Factory Acceptance Test Protocol

Table of Contents

Table of Contents
Pre-Approval
Objective
Scope of this Document
Acceptance criteria
Responsibility
Protocol Executor
Installation Qualification Test Plan

List of Reference Drawings
Material History Chart
Bought-Out Components
Safety feature Identification
Instrument Details and Calibration Status
Verification of safety
Dimensional Measurement

Operational Qualification test plan
Machine Functional Test

Power Supply Test
Key functionality test
Display Functionality Test
Alarm Verification Test

Equipment Trial Run
Exception Report Log
Exception Report Form
List of Annex
Reference
List of Abbreviation
Glossary
FAT Report
FAT Report Approval

Pre-Approval
This FAT protocol is prepared By:

Functional Area	Name	Designation	Signature	Date
Validation

This FAT protocol is reviewed by the following functional areas:

Functional Area	Name	Designation	Signature	Date
Technical Reviewer
User Department
Engineering
Quality Assurance

This FAT protocol is approved by:

Functional Area	Name	Signature	Date
Head Operation
Head Quality

Objective

The objective of this FAT protocol is to verify:

The fabrication and assembly of the equipment and any auxiliary support systems by physical inspection and testing conforms to the parameters as defined in the URS and Design Qualification.
All design Documents, specifications and test certificates are approved, available and accurate.
Physical Inspection of the electrical hardware.
Functional testing (including safety tests) of the equipment, with printouts for tests that require supporting documentation.

Scope

This Factory Acceptance Test (FAT) protocol is applicable to the Equipment Name.

The tests shall be carried out at Supplier Name and Address.

Acceptance criteria

The design documents specifications and test certificates shall be approved and accurate. The electrical hardware shall comply with the approved design specifications.
The individual tests performed shall conform to the agreed acceptance criteria.
Any tests not performed (due to limitations of resources, complexity of the complete assembly of the equipment and complexity of the tests) during the FAT shall be performed during the SAT or OQ of the equipment at site and shall clearly indicate these tests.
If any deviations from the approved protocol occur or the user requests any changes, these deviations shall be reviewed by the SAT or OQ execution team, agreed upon and then hand marked in the original protocol with initials and date.

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All non-conformances shall be noted and corrective actions listed.

The vendor shall agree upon an action plan on the corrective actions with mutually agreed time frame.
The FAT may be repeated fully or in part (related to the deviation observed) depending upon the impact of the deviation.

Responsibility

Department	Responsibility
Supplier	Execution of FAT as per the protocol. Post approval of the protocol.
Validation	Preparation and final review of the FAT protocol. Its compliance to meet the acceptance criteria of the FAT protocol. Collection and recording of data. Overall co-ordination of the activity. Raise of exception if required.
User Department	Review and approval of the FAT protocol.
Engineering	Review and approval of the FAT protocol.
Quality Assurance	Review and approval of the FAT protocol.

Protocol Executor

The persons below signed means that they understand the contents of this protocol, and they have taken or will be taken part in the execution of the activity which is the part of this protocol. The below table represents a record of each individual who signs or initials any page included in the FAT Protocol.

Name	Department	Designation	Signature	Initials	Date

Reviewed By Name: Sign/Date:

Installation Qualification Test Plan

Section	Test Description
1	List of Reference Drawings
2	Material History Chart
3	Bought-Out Components
4	Verification of Safety
5	Instrument Details and Calibration Status
6	Safety Features Identification
7	Dimensional Measurement
8	Surface Finish Report

1. List of Reference Drawings

Objective	To check reference drawing required for job against list mention below.
Requirements	Approved Drawings list
Test Procedure	The Vendor shall present all the drawings as listed in the “List of Reference Drawings”. The submitted Drawings shall be checked for correct Drawings No., version No., date and authorization details against the details submitted in the FAT Test form by the vendor. Record all the data on Form.
Acceptance criteria	The drawings submitted shall be as specified in the list of reference drawing.

Sr. No.	Title Of Drawing	Submittal Stage	Drawing No.	Rev.	Remarks
1.	G. A. Drawing	FAT
2.	P & I Diagram	FAT
3.	Wiring Diagram	FAT
4.	Pneumatic diagram	FAT
5.	PLC Logic Diagram	FAT

Remark:

________________________________________________________

	Performed by	Checked by
Name
Signature
Company Name
Date

2. Material History Chart

Objective	To prove that the materials used for construction of components are as per the DR specification/ Approved drawing.
Material	Material test certificates.
Method	The Vendor shall present certificates for the materials listed in the “Material History Chart”. The submitted certificates shall be checked for correct material usage against the details submitted in the DR, by the vendor.
Acceptance criteria	The certificates shall prove that the materials used for construction of components are as per the approved specifications.

Sr. No.	Part Description & Size	Acceptance Criteria		Result	Remarks
Sr. No.	Part Description & Size	Material	Certificate No.	Result	Remarks
1.
2.
3.
4.
5.
6.

Remark:

________________________________________________________

	Performed by	Checked by
Name
Signature
Company Name
Date

3. Bought-Out Components

Objective	To prove that Bought Out components used for construction of the equipment are as per the approved specifications.
Material	Bought Out component’s specification sheets (From the original manufacturer)
Method	The Vendor shall present previously approved specification sheets for the Bought-Out components listed in the “Bought Out components list” for review at the start of the FAT exercise. Inspect the installed component. Compare Quality Certificate of the component the make, Model No. and other specifications with the approved specifications.
Acceptance criteria	The verification shall prove that the Bought Out components used for construction of the equipment is as per the approved specifications.

Sr. No.	Component	Make	Certificate Type	QTY.
MECHANICAL COMPONENTS
1.
2.
3.
ELECTRICAL COMPONENTS
1.
2.

Remark:

________________________________________________________

	Performed by	Checked by
Name
Signature
Company Name
Date

4. Safety feature Identification
To identify and list all Safety features for proper installation on the equipment.

Sr. No.	Safety feature description	Properly Installed (Yes/No)	Sign/Date
1
2
3

Remark:

________________________________________________________

	Performed by	Checked by
Name
Signature
Company Name
Date

5. Instrument Details and Calibration Status Procedure

Review and identify instrument details and Calibration status. Record the observation in the test data sheet.

Acceptance Criteria: All critical instruments are identified and are verified to be within calibration.

Instrument Name	Instrument ID	Calibration Date	Calibration Due Date	Pass/Fail	Sign/Date

6. Verification of safety

a. Test Name

Objective
Requirements
Test Method / Instrument
Test Procedure
Acceptance criteria
Verification	Specified Results	Result		Sign/Date
		Pass	Fail

Exception Report (If applicable)

Remark:

________________________________________________________

	Performed by	Checked by
Name
Signature
Company Name
Date

7. Dimensional Measurement

Objective	Dimension check against Approved GA Drawings.
Instruments	Measure Tape 0-3000mm, Vernier Caliper 0- 300 mm,
Method	Direct measurement of Overall dimensions, Connection Points. Install the plant on the suitable place. Measure the indicated dimensions and fill in the dimension report.
Acceptance Criteria	All the measured dimensions shall be within the dimensional tolerances.

Dimension checks
Overall dimension: height (h), length (l), width (w)

Utility connections checks
Check dimension against ga drawing. E.g. Feed water inlet, steam water inlet

Sr. No.	Parameter	Value from G.A Drawing (mm)	Actual Value (mm)	Conclusion
1	Overall Height H
2	Overall Width W
3	Overall Depth D

Utility Connection Points Checks

Sr. No.	Description	Value from GA Drawing	Actual Value	Corresponding / Non corresponding
1.
2.
3.

Remark:

________________________________________________________

	Performed by	Checked by
Name
Signature
Company Name
Date

8. Surface Finish Report

Objective	To check the surface finish of the surface of the plant and to verify against the approved drawing requirement.
Instruments	Surface Finish Tester
Method	Check the Surface Finish of the product contact surfaces with the calibrated Roughness Tester according to the instrument manual. Wipe dry the surfaces using a moist cloth and check for any fibers getting caught by the surface rubbed. Measure the indicated surfaces at 3 different points. Results shall be recorded.
Acceptance Criteria	All the surfaces tested shall meet the requirements.

Sr. No.	Surface	Checking Point	Accessibility limit (µm RA)	No of measurements	Actual Value (µm RA)	Conclusion
1		1	≤ 0.60	1
		2		1
		3		1
2		1	≤ 0.60	1
		2		1
		3		1

Remark:

________________________________________________________

	Performed by	Checked by
Name
Signature
Company Name
Date

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Operational Qualification test plan

Section	Test Description
1	Machine Functional Test
2	Power Supply Test
3	Key functionality test
4	Display functionality test
5	Alarm Verification test

Machine Functional Test

1. Power Supply Test

Objective	To check the power supply on/off.
Requirements	Utilities as required
Test Method / Instrument	Operational
Test Procedure	Turn on the mains. Check the machine for power supply. Turn off the mains, the power to machine shall be OFF.
Acceptance criteria	System gets start only after keeping mains ON and get OFF after keeping mains OFF.
Verification	Specified Results Visually check that system gets switched ON after keeping mains ON. Visually check that system gets OFF after keeping mains OFF.
Exception Report (If applicable)

Remark:

________________________________________________________

	Performed by	Checked by
Name
Signature
Company Name
Date

2. Key functionality Test

Objective:

The objective of this procedure is to demonstrate that the control panel of equipment name provides the proper functionality as specified by the manufacturer.

Procedure:

Check that all the displays on the panel are properly Labeled / Identified.
Turn on the power from the electrical panel.
Set the control (s) on the panel.
Verify functionality of each component on the panel against its Specified functions.
Observe and record the responses of the control panel.

Key Functionality Test:

Sr. No.	Key / switch Description	Specified Function	Results Satisfied (Yes / No)	Checked By (Sign/Date)
1.
2.
3.
4.
5.

Remark:

________________________________________________________

	Performed by	Checked by
Name
Signature
Company Name
Date

3. Display Functionality Test

Sr. No.	Key Indicator	Specified Function	Results Satisfied (Yes / No)	Checked By (Sign/Date)
1.
2.
3.
4.
5.

Remark:

________________________________________________________

	Performed by	Checked by
Name
Signature
Company Name
Date

4. Alarm Verification Test

a. Alarm name

Objective
Requirements
Test Method / Instrument
Test Procedure
Acceptance criteria
Verification	Specified Results	Result		Sign/Date
		Pass	Fail

Exception Report (If applicable)

Remark:

________________________________________________________

	Performed by	Checked by
Name
Signature
Company Name
Date

Equipment Trial Run

Objective	To carry out equipment trial run for observing performance/operation of all the items installed on the equipment.
Method	Perform the operations as per Instruction given in the manual.
Acceptance Criteria	Equipment shall run as per the procedure given in the manual.

Remark:

________________________________________________________

	Performed by	Checked by
Name
Signature
Company Name
Date

Exception Report Log

If any of the studies carried out in the Operational Qualification test does not meet the acceptance criteria. A copy of the Exception report in section 12.0 must be completed and provided a unique ID # traceable to this protocol (Protocol # - ER – XX). Any corrective actions identified must be verified based on the investigation findings.

The following exceptions and deviations were noted during the execution of the protocol:

Exception Report No.	Description	Status Open/Closed

Exception Report Form

Make copies of this form as necessary.

Validation Exception Report Number:
1. Identification of Exception
Test Affected
Date of Occurrence
Date of Observation
Date QA Notified		QA Initial Date
2. Nature of Exception
3. Root Cause Investigation
4. Impact of Exception
5. Corrective Actions
Prepared By Name: Signature: Date:
6. Approval to Proceed Signatures below indicate the relevant department managers and QA Validation Compliance concur with root cause analysis and approve the implementation of proposed corrective actions. Where no corrective actions are required or implementation of actions was required prior to preparation of this report, these signatory boxes may be lined out and Section 8. Signatures shall represent Approval to proceed.
Validation Manager or Delegate

Validation Exception Report Number:

Name:

Signature:

Date:

Responsible Area Manager or Delegate Area:

Name: Signature:

Date:

QA Manager or Delegate

Name:

Signature:

Date:

7. Corrective Action Verification

Prepared By

Name:

Signature:

Date:

8. Exception Report Approval

Signatures below verify that:

The stated actions have been implemented and are deemed appropriate to resolve the exception.

Where actions were completed prior to preparation of the report, justifications provided in Section 5. Adequately explain why actions were required in advance.

Where actions have not been implemented, the ongoing actions are assigned to XXX quality systems. The ongoing actions are appropriately referenced in the report and are traceable to conclusion.

The exception report number is listed on the deviation log associated with the protocol document and will be included in the final validation package.

Validation Manager or Delegate

Name: Signature:

Date:

Responsible Area Manager or Delegate Area:

Name: Signature:

Date:

Name:

Signature:

Date:

List of Annexures

Sr. No.	Details of Annex.	Annex. Number
1
2
3
4
5

Reference

Validation of aseptic Pharmaceutical Processes – James P. Agalloco How to develop and Manage Qualification Protocols – Philip Cloud

List of Abbreviation

Abbreviations	Full Form

Glossary

Qualification terms	Definition
User Requirement Specification (URS)	User Requirement Specifications (URS) are prepared for each critical utility or piece of equipment prior to the manufacturing stage. The specification provides a list of requirements for the planned system. The User Requirements Specification specifies the needs of the end user as well as any regulatory requirements.
Design Qualification (DQ)	Detailed Design Specifications (DDS) are prepared for each critical utility or price of equipment prior to the manufacturing stage. The specification provides a detailed description of the utility or piece of equipment design based on the Functional Requirement Specification (FRS) document.
Factory Acceptance Test (FAT)	The Factory Acceptance Test protocol provides documented evidence that a piece of equipment, system or integrated process has been adequately tested at the manufacturer’s facility and performed to the end user’s expectations prior to the piece of equipment, system, or integrated process being delivered to the end user.
Site Acceptance Test (SAT)	A Site Acceptance Test protocol provides documented evidence that a piece of equipment, system, or integrated process that has been delivered to the end user has not been affected in the transportation and has been adequately tested at the end user’s facility and performed to the end user’s expectations after Operational.
Installation Qualification (OQ)	The documented verification that the facilities, systems and equipment, as installed or modified, comply with approved design and manufacturer’s recommendations.
Operational Qualification (OQ)	The documented verification that the facilities, systems and equipment as installed or modified, perform as intended throughout the anticipated operating ranges.
Performance Qualification (PQ)	The documented verification that the facilities, systems and equipment, as connected together, can perform effectively and reproducibly, based on the approved process method and product specification.
Standard Operating Procedure (SOP)	Standard Operating Procedures (SOP) are prepared for each critical utility or piece of equipment to provide all personnel working with the equipment information and instructions on what is required in order to maintain, operate and clean the utility or piece of equipment.
Critical Equipment / Parameter	Describes a process step, process condition, test requirements, or other relevant parameter or item that must be controlled within predetermined criteria to ensure that the product meets the specification. Non-Compliance to which would impact the product or patient safety, stability or efficacy.
Amendment	Additional data to an approved protocol and summary report that further substantiate and clarify the original acceptance criteria.
Validation / Qualification	The documented act of proving that any procedure, process equipment, material activity, or system actually leads to the expected results.
Re-qualification	Re-qualification is the repetition of the prospective qualification study or a specific portion of the study to demonstrate that the system under investigation operates as expected.

FAT Report

Summary of the results obtained:

________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Significant deviations observed:

Conclusions

FAT Report Approval

Supplier Signature

Functional Area

Name

Designation

Signature with

stamp

Date

Supplier

This FAT protocol is compiled by following functional areas:

Functional Area	Name	Designation	Signature	Date
Validation

This FAT protocol is reviewed by following functional areas:

Functional Area	Name	Designation	Signature	Date
User Department
Engineering
Quality Assurance

This FAT protocol is approved by:

Functional Area	Name	Signature	Date
Head Operation
Head Quality

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Factory Acceptance Test Protocol

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