SMB Validation

What does a FAT contain?

Factory Acceptance Test Protocols include (but are not limited to) the following common sections:

Identification of Writer, Approvers:
Provides documented evidence on the personnel involved in preparing and approving the document.

Revision History:
A revision history is maintained to record any changes to the document and the date they occurred.

Objective, Acceptance Criteria, and Identification of Test Equipment Required:
Defines the intent and limitations of the protocol and specifies the quality critical functions of the equipment. Specifies the criteria for a successful implementation and provides the customer with a list of test equipment to supply.

Equipment/Process Description:
A detailed written description of the entire system is included so as to provide the less-informed reader with the level of information required to gain comprehensive understanding of how the system as a whole is designed to operate.

Operation Testing:
This section includes all the verifications and testing performed to the piece of equipment, system, or integrated process that include Equipment Identification, Purchase Order Verification, Design Specification Verifications (Functional, Hardware, Software, etc.), I/O Hardware Verification, and Performance Testing.

FAT Notes, Appendices, and Test Incidents:
These sections are provided to allow for proper documentation of any unforeseen occurrences during protocol execution.

Close Out and Sign Off:
Final approval of the executed document by authorized personnel is required in order to close out the document.