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
  1. List of Reference Drawings
  2. Material History Chart
  3. Bought-Out Components 
  4. Safety feature Identification
  5. Instrument Details and Calibration Status
  6. Verification of safety
  7. Dimensional Measurement
  • Operational Qualification test plan
  • Machine Functional Test
  1. Power Supply Test
  2. Key functionality test
  3. Display Functionality Test
  4. 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.


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

 

 


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

Material

Certificate No.

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

 

 


ALSO READ: 
Skip Testing in Pharmaceutical Industry: Where to Apply?

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:

QA

 

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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