Deviations


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Human performance (HuP): Guide to implementing and maintaining a leader observation and coaching program

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): Changing the performance paradigm in pharma/biotech: Integrating human performance in global organizations

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.

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Raw materials: Patient-centric requirements for the supply of raw materials

Raw material variability and control in the supply chain are important matters for the biopharmaceutical industry. The industry is still working to align the supply performance with biopharma’s needs. More still needs to be done to understand, monitor and control of raw materials. Patient well-being is best assured by reducing or eliminating variability of the finished drug product, and this can be achieved, in part by targeted reduction and/or elimination of variation in raw materials. This paper identifies ten areas of practice endorsed by leading global biopharmaceutical manufacturers to start to address and reduce raw material variation through our supply chains.

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