How CloudSuite Food & Beverage facilitates FSMA compliance
The FDA Food Safety Modernization Act (FSMA) requires that food and beverage companies take a more proactive approach to food safety. This is a shift from the more reactive approach that food and beverage companies have historically followed. With FSMA in place, companies must identify risks, create procedures for mitigating hazards, and execute against those procedures to ensure all threats to the safety of the food supply chain are contained, as well as demonstrate that their programs are valid and that they are continually being improved upon. As ambitious as this may seem, what many don't realize is that the software systems they already use, such as Infor CloudSuite™ Food & Beverage, can already handle this shift and provide a solid foundation to complete their FSMA compliance plan.
This paper details some of the more exacting aspects of FSMA and discusses how CloudSuite Food & Beverage can help food and beverage companies address these challenges.
Why FSMA compliance matters
Each year, 48 million people in the US get sick from a foodborne illness, while 128,000 are hospitalized and 3,000 die, according to the Centers for Disease Control.1 In response, the US Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) seeks to ensure food safety and compliance—and reduce outbreaks of illness.
While the initial set of rules for FSMA were implemented in 2015, new rules will continue to be phased in through 2024.2 These rules require food and beverage companies to be more proactive in preventing food safety problems. Not only does that mean establishing preventive controls, but also validating and verifying them—while also documenting every step along the way. Food and beverage companies, which have historically been more reactive to events such as food recalls, must now commit to a drastic change in how they do business to keep up with regulatory requirements.
Track and trace tools have long been part of the food and beverage industry's preparedness planning in the event of a recall. Just one recall can have sweeping, negative effects on a business. But with FSMA, food and beverage companies must take a broader view of the safety and quality concerns that can affect their products and their business—and documentation is a crucial part of FSMA.
FSMA also requires tighter record and documentation storage. This means having the document management tools and processes in place to ensure traceability, reliability, and compliance throughout the entire supply chain—to prevent contaminations and non-conformance.
FSMA compliance stresses that the safety of consumers is paramount. By adhering to FSMA's quality management mandates, and taking the right steps today, food and beverage manufacturers, central kitchens, distribution centers, food importers, and even transportation companies can ensure full documentation and food traceability throughout their supply chain—as well as high-quality products.
What is FSMA's main challenge for F&B companies?
When it comes to FSMA compliance, the need to increase and improve documentation and record storage cannot be understated. The amount of documentation that food and beverage companies will need is going to continue to grow. Infor CloudSuite Food & Beverage can help maintain the physically signed documents that may be required. FSMA requires written, documented compliance from food and beverage companies that includes:
- Hazard analysis—Documentation to identify and evaluate known and foreseeable hazards for each food type stored, packed, processed, or manufactured at a specific facility. This includes human food and animal feed, as well as raw foods such as produce.
- Preventive controls—To maintain compliance with hazard analysis needs, companies must create a food safety plan that includes preventive steps, monitoring procedures, corrective actions, good hygiene and sanitation practices, and food labeling requirements.
- Foreign supplier verification program—According to the FDA's final rule on the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals, importers must "perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards."3
- Corrective action procedures—These are written procedures that should be taken if a facility is not in compliance, which means documenting problems with the controls and food safety—and re-evaluating the plan.
- Sanitary transportation—From plants to trucks to receiving facilities, companies must document all safety procedures and training for the safe and sanitary transportation of food.
- Recall plan—This written plan includes all of the steps that are necessary to document and take action in the event of a recall. The plan also includes documentation for notifying all relevant parties to remove and dispose of products that have been contaminated.
Compliance with FSMA will require food companies to think differently about their processes and the data they’re collecting. They will need to use the data already being gathered across all aspects of their operations; this is more than just manufacturing data (e.g., tracking visitors, employee training records, and vetting suppliers). New data elements pertaining to suppliers, raw materials, environmental elements (transport conditions, temperatures, metal detectors, etc.), and the products they produce may need to be collected, analyzed, and finally addressed if a non-compliance surfaces.
Most business processes produce data and the vast majority of that data shows that all conditions are “in-compliance.” However, most companies that deal with food have many processes across their organization. How can these processes and systems be enhanced to identify and react to these threats to improve a company’s quality and compliance? Fortunately, Infor CloudSuite Food & Beverage provides the right tools and infrastructure to identify and react to these threats, while complying with FSMA mandates.
How Infor CloudSuite Food & Beverage can help
Infor CloudSuite Food & Beverage is a purpose-built, industry specific solution suite available in the cloud, on-premises, or as a hybrid solution that is easy to upgrade and fully secure. The suite uses our social collaboration engine, Infor Ming.le®, which facilitates internal and external communications between customers and their suppliers to help speed the documentation of all of the supply chain processes for producing high-quality food and beverage products.
How you benefit
Infor CloudSuite Food & Beverage has all of the tools food and beverage companies need to create detailed documentation to maintain FSMA compliance—from inception to delivery and all along the supply chain. These tools can help companies to proactively prepare their businesses to comply with FSMA and ensure that they are producing high-quality products.
1 “Key Facts About Food Poisoning,” Centers for Disease Control and Prevention, March, 2020.
2 “FSMA Final Rules: Key Dates,” U.S. Food & Drug Administration.
3 US Food & Drug Administration, "FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals," Aug 18, 2020.