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Design changes that happen early in the design process are less expensive when compared to those that take place after it is introduced into full-scale production. The cost of the change increases with its development time. [3] Fundamentally, design changes can be classified into pre production and post production changes.
Design management is the business side of design. Design managers need to speak the language of the business and the language of design. Design management is a field of inquiry that uses design, strategy, project management and supply chain techniques to control a creative process, support a culture of creativity, and build a structure and organization for design.
Lean Change Management is an ecosystem of modern change management ideas created by Jason Little. Inspired by Lean Startup, Agile, and Design Thinking, Lean Change Management is designed to help change agents create an adaptable, and contextual approach to change focus on creating shared purpose over creating false urgency
Change impact analysis is defined by Bohnner and Arnold [4] as "identifying the potential consequences of a change, or estimating what needs to be modified to accomplish a change", and they focus on IA in terms of scoping changes within the details of a design.
The plan–do–check–act cycle is an example of a continual improvement process. The PDCA (plan, do, check, act) or (plan, do, check, adjust) cycle supports continuous improvement and kaizen. It provides a process for improvement which can be used since the early design (planning) stage of any process, system, product or service.
Strategic design is the application of future-oriented design principles in order to increase an organization's innovative and competitive qualities. Its foundations lie in the analysis of external and internal trends and data, which enables design decisions to be made on the basis of facts rather than aesthetics or intuition.
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Design review; Design transfer ensuring that the device design is correctly translated into production specifications; Design changes; Design history file, a demonstration that the design was developed according to the approved design plan and 21 CFR 820.30.