Validation Protocol Temp

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VALIDATION PROTOCOL
DRAFT Date: 5/2/23 12:18 PM : Validation Protocol Template for LinkedIn.doc

Title: Installation and Operational Qualification (IQ/OQ) Doc No.: Vx-XXXXX Page: 1 of 63
“Boilerplate Template”, Identification Number
The undersigned individuals have reviewed the protocol and concur with the approach to validation.
APPROVAL
SIGNATURE DATE
Name – Author
Title, Department
Name
Title, Department
Name
Title, Quality Assurance
Name
Title, Validation
The undersigned individuals have reviewed and approved the executed protocol.
POST-EXECUTION APPROVAL
SIGNATURE DATE
Name – Author
Title, Department
Name
Title, Department
Name
Title, Quality Assurance
Name
Title, Validation
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TABLE OF CONTENTS
1 Purpose ........................................................................................................................................................... 4
2 Scope ............................................................................................................................................................... 4
3 Responsibilities .............................................................................................................................................. 4
4 Equipment/System Description .................................................................................................................... 5

4.1 Location and Detailed Description .................................................................................................................... 5
4.2 Utility Requirements ......................................................................................................................................... 5
5 Installation Qualification (IQ) Verification ................................................................................................ 5
5.1 Signature Verification List (Attachment 1) ....................................................................................................... 5
5.2 Standard Operating and Preventive Maintenance Procedures (Attachment 2) .................................................. 5
5.3 Equipment/System Calibration Documentation (Attachment 3) ....................................................................... 6
5.4 Test Equipment and Calibration Documentation (Attachment 4) ..................................................................... 6
5.5 Documentation and Drawings (Attachment 5) .................................................................................................. 6
5.6 Utilities and Services (Attachment 6) ............................................................................................................... 7
5.7 Installation Check (Attachment 7) .................................................................................................................... 7
5.8 Electrical Checks (Attachment 8)...................................................................................................................... 7
5.9 Mechanical Checks (Attachment 9) .................................................................................................................. 7
5.10 Control System (Attachment 10) ....................................................................................................................... 7
5.11 Consumables (Attachment 11) .......................................................................................................................... 9
6 Operational Qualification (OQ) Verification .............................................................................................. 9
6.1 System Safeguards/Alarms/Interlocks Testing (Attachment 12) ...................................................................... 9
6.2 General Controls/Screen Verification (Attachment 13) .................................................................................... 9
6.3 OQ Test Equipment and Calibration Documentation........................................................................................ 9
6.4 Operational Testing (Attachments 12 – 30) ...................................................................................................... 9
7 References (Attachment 31)......................................................................................................................... 10
8 Conclusion ...................................................................................................................................................... 10
9 Exceptional Conditions (Attachment 32) .................................................................................................... 10
10 General Form (Attachment 33) .................................................................................................................... 10
11 Attachments ................................................................................................................................................... 11
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TABLE OF ATTACHMENTS
Attachment 1: Signature Verification List ........................................................................................................................... 13
Attachment 2: Standard Operating and Preventive Maintenance Procedures ................................................................. 14
Attachment 3: Equipment/System Calibration Documentation ......................................................................................... 15
Attachment 4: Test Equipment and Calibration Documentation ...................................................................................... 16
Attachment 5: Documentation and Drawings ...................................................................................................................... 17
Attachment 6: Utilities and Services ..................................................................................................................................... 18
Attachment 7: Installation Check........................................................................................................................................... 19
Attachment 8: Electrical Checks ........................................................................................................................................... 20
Attachment 9: Mechanical Checks ........................................................................................................................................ 21
Attachment 10: Control System ............................................................................................................................................ 32
Attachment 11: Consumables ................................................................................................................................................ 37
Attachment 12: System Safeguards/Alarms/Interlocks Testing ......................................................................................... 38
Attachment 13: General Controls/Screen Verification........................................................................................................ 39
Attachment 14: Operation of Motors .................................................................................................................................... 40
Attachment 15: Operation of Pumps .................................................................................................................................... 41
Attachment 16: Operation of Valves ..................................................................................................................................... 42
Attachment 17: Pressure/Vacuum Hold Test ....................................................................................................................... 43
Attachment 18: Temperature Control Test .......................................................................................................................... 44
Attachment 19: Pressure Control Test.................................................................................................................................. 45
Attachment 20: Level Control Test ....................................................................................................................................... 46
Attachment 21: DO Control Test .......................................................................................................................................... 47
Attachment 22: pH Control Test ........................................................................................................................................... 48
Attachment 23: Flow Control Test ........................................................................................................................................ 49
Attachment 24: Temperature Mapping/Distribution Study ............................................................................................... 50
Attachment 25: Steam In Place (SIP) Test ........................................................................................................................... 55
Attachment 26: Clean In Place (CIP) Test ........................................................................................................................... 56
Attachment 27: Adjustment Mechanisms Test .................................................................................................................... 57
Attachment 28: Controller Test ............................................................................................................................................. 58
Attachment 29: Readout/Printout Checks ............................................................................................................................ 59
Attachment 30: Testing for Invalid Input............................................................................................................................. 60
Attachment 31: References .................................................................................................................................................... 61
Attachment 32: Exceptional Condition Form ...................................................................................................................... 62
Attachment 33: General Form ............................................................................................................................................... 63
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1 Purpose
The purpose of this validation protocol is to provide documentation that the (equipment/system name, make, model)
located in (building/room number) of (Client facility name) is assembled, installed and operates in accordance with
the manufacturers’ and (Client facility name) specifications.
2 Scope
The qualification of the (equipment/system name, make, model, ID number) provides documented evidence, with a
high degree of assurance that the equipment and/or process was installed properly and operates according to
operations and maintenance procedures (SOPs).
This validation protocol includes the following (as applicable):
• Standard Operating Procedures
• Calibration Documentation
• Utility and Service Requirements
• Electrical Assembly
• Mechanical Assembly
• Control Assembly
• Site Installation Confirmation
• Operational Testing
3 Responsibilities
Responsibilities for the qualification and completion of the documentation for the (system name) are defined in the
table below.
FUNCTION RESPONSIBILITY
Writing IQ/OQ Validation or Owner
Review of IQ/OQ Validation
Execution of IQ/OQ Validation or designee
Review of completed package Validation / QA
Approval of final package Validation / QA / Equipment Owner

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4 Equipment/System Description
4.1 Location and Detailed Description

The (equipment/system name, make, model, ID number) is located in (building/room #) of (Client facility
name). The (equipment/system name) is designed to (describe system adequately including hardware,
control system, etc.).
4.2 Utility Requirements

The supporting utilities for the (equipment/system name) include (provide a detailed description of all
utilities required for proper operation of the equipment/system and how they are utilized by the
equipment/system).
5 Installation Qualification (IQ) Verification

The Installation Qualification (IQ) provides documentation that the (equipment/system name, make, model, ID
number) has been assembled with the components specified, that all critical instruments have been calibrated and are
within their calibrated frequency, and that all required documentation has been attached to the protocol or its
location identified.
The execution of this protocol is performed on standardized forms that are used to document the data. These forms
are described below. All forms must be completed at the time of execution. Where more than one form is needed to
complete the documentation, the field copy page can be copied and used to complete the documentation. All data
must be recorded on the attached forms. Any manual calculations, charts or printouts (e.g., chart recordings, printer
tapes, etc.) associated with the testing must be attached to the protocol.
The notation “N/A” has the meaning Not Applicable for the purpose of this protocol.
5.1 Signature Verification List (Attachment 1)

This is a record of each individual who signs or initials any page of this document during execution or
review of the completed attachments. Anyone who signs or initials the executed protocol (other than the
Approvals page) has read and understood this document, as it applies to their job-specific functions.
5.2 Standard Operating and Preventive Maintenance Procedures (Attachment 2)

Identify relevant operational Standard Operating and Preventive Maintenance Procedures (SOP) documents
and confirm that they have been reviewed and are adequate to startup and run the (equipment/system). The
SOPs will be assessed for usability and accuracy during the Operational Qualification of the
(equipment/system). Non-approved SOPs (drafts or redlined) must be attached. Post execution approval
signatures can not be obtained until SOPs are approved.
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5.3 Equipment/System Calibration Documentation (Attachment 3)

Identify all instruments associated with the (equipment/system). Categorize the instruments according to
(Client SOP) as “For Reference Only (FRO), Functional Check Only (FC) and Critical (C) based on the
requirements of the system and the intended purpose of the instrument. Provide documentation showing
that the critical instruments have been calibrated and are within the calibration frequency as defined by the
manufacturers’ or (Client facility name) specifications. Include a copy of the Calibration Record for each
critical instrument.
5.4 Test Equipment and Calibration Documentation (Attachment 4)

Provide documentation that the instruments/equipment which were used to perform the IQ/OQ testing (e.g.,
Voltmeter, Amp Probe) have been calibrated and are within the calibration frequency as defined by the
manufacturers’ or (Client facility name) specifications. Include a copy of the Instrument Calibration
Record for each instrument.
5.5 Documentation and Drawings (Attachment 5)

Identify relevant documentation, which supports the (equipment/system), verifying the availability and
location of required documentation, including but not limited to; P&IDs and slope drawing must be field
verified.
• Operation and Maintenance Manuals
• Shop Drawings
• P&IDs
• Approved consumable and lubricants
• Cut sheets and specifications (electro/mechanical)
• Documentation of Engineering and Control System
• Changes (Change Log)
• Certification of Stainless Steel (pipes and vessels)
• ASME Certification
• Weld Reports
• Passivation/Flushing Reports
• Pressure Testing Report
• Control Systems
- Functional Requirements Specifications (computerized system)
- Source Code (computerized system)
- Hardware/Software Environment
- Ladder Logic (PLC)
- Modules (PLC)
- List of I/Os
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5.6 Utilities and Services (Attachment 6)

Identify the utilities and services required by the (equipment/system) and confirm that they provide the
required voltage and amperage, pressures, flows, capacity, environmental requirements and/or other
requirements as specified by the manufacturer.
5.7 Installation Check (Attachment 7)

Inspect the (equipment/system) to insure that it has been installed properly with all restraints, leveling and
other requirements as recommended by the manufacturer.
5.8 Electrical Checks (Attachment 8)

Inspect the (equipment/system) to insure that proper fuses/circuit breakers are in place, all wiring has been
positively identified by label and color code, that it is neatly bundled and assembled, and that all electrical
connections are tight and secure.
5.9 Mechanical Checks (Attachment 9)

Identify and document the mechanical components of the (equipment/system). Compare the expected
results for individual components to those actually installed in the equipment, as applicable, including but
not limited to:
• Motors
• Pumps
• Valves
• Vessels
• Mixing Blades/Impellers
• Piping
• Product Contact Components
• Alarms/Lockouts/Interlocks
• Gauges/Sensors
• Adjustment Mechanisms
5.10 Control System (Attachment 10)

Identify and document the control system, (e.g., ladder logic, software, source code, revision levels, and
location of backup) where applicable, and its components.
5.10.1 Controller (Electrical Mechanical)

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• Switches, Knobs, Lights, Indicators

• Wiring Diagram(s)
• Safety Interlocks
5.10.2 Control System (PLC)

• Ladder Logic
• Modules
• I/Os
• Security Provisions
• Customer Support availability
• Change History
5.10.3 Control System (Computerized System)

• Functional Requirements Specification
• Source Code (supplied to client or in escrow)
• I/Os
• Communication
• Design Specifications
• Alarms, Interlocks
• Power Failure Check
• Algorithms, formulas, calculations
• Archiving Procedure
• Disaster Recovery Procedures
• Security Provisions
• Customer Support availability
• Change History
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5.11 Consumables (Attachment 11)

Provide a list of all approved consumables, lubricants, and other items used during use of the
equipment/system.
6 Operational Qualification (OQ) Verification

The Operational Qualification (OQ) provides documentation that the (equipment/system) and components perform
as specified in the Standard Operating Procedures and are in accordance with manufacturers’ recommendations. It
confirms that the equipment/system is capable of meeting its intended purpose by comparing the specified
parameters to actual performance. Test design and acceptance specifications contained on the attached forms as
outlined below (as applicable) are based on requirements for the equipment/system to be validated.
6.1 System Safeguards/Alarms/Interlocks Testing (Attachment 12)

Provide documentation that all required safety devices, such as protective shields, interlocks, emergency
stop buttons and alarms are present and functional
6.2 General Controls/Screen Verification (Attachment 13)

Provide documentation for testing all screens and/or controls associated with the operation of the
(equipment/system), if applicable. Include verification of security codes, ability to access all screens, and
that all screens are functional.
6.3 OQ Test Equipment and Calibration Documentation

Confirm that documentation is provided showing that all instruments which were used to perform the OQ
testing are calibrated in accordance with industry accepted standards. Refer to Section 5.3 and update
Attachment 4 as necessary.
6.4 Operational Testing (Attachments 12 – 30)

The following operational checks are to be performed during execution of the protocol (where applicable).
Details of the testing methods and the documentation are included on the specific attachment for each test.
• Operation of Motors
• Operation of Pumps
• Operation of Valves
• Pressure/Vacuum Hold Test
• Temperature Control
• Pressure Control
• Level Control
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• DO Control
• pH Control
• Flow Control
• Temperature Mapping / Distribution Study
• Steam in Place (SIP)
• Clean in Place (CIP)
• Adjustment Mechanisms
• Controllers
• Readout/Printout
• Invalid Input
7 References (Attachment 31)

List any reference materials or related documents necessary to execute and analyze this IQ/OQ protocol, in addition
to the documentation identified in previous sections of this protocol, including specifications, standards or
procedures, regulatory references, drawings, manuals or project documentation.
8 Conclusion
The results of the IQ/OQ validation performed on the (equipment/system name, make, model, ID) confirm that the
(equipment/system) met the expected results and is acceptable for its intended use. All SOPs have been submitted for
revision and approval.
9 Exceptional Conditions (Attachment 32)

Exceptional conditions occurring during the execution of a validation protocol will be documented and justified
using the Exceptional Condition Form or on the General Form.
An exceptional condition is defined as any documentation or testing parameter that did not meet the expected result
or the acceptance criteria of the protocol during execution of the document.
10 General Form (Attachment 33)

This form is used to document observations or other information obtained during execution which is not covered by
another attachment, and will be included after all other attachments.
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11 Attachments
Attachment 1 Signature Verification List
Attachment 2 Standard Operating and Preventive Maintenance Procedures
Attachment 3 Equipment/System Calibration Documentation
Attachment 4 Test Equipment and Calibration Documentation
Attachment 5 Documentation and Drawings
Attachment 6 Utilities and Services
Attachment 7 Installation Check
Attachment 8 Electrical Checks
Attachment 9 Mechanical Checks
Attachment 10 Control System
Attachment 11 Consumables
Attachment 12 System Safeguards/Alarms/Interlocks Testing
Attachment 13 General Controls/Screen Verification
Attachment 14 Operation of Motors
Attachment 15 Operation of Pumps
Attachment 16 Operation of Valves
Attachment 17 Pressure/Vacuum Hold Test
Attachment 18 Temperature Control Test
Attachment 19 Pressure Control Test
Attachment 20 Level Control Test
Attachment 21 Do Control Test
Attachment 22 pH Control Test
Attachment 23 Flow Control Test
Attachment 24 Temperature Mapping/Distribution Study
Attachment 25 Steam in Place (SIP) Test
Attachment 26 Clean in Place (CIP) Test
Attachment 27 Adjustment Mechanisms Test
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Attachment 28 Controllers Test

Attachment 29 Readout/Printout Checks
Attachment 30 Testing for Invalid Input
Attachment 31 References
Attachment 32 Exceptional Condition Form
Attachment 33 General Form
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Attachment 1: Signature Verification List

Page ____ of _____
All individuals who execute or review the attachments of this protocol must complete the information below. All individuals
performing operations associated with this protocol have read and understood this document and understand their job specific
functions. Make additional copies of this attachment as necessary.
Print Name Signature Department / Company Initial/Date
Comments:
Reviewed By: Date:

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Attachment 2: Standard Operating and Preventive Maintenance Procedures
Identify relevant SOP documents and confirm that they have been reviewed and are adequate to startup and run the
equipment/system. Non-approved SOPs (drafts or redlined) must be attached. Post execution approval signatures can not be
obtained until SOPs are approved.
Document No. Edition Title Date Initial/Date
Comments:
Reviewed By: Date:

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Attachment 3: Equipment/System Calibration Documentation
Page ____ of _____
Provide documentation showing that the instruments have been calibrated and are within the calibration frequency as defined
by the manufacturers’ or (Client facility name) specifications. Include a copy of the Calibration Record for each critical
instrument.
Equipment Identification Serial Calibration Calibration Calibration Initial/

Status
Used Number Number Certification # Date Due Date Date
Comments:
Reviewed By: Date:

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Attachment 4: Test Equipment and Calibration Documentation
Page ____ of _____
Provide documentation showing that the instruments/equipment used to perform the IQ/OQ testing have been calibrated and
are within the calibration frequency as defined by the manufacturers’ or (Client facility name) specifications. Include a copy
of the Instrument Calibration Record for each instrument.
Equipment Identification Serial Calibration Calibration Calibration

Initial/Date
Used Number Number Certification # Date Due Date
Comments:
Reviewed By: Date:

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Attachment 5: Documentation and Drawings
Page ____ of _____
Identify relevant documentation that supports the (equipment/system) and verify its availability and location.
Document or Rev. /
Title / Description Date Location Initial/Date
Drawing No. Edition
Manuals (example)
Purchase Orders (example)
Cut Sheets (example)
Engineering Specifications (example)
Factory Acceptance Tests (FATs) (example)
Site Acceptance Tests (SATs) (example)
Commissioning Documentation (example)
Comments:
Reviewed By: Date:

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Attachment 6: Utilities and Services
Identify the utilities and services required by the (equipment/system) and verify that they provide the required voltage and
amperage, pressures, flows capacity and/or other requirements as specified by the manufacturer.
Actual Matches
Service / Utility Expected Result Actual Result Expected Initial/Date
(Yes/No)
Voltage 110  10% (example)
Amperage
Water
Steam
Gasses
Compressed Air
Oxygen
Nitrogen
Comments:
Reviewed By: Date:

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Attachment 7: Installation Check
Inspect the (equipment/system) to insure that it has been installed properly as recommended by the manufacturer.
Actual Matches
Description Expected Result Actual Result Expected Initial/Date
(Yes/No)
Restraints
Leveling
Comments:
Reviewed By: Date:

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Attachment 8: Electrical Checks
Inspect the (equipment/system) to insure that electrical connections and components are properly and safely installed.
Actual Matches
Description Expected Result Actual Result Initial/Date
Expected (Yes/No)
All connections checked for tightness All connections tight
All wiring checked for labeling and Clearly labeled and color coded
color coding
All wiring checked for routing and Neat cable runs with all wiring
neat bundling bundled and tied
Check for visible damage to wiring No damage to wiring or insulation

and insulation
Check that all unused wires are All unused wires are capped or
capped or sealed sealed
Check that transformer is tapped for Transformer is tapped for specified

specified voltage voltage:
Check that all fuses/breakers conform All fuses/breakers conform to

to specified rating specified rating:
amps
amps
amps
Comments:
Reviewed By: Date:

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Attachment 9: Mechanical Checks
Page ____ of _____
Identify and document the mechanical components of the (equipment/system). Compare the expected results for individual
components to those actually installed.
Actual Matches
(Yes/No)
Motors
Manufacturer
Model
Serial Number
Voltage
Amperage
Frequency
Phases
RPM
Motor Duty Rating
Comments:
Reviewed By: Date:

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Attachment 9: Mechanical Checks (Continued)
Page ____ of _____
Actual Matches
(Yes/No)
Pumps
Manufacturer
Model
Serial Number
Type
Impeller Size/Material of Construction
GPM
Pressure
Material of Construction, Case
Material of Construction, Seals
Comments:
Reviewed By: Date:

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Page ____ of _____
Description Expected Result Actual Result Actual Matches Initial/Date

Expected (Yes/No)
Valves
Manufacturer
Model
Serial Number
Type
Material of Construction
Size
Valve Actuator, if present
Manufacturer
Model
Size
Material of Construction, Seals
Material of Construction, Diaphragm
Comments:
Reviewed By: Date:

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Page ____ of _____
Actual Matches
(Yes/No)
Vessels (Vessel #________________)
Manufacturer
Dimensions
Pressure Rating
Interior Finish (minimum 150 grit)
Dish Design
Number of Penetrations
Gasket Material (Manway)
Gasket Material (Unions)
Jacketed
Comments:
Reviewed By: Date:

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Page ____ of _____
Actual Matches
(Yes/No)
Mixing Blades / Impellers
Comments:
Reviewed By: Date:

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Page ____ of _____
Actual Matches
(Yes/No)
Piping
Manufacturer
Model
Serial Number
Schedule
Interior Finish
Interior Diameter
Dead Legs  6 pipe diameters
Slope 1/8 to 1/4 inch/foot
Gasket Material (if union)
Comments:
Reviewed By: Date:

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Page ____ of _____
Actual Matches
(Yes/No)
Product Contact Components
Comments:
Reviewed By: Date:

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Page ____ of _____
Actual Matches
(Yes/No)
Alarms / Lockouts / Interlocks
Comments:
Reviewed By: Date:

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Page ____ of _____
Actual Matches
(Yes/No)
Gauges / Sensors
Comments:
Reviewed By: Date:

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Page ____ of _____
Actual Matches
(Yes/No)
Adjustment Mechanisms
Comments:
Reviewed By: Date:

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Page ____ of _____
Actual Matches
(Yes/No)
Comments:
Reviewed By: Date:

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Attachment 10: Control System
Page ____ of _____
Identify and document the control system (e.g., ladder logic, software, source code, revision level, and location of backup,
where applicable) and its components. Compare the control system specifications to those actually installed in the
equipment, as applicable.
Actual Matches
(Yes/No)
Controller (Electrical/Mechanical)
Switches
Knobs
Lights
Indicators
Wiring Diagram(s)
Safety Interlocks
Comments:
Reviewed By: Date:

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Attachment 10: Control System (Continued)
Page ____ of _____
Actual Matches
Expected (Yes/No)
Computer / PLC Hardware and Software
PC / PLC
Hard Drive / CPU
RAM
Ladder Logic
Wiring Diagram(s)
Modules
I/Os (Input / Outputs)
Security Provisions
Customer Support availability
Change History
Software (Title / Version #)
Comments:
Reviewed By: Date:

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Page ____ of _____
Actual Matches
Expected (Yes/No)
Computerized System
Functional Requirements Specification
Source Code
Wiring Diagram(s)
I/Os (Input/Outputs)
Communication
Design Specification
Alarms/Interlocks
Power Failure Check
Algorithms, formulas, calculations
Archiving Procedure
Disaster Recovery Procedures
Security Provisions
Customer Support availability
Change History
Comments:
Reviewed By: Date:

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Page ____ of _____
Screens Match
Screen Title Display Initial/Date
(Yes/No)
Screens / Explanations
Comments:
Reviewed By: Date:

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Page ____ of _____
Actual Matches
(Yes/No)
Comments:
Reviewed By: Date:

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Attachment 11: Consumables
Page ____ of _____
Provide a list of all approved consumables, lubricants, and other items used during use of the (equipment/system).
Actual Matches
(Yes/No)
Comments:
Reviewed By: Date:

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Attachment 12: System Safeguards/Alarms/Interlocks Testing
Page ____ of _____
Provide documentation that all required safety devices, such as protective shields, interlocks, emergency stop buttons and
alarms are present and functional.
Actual Matches
(Yes/No)
Check all switches, dials and buttons All switches, dials and buttons
for (mechanical) operability are operable (mechanically)
Check that all indicators are present and

have working bulbs (if applicable)
Comments:
Reviewed By: Date:

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Attachment 13: General Controls/Screen Verification
Page ____ of _____
Document testing of all screens and/or controls associated with the (equipment/system) operation. Include verification of
security codes, ability to access all screens, and functionality of all screens.
Screen Name:
Screen Description:
Actual Matches
Test Description Expected Result Actual Result Initial/Date
Expected (Yes/No)
Comments:
Reviewed By: Date:

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Attachment 14: Operation of Motors
Page ____ of _____
Document testing of motors associated with the (equipment/system) operation.
Motor Identification:
Serial No.: ID No.:
Actual Matches
Test Procedure Expected Result Actual Result Initial/Date
Expected (Yes/No)
Use an RPM meter to determine the

RPM of the motor
Check the direction of rotation of the

shaft
Check the current draw Amps (1 Phase) _____ Amps
Amps (3 Phase)
A – B _____ Amps
B – C _____ Amps
A – C _____ Amps
Difference between phases

must be ________ Amps
Comments:
Reviewed By: Date:

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Attachment 15: Operation of Pumps
Page ____ of _____
Document testing of pumps associated with the (equipment/system) operation.
Pump Identification:
Serial No.: ID No.
Actual Matches
Test Procedure Expected Result Actual Result Initial/Date
Expected (Yes/No)
Use a bucket and a stopwatch and

collect sample for 1 minute OR use GPM GPM
a calibrated flow meter.
Determine the system pressure by

use of an installed (calibrated)
gauge or a calibrated gauge that has psig psig
been installed for the validation.
Determine the velocity of the flow

(Ft/sec)
GMP = ______________
Ft/sec
Pipe ID = ___________ in.
GMP x 0.409
Ft/sec =
Pipe ID
__________________ Ft/sec
Comments:
Reviewed By: Date:

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Attachment 16: Operation of Valves
Page ____ of _____
Document testing of valves associated with the (equipment/system) operation.
Valve Identification: Tag No.
Actual Matches
Test Procedure Expected Result Actual Result Expected Initial/Date
(Yes/No)
Comments:
Reviewed By: Date:

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Attachment 17: Pressure/Vacuum Hold Test
Page ____ of _____
Actual Matches
(Yes/No)
Comments:
Reviewed By: Date:

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Attachment 18: Temperature Control Test
Page ____ of _____
Actual Matches
(Yes/No)
Comments:
Reviewed By: Date:

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Attachment 19: Pressure Control Test
Page ____ of _____
Actual Matches
(Yes/No)
Comments:
Reviewed By: Date:

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Attachment 20: Level Control Test
Page ____ of _____
Actual Matches
(Yes/No)
Comments:
Reviewed By: Date:

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Attachment 21: DO Control Test
Page ____ of _____
Actual Matches
(Yes/No)
Comments:
Reviewed By: Date:

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Attachment 22: pH Control Test
Page ____ of _____
Actual Matches
(Yes/No)
Comments:
Reviewed By: Date:

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Attachment 23: Flow Control Test
Page ____ of _____
Actual Matches
(Yes/No)
Comments:
Reviewed By: Date:

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Attachment 24: Temperature Mapping/Distribution Study
Testing Equipment Calibration
Purpose
To calibrate and verify testing equipment. Thermocouples will be calibrated by comparison against a measurement standard
of known accuracy in order to detect, correlate, report, or eliminate (by adjustment) any unacceptable variation in the
accuracy of the instrumentation being measured.
Test Procedure
Verify testing equipment has been calibrated. Record testing equipment calibration documentation on Attachment 3.
Acceptance Criteria
Thermocouples will pre-calibrate within _______C of the reference temperature.
Operational thermocouples will post-verify within ______C of the reference temperature.
At least ninety percent of the thermocouples used must be operational upon completion of the study.
Comments:
Documented By: Date:
Reviewed By: Date:

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Attachment 24: Temperature Mapping/Distribution Study (Continued)
Page ____ of _____
Testing Equipment Calibration Data Sheet
Pass / Fail
Thermocouples pre-calibrate within ______C of the reference temperature.
Operational thermocouples post-verify within ______C of the reference temperature.
At least ninety percent of thermocouples are operational upon completion of the study.
If no, explain:
Filename to which the data was written:
Location of the file:
Print Outs Attached YES / NO
Comments:
Reviewed By: Date:

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Page ____ of _____
Actual Matches
(Yes/No)
Comments:
Reviewed By: Date:

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Page ____ of _____
Thermocouple Placement Data Sheet
Channel Thermocouple Location Description Channel Thermocouple Location Description
Comments:
Reviewed By: Date:

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Page ____ of _____

Results
Cycle
Study Start Time Study End Time
Study Duration Setpoint Temperature
Summary
Minimum Temperature Reading During Study (Cold Spot)
Minimum Temperature Thermocouple Number
Maximum Temperature Reading During Study (Hot Spot)
Maximum Temperature Thermocouple Number
Average Temperature
Standard Deviation
Attach Temperature Mapping Documentation.
Acceptance Criteria Pass/Fail
Comments:
Reviewed By: Date:

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Attachment 25: Steam In Place (SIP) Test
Page ____ of _____
Actual Matches
(Yes/No)
Comments:
Reviewed By: Date:

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Attachment 26: Clean In Place (CIP) Test
Page ____ of _____
Actual Matches
(Yes/No)
Comments:
Reviewed By: Date:

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Attachment 27: Adjustment Mechanisms Test
Page ____ of _____
Actual Matches
(Yes/No)
Comments:
Reviewed By: Date:

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Attachment 28: Controller Test
Page ____ of _____
Actual Matches
(Yes/No)
Comments:
Reviewed By: Date:

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Attachment 29: Readout/Printout Checks
Page ____ of _____
Test the permutations of the equipment’s ability to calculate, display and print out various combinations of numbers, which
tests the extremes of the anticipated outputs.
Actual Matches
Test Description Expected Result Actual Result Expected Initial/Date
(Yes/No)
99 + 99
(-) 99 + (-) 99
91 + (-) 24
(-) 57 + 73
36 + 88
9+9
0+0
0 + 18
(-) 54 + 0
Comments:
Reviewed By: Date:

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Attachment 30: Testing for Invalid Input
Page ____ of _____
Test the inputs to the equipment to confirm that invalid entries do not cause the system to crash or give erroneous results.
Actual Matches
Test Description Expected Result Actual Result Expected Initial/Date
(Yes/No)
Enter a number  the valid input Cannot be entered
Enter decimal numbers  the valid input

and confirm proper rounding of result.
Attempt to enter invalid characters.
Attempt to enter no data. Press Enter.
Comments:
Reviewed By: Date:

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Attachment 31: References
Page ____ of _____
List any reference materials or related documents necessary to execute and analyze this IQ/OQ protocol, in addition to the
documentation identified in previous attachments.
Revision/
Document No. Title Date Location
Edition
Comments:
Reviewed By: Date:

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Attachment 32: Exceptional Condition Form

Page ____ of _____
Description of Exceptional Condition
Corrective Action
Effect on Protocol Execution
Comments:
Reviewed By: Date:

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Attachment 33: General Form
Page ____ of _____
Document observations or other information obtained during IQ/OQ execution which is not covered by another attachment.
Comments:
Reviewed By: Date:

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CONFIDENTIAL

DRAFT Date: 5/2/23 12:18 PM : Validation Protocol Template for LinkedIn.doc

DRAFT Date: 5/2/23 12:18 PM : Validation Protocol Template for LinkedIn.doc

4 Equipment/System Description .................................................................................................................... 5

9 Exceptional Conditions (Attachment 32) .................................................................................................... 10

10 General Form (Attachment 33) .................................................................................................................... 10

DRAFT Date: 5/2/23 12:18 PM : Validation Protocol Template for LinkedIn.doc

DRAFT Date: 5/2/23 12:18 PM : Validation Protocol Template for LinkedIn.doc

Review of IQ/OQ Validation

Execution of IQ/OQ Validation or designee

Review of completed package Validation / QA

Approval of final package Validation / QA / Equipment Owner

DRAFT Date: 5/2/23 12:18 PM : Validation Protocol Template for LinkedIn.doc

4.1 Location and Detailed Description

4.2 Utility Requirements

5 Installation Qualification (IQ) Verification

5.1 Signature Verification List (Attachment 1)

5.2 Standard Operating and Preventive Maintenance Procedures (Attachment 2)

DRAFT Date: 5/2/23 12:18 PM : Validation Protocol Template for LinkedIn.doc

5.3 Equipment/System Calibration Documentation (Attachment 3)

5.4 Test Equipment and Calibration Documentation (Attachment 4)

5.5 Documentation and Drawings (Attachment 5)

DRAFT Date: 5/2/23 12:18 PM : Validation Protocol Template for LinkedIn.doc

5.6 Utilities and Services (Attachment 6)

5.7 Installation Check (Attachment 7)

5.8 Electrical Checks (Attachment 8)

5.9 Mechanical Checks (Attachment 9)

5.10 Control System (Attachment 10)

5.10.1 Controller (Electrical Mechanical)

DRAFT Date: 5/2/23 12:18 PM : Validation Protocol Template for LinkedIn.doc

• Switches, Knobs, Lights, Indicators

5.10.2 Control System (PLC)

5.10.3 Control System (Computerized System)

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5.11 Consumables (Attachment 11)

6 Operational Qualification (OQ) Verification

6.1 System Safeguards/Alarms/Interlocks Testing (Attachment 12)

6.2 General Controls/Screen Verification (Attachment 13)

6.3 OQ Test Equipment and Calibration Documentation

6.4 Operational Testing (Attachments 12 – 30)

DRAFT Date: 5/2/23 12:18 PM : Validation Protocol Template for LinkedIn.doc

7 References (Attachment 31)

9 Exceptional Conditions (Attachment 32)

10 General Form (Attachment 33)

DRAFT Date: 5/2/23 12:18 PM : Validation Protocol Template for LinkedIn.doc

DRAFT Date: 5/2/23 12:18 PM : Validation Protocol Template for LinkedIn.doc

Attachment 28 Controllers Test

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Attachment 1: Signature Verification List

Print Name Signature Department / Company Initial/Date

Reviewed By: Date:

DRAFT Date: 5/2/23 12:18 PM : Validation Protocol Template for LinkedIn.doc

Attachment 2: Standard Operating and Preventive Maintenance Procedures

Document No. Edition Title Date Initial/Date

Reviewed By: Date:

DRAFT Date: 5/2/23 12:18 PM : Validation Protocol Template for LinkedIn.doc

Attachment 3: Equipment/System Calibration Documentation

Page ____ of _____

Equipment Identification Serial Calibration Calibration Calibration Initial/

Reviewed By: Date:

DRAFT Date: 5/2/23 12:18 PM : Validation Protocol Template for LinkedIn.doc

Attachment 4: Test Equipment and Calibration Documentation

Page ____ of _____

Equipment Identification Serial Calibration Calibration Calibration

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