Hazard Analysis Requirements for HACCP Systems
Guidance Aligned with Codex HACCP Principles and Global Food Safety Best Practices
Published by HACCP Systems | A Service by Consultare Inc. Group – A Compliance Company
Food businesses—covering manufacturers, processors, importers, distributors, and food service operators—must evaluate all potential food safety hazards that may occur at each stage of their process. Conducting a structured Hazard Analysis is essential to identify where hazards may enter, increase, or become uncontrolled. This step forms the backbone of a compliant and effective HACCP Plan.
This guide provides a practical checklist inspired by globally recognized hazard analysis methodologies outlined in Codex Alimentarius HACCP, FDA/USDA requirements, and GFSI-benchmarked certification frameworks. It supports facilities preparing for certification, audit readiness, or internal system enhancement.
Hazard Analysis Compliance Checklist
Understanding Product & Process Characteristics
✓ Define product composition, ingredients, and raw material characteristics
✓ Identify target consumers, including vulnerable populations
✓ Determine intended use, storage, and distribution conditions
✓ Review all steps in the process flow diagram for accuracy
Identification of Potential Hazards
✓ Identify biological hazards (pathogens, spoilage organisms, viruses)
✓ Identify chemical hazards (allergens, additives, residues, toxins)
✓ Identify physical hazards (glass, metal, stones, hard plastics)
✓ Determine hazards associated with personnel, equipment, or environment
Hazard Assessment: Severity & Likelihood
✓ Assess potential severity of each identified hazard
✓ Evaluate the likelihood of occurrence in normal operations
✓ Utilize a risk-ranking matrix aligned with Codex HACCP recommendations
✓ Classify hazards requiring strict control measures
Preventive Measures & Control Strategies
✓ Identify existing controls such as sanitation, GMPs, allergen programs
✓ Determine whether preventive controls or CCPs are needed
✓ Assess adequacy of current risk mitigation measures
✓ Recommend additional measures to eliminate or reduce hazards
Evaluation of Prerequisite Programs (PRPs)
✓ Verify sanitation and hygiene controls that reduce hazard risks
✓ Confirm operational PRPs support hazard prevention
✓ Review facility design, equipment layout, and workflow issues
✓ Assess supplier controls and raw material verification
Review and Documentation Requirements
✓ Maintain a documented hazard analysis for all product categories
✓ Record justification for each hazard identified or excluded
✓ Document risk-ranking decisions and supporting data
✓ Ensure hazard analysis aligns with flow diagrams and process descriptions
Allergen Management (If Applicable)
✓ Identify potential allergens in raw materials and finished products
✓ Implement controls to prevent cross-contact during processing
✓ Label products accurately to inform customers of allergen presence
Food Fraud and Food Defense Risk Mitigation
✓ Conduct vulnerability assessments to identify potential fraud risks
✓ Develop and implement mitigation strategies to protect against intentional adulteration
✓ Secure facilities to prevent unauthorized access and tampering
Crisis Management & Recall Preparedness
✓ Develop a crisis management plan outlining roles and responsibilities
✓ Establish procedures for product recall and withdrawal
✓ Conduct mock recalls to test the effectiveness of recall procedures
Audit & Validation Activities
✓ Perform internal audits to assess compliance with food safety requirements
✓ Validate control measures to ensure they effectively manage identified hazards
✓ Address non-conformities promptly and implement corrective actions
Corrective Actions & Continuous Improvement
✓ Establish a system for identifying and correcting non-conformities
✓ Analyze root causes to prevent recurrence of issues
✓ Review and update food safety practices regularly to drive continuous improvement
Support for Hazard Analysis & HACCP Development
HACCP Systems provides structured, audit-ready solutions to help organizations develop and maintain compliant hazard analysis:
• Hazard analysis templates and structured assessment tables
• Biological, chemical, and physical hazard reference lists
• Process flow diagram development and validation tools
• HACCP team training and competency development
• Internal audit checklists aligned with Codex HACCP
• Risk matrix scoring models aligned with Codex and GFSI expectations
• PRP evaluation checklists and verification tools
• HACCP team training and competency development materials
Let us simplify the hazard analysis process so you can build a strong, defensible, and compliant HACCP system.
End-to-End HACCP Compliance & Audit-Ready Services
| HACCP Service | Description | Price | Action |
|---|---|---|---|
| Full Hazard Analysis (Per Product Line) | End-to-end identification of biological, chemical, and physical hazards; assessment of severity and likelihood; flow diagram review; documentation aligned with Codex HACCP principles. | $1,450 / line | Book Consultation |
| Hazard Identification Workshop | Structured hazard mapping session including pathogen, allergen, chemical residue, toxin, and physical hazard review; staff participation; tailored to specific processes and products. | $699 / session | Book Workshop |
| Risk Ranking & Severity Scoring | Application of Codex-aligned matrices for severity, likelihood, and risk ranking; hazard justification; categorization of hazards requiring preventive controls or CCP designation. | $899 / analysis | Book Consultation |
| Prerequisite Program Evaluation | Assessment of sanitation, GMPs, allergen control, personnel hygiene, supplier controls, and facility layout to confirm effectiveness in hazard prevention and risk reduction. | $1,050 / site | Schedule Review |
| Hazard Analysis Documentation Package | Audit-ready documentation including hazard tables, risk matrix, justification logs, PRP verification sheets, supplier verification mapping, and process hazard summaries. | $1,250 / package | Request Package |
| Hazard Analysis Toolkit | Digital tools including hazard reference lists, risk scoring models, PRP evaluation forms, flow diagram templates, internal audit checklists, and HACCP team training materials. | $1,650 one-time | Get Toolkit |
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Reference Note
This content is adapted from publicly available HACCP principles and compliance requirements commonly referenced in Codex Alimentarius, FDA guidance, and GFSI-recognized certification frameworks. For regulatory compliance or certification, organizations must follow the official requirements published by the respective authorities.
Disclaimer
HACCP Systems is an independent service provider and is not affiliated with, endorsed by, or certified under any specific HACCP or GFSI program owner. References to Codex, FDA, or GFSI frameworks are for educational and informational purposes only and do not imply endorsement or partnership.
