I had a girls trip a few weeks ago at a winery in southwestern Virginia. We went tubing and sat around the campfire — totally unplugged. Literally. There was no service at all: no wifi, no phone service, just us on the farm. At first it was a little creepy, but then by day two, I was all into being unplugged.

Something we didn’t consider when being unplugged: Google maps, Apple maps, or even Waze don’t work, which could have left us stranded if my handy dandy girlfriend didn’t have an atlas (well worn) of the area. We literally sat around the campfire the first night and mapped out where we were going and how to get there. It brought me back to the old days of mapping out my journey ahead of time.

Maps are always handy to have in the car as my example just showed, but they are also handy to have in our work environment as well. Let’s think about validation studies. I know that establishments send validation studies out to third party or universities. But establishments still have a responsibility to understand how these studies are being conducted, what processes are being used, what methodologies are being incorporated, and how those processes relate to their own establishment. Data generated is only as good as the data inputs. Good data can save us all one day from a potential recall and or lawsuit.

I have visited many establishments during my career to discuss food safety programs and documentation. I have also conducted many HACCP classes over the years. One same pattern and question always stands out: How do we (establishment) conduct a proper validation/challenge study? These are expensive and you get one shot at doing it correctly. Input and working closely with your third party lab is critical.

Do you know there is a road map for this process? The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) created a document at the request of the U.S. Department of Agriculture, Food Safety and Inspection Service, U.S. Department of Health and Human Services, Food and Drug Administration, and Centers for Disease Control and Prevention, U.S. Department of Commerce, National Marine Fisheries Service, and the U.S. Department of Defense, Veterinary Service Activity. This document is called “Parameters for Determining Inoculated Pack/Challenge Study Protocols” and was published in 2009 in the Journal of Food Protection.

This road map is critical to ensuring a proper study is conducted; as I said earlier, the data generated is only as good as the data inputs. This NACMCF published study outlines and discusses guidelines for choice of microorganisms, types of challenge studies, definitions of common terms used in challenge studies, inoculum preparation, level, and methods, incubation times and temperatures, sampling considerations, limitations to challenge studies, and data analysis or interpretation of test results. It even provides examples of appropriately designed growth inhibition and inactivation studies. It is an atlas (road map) of challenge studies.

In addition, to keeping an atlas in your car for those off grid moments, I also suggest keeping this publication handy and reviewing it prior to starting any challenge study. This is a road map everyone in the industry should to ensure challenge studies are conducted appropriately and that the data generated is representative of the process and risks within products.

Road maps

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