Foreign Supplier Verification Program Plan in 8 steps
Step 1. Letter of Engagement.
When your company will decide to choose to enlist BRAVO to act as its FSVP Agent, BRAVO will issue your company a signed Letter of Engagement. This Letter will formally transfer the responsibility of your company’s FSVP compliance program to BRAVO and direct all FDA-related inquiries to our office regarding the FSMA regulation.
Step 2. FSVP’s Regulation Compliance Check.
BRAVO Compliance as FSVP’s Agent initial evaluation will review all the information and documents provided by the foreign supplier/facility through our Compliance CHECK FORM and check the applicable US regulatory requirements that apply to exported food products. In addition, BRAVO will check the FSVP’s regulatory status of compliance of the foreign supplier/facility with FSMA regulation.
BRAVO will create for your company a dedicate and secure client account on its own portal with a dedicate client username and password. Based on the finding of checks and on the imported food category, BRAVO will send though our secure portal to your company dedicate client account an e-mail/form. When your company received the e-mail/form you need to fill it out with all the information requested and upload all the food safety documents linked to FSMA regulation required. When your company will submit all the information and documents from your account, our portal will signal an alert on our end and one of our certified Preventive Control Qualified Individual (PCQI) will review the documents and information provided to make sure that they are complete and nothing is missing.
Step 4. FSVP Plan Development.
After the first check of the information and documents, BRAVO will start to develop work made by its certified Preventive Control Qualified Individual (PCQI), maintain, and follow a customized Foreign Supplier Verification Program Plan for you (as required under the Foreign Supplier Verification Program regulation in 21 CFR part 1, subpart L.) to make sure that your company will be in compliance with FSVP rule of FSMA regulation.
Step 5. FSVP Evaluation and Approval.
BRAVO will perform an own food safety Hazard Analysis on the finished products, review and assess the Food Safety Plans or HACCP Plans and the Hazard Analysis performed by the foreign supplier and determine if the supplier is controlling the hazards posed by the food correctly as required under the Foreign Supplier Verification Program regulation in 21 CFR part 1, subpart L. In addition, BRAVO will generate an evaluation of foreign supplier status based on its performance; approval or corrective actions needed and monitor any notification of Import Alerts, Recall, Warning Letter and Import Refusals by FDA as well as regulatory requirements for full FSVP compliance.
Step 6. Verification Plan.
As required under FSMA regulation, BRAVO will create procedures for ensuring appropriate verification activity to ensure the supplier provides the required food safety documents at a specific frequency throughout the years, proving all foreseeable hazards are controlled adequately.
Step 7. Recordkeeping, and procedures for importing food only from approved Foreign Suppliers.
For each entry BRAVO will make a check and an evaluation on any notification by FDA of recall, Import Alerts, Warning Letters, Import Refusals or any other kind of problems regarding the General Food Safety law and FSMA Regulation that involved the foreign supplier. BRAVO will review again the new 3rd Party Audits, COAs, Test Results, etc., Corrective Actions and Reanalysis of Food Safety Plan if there were any changes on them. In addition, BRAVO will keep all the FSVP records for two years from the date of entry available to an authorized FDA representative.
Step 8. FSVP re-evaluation and re-approval of the foreign supplier
BRAVO as FSVP Agent of your company must to re-evaluated and re-approved the foreign suppliers:
At least every 3 years, or
When BRAVO become aware of any information that could potentially affect food safety.
When the foreign supplier and his products is object of a recall, Import Alerts, Warning Letters, Import Refusals.