Validation and Verification of Food Safety Control Measure
Food manufacturers have the effect of 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 event and meaning of these within 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 will result in 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 an easy area and can be applied to all segments of manufacturing. Many food safety professionals use validation and verification interchangeably, but each includes a different meaning and purpose. This article describes their functions from the kill-step perspective.
Validation.
Although most food products 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 a particular process (e.g., cooking, frying, chemical treatment, extrusion, etc.) is capable of consistently delivering a product that meets predetermined specifications. In other words,Food verification
it?s an accumulation of scientific proof that a particular process involving chemical, physical, and biological inputs is consistently delivering a desired effect to guarantee 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). In accordance with 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 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. 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 that a particular process is consistently delivering the required lethal effect to ensure the destruction of pathogenic microorganisms.
The major steps involved in validation include: determining the method(s), choosing the 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 should include the following 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 ought to be written in sufficient detail so the purpose, significance, and outcome of the analysis are clearly understood by other food safety experts. Once the process validation is completed, the facility must establish verification procedures.
Verification.
Here is the activity or activities conducted to make sure that the implemented processes are effectively and consistently carried out. In other words, it is the confirmation you are doing what you intended or planned to do and that it's effective. In line with 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 according to the plan. Verification activities can include the food safety plan review; walk-through; document review; testing; internal auditing; confirmation that the CCPs, HACCP plan, and other preventive controls are effective, etc.
Validation and verification are vital food safety components, but food manufacturers often confuse the event and meaning of these within 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 will result in 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 an easy area and can be applied to all segments of manufacturing. Many food safety professionals use validation and verification interchangeably, but each includes a different meaning and purpose. This article describes their functions from the kill-step perspective.
Validation.
Although most food products 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 a particular process (e.g., cooking, frying, chemical treatment, extrusion, etc.) is capable of consistently delivering a product that meets predetermined specifications. In other words,Food verification
it?s an accumulation of scientific proof that a particular process involving chemical, physical, and biological inputs is consistently delivering a desired effect to guarantee 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). In accordance with 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 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. 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 that a particular process is consistently delivering the required lethal effect to ensure the destruction of pathogenic microorganisms.
The major steps involved in validation include: determining the method(s), choosing the 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 should include the following 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 ought to be written in sufficient detail so the purpose, significance, and outcome of the analysis are clearly understood by other food safety experts. Once the process validation is completed, the facility must establish verification procedures.
Verification.
Here is the activity or activities conducted to make sure that the implemented processes are effectively and consistently carried out. In other words, it is the confirmation you are doing what you intended or planned to do and that it's effective. In line with 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 according to the plan. Verification activities can include the food safety plan review; walk-through; document review; testing; internal auditing; confirmation that the CCPs, HACCP plan, and other preventive controls are effective, etc.