Become FSMA and FSVP Compliant

March 7, 2016

By Sparta Systems


What the Latest FDA FSMA and FSVP Rules Mean For You

The next time you buy fresh fruit in the middle of winter, think about this: More than 15 percent of the U.S. food supply is imported, with imports accounting for 50 percent of fresh fruit and 20 percent of fresh vegetables.

Surely produce imported to the U.S. is safe, isn’t it?

Currently, foreign suppliers are not held to the same level of safety as domestic growers. But this is about to change: The FDA recently finalized rules implementing the Food Safety Modernization Act (FSMA), including the Foreign Supplier Verification Program (FSVP), which requires importers to perform risk-based foreign supplier verification activities, to verify that food or food ingredients manufactured out of the U.S. are as safe as those manufactured in the U.S.

However, this creates a major challenge for companies that may not be equipped to monitor and manage suppliers to the extent required.

Most food companies have a good grasp on internal quality management, but many will struggle to manage supplier quality outside their four walls because they are not used to managing suppliers at that level of detail. For example, under FSMA, importers will be responsible for determining known or reasonably foreseeable hazards with food. Importers must, therefore, evaluate the following of their supplies/suppliers:

  • Determine known or reasonably foreseeable hazards with each food;

  • Evaluate the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance;

  • Approve suppliers and determining appropriate supplier verification activities;

  • Conduct corrective actions

In addition to hazard analysis and food risk evaluation, further supplier verification may be required, such as on-site audits of the supplier's facility and food safety. This is an incredible amount of information to process, but successfully logging, tracking and reporting this data is critical to being FSMA compliant.

Recommended Steps for FSVP Compliance

  1. Establish a global catalogue of all the suppliers, supplier sites, importers and importer sites you receive ingredients from. Food and beverage companies will need to know where the food or ingredients they are importing are actually produced.

  2. Organize all of the food safety documents and certifications required from suppliers and importers. Leveraging a supplier document control solution as part of a quality management system can greatly help here.

  3. Perform regular supplier and importer risk assessments

  4. Schedule auditing of supplier sites and importer sites. Keep a record of the audits performed and the status of any corrective actions that were sent to the supplier as result of an audit.

  5. Remain in continuous communication with suppliers and importers to stay up to date on incident follow-up, corrective action, supplier document requests and specification changes. Ideally, this would be accomplished through a supplier quality management portal (vs. simply phone or email) to ensure accountability.

  6. Implement a system that providers alerts and notifications when a supplier or importer is out of specification or behind on action requests. This system should also ensure that audit programs and any follow-ups are being executed in a timely manner, and if they are not that all parties involved are notified.

  7. Leverage data for supplier and importer analysis, utilizing reporting and analytics to monitor supplier performance and to determine if the safety programs put in place are effective.

Following these steps will help prepare companies to meet FSVP rule requirements and ensure compliance.

To learn how an enterprise quality management system (EQMS) can help food and beverage organizations comply with new FSMA regulations, please visit You can also review our Food and Beverage industry page for more information about how F&B organizations have implemented an EQMS to improve their quality and compliance processes.


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