FDA Raising Quality Technology Expectations

July 16, 2020

By Sparta Systems

 

Former regulator shares insights from FDA perspective on quality management and fostering a culture of quality 

Sparta welcomed Cynthia Schnedar, Executive Vice President of Regulatory Compliance at Greenleaf Health, for a spirited conversation about regulation and fostering a culture of quality as part of its Virtual Sparta Connection event in June 2020. 

Schnedar, formerly of US FDA and US Department of Justice, shared her experience as a regulator, as relates to quality leaders today and in the future. From her unique perspective, she is seeing how quality plays out not just with the companies interacting with FDA, but also quality management within government itself.  

According to Schnedar, FDA has come to expect minimum technology support for quality systems. But beyond that, FDA recognizes the role of advanced technology needed to achieve improved quality. Those technology advances can include real-time data connections on the shop floor to QMS, leveraging AI/ML to provide insights and faster decisions. Schnedar acknowledged that the life science industries have a long journey ahead, to achieve widespread proactive quality in manufacturing, but that FDA is encouraging it for its undeniable benefits for increased capacity, supply quality and more.  

In speaking to creating a culture of quality within an organization, Schnedar stressed the importance of communication in driving home company values and how to live those values in quality management. Leaders shouldn’t be shy to repeat themselves on these points.  

Quality goes beyond manufacturing and supply site compliance, she said, and she described the importance. “You need to have that culture where there’s a reward for bringing problems forward, and people understand that’s the right thing to do. Whistleblowers need to be recognized as bringing value to the company. Otherwise, no one is going to be brave enough to bring a problem forward, instead they’ll be afraid that they’ll be blamed.” 

Schnedar asks quality managers to make that culture shift a personal priority, and to listen. “Walk the talk and respond. Model behavior.” 
 

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