tailieunhanh - Six Sigma for medical device design_2

Tham khảo tài liệu 'six sigma for medical device design_2', kinh doanh - tiếp thị, quản trị kinh doanh phục vụ nhu cầu học tập, nghiên cứu và làm việc hiệu quả | Chapter three Six Sigma roadmap for product and process development 45 Are we going to meet the business targets . schedule cost risk and reliability levels Where are we on this project Where when and how can top management help What is the critical path How can we ensure that falling behind schedule is not compensated with compromised quality and reliability Do the list of planned activities include addressing all quality systems requirements such as Bio-compatibility Product risk analysis System FMEA Design FMEA Process FMEA Environmental impacts Component qualifications Accelerated aging Pre- and post-sterilization correlation analysis Process stability Product stability shelf life Packaging stability Validation of test methods GR Rs measurement capability analysis etc. Process and design validation Stakeholder requirements identification and analysis This analysis captures the Critical-to-Business CTB requirements and helps the teams identify key stakeholders that need to be managed during the project. It is a simple DFSS tool that must be completed just before or after the development of the project plan. Table is a sample template for this tool. It must be noted that not all stakeholders wants and needs are directly linked to the product that is developed by the project team. Stakeholders in a medical device company can include senior management in various functional organizations such as quality regulatory finance operations and information technology. Identifying these key groups and planning activities to mitigate any potential surprises will go a long way in the team s ability to complete the project successfully. Teams typically fail or get caught in organizational politics if CTB needs are not accounted for in their project planning efforts or for that matter in their product design. How often have you heard the following questions or comments 2005 by CRC Press 46 Six Sigma for Medical Device Design Table Template to complete stakeholder .