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Design Risk Assessment is the process of determining what can possibly go wrong during the production of a product. This is often implemented during the "idea gathering" process before production is even considered. If the risks far outweigh the benefits, many times, the documentation is simply saved and the product is never created. However, if the risk potential is low, the go ahead is often given.

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In order to perform a design risk assessment, everything from the very idea of the product to the design phase must be thoroughly examined to find any errors, no matter how small. Since something as small as an idea can adversely affect a product, all aspects must be completely thought through. Six Sigma assists in this department through the creation of a group of experts commonly known as Master Black Belts or Black Belts. These are people from throughout the company who are experts in their particular area that are brought together to brainstorm. They have been trained and certified in the Six Sigma Methodologies and Tools and how use them to their utmost capabilities from day one.