Special circumstances require special measures FDA announced temporary changes related to onsite audits requirements
In response to the global pandemic of COVID-19, the FDA temporarily does not enforce supplier verification onsite audit requirement for receiving facilities and importers, if other supplier verification methods are used instead. This applies for an onsite audit in the following circumstances:
- Onsite verification activity audit for an approved supplier conducting by a receiving facility or Foreign Supplier Verification Program (FSVP), as reflected by its written food safety plan or FSVP.
- Onsite audit for a supplier in a region or country covered by a government travel restriction or travel advisory related to COVID-19; (e.g France, Italy, Spain…)
- Onsite audit of the supplier is temporarily impracticable for the receiving facility or FSVP importer because of the travel restriction or travel advisory.
Alternatively, the receiving facility or FSVP importer can temporarily select an alternative verification activity or activities (e.g. reviewing relevant food safety records). Alternative activities must be incorporated in the food safety plan or FSVP.
The alternative verification activities are designed to provide temporary assurance that the hazard requiring a supply-chain-applied control (or, for FSVP, the hazard that is being controlled by the foreign supplier) has been significantly minimized or prevented during the period of onsite audit delay.
However, receiving facilities and FSVP importers will have to resume onsite audits within a reasonable period of time after it becomes practicable to do so, and update their food safety plans and FSVPs accordingly.
Source : FDA Issues Temporary COVID-19 Policy for Receiving Facilities and FSVP Importers in Meeting FSMA Supplier Verification Onsite Audit Requirements, published on the 17th of March 2020.
Further information for Management of Extraordinary Events or Circumstances Affecting ABs, CABs and Certified Organizations: https://www.iaf.nu/upFiles/IAFID32011_Management_of_Extraordinary_Events_or_Circumstances.pdf?utm_source=website&utm_medium=website&utm_content=coronavirus-update-IAF&utm_campaign=+GL-RegSrv-SRV-MD-coronavirus-update-2002
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Author: Alix Auter, Life Science Consultant KVALITO
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