Conducting an FSVP hazard analysis

A hazard analysis is the foundation of every FSVP file. Before you can verify a foreign supplier, you have to know what hazards their food might present and how serious each one is. The FDA expects this analysis per food, not per supplier — though in practice the two are often paired.

Four hazard categories to evaluate:

• Biological — pathogens (Salmonella, Listeria, E. coli O157:H7), parasites, viruses
• Chemical — pesticides, heavy metals (lead, cadmium, arsenic), drug residues, allergens, mycotoxins, intentional adulterants
• Physical — glass, metal, hard plastic, stones — anything that can cause injury
• Radiological — relevant for foods sourced from regions with elevated background radiation

For each hazard, document:

1. The hazard itself (e.g., "Salmonella in raw almonds")
2. Whether it's known (documented history) or reasonably foreseeable (plausible based on food + region + processing)
3. Severity if it occurs (illness, injury, death)
4. Probability given the supplier's controls
5. Whether a preventive control is needed at the supplier or a verification activity at your end

TIP: If a hazard requires a control, that's what drives your supplier verification activity. High-severity, high-probability hazards typically demand onsite audits; lower-risk hazards may be verified through sampling, testing, or records review.

Common pitfalls:

• Treating allergens as low-risk because the supplier "doesn't run other allergens" — undocumented assumptions don't satisfy FSVP
• Using a generic hazard analysis across multiple foods — FDA expects food-specific analysis
• Not updating the analysis when the supplier changes processes, ingredients, or facilities

WARNING: Your hazard analysis must be performed or reviewed by a Qualified Individual (QI). The QI's training and credentials become part of your FSVP record.