48: External Quality: Sharing HOP and Better Operational Learning With Our Suppliers

This session will cover AstraZeneca's external quality approach to sharing Human and Organizational Performance (HOP) and our Human Performance Event Learning (HPEL) training/tool with external suppliers. Like many companies, we partner with commercial manufacturing organizations and external suppliers to deliver our products to patients. Part of this involves quality compliance oversight and the investigation and tracking of deviations. Historically, there was variation in the quality of the investigations and the corrective actions/preventive actions (CAPA). Human error was a common “root cause” and the CAPA’s sometimes involved naming, shaming and retraining of front-line workers. Through the support of some of our leaders in External Quality who were keen to increase the quality and depth of operational learning, we shared the HOP principles, the HPEL tool and our training with external suppliers. As a result, human error is no longer offered or accepted as a root cause. CAPA’s are more robust. And major deviations are down. This presentation will cover this novel approach. It includes topics such as training content, translations, and some of the results.