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The Food Safety Modernisation Act (FSMA) is the first major overhaul of US food safety practices since 1938 and includes new regulations for farms that grow fresh produce and for facilities that process food for people to eat.

The FDA FSMA rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is final, and the first compliance dates begin May 30, 2017.

The final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.

Below we will outline the key requirements of a FSVP and how you can utilize QADEX to manage compliance. QADEX customers typically utilize our systems to deliver more than compliance by achieving enhanced food safety, substantial cost savings and substantial reductions in audit non-conformity.

To talk to us directly about how we can help with your FSVP compliance CLICK HERE TO CONTACT US

The key requirements of a FSVP are:

Determining known or reasonably foreseeable hazards with each food – Hazard Analysis

FDA Requirement

  • What do we mean by ‘hazard’? An importer is required to identify and evaluate—based on experience, illness data, scientific reports and other information—the known or reasonably foreseeable hazards for each type of food it imports to determine if there are any hazards requiring a control. These include:
    • Biological hazards, including parasites and disease-causing bacteria.
    • Chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved food or color additives, and food allergens.
    • Physical hazards, such as glass.
  • They may be hazards reasonably likely to cause illness or injury that occur naturally, are unintentionally introduced, or are intentionally introduced for purposes of economic gain, such as substituting a less costly ingredient.
  • The analysis must assess the probability that these hazards will occur in the absence of controls and the severity of the illness or injury that could occur.
  • The evaluation would have to consider factors that include the:
    • Formulation of the food.
    • Condition, function and design of the establishment and equipment of a typical entity that produces the food.
    • Raw materials and other ingredients.
    • Transportation practices.
    • Harvesting, raising, manufacturing, processing and packing procedures.
    • Packaging and labeling activities.
    • Storage and distribution.
    • Intended or reasonably foreseeable use.
    • Sanitation, including employee hygiene.
  • An importer can rely on another entity to conduct the hazard analysis, so long as the importer reviews and assesses the relevant documentation.

QADEX Solution

Conduct an Advanced Risk Assessment of each product using the following Risk Assessment Template which we can provide you with.

Product Risk Assessment Sections

  • Biological Hazards
  • Chemical Hazards
  • Physical Hazards
  • Vulnerability Assessment

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

FDA Requirement

  • What evaluation must be done of the risk posed by an imported food and a supplier’s performance? An importer must evaluate:
    • The hazard analysis.
    • The entity that will be significantly minimizing or preventing the hazards, such as the foreign supplier or the supplier’s raw material or ingredient supplier.
    • A foreign supplier’s procedures, processes and practices related to the safety of food.  
    • Applicable FDA food safety regulations, and information regarding the foreign supplier’s compliance.
    • The foreign supplier’s food safety history, including the responsiveness of the foreign supplier in correcting past problems.
    • Other factors as necessary, including storage and transportation practices.
  • The importer can rely on another entity (other than the foreign supplier) to perform the evaluation of risk, so long as the importer reviews and assesses the relevant documentation.

QADEX Solution

Conduct an Advanced Risk Assessment of each foreign supplier using the Supplier Risk Assessment Template which we can provide you with.

Supplier Risk Assessment Sections

  • The hazard analysis incl in-house preventive controls for the identified hazards in the food.
  • Suppliers HACCP.
  • Supplier food safety system & certifications.
  • Suppliers FDA compliance record.
  • Suppliers food safety history and responsiveness in correcting past problems.
  • Other factors including storage and transportation.

Using the evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities

FDA Requirement

  • Based upon the evaluation of risk conducted, the importer must establish and follow written procedures to ensure, in most instances, that it only imports from approved foreign suppliers and must conduct appropriate supplier verification activities.
  • Importers have the flexibility to tailor supplier verification activities to unique food risks and supplier characteristics. The options include:
    • Annual on-site audits of the supplier’s facility. This is generally required when there is a reasonable probability that exposure to a hazard controlled by the foreign supplier will result in serious adverse health consequences or death to humans or animals (called a SAHCODHA hazard). However, the importer can choose another means of verification provided that the importer documents that the alternate choice is appropriate and provides adequate assurances that the foreign supplier is producing the food in accordance with applicable U.S. safety standards.
    • Sampling and testing.
    • A review of the supplier’s relevant food safety records.

QADEX Solution

Using the advanced risk assessment module the QADEX solution automatically generates recommendations for appropriate supplier verification activities.

Conducting supplier verification activities

FDA Requirement

  • Based upon the evaluation of risk conducted, the importer must establish and follow written procedures to ensure, in most instances, that it only imports from approved foreign suppliers and must conduct appropriate supplier verification activities.
  • Importers have the flexibility to tailor supplier verification activities to unique food risks and supplier characteristics. The options include:
    • Annual on-site audits of the supplier’s facility. This is generally required when there is a reasonable probability that exposure to a hazard controlled by the foreign supplier will result in serious adverse health consequences or death to humans or animals (called a SAHCODHA hazard). However, the importer can choose another means of verification provided that the importer documents that the alternate choice is appropriate and provides adequate assurances that the foreign supplier is producing the food in accordance with applicable U.S. safety standards.
    • Sampling and testing.
    • A review of the supplier’s relevant food safety records.

QADEX Solution

Based on the automatically generated recommendations for appropriate supplier verification activities the QADEX software either:

  • Enables scheduling and management of on-site audits of the suppliers facility using the audits and visits module.
  • A review of the suppliers food safety records using the self audits module.
  • Sampling and testing using the Goods In Module or QA Checks module or an integration with an existing software system being used for sampling and testing.

Where-ever something goes wrong the standard QADEX supplier non-conformance functionality manages corrective actions.  

Conducting corrective actions

FDA Requirement

Importers must promptly take appropriate corrective actions if they determine that a foreign supplier has not used processes and procedures that provide the same level of public health protection as required under the produce safety and preventive controls regulations, as applicable, or that the supplier produces food that is adulterated or misbranded with respect to allergen labeling.

  • The appropriate corrective measure will depend on the circumstances, but could include discontinuing use of the foreign supplier until the cause of noncompliance, adulteration or misbranding has been adequately addressed.

QADEX Solution

Standard QADEX supplier non-conformance functionality can be used to manage corrective actions.

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