Background
A prominent player in the biotechnology manufacturing industry, operates globally with a substantial revenue of billions of dollars and a workforce of thousands of global employees. The company’s largest manufacturing sites are critical, focusing on the production of life-saving products. Despite its global reach and importance, the company is facing significant risks impacting its overall operations, performance, and product delivery timelines.
Challenge
➢ Fragmented Risk Management Practices: Disparate approaches to risk identification, assessment, and mitigation across global sites created inconsistencies.
➢ Delayed Action Item Closure: A significant backlog of open action items led to decreased responsiveness and compliance risks.
➢ Ineffective Tracking Mechanisms: Existing tools and processes struggled to provide actionable insights into on-time action closures.
Implementation
➢ Comprehensive Gap Analysis: Conducted site-specific evaluations to identify key deficiencies in existing risk management processes. Benchmarked practices against global best standards to highlight improvement opportunities.
➢ Standardization and Process Redesign: Developed a unified risk management framework integrating Biogen’s global policies and regulatory requirements. Created standardized templates for risk assessments, mitigation plans, and tracking mechanisms.
➢ Technology Integration: Leveraged advanced risk management software to centralize data tracking and enhance visibility into action items. Implemented automated reminders for action item owners to improve on-time closures.
➢ Training and Stakeholder Engagement: Conducted targeted workshops to train key personnel on new processes and tools. Established cross-functional teams to ensure alignment and buy-in across all levels.
➢ Continuous Monitoring and Feedback: Established KPIs to measure open action items and on-time closures. Set up quarterly reviews to ensure sustained improvements.
Results
➢ 36% Reduction in Open Action Items: Streamlined processes and improved tracking mechanisms significantly reduced the backlog.
➢ 92% On-Time Action Closure: Automated workflows and enhanced accountability led to improved timeliness in addressing risk mitigation actions.
➢ Global Process Optimization: A standardized risk management framework across all sites resulted in better consistency, collaboration, and compliance..
➢ Improved Decision-Making: Centralized data and reporting provided actionable insights, empowering leadership to make informed decisions swiftly.
“The new risk management framework has transformed how we approach and resolve risks. The reduction in open action items has boosted our operational efficiency significantly.” – Director of Manufacturing
“Standardizing our processes with a global framework has fostered better collaboration between sites. The results speak for themselves.” – Sr Director of Supply Chain
“Achieving 92% on-time action closure demonstrates the effectiveness of this initiative. Instead of waiting for the consequences of those risks, teams learned how to address them and this is very critical for the company’s commitment to operational excellence.” – VP of Quality
