Conduct Hazard Analysis
Aligned with HACCP Principles – Principle: Conduct a Hazard Analysis
Requirement Overview
Under HACCP Principle 1, food safety teams must conduct a thorough hazard analysis to identify and evaluate all known or reasonably foreseeable biological, chemical, and physical hazards associated with each step of the production process.
This foundational activity ensures that food safety risks are systematically understood, assessed for severity and likelihood, and controlled through appropriate measures such as prerequisite programs (PRPs) or Critical Control Points (CCPs).
This step directly supports regulatory compliance with 21 CFR Part 117 and Codex HACCP guidelines.
Aligned with BRCGS for Storage & Distribution Issue 4 – Clause 4.3.1 & 4.3.3
Requirement Overview
BRCGS for Storage & Distribution requires that products moved via cross-docking are traceable and controlled at all times, even when they are not held in storage for extended periods.
Clause 4.3.1: “The company shall ensure that traceability is maintained at all stages, including during cross-docking operations.”
Clause 4.3.3: “Procedures shall be in place to ensure that all products handled, including those not stored on-site, remain under control and are not subject to contamination or substitution.”
Cross-docking operations must not compromise product traceability, safety, or integrity. Even with minimal handling and temporary presence, each product must be accurately identified, documented, and protected.
Key Compliance Objectives
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✓ Identify potential hazards at each process step
✓ Assess the severity and likelihood of each hazard
✓ Determine control measures or preventive strategies
✓ Document rationale for CCP determination
Step-by-Step Compliance Implementation
1. Map the Process Flow
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Start with a complete, validated flow diagram of the product process from receiving to distribution.
Evidence to Maintain:
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• Signed process flow diagram
• Verification records confirming on-site accuracy
- • Signed process flow diagram • Verification records confirming on-site accuracy
2. List All Inputs and Activities
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For each process step, list all ingredients, packaging materials, equipment, handling activities, and environmental factors that could introduce or contribute to hazards.
Evidence to Maintain:
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• Input inventory by process step
• Material spec sheets and environmental data
- • Input inventory by process step • Material spec sheets and environmental data
3. Identify Reasonably Foreseeable Hazards
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Classify hazards as:
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• Biological: pathogens, microbial toxins, spoilage organisms
• Chemical: allergens, cleaning agents, pesticide residues, undeclared additives
• Physical: metal, glass, wood, plastic, bone fragments
Evidence to Maintain:
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• Hazard identification matrix
• Past product complaint logs or recall history
- • Biological: pathogens, microbial toxins, spoilage organisms • Chemical: allergens, cleaning agents, pesticide residues, undeclared additives • Physical: metal, glass, wood, plastic, bone fragments
- • Hazard identification matrix • Past product complaint logs or recall history
4. Evaluate Each Hazard
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For every identified hazard, assess:
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• Severity (minor, moderate, severe)
• Likelihood (unlikely, possible, likely)
• Determine risk level and whether further control is required
Evidence to Maintain:
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• Hazard analysis worksheet with justification
• Scientific references or historical data used in evaluations
- • Severity (minor, moderate, severe) • Likelihood (unlikely, possible, likely) • Determine risk level and whether further control is required
- • Hazard analysis worksheet with justification • Scientific references or historical data used in evaluations
5. Determine Preventive Controls
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Assign one or more of the following controls based on risk level:
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• Prerequisite Program (PRP)
• Critical Control Point (CCP)
• Process Preventive Control
• Allergen Control
• Supply Chain Preventive Control
Evidence to Maintain:
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• Control assignment decision tree
• Justification for control selection
• Summary of CCP determinations
- • Prerequisite Program (PRP) • Critical Control Point (CCP) • Process Preventive Control • Allergen Control • Supply Chain Preventive Control
- • Control assignment decision tree • Justification for control selection • Summary of CCP determinations
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| Hazards not identified for each step | Review all inputs and activities in flow diagram |
| No justification for risk decisions | Provide written rationale with severity/likelihood scores |
| Overuse of CCPs or PRPs | Re-evaluate using a decision tree to avoid misclassification |
| Incomplete hazard list | Use historical data, supplier info, and regulatory recall alerts |