Abstract

The audits and inspections process is a critical component related to a pharmaceutical firm’s compliance in the industry. To be out of compliance has significant ramifications both on the safety and purity of the firm’s products and its viability in the industry. Such firms are routinely audited by boards of health and customers that purchase the firm’s products to ensure they are in compliance with expected standards. The success of hosting the audits and inspection program is the first line of defense in demonstrating compliance. To succeed at these audits and inspections changing with the times is a necessity. The implementation of change in an organization is fraught with challenges. Issues such determining who in the organization are the right people to discover, develop, and diffuse change is a complex process for management. This study will describe how the use of Liberating Structures and coaching were used to change the audits and inspection process for a major pharmaceutical firm. The changes are evaluated through the lens of Adaptive Space and the use of action research to integrate theory and action with the goal of answering the following questions: How might I get the right people on the team to implement a digital auditing process? How might I implement a digital auditing process? In the time involved with the completion of this action research study, COVID-19 hit. This led me to another question: What modifications to the auditing process must be made as a result of COVID-19, how can I modify the auditing approach to incorporate site restrictions The outcome of this effort transformed the auditing process at the firm and was implemented at the firm’s sites worldwide.