Building a Quality Management Program from within an Organization

Presenter: Cherron Blakely, Carol Sheets, and Lee Whitener

Our team is from the Food and Drug Administration (FDA) in the Center for Devices and Radiological Health (CDRH). Within the Office of Product and Evaluation Quality (OPEQ) is a super office within CDRH formed after combining 4 offices to align with the Total Product Life Cycle for medical devices. Our team is the Quality and Analytics Staff (QAS) for the super office responsible for quality activities. The mission of CDRH is to protect and promote the public health and ensure patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world. After restructuring 4 offices into one super office in 2019, we continue to normalize current operations. Documents and procedures are being further streamlined to eliminate redundancy. Lean and Six Sigma methodologies are used to analyze, develop, and continuously improve our processes. Key performance metrics have been developed and are being monitored to measure success. The performance metrics currently in place, along with the leaning of our processes, helped the organization pivot during the Covid-19 pandemic. Staff use a team management approach and while engaging customers to meet the needs of the medical device industry.