Home / Guides / Hygienic design at audit
HYGIENIC DESIGN · FSSC 22000 · BRCGS · AUDIT READINESS
Key facts
- FSSC 22000 equipment management additional requirement: purchase specification, supplier evidence, commissioning, change management
- BRCGS Issue 9 documented specification for new equipment, supplier confirmation before dispatch, commissioning for cleanability
- ISO 22002 series the PRP baseline: equipment designed and built to be cleanable, in suitable impervious materials
- South African law R638 regulation 6: smooth, rust proof, non absorbent surfaces, free of open joints or seams
- The audit test does equipment enter and change through a documented gate, or does it just arrive
- Course building the full system is Advanced Hygienic Design and Engineering, 24 hours, R6 500 until 30 November
Walk into the next audit with the file already built
Advanced Hygienic Design and Engineering takes you from the ten rules to a working site system: the specification, the acceptance gates, the risk register and the change control an auditor expects to see. 24 hours at Level 5, with workshops that build the documents on a realistic site.
See the Advanced course, R6 500 →
R6 500 until 30 November, then R7 900. Lifetime access, certificate on completion.What changed, and why your last audit was quieter than your next one
Hygienic design used to surface at audit only when a finding tripped over it: standing water under a conveyor, rust on a bracket, a gasket in pieces. The schemes have closed that gap from the specification end. The question is no longer whether the machine looks clean on the day. It is whether you can show the machine was specified, accepted and maintained to be cleanable, with documents that existed before the audit was booked.
This is the GFSI pattern across the board: a requirement moves from good practice to explicit clause, certification bodies brief their auditors, and a season later the same sites that always passed start collecting nonconformities against paperwork they never knew they needed. Equipment management is in that season now. The sites that write the specification once are spending an afternoon. The sites that wait are explaining to a customer why the new line has no acceptance file.
What each document actually asks for
| Document | What it expects of your equipment |
|---|---|
| ISO 22002 prerequisite standards, the base of FSSC 22000 | Equipment designed and constructed to facilitate cleaning, maintenance and inspection, with product contact surfaces in suitable, impervious, cleanable materials |
| FSSC 22000 additional requirements | A documented purchase specification addressing hygienic design, supplier evidence of conformance before installation, risk based acceptance and commissioning, and management of change for modifications |
| BRCGS Food Safety Issue 9 | A documented specification for new equipment covering hygienic design and legal requirements, supplier confirmation it is met before dispatch, and commissioning that confirms effective cleaning, including second hand equipment |
| R638 of 2018, regulation 6 | The legal floor in South Africa: food contact surfaces smooth, rust proof, non toxic, non absorbent, free of open joints or seams, withdrawn when chipped, split or cracked, and cleanable to no more than 100 viable microorganisms per square centimetre |
Notice what is not on the list: a requirement to buy certified equipment. The schemes do not name EHEDG or 3-A as mandatory. They require you to define your requirements, buy against them and verify them. EHEDG and 3-A are where the engineering content of those requirements comes from, which is why a competent specification cites them. If you want the comparison between those source documents, read EHEDG, 3-A or R638: which standard applies to your plant.
Which five documents will the auditor ask for?
The purchase specification. For the newest significant machine on site. If it does not exist, that is the finding. If it exists but says nothing about hygienic design, that is the same finding with extra steps. The structure that works is in how to write an equipment purchase specification that holds up at audit.
Supplier evidence against it. Drawings, material certificates, surface finish confirmation, weld documentation, a signed conformance statement. Dated before dispatch, not reconstructed after delivery.
Acceptance and commissioning records. The factory and site acceptance checks, and above all the cleanability evidence: the first validated clean, coverage proof on vessels, baseline swabs. The full sequence is in commissioning new food equipment: the FAT and SAT gates.
Change management. The modification register, each entry risk assessed and signed off by QA before the work, because the welder who adds a bracket in twenty minutes can create a harbourage niche that outlives everyone in the audit room.
The risk register for legacy equipment. No plant is fully compliant and auditors know it. What separates a managed site from an exposed one is a scored register of known design faults with interim controls, owners and dates. Found by you first.
Every person who signs these documents needs the same eye
The Hygienic Design Pathway trains QA, engineering and maintenance on one standard: Essentials for the rules, Intermediate for the materials and the factory, and Food Safety for Engineering and Maintenance Teams for the people who modify equipment on night shift.
Enrol in the Pathway, R6 337 →
Three courses, lifetime access. Saves R1 162 against the three at today’s prices.Getting ready in one quarter
Month one: write the purchase specification template and put the procurement rule in place, no order without it. Month two: build the acceptance gate, a checklist for FAT and SAT with cleanability proof, and start the modification register with the last twelve months of known changes. Month three: walk the highest risk lines with the free 30 point Hygienic Design Walk, score the legacy findings onto the risk register, and brief management on the worst three with costs and dates. That is a defensible system, built from standing start, before the next surveillance audit.
None of it requires a consultant on site every week. It requires one or two people who can see equipment the way the standards do, which is a trainable skill, and it is exactly what the ASC hygienic design series trains. Essentials gives any QA or production professional the rules and the walk in five hours. Advanced gives the system owner the full framework in 24 hours, with the documents built in workshops as you go.
Frequently asked questions
Does FSSC 22000 require hygienic design?
Yes, from two directions. The ISO 22002 prerequisite programme standards that FSSC 22000 is built on require equipment to be designed and constructed so it can be cleaned and maintained, using suitable, impervious materials. On top of that, FSSC 22000 carries a dedicated equipment management additional requirement: a documented purchase specification that addresses hygienic design, evidence the supplier met it before installation, a risk based commissioning check, and change management when equipment is modified.
What does BRCGS require for equipment hygienic design?
BRCGS Food Safety Issue 9 strengthened the equipment section. Sites need a documented purchase specification for new equipment that covers hygienic design and legal requirements, confirmation from the supplier that the equipment meets it before dispatch, and commissioning arrangements that confirm the equipment can be cleaned effectively before it enters production. Second hand and modified equipment go through the same gate.
Is hygienic design a legal requirement in South Africa?
The duties exist in law. R638 of 2018, regulation 6, requires food contact surfaces to be smooth, rust proof, non toxic, non absorbent and free of open joints or seams, not used when chipped, split or cracked, and cleanable to no more than 100 viable microorganisms per square centimetre on a surface swab. A machine that cannot meet those conditions in service puts the Certificate of Acceptability holder on the wrong side of the regulation.
What hygienic design evidence does an auditor ask for?
The usual requests are the purchase specification for the newest machine on site, the supplier’s evidence against it, the commissioning and acceptance records including cleanability checks, the risk assessment and sign off for recent modifications, and the cleaning validation or verification data for the equipment in service. The pattern the auditor is testing is simple: does equipment enter and change in this plant through a controlled, documented gate, or does it just arrive.
Who should own hygienic design in a food business?
A named owner with a cross functional gate behind them. In practice QA holds the standard and the sign off, engineering holds the specification and the acceptance tests, and procurement holds the rule that no order is placed without the specification attached. Where it fails is where each of the three assumes one of the others is doing it.
Do I need EHEDG certified equipment to pass a GFSI audit?
No scheme requires EHEDG certification outright. The schemes require you to define your hygienic design requirements, buy against them and verify them. An EHEDG certificate on a component is strong evidence for that component, but a documented specification, inspection at acceptance and cleanability verification is what the audit actually tests, and it can be built around any competent supplier’s equipment.
The finding is already on your line. Decide who finds it.
Train before the audit rather than after the nonconformity. Every course is online, self paced, with lifetime access and a certificate.
Essentials, 5 hours, R2 400 Intermediate, 9 hours, R3 700 Advanced, 24 hours, R6 500
Advanced is R6 500 until 30 November, then R7 900. Or take the three course Pathway for R6 337 and save R1 162.Sources and further reading
- FSSC 22000 scheme documents, fssc.com
- BRCGS Food Safety standard, brcgs.com
- How to write an equipment purchase specification that holds up at audit
- What is hygienic design? The ten rules
- The ASC hygienic design course series