(20c) Utilizing Failure Mode and Effects Analysis (FMEA) to Improve Commercialization Process

Demands for new products with high quality and increased speed to market continue as resources remain limited. Two risk management tools, Design Failure Mode and Effects Analysis and Process Failure Mode and Effects Analysis (FMEA), are often completed in the design phase of commercializing new products due to requirements from a customer or as part of a corporate project execution strategy. Changing the mindset and discussion around the use of these tools from a project execution check list to a source of valuable information can improve quality, while also reducing costs and improving speed to launch for these new products.

A case study will be used to demonstrate the value these tools can bring to commercialization. A Design FMEA was used to identify key areas of the product formulation that would lead to customer failures. A set of experiments was completed based on results from the FMEA scoring that exposed an unexpected failure mode. Further investigation revealed a product re-formulation was required, the experimentation driven by the FMEA output played a key role in defining the new formulation. A Process FMEA was then created that identified crucial process steps that were studied at a small scale. Information gained allowed for a successful initial scale-up improving time to market for this product and reducing costs associated with the scale-up activity.

Overall the systematic team approach to creating FMEA documentation throughout a project can lead to improvements in work planning and execution. Such methods reduce time to commercialization improving resource efficiency while enhancing the likelihood of higher market success.