The Validation Conversation

By Joy Dell’Aringa
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A FSQA primer on the organization and execution of validation and verification processes and programs.

The Future: What Can We Expect?

With consumer demands high for more innovation around ‘natural’ or ‘preservative-free’ and even ‘raw’ food products, we can expect that innovations to keep these products safe will also increase.

  • Process authorities are reviewing new applications for product formulations and manufacturing, as well as technologies to detect and identify food safety threats earlier in the process. These processes must be validated and verified.
  • Sanitation companies are developing new chemicals, applications and best practices for cleaning facilities. These products and practices must be validated and verified.
  • Diagnostic manufacturers are developing faster and more sensitive technologies to detect pathogens, indicator and spoilage organisms. These technologies must be validated and verified.
  • Laboratories are employing new methods and automation to turn around results faster, more accurately, and in a competitive low-margin market. These methods must be validated and verified.

The need for clear understanding on this topic is paramount. As we continue the validation conversation in the larger discussion of food safety, the finer points of semantics, the nuances of application, and the drive for open communication and standardization is where the success of our industry will lie.


  1. FDA. (September 2015). FSMA Final Rule for Preventive Controls for Human Food. Docket Folder FDA-2011-N-0920. Retrieved from
  2. FDA. May 2017. FSMA Fact Sheet. Retrieved from
  3. U.S. Department of Health and Human Services, Food and Drug Administration – Center for Food Safety and Applied Nutrition. (January 2017). Draft Guidance of Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods.
  4. Brackett, R., et al. (2014) Institute for Food Safety and Health. Validation and Verification: A Practical, Industry-driven Framework Developed to Support the Requirements of the Food Safety Modernization Act (FSMA) of 2011. Food Protection Trends, November / December.

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Joy Dell'Aringa, bioMerieux

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