Risk Management Thoughts

The topic of product risk management doesn’t usually cause people to get excited. Usually when risk management is mentioned, people groan and often hide. The reasons why risk management is a thorn in the side of a product development team are simple. Risk management is quite often too detailed to be very useful. Risk management activities are often “check boxes” within a project. The risk management tools chosen are difficult to apply to the product or process in question. Simply put, risk management is seldom used as a tool to aid and enhance the product development process.

Future posts will get into specific tools and application of risk management during product development. In the meantime, let me share some overarching thoughts.

• Risk management activities should start early on in a project. Start high-level risk activities (e.g. hazard analysis) while in research and during project planning.
• Risk management should be a lifecycle process. This means risk management should be evaluated early and often throughout product development. It also means that risk management should be updated after the product is launched and continue throughout the product’s life.
• Risk management tools should be chosen to best capture and represent the product or process in question. For example, failure modes and effects analysis (FMEA), a common risk tool, may not be applicable for every risk study.
• Risk management is a team activity. One person should not be responsible for completing a risk study. Everyone knows this but seldom have I seen a team complete risk management activities.
• Discoveries from risk management activities should be an integral part of product development and process development. Products and processes should be refined and mitigated in order to reduce risk as much as possible and is pratical. Remember the purpose of risk management is a tool to identify potential risks and to make products and processes as safe as possible.

Risk management continues to be somewhat esoteric and difficult to grasp. Some tools are easier and more user-friendly than others. There are also resources available to help make the process a little more tolerable. For medical devices, ISO 14971:2000 is a global harmonized standard that does a good job explaining risk management. There are numerous workshops, seminars, books, websites, and software on the topic. When in doubt, consult these resources, ask questions, seek guidance.

I’m interested to hear about your experience with the risk management process, tools, and related topics. Leave a comment or send me an email at jspeer@creoquality.com.