A cabina di pesatura qualification file usually lists two acceptance events — FAT and SAT — but the harder question is what belongs in each one. Treat the split as a formality and the project either pays for duplicate testing it did not need or discovers at site that a requirement was never actually verified anywhere. Getting the scope boundary right at the start of the test program is what makes the rest of the acceptance record defensible.

Start With the URS and Acceptance Matrix

Every requirement in the user requirement specification implies a location where it can be checked, a condition that must exist for that check to mean anything, someone accountable for producing the result, and a path for what happens if the result does not match. Skipping this mapping is what causes FAT/SAT disputes later, because a requirement written in general terms (“airflow shall be verified”) does not say whether the factory floor or the finished room is the valid place to verify it.

The location question matters because a check performed in the wrong setting can produce a result that looks complete but carries no real evidence value. A control sequence can be exercised on a bench with no duct run attached; an alarm can be triggered with a test signal before any sensor is actually mounted in its final position. Both produce a passing result. Neither tells the project whether the behavior holds once the booth is installed, connected, and operating as part of the room. The prerequisite column in a traceability matrix exists precisely to capture this: it states what has to be true — agreed factory conditions, or the approved site setup — before a given check is allowed to count as evidence.

Assigning an evidence owner is not an administrative step. Where the supplier generates and holds the data, the project team’s job shifts to review and acceptance; where the site team generates the data, the supplier’s prior documentation becomes a reference baseline rather than the final record. Conflating the two roles is how gaps appear — each side assumes the other closed out a requirement that neither actually tested under valid conditions.

The exception route is the part most often left implicit. If a requirement cannot be met at the assigned stage — a specification was unavailable, a utility was not yet connected, a document had not been finalized — the matrix needs a defined route for raising, tracking, and closing that gap before it reaches qualification. Without that route, exceptions get carried forward informally and resurface as objections during IQ/OQ/PQ review, when correcting them is harder and slower than resolving them at the stage where they were first identified.

Assign Build and Functional Checks to FAT

FAT exists to confirm what the supplier can demonstrate under conditions the supplier controls. That boundary is the test: if a check depends only on how the unit is built, wired, and configured — not on the room it will sit in — it belongs at FAT.

Construction and document review fall cleanly inside this boundary. Material certificates, surface finish, dimensional conformance to the approved drawing, nameplate and labeling accuracy, and the internal wiring and control panel layout can all be verified against the design record without any site condition in play. The same applies to control logic: sequence of operation, interlocks between components that are already part of the unit, and alarm generation at the control level can be exercised using the booth’s own internal signal paths, independent of how it will eventually be ducted or powered at site.

Functional checks that rely only on the booth’s self-contained systems also sit naturally in FAT. A blower can be run up, a differential pressure gauge can be read against a simulated resistance, a filter can be checked for correct seating and leak integrity using the supplier’s own test rig, and a local alarm can be confirmed to trigger and annunciate correctly. None of these results change when the unit is later connected to site ductwork, power, or a building management system — they test the equipment’s own build quality and internal logic, not its behavior as an installed system.

Where a requirement sits at the boundary — for example, an alarm that will eventually interface with a site-level monitoring system — the FAT scope should cover what the booth’s own output does (does it generate the correct signal, at the correct point, in the correct format) without claiming to verify how that signal behaves once it reaches a system the supplier does not control. That distinction keeps the FAT record honest about what it actually proves, which matters when the same requirement reappears at SAT in a different form.

Move Site-Dependent Interfaces and Performance to SAT

SAT exists because some requirements cannot produce valid evidence until the booth is physically installed in its intended location, connected to the actual site utilities, and operating as part of the finished room. The governing condition is the approved site setup: if a result depends on the real duct run, the real power supply, the real room pressure cascade, or the real position of the booth relative to other equipment, no factory test — however carefully built — can substitute for it.

Airflow behavior is the clearest example. A supplier can confirm a fan curve and a nominal flow rate on a test rig, but the actual velocity profile, uniformity, and recovery behavior inside the booth depend on the ductwork geometry, the static pressure the site system imposes, and the room’s own air balance. These are properties of the installed system, not the standalone unit, and they can only be meaningfully measured once that installation is complete.

Room integration points follow the same logic. Differential pressure against the surrounding room, interface with the facility’s building management or monitoring system, and the behavior of alarms once they are wired into a site-level panel all depend on connections and conditions that do not exist at the factory. A control signal that was confirmed correct at FAT still needs confirmation that it reaches the intended destination, in the intended format, once the site wiring is in place — that is a different check from the one performed earlier, even though it touches the same alarm.

Utility-specific checks also belong here: actual supply voltage and quality, the real compressed air or process utility connection where applicable, and any site-specific environmental condition the booth will operate under. Where the URS specifies a performance requirement in terms of the room rather than the unit — stated cleanliness behavior, cross-contamination control relative to adjacent operations — that requirement is inherently a SAT item, because the room is the thing being evaluated, not the booth in isolation. The acceptance criteria referenced for a comparable sampling booth installation reflect this same principle: performance tied to the installed environment is confirmed in that environment.

Decide What Must Be Repeated After Delivery

Automatically repeating every FAT test at SAT wastes effort on checks that cannot have changed; automatically skipping repeats risks accepting a result that transport, reassembly, or site connection has silently invalidated. The governing question is narrower than “was this tested before”: it is whether the thing that could affect this specific result has changed since the last valid test.

Transport is one such condition. Vibration, shock, or handling during shipping can loosen a connection, shift a seal, or disturb a calibrated setting that was correct when it left the factory. Where a requirement depends on a physical condition that transport could plausibly disturb — seal integrity, filter seating, mechanical alignment — that check is a candidate for repeat, not because the original FAT result was wrong, but because the condition it depended on may no longer hold.

Reassembly introduces a related but distinct risk. Where a unit is partially disassembled for shipping and rebuilt at site, any check that depends on correct reassembly — component fit, internal wiring continuity, control panel connections — needs reconfirmation, because the FAT result verified the original assembly, not the one that exists after the unit was taken apart and put back together.

Site connection is the third trigger, and it is the most direct extension of the FAT/SAT boundary already established: once utilities, ductwork, or monitoring interfaces are connected, any requirement whose result depends on that connection needs to be evaluated again, because the FAT result only ever covered the unit’s behavior in isolation.

The approved protocol itself can also require a repeat, independent of any physical change, where the project’s qualification plan specifies that certain checks must be demonstrated under site conditions regardless of a prior factory result. In that case the repeat is a documentation and acceptance requirement rather than a response to a known risk — the project has decided, in its protocol, that site-condition evidence is the only evidence it will accept for that requirement. A weighing booth’s OQ-stage checks for airflow, particle monitoring, and alarm verification illustrate the kind of requirement where site-condition evidence is typically the standard the protocol expects, rather than a factory result carried forward.

Close Exceptions Before Qualification Handover

An exception that is noted but not closed does not disappear at qualification — it resurfaces as a gap in the traceability record, at the point where it is hardest to resolve. Every deviation recorded during FAT or SAT needs a defined disposition before the file moves forward: either the requirement is retested and shown to pass, the specification is formally revised to match what was actually achievable, or the deviation is accepted through whatever change-control or deviation process the project has approved, with a documented justification.

What closure must not mean is a verbal agreement or an informal understanding that the item will be addressed later. Qualification activities — installation, operational, and performance qualification — depend on a complete and traceable acceptance record as their starting evidence base. A gap carried forward without formal disposition means the qualification stage inherits an unresolved question about whether the equipment, as built and installed, actually meets its specified requirement. That is a different and harder problem to solve once PQ-level activity is already underway, because the conditions under which the original exception arose may no longer be reproducible.

The project’s own change-control and deviation procedures govern how an exception is formally accepted, and the specific limits for any given requirement belong in the approved project protocol rather than in a general FAT/SAT framework — this is the boundary EudraLex, volume 4, allegato 15 draws between vendor and site acceptance activities on one hand and the IQ, OQ, and PQ evidence built from installation and challenge testing under intended operating conditions on the other. The traceability matrix that assigned each requirement to FAT, SAT, or a repeat should also be the record that shows every exception’s disposition, so that qualification handover can rely on one complete document rather than reconstructing the acceptance history from separate test reports. Where the project information supplied at the start — the URS, the agreed test locations, the evidence owners — was used to configure the acceptance plan during quotation review, that same information should match what the closed-out matrix actually shows, with no requirement left pointing to a location or condition that was never verified.

Domande frequenti

Q: Does a successful FAT remove the need for SAT on a weighing booth?
A: No. FAT can establish evidence for construction, controls, alarms, and functions demonstrated under agreed factory conditions, while SAT must address site utilities, room integration, airflow behavior, and alarm interfaces under the approved site setup.

Q: Can FAT evidence be carried into the qualification package?
A: It can be carried forward when the approved protocol accepts the evidence and the FAT conditions satisfy the relevant URS requirement. Map each item to its prerequisite and test location rather than treating FAT as an automatic substitute for site qualification evidence.

Q: Which FAT checks should be repeated after delivery?
A: Repeat a check when transport, reassembly, site connections, or the approved protocol could affect its result. Record the repeat decision against the relevant URS requirement so the team can distinguish necessary confirmation from routine duplication.

Q: What information should be ready before the FAT and SAT protocols are agreed?
A: Prepare the current URS, the approved factory and site test conditions, site utility and room-interface information, alarm-interface requirements, evidence ownership, and the approved exception route. These details determine where each check can produce valid evidence.

Q: How should an exception found during FAT or SAT be handled?
A: Link it to the affected URS requirement, assign the evidence owner, and follow the approved project exception route. Confirm whether it affects any dependent test, then close the exception before qualification handover.