Understanding the FDA’s Foreign Supplier Verification Program Rule (FSVP) for Food Importers

BRAVO!!! WE ARE NOW FSVP CERTIFIED PLANT NOW FOR CARGO TO USA!!!. 

Selecting A Qualified Individual (“QI”)

A key concept within the FSMA rule is the “Qualified Individual,”. The idea is that anyone with a critical responsibility that may impact food safety of products should be specially qualified for that role through a combination of job experience, knowledge, and training.  In essence, it comes down to employee competence, similar to any GFSI audit or ISO-based audit.  It makes sense if you consider it; anyone who approves or verifies suppliers, assesses hazards, or maintains documentation, should be qualified to do so.

It’s also worth noting that you can use contractors or third-party service providers to conduct some of the functions required by the regulation.  If you require such assistance, feel free to contact Safe Food Alliance for help.

Implementing The FSVP Rule With Preventive Controls

For companies who not only import but also process, there is an important consideration regarding the FSVP rule. In short, companies who have programs in place to comply with the Preventive Controls rule are considered in compliance with the FSVP rule if they fully comply with the PC rule supply chain requirements. The requirements are ultimately equivalent, although not the same word for word. That being said, import documentation requirements still must be complied with.

What The FDA Is Saying About FSVP

In 2018, members of the Safe Food Alliance staff attended a train the trainer course where the FDA pointed out areas of concern for implementing the FSVP rule. As a result, we wanted to share a few notable items from the training.

1. It’s essential to identify which U.S. regulations your imported items fall under.

2. If the FDA requests records, you must submit them within 24 hours of the request. Cloud-based systems are extremely effective for this reason.

3. Many importers need to seek outside help to comply with all the aspects of the regulation.

4. The FSVP party regulated by the FDA is not necessarily the importer of record.

5. Supplier verification records must be in English. If said documents are not in English, they must be translated.

Next Steps

1. First, make sure you understand the requirements of the regulation.  If this involves training, be sure to get it.

2. Next, identify critical roles required by the regulation, and whom your organization relies on to complete those roles.

3. Last, ensure that you have a sound system for tracking documents and records.  We strongly recommend a cloud-based system, whether something like Dropbox, Google Documents, or a paid provider. You need to have records readily available.

To summarize, the Foreign Supplier Verification Rule is complex. It is important to get the proper training and implement the rule properly, not only to prevent liabilities for your organization but also to create safer food for our communities.