According to a report by the U.S. Public Interest Research Group, the total number of food recalls in the U.S. increased by 10 percent between 2013 and 2018. In the last year alone, the USDA Food Safety and Inspection Service recalled over 10,000 tons of food. Food quality issues have contributed to the roughly 48 million who people get sick, 128,000 who are hospitalized, and 3,000 who die from foodborne diseases each year in the U.S., based on estimates by the U.S. Centers for Disease Control and Prevention.
One of the key challenges that food manufacturers face in preventing recalls is how to ensure their suppliers maintain effective quality management procedures. This includes monitoring food supplies that come from foreign countries; there are more than 200 countries or territories (and roughly 125,000 food facilities and farms) that supply 32 percent of the fresh vegetables, 55 percent of the fresh fruit, and 94 percent of the seafood that Americans consume annually.
Unfortunately, many importers still rely on manual processes that are limiting their ability to keep track of supplier data and quality processes. This not only puts consumer safety at risk but can also inhibit a company’s ability to comply with FDA regulations. Organizations that struggle to locate data because they’re forced to sift through paper records are likely to be flagged during an inspection. Instead of relying on manual methods, importers should look for a software solution that can house all their critical quality data in one central, easy-to-access location. Not only does centralizing data make it easier for importers to address the FDA’s questions, but it also enables them to more efficiently and effectively manage suppliers.
Finding a Solution for Food Suppliers
By investing in a supplier quality management tool, importers will have direct access to critical compliance and quality data, such as materials, testing and sampling records, audit findings, and corrective actions. Additionally, with the right tool, importers will be able to update data in real-time and require their suppliers to do the same. As an added bonus, this level of automation will significantly streamline previously manual processes, giving both importers and suppliers the resources they need to focus on what matters most: the safety and quality of the product.
The most effective supplier quality management tools can ensure finished product quality with automated control and visibility over all elements in an organization’s supply chain—from local manufacturers to global suppliers. Importers should look for solutions that can track suppliers and materials, build qualitative and quantitative supplier ratings, and trigger actions to improve supplier quality, all from one, easy-to-use interface. Ideally, the solution will be able to automatically:
- Track and evaluate the quality of supplier goods in real-time.
- Identify scenarios that may warrant supplier corrective action, such as nonconforming material, missed or delayed delivery, and investigation of a customer complaint.
- Manage the approval process for changes to products and processes made by suppliers.
- Generate reports for suppliers categorized by commodity and date.
For one global provider, leveraging a sophisticated quality management solution that incorporated the above features was critical to its success. With the right software in place to automate contract management processes, the organization was able to achieve a 5,000 percent return on investment and significant productivity gains. Another national fast-food chain centralized and automated its vendor approval system, which allowed it to shave weeks off its vendor approval process and get new products to market faster without sacrificing food safety.
This type of solution is especially helpful when navigating the complexities of the FDA’s recently enforced Foreign Supplier Verification Program (FSVP), a key compliance and safety rule under its Food Safety Modernization Act (FSMA). With the number of food recalls increasing and the threat they represent to U.S. consumers, manufacturers, and the economy, it’s no surprise that the FDA is cracking down by enforcing one of its key regulations around imported goods. Foreign food suppliers and U.S. importers that are uncertain about whether they’re ready for the inspections should first take a step back and review their quality processes to ensure they—and the other companies operating in their supply chain—are meeting every one of the FDA’s compliance and safety rules.
Getting to Know the FSVP
The FSMA has been referred to as the most sweeping reform of U.S. food safety laws in more than 70 years. The focus of the act is to ensure more effective prevention of safety issues in the U.S. food supply by taking a comprehensive overhaul of every segment of the supply chain, from farm to fork. It was signed into law by then-President Obama on Jan. 4, 2011, and in the years since the FDA has been working to develop the final rules.
One of those rules is the FSVP, which at its most basic level requires that the same food safety standards are applied to all foods sold in the U.S., whether they’re produced in Minnesota, Mexico, Morocco, or Montenegro. The program puts the onus on U.S. importers to verify that their foreign suppliers are producing food in a manner that provides public health protection and to ensure that the supplier’s food isn’t adulterated or misbranded with respect to allergen labeling.
The rule was formally finalized in 2015 and the first compliance date was set in May 2017, with compliance dates extending throughout 2020. According to the FDA, compliance dates for FSVP are based on:
- The foreign supplier’s size: Companies will have a longer amount of time to comply with FSVP rules when suppliers qualify as small or very small businesses. The FDA has helpfully provided a Small Entity Compliance Guide
- The company’s role in the food supply chain: Importers that are also manufacturers and subject to supply-chain provisions of preventive control rules should refer to compliance dates in those established rules. If this is applicable, then those rules may provide more time for compliance than the FSVP dates outlined on the FDA website.
- Whether suppliers are subject to other rules: Importers whose suppliers are already subject to preventive control or produce safety rules may also have more time to demonstrate compliance.
Evaluating Foreign Food Suppliers
Under the FSVP, importers are responsible for leading the evaluation of their foreign suppliers, which includes taking actions such as:
- Determining known or reasonably foreseeable hazards with each food.
- Evaluating the risk posed by a food, based on the hazard analysis and the foreign supplier’s performance.
- Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities.
- Conducting supplier verification activities.
- Conducting corrective actions.
“Hazards” are anything defined as being reasonably likely to cause illness or injury that occur naturally, are unintentionally introduced, or are intentionally introduced for the purposes of economic gain, such as substituting a less-costly ingredient. This could include:
- Biological hazards, such as parasites and disease-causing bacteria.
- Chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved food or color additives, and food allergens.
- Physical hazards, such as glass or metal.
If an importer finds that one of their foreign suppliers is at risk for nonconformity or is using processes and procedures that might put public health at risk, the importer must promptly take corrective actions. These actions could include discontinuing the use of that supplier until the cause of noncompliance has been addressed. Importers are also subject to their own set of conformities that ensure their quality and safety standards adhere to the FDA’s regulations.
Beyond investing in software, importers should also identify ways to prepare their suppliers for FSVP inspections, such as performing a mock inspection. By taking the time to walk through all the FSVP criteria ahead of time, importers will be able to pinpoint any challenges or quality concerns that need to be addressed before the FDA inspectors arrive.
While FSVP preparedness is undoubtedly time-consuming for suppliers and importers alike, it’s also critical to ensuring the safety of our products and, ultimately, our consumers. And although it’s essential that importers get themselves and their foreign suppliers ready for inspection as soon as possible, it’s even more important that they establish quality management best practices to consistently ensure the quality of the products they deliver to the public, support more efficient supply chain management, and instill consumer trust. Thankfully, with the right tools and processes in place, every company will be able to easily maintain compliance and product quality year-round.
Isaacson is senior director of product marketing at ETQ. Reach him at firstname.lastname@example.org.