The FDA Third Party Auditing Program – Will There Be Any Takers?

FDA has issued Draft Guidance on Model Accreditation Standards for Third-Party Auditor/Certification Body Accreditation for Food Safety Audits with recommendations on the qualifications that third-party auditors/certification bodies, and their auditing agents, should have in such areas as education and experience. After considering several voluntary consensus standards and identifying those most commonly used, FDA based much of its draft guidance on the International Organization for Standardization ISO/IEC 17021:2011. Thus, throughout the guidance, FDA provides references to ISO/IEC 17021:2011 clauses relevant to specific sections, noting some instances where the guidance differs from the ISO standard, and that, where the draft guidance differ, the recommendations of the guidance apply.

This is an interesting rule, and some have asked “Does this mean all auditors have to be FDA certified?”  The answer is no. This program is just for auditors who wish to audit for purposes of issuing certificates for the Voluntary Qualified Importer Program, or issuing required certificates for imported high-risk foods. So far FDA has not identified any high-risk foods that will require certification, but I will bet a paycheck that they will as soon as they can get the system up and running.