The quality plan is a very essential document, because it outlines the procedures/methods you intend to follow in the project to ensure that the product you develop meets all quality standards of your company and regulations of the governing body. 21 CFR 820 Subpart B states, “Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.” I would say yes, it is really needed, because if you don’t have a strategy in place to define how you are going to assess the quality of the product, how can you be confident that you will be able to develop a product of high quality? It follows the same concept as the planning phase in project management. Can you just skip the planning phase and move right into execution? As we learned, the planning phase is a vital phase of project management to make sure the rest of the project runs smoothly and ultimately is successful. I believe the same concept applies to the quality plan.