Risk Management in Process Development By Perry Parendo, founder, Perry’s Solutions, LLC
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he product development process is challenging to execute. There are technical, manufacturing and business considerations to balance. Any issue can cause a significant delay in project completion and the ultimate product launch. Production issues can damage company image and negatively impact financial success. How can companies avoid these delays? How can they anticipate things that they are not expecting? Risk management provides an opportunity for launch predictability. How does this happen?
Development process
First, companies need to consider the development process. Organizations will emphasize different aspects of the process, but the core elements tend to be common for many. A general flow of these core development elements are as follows: y Project Planning y Requirements y Concept Design y Product Development y Manufacturing Development y Validation y Clinical Evaluations (in the medical device industry) y Product Launch Many organizations consider risk management as a deliverable at project completion, just before launch, vs. a tool to improve project execution. However, to truly help their project, risk management should be implemented early in the process. But how is that done? This article will give tips for each stage of the product development process. 6 Inside Rubber // 2022 Issue 2
During the Project Planning stage, one should consider areas of uncertainty. Are enough resources allocated? Resources can include people, prototypes and time for training. From a process point of view, companies need to consider things they need to be successful. Make sure to ask the right questions and get those questions resolved. Anything not provided is a level of uncertainty for project predictability. The next uncertainty to address is Requirements. This stage includes technical requirements but also can include business and operational requirements. Examples include product cost, production cycle time and expected yields. As the processing needs are identified, there is a need to assess capabilities. Which requirements are difficult to achieve? Challenging requirements provide uncertainty and risk and a need for a plan and resources to resolve them. At the Concept Design phase, a functional assessment of the product performance as well as the manufacturing process can be done. New designs can produce production challenges. This can influence fixturing, equipment or finding a process sweet spot. A high-level review of the project can really benefit the later stages of the development process. During the Product Development stage, the design team will create a detailed assessment of the product situation. The team also should dig deeper into the initial concept level testing and analysis. Design of Experiments (DOE) can be a big help by evaluating multiple input variables and finding optimum performance. Companies want to avoid focusing on the first solution that shows promise. Instead, they need
