Equipment management — hygienic design and change control
Plain-language summary
A purchase specification that covers hygienic design before equipment is bought, and risk-based change management with commissioning evidence for new or changed equipment.
What the clause is really asking
Equipment brought in without a food-safety view is a hazard bolted to the floor. For every category except brokers and traders you need a documented purchase specification addressing hygienic design, applicable legal and customer requirements, and the equipment's intended use including the product it will handle — and the supplier must show it meets that specification before installation. New equipment and changes to existing equipment must go through a risk-based change management process, adequately documented, with evidence of successful commissioning, an assessment of effects on existing systems, and control measures determined and implemented.
What auditors look for
Auditors pick the newest piece of equipment on site and ask for its purchase specification, the supplier's evidence against it, the change assessment and the commissioning record. A machine that arrived and started running the same week is a finding waiting to happen.
Typical evidence
Equipment purchase specification template and completed specifications; supplier evidence of conformance prior to installation; change management records with risk assessment; commissioning evidence; updated PRPs, cleaning validations and hazard analysis after the change
How to comply — recommendations
Put hygienic design and cleanability into the purchase specification before the order is placed, and make supplier evidence a condition of delivery. Run equipment changes through the same change form as product changes, with commissioning and cleaning validation as sign-off steps.
Common nonconformities
No purchase specification, or one written after delivery; supplier evidence never requested; equipment changes undocumented; commissioning not recorded; cleaning validation and hazard analysis not updated after a change
Related clauses
ISO 22000 7.1.3 (infrastructure), 8.2.4 (PRPs), 6.3 (planning of changes); ISO 22002-1:2025 (equipment suitability); FSSC 22000 2.5.13
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