Factory Acceptance Test (FAT)
Factory Acceptance Test
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A structured verification performed at the equipment manufacturer’s facility, before shipment, confirming that a piece of equipment or system meets its purchase specification and functions as intended prior to delivery to the regulated site — reducing the risk of discovering design or build defects only after installation.
FAT is conducted against the equipment’s functional and design specification, often with the purchaser’s quality and engineering representatives present to witness the testing directly. Any defects, deviations, or open items found are logged as a punch list and resolved — either at the vendor’s site or accepted with a documented rationale — before the equipment ships.
A well-executed FAT does not replace on-site qualification, but it meaningfully reduces the risk that IQ or OQ execution uncovers a fundamental design flaw only after the equipment has already been installed, connected to site utilities, and scheduled into a validation timeline.
- —Performed at the vendor’s facility before shipment, not at the regulated site
- —Verified against the purchase order, URS, and functional specification
- —Often witnessed by the purchaser’s quality/engineering representatives
- —Findings are resolved via a documented punch list before shipment
- —Complements, but does not replace, on-site IQ/OQ qualification
ISPE Baseline Guide Vol. 5 (Commissioning & Qualification); ASTM E2500-25
Frequently asked questions
What does Factory Acceptance Test (FAT) stand for?
Factory Acceptance Test (FAT) stands for Factory Acceptance Test.
What is Factory Acceptance Test (FAT)?
A structured verification performed at the equipment manufacturer’s facility, before shipment, confirming that a piece of equipment or system meets its purchase specification and functions as intended prior to delivery to the regulated site — reducing the risk of discovering design or build defects only after installation.
Which regulations cover Factory Acceptance Test (FAT)?
ISPE Baseline Guide Vol. 5 (Commissioning & Qualification); ASTM E2500-25