What is a Factory Acceptance Test (FAT)?

A Factory Acceptance Test (FAT) is a formal process where equipment or systems are tested at the manufacturer’s facility before shipment. The goal is to verify that the equipment meets design specifications, functionality, and contractual requirements.

 Purpose of a FAT Protocol

The FAT protocol is a written document that:

• Defines how the FAT will be conducted.

• Lists the testing criteria and methods.

• Specifies the pass/fail conditions.

• Outlines the roles and responsibilities of each party involved.

 Key Components of a FAT Protocol

1. Title and Document Information

Include:

• Document title (e.g., “Factory Acceptance Test Protocol – XYZ System”)

• Version/revision number

• Date of issue

• Prepared by / approved by sections

2. Objective / Purpose

Clearly state why the FAT is being conducted. Example:

“The purpose of this FAT is to verify that the XYZ system meets the functional, safety, and performance requirements specified in the approved design documentation.”

3. Scope

Define what equipment or systems are covered, and the boundaries of testing. Example:

“This FAT covers the complete control panel and associated software for the XYZ line. Excludes site-specific integration testing.”

4. Responsibilities

List roles and responsibilities of involved parties:

• Manufacturer

• Customer representatives

• Third-party inspectors (if applicable)

5. Reference Documents

Include references to:

• Design specifications

• Technical drawings

• User manuals

• Contracts or purchase orders

• Regulatory standards (e.g., ISO, GMP)

6. Test Items / Equipment Description

Describe the system/equipment being tested, including:

• Serial numbers

• Model numbers

• Key components

• Software version (if applicable)

7. Test Procedures

This is the core of the FAT protocol. For each test:

• Identify the Test Name (e.g., “Power-on Test”)

• State the Objective (e.g., “Verify system powers on without error”)

• Describe the Procedure (step-by-step instructions)

• List the Expected Results

• Define the Acceptance Criteria (e.g., “System boots in under 30 seconds with no error messages”)

Include space for:

• Actual test results

• Pass/Fail status

• Comments or deviations

8. Test Schedule

Provide a timeline or estimated duration for the testing process.

9. Deviation Handling

Explain how deviations from expected results will be handled:

• Who approves them

• How they are documented

• Retesting procedures

10. Acceptance and Sign-Off

Include a section where all parties sign to confirm the FAT was conducted and whether the system passed or failed.

 Example FAT Test Case Format

 Best Practices

• Use checklists and photos for clarity.

• Keep test language objective and measurable.

• Include retest procedures for failed tests.

• Review and approve the FAT protocol before testing begins.

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