What prompted CDRH to craft a new inspection technique?
In the late 1990s, CDRH Director Bruce Burlington took the opportunity to look at processes within the device segment of FDA and reengineer them. That was a time when the highest levels of government were encouraging improvement in performance of the agencies and the agency programs. Numerous areas within devices were looked at for improvement. One of those areas was the inspection process. The inspection process was chosen for reengineering because the Quality System Regulation (QSR) had recently been issued, but the inspection technique was not upgraded to incorporate quality system principles. The agency was using the bottom-up approach for device inspections, which was to start the inspection with complaints and often to document how bad things were based on those complaints. We believed there was a need for a top-down inspection that would look at the system as opposed to the data that resides within that quality system. Two initial purposes of quality system inspection reengineer
