FDA Quality Culture Diagnostic for Life Science Manufacturers

Quality culture is one of FDA-regulated industry’s most discussed topics. Understanding the drivers of behavior behind quality and compliance outcomes can be frustrating and challenging. Stated Corporate intent and policy can be disconnected from actual employee conduct. Pockets of information can lead to lack of transparency, and to personnel not working together as a team towards common goals, and with common understandings.

Compliance Architects® has developed industry’s first plant-floor and staff-focused innovative methodology, based on proven cultural survey science, to assess staff and line employee perceptions of quality culture – and its potential impact – by assessing and measuring individual and aggregate employee responses to fact-based questions scenarios simulating actual business situations.

The Quality Pulse® quality culture diagnostic is a scientific, research-based quality culture assessment model designed specifically for FDA-regulated and life sciences companies. The methodology was developed and adapted from well-established research, including:

• Organizational culture principles of Edgar H. Schein (MIT/Sloan);
• System dynamics principles of Peter Senge (MIT/Sloan);
• Dozens of research articles on corporate culture, quality culture, and organizational behavior, many in the life science context from 2000-present; and
• Decades of direct experience in quality operations across a variety of life science (pharma/device/biotech) organizations (100-100,000 employees).

Developed specifically to help organizations of all sizes understand the drivers of their culture of quality, the methodology and outcome reporting provides actionable intelligence that helps company leadership direct and implement improvement programs that will result in better quality outcomes and improved organizational excellence.