How can design control ensure a product meets user needs?

1 What is design control?

Design control is a set of activities and practices that guide the development of a product according to its design inputs and outputs. Design inputs are the needs and expectations of the users, customers, and stakeholders, as well as the technical, functional, and regulatory requirements. Design outputs are the specifications, drawings, models, prototypes, and test results that define the product's characteristics and performance. Design control ensures that the design inputs and outputs are consistent, traceable, and controlled throughout the product development process.

2 Why is design control important?

Design control is important for several reasons. First, it helps you avoid costly and time-consuming design changes, errors, and defects that can compromise the quality and safety of your product. Second, it helps you ensure that your product meets the user needs and expectations, as well as the market and competitive demands. Third, it helps you comply with the regulatory standards and guidelines that apply to your product's industry and domain. Fourth, it helps you document and demonstrate the evidence and rationale behind your design decisions and actions.

3 How to implement design control?

Design control can be implemented using various methods, tools, and frameworks, depending on the complexity and nature of your product. However, a common approach is to follow the design control process defined by the ISO 13485 standard for medical devices, which consists of seven steps. This process begins with design and development planning, where you establish the scope, objectives, responsibilities, resources, and schedule of your design project. Then you identify and document the user needs and expectations as well as the technical, functional, and regulatory requirements for your product. You also generate and document the specifications, drawings, models, prototypes, and test results that define your product's characteristics and performance. After that, you evaluate and approve the design outputs against the design inputs and plan. To confirm that the design outputs meet the design inputs, you use objective and measurable methods such as testing, inspection, analysis or simulation. You also validate that the product meets the user needs and expectations by using representative samples and realistic scenarios. Lastly, you ensure that the product can be manufactured, assembled, installed, operated and maintained according to the design outputs and specifications.

4 What are some examples of design control?

Design control can be applied to any product that requires a systematic and rigorous design process, such as medical devices, software, electronics, machinery, or vehicles. As an example, a medical device company might use design control to develop a blood glucose meter that is accurate, reliable, easy to use, and compliant with the FDA regulations. They would define the design inputs based on user feedback, market research, and regulatory requirements and generate design outputs such as the device specifications, software code, user interface, and test protocols. Design reviews, verification, and validation would be conducted to ensure that the device meets the design inputs and user needs before it is transferred to the production team with clear instructions and documentation. Similarly, a software company could use design control to develop a mobile app that helps users track their fitness goals and activities. Design inputs would be based on user personas, scenarios, and stories while design outputs would include app features, functions, and interface. Design reviews, verification, and validation would need to ensure that the app works as intended and meets user expectations as well as app store guidelines before it is transferred to the deployment team with source code, test cases, and release notes. Lastly, an electronics company could use design control to develop a smart speaker that can play music, answer questions, and control other devices. Design inputs would be based on user requirements, market trends, and technical specifications while design outputs would include speaker components, circuit diagrams, firmware, and voice recognition software. Design reviews would help ensure that the speaker performs well and meets quality and safety standards before it is transferred to the manufacturing team with a bill of materials, assembly instructions, and quality control procedures.

5 How to improve design control?

Design control is not a one-time activity, but a continuous improvement process that requires constant monitoring, evaluation, and feedback. To improve your design control, involve users, customers, and stakeholders in the design process and solicit their input throughout the project. Clear, concise, and consistent documentation should be used to record and communicate design inputs, outputs, reviews, verification, and validation. Appropriate methods, tools, and frameworks should also be used to plan, execute, and manage your design project. Regular design reviews should be conducted to check progress, quality, and performance of the project. Change control procedures should be implemented to document and approve any changes to design inputs or outputs. Finally, train and educate your design team on the design control process and ensure their competence and compliance.