How to Run a Factory Acceptance Test
Verify equipment at the vendor before it ships — and leverage that evidence later.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
A Factory Acceptance Test (FAT) verifies that equipment meets its specifications at the vendor’s site before shipment. Done well, a FAT catches problems while the equipment is still with the maker (cheap to fix) and generates documented evidence that can be leveraged in later qualification, reducing duplication under a risk-based (ASTM E2500) approach.
- 1
Define the FAT protocol from the specifications
Build the protocol from the specifications rather than from the supplier’s standard test sheet, so that what is tested is what was ordered. A supplier FAT demonstrates that the machine works as the supplier built it; the purpose of your protocol is to demonstrate it works as you specified it, and the difference between those is where the disputes are.
- 2
Focus on what is hard to fix later
Concentrate on what is hard or expensive to fix once the equipment is on site: fabrication quality, materials and finishes, drainability, dimensional conformity, and the software functions that would require a return visit to change. Anything that can be verified at site with equal cost can wait; anything that cannot is the reason for being in the supplier’s factory at all.
- 3
Witness and record
Witness the tests rather than receiving the results, and record what was observed, including the conditions and any deviations from the protocol. A FAT report signed on the basis of the supplier’s own execution is a supplier document; the witnessing is what makes it evidence, and evidence is what can later be leveraged into qualification.
- 4
Resolve punch-list items before shipment
Resolve punch-list items before shipment where the item is easier to fix in the factory, and classify the rest explicitly. The leverage available before the equipment leaves is far greater than the leverage available after, and items carried to site with an agreement to resolve later are resolved later only sometimes.
- 5
Link FAT evidence to qualification
Link the FAT evidence to the qualification plan deliberately, recording which tests are intended to be leveraged and why they are adequate. Leverage decided in advance shapes how the FAT is documented; decided afterwards it usually finds records that are not of a standard that can be used, and the test is repeated.
- !Treating the FAT as a vendor demo rather than a documented, witnessed verification.
- !Not defining acceptance criteria in advance, so "pass" is subjective.
- !Letting the equipment ship with open critical defects.
- !Failing to document the FAT so its evidence cannot be leveraged in qualification.
How to Run a Factory Acceptance Test: frequently asked questions
Common questions on run a factory acceptance test.
What is a Factory Acceptance Test?
A FAT verifies that equipment meets its specifications at the vendor’s facility before shipment, using a pre-agreed protocol with defined acceptance criteria. It catches problems while the equipment is still with the maker and generates evidence usable in later qualification.
What is the difference between FAT and SAT?
A Factory Acceptance Test is performed at the vendor before shipment; a Site Acceptance Test (SAT) is performed after installation at your site. FAT verifies the equipment as built; SAT verifies it after transport and installation in its actual environment.
Can FAT evidence reduce qualification effort?
Yes. Under a risk-based approach (ASTM E2500, Annex 15), well-documented FAT (and commissioning) evidence can be leveraged so IQ/OQ focuses on what changed or what is critical, rather than repeating what the FAT already verified.