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In last week’s newsletter, we provided an overview of FDA’s new Voluntary Qualified Importer Program (VQIP) final guidance and what it means to you. This week, we are following up on that general discussion with the specifications of the written Quality Assurance Program (QAP) required by the rule. As you will see below there are a lot of requirements that go beyond the basic FDA FSMA requirements. As explained by FDA, “The QAP is a compilation of the written policies and procedures you will use to ensure adequate control over the safety and security of the foods you import.” Like requirements for other written plans, FDA does not mandate a specific format, but it does specify what must be in the written QAP – including a Table of Contents for reference to the information. In addition to the Table of Contents, the QAP is required to include: Your Corporate Quality Policy Statement. Describe the policy as it relates to food safety and security throughout the supply chain. Explain how the policy is communicated to all employees throughout the organization and to non-applicant entities involved in implementing your QAP, and how you will ensure it is received and understood by all of them. Organizational Structure and Functional Responsibilities. An organizational chart or written explanation of the management structure, including those responsible for implementing your QAP. Explain the functional responsibilities for those within the organization involved in developing, implementing, and maintaining your QAP, including the name and title of the individual responsible for administering it. Identify the functional responsibilities of the non-applicant entities needed to implement your QAP and how those responsibilities are communicated (e.g., contracts). Food Safety Policies and Procedures. Describe the policies and procedures you will implement to ensure food safety from source to entry into the U.S. (e.g., temperature and storage controls). Include policies and procedure documents, to include: If the food is subject to the FSVP or HACCP importer regulations and you are the FSVP or HACCP importer: a statement affirming you have established procedures to ensure compliance. If the food is subject to the FSVP or HACCP importer regulations and you are not the FSVP or HACCP importer: procedures for ensuring the importer is in compliance. Written procedures for maintaining current foreign supplier certifications and any applicable food certifications required under section 801 the FD&C Act. Your procedures for controlling the safety of each VQIP food throughout the transportation supply chain, including compliance with FDA’s sanitary transport rule, if applicable. Procedures for communicating information to FDA and others (e.g., non-applicant entities, consumers) relating to food and foreign supplier non-compliances that pose a risk to public health. Identify the scope of communications that will be limited to within the organization, and the criteria for, as appropriate, communicating non-compliances to your foreign supplier and other regulatory authorities. Procedures for corrective actions to address such food and foreign supplier non-compliances, including procedures to trace and track non-compliant food, prevent further distribution of the food, and initiate recall if necessary. Procedures for working with a non-compliant foreign supplier to correct the problem, criteria for discontinuing use of a foreign supplier, and procedures to identify alternate suppliers. Food Defense Policies and Procedures. Describe your food defense system for foods that are subject to FSMA’s Intentional Adulteration (IA) rule including procedures for ensuring your foreign supplier’s food defense system is in compliance, and describe procedures for controlling the security of each VQIP food throughout the transportation supply chain. However, if your food defense system includes participation in CBP’s C-TPAT (Level 2 or Level 3) and this is acknowledged in your application, you do not need to provide additional information regarding your transportation food defense procedures. Qualifications. Identify the qualification requirements for employees responsible for implementing the QAP. For each employee who has responsibilities in developing, implementing, and maintaining the QAP, include requirements for knowledge about the FD&C Act and implementing regulations that apply to the foods and the foreign suppliers of foods you import under VQIP (e.g., current good manufacturing practices [CGMPs], produce safety, FSVP, preventive controls, juice HACCP, seafood HACCP, low-acid canned food, intentional adulteration, sanitary transport, and food labeling); and the qualifications (e.g., knowledge, skills, and training) required. QAP Implementation. Describe your procedures for ensuring your QAP is current and appropriately implemented, including procedures for its auditing and updating and for providing updates in your VQIP application. Records. Provide your written procedures for establishing and maintaining records related to the structure, processes, procedures, and implementation of your QAP, ensuring that they are legible and available to FDA upon request. Records may be in another language if you can provide FDA with an English translation of any requested records within a reasonable time. The QAP structure, processes, and procedures documents should be signed and dated by the individual who has overall responsibility for the QAP, with their effective date noted. These records must be maintained for as long as they are in effect. The QAP implementation records should be signed and dated by the responsible individual and maintained for at least two years after they are created. Definitions. Define terms used in your QAP, as necessary to facilitate understanding and implementation. References. Provide references to information or sources used to develop and implement your QAP, as appropriate. After reading this list of requirements for the VQIP program I was struck how they fill in some of the gaps between the current GFSI standards and the Preventive Control Rule. While we have not done a direct comparison between GFSI guidance (or specific schemes) and the VQIP requirements, it does appear that being certified to GFSI standards will also help you meet these new VQIP certification requirements. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com

Writing Your VQIP QAP: What is Required?