As Prof. Simon mentioned in his lecture, the validation process consists of design validation and process validation. In a design validation, you assess whether the product meets all of the user needs, and this validation is usually conducted by a selected group of end users. The key to a successful design validation is first of all getting good VOC feedback in the beginning of the project to create a user needs list, and second of all keeping users engaged throughout the development of the product, by showing them prototypes and having them assess these prototypes to ensure that the product is on the right track and meets all of their needs. If all the work was done thoroughly and correctly leading up a design validation, the design validation should really be just a final check confirming that all user needs were met, and the risk of failing the validation should be low. For a process validation, you assess whether the supplier is able to consistently and reliably produce the product that you have designed to the specifications you have set. The key to a successful process validation once again starts right at the beginning of the project. Assuming the company is using a supplier to manufacture their product, the supplier must be assessed for their capability to achieve the process validation that will be required by the company. It is also very important that the supplier and the design team collaborate and have DFM discussions throughout the design and manufacturing process to alleviate any process capability concerns before actually executing the process validation.