Validation and Verification of Food Safety Control Measures

Food manufacturers have the effect of developing and implementing a food safety program that's 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 in their programs. THE MEALS 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 can lead to safer product, instead of relying primarily on reacting to foodborne disease outbreaks.

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


Validation.
Although most food products undergo a supposed kill step at the idea 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 a particular process (e.g., cooking, frying, chemical treatment, extrusion, etc.) is with the capacity of consistently delivering a product that meets predetermined specifications. Quite simply, it?s an accumulation of scientific proof a particular process involving chemical, physical, and biological inputs is consistently delivering a desired effect to ensure the destruction of pathogenic microorganisms. This is expressed as ?log reduction.?

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

Validation proof can come from the variety of sources such as peer-reviewed scientific literature, mathematical modeling, or regulatory resources. When such information is not available or sufficient, in-house challenge studies can be used. Generally 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 a particular process is consistently delivering the required lethal effect to guarantee 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 way of 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 about 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 so that the purpose, significance, and upshot of the analysis are clearly understood by other food safety experts. After the process validation is completed, the facility needs to establish verification procedures.

Verification.
This is actually the activity or activities conducted to ensure the implemented processes are effectively and consistently completed. In other words, it is the confirmation that you are doing what you intended or planned to accomplish and that it is effective. Based on the FSMA proposed rule, they are activities, other than monitoring, that establish the validity of the meals safety plan and that the machine is operating according to the plan. Verification activities range from the food safety plan review; walk-through; document review; testing; internal auditing; confirmation that the CCPs, HACCP plan, along with other preventive controls are effective, etc.