In the larger organizations I worked for as a quality leader, supplier auditing was almost always calendar-driven. Sometimes supplier audits happened once a year; in other places, they might happen twice. I’d build the schedule to accommodate that, and the system would just run.

Over time, I shifted to a risk-based approach where how deeply and how often I audited a supplier wasn’t based on a calendar date, but rather on individual supplier risk.

How you determine high vs. low risk is critical, and a key focus for regulators under the new U.S. Food and Drug Administration (FDA) quality management system regulation (QMSR).

Let’s take a closer look at the benefits of risk-based supplier audits and the data that supports them, plus what the FDA and registrars look for when evaluating your supplier program.

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