📘 How to Write a Factory Acceptance Test (FAT) Protocol

A Factory Acceptance Test (FAT) is a documented process conducted at the vendor’s premises to verify that equipment, systems, or instruments meet the agreed design, functional, and regulatory requirements before delivery to the site.

✅ Steps to Write a FAT Protocol

1. Header Information

• Title: Factory Acceptance Test (FAT) Protocol

• Document No. / Revision No.

• Prepared by / Reviewed by / Approved by (signatures and dates)

• Equipment / System Name & ID

• Vendor / Manufacturer details

2. Objective

• Define the purpose of the FAT (e.g., “to ensure the equipment meets User Requirement Specifications (URS), Design Specifications, and GMP compliance before shipment”).

3. Scope

• Describe the equipment/system being tested.

• State which parameters/functions will be verified.

• Identify inclusions and exclusions.

4. Responsibilities

• Vendor responsibilities (test execution, documentation).

• Client responsibilities (witnessing, review, approval).

5. Reference Documents

• URS

• Design Qualification (DQ)

• Functional Design Specification (FDS)

• Applicable regulatory guidelines (FDA, EU GMP, ISPE, etc.)

6. Equipment / System Description

• Overview of the system.

• Critical components and utilities required.

• Safety features.

7. Pre-requisites

• Calibration status of instruments.

• Utilities availability (power, air, water, etc.).

• Test equipment required.

8. Test Procedures

Prepare test cases and acceptance criteria, such as:

• Mechanical Checks – dimensions, weld quality, surface finish, component verification.

• Functional Tests – power ON/OFF, alarms, interlocks, safety features.

• Software/Automation Checks – HMI displays, data logging, recipe management.

• Performance Tests – capacity, accuracy, repeatability.

• Compliance Checks – documentation, manuals, certificates.

Each test case should include:

• Test step

• Expected result (acceptance criteria)

• Actual result

• Pass/Fail

• Remarks

9. Deviations & Non-conformances

• Procedure to document deviations during FAT.

• Corrective action requirements.

10. Documentation & Records

• Attach checklists, calibration certificates, test sheets, and FAT report templates.

11. Acceptance & Approval

• Final summary of results.

• Approval section with client and vendor sign-off.

✍️ Example of FAT Test Case Format

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