Design Controls Component
This week when learning about design controls we viewed the nine parts within this process. Planning, Input, Output, review, verification, validation, transfer, design changes, and design history files are all important components to ensure safe and productive measures are in control. Choose three of your favorite components and discuss why it is most needed during the task.
My three favorite components are design inputs, design review, and design verification. customer requirements internally and externally from the design inputs are important. The development of a solid foundation of requirements is the most important design control activity. This is because it forms the basis for subsequent design tasks and is used to validate the entire device for its intended use. A specific and functionally accurate description of the device's intended use should be given at the input stage. As part of the input stage, device manufacturers are also responsible for risk management, reviewing recall data, competitor product issues, and other resources to mitigate hazards through design. A design review is part of a formal process for assessing the effectiveness of a device design, a production design, and a support design. The formal design review will ultimately determine whether the project is ready to move forward into the next phase. Verification of design output is the process of confirming that the output matches the input specifications, including risk analysis. As opposed to design validation, design verification involves tests across all layers of the design process, rather than at the system level. Test equipment must be calibrated and controlled by the quality system requirements for the most accurate results and data accuracy during the design verification process.
@mayasaunders Hey Maya, I would say that I like the same components except for design input, I would substitute that to design changes. I think being able to modify a design would be challenging while still operating under time constraints. It forces the team to think past the original goal while still keeping certain basic requirements for the design. I would definitely be interested in a position in design change for devices.
The nine components of the design control process are extremely important to ensure that the final version of a product addresses all requirements and customer needs. Of all nine components, the three that are most interesting to me are the planning, input, and design transfer steps. The project planning phase is probably one of the most important steps in the design control process because it is during this phase that the project proposal is created and those working on this document are able to show their creativity and desire to develop a device. Without a proper planning phase, the proposed device becomes much more difficult to develop, or might not even be developed. The design input phase is also a component where creativity plays a big role. Within this phase, the entire team and customers give inputs on how they think the device should be developed. In other words, the basic desires for a device are put into a document during this stage, which leads to the start of the design process and the other components of the design control process. The design transfer process is also one of my favorites because, during this step, those working on design transfer documents are able to translate all of the previous work into documents that lead to the actual manufacturing of the product. Essentially, this phase is the last one before device production begins. I consider this one of my favorite phases because it’s probably really satisfying to see the production of a product begin after all of the work that was put into it.
For me, I am most interested in the planning, verification and validation process. I think the verification and validation steps are where you do the check on "was my planning good?" It serves as a way to look back at the beginning of the project and where you can learn most about where possible mistakes may have happened and how to apply those learnings to the next project. In my current role, I am involved in planning of production but I have held roles in Quality Validation and Assurance. Having experience in these three roles really helps me see how everything ties back into the supporting the business and how if one step in the whole project is not aligned, then it can totally throw off the timeline.
My favorite components are the design inputs, verification, and validation. Design inputs are needed in order for the team to know what the consumer needs are and what the details of the device design are. Without proper design inputs the team wouldn't know what what device they need to build. Verification is important because the testing ensures that the device is built correctly and that it fulfills the designated specifications. Validation testing ensures that the device that is created actually meets the consumer need and accomplishes its intended function.
The three components that interest me out of the design controls would be inputs, verification, and validation. I can recall back to my capstone project, that the whole process of design controls could be applied to that project and I distinctly remember that I enjoyed working on these parts of the process. With inputs one is responsible is taking all the customer needs and incorporating them into the final design of the product. This part intrigues me as it requires problem solving and creative thinking to be able to incorporate all the customer needs while ensuring that the product's primary purpose is still functional. The beauty behind this process is being able to integrate external needs with a baseline design and having them work together synchronously without any issues. The next steps can somewhat go hand in hand where they are testing the product after it has been assembled or constructed or executed. In our capstone group we were required to draft specific testing plan literature that was required to be conducted in order to ensure that our inputs had translated into our outputs and that our customer needs were met, which is exactly what design verification and design validation encompass. Verification specifically focuses on the inputs equalling outputs which basically means that the product meets the physical specifications that define the product (measurements, dimensions). Validation on the other hand assesses the product's usability in the lens from the customer and ensures that it is a product that the customer could benefit from (functionality, usability, application).
Of the nine components, the three most interesting ones are: inputs, design history file, and planning. Inputs are essential to the overall success of a product. This phase pushes manufacturers to address the product as an attainable device that fulfills the user needs, rather than a far off concept/idea. Defining inputs such as device performance, safety, reliability characteristics, and environment limits give rise to an organized and clear goal. There is no ambiguity in the intention of the device as user needs are the basis for design inputs. The design history file (DHF) ensures product information is organized within one source. It is a comprehensive compilation of information about the product. It is the overarching document. Its main function is to demonstrate that the proper application and documentation of the design control procedures has occurred. It acts as a major resource to better understand how to design the product to fulfill its intended user needs. As a part of the PMA, it is also reviewed by the FDA. Therefore, it is important to show compliance through establishing and maintaining this documentation collection. Planning is the first step in the process. It is important to determine the feasibility of the product. The project proposal (PDF) is how management determines whether or not to move forward with the project. The PDF enables individuals to have a more clear picture of what the potential device entails in terms of business need, business strategy contribution, timeline, and other factors. The concept of the product is organized into a more definite device with clear benefits and realistic goals.