By Joe Bailey, Food and Beverage Product Lifecycle Management (PLM) Subject Matter Expert.
Recently a Food and Drug Administration warning letter was issued to a major United States ready-to-eat food manufacturer for declaring allergens on multiple product labels contains statements, even though the allergens were not in the product formulations. It reminded me of an experience several years ago where a combination of business process and product lifecycle management (PLM) system updates were created and implemented to help prevent allergen issues before impacting supply chain.
At the time, we were reviewing a product label stating that the formula did not contain soy. After initial review and approval, a small amount of soy was added to the product formulation as the product was produced on a line that used soy and could not be cleaned easily. The formulation got approved and updated, but unfortunately the labels were ordered and brought in without soy being listed on the packaging allergen statement.
There were many reasons for the breakdown and luckily the issue was caught before any product reached customers, although trucks had to be turned around mid-shipment. An in-depth root cause analysis was completed, lessons were captured, and corrective preventive actions implemented. I will not go through all that we learned and/or changed, but we did make some critical process and system updates to help prevent similar issues from occurring again.
1) Product Label Checklists
We created and implemented mandatory checklists for product label reviews for each type of label. I liken it to pilots doing a pre-flight inspection and why they use such checklists. E3 Aviation Association indicates the following on why pilots use checklists: “Checklists are the backbone of safety. The simple answer to why we use checklists is that humans are both complex and forgetful…”. Regulations and change management within a company can be complex and constant, but those involved are human and sometimes look at their myopic role only focusing on what they are concerned about that day. It is easy to miss something while focusing on certain items and forgetting others.
We got push back from some departments on having a checklist and had to defend it. I tried to explain the checklist in a way that focused on helping my colleagues understand why it benefits them. It helped to ensure that the reviewer looked at all the applicable information on the label, and hopefully prevented them from missing something the first time on an artwork review that could cause extra product label reviews later. This helped avoid rework as well as human error. It also provided a guideline for other departments on what information was reviewed on the label so that they knew in advance what to consider before it even got to regulatory and quality. Eventually everyone came around and it was agreed that the checklist was a good idea. I have found that people are not always interested in how something may assist you, but it does help buy in if they understand how it benefits them, the organization overall, and why they should want to do it. The checklists helped ensure all regulations were met, all formula/bill of materials changes were accounted for, and helped prevent rework.
2) Establishing Marketing and Quality/Regulatory Partnerships
We found many times that our marketing and quality/regulatory teams operated in silos until it was too late. This caused product labels to come through for review that were getting rejected, resulting formulation changes and timeline delays. Certifications were listed on artwork, but no application process had been started which were causing timeline delays and potential project blockers. Bottomline is that things were happening too late in the process. We found it critical that all departments worked more closely together by helping each other understand what was happening and how to prevent issues earlier in the development process. We started quarterly face-to-face meetings with marketing and quality/regulatory to discuss critical initiatives, explain why things were happening, and develop an aligned game plan. These discussions were the building blocks for developing trust with each other and creating an aligned partnership moving forward.
3) PLM System Updates
Our PLM system at the time did not automatically rollup allergens in a format that we could use for an artwork update, so we had to add the allergens manually below the ingredient statement in a contains statement. While we were diligent in adding the allergens for the product contains statement, it was still manual and subject to human error. When we upgraded our PLM system, we added a rollup field for the product allergen contains statement that automatically added the allergens in the required format. The report that we ran for product artwork updates also automatically pulled in the allergen contains statement, ingredient statement, and nutrition facts without any manual intervention. This way items were always listed based on what the system indicated for artwork agency without manual intervention before the information was reviewed for accuracy.
Another change we made to our PLM system was including allergens on plant and production lines for the products running in each. When a user created a production formula for operations, the system already knew what allergens were on each line. This meant if someone was adding a new product to a production line that contained an allergen not already on that line, the system would flag the product and indicate that. Before the product could be added to that line it required approval so that it could be communicated out to the plants early on in a project. This helped in two major ways:
- We could easily run customer reports indicating allergens contained in the product and on the impacted production lines and facilities for that product.
- We could prevent operational inefficiencies, if desired, due to adding new allergens to a line that previously did not require an allergen clean and planning/scheduling changes.
Product recalls continue to be heavily impacted by undisclosed allergens. The above ideas are just a few of how to combat that. We at Dynamic FRM™ can help you navigate allergen controls and other issues in your product lifecycle. For more information or to schedule a demo please reach out to us at: https://www.newdynamicllc.com/contact/.
Working with New Dynamic
New Dynamic, LLC is a certified Microsoft Solutions Partner and creator of Dynamic FRM™, a formula and recipe management solution that helps food and beverage producers eliminate spreadsheets and inefficient processes. Built on a familiar Microsoft platform, the solution naturally integrates with the Microsoft Office stack. Visit www.dynamicfrm.com to learn more.
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