Hazard Analysis Development & Evaluation
Compliant with 21 CFR §117.130 — Hazard Identification & Risk-Based Evaluation
A written Hazard Analysis is a foundational requirement of a compliant Food Safety Plan under 21 CFR §117.130, involving the identification and evaluation of known or reasonably foreseeable hazards to determine whether preventive controls are required, and this service provides a structured, PCQI-led hazard analysis framework aligned with the Food Safety Modernization Act (FSMA) to ensure your facility maintains a risk-based, scientifically supported, and audit-ready hazard evaluation system.
Program Objective
- To develop and document a comprehensive Hazard Analysis that:
- • Identifies biological, chemical, and physical hazards across products and processes
- • Evaluates hazards based on severity and likelihood of occurrence
- • Determines the need for preventive controls
- • Integrates with the overall Food Safety Plan structure
- • Provides defensible documentation for FDA inspections and audits
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
- • Structured for integration into the Food Safety Plan
2. Hazard Identification
- • Comprehensive identification of hazards, including:
- ◦ Biological: pathogens, parasites, environmental organisms
- ◦ Chemical: allergens, pesticides, residues, natural toxins, radiological hazards, additives
- ◦ Physical: metal, glass, plastic, stones, and foreign materials
- • Evaluation of hazard sources, including:
- ◦ Naturally occurring hazards
- ◦ Unintentional contamination
- ◦ Economically motivated adulteration (food fraud)
3. Hazard Evaluation (Risk-Based)
- • Assessment of hazard severity and probability of occurrence
- • Application of structured risk-ranking methodologies (qualitative or quantitative)
- • Documentation of decision-making rationale for each hazard
4. Special Considerations for Ready-to-Eat (RTE) Foods
- • Evaluation of environmental pathogen risks for exposed products
- • Assessment of control measures, including lethality steps and post-process controls
- • Determination of additional preventive controls where necessary
5. Assessment of Contributing Factors
- • Product characteristics (e.g., pH, water activity)
- • Facility and equipment design
- • Ingredient sourcing and supplier risks
- • Manufacturing, labeling, storage, and distribution practices
- • Employee hygiene and sanitation program effectiveness
- • Transportation conditions and foreseeable consumer use
- • Seasonal and environmental risks (e.g., mold growth, mycotoxins such as aflatoxins)
6. Supporting Scientific & Regulatory Data Integration
- • Incorporation of data from:
- ◦ FDA and CDC guidance
- ◦ Scientific literature and industry studies
- ◦ Historical outbreak data and trend analysis
- • Application of product- and process-specific risk insights
7. Audit-Ready Documentation
- • Tabulated hazard analysis with justification for inclusion or exclusion
- • Hazard evaluation summaries aligned with regulatory expectations
- • Optional hazard control decision tree documentation
- • Full alignment with Food Safety Plan structure under 21 CFR §117.126
Ideal For
- • FDA-registered food facilities developing or updating Food Safety Plans
- • Manufacturers launching new products or expanding product lines
- • Exporters aligning with U.S. FSMA requirements under FSVP
- • Co-packers and processors requiring hazard reanalysis due to process or product changes
- • Facilities preparing for FDA inspections or third-party audits
