FSVP SOP

Approval (sign) Doc # Title: FSVP SOP

Print name Revision Date Replaces

Identifying information about your facility

Company Name: Facility State or province:
Facility Address: Facility zip or postal code:
Facility City: Facility Phone:
DUNS#:

● Scope - This SOP delineates the actions and responsibilities for the Foreign Supplier Verification
Program for (insert facility name)
● Purpose - This SOP is in conformance with FD&CA 801 (q) and the Foreign Supplier Verification
Program rule under FSMA and any GFSI scheme requirements
● Requirements – None
● Responsibilities - It is the responsibility of the owner or designee to understand and comply with this
SOP. This SOP, and the suppliers interviewed must be updated every 3 years.
● Storage - The documentation generated for this SOP will be stored on site for 6 months, and then
available from either onsite or offsite storage with 48 hours of request for a minimum of 3 years.

Procedure
In compliance with the FSVP SOP:
 Importer Identification Number. This facility will have an importer identification number
(DUNS) for each line entry of food that is imported.
 Foreign Supplier Assessment. This facility will conduct, an assessment based on FD&C 801 q
requirements and industry standards on each one of its foreign suppliers. Results will be recorded
on the foreign supplier assessment form. This assessment will be part of the foreign supplier
approval or denial process.
 Compliance Status Review. This facility will conduct a compliance status review on each of its
foreign suppliers, every 3 years. This will done by way of querying local government, FDA and
foreign governments for warning letters and alerts pertaining to the foreign supplier. This will be
recorded on the compliance status review form. This compliance status review will be part of the
foreign supplier approval or denial process.
 Hazard Analysis. This facility will evaluate each foreign food it imports for potential physical,
chemical or microbial hazards that are reasonably likely to occur (RLTO). This hazard analysis will
be recorded on the Hazard Analysis form. This hazard analysis will be part of the foreign supplier
approval or denial process.
 Foreign Supplier Registry. This facility will add each of its approved foreign supplier to the
foreign supplier registry.
 FSVP Customer complaint. This facility will track its corrective actions based on customer
complaints. Customer complaints will be recorded on the FSVP customer complaint form.

FOREIGN SUPPLIER VERIFICATION PROGRAM SOP

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 FSVP SOP
 FSVP Monitoring Foreign Suppliers. This facility will monitor its foreign food suppliers on an
ongoing basis. Monitoring activities of foreign suppliers will consist of reviewing all relevant
documents in a timely fashion.
 FSVP Verification checklist. This facility will conduct a verification of its FSVP every 3 years in
accordance with the FSMA rule. If this facility is certified under a GFSI scheme the verification must
be conducted annually (once a year).
If the supplier has a HACCP plan certified by an accredited 3rd party, that HACCP plan will suffice for the
hazard analysis. Records review of the HACCP, focusing on those hazards deemed RLTO will include:
 Onsite audits records
 Sampling and testing records
 Food safety records review
These documents may be verified by a suitable 3rd party auditor. In addition, once the supply is received,
(insert your facility name) will conduct periodic sampling and testing of product lots.
 Verification/Validation - Owner or designee will review the records generated by this SOP
 Corrective Action Program - Owner or designee will assess the procedures and implement CAR as
needed for failure to comply
 Documents – FSVP Registry, FSVP Assessment, FSVP Compliance Status Review, FSVP Hazard
Analysis, FSVP Customer Complaint, FSVP Monitoring and FSVP Verification Checklist

Signatory Authority:

Print Name:
Sign Name:
Job:
Date:

Implementation/Revision History:

Date Action

Implementation

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 FSVP SOP
Foreign Supplier Verification Program (FSVP) Standard Operating Procedure (SOP)

Effective Date: [Insert Date]

Review Date: [Insert Date]

1. Purpose: The purpose of this Standard Operating Procedure (SOP) is to establish the protocol for the Foreign
Supplier Verification Program (FSVP) to ensure that imported food products meet the requirements of the Food
Safety Modernization Act (FSMA) and other relevant regulations.

2. Scope: This SOP applies to all employees involved in the procurement, import, and verification of foreign
suppliers for food products intended for distribution and sale in [Company Name] or to [Specify Market or Region].

3. Responsibilities:

 FSVP Responsible Individual: [Name and Title]

 Designated individual responsible for overseeing and implementing the FSVP.
 Purchasing Department: [Name and Title]
 Responsible for initiating and maintaining supplier verification records.
 Quality Assurance Department: [Name and Title]
 Responsible for assessing and verifying the safety of imported food products.

4. Procedure:

4.1. Identify and Document Foreign Suppliers:

 Maintain a list of all foreign suppliers used by the company.

 Ensure that all suppliers' contact information and relevant documentation are up-to-date.

4.2. Determine Hazards:

 Identify potential hazards associated with each imported food product.

 Consider biological, chemical, physical, and radiological hazards.

4.3. Verify Foreign Supplier Compliance:

 Assess the foreign supplier's compliance with applicable food safety regulations.
 Collect and review supplier documentation, including Certificates of Analysis (COAs), third-party audit
reports, and other relevant records.

4.4. Evaluate the Food Safety Plan:

 Review the foreign supplier's food safety plan to ensure it addresses identified hazards and complies with
FSMA requirements.

4.5. Determine Verification Frequency:

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 FSVP SOP
 Determine the frequency of verification activities based on the risk posed by the supplier and the product.

4.6. Conduct On-Site Audits (if applicable):

 Perform on-site audits of high-risk foreign suppliers to assess compliance with food safety standards.

4.7. Corrective Actions:

 Establish procedures for addressing non-compliance or safety issues identified during supplier verification.
 Communicate corrective actions to the supplier and track their implementation.

4.8. Re-evaluation of Suppliers:

 Regularly re-evaluate foreign suppliers to ensure ongoing compliance with FSMA and food safety standards.

5. Records and Documentation:

 Maintain comprehensive records of supplier verification activities, including all correspondence,

documentation, and audit reports.
 Retain records for a minimum of [Specify Duration] years.

6. Training:

 Ensure that employees involved in FSVP activities are adequately trained in food safety regulations, hazard
analysis, and verification procedures.

7. Review and Update:

 Regularly review and update this SOP to reflect changes in regulations, processes, or supplier relationships.

8. References:

 List any relevant regulations, guidelines, or standards that this SOP is based on.

9. Approval:

 This SOP must be approved by [Name and Title] and reviewed at regular intervals to ensure its continued
effectiveness and compliance.

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 FSVP SOP
Please customize this SOP to fit the specific needs and requirements of your organization, taking into account any
applicable regulations and industry standards. Additionally, consult with legal and regulatory experts to ensure full
compliance with relevant laws and guidelines.

Foreign Supplier Verification Program (FSVP) - SOP

Scope: This SOP outlines the actions and responsibilities for the Foreign Supplier Verification Program
for [Insert Facility Name].

Purpose: This SOP is in compliance with FD&CA 801(q) and the Foreign Supplier Verification Program
rule under FSMA, as well as any applicable GFSI scheme requirements.

Requirements: None

Responsibilities:

 The owner or designee is responsible for understanding and complying with this SOP.
 This SOP and supplier information must be updated every 3 years.

Storage:

 All documentation generated by this SOP will be stored on-site for 6 months.
 After 6 months, the documents will be available from either on-site or off-site storage within 48
hours of request for a minimum of 3 years.

Procedure:

1. Importer Identification Number:

 Obtain an importer identification number (DUNS) for each imported food product line.
2. Foreign Supplier Assessment:
 Conduct an assessment of each foreign supplier based on FD&C 801(q) requirements
and industry standards.
 Record assessment results on the Foreign Supplier Assessment Form.
 Use this assessment as part of the foreign supplier approval or denial process.
3. Compliance Status Review:
 Conduct a compliance status review of each foreign supplier every 3 years.
 Query local government, FDA, and foreign governments for warning letters and alerts
related to the foreign supplier.

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 FSVP SOP
 Record the results of the compliance status review on the Compliance Status Review
Form.
 Incorporate this review into the foreign supplier approval or denial process.
4. Hazard Analysis:
 Evaluate each foreign food product for potential physical, chemical, or microbial hazards
that are reasonably likely to occur (RLTO).
 Document the hazard analysis on the Hazard Analysis Form.
 Include this hazard analysis in the foreign supplier approval or denial process.
5. Foreign Supplier Registry:
 Add approved foreign suppliers to the Foreign Supplier Registry.
6. FSVP Customer Complaint:
 Track corrective actions based on customer complaints.
 Record customer complaints on the FSVP Customer Complaint Form.
7. FSVP Monitoring Foreign Suppliers:
 Continuously monitor foreign food suppliers by reviewing all relevant documents in a
timely manner.
8. FSVP Verification Checklist:
 Conduct an FSVP verification every 3 years in accordance with the FSMA rule.
 If certified under a GFSI scheme, perform annual verifications (once a year).
9. Verification of HACCP Plans:
 If the supplier has a HACCP plan certified by an accredited 3rd party, use that plan for
hazard analysis.
 Review HACCP records, focusing on RLTO hazards, including onsite audit records,
sampling and testing records, and food safety records.
 These documents may also be verified by a suitable 3rd party auditor.
 Additionally, conduct periodic sampling and testing of product lots upon receipt.

Verification/Validation:

 The owner or designee will review the records generated by this SOP.

Corrective Action Program:

 The owner or designee will assess procedures and implement Corrective Actions (CAR) as
needed for non-compliance.

Documents:

 FSVP Registry
 FSVP Assessment
 FSVP Compliance Status Review
 FSVP Hazard Analysis
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 FSVP SOP
 FSVP Customer Complaint
 FSVP Monitoring
 FSVP Verification Checklist

Please ensure that this simplified FSVP aligns with your specific requirements and the relevant
regulations in your region. You may need to adapt and expand upon this SOP as needed to meet the
unique needs of your facility and your foreign supplier verification program.

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