Product design and development — new products and changes
Plain-language summary
A documented design and development procedure for new products and for changes to products or processes, with trials, shelf-life verification, validated cooking instructions and packaging design principles.
What the clause is really asking
Most food safety failures trace back to a change nobody assessed. For categories BIII, C, D, E, F, I and K you need a documented procedure for new products and for changes to products or manufacturing processes that ensures the result is safe and legal. It must evaluate the impact on the FSMS — new hazards including allergens, with the hazard analysis updated — consider the impact on the process flow for new and existing products, and cover resource, training, equipment and maintenance needs. Manufacturing categories BIII, C, D and K must run production and shelf-life trials to validate the formulation and process, with ongoing risk-based shelf-life verification. Ready-to-cook products need validated cooking instructions on the pack. Organisations that design primary packaging must consider containment and protection through the supply chain, shelf-life preservation, minimising food loss and waste, and clear consumer instructions — without any of it compromising food safety.
What auditors look for
Auditors pick your newest product or most recent process change and follow the paper trail: the change request, the updated hazard analysis, the trial data, the shelf-life validation and verification, the cooking-instruction validation. Gaps between 'we changed it' and 'we assessed it' are the finding.
Typical evidence
Design and development procedure; change records with FSMS impact assessment and hazard analysis updates; process flow updates; trial records and shelf-life validation; ongoing shelf-life verification schedule; cooking-instruction validation studies; packaging design considerations
How to comply — recommendations
Use one change form for new products and process changes alike, with a mandatory 'hazard analysis updated?' line signed by the food safety team leader. Keep shelf-life validation separate from the routine verification that follows it. Validate cooking instructions on the worst-case appliance, not the best.
Common nonconformities
Product or process changed with no FSMS impact assessment; hazard analysis not updated for a new allergen; shelf life asserted, not validated; no ongoing shelf-life verification; cooking instructions never validated
Related clauses
ISO 22000 6.3 (planning of changes), 8.5.1 (preliminary steps), 8.5.4, 8.6 (updating); FSSC 22000 2.5.6 (allergens), 2.5.15 (equipment change management), 2.5.16 (food loss and waste)
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