The Seatbelt in Food Safety...
- Fatma Inceoglu
- Feb 1, 2011
- 3 min read
VALIDATION OF FOOD SAFETY CONTROL MEASURES
With the establishment of the HACCP system in the food chain (ISO 22000 efforts), control measures are determined at points where hazards must be managed. These measures are like wearing a seatbelt for accidents while driving a car. However, we must answer the questions: Does the measure we determined truly reduce the hazard to the target level? Or does it eliminate it? If studies had not been conducted, or if there were no evidence, that wearing a seatbelt reduces the risk of death in an accident, how many of us would actually wear one? The studies we conduct or the evidence we find regarding the sufficiency of the control measures in food safety system setups are what we call validation studies.
Validation, which we see as 'validation' in English, is often used interchangeably with the word 'verification' in Turkish. Yet, the meaning of verification is different. If we use the seatbelt example; when the car is in motion, we need to monitor periodically or continuously to be sure the belt is fastened, right? Just as we need to monitor the control measures we determine in food safety. Traffic police checking drivers periodically to see if they are wearing seatbelts is what we call verification. The scientific studies where seatbelt statistics are obtained from past accidents and the measure's effectiveness is demonstrated are the validation studies.
In the ISO 22000:2005 standard, the requirement for validation is requested in clause 8.2 of the standard.
The validation of control measures in food safety should be done when the measures are designed, before they are implemented, or repeated (re-validation) when a change occurs that affects the measure.
While verifying whether the control measure is being applied can be done through many methods; 5 different approaches have been defined in the literature for validating control measures.
The choice of which approach or combination of approaches to select for validating control measures depends on the type of hazard, the product, the system, and the nature of the measure.
Validation Methods:
Reference to previous validation studies, literature, or technical information. This can include legal and international regulations, guidelines, university studies, or validation work done by sector organizations or machine manufacturers. For instance, citing time-temperature combinations for pasteurization in fruit juice, obtained from monitoring microbiological growth at a university.
Scientifically valid experimental results or pilot plant studies. For example; studies related to the reduction of pathogens (log reduction studies). It should be remembered that in this choice, the data obtained from experimental studies may show a greater deviation in actual large-scale production runs.
Validation can be performed by developing a sampling plan from production and collecting sufficient records (approximately 3-6 weeks) to allow for statistical analysis. For example; determining the limit for chlorine to be added to water.
The use of mathematical modeling programs (based on the analysis of scientific data mathematically). For example; calculating the probability of pathogen growth based on pH and water activity, or determining Fo and z-values in canned goods.
Survey; surveys can be conducted regarding whether the hazards are at the desired level. It should be remembered that consumer-based surveys are conducted after the product is put on the market.
Steps required for validation after HACCP plans are prepared:
Deciding on the method or combination of methods,
Defining the control measure parameters and acceptable limits,
Relating the measure to the relevant validation source or performing the foreseen study,
Analyzing the results,
Recording the validation study.
Ultimately, the answer to the question—does the selected control measure reduce the hazard to the desired level or not?—must be obtained. If the measure is unsuccessful, the need for changes in product formulation, process parameters, or other activities should be reviewed.
The information obtained from validation can and should be used when designing monitoring and verification procedures. For example; if the control measure is highly effective in reducing the hazard, the frequency of verification can be reduced.
Situations requiring re-validation:
When nonconformities increase in the system,
When the process changes,
When there is new scientific information or a change in legal regulations.
Validation studies, in a sense, provide guidance in Food Safety systems, using scientific or experimental evidence (including actual production study results) to ensure the correct control measures and thus the critical limits have been selected.
Fatma İNCEOĞLU- Şubat’2011
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