Hazard Analysis Development & Evaluation
Compliant with 21 CFR §117.130 – Hazard Identification and Risk-Based Evaluation
To conduct and document a written Hazard Analysis for food products in compliance with the Food Safety Modernization Act (FSMA) and 21 CFR §117.130. This service identifies biological, chemical, and physical hazards, evaluates their likelihood and severity, and determines whether they require preventive controls.
Deliverables
1. Written Hazard Analysis Report
- • Developed or overseen by a Preventive Controls Qualified Individual (PCQI)
- • Completed per product line, process flow, or facility operation
2. Identification of Hazards
- • Biological: pathogens, parasites, and environmental organisms
- • Chemical: pesticides, allergens, radiological materials, additives, natural toxins
- • Physical: metal, glass, plastic, stones, or other foreign materials
- • Sources: natural, unintentional, or economically motivated adulteration
3. Hazard Evaluation (Risk-Based)
- • Severity and likelihood evaluation
- • Risk ranking matrix or structured hazard scoring (qualitative or quantitative)
4. Special Consideration for RTE Foods
- • Evaluation of environmental pathogen risk for foods exposed to the environment prior to packaging
- • Identification of whether additional kill steps or control measures are in place
5. Assessment of Contributing Factors
- • Food formulation (pH, aW, etc.)
- • Facility and equipment design
- • Ingredient origin and sourcing
- • Manufacturing, labeling, storage, and distribution practices
- • Employee hygiene and sanitation program effectiveness
- • Transportation and foreseeable consumer use
- • Weather-related and seasonal hazard variation (e.g., aflatoxins, molds)
6. Supporting Data Integration
- • Illness outbreak reports, scientific literature, FDA/CDC data, and industry alerts
- • Applicable product and process-specific risk insights
7. Audit-Ready Documentation
- • Tabulated hazard listing with justification for inclusion/exclusion
- • Hazard control decision tree (if requested)
- • File aligned with the food safety plan structure under §117.126
Fees and Subscriptions
Service Fee Structure
| Plan | Description | One-Time Fee | Included Support |
|---|---|---|---|
| Basic Hazard Analysis | For a single product or limited scope | $1,250 | Finalized hazard identification table and risk ranking |
| Standard Multi-Product Analysis | For 3–5 SKUs or process types | $2,750 | PCQI-reviewed risk assessment, integration with FSP |
| Enterprise Risk Mapping | For facilities with complex operations or 6+ product lines | Custom Quote | Full hazard analysis matrix, PCQI strategy session, validation references |
Ideal For:
- • FDA-registered food facilities creating or revising their Food Safety Plan
- • Manufacturers launching new SKUs or contract manufacturing programs
- • Exporters to the U.S. seeking FSMA alignment under FSVP
- • Co-packers and processors needing hazard reanalysis following product changes