FAT and SAT for Packaging Machines: What to Require, What to Document, and What to Hold Payment Against

Write the acceptance criteria before the machine is built

Acceptance criteria belong in the purchase documents, not in the conversation at the factory. A written validation protocol should specify the critical process steps, the acceptance criteria, the type of validation and the number of process runs.

It should also be reviewed and approved by the quality unit before the activity starts¹. That protocol is written for API manufacturing, but the structure transfers: you name what will be measured, what value passes, and how many runs count.

The reason to fix the numbers early is that the vendor's headline figure is not a production figure. Rated speeds are often achieved under conditions that do not reflect real production runs.

So the documented specification you request should carry tested output rates on your actual product rather than the manufacturer's rated maximum on ideal test material¹⁹. A machine that runs at its rated rate on the vendor's demo film tells you nothing about your laminate, your fill weight or your pack format.

So decide now which values you will accept as pass/fail, and write them against your product and format. If you leave the criteria to be agreed on the factory floor, you are accepting the machine against the vendor's rated maximum — the one number the evidence says not to rely on¹⁹.

Rule out quotes that do not commit to a full install package

Treat the install package as a single deliverable and check that the quote names all of it. A complete install package from a packaging-machine supplier is described as including FAT/runoff validation, defined acceptance criteria, on-site commissioning, and training for both operators and maintenance staff³⁰.

A quote that offers the machine and commissioning but leaves the runoff validation or the training to a later negotiation has not committed to that package.

The same source also links the install package to post-sale support, but what it records there is a supplier claim about how support is structured — response targets, tiered escalation, proactive maintenance and reporting are the supplier’s own description³⁰.

The spare-parts strategy covers recommended spares lists, realistic lead times, in-stock availability expectations and an obsolescence plan³⁰. Those are supplier positions on what good support looks like, not contract terms you can assume.

Ask for them in writing and price them into the comparison. A vendor who will not put FAT/runoff validation, acceptance criteria, commissioning and training into the offer is telling you where the argument will happen after the deposit clears.

Separate brochure figures from acceptance values

Published speed and changeover figures describe typical or rated capability, so they are claims to verify rather than values to sign against¹⁹¹². The clearest example is changeover.

Machines in the 10-30 cases/min case-erecting bracket are described as typically featuring quick-changeover tooling and HMI recipe management that let operators switch SKUs in under 15 minutes¹². That is a reported capability of a machine class, not a measurement of the unit you are buying.

Changeover also attracts targets from outside equipment specification. SMED, a general improvement method, aims to reduce changeover to under 10 minutes, though the source notes this is not always possible depending on line size and scope.

It reports an average reduction of 94% across the companies where it was applied²⁴. A methodology target and a machine's reported capability are different kinds of number, and neither is a pass/fail value for your machine.

For your contract, the acceptance value is the one measured on your product, your film and your pack format during the runoff¹⁹. Ask the vendor to state, in the offer, which figures are rated and which will be demonstrated on your material — and hold the demonstrated ones as the criteria.

Make safety documentation a precondition, not an afterthought

A system operating near human workers typically needs to meet specific safety standards. Sourcing guidance for robotic packaging automation lists what to look for: compliance with relevant robotic safety standards, proper guarding, light curtains or safety-rated monitored stopping for non-collaborative cells.

It also lists documentation supporting risk assessments and safety validation for the specific installation²². The documentation is the part buyers forget to ask for until the line is already standing on the floor.

Regional practice supports treating this as a gate. German plant engineering teams are described as emphasising machinery safety and control documentation before changing a validated line that supports recurring production¹⁰.

That is a description of a market's habit, not a rule that binds your project. But it shows the documentation is treated as a precondition rather than a formality in at least one major equipment market.

Before you accept the installation, ask the vendor which standards it is actually claiming for your machine and get the risk assessment and safety validation documents for your specific installation²².

Which named standards apply to a given packaging machine is not settled by these sources, so make the vendor state its claim and support it.

The document list to hand the vendor before the FAT

Build the list from what the sources actually establish, then add your own product-specific items. The evidence shows equipment acceptance is documentation-heavy in adjacent regimes.

Qualification is carried out as documented verification activities with a validation report that cross-references the protocol, summarises results, comments on deviations and recommends corrective changes¹. But it does not hand you a packaging-machine FAT document set.

Use the checks below as the framework and let the vendor fill the specifics.

• ✓A written acceptance protocol naming the critical process steps, the acceptance criteria and the number of runs, approved before the FAT
• ✓The FAT/runoff validation and the defined acceptance criteria, named in the offer rather than agreed later
• ✓Tested output rate on your actual product, not the rated maximum on ideal test material
• ✓The changeover figure the vendor will demonstrate, stated as a tested value for your SKUs
• ✓Risk assessment and safety validation documentation for your specific installation
• ✓On-site commissioning and operator and maintenance training as part of the same package
• ✓Recommended spares list, lead times and an obsolescence plan

When the plant is regulated or the product goes to the EU

A commercial acceptance test is not the whole obligation in every market. Regulated plants are described as requiring documented validation before commercial use of packaging equipment¹⁰.

So if your line sits in a regulated category, the acceptance record feeds a compliance file rather than just a payment decision.

Packaging placed on the EU market carries its own paperwork: a Declaration of Conformity and complete technical documentation are required, with further obligations phased in from harmonised labelling in 2028 to recycled content and reuse targets in 2030¹⁶.

That obligation attaches to the packaging, not to the machine's FAT, but it changes what you need from the vendor at handover. Ask early whether your installation is in scope for either regime, because the answer changes the document list and the timing of release.

The sources do not establish which specific standards or approval routes apply to a given packaging machine, so confirm scope with your own regulatory function before the PO is signed.

Clauses to settle before the PO, not at the factory

The sources do not supply standard commercial figures for any of these, so treat each line as a term you write and negotiate rather than a benchmark you can look up.

The protocol requirement is the anchor: the number of process runs and the acceptance criteria should be fixed in the written protocol before the activity begins¹.

• ✓How many runs count as a valid test, and what invalidates a run — fixed in the protocol before the FAT
• ✓Who supplies product, film and utilities for the runoff, and who bears the cost of a retest
• ✓Whether you or the vendor witnesses the FAT, and who pays travel for witnessing
• ✓What happens if a criterion fails: rework, retest, or rejection, and who pays for each
• ✓Payment milestones you require around the FAT result, the SAT result and the training completion — the sources do not supply standard terms
• ✓SLA and warranty terms, verified rather than accepted on promise
• ✓Spare-parts list, lead times and obsolescence plan attached to the handover package

Where the sources disagree on changeover

Changeover is the one performance figure where two sources give different numbers for something a buyer might write into a contract. They are not measuring the same thing, which is exactly why you should not copy either into an acceptance clause without deciding what you are testing.

What to confirm before you order

• Ask the supplier for model-specific evidence and record the condition that would change your buying decision.
• Request certificate numbers, issuing bodies, scope and validity for the exact model and destination market.
• Confirm factory audit access, production equipment, inspection stages and FAT/SAT records.
• Confirm named service coverage, response expectations and warranty terms for your destination.