A well established Human Performance program will significantly reduce failures and deviations in any biomanufacturer’s operation. Critical to this is the creation of a culture where leaders partner with workers to learn about what enables success and what creates challenges. This learning is most effectively done through first-hand observation, active listening and ensuring candid discussions about systems’ issues related to risk. Written by BioPhorum’s Human Performance Workstream, this guide details how to implement and maintain a leader observation and coaching program, what such a program entails, the expected benefits, the expectations for leaders and a suggested implementation plan.
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Human performance (HuP): Training for biotech manufacturing operator competence
Mar 2016 | Drug Substance, Fill Finish, POI - Drug Substance
For decades, the biopharmaceutical industry has trained its workforce with a ‘read and understand’ approach. This approach is outdated and ineffective at delivering effective learning and competent staff. This ‘Training for competence’ guidance enables companies to understand how their organisation compares to their peers, and to identify what ‘best in class’ looks like for operator training, and will help to identify how to implement this approach across their networks
Human performance (HuP): Changing the performance paradigm in pharma/biotech: Integrating human performance in global organizations
Sep 2015 | Drug Substance, Fill Finish, POI - Drug Substance
In 2015 when the BioPhorum Human Performance team started to understand how the industry could reduce error rates many were seeing a plateau of performance. Industry data showed 50% of deviations were attributable to human error and that the error rate has been constant over several years. Comparing us to other high-risk industries with unparalleled levels of reliability, such as nuclear power and aviation, the team saw that changes that could be made with the integration of HuP into our operations.
This article utilizes the experience of two large, global biotech companies, at the time to illustrate the pathways to integrate HuP and the benefits realized not just in human error reduction, but also to quality, safety, compliance, and on-time delivery—the critical measures that will make or break a biotech company’s performance.