Tham khảo tài liệu 'six sigma for medical device design by jose justiniano and venky gopalaswamy_8', kinh doanh - tiếp thị, quản trị kinh doanh phục vụ nhu cầu học tập, nghiên cứu và làm việc hiệu quả | Chapter four Design Control and Six Sigma roadmap linkages 85 The importance of documentation is not only the evidence the firm needs to show FDA inspectors and ISO assessors that they have compiled design inputs. It becomes the norm or standard by which many decisions will be made later in the design and development process. Defaulting to the VOC is the easiest way to solve the typical design project disputes that should normally be expected of team members. In fact this is why the QSR requires a way for solving conflicting requirements. DFSS is said to be a program under which cross-functional teamwork is facilitated . concurrent engineering . However in the medical device industry if the medical or anatomic subject is not mastered by the team members and their design reviewers the cross-functional aspect may never bring the expected returns. For example reviewers from manufacturing demand management quality sciences quality systems regulatory compliance and Six Sigma black belt groups will prove to be mostly bureaucratic obstacles during design reviews if these elements of knowledge are not part of their skills set. Play with the predicate device. Reverse engineer use it out of the recommended conditions assess reliability and find weaknesses of manufacturing or design. All data gathered can also serve the strategic purpose of product family or multigeneration product planning. Thus VOC is the foundation for design inputs and for strategic planning as well. Survey and interviews are the default tools for marketing research. The most relevant pre-requirements before you start surveying customers are To understand the human anatomy . human and animal biochemistry for IVDs . To understand medical practice whether your device is a technological breakthrough or just another catheter . To understand their jargon. For example for cardiac surgeons IMA stands for Internal Mammary Artery while for academic anatomists and general surgeons IMA stands for Inferior .
