《《NE03. Biogen Idec Approach》.pdf

The Biogen Idec Approach The Biogen Idec Approach to Managing Corrective and to Managing Corrective and Preventive Action Preventive Action - Internal - Internal - External - External Michael J Cross Biogen Idec 26FEB04 Michael J Cross Biogen Idec 26FEB04 Strategies for CAPA Management Strategies for CAPA Management • Components for CAPA Success • How does it work in Cambridge? • Applying CAPA to the Contract World • Review some contractor case studies Review of CAPA; Components for Review of CAPA; Components for Success Success • Strong Investigation Program • Sr. Management Support • Accurate Status Tracking • Metrics Reports Forum for Review Strong Investigation Program Strong Investigation Program • Investigating to true root cause leads to effective CAPA • Use multi-discipline investigation teams • Timely follow up (30 day target) • Tools in the Toolbox – Brainstorming – Cause-Effect Diagram – Data Gathering – Interviews – Repetitive Why Sr. Management Support Sr. Management Support • Sets tone for commitment to CAPA • Accountability of managers operators • Quality Assurance should not be the only driver • Provide resources for CAPA: personnel, equipment, schedule modifications Accurate CAPA Status Tracking Accurate CAPA Status Tracking • Allows for progress tracking and ensures closure • Provide basis for reporting metrics and cycle time calculations • Quality maintained • Linked to exceptions, searchable Metrics and Trending Metrics and Trending • Need to identify system meas