Operational Readiness
Results Achieved
War Room focused on critical
path activities
“Go Live” Readiness
activities completed
Improved problem-solving
skills of employees
Reduction in cycle time
to close CAPA
Client Challenge
Establish a new manufacturing facility to produce medical product on behalf of one of the world’s largest medical device and diagnostics company, install equipment, hire people, conduct test runs, meet regulations, seek approval in a compressed timeline
Key Solutions Implemented
- Established a war room, engage all support functions, Engineering, Facilities, Materials, EHS and IT to ensure an integrated readiness
- Developed detailed Operational Readiness checklists and deployed them for each factory and functional group
- Defined the operating model, shifts patterns and staffing levels across all functions supporting production
- Enhanced and streamlined CAPA process to focus on root cause (RCA), tools, training and individual’s role