Since the Covid pandemic, regulators and notified bodies have been doing more remote audits to conduct routine inspections. In fact, it helped the FDA exceed domestic inspections in FY2021 by more than double the number projected. As a result, the FDA and EMA have released guidance on what to expect during a remote audit.
However, remote audits can extend beyond demonstrating compliance with regulations and standards. Manufacturers themselves can use remote supplier quality audits to minimize product risks as they struggle with ongoing supply chain challenges.
This article looks at conducting remote supplier quality audits, as well as which tools to use in the quality management system (QMS) to streamline the process.
Shortages and the Supplier Landscape
Ongoing shortages and supply chain bottlenecks are forcing changes to how manufacturers manage supplier quality programs. When suppliers can’t fill orders, companies need to decide whether to reduce output, modify features, or find new suppliers. Oftentimes, they usually look to suppliers they’ve worked with in the past.
Unfortunately, there is a problem with this approach. In many cases, you may discover that you stopped working with those suppliers for good reason.
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