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