January 14, 2021

The objective of this pilot study is to leverage a quality system maturity and integration approach to provide manufacturers with systemic insight that may improve the effectiveness of the quality system; focus and accelerate improvement efforts to reach a state of sustainable compliance faster; structure systems for continuous improvement; identify objective performance metrics, and develop reports that may provide the agency with the information it needs to oversee product safety throughout the pilot process.

To encourage manufacturers to enroll and participate, this pilot study will cover the costs of the activities listed and defined in this playbook.