Background
A global leader in advanced pharmaceutical products, equipment and consumables, chemistry, and biotechnology, operates with an annual revenue of billions and employs thousands of people worldwide. The advanced pharmaceuticals site, responsible for producing 40-60 different products, faced significant overdue deviations, corrective and preventive actions (CAPA)s, change controls, and operational challenges impacting timely batch release and overall customer satisfaction.
Challenge
➢ Manual Data Management: Quality data for deviations, CAPAs, change controls, and batch releases were tracked manually,
leading to delays and inefficiencies. Inconsistencies in data availability and accuracy hindered proactive decision-making.
➢ Lengthy Deviation Cycle Times: High deviation cycle times caused delays in closing quality investigations, impacting overall
operational timelines.
➢ Significant Deviation Backlog: A large number of unresolved deviations at two critical sites created bottlenecks in quality assurance
processes.
➢ Lack of Visual Transparency: Teams lacked clear, real-time visibility into key quality metrics, slowing cross-functional collaboration and issue resolution.
➢ Inefficient Investigations at Gene Therapy Sites: Extended cycle times and a high number of open investigations at gene therapy facilities posed challenges to compliance and timely batch releases.
Implementation
➢ Automated Visual Quality Data Management System: Integrated a centralized system pulling real-time quality data from Trackwise. Automated dashboards provided up-to-date tracking of deviations, CAPAs, change controls, and batch releases. Designed user-friendly interfaces to present actionable insights for quality teams.
➢ Deployment of Digital Visual Management Boards: Rolled out interactive, digital visual boards at two critical sites, enabling teams to monitor and manage quality metrics in real-time. Boards displayed key performance indicators (KPIs), highlighting open deviations, cycle times, and backlog metrics.
➢ Value Stream Mapping (VSM): Conducted detailed VSM workshops with local teams to identify bottlenecks in deviation and investigation processes. Designed streamlined workflows to enhance efficiency and reduce waste.
➢ Teamwork and Collaboration: Established cross-functional task forces to address deviation and investigation backlogs. Created an accountability framework with clear ownership and timelines for quality action items.
➢ Continuous Monitoring and Feedback: Implemented regular reviews and progress meetings to ensure sustained improvements. Integrated real-time feedback loops into the visual management system.
Results
➢ Reduction in Deviation Metrics at Critical Sites: 33% Deviation Cycle Time Reduction: Streamlined workflows and automated data tracking improved response times. 12% Reduction in Open Deviations: Enhanced visibility and accountability led to proactive issue resolution. 95% Deviation Backlog Reduction: Focused team efforts and digital tools eliminated bottlenecks in two critical sites.
impactful improvement projects. Developed a pipeline of skilled problem solvers capable of driving sustained operational excellence.
➢ Improvements at Gene Therapy Sites: 28% Reduction in Open Investigations: Digital visual management boards and teamwork addressed longstanding issues. 22% Reduction in Investigations Cycle Time: VSM-driven workflows and enhanced collaboration expedited resolutions.
➢ Enhanced Operational Transparency: Real-time dashboards empowered leadership to make data-driven decisions. Teams gained better visibility into key quality metrics, fostering a culture of continuous improvement.
“The automated system and digital boards have revolutionized how we handle deviations. Seeing a 95% backlog reduction was beyond our expectations.” – Sr Quality Manager
“The integration of VSM and visual management has significantly improved our investigation processes. Achieving a 28% reduction in open investigations is a testament to the power of teamwork and digitalization.” – Site Director
“This initiative demonstrates how digital tools and lean practices can transform quality management processes. The systematic approach addressed a major issue with great visibility and time efficiency. We are very pleased with the new batch release times” – Global Head of Quality Operations
