Former Merck QA Chief Says Quality Departments Need to Communicate ‘Impact’
Drugmakers need to rethink the role of their quality departments, particularly when engaging with stakeholders and the broader company, says Marla Phillips, director of health initiatives at Xavier University, who previously served as head of quality at Merck’s North Carolina facility.
Quality departments must shift from communicating through data and studies to “communicating in impact,” Phillips told the 13th Annual FDA Inspections Summit hosted by FDAnews. Instead of using fear tactics such as the implicit threat of FDA enforcement to influence company behavior, quality departments must convey the value of an action, she said.
To shift thinking on quality, Phillips said, quality departments must communicate with the rest of the organization in a way that makes clear why an action or correction is essential, rather than starting with the “what” or the “how.”