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Answers to Your Toughest QA Questions.

Q.  I work in a facility where our finished product is an ingredient for our customer’s product. I recently received a letter from our customer that, under their new policy, every raw material coming into my facility has to be tested or treated to make sure no pathogens are present. We work with flour, corn, rice, and other agricultural commodities that will be further processed in our plant as well as theirs. We have never done this in the past and really do not understand why they are requiring us to do this now. Any thoughts?


A. You are as confused about this as are so many others. Pathogen contamination of any food product is a serious and sometimes deadly event that no one wants to happen. However, microphobia appears to be a trend in the food industry. As with so many complex issues, we seem to have a few people with very little experience or in-depth knowledge writing policies without checking scientific facts.

Certainly, we need to ensure that safe foods are produced and provided to consumers, but this process is not as simple as just sterilizing ingredients. Nor can we test our way out of an issue. We can’t just say “I used to take 10 samples, but now I take 100 and my products are safer.” Testing high-risk ingredients with a known history of pathogens is appropriate, but there are limits to how much product can be tested and when.

Too many people are putting the focus on the ingredient and not taking into consideration the processing environment or use of the product. Some have suggested that raw materials be irradiated to reduce the likelihood of a pathogen presence. But, there is no long-lasting antibacterial action, so releasing this product into a poorly maintained process environment where there is a likelihood of contamination nullifies any benefit of the irradiation or any other step taken to eliminate the potential for pathogen presence.

An accurate and science-based HACCP review of raw materials and the process should identify the risks and course of action to be taken. If there is a concern, you should have fully functional prerequisite programs and a validated kill step in your process. Finished product testing can help verify that the objectives were reached. This process provides a higher level of confidence in the product than just testing raw materials. Managing microbiological issues requires an approach that covers many possibilities and is not limited to just a few at the beginning of the process.

There are times when concerns and restrictions on raw materials are appropriate. When the process does not involve a kill step and a pathogen or spoilage micro concern must be addressed, rigid micro testing protocols and a Certificate of Analysis (COA) for the material should be required before processing. This, coupled with rigid controls in the process environment, can reduce the potential for issues.

A well-developed microbiological control program goes beyond taking samples. The entire process, from supply chain to user, should be considered. Some pathogen issues are within your control; others are not. Good science determines what you can control and guides the consumer preparation instructions.



The author is Head of Food Safety Education, AIB International