FACTORY ACCEPTANCE TEST

FOR
EQUIPMENT NAME

Table of Contents
Table of Contents...........................................................................................................2
1.0Pre-Approval..............................................................................................................3
2.0Objective....................................................................................................................4
3.0Scope of this Document...........................................................................................4
4.0Acceptance criteria ..................................................................................................4
5.0Responsibility............................................................................................................5
6.0Protocol Executor......................................................................................................6
7.0Installation Qualification Test Plan.........................................................................7
7.1LIST OF REFERENCE DRAWINGS .................................................................................................8
7.2MATERIAL HISTORY CHART.......................................................................................................9
Objective....................................................................................................................................................9
Acceptance criteria....................................................................................................................................9
7.3BOUGHT-OUT COMPONENTS.....................................................................................................10
Objective..................................................................................................................................................10
Acceptance criteria..................................................................................................................................10
7.4SAFETY FEATURE IDENTIFICATION............................................................................................11
7.5INSTRUMENT DETAILS AND CALIBRATION STATUS..................................................................11
7.6VERIFICATION OF SAFETY.........................................................................................................12
7.6.1Test Name.........................................................................................................................................12
7.7DIMENSIONAL MEASUREMENT..................................................................................................13
Objective..................................................................................................................................................13
7.8SURFACE FINISH REPORT..........................................................................................................14
Name 15
8.0Operational Qualification test plan........................................................................15
9.0Machine Functional Test........................................................................................15
9.1POWER SUPPLY TEST................................................................................................................15
Name 16
9.2KEY FUNCTIONALITY TEST........................................................................................................16
Name 17
9.3DISPLAY FUNCTIONALITY TEST ...............................................................................................17
Name 17
9.4ALARM VERIFICATION TEST.....................................................................................................18
9.4.1Alarm name......................................................................................................................................18
Name 18
10.0Equipment Trial Run.............................................................................................18
Objective..................................................................................................................................................18
Name 19
11.0Exception Report Log...........................................................................................19
12.0Exception Report Form.........................................................................................21
13.0List of Annex:.........................................................................................................22
14.0Reference...............................................................................................................24
15.0List of Abbreviation...............................................................................................24
16.0Glossary.................................................................................................................24
17.0FAT Report.............................................................................................................26
18.0FAT Report Approval............................................................................................28

1.0

Pre-Approval

This FAT protocol is prepared By

Functional Area

Name

Designation

Signature

Date

Validation

This FAT protocol is reviewed by following functional areas

Functional Area

Name

Designation

Signature

Date

Signature

Date

Technical Reviewer
User Department
Engineering
Quality Assurance

This FAT protocol is approved by -

Functional Area
Head Operation
Head Quality

Name

2.0

3.0

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 of this Document

This Factory Acceptance Test (FAT) protocol is applicable to the Equipment Name.
The tests shall be carried out at Supplier Name and Address.

4.0

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.

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.

5.0

Responsibility
Department
Supplier

Validation

User Department
Engineering
Quality Assurance

Responsibility
Execution of FAT as per the protocol.
Post approval of the protocol.
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.
Review and approval of the FAT protocol.
Review and approval of the FAT protocol.
Review and approval of the FAT protocol.

6.0

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. 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: _________________

7.0
Installation Qualification Test Plan
Section
Test Description
7.1
List of Reference Drawings
7.2
Material History Chart
7.3
Bought-Out Components
7.4
Verification of Safety
7.5
Instrument Details and Calibration Status
7.6
Safety Features Identification
7.7
Dimensional Measurement
7.8
Surface Finish Report

7.1
List of Reference Drawings
Objective
To check reference drawing required for job against list mention below.
Requirements
Approved Drawings list
The Vendor shall present all the drawings as listed in the List of Reference
Drawings.
Test Procedure
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
The drawings submitted shall be as specified in the list of reference drawing.
criteria
LIST OF REFERENCE DRAWINGS
Sr. No.

Title Of Drawing

Submittal
Stage

1.

G.A.Drawing

FAT

2.

P & I Diagram

FAT

3.

Wiring
Diagram

FAT

4.

Pneumatic diagram

FAT

5.

PLC Logic Diagram

FAT

Drawing No.

Rev.

Remarks

Remark:

Performed by
Name
Signature
Company Name
Date

Checked by

7.2
Objective
Material

Material History Chart

To prove that the materials used for construction of components are as per the
DR specification/ Approved drawing.
Material test certificates.

Method

Acceptance criteria

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.
The certificates shall prove that the materials used for construction of components
are as per the approved specifications.
MATERIAL HISTORY CHART
Acceptance Criteria

Sr. No.

Part Description & Size

Material

Result

Certificate
No.

1.
2.
3.
4.
5.
6.
Remark:

Performed by
Name
Signature
Company Name
Date

Checked by

Remarks

7.3
Objective
Material

Bought-Out Components
To prove that Bought Out components used for construction of the equipment are
as per the approved specifications.
Bought Out components specification sheets (From the original manufacturer)

Method

Acceptance criteria

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.
The verification shall prove that the Bought Out components used for
construction of the equipment is as per the approved specifications.
BOUGHT OUT COMPONENTS

Sr.
Component
No.
MECHANICAL COMPONENTS

Make

Certificate Type

1.
2.
3.
ELECTRICAL COMPONENTS
1.
2.
Remark:

Performed by
Name
Signature
Company Name
Date

Checked by

QTY.

7.4
Sr.
No.

Safety feature Identification

To identify and list all Safety features for proper installation on the equipment.
Properly Installed
Safety feature description
Sign/Date
(Yes/No)

Remark:

Performed by

Checked by

Name
Signature
Company Name
Date
7.5

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 Calibration Calibration
Pass/Fail
Sign/Date

ID

Date

Due Date

Remark:

Performed by

Checked by

Name
Signature
Company Name
Date

7.6
Verification of safety
7.6.1
Test Name
Objective
Requirements
Test Method /
Instrument
Test Procedure
Acceptance
criteria
Verification
Exception Report
(If applicable)

Specified Results

Result
Pass
Fail

Sign/Date

Remark:

Performed by

Checked by

Name
Signature
Company Name
Date
7.7
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
DIMENSIONAL MEASUREMENTS
Sr.
No.

Parameter

Overall Height H

Value from G.A

Drawing
(mm)

Actual Value
(mm)

Conclusion

2
3

Overall Width W
Overall Depth D
UTILITY CONNECTION POINTS CHECKS

Sr.
Description
No.
1.
2.
3.
Remark:

Value from GA
Drawing

Actual Value

Performed by

Corresponding /
Non corresponding

Checked by

Name
Signature
Company Name
Date
7.8

Surface Finish Report

Objective

To check the surface finish of the surface of the plant and to verify against the
approved drawing requirement.
Surface Finish Tester
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.

Instruments
Method

Acceptance
Criteria

Sr.
No.

All the surfaces tested shall meet the requirements.

Surface

Checking
Point
1
2
3
1
2
3

1
2
Remark:

Accessibility
limit
(m RA)
0.60
0.60

No of
measurements
1
1
1
1
1
1

Actual
Value
(m RA)

Conclusion

Performed by

Checked by

Name
Signature
Company Name
Date

8.0
Operational Qualification test plan
Section
Test Description
9.0
Machine Functional Test
9.1
Power Supply Test
9.2
Key functionality test
9.3
Display functionality test
9.4
Alarm Verification test
9.0
Machine Functional Test
9.1
Power Supply Test
Objective
To check the power supply on/off.
Requirements
Utilities as required
Test Method /
Operational
Instrument
Turn on the mains.
Test Procedure Check the machine for power supply.
Turn off the mains, the power to machine shall be OFF.
Acceptance
System gets start only after keeping mains ON and get OFF after keeping mains
criteria
OFF.
Specified Results
Verification
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
9.2

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:
1.
2.
3.
4.
5.

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.
1.

Key / switch Description

Specified Function

Results Satisfied
(Yes / No)

Checked By
(Sign/Date)

2.
3.
4.
5.
6.
7.
8.
Remark:

Performed by

Checked by

Name
Signature
Company Name
Date
9.3

Display Functionality Test

Sr.
No.
1.

Key Indicator

Specified Function

Results Satisfied
(Yes / No)

Checked By
(Sign/Date)

2.

3.

4.

5.

Remark:

Performed by
Name
Signature
Company Name
Date

Checked by

9.4
Alarm Verification Test
9.4.1 Alarm name
Objective
Requirements
Test Method /
Instrument
Test Procedure
Acceptance
criteria
Verification

Result
Pass
Fail

Specified Results

Sign/Date

Exception Report
(If applicable)
Remark:

Performed by

Checked by

Name
Signature
Company Name
Date
10.0

Equipment Trial Run

To carry out equipment trial run for observing performance/operation of all the
Objective
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.
Remarks:

Performed by

Checked by

Name
Signature
Company Name
Date
11.0

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

12.0

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
2. Nature of Exception

QA Initial Date

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:
Responsible Area Manager or Delegate Area: __________

Date:

Name:
QA Manager or Delegate

Signature:

Date:

Name:
7. Corrective Action Verification

Signature:

Date:

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:
Responsible Area Manager or Delegate Area: __________

Date:

Name:
QA

Signature:

Date:

Signature:

Date:

Name:
13.0
Sr. No.

List of Annex:
Details of Annex.

Annex. Number

14.0

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

15.0 List of Abbreviation

Abbreviations

16.0

Full Form

Glossary

Qualification terms Definition

User
Requirement User Requirement Specifications (URS) are prepared for each critical utility or
Specification (URS) 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 Detailed Design Specifications (DDS) are prepared for each critical utility or
(DQ)
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 The Factory Acceptance Test protocol provides documented evidence that a
Test (FAT)
piece of equipment, system or integrated process has been adequately tested at
the manufacturers facility and performed to the end users expectations prior
to the piece of equipment, system, or integrated process being delivered to the
end user.
Site Acceptance Test A Site Acceptance Test protocol provides documented evidence that a piece of
(SAT)
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 users facility and performed to the end users expectations after
Operational.
Installation
The documented verification that the facilities, systems and equipment, as
Qualification (OQ)
installed or modified, comply with approved design and manufacturers

Qualification terms

Definition
recommendations.
Operational
The documented verification that the facilities, systems and equipment as
Qualification (OQ)
installed or modified, perform as intended throughout the anticipated operating
ranges.
Performance
The documented verification that the facilities, systems and equipment, as
Qualification (PQ)
connected together, can perform effectively and reproducibly, based on the
approved process method and product specification.
Standard Operating Standard Operating Procedures (SOP) are prepared for each critical utility or
Procedure (SOP)
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 / Describes a process step, process condition, test requirements, or other relevant
Parameter
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
/ The documented act of proving that any procedure, process equipment,
Qualification
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.

17.0

FAT Report

Summary of the results obtained:

Significant deviations observed:

Conclusions:

18.0

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
Head Operation
Head Quality

Name

Signature

Date