Senior QA Advisor Tamara Kee
Our consultants receive a wide variety of QA questions. In this article, we share some real-world questions about allergen management, and allergen specialist and Senior QA Advisor Tamara Kee provides you with advice. For example, she addresses questions about cleaning and sanitizing and how to know if you've cleaned enough. She also discusses Precautionary Allergen Labeling and gives tips on when to use which type of allergen test.
How do you know if you've cleaned enough?
In companies, a cleaning protocol is a standard document. What is important for allergen management is that the cleaning has also been verified. You can check this visually, but for better substantiation, quick tests are used for this. These are available from Normec Foodlab for research on allergen proteins. These tests can be used for some time and offer quick results. Take a worst-case scenario for this.Before you start, you must first get clear on which allergens are present in the production and where they are located. A helpful tool here is to make this visual on a company map. Find out where cross-contamination may occur so that you can take these as sampling spot(s), keeping in mind homogeneous cross-contamination or particles (nuts, pieces of dough). In doing so, grab the hard-to-clean spots. Think for example of dumping cabinet, dosing unit on a process line, weigh stations and transport. Find out what visually remains after cleaning and whether these places can be cleaned better by, for example, a technical adjustment. Then perform a validation for each type of cleaning that is deployed.
How do you know if that quantity leads to yes/no PAL?
PAL (Precautionary Allergen Labeling) should be included on the label or product specification only if there is an actual risk to the allergic consumer. The risk must be demonstrable. The starting point should be the prevention of cross-contamination. If the amount of allergens present after all possible adjustments and prevention still exceeds the safe limit, PAL may be applied. How to compare total cross-contamination with the safe limit is included in the Cross-contamination Allergen Guidelines. I sometimes come to customers who are already doing the risk assessment without first checking whether the cross-contamination can be prevented. If you want to calculate how many protein allergens you are actually dealing with, you can use the raw material specifications and recipe. If quantitative information on a specification is missing, you can make your own assumptions or estimate the amount of protein allergen. You may already come out below the set reference values. Eventually you will have to record all this in a report and substantiate it.
Prepare well
Do you have questions about preparing for the new allergen policy or are you running into something? If so, we will be happy to help. Want to know more about allergen management and how to ensure the safety of your products? Then download our free white paper on allergen management and discover practical tips and insights that you can immediately apply in your business operations. The following topics are covered:
- Allergen management over time
- The impact of allergens from a product and process perspective
- Concrete steps for a successful allergen management system
How to avoid analyses that say nothing?
Which allergens should I test for?
After implementing allergen-building production planning, validated cleaning protocols and using the correct recipes and complete raw material information, you can start analyzing how much residual protein allergen is left on the line. This amount of protein allergen can cause potential cross-contamination to the next allergen-free product. In a bakery, almost all finished products contain the allergen wheat, but not every product will also contain nuts. This means that if we want to produce nut-free products we want to know if nut protein is present in the nut-free product after cleaning it.
When do I use which type of test?
I often get the question from my customers, "Which test should I use when?" Unfortunately, a test has not yet been developed for every allergen, but an ELISA is available for the most common allergens. An ELISA test provides a precise amount of the allergen protein in products. For this, however, the amount must fall within the measuring range of the test. The result of the theoretical allergen cross-contamination calculation is compared with the lab analysis in the product of the protein allergen in question. Usually this is expressed in ppm, or mg/kg. Repeat this test with regularity. Always use a worst-case scenario for your validation.
How do you know what you are measuring?
I have more than 100 products, do I need to do 100 quantitative risk analyses? The answer is "no. Start with:
- Clustering product groups
- Clustering groups with the same process
- Clustering groups with the same consumption size
Then figure out where cross-contamination is in the process so you know what analyses to employ. Calculate in advance the theoretical amount of cross-contamination based on raw material specifications and recipe so that you know what you are going to measure and can deploy the appropriate test. Keep in mind the LOQ (reporting limit), which is the lowest concentration of a substance that can be quantitatively analyzed.
Do you have a quality question of your own or are you running into a specific problem?
Our experts will gladly think with you and help you quickly on your way.