FDA Food Safety Requirements FSMA Traceability BRC Standards

FDA Food Safety Requirements FSMA Traceability BRC Standards

GFSI BRC FDA Food Safety


Meeting FSMA compliance requirements is one of the most important things a manufacturer can do to protect their business. The Food Safety Modernization Act (FSMA) was passed by Congress in 2011, and it places new regulations on food producers and manufacturers.  While there are many ways to meet FSMA regulations, one way is through implementing data collection for your supply chain and production processes. 

Achieving GFSI BCBS239 certification demonstrates that your company has met the highest safety standards.  Certification assures consumers that products meet high-quality standards. This helps them make informed choices when buying food and drink products. In addition, it also gives companies a competitive advantage as it shows customers that they take food safety seriously. This article will discuss the key components of an effective FSMA traceability solution and how it can help bring your organization into compliance with this important regulation.

FDA FSMA Food Safety Requirements:

FSMA is a new set of rules that will change how food companies operate. It’s a law that was passed by Congress in 2011 and signed by the President in January 2011. BRC Global Standards (BRC) is a product certification program used by over 29,000 certificated suppliers in 123 countries, with certification issued through a worldwide network of accredited certification bodies.

BRC has recently revamped its standards, and the new BRC 9.0 standard was released in September 2018. The revised standard provides food safety assurance and quality management requirements aligned with FSMA requirements while addressing environmental protection, sustainability, and brand protection issues as well as modernizing food processing technologies like robotics and technology-enabled traceability systems to meet consumer needs for authenticity and trustworthiness across global supply chains.

Benefits of being certified: Demonstrate Compliance with International Regulations, Insurance, training & brand awareness:

Certification helps companies meet global requirements and maintain high levels of customer confidence. It also helps them to attract new customers by demonstrating their commitment to safety and quality.

Certification assures consumers that products meet high-quality standards. This helps them make informed choices when buying food and drink products. In addition, it also gives companies a competitive advantage as it shows customers that they take food safety seriously.

Certification assures consumers that products meet high-quality standards. This helps them make informed choices when buying food and drink products. In addition, it also gives companies a competitive advantage as it shows customers that they take food safety seriously.

Consumers trust certified brands more than non-certified ones. They believe that certified products are safer and of better quality. As a result, they are more likely to buy these products.

Reassurance for your Employee and Clients:

Employees who work with food products need to feel confident that the products they are using are safe. They also need to trust that the companies they buy from are trustworthy. By being certified, you demonstrate that your company meets these high standards.

In addition to meeting international standards, achieving GFSI BCBS 239 certification demonstrates that your company meets the highest safety standards. This means that your products and services are safe for use by consumers.

FSMA Traceability:

FSMA traceability is mandated by the Food Safety Modernization Act (FSMA). The final rule, called Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Human Food, also known as FSMA Preventive Controls, was published on September 17, 2015.

The objective of this law is to reduce foodborne illness by improving the safety of all foods imported into the US and reducing contamination at domestic facilities that produce processed or packed foods. It also requires food producers to identify which facilities they do business with and track their products throughout each facility’s supply chain.

For your company to meet FSMA requirements you need an effective way to manage food safety data from the field through the distribution center (DC) back down through production lines until it reaches consumers’ plates at restaurants or grocery stores across America.”

BRC Global Standards 9.0:

The BRC Global Standards 9.0 is the most current version of BRC Standards, a global standard for food safety and quality management. It includes requirements for hygiene and sanitation, employee hygiene practices, hazard analysis critical control point systems, record keeping, and traceability.

BRC 9.0 has increased requirements for hygiene and sanitation—particularly regarding cleaning protocols that must be adhered to when an establishment has received a non-compliance rating on its HACCP plan during a USDA inspection (which can affect an establishment’s ability to sell products). In addition, it now requires that employees are well trained in food safety procedures; this includes regular refresher training sessions that address food safety topics such as temperature monitoring during storage or transportation of products among other things.

One aspect of the FSMA Traceability Rule that impacts businesses at all stages of handling raw materials or ingredients used in manufacturing processes is its requirement that facilities maintain records detailing how each product was sourced from its origin through any subsequent processing steps before arriving at their destination (i.e., retailers’ shelves).

BRC 9 Non-Conformity Management:

BRC 9 Non-Conformity Management is a key component of BRC Global Standards 9.0.

BRC 9 Non-Conformity Management provides a framework for identifying and managing non-conformities in the food supply chain. BRC 9 Non-Conformity Management covers the full spectrum of food safety and quality requirements, from preoperational to post-operational.

The module for the identification of non-conforming products in the supply chain includes:

  • A detailed breakdown of critical control points (CCPs) with an explanation of why they are critical.
  • How these CCPs interact with one another.
  • How these CCPs relate to prerequisite programs.
  • The importance of effective record keeping for compliance with regulations such as HACCP (Hazard Analysis Critical Control Point), FSMA (Food Safety Modernization Act), GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), GHP (Good Hygienic Practice) and OIE (Office International des Epizooties).

HACCP Compliance Solutions:

HACCP is a system that helps you identify and control hazards in your production process. Developed by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF), HACCP is a systematic approach to food safety. It requires you to analyze your production processes and identify potential hazards, then develops controls for those hazards.

HACCP can be used to meet FDA FSMA requirements for traceability and if you have some degree of FDA-mandated third-party verification, like BRC certification, it’s especially useful because it will ensure that the appropriate records are being kept supporting claims about ingredient sources as well as product origins.

However, HACCP isn’t a “one size fits all” solution; every company needs its own unique plan tailored specifically for its operations, facilities, and products. And while many manufacturers have voluntarily adopted HACCP systems to ensure compliance with regulations such as FSMA or FSSC 22000:2007—the international standard on food safety management systems—not everyone has done so yet (though this trend may have changed now that the NLEA rules have been finalized).

FDA Compliance Management Solutions:

FDA Compliance Management Solutions is a comprehensive suite of solutions that help food and beverage manufacturers meet the requirements of the Food Safety Modernization Act (FSMA) and other food safety regulations. The FSMA requires food companies to take steps to prevent contamination, or at least detect it when it occurs. Preventative Controls are one-way companies can achieve this goal. They focus on preventing problems rather than reacting to them after they occur.

Preventative Solutions help users develop plans for identifying hazards and implementing effective corrective action practices through process hazard analysis (PHA). This tool also allows users to generate corrective actions plans (CAPs), monitor critical control points (CCPs), monitor HACCP systems, and track complaints and product withdrawals associated with a CAP/HACCP plan or CCPs/PCPs in real time using an enterprise-wide Quality Management System (QMS) with built-in integration features that connect disparate systems into a single platform for continuous improvement initiatives across all departments within an organization’s supply chain network infrastructure

Integrating Supply Chain Data:

Integrating data from your supply chain, production, and packaging areas will allow you to manage your food safety and quality processes with ease and efficiency. You can use a single system to manage food safety, quality and traceability. This allows you to have better visibility across the entire organization, which results in more effective management of your suppliers’ performance. It also helps you respond faster if there’s an issue with one of their products – for example if an ingredient has been recalled.

How to sell to larger retailers – typically by meeting third-party certifications required by supplier programs. Managing multiple certifications effectively adapting your processes as requirements change.

0/5 (0 Reviews)

Looking for Regulatory Compliance Help?

Whether you seek compliance with the latest regulations or need further information, connect with an experienced FDA / Heath Canada compliance consultant today.

Kindly complete our inquiry form to book your FREE consultation session, ensuring seamless adaptation and avoiding potential regulatory hurdles.

30 Minute Free Consultation

About the author

Quality Smart Solutions
Quality Smart Solutions


Don't miss updates from Health Canada and FDA.

If you are looking for the latest regulatory updates or want the newest regulatory requirements guides, please leave your email and we'll keep you posted.

This website uses cookies to provide necessary site functionality and improve your online experience. By using this website, you agree to the use of cookies as outlined in Quality Smart Solutions's online privacy statement.