Trustwell Blog

The Risks of Waiting to Be FSMA & FSVP Compliant

Written by Katy Jones | Dec 12, 2017 8:00:00 AM

The Food Safety Modernization Act now requires greater transparency from the entire supply chain and fundamentally changes the way food is regulated in the U.S. and abroad, from farm-to-fork. Additionally, the Food Supplier Verification Program (FSVP) shifts certain food safety responsibilities from the government to food companies. Now that companies shoulder much of the burden, proactive measures are essential.

Proactive Measures are Essential

A reactive stance -- responding to violations only after the fact -- often proves costly both in terms of lost profits and damaged reputation. It’s better to take action now rather than wait. Supplier verification requires a thorough understanding of every entity in the supply chain, and the proper development of appropriate written standards takes time.

FSMA's document-intensive supplier verification standards are more stringent than the voluntary programs of the past. Keep in mind that supplier verification is but one of four key steps to FSMA compliance. The others are records availability, traceability and audit readiness.

Real-time food safety documentation saved in a central repository helps to generate the records the FDA wants to see and will save you the hassle of searching across disparate systems and file cabinets. Recalls must be thoroughly documented and contain time-date stamps. It’s important to document tracking events across your entire supply chain.

A food supplier management solution can automate essential tasks and alert you to approaching document expirations, which better prepares you for FDA audits. You also want the ability to successfully complete internal and third-party audits of your suppliers and then save them in a centralized location, accessible to stakeholders across your company.  To ensure both food safety and FSMA compliance, particularly with high-risk foods, visualization of events across your supply chain is important.

Make Sure You Have a Plan in Place Now

You should have a plan in place including the ability to easily track compliance, a procedure to identify and address suppliers that have repeated corrective actions, and the ability to supply requested documents within 24 hours. The plan should establish compliance, keeping the Key FSMA Compliance Dates in mind. Make sure your plan answers the following questions.

  • Can you provide records quickly and efficiently?  Under FSMA regulation, your food safety documentation is critical to demonstrate how you managed recalls and other issues effectively - and these records must be compiled within 24 hours of an FDA request and maintained for a minimum of two years.

  • Can you verify foreign suppliers in your supply chain? Supplier verification is a critical component of FSMA compliance - and looks quite different from voluntary requirements. FSMA regulation requires food companies to verify and document the “hazards” that you are relying on your foreign suppliers to control — and then making sure they are taking the necessary steps to control those hazards adequately.  

  • Can you enhance your product traceability? : Go beyond “one-up and one-back” with your product traceability. With increasingly complex supply chains, traceability across your entire supply chain is critical for effective recall management and managing quality of your products. For high-risk foods within your supply chain, it is especially critical to have visibility into the “last mile” of that product’s journey to the consumer.

  • Are you prepared for an FDA Audit? For the first time, the FDA has mandatory recall authority for all food products along with more flexible standards for detaining products that are potentially in violation of the law - including the ability to halt operations of a facility that is under suspension.  

FDA and Noncompliance

When there is a problem with a foreign food supplier, the FDA may require a company to stop using the supplier "until the cause of noncompliance, adulteration or misbranding has been adequately addressed." The resulting disruption to the supply chain may be costly.

Non-compliant organizations may also face expensive voluntary recalls. Although FDCA Section 423(a) gives food companies an opportunity to recall the product and voluntarily discontinue distribution in a timely manner, the process frequently diminishes the brand.

When the FDA deems a company's response inadequate, the agency may issue a mandatory recall under provisions of Section 423. Mandatory recalls are less common, because they require either a refusal to stop distribution or a failure to recall a product in a timely manner.

Protect Your Brand

In the post-FSMA universe, a compliant supply chain is essential to protect your brand. A recall costs a food company an average of $10 million. Be proactive about FSMA and FSVP compliance and make consumer safety a top priority. By effectively managing your supplier relationships you can deliver your brand promise and give your customers exactly what they’re asking for.

FoodLogiQ is a robust supplier management solution that advances the quest for FSMA and FSVP compliance. Streamline supplier documentation and template workflows to implement corrective actions, support supplier verification and centralize required record keeping.

To learn more, read how National Cortina used FoodLogiQ for FSMA and FSVP compliance and breezed through their FDA inspection. If you’re interested in learning more about our supplier engagement platform, Manage + Monitor, request a demo.

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