FDA FSVP DOCUMENTATION
The United States (U.S.) Food and Drug Administration's (FDA) Foreign Supplier Verification Program (FSVP) is fundamentally concerned with food safety. As a properly designated and qualified FSVP Importer or Agent, United Safety Agents’ primary responsibility is to develop, maintain, and follow an FSVP Plan that provides adequate assurances that imported food meets applicable U.S. food safety standards. Required documents may vary and are based upon several variables. This page contains the names and descriptions of common documents used by food manufacturers. Should you have any questions, our team is available at your convenience. Feel free to contact us directly, or schedule a time to speak via telephone. NOTE: FSVP does not require the foreign supplier to control every hazard prior to import, only that all hazards be controlled prior to human or animal consumption. All documents must be written in English.
FOOD SAFETY PLAN
A Food Safety Plan (FSP) consists of the primary documents in a preventive controls food safety system that provides a systematic approach to the identification of food safety hazards that must be controlled to prevent or minimize the likelihood of foodborne illness or injury. It contains a collection of written documents that describe activities that ensure the safety of food during manufacturing, processing, packing, and holding. See 21 CFR 117.126.
The Food Safety Plan starts with a hazard analysis (see HACCP, below) of all ingredients and process or manufacturing steps. A “hazard” is any biological, chemical (including radiological), or physical agent that has the potential to cause illness or injury. It is important to understand that for the purposes of food safety, the term “hazard” refers only to the conditions or contaminants in food that are capable of causing illness or injury to people. These include hazards that occur naturally, that are unintentionally added or that may be intentionally added to a food for purposes of economic gain (i.e., economic adulteration). Many conditions are highly undesirable in food, such as the presence of insects, hair, filth or spoilage, and violations of regulatory food standards. All of these defects should be controlled in food processing; often, however, these defects do not directly affect the safety of the product. Unless these conditions directly affect food safety, documents addressing these issues are not included in an FSP. If the hazard analysis does not identify any hazards requiring a preventive control, the only document in the FSP would be the hazard analysis. While there is no standardized format for an FSP, required components include:
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Hazard Analysis*
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Preventive Controls*
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Supply‐Chain‐Applied Controls*
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Process Controls*
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Sanitation Controls*
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and/or Other Controls (if applicable)
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Preventive Control Management Components*
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Monitoring*
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Corrective Actions and Corrections*
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Verification Activities* such as
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Validation
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Verification of Implementation and Effectiveness
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Recall Plan*
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Reanalysis
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Implementation Records
*Note: required as appropriate when a facility’s hazard analysis determines there is a hazard requiring a preventive control.
While these are the required components, the Food Safety Plan should be thought of as a tool to help communicate the food safety system to employees, customers, and regulatory authorities. For this reason, it is recommended that additional background information be included in the Food Safety Plan. This background information can provide helpful context to other components of the Food Safety Plan. An industry good practice would be to include an overview of the facility, the members of the food safety team, a description of the facility, and a diagram showing equipment within the facility. The next section describes a recommended way to organize this information so it can be used in a practical manner.
HACCP PLAN
Hazard Analysis and Critical Control Points (HACCP) is a preventive food safety strategy that is a systematic approach to the identification and assessment of the risk of hazards from a particular food or food production process or practice and the control of those hazards that are reasonably likely to occur.
In developing a HACCP plan, the hazard analysis leads to the identification of critical control points (CCPs) where essential process controls are needed to prevent a foodborne hazard from causing illness or injury. Once CCPs are identified, critical limits are established that define the operating conditions in the process that must be effectively managed and monitored to control the hazard. When critical limits are not met, predefined corrective actions are taken. All of the steps in a HACCP plan are recorded and verified to ensure the system is operating as intended. The basic parts of a HACCP are as follows:
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Hazard Analysis
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Determine the Critical Control Point
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Establish Critical Limits
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Critical Control Point Monitoring
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Corrective Actions
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Verification Procedure
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Record-Keeping Procedures
ON-SITE AUDIT REPORT
The systematic, independent, and documented examination (through observation, investigation, records review, discussions with employees of the audited entity, and, as appropriate, sampling and laboratory analysis) to assess a supplier’s food safety processes and procedures.
An audit should be conducted by a qualified auditor (i.e. a person who is a qualified individual as defined in part 117 and has technical expertise obtained through education, training, or experience – or a combination thereof – necessary to perform the auditing function as required by 21 CFR 117.180c2) that is not an employee of either the receiving facility or the supplier. Section 21 CFR 117.435 specifies requirements applicable to onsite audits, including who must conduct an onsite audit; consideration of applicable food safety regulations; and when the written results of an inspection can be substituted for an audit.
Onsite audit certificates, although helpful, fall short to provide sufficient information for full FSVP certification. A complete copy of an Onsite Audit Report is required.
LABORATORY TESTING / SAMPLING RESULTS
Although not considered a CCP, laboratory testing of either raw material or finished product is an acceptable method to demonstrate that specific biological and/or chemical hazards have been effectively controlled for a given batch/lot. Sampling and testing can be on a periodic basis or on a lot-by-lot basis. We recommend that you establish the frequency of such testing by first conducting the sampling and testing on a relatively frequent basis (e.g., monthly) until the supplier establishes a good history of supplying an acceptable raw material or other ingredient, after which time you could sample and test less frequently, such as quarterly.
Certificate of Analysis must include: (i) Identification of the raw material or other ingredient tested (including lot number, as appropriate) and the number of samples tested; (ii) Identification of the test(s) conducted, including the analytical method(s) used; (iii) The date(s) on which the test(s) were conducted and the date of the report; (iv) The results of the testing; (v) Corrective actions taken in response to detection of hazards; and (vi) Information identifying the laboratory conducting the testing.
Laboratory ISO 17025 accreditation is preferred.
GOVERNMENTAL LICENSE
A government-issued document, or site license that demonstrates a foreign supplier is in, and under the regulatory oversight of, a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States, and that the food is within the scope of that official recognition or equivalency determination. This document or site license must demonstrate that the supplier is in good compliance standing with the food safety authority of the country in which the foreign supplier is located.
Provision is currently only applicable to suppliers that are located in either Canada, Australia, or New Zealand.
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