Importance of Annual Risk Assessments

      Subscribe To Blog


      Unforeseen risks to food safety often go undetected. Most of the time, these risks do not manifest into actual events such as recalls. However, knowing what, when, and where dangers exist within your production, processing environment, and food safety programs is critical, so proper mitigation strategies may be applied to control these formidable risks.

      Yearly audits of a facility, as well as programs, policies, and procedures, are important. These are usually predetermined checklists companies can prepare for the same audit each year. As stated, this is important and is a great verification of sustained food safety programs. However, recalls still occur with the best audit systems in place. The question now is: are they the right programs implemented? Each food establishment is not only different in the commodity and products produced but also has intrinsic risks that take a Subject Matter Expert, SME, as an experienced investigator, to understand and uncover the unique risks to your business. For example, not all ice cream plants are created equal. All spray-dried operations are not created equal.

      There are many examples of how a risk assessment can better prepare your company for a costly recall and keep the customers from harm. Merieux NutriSciences has identified over 30 categories within a food processing operation needing deep investigation. We may look at this as a validation of these programs, which, therefore, accomplish the goal of food safety. Here are a few of those and some reasoning behind the topic examined.

      Sanitation Practices

      Many questions in a 3rd party audit cover most aspects of sanitation practices. One question that often gets little or no attention is deep cleaning schedules. This is scheduled downtime; the equipment is sometimes torn down to nuts and bolts. This will depend on factors such as the history of the plant, age of equipment, production types, wet vs. dry, products produced, etc. These deep cleans are usually scheduled weekly, monthly, or quarterly. Often, we see that these are not planned or that equipment is not dismantled sufficiently. A comprehensive risk assessment by an SME Expert with food category knowledge and knowledge of where pathogenic and spoilage organisms harbor and hide is critical to a properly implemented sanitation program. This is usually a lengthy plant visit with interviews with maintenance, sanitation, and operators.

      Evaluation of the preoperational inspections involves not just looking at the data recording sheets but walking with the preoperational technician to determine where opportunities for improvement can be made, thus lowering the risk of product contamination. Getting under equipment and climbing ladders or mezzanines may also not be part of existing preoperational inspections.

      Assessments here must include a hazard analysis of all ingredients and the high-risk ingredients identified. During some routine 3rd party audits, the question is whether a hazard assessment has been performed. With a yes or no answer, you may stop here. The risk here must be appropriately determined and all ingredients properly reviewed. This would include literature searches, which can be a lengthy process. A comprehensive risk assessment would consist of proper identification and verification of the risks for all ingredients, not just that it has been done. This lengthy process does not fit the time allotment of a routine audit. Investigation into the proper test, certified method, and organisms selected and sample sizes are applied to each ingredient. In other words, is your COA’s complete with the right protection for your company? For example, is there a sufficient sample size submitted to the testing lab for Salmonella testing? Usually, this is anywhere from 25 grams to 375 grams and more. We have seen 1, 5, and 10 grams submitted. Is Salmonella identified as a hazard likely to occur with that ingredient? Is the lab certified for the test being performed, or is the supplier using a local lab for convenience? Are the methods adequately chosen from references such as AOAC, BAM, USP, etc.? Ask yourself, does testing a sprayed dried milk production lot for 10g by the USP method protect you and your company? 

      The decision process is validated in the supplier ingredient process during our risk assessments, not just checking a box where one is present. This thought process and deep review are also applied to your finished product testing programs.

      Environmental Monitoring Programs – EMP

      A large part of a risk assessment is determining how a company developed its EMP program and whether it is robust enough to protect the company and brand name. Each EMP should evaluate the products manufactured, facility layout, equipment used, and hygienic design (does it fit the operation it is being used for), the facility's swabbing history, and, most importantly, site selection. Can the results tell a story to aid in the identification of the harborage or growth niche site and protect the company and brand?

      What is often missed in routine audits is a deeper dive into the tools needed for a properly implemented EMP. Examples include swabs or sponges used as the proper buffer that will neutralize the sanitizers your facility is using. If not, false negatives may occur in the data and greatly increase risk. Are the size areas sampled sufficient? Are the samples properly shipped to the lab within 24 to 72 hours refrigerated, not to exceed 7C, and not frozen. The amount of time spent shipping greatly depends on the buffer used in the sponges.

      Listeria and Salmonella are associated with cool, wet vs. dry processing environments, respectively. However, these pathogens have not taken micro courses like many of us. Many production facilities have a blend of both, and this is often not properly addressed in the EMP plan, which may be missed during a routine audit. The risk assessment will determine if both need to be in the testing program and at what ratio and frequency.

      Shared and Altered Equipment

      Companies often make the mistake of adapting equipment that is suited for one purpose and using it for another. Equipment designed for a wet operation should not be reconfigured for a dry operation, and vice versa. The sanitation of 1000 will eventually fail, and pathogens will take up residence.

      A risk assessment will look at the sharing of equipment. Equipment shared between raw operations and equipment used after a lethal process poses a risk to the finished product. This is not an ideal practice, and if done, are there proper mitigation strategies applied and monitored to lower the risk? Are there shared washrooms for raw and finished products? How is the finished product protected, and are current practices sufficient? Recommendations for improvement will be made by addressing the concerns identified.


      The topics above are just a brief synopsis of how MXNS would conduct a deep dive into potential risks to your company. We want to specify that a food safety risk assessment is not a checklist.  Each risk area we identify will get these types of investigational approaches to understand the thought process and help in lowering the risk even further. It is a partnership, and deep thinking and discussions around the potential undisclosed risks are still to be addressed and eliminated. Discover how our consulting services and food risk assessments can help safeguard your company against unforeseen dangers.

      Similar Posts

      Stay Up-To-Date With the Latest Developments in the Food Industry

      Get the latest news on food safety and quality directly in your inbox.