Afrexai Food Safety

For each process step, evaluate:

Biological hazards: Salmonella, Listeria monocytogenes, E. coli O157:H7, Clostridium botulinum, Staphylococcus aureus, Norovirus, Campylobacter, Bacillus cereus

Chemical hazards: Allergens, sanitizer residue, pesticides, antibiotics, heavy metals, mycotoxins, sulfites, nitrites

Physical hazards: Metal fragments, glass, plastic, stones, wood, bone, personal effects

Step 3: Critical Control Points (Principle 2)

Apply the CCP Decision Tree to each significant hazard:

1. Do control measures exist? → If no, modify step/process
2. Is this step specifically designed to eliminate/reduce hazard? → If yes, CCP
3. Could contamination occur at unacceptable levels? → If no, not CCP
4. Will a subsequent step eliminate/reduce hazard? → If no, CCP

Step 4: Critical Limits (Principle 3)

Each CCP gets measurable limits:

Step 5: Monitoring Procedures (Principle 4)

For each CCP: What is monitored? How? How often? Who?

Step 6: Corrective Actions (Principle 5)

When critical limit is not met:

1. Identify and isolate affected product
2. Restore CCP to control
3. Determine disposition of affected product (reprocess, divert, destroy)
4. Record deviation and corrective action
5. Conduct root cause analysis if recurring

Step 7: Verification (Principle 6)

• Initial HACCP plan validation
• CCP monitoring device calibration (thermometers: daily ice point check)
• Monthly CCP record review
• Annual HACCP plan reassessment
• Environmental monitoring program (Listeria: Zone 1-4 sampling)
• Finished product testing schedule

Step 8: Record-Keeping (Principle 7)

Required records (retain minimum 2 years, 3 years for shelf-stable):

• Hazard analysis worksheets
• CCP monitoring logs
• Corrective action reports
• Verification records (calibration, record review)
• HACCP plan with signatures and dates
• Supplier approval records
• Training records

Prerequisite Programs (PRPs)

Before HACCP, these foundations must be in place:

1. Supplier Approval

• Approved supplier list with certificates (COA, audit reports)
• Receiving inspection criteria
• Rejection/return procedures

2. Allergen Management

• Big 9 allergen matrix by product
• Segregation: dedicated lines, color-coded utensils, separate storage
• Cleaning validation between allergen changeovers
• Label review protocol (21 CFR 101.4, FALCPA)
• Shared equipment advisory statements

3. Sanitation

• Master sanitation schedule (daily, weekly, monthly, quarterly)
• Cleaning and sanitizing procedures per surface type
• Chemical concentration verification (test strips, titration)
• Pre-operational inspection checklist
• EPA-registered sanitizer concentrations: Chlorine 50-200ppm, Quat 150-400ppm, Iodine 12.5-25ppm

4. Pest Control

• Licensed PCO contract with service schedule
• Interior/exterior bait station map
• Trend analysis of pest activity
• Exclusion: door sweeps, screens, sealed penetrations

5. Water Safety

• Municipal water: annual report review
• Well water: coliform testing per state schedule
• Ice machine: quarterly cleaning + sampling

6. Personal Hygiene

• Handwashing: 20-second protocol, when required (FDA Food Code 2-301.14)
• Illness reporting policy (Big 5: Salmonella Typhi, Shigella, E. coli O157:H7, Hepatitis A, Norovirus)
• Hair restraints, jewelry policy, clean outer garments
• Bare-hand contact prohibition with RTE foods

7. Training

• New hire food safety orientation
• Annual refresher training
• Job-specific CCP training
• Training effectiveness verification (written test, observation)

Regulatory Framework Reference

FDA (21 CFR Parts 110, 113, 114, 117, 120, 123)

• FSMA Preventive Controls (21 CFR 117): Required for food facilities. Written food safety plan, hazard analysis, preventive controls, monitoring, corrective actions, verification, recall plan
• Seafood HACCP (21 CFR 123): Mandatory HACCP for fish/fishery products
• Juice HACCP (21 CFR 120): Mandatory HACCP for juice processors
• Acidified Foods (21 CFR 114): Registered process, scheduled process authority
• FSMA Produce Safety Rule: Applies to farms growing/harvesting RACs

USDA-FSIS (9 CFR Parts 417, 430)

• HACCP (9 CFR 417): Required for meat and poultry establishments
• Listeria Rule (9 CFR 430): Post-lethality treatment requirements for RTE products
• SSOP: Required written sanitation SOPs
• Performance standards: Salmonella, Listeria, generic E. coli

State/Local

• Health department permits and inspections
• Food handler certifications (varies by state)
• Cottage food laws (if applicable)
• Commissary requirements for mobile operations

Third-Party Audits

Temperature Quick Reference

Recall Readiness

Classification

• Class I: Reasonable probability of serious health consequences or death
• Class II: Temporary or medically reversible adverse health consequences
• Class III: Not likely to cause adverse health consequences

Mock Recall (conduct annually)

1. Select random lot/batch code
2. Trace forward (distribution records → 100% customer notification within 4 hours)
3. Trace back (ingredients → all suppliers within 2 hours)
4. Calculate recovery rate (target: ≥100% of product produced)
5. Document gaps and corrective actions

FDA Reportable Food Registry

• Facilities must report when there's reasonable probability food will cause serious adverse health consequences (21 CFR 1.361)

Audit Output Format

When auditing an operation, produce:

1. Executive Summary: Pass/fail with score, top 3 risks
2. Non-Conformance Report: Finding, clause reference, severity (critical/major/minor), corrective action, due date
3. Positive Findings: What's working well
4. Recommendations: Improvements beyond compliance

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