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

Resources for this clause

• ArticleFSSC 22000 Version 7 explained: what changed, the dates that matter, and how to prepare for the upgrade audit
• Free downloadFSSC 22000 V7 Gap ChecklistEvery change from FSSC 22000 Version 6 to Version 7 as a tracked project — V6 audits end on 30 April 2027, and this is the file that gets a site to its upgrade audit with the evidence ready.
• Free masterclass · ~18 minFSSC 22000 V7 MasterclassV6 audits end 30 April 2027. Every V7 change clause by clause — the new ISO 22002 family, allergen testing, culture evidence, fraud/defence competence, food loss & waste targets — and a 90-day plan.