Manufacturing Traceability System Replacement to Maintain Business Continuity in a Medical Device Company

Abstract

Abstract - This project was focused in the Manufacturing Traceability System Replacement in a Medical Device Company. The existing Manufacturing Traceability System is obsoleted, therefore, a new Traceability system is being implemented in order to maintain Business Continuity. The system to be implemented, Manufacturing Execution System (MES), is the current standard in the industry. Project Management Planning methodology was used to develop an appropriate implementation plan that consisted in the evaluation of Requirements, Development, Test, Implement, and Sustain. During the implementation phase, several items were identified and incorporated to the initial plan. Requirements were evaluated on a line to line basis, in order to create a comprehensive plan, flexible enough to accommodate to the needs associated of each line. MES was implemented successfully in the first two manufacturing areas. Project plan was updated per lessons learned from initial implementation in order to achieve implementation goals in future lines. Key Terms- Manufacturing Execution System (MES), Project Management, Project Plan, Traceability System