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Our supply chain has become increasingly global and fragmented. We are finding it nearly impossible to conduct on-site "Supplier Audits" for every tier-2 vendor. How are other Quality Managers handling "Supplier Quality Assurance" (SQA) in 2024? Are "Virtual Audits" using smart glasses or remote video actually accepted by major regulatory bodies like the FDA or ISO
3 answers
Virtual audits have become a permanent fixture since the pandemic. ISO 19011 now provides guidelines for remote auditing. However, the key to success isn't just the video; it's the "Pre-Audit Document Review." You need a robust "Quality Agreement" that specifies the vendor must provide real-time access to their "eQMS" or "LIMS" data. We use a "Hybrid Model" where we only visit "High Risk" suppliers in person, while using remote "Surveillance Audits" for established partners. This saves thousands in travel costs while maintaining a high level of oversight on "Critical-to-Quality" (CTQ) components.
Deborah, how do you prevent a vendor from "staging" a virtual audit by only showing you the clean parts of the facility on camera?
We use "Self-Assessment Questionnaires" (SAQ) as a first filter. If a vendor can't provide clear evidence in their SAQ, they automatically trigger a physical audit.
Smart approach, Karen. It acts as a "Triage" system for your quality resources. No point flying across the world if they fail the basic document check.
Kevin, that’s the biggest risk. To mitigate this, we use "Unscripted Walkthroughs." We ask the camera operator to turn left or open a random storage bin that wasn't on the itinerary. Also, we insist on "Live Data Feeds" from their testing equipment. If the data is flowing directly from their machine to our portal, they can't fudge the numbers. Susan, you should also look into "Blockchain" for supply chain traceability; it’s becoming the gold standard for verifying the "Chain of Custody" without needing to be physically present at every node.