Sep 30, 2026Translation missing: en.blog.post.reading_time

Aesthetic Machine Factory Acceptance Test Before Shipment

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LEFISA factory acceptance test, or FAT, gives the buyer a defined point to confirm that the machine matches the order and completes agreed checks before shipment. It does not replace regulatory review, installation qualification or clinical training. It does reduce avoidable disputes about configuration, accessories, visible damage and basic operation.

The most useful FAT is agreed before production and recorded against the exact serial number. A last-minute video chosen by the supplier is better than nothing, but it is not the same as a buyer-approved test plan with pass criteria.

Quick Answer

A factory acceptance test should prove that the finished, serial-numbered machine matches the approved order and passes agreed checks before shipment. Freeze the configuration, test conditions, pass criteria and evidence format in advance. The FAT should cover identity, accessories, safety controls, functional operation, software, documents and packaging, with every failure recorded, corrected and retested.

Best for: Clinics and distributors ordering customized, high-value or multiple aesthetic machines.
Verify first: Ordered configuration, unit identity, measurement method, pass criteria and evidence ownership.
Decision standard: Authorize payment and shipment only after open items are closed or formally accepted in writing.

Write the FAT protocol before the machine is finished

The factory acceptance test should be agreed while production and configuration decisions can still be changed. Attach the protocol to the final quotation or order and identify the machine category, exact model, voltage, plug, software language, handpieces, applicators, wavelengths, cartridges, consumables, accessories, manuals and packaging. The FAT is then a check against a defined order, not a general demonstration chosen at the last minute.

For each test, state the method, operating condition, number of repetitions, expected result, acceptance range and evidence to retain. Identify who performs the test, who witnesses or reviews it and who has authority to release the machine. If the buyer will attend remotely, agree on camera coverage, live questions, continuous recording and the way measurement screens or instruments will be shown.

Avoid vague criteria such as 'machine works normally' or 'quality is good.' Useful criteria can be observed or measured: all ordered channels operate, accessories are recognized, safety controls behave according to the manual, cooling remains stable during the agreed run, labels match the destination and no open defect affects release. The level of testing should reflect the device, contract, destination and order risk.

Figure 1. A useful FAT begins with the complete ordered configuration and a buyer-approved test plan.

Freeze the ordered configuration first

The acceptance plan should reference the final quotation or specification sheet. List the model, voltage, plug, software language, handpieces, applicators, wavelengths, cartridges, accessories, consumables, labels, manuals and packaging marks. If the buyer approves a substitution, record it in writing before the test.

Configuration field	Record	Why it matters
Legal manufacturer	Name and manufacturing address	Links the device to labels and documents
Model and serial number	Console and major accessories	Creates unit-level traceability
Electrical rating	Voltage, frequency, power and plug	Prevents installation mismatch
Software	Version, language and enabled functions	Confirms the ordered interface
Energy delivery parts	Laser source, tube, handpiece, applicator or cartridge	Confirms the functional configuration
Accessories	Eyewear, footswitch, holders, cables and tools	Prevents missing-item disputes
Documents	Manual, labels, test record and certificates	Supports installation and market review
Packaging	Case, cushioning, moisture protection and marks	Supports transport and receipt inspection

Make every result traceable to the tested unit

Every FAT record should identify the machine serial number and the serial or part identity of major handpieces, applicators or modules where applicable. Record the software version, test date, environmental conditions, warm-up, settings, load or applicator configuration and the measuring instrument. If an instrument is used, retain its identity and calibration status so the result can be interpreted later.

Video evidence should begin with a continuous view of the complete machine and rating label before moving to the screen, connections and functional test. This makes it harder for results from another unit to be substituted accidentally. For measurements, show the method and result rather than filming only the console display. If settings are changed between repetitions, record them clearly.

When an item fails, document the finding, corrective action, replaced part and retest. The corrected unit should pass the original acceptance criterion; a note saying 'fixed' is not a retest. Classify the final decision as accepted, accepted with clearly listed open items, or not accepted. Open items need an owner, deadline and evidence requirement, and serious configuration or safety differences should pause shipment or balance release.

Figure 2. Serial numbers, connectors, accessory identities and test records should all point to the same unit.

Agree on test conditions and pass criteria

A result is meaningful only when the method is stated. Record the instrument, calibration status, test location, machine settings, warm-up, environmental conditions, load or applicator configuration, number of repetitions and acceptance range. The FDA’s laser quality-control guidance emphasizes valid measurement techniques, calibration, evaluation during and after production, rejection criteria and re-testing of corrected units. [1]

Not every buyer needs to reproduce a laboratory test. The goal is to distinguish a documented production check from an unsupported number on a screen. Complex safety or performance testing should be conducted by qualified personnel with suitable equipment.

Figure 4. Acceptance decisions require defined limits, calibrated instruments and recorded measurements.

Use a four-part acceptance sequence

1. Identity and visual inspection

Show the complete machine, rating label, model and serial number in one continuous recording.
Inspect panels, screen, connectors, cables, handpieces, wheels, vents and fasteners.
Confirm labels are legible and match the ordered language and destination.
Compare every included accessory with the packing list.

2. Power-on and safety controls

Start the machine using the normal procedure and show the software version.
Demonstrate key switch, user access, emergency stop and applicable interlocks.
Confirm alarms appear and clear according to the manual.
Check that fans, pumps, flow indicators and temperature monitoring operate as designed.

3. Functional operation

Operate every ordered handpiece, channel or applicator.
Demonstrate representative settings within the device instructions.
Check screen controls, counters, footswitch and accessory recognition.
Observe continuous operation long enough to identify unstable cooling, connection or restart behavior.
For measured output, record the method and results rather than filming only the display.

4. Shutdown, documents and packing

Complete the normal shutdown and restart.
Review maintenance instructions, service contacts and warranty documents.
Photograph accessories and consumables before packing.
Show protective caps, locks, cushioning and moisture protection.
Seal and mark the package, then retain final weight and dimensions.

Device-specific additions

Machine category	Useful additional checks	Do not accept
Diode laser	Handpiece identity, water flow, cooling stability, window condition	Only a cold-start temperature photo
Picosecond or Q-switched	Wavelength modules, spot control, warm-up and documented energy test	Screen energy used as independent proof
CO2 laser	Tube or source identity, scanner movement, delivery system and plume accessories	Operation without room and safety requirements
HIFU	Handpiece and cartridge recognition, counters and ordered depths	Untraceable or unpackaged cartridges
RF microneedling	Handpiece, supported cartridges, depth control and packaging	Reused demonstration cartridge presented as new
EMS or body contouring	All channels, applicators, holders, alarms and cooling	One applicator tested for a multi-applicator order

Figure 5. Sustained-load testing reveals cooling and output problems that may not appear at startup.

Handle failures without lowering the standard

If an item fails, record the finding, corrective action, replaced part and repeat test. The corrected unit should pass the same relevant acceptance step; a message saying “fixed” is not a retest. For a major configuration or safety discrepancy, pause balance payment or shipment until the evidence is complete.

The FAT should end with one of three decisions: accepted, accepted with clearly listed open items, or not accepted. Open items need an owner and completion evidence. Avoid signing a blank or generic inspection form.

What the FAT cannot prove

It does not establish that the device is legally marketable in the destination.
It does not replace independent safety or performance testing required by regulation.
It does not validate clinical outcomes or create a treatment protocol.
It does not confirm that the shipping carrier will avoid damage.
It does not replace installation, training, maintenance or post-market support.

Close the FAT with packaging and an evidence pack

Acceptance is not complete when the machine powers down. Photograph every included accessory, consumable and spare part before packing, then compare the count with the quotation and packing list. Show protective caps, locks, cushioning, moisture protection, accessory boxes and crate markings. Record final packed weight and dimensions when they are relevant to freight or site access.

The evidence pack should include the approved order, FAT protocol, signed results, serial-number photographs, test videos, final manuals, label images, accessory list, packing photographs and open-item closure. Provide the buyer with durable access before shipment rather than relying on links that may expire. The same pack should be available to the installer so delivery and commissioning can be compared with the factory record.

At receipt, inspect the crate before signing, photograph external damage and verify seals. During installation, repeat identity, electrical, accessory, startup, alarm and functional checks under local room conditions. The factory test does not replace installation or training, and it cannot guarantee that shipping will avoid damage. It provides the baseline that allows the buyer and supplier to identify where a discrepancy occurred and resolve it with evidence.

Figure 3. Final packaging evidence should show the protected machine, accessories and packing record before shipment.

Retest at delivery and installation

At receipt, inspect the package before signing, photograph any external damage, verify seals and compare the contents with the FAT record. During installation, confirm electrical compatibility, room conditions, startup, accessories and training. Keep the FAT, receipt inspection and commissioning record together under the machine serial number.

Figure 6. Site acceptance checks transit condition, serial identity, utilities and operation after delivery.

Use a sampling plan for multi-unit orders

Testing one machine is not enough when several units are being shipped. Identify which checks apply to every serial number and which deeper tests may use a buyer-approved sample. Identity, configuration, visible condition, accessories, power-on behavior and basic safety controls should normally be traceable to each unit. More time-consuming performance or endurance checks can follow a documented sampling rule when appropriate.

The plan should state how units are selected, how sample size changes with order quantity and what happens when one unit fails. A failure may require expanded sampling or testing of the full lot. Do not let the factory replace a failed sample with a convenient passing unit without recording the event. The final report should show which tests belong to which serial numbers.

Lock software and configuration versions before shipment

The FAT record should identify the installed software or firmware version together with the enabled functions, language and key configuration settings. Photograph or export the available version screen and link it to the serial number. Confirm whether the tested version is the same version that will ship and whether any update is planned before packing.

If software changes after testing, define which checks must be repeated. An update can affect menus, alarms, accessory recognition, saved settings or service functions even when the hardware is unchanged. Record the reason, new version and retest result. The buyer should receive release notes or a written explanation of material changes needed for operation and training.

Close every nonconformity with an evidence-based retest

A useful failure log states the requirement, observed result, affected unit, evidence, owner and due action. Avoid vague entries such as fixed or adjusted. The supplier should describe the correction, identify any replaced part or changed setting and explain whether other units or records may be affected.

Retest against the original method and pass criterion, then attach the new result to the same item. Keep the first failure visible rather than deleting it from the final report. Open items should have a written disposition: corrected and passed, accepted with a defined condition, or not accepted. Final shipment approval should reference the closed log so that commercial release is tied to the actual evidence.

Figure 7. Every nonconformity should show the correction, independent retest and final release decision.

Tie FAT closure to payment and shipment authority

The contract should identify who may approve the FAT, release the remaining payment and authorize shipment. These decisions may belong to different people. Define the evidence each person receives and make sure approval is attached to the final serial-number report rather than a sales summary or an earlier demonstration.

State how open items affect payment and dispatch. Minor agreed items may be listed with an owner and deadline, while a safety, configuration or performance failure should block release until retest. The shipping team should receive the accepted report and closure list. This prevents a packed machine from leaving the factory while the buyer still believes acceptance is pending.

Close the FAT With Two Decision Records

The final FAT decision should be traceable without replaying a long video or reconstructing a chat thread. These records show what passed, who accepted it and how any exception affects shipment authority.

FAT Evidence Register

Complete the register for each tested unit or approved sampling group. Reference the actual file name, photograph, video segment or measurement record rather than writing pass without supporting evidence.

Test block	Acceptance evidence	Sign-off owner
Identity and configuration	Nameplate, serial number, software, accessories and ordered options match the frozen specification.	Supplier quality and buyer representative
Safety and controls	Startup, stop, alarms, interlocks and abnormal conditions follow the approved protocol.	Technical or safety reviewer
Function and output	Required modes, applicators and measured outputs meet stated acceptance criteria.	Test engineer
Sustained operation	Agreed load period records stable cooling, alarms and operating behavior.	Test engineer and quality reviewer
Packing and documents	Accessories, labels, manuals, evidence files and transport protection match the release list.	Shipping and quality owners

Keep acceptance criteria separate from observed results. A clear record allows a buyer to confirm that the test followed the agreed protocol instead of accepting a result because the machine appeared to operate.

Nonconformity Release Matrix

Define severity before testing begins. The examples below are decision categories, not a substitute for the buyer's product-specific acceptance criteria or applicable safety requirements.

Severity	Required correction	Shipment status
Critical safety	Correct the cause and repeat all affected safety and functional tests with complete evidence.	Shipment prohibited until written closure.
Major functional	Repair or replace the affected assembly and repeat the defined operating test.	Hold the unit until buyer approval of the retest.
Configuration or document	Correct the mismatch and verify every linked label, file and packing record.	Hold if identity, use, import or installation could be affected.
Cosmetic	Document location and extent; repair or obtain explicit buyer acceptance.	Ship only under the agreed cosmetic acceptance rule.
Observation	Record the point and confirm that no acceptance criterion is breached.	May ship if the protocol permits and the observation remains traceable.

No open item should disappear into a general promise to fix later. The FAT file should show the correction, retest evidence, approver and final shipment status for every nonconformity.

Request a LEFIS acceptance plan

Review our aesthetic machine manufacturing page, factory information and quality-control process. To discuss a model-specific pre-shipment inspection and quotation, contact LEFIS Laser with your destination, configuration and required acceptance evidence.

FAQs

Is a factory acceptance test the same as a certificate?

Short answer: No. A certificate indicates that a quality system, product or assessment has met a defined scope, while a factory acceptance test checks whether the actual ordered unit satisfies agreed commercial and functional criteria before shipment.

What to check: The FAT may confirm configuration, serial identity, accessories, startup, output, safety functions, cooling, software and documentation, but it does not create market authorization or replace required compliance evidence. Both can be important and they answer different questions.

Buyer action: keep the certificate register and FAT report as separate purchase records, then cross-check that their manufacturer, model and configuration details agree before releasing final payment This keeps the records auditable..

Keep on file: Keep the agreed FAT protocol and serial-specific results separate from certificates, declarations and regulatory evidence so each document's purpose remains clear.

Can the FAT be completed by video?

Short answer: A video FAT can be useful when travel is impractical, provided the test is planned, witnessed live and supported by a complete report.

What to check: The buyer should control the agenda, see the serial number and uncut test sequence, request close views of measurements and ask the operator to repeat selected steps. Prerecorded highlights alone are weak evidence because they may not show the purchased unit or failures. Review LEFIS Laser's aesthetic machine manufacturing process before agreeing how the test will be witnessed.

Buyer action: require a continuous time-stamped recording, copies of instrument readings and signed results, and reserve the right to use an independent inspector for high-value or technically complex orders.

Keep on file: Retain the recording plan, continuous time-stamped footage, serial and configuration views, instrument readings, witness details and original files or independent inspection report.

When should the buyer approve the FAT plan?

Short answer: Approve the FAT plan before production is complete and preferably before the deposit becomes non-refundable.

What to check: Early agreement gives the factory time to prepare fixtures, calibrated instruments, sample loads and documentation, and it prevents arguments about what “normal operation” means after the machine is built. The plan should identify the ordered configuration, test sequence, acceptance limits, evidence format, witness method, nonconformity process and authority to release shipment.

Buyer action: attach the approved FAT protocol to the purchase order and state that changes require written agreement; this turns the test from an informal factory demonstration into an enforceable acceptance step Include the buyer's witness details..

Keep on file: File the buyer-approved FAT plan before production, including configuration, methods, test conditions, acceptance limits, evidence format, approvers and payment or shipment gates.

What evidence should appear in the FAT report?

Short answer: The report should identify the buyer, supplier, legal manufacturer, model, serial number, software version and ordered accessories.

What to check: For every test, it should show the method, instrument used, calibration status where relevant, measured result, acceptance criterion, pass or fail status, date and responsible person. Add photographs of labels, configuration, included items and key measurements, plus a list of deviations and their closure evidence. LEFIS Laser's factory information can help buyers understand where assembly and inspection records originate.

Buyer action: insist on the completed report before shipment approval and reject blank pass boxes, cropped photos or results that cannot be tied to the serial-numbered unit.

Keep on file: Keep the exact unit identity, measured values, instruments and calibration status, test conditions, pass criteria, photographs or video references, deviations and signatures.

How should the cooling system be tested under load?

Short answer: Test cooling during a sustained operating sequence that represents the intended clinical workload, not only at startup.

What to check: Record initial and operating temperatures, coolant level or flow where applicable, fan and pump behavior, alarms, noise, leakage and recovery after repeated energy delivery. Run all relevant handpieces or channels and observe whether output is reduced as the system heats. The acceptance limit should come from the model specification and approved protocol.

Buyer action: begin with a cold machine, document room temperature, run the full cycle without unexplained pauses and retain the time-series readings; this makes later service comparisons possible if overheating or instability appears.

Keep on file: Retain the sustained-run log showing settings, duration, coolant or temperature observations, flow or ventilation status, alarm behavior, calibration details and recovery result.

What should happen when an item fails the FAT?

Short answer: The failed item should be recorded as a nonconformity with its requirement, observed result, evidence, risk, owner and due date.

What to check: The supplier should investigate the cause, correct the issue and repeat the affected test plus any related tests that could have been influenced. The buyer should not accept a verbal promise or a photo of a replaced part as automatic closure. Shipment and payment status should follow the contract's severity rules.

Buyer action: classify failures as blocking, conditional or minor before testing begins, and require signed retest evidence for every blocking item; unresolved failures should remain visible on the final report rather than being deleted.

Keep on file: File the nonconformity report with severity, affected requirement, containment, root cause, correction, corrective action, retest evidence, approver and final release decision.

Does pre-shipment acceptance replace installation acceptance?

Short answer: No. Factory acceptance verifies the unit before it leaves the supplier, while site acceptance confirms that the delivered machine, accessories, utilities, installation and operation are correct at the clinic.

What to check: Transit damage, missing parts, electrical differences or setup problems can arise after a successful FAT. The clinic should compare serial numbers and packing contents, inspect condition, verify utilities, repeat critical functional checks and complete training before clinical release. LEFIS Laser's quality control information can be used to align pre-shipment evidence with site checks.

Buyer action: write both acceptance stages into the contract and retain a final payment portion until the agreed installation or site acceptance requirements are complete.

Keep on file: Keep separate FAT and site-acceptance checklists linked by serial number, covering transit condition, utilities, installation, accessories, room controls, function and final handover.