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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

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Partner with our experienced Preventive Controls Qualified Individuals (PCQIs) for practical FDA compliance guidance, documentation support, Food Safety Plan development, regulatory consulting, and ongoing compliance services tailored to your operation.