tailieunhanh - Six Sigma for Medical Device Design by Jose Justiniano and Venky Gopalaswamy_9

Tham khảo tài liệu 'six sigma for medical device design by jose justiniano and venky gopalaswamy_9', kinh doanh - tiếp thị, quản trị kinh doanh phục vụ nhu cầu học tập, nghiên cứu và làm việc hiệu quả | 98 Six Sigma for Medical Device Design Table Flow-up cascading for extra-strong IV set Domain mapping Performance requirements Component manufacturing and process control specifications design verification design transfer and process validation Component acceptance specifications design verification design transfer and process validation Subassembly subsystems assembly and testing specifications design verification and validation design transfer and process validation Systems assembly final configuration and final acceptance specifications design verification design transfer and process validation Validated design with a validated manufacturing and assembly process A process capability ratio of is required for entire operating range of the process parameters in injection molding of the luer lock. There are three relevant or critical dimensions in the luer lock that must be met at .001 . These dimensions are length . at and . at . Before inserting the tubing into the luer lock the solvent will be applied and a curing of T minutes will be allowed. The required bond strength is P pounds when stretched. The extra-strong IV set has the same functionality capabilities and dimensions that a normal IV set has. Additionally it has a special strength and a special labeling indicating it to be extra strong. The DMR and the DHF are complete. Flow up process and design capabilities The injection molding process is statistically stable with a Cpk of and a Ppk of across the entire universe of possible combinations of process parameters worst-case conditions . All three critical dimensions were met including all those devices made under the worst-case conditions. At 99 reliability and 95 confidence a safety factor of 3 was obtained during a stress-strength test. Curing time is a design parameter that needs control in manufacturing. During the reliability test it was realized that the connection luer lock to tubing is stronger than the .