tailieunhanh - Six Sigma for medical device design_1

văn bản này thiết lập một cách để sắp xếp tất cả các cấp của tổ chức để sản xuất một mức độ cao của phát triển mà là cả hai kịp thời và phù hợp. Đây cũng là một công cụ tuyệt vời cho các nhân viên kỹ thuật và khoa học để hiểu được thực tế của doanh nghiệp và thị trường và để tối ưu hóa quá trình tạo sản phẩm. | Chapter two Design Control roadmap 31 Table Design changes and the product life During design and development After product has been released to the market existing products Document control Change control elements . design reviews and new elements of change while still going through design iterations or doing design verification or validation Figure depicts design changes with a diagonal line that implies multiple changes in this temporary or conditional DMR during the entire design and development life cycle of the device. It is important to realize that not only DMR but also elements of design verification and validation can be affected and thus the DHF . Change control per se has to do with the physical characteristics of the device or its acceptance criteria or its testing or evaluation methods. For product under development there has to be a logical procedure to expose the entire design and development team as well as reviewers to the changes. This is very much in line with the last two statements of the previous paragraph. A bigger challenge in terms of regulatory compliance and business risk is the control of design changes on existing products. The changes can not only alter the design but also the intended use and thus the 510 k or PMA submission to FDA . Another possibility is the change affecting some other device or subsystem manufactured. Our greatest concern in this situation is the fact that manufacturing operations are typically the ones requesting the changes in response to raw material or component deviations. Without competent personnel with access and understanding of the DHF how can approvers of change be able to make a conscious decision Also manufacturing operations may never have the means for executing a design re-validation upon design changes. In this book we will introduce the DFSS concept called design requirements cascade which is in line with classical 1980s system engineering programs. Later in Chapter 6 we will talk .