Hazard Analysis and Risk Assessment
From hazard list to justified decision
Hazard analysis is Principle 1 and the most heavily examined. Break hazards into biological (pathogens such as Salmonella, Listeria monocytogenes, E. coli O157:H7, Clostridium botulinum; toxins; viruses; parasites), chemical (cleaners, sanitisers, lubricants, allergens, mycotoxins, veterinary residues, packaging migrants) and physical (glass, hard plastic, metal, bone, stones). Consider each raw material and ingredient, each process step, rework, packaging, storage, distribution, and the intended use and consumer - infants, elderly and immunocompromised people change the severity judgement.
For each hazard, decide whether it is reasonably likely to occur at an unacceptable level, and record why. Codex expects documented justification: the hazard, its source, the evidence (historical data, literature, industry data, survey results), the severity of the effect and the likelihood of occurrence. Risk assessment is the broader formal discipline of estimating risk; hazard analysis is the plant-specific step that applies it. Questions often blur the two.
Traps: stating “not significant” with no justification; missing hazards introduced by the process itself (metal fragments from a worn blade, allergen cross-contact on a shared line); assuming “we have never had a recall” is evidence; and forgetting that every significant hazard must be either a CCP or controlled by a PRP.
Worked example: raw poultry receiving. Salmonella and Campylobacter are reasonably likely, so severity and likelihood are both high - a significant hazard. It is controlled downstream at the cooking CCP, and the hazard analysis must say so explicitly rather than leave it implied.