Your company has received an FDA warning letter, now what? As an organization finds itself in uncharted waters due to inspection results, the leader’s job is to chart a course and speed to re-inspection success without everyone jumping ship. Leaders must remember historical averages for change success hovers between 30-50% (Adam & Danaparamita, 2016; Beer et al., 1990; Kotter, 1995) during normal operations, let alone high stakes environments. Abnormal operating conditions decreases colleagues’ cognitive processing ability and result in behavioral decision making. This combination is dangerous in ambiguous operating environments with underdeveloped cultures. The organization takes social cues from leadership, which influence colleague attitudes based on responsibility and accountability. Leadership’s ability to control stress in the organization preserves resources by reducing tension, providing clarity, making trade-off decisions, and fostering effective two-way communication. Developed leaders know these attributes preserves resources, sustains culture, and leads organizations through high stakes change management environments.
High Stakes Change Management:
Remediation Post FDA Warning Letter
Principal Consultant, CAI
Chris currently serves as a Principal Consultant for CAI, Inc where he provides biopharmaceutical clients with guidance on Organizational and Human Performance. In his past, Chris has led functional elements and multi-site organizations in pharmaceutical, beverage, and the plastics industries. He is a Lean Six Sigma Black Belt, Associate Certified Coach, and currently pursuing his PhD in Industrial and Organizational Psychology from Northcentral University.