Who should write the filling-machine URS?
The customer should own the URS because it describes the production and site requirement, but it is normally developed with input from production, engineering, quality, safety, maintenance, procurement and the machinery supplier. The supplier can identify missing information and propose a solution, but should not silently define the customer’s acceptance criteria.
Name an owner for each requirement and an approval route for changes. Unresolved points should be visible assumptions or actions rather than hidden in general quotation wording.
How should mandatory requirements be separated from preferences?
Mark each statement as mandatory, preferred, optional or for information. A mandatory requirement must have a reason and a practical verification method. Preferences can guide design without causing a compliant solution to be rejected unnecessarily. Options should be priced or scoped separately when they are not part of the base duty.
Avoid words such as “suitable”, “fast” or “easy” without defining what will be observed. Replace them with the decision or result the team needs to verify.
State the product, dose, container, number of active heads, measurement method, sample method and production condition associated with the requirement. Separate peak machine rate from sustained complete-line output. Define how first-off, steady running, refill, pause and restart are treated, and whether every head must be assessed.
Do not insert an unsupported percentage simply because it is easy to quote. Where evidence is not yet available, make the trial responsible for setting a verified acceptance value.
How should assumptions and unknowns be controlled?
List each assumption with its owner, effect and resolution date. Examples include product viscosity at fill temperature, bottle tolerance, site utilities, existing conveyor signals or the amount of cleaning access. An assumption should not be presented as a confirmed fact, and a quotation should state what changes if it proves wrong.
Use a requirements and action register through design review, trial, FAT and SAT so open points do not disappear between commercial and engineering documents.
How does the URS connect to FAT and SAT?
Each testable URS requirement should trace to a design response and an acceptance activity. FAT normally verifies what can be demonstrated at the supplier’s premises; SAT confirms installation, utilities, interfaces and production behaviour at site. Some requirements need evidence from both stages or from later performance qualification.
Agree the traceability method before FAT. A requirement without a defined verification route is likely to become a subjective dispute at handover.
How can a URS avoid over-specifying the machine?
Describe the required outcome, constraints and evidence, then allow the supplier to propose the dosing and handling method unless a technology is genuinely mandatory. Prescribing a particular actuator, pump or layout without an application reason can exclude simpler or more suitable options. Conversely, safety, hygiene, compatibility and interface constraints must not be left vague.
Use “shall” for controlled requirements and explain the production reason. Keep design preferences in a separate section that can be challenged during review.
