Making Sense Of Microbial Validation And Verification

By Sam Lewis

An enormous amount of responsibility lies on the shoulders of food processors and manufacturers to create food safety programs that are both scientifically effective in controlling hazards and comply with benchmarks of safety set forth by recognized, accrediting bodies. Needless to say, this can create a lot of confusion for food makers. Here, Melinda Hayman, Director of Microbiology at the Grocery Manufacturers Association, answers my questions on microbial validation and verification.

Food Online: Clearly define what validation and verification are. What are their functions?  

Hayman: Validation and verification are terms used to explain how food manufacturing practices are implemented to control microorganisms. Validation is making sure that the science is sound; verification is making sure that the processor is implementing the control properly within the facility. Validation answers the question “are my controls working to achieve a reduction in hazards?” Verification answers the question “are the controls I’ve put forth controlling what they are intended to control?” For a long time, the two terms have been used somewhat interchangeably, which is confusing. Validation and verification are two different concepts that serve two different purposes.

Food Online: What are some key considerations when developing third-party validation and verification methods? 

Hayman: Food processors and manufacturers are responsible for making sure that they control hazards associated with their product and if they are using a third party as part of this process, then they had better be making sure that the third party is doing it correctly. You can use a third party to help conduct a validation study, and you can rely on them to help set up a verification testing plan, but, at the end of the day, the responsibility of controlling hazards and keeping consumers safe belongs to the food manufacturer or processor.

Food Online: What type of event(s) would necessitate a reassessment of these methods? 

Hayman: You need to reassess when something changes. A recall (either internal or by another company producing a similar product, the identification of new hazards (e.g. Salmonella in low moisture foods), or new scientific information are among the main triggers for reassessment.

Food Online: How will food manufacturers and processors know if their verification and validation methods are working? 

Hayman: I think the proof will be in the pudding. Food makers will know their methods are working by seeing no problems in their facilities. However, it’s almost the other way around; if the methods implemented are not working, then you will not have a sound food safety plan and there is a chance that you will create food safety problems.

Food Online: What is FSMA mandating about verification, validation, and microbial controls? 

Hayman: The Human Preventive Control Rule has focused largely on microbial issues due to recent illness and outbreaks due to organisms such as Salmonella and Listeria. We expect the final rule to contain specific provisions for both Verification and Validation. Requirements for verification will likely include environmental monitoring and product testing (under certain conditions). Validation requirements will include expectations about how validation is conducted, and that scientific information must be collected if none is available.

Food Online: Where can food manufacturers find more information about microbial validation and verification?

Hayman: Because validation and verification procedures can be confusing and complicated, GMA is holding a two-day workshop to go through these concepts. GMA has been closely following FSMA as it has progressed and our scientific experts can also share their knowledge of the current regulatory environment. We work closely with our members to review their food safety plans and can give a “check up” of their approach to validation and verification.

About Melinda Hayman
Melinda Hayman is a food microbiologist specializing in Food Safety. Melinda received her Ph.D. in Food Science from the Pennsylvania State University and a B.S. Hons in Microbiology and Biochemistry from the University of Sydney. Melinda joined GMA in 2012 as Director of Microbiology. In this role she oversees critical food safety research, supports membership through technical and laboratory services, and interacts with many segments of the food industry, as well as the academic and food regulatory communities, in order to track and interpret food safety issues and deliver effective solutions.

Prior to joining GMA, Melinda was the Director of Technical Services at Food Safety Net Services, where she managed Laboratory Quality Systems, Training, Method Validation, and Special Projects. In addition, Melinda worked as a Food Microbiologist for the Commonwealth Scientific and Industrial Research Organization (CSIRO) in Sydney, Australia.