFORMED BY/DATE

Tag ID

Manufacturer

Model

Serial No.

Feed

Pum

p

Tag ID

Manufacturer

Model

Serial No.

Ant

isca

lant

Dos

ing

Syst

em

Tag ID

Manufacturer

Model

Serial No.

Con

trol

Pan

el

Manufacturer

Model



Reviewed by: Date:


Dual Reverse Osmosis (Service unit B)


Tag ID

Manufacturer

Model

Serial No.

Feed

Pum

p

Tag ID

Manufacturer

Model

Serial No.

Ant

isca

lant

Dos

ing

Syst

em

Tag ID

Manufacturer

Model

Serial No.

Con

trol

Pan

el

Manufacturer

Model



Reviewed by: Date:


Dual R.O. unit (Cleaning Skid)


Tag ID

Manufacturer

Model

Serial No.

Cle

anin

g Pu

mp

Tag ID

Manufacturer

Model

Serial No.



Reviewed by: Date:


De-gasification unit


BY/DATE

Tag ID

Manufacturer

Model

Serial No.

Pum

p

Tag ID

Manufacturer

Model

Serial No.



Reviewed by: Date:


Dual Mixed Bed unit


BY/DATE

Uni

t A

Tag ID

Manufacturer

Model

Serial No.

Uni

t B

Tag ID

Manufacturer

Model

Serial No.

Con

trol

Pan

el Manufacturer

Model

Aci

d &

C

aust

ic

Type



Reviewed by: Date:


Microza “ultra filtration” filters


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

Pr

a. Per equipment, collect all related documentation

ocedure:

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

DOCUMENT INVENTORY VERIFICATION 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:


Filter set 2A & 2B

DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Drawings

P & ID’s

Other Documents



Reviewed by: Date:


Filter set 3A & 3B

DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Drawings

P & ID’s

Other Documents



Reviewed by: Date:

Filter set 4A & 4B

DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Drawings

P & ID’s

Other Documents



Reviewed by: Date:


Filter set 5A & 5B

DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Drawings

P & ID’s

Other Documents



Reviewed by: Date:


Dual Softener unit

DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Electrical Drawings

Mechanical Drawings

P & ID’s

PLC Software Backup &

Report

MSDS

Other Documents



Reviewed by: Date:


6,000 Gal. Tank

DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Drawings

P & ID’s

Other Documents



Reviewed by: Date:



DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Electrical Drawings

Mechanical Drawings

P & ID’s

Other Documents



Reviewed by: Date:


8,000 Gal. Tank

DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Drawings

P & ID’s

Other Documents



Reviewed by: Date:



DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Electrical Drawings

Mechanical Drawings

P & ID’s

Other Documents



Reviewed by: Date:


Ozone Generator

DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Electrical Drawings

Mechanical Drawings

P & ID’s


Report

Other Documents



Reviewed by: Date:


Ozone Destructor

DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Electrical Drawings

P & ID’s


Report

Other Documents



Reviewed by: Date:


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

DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Electrical Drawings

P & ID’s

Other Documents



Reviewed by: Date:


Dual Reverse Osmosis unit

DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Electrical Drawings

Mechanical Drawing

P & ID’s


Report

MSDS

Other Documents



Reviewed by: Date:


Degasification unit

DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Electrical Drawings

Mechanical Drawings

P & ID’s

Other Documents



Reviewed by: Date:


Dual Mixed Bed unit

DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Electrical Drawings

P & ID’s


Report

Other Documents



Reviewed by: Date:



DOCUMENT TYPE



PERFORMED BY/DATE


Purchase Order

Electrical Drawings

P & ID’s

Other Documents



Reviewed by: Date:

DRAWING VERIFICATION IQ-03 Objective:

• Assure concordance between drawings (P & I D’s and Electrical Schematics, etc.) and field installation of the Purified Water System

Pr

a. Collect and document the drawings found thru IQ - 02: “Document Inventory Verification”

ocedure:

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

DRAWING VERIFICATION 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

Pr

• Verify system installation as per specifications by performing a physical verification and/or providing documented evidence

ocedure:

• Document findings and evaluate against expected results

Note: This verification is best performed during “Drawing Verification”


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


• Actual results match expected results as per Purified Water specifications

SYSTEM DESIGN VERIFICATION IQ-04


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.

Piping

Piping will provide constant circulation of Purified water.

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).

Contact material

All material in direct contact shall be non-reactive to Purified Water.



Reviewed by: Date:

PLACEMENT VERIFICATION IQ-05 Objective:

• Assure that the equipments have the appropriate conditions to perform setup and maintenance and to operate accordingly.

Pr

• Per equipment, verify field conditions by performing a physical inspection as per expected results

ocedure:

• Document and evaluate findings against expected results


• Skid Drawings


• Actual results match expected results as per ___ requirements

PLACEMENT VERIFICATION IQ-05

SKID #1 - Filter Set 1A, 1B


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.



Reviewed by: Date:


SKID #2 - Filter set 2A, 2B








Reviewed by: Date:


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








Reviewed by: Date:


SKID #4 - R. O. Piping/Valves








Reviewed by: Date:


SKID 5 - Pumps 2A, 2B








Reviewed by: Date:


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








Reviewed by: Date:


SKID 7 - Filter set 5A, 5B








Reviewed by: Date:


Water Softener Skid








Reviewed by: Date:


Ozone Generator Skid








Reviewed by: Date:


Ozone Destructor Skid








Reviewed by: Date:


R.O. Skid








Reviewed by: Date:


R.O. Cleaning Skid








Reviewed by: Date:

UTILITY VERIFICATION IQ-06 Objective:

• Assure that the installed utility meets the Purified Water System requirements

Pr

• Utility Verification

ocedure:

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 Acceptance Criteria:

• Utilities comply with expected results (manufacturer specifications)

• All calibrations/certifications are up to date

UTILITY VERIFICATION 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: ____________________________ License Number: ____________________________

OTHER SPECS EXPECTED RESULT ACTUAL RESULT PASS/FAIL PERFORMED BY/DATE

Compressed Air

Chemical



Reviewed by: Date:


Ozone Generator

ELECTRICAL SPECS

EXPECTED RESULT ACTUAL RESULT PASS/FAIL PERFORMED

BY/DATE

OZ-

1

Voltage Phase

Amperage Frequency Panel ID

P-O

Z1

Voltage Phase


P-O

Z2

Voltage Phase


Tran

sfor

mer

Voltage Phase

Amperage

Frequency


Electrician signature: ___________________________ License Number: ___________________________

OTHER SPECS EXPECTED RESULT ACTUAL RESULT PASS/FAIL PERFORMED

BY/DATE

Compressed Air 90-110 psig



Reviewed by: Date:


Ozone Destructor


BY/DATE

Voltage

Phase

Amperage

Frequency

Panel ID

Bulb installation

To be filled by a licensed electrician or electrical engineer with PE license Does electrical installation comply with NEC standards? (YES/NO) _______________

Electrician signature: ____________________________ License Number: ____________________________



Reviewed by: Date:


UV lamps (1A, 1B)


BY/DATE

Voltage

Phase

Amperage

Frequency

Panel ID

Bulb installation


Electrician signature: ____________________________ License Number: ____________________________ Comments/Observations:


Reviewed by: Date:


UV lamps (2A, 2B)


BY/DATE

Voltage

Phase

Amperage

Frequency

Panel ID

Bulb installation


Electrician signature: ____________________________ License Number: ___________________________



Reviewed by: Date:




BY/DATE

Voltage

Phase

Amperage

Frequency

Panel ID


Electrician signature: ____________________________ License Number: ___________________________ Comments/Observations:


Reviewed by: Date:



ELECTRICAL SPECS


BY/DATE

Uni

t A

Voltage1

Voltage2

Phase1

Phase2

Amperage1

Amperage2

Frequency

Panel ID

Uni

t B

Voltage1 Voltage2

Phase1 Phase2

Amperage1

Amperage2 Frequency Panel ID


Electrician signature: ____________________________ License Number: _____________________________


Compressed Air 80-110 psig

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


Reviewed by: Date:


Dual Reverse Osmosis unit (Cleaning Skid)

ELECTRICAL SPECS EXPECTED RESULT ACTUAL RESULT PASS/FAIL PERFORME

D BY/DATE

Voltage

Phase

Amperage

Frequency


Electrician signature: ____________________________ License Number: _________________________


Chemicals



Reviewed by: Date:


Dual Reverse Osmosis unit (pumps)


BY/DATE

R.O

Fee

d Pu

mp

Voltage

Phase

Amperage

Frequency

Panel ID

R.O

. Cle

anin

g Pu

mp

Voltage

Phase

Amperage

Frequency

Panel ID

AD

S Pu

mp

Voltage

Phase

Amperage

Frequency

Panel ID

To be filled by a licensed electrician or electrical engineer with PE license Does electrical installation comply with NEC standards? (YES/NO) _______________ Electrician signature: ____________________________ License Number: ____________________________ Comments/Observations:


Reviewed by: Date:


Degasification unit

ELECTRICAL SPECS


BY/DATE

Deg

as P

anel

Voltage

Phase

Amperage

Frequency

Panel ID

Vacu

um P

ump

Voltage

Phase

Amperage

Frequency

Panel ID

To be filled by a licensed electrician or electrical engineer with PE license Does electrical installation comply with NEC standards? (YES/NO) _______________ Electrician signature: ___________________________ License Number: _____________________________

OTHER SPECS EXPECTED RESULT ACTUAL RESULT PASS/FAIL PERFORMED

BY/DATE

Compressed Air



Reviewed by: Date:


Dual Mixed Bed unit


BY/DATE

Voltage

Phase

Amperage

Frequency

Panel ID


Electrician signature: ___________________________ License Number: ____________________________


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

Pr

a. Inspect all instruments evaluated with the “Calibration Program Addition Form” and verify that all instruments installed at the Purified Water System were included

ocedure:

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

INSTRUMENTATION VERIFICATION 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

Pr

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

ocedure:

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” Acceptance Criteria:

• All equipment is included in a PM schedule

• All equipment has spare part list

• “Not applicable” lubricant requirements were properly explained

MAINTENANCE VERIFICATION IQ-08

Filter set 1A &1B


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.



Reviewed by: Date:


Filter set 2A & 2B


PMP


PM program.

Spare Parts


equipment.





Reviewed by: Date:


Filter set 3A & 3B


PMP


PM program.

Spare Parts


equipment.





Reviewed by: Date:


Filter set 4A & 4B


PMP


PM program.

Spare Parts


equipment.





Reviewed by: Date:


Filter set 5A & 5B


PMP


PM program.

Spare Parts


equipment.





Reviewed by: Date:


Dual Softener unit


PMP


PM program.

Spare Parts


equipment.





Reviewed by: Date:


Ozone Generator


PMP


PM program.

Spare Parts


equipment.





Reviewed by: Date:


Ozone Destructor


PMP


PM program.

Spare Parts


equipment.





Reviewed by: Date:


6,000 Gal. Tank


PMP


PM program.

Spare Parts


equipment.





Reviewed by: Date:


8,000 Gal. Tank


PMP


PM program.

Spare Parts


equipment.





Reviewed by: Date:




PMP


PM program.

Spare Parts


equipment.





Reviewed by: Date:


UV lamps (1A, 1B)


PMP


PM program.

Spare Parts


equipment.





Reviewed by: Date:


UV lamps (2A, 2B)


PMP


PM program.

Spare Parts


equipment.





Reviewed by: Date:




PMP


PM program.

Spare Parts


equipment.





Reviewed by: Date:


De-gasification unit


PMP


PM program.

Spare Parts


equipment.





Reviewed by: Date:


Dual Mixed Bed unit


PMP


PM program.

Spare Parts


equipment.





Reviewed by: Date:




PMP


PM program.

Spare Parts


equipment.





Reviewed by: Date:

SAFETY & ERGONOMICS VERIFICATION IQ-09 Objective:

• Assure that the Purified Water System complies with ___’s EHS Safety and Ergonomics requirements

Pr

• Collect documented evidence (i.e. EHS checklist) of EHS evaluation of the Purified Water System

ocedure:

• Document evaluation results and compare against expected results


• Evidence of EHS evaluation - EHS checklist, etc. Acceptance Criteria:

• EHS checklist is approved by EHS representative

SAFETY & ERGONOMICS VERIFICATION IQ-09


BY/DATE

PWS Safety & Ergonomics Compliance

EHS Change Management AWO column checklist was completed and approved.

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 Pr

a. Per equipment, collect and evaluate written procedures (i.e. operating, maintenance, cleaning) and document findings

ocedure:

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) Acceptance Criteria:

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

PROCEDURE VERIFICATION IQ-10

Filter set 1A & 1B

SOP EXPECTED RESULT

ACTUAL RESULT (DOC. NO., REV. NO., TITLE, STATUS) PASS/FAIL PERFORMED

BY/DATE

Operating Procedure

A procedure exists at least in

Draft form.

Maintenance Procedure


Draft form.



Reviewed by: Date:


Filter 2A & 2B

SOP EXPECTED RESULT


BY/DATE

Operating Procedure


Draft form.



Draft form.



Reviewed by: Date:


Filter set 3A & 3B

SOP EXPECTED RESULT


BY/DATE

Operating Procedure


Draft form.



Draft form.



Reviewed by: Date:


Filter set 4A & 4B

SOP EXPECTED RESULT


BY/DATE

Operating Procedure


Draft form.



Draft form.



Reviewed by: Date:


Filter set 5A & 5B

SOP EXPECTED RESULT


BY/DATE

Operating Procedure


Draft form.



Draft form.



Reviewed by: Date:


Dual Softener unit

SOP EXPECTED RESULT


BY/DATE

Operating Procedure


Draft form.



Draft form.



Reviewed by: Date:


Ozone Generator

SOP EXPECTED RESULT


BY/DATE

Operating Procedure


Draft form.



Draft form.



Reviewed by: Date:


Ozone Destructor

SOP EXPECTED RESULT


BY/DATE

Operating Procedure


Draft form.



Draft form.



Reviewed by: Date:



SOP EXPECTED RESULT


BY/DATE

Operating Procedure


Draft form.



Draft form.



Reviewed by: Date:


8,000 Gal. Tank

SOP EXPECTED RESULT


BY/DATE

Operating Procedure


Draft form.



Draft form.



Reviewed by: Date:


6,000 Gal. Tank

SOP EXPECTED RESULT


BY/DATE

Operating Procedure


Draft form.



Draft form.



Reviewed by: Date:


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

SOP EXPECTED RESULT


BY/DATE

Operating Procedure


Draft form.



Draft form.



Reviewed by: Date:



SOP EXPECTED RESULT


BY/DATE

Operating Procedure


Draft form.



Draft form.



Reviewed by: Date:

PROCEDURE VERIFICATION IQ-10 Degasification unit

SOP EXPECTED RESULT


BY/DATE

Operating Procedure


Draft form.



Draft form.



Reviewed by: Date:


Dual Mixed Bed unit

SOP EXPECTED RESULT


BY/DATE

Operating Procedure


Draft form.



Draft form.



Reviewed by: Date:



SOP EXPECTED RESULT


BY/DATE

Operating Procedure


Draft form.



Draft form.



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)

ACCEPTANCE CRITERIA

MET? (YES/NO)

DEVIATION NUMBER

(if applies)

DEVIATION SOLVED

(YES/NO)

IQ-01 EQUIPMENT VERIFICATION

IQ-02 DOCUMENT INVENTORY VERIFICATION

IQ-03 DRAWING VERIFICATION

IQ-04 SYSTEM DESIGN VERIFICATION

IQ-05 PLACEMENT VERIFICATION

IQ-06 UTILITY VERIFICATION

IQ-07 INSTRUMENTATION VERIFICATION

IQ-08 MAINTENANCE VERIFICATION

IQ-09 SAFETY AND ERGONOMICS VERIFICATION

IQ-10 PROCEDURE VERIFICATION

Performed by: Date: