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Validation and Verification of Food Safety Control Measures

Food manufacturers are responsible for developing and implementing a food safety program that is scientifically effective (validation) in controlling hazards and complies with current food safety programs (verification).
Validation and verification are vital food safety components, but food manufacturers often confuse the function and meaning of these within their programs. The Food Safety Modernization Act (FSMA) gives FDA the energy to scientifically evaluate food safety programs and preventive controls implemented in a food establishment. Regulations focuses more on preventing food safety issues, including providing documentary evidence that methods used will result in safer product, rather than relying primarily on reacting to foodborne disease outbreaks.

FSMA?s framework is applicable to all or any segments of food production that the FDA regulates. Validation and verification cover an easy area and can be employed to all or any segments of manufacturing. Many food safety professionals use validation and verification interchangeably, but each has a different meaning and purpose. This article describes their functions from the kill-step perspective.

Although most foods undergo a supposed kill step at the point of production (such as for example baking, roasting, extruding, or frying) these control points lack scientific validation. Validation is a preemptive scientific evaluation that provides documented evidence that a particular process (e.g., cooking, frying, chemical treatment, extrusion, etc.) is with the capacity of consistently delivering something that meets predetermined specifications. In other words, it?s a collection of scientific proof that a particular process involving chemical, physical, and biological inputs is consistently delivering a desired effect to ensure the destruction of pathogenic microorganisms. This is often expressed as ?log reduction.?

Logarithmic reduction reduces the count of pathogenic organisms by a specific exponent, such as for example reducing the count from 106 (1,000,000) bacterial cells to 101 (10 bacterial cells). In accordance with FSMA?s proposed rule, it?s the collection and evaluation of scientific and technical information to determine whether the food safety plan, when properly implemented, will effectively control identified hazards.

Validation proof can come from a variety of sources such as for example peer-reviewed scientific literature, mathematical modeling, or regulatory resources. When such information isn't available or sufficient, in-house challenge studies may be used. In most situations, validation is conducted ahead of implementing a fresh method or process. Activities include challenge testing, shelf-life testing, etc. A kill-step validation is the only way to prove that a particular process is consistently delivering the desired lethal effect to ensure the destruction of pathogenic microorganisms.

The major steps involved in validation include: determining the method(s), selecting a surrogate or pathogenic microorganism, identifying worst-case scenarios, executing the validation study by a qualified microbiologist or food safety expert, collecting and analyzing data, and preparing a validation report.

The validation report will include the next sections: introduction, contact information, background information, general information regarding the product, parameters studied, information on equipment (type and make) used, method used, microbial strains used, results, date of the validation study, detailed discussion, significance, etc. Also, the validation report should be written in sufficient detail in order that the purpose, Food verification site significance, and upshot of the study are clearly understood by other food safety experts. After the process validation is completed, the facility must establish verification procedures.

This is actually the activity or activities conducted to ensure the implemented processes are effectively and consistently carried out. In other words, it is the confirmation that you will be doing everything you intended or planned to accomplish and that it is effective. According to the FSMA proposed rule, these are activities, other than monitoring, that establish the validity of the food safety plan and that the system is operating based on the plan. Verification activities can include the meals safety plan review; walk-through; document review; testing; internal auditing; confirmation that the CCPs, HACCP plan, along with other preventive controls are effective, etc.

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