tailieunhanh - Six Sigma for Medical Device Design by Jose Justiniano and Venky Gopalaswamy_10

Tham khảo tài liệu 'six sigma for medical device design by jose justiniano and venky gopalaswamy_10', kinh doanh - tiếp thị, quản trị kinh doanh phục vụ nhu cầu học tập, nghiên cứu và làm việc hiệu quả | appendix one Glossary and acronyms Black belt This term is derived from the martial arts such as karate. A black belt is an expert who coaches and trains others as well as demonstrates a mastery of the art. In terms of Six Sigma the black belts have studied and demonstrated skill in implementation of the principles practices and techniques of Six Sigma for maximum cost reduction or profit improvement. They are typically team leaders or internal consultants typically mastering quantitative methods such as the statistical tools and project management Six Sigma methodologies. CAPA FDA jargon Corrective and Preventive Action cGMP Current Good Manufacturing Practices Concept design concept The approximate description of the technology scientific and engineering principles and form of the product. Description of how the product will satisfy the potential customer needs and why. It is said that the NPD process can ruin a good concept but a bad or poor concept will never be a good commercialized device. COGS Cost of Goods Sold Cpk Potential Process Capability ratio DFx Design for x DFa Design for Acquisition DFm Design for Manufacturing Estimate the costs of manufacturing Reduce cost of components or raw materials Reduce cost of assembly or preparation Reduce necessary overhead See the effect of the above in the intended design 115 2005 by CRC Press 116 Six Sigma for Medical Device Design DMADV Define Measure Analyze Design Verify DMAIC This is a Six Sigma project methodology used when a product or its process is in existence but the output is not performing adequately meeting the specifications . The DMAIC methodology is almost universally recognized and defined as comprising of the following five phases Define Measure Analyze Improve and Control. In some businesses only four phases Measure Analyze Improve and Control are used in this case the Define deliverables are then considered pre-work for the project or are included within the Measure phase. In other companies a .