Curtis L. Weller, Ph.D., P.E.
Department of Food Science and Technology, University of Nebraska-Lincoln, USA
The Food Safety Modernization Act (FSMA) gives the United States Food and Drug Administration (FDA) the power to evaluate scientifically control measures implemented in a food establishment. FSMA focuses on preventing safety issues, including providing documentary evidence that measures used will result in safe food products. The framework of FSMA is applicable to all segments of food production and processing that the FDA regulates. Food manufacturers are responsible for developing and implementing control measures that are scientifically effective (validation) in controlling hazards and comply with current food safety programs (verification). Many food industry professionals confuse the function and the meaning of validation and verification however each term has distinct meaning and purpose. Validation (the science before use of any measure) and verification (the checking after use of any measure) are defined and described in general. Comparison and contrasting validation steps and verification steps for an example process (canning pineapple juice) help further differentiate the terms. Because accepted best practices for control measures are still evolving and not all regulatory framework is fully in place, process validation and verification will continue to improve.