Validation of Food Processes: In-Plant Approaches

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Presented at 2013 Arkansas Association for Food Protection annual conference.

James S Dickson, PhD
Iowa State University
Department of Animal Science
Inter-Departmental Program in Microbiology

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Validation of Food Processes: In-Plant Approaches

  1. 1. Validation of Food Processes: In-Plant Approaches James S Dickson, PhD Department of Animal Science Inter-Departmental Program in Microbiology
  2. 2. Do the security measures at the airport work?
  3. 3.  Validation involves obtaining evidence that control measures, if properly implemented, are capable of controlling the identified hazards. (Codex)
  4. 4. MONITORING VERIFICATION VALIDATION
  5. 5.  Section 417.4 of the meat and poultry regulations requires “Every establishment shall validate the HACCP plan’s adequacy in controlling the food safety hazards identified during the hazard analysis.…”  9 CFR part 417.4 (1996)
  6. 6.  Sec 103. Hazard Analysis and Risk-Based Preventive Controls  Hazard Analysis  Preventive Controls  Corrective Actions  Verification  Recordkeeping  Written Plan and Documentation
  7. 7.  Доверяй, но проверяй  Trust, but verify
  8. 8. DOES HACCP WORK? DOES YOUR HACCP WORK?
  9. 9.  adequate validation:  supporting scientific information  in-plant operational data  Demonstrate:  HACCP plan is theoretically sound  can be implemented and that it works
  10. 10.  Considered the level of contamination  Used that information to demonstrate that the intervention can address the expected level of contamination
  11. 11.  Salmonella o Incidence? o Population? o Resistance to intervention?
  12. 12.  An establishment must develop data to demonstrate, with its own employees and equipment, and that its HACCP system, as implemented, is capable of achieving the expected results.
  13. 13.  What are you validating?  Level of incoming contamination  Effect of treatment  Effect of overall process  Variability of treatment/process Iowa State Univ.
  14. 14.  Validating a Process?  Validating an individual CCP?  Pathogen incidence vs pathogen reduction Iowa State Univ.
  15. 15. Net reduction in Population ~ 1.5 log10 cfu/100g sample
  16. 16.  Dilution?  One ingredient contaminated, other not?  Inactivation?  One process is lethal to the bacteria  Uneven distribution in product?  Probability of detection?
  17. 17.  Contamination  Microbial growth  Microbial death  Joining  Mixing  Fractionation  Combining two or more mechanisms  (Impact of Microbial Distributions on Food Safety; ILSI 2010)  Similar to “Modular Process Risk Model” (Nauta, 2002; Int. J. Food Micobiol. 73:297)
  18. 18.  Quantitative  Indicators?  Aerobic bacteria  Enterobacteriaceae  Coliforms  Surrogates?  Qualitative  Pathogens?  Salmonella  Listeria  STEC’s Iowa State Univ.
  19. 19.  Performance of the method  Quantitative  Minimum detection limit  Qualitative  Positive/negative in ?? grams Iowa State Univ.
  20. 20. Impact of a 5 log10 reduction on bacterial population Intervention Log10Population/gram 0 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 ? Detection Limit
  21. 21.  How are the results influenced by process variation?  How are the results influenced by random chance?
  22. 22.  1.0 - 1.8 log reduction – 8.0% (+)  1.3 – 1.8 log reduction – 0.6%(+)  1.5 - 1.8 log reduction – 0.0%(+)
  23. 23. Servings/hour Servings/hour (2 processing lines) HOURS Hours to 1 million units 36,000 72,000 1 144,000 288,000 4 288,000 586,000 8 432,000 864,000 12 ~14 576,000 1,152,000 16
  24. 24.  Influenced by variance  More variance = More replications  Calculate sample size and power
  25. 25.  Are your interventions working?  Is your investment in food safety paying off?  Does your HACCP system work?
  26. 26. QUESTIONS?

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