Pre-Shipment Assurance: Crafting a Robust Factory Acceptance Test (FAT) Protocol

The Factory Acceptance Test (FAT) is a vital quality checkpoint performed at the equipment manufacturer's site before the equipment is shipped to the purchaser's facility. A thorough FAT is the first line of defense against costly installation delays and operational issues, significantly minimizing problems that could occur during the Installation Qualification (IQ) phase.

By verifying the equipment's design, functionality, and documentation against the purchase specifications, the FAT ensures the asset is fit for purpose before it leaves the vendor's control.

Key Components of a Comprehensive FAT Protocol

A formal FAT protocol is a structured document that guides the testing process. It is the roadmap for both the vendor and the purchaser's representatives, ensuring all critical aspects are checked.

1. Purpose and Scope

Purpose: The FAT protocol's purpose is twofold:

To ensure that the equipment is designed and built as per the agreed-upon technical specifications.
To check the basic performance and operational integrity of the equipment before delivery.

Scope: The scope clearly defines the applicability of the protocol. Example: "This protocol is applicable to the [Specific Equipment Name] manufactured by ABC Ltd. against Purchase Order [PO Number]."

2. Procedure and Execution

This section details the step-by-step process for carrying out the Factory Acceptance Test:

Operational Checks: Write the detailed procedure to check the equipment's core operation, including functional testing of all primary mechanisms, interlocks, and utility requirements.
Deviation Handling: Define the immediate action to be taken when any deviation is observed. This typically includes recording the deviation, halting the test (if critical), and requiring a formal investigation and corrective action plan by the vendor.
Document List: List all necessary documents that must be checked, reviewed, and approved during the FAT (e.g., drawings, Bill of Materials, welding logs, calibration certificates).

3. Documentation

Provide clear instructions on the records and data to be collected during the FAT. This includes:

Detailed recording of test parameters, witnessed observations, sign-offs, and any photographic or video evidence.
All test data and check sheets must be signed and dated by both the vendor and the purchaser’s authorized representatives.

🔍 Verification Sheet and Acceptance Criteria

The Acceptance Criteria and Verification Sheet are the core sections of the FAT protocol, quantifying what constitutes a successful test.

Acceptance Criteria

The equipment is deemed acceptable if:

The equipment and all accessories are consistent with the Purchase Order (PO).
The equipment and its performance meet all pre-designed and agreed-upon parameters (as defined in the URS and technical specifications).

Verification Sheet (Detailed Check Points)

This section includes specific parameters to be verified physically and against documentation:

Parameter	Required Specification Check	Example
Basic Identification	Make, Model, and Required Capacity	Make: ABC Ltd., Model: XYZ-200, Capacity: 500 kg/hr
Design & MOC	Detailed parts list, dimensions, and Material of Construction (MOC) verification.	MOC for contact parts: SS-316L. MOC for non-contact parts: SS-304.
Control Panel	Requirements for operation (e.g., Auto/Manual mode selector, Emergency Stop functionality, indicator lights).	Quantity: 1. Features: HMI, VFDs, Emergency Stop push button.
PLC	Make, Model, and Quantity of the Programmable Logic Controller (PLC).	Make: Siemens, Model: S7-1500, Quantity: 1 set.
Instrumentation	Type, Make, Model, and Quantity of critical sensors (Temperature, RH, Pressure, etc.).	Temperature Sensors: Type: PT-100, Make: Wika, Quantity: 4.
Safety Features	Functionality and placement of safety features (e.g., Emergency stops, mechanical guards, electrical safety interlocks).	Interlocks confirmed: Door open interlock prevents operation.
Required Documents	List of all technical and quality documents to be handed over.	MOC Certificates, Calibration Certificates, Operational/Maintenance Manuals, and Warranty Cards.

📝 Post-Execution and Approval

Observed Deviations

Any issues found during the FAT must be documented here. For each deviation, the following must be recorded:

Description of the observed deviation.
Investigation and root cause analysis.
Corrective Action taken by the vendor.
A formal statement on whether the deviation is acceptable (minor and closed) or unacceptable (requiring re-test or major rework).

Conclusion and Approval

Conclusion: Provides an overall summary of the FAT results, clearly stating whether the equipment has passed or failed the acceptance criteria.
Approval: The final sign-off section, including signature lines for the protocol preparer, the head of the purchaser’s concerned department (e.g., Engineering), and the Head of Quality Assurance (QA) for final approval.

By executing a rigorous FAT, pharmaceutical companies significantly reduce the risks associated with equipment delivery and installation, setting a solid foundation for the subsequent qualification phases.