Implementing a robust risk management program into your life science organization requires a solid understanding of your needs, capacities, and goals. Whether to improve alignment with regulatory requirements and standards or adjust your overall risk procedures, identifying what you can do to bolster your current risk management programs is vital to promoting long-term growth. There are many ways out there to improve your risk management, but there are a few worth using as a baseline to build on.
While FDA does not specify risk management activities, the requirements for design validation under 21 CFR 820.30 mandate that any validation activities incorporate risk analysis where appropriate. Beyond regulatory requirements, there are several guidance documents and standards organizations can rely on when building their risk management programs. These include, but are not limited to:
Life science organizations tend to specialize in products and product types. As a result, there is a lot of similar data that gets generated with each new product release. Rather than collecting risk-related information with each new project, a risk management program with reuse procedures in place can save time and resources while preserving knowledge and insights previously obtained.
Controlling immediate risks to users and patients that occur during use of life science products is often the priority for most organizations. While this is no doubt crucial, these interactions are not the only source of hazards, hazardous situations, and harms posed to users. There are risks throughout the product life cycle—production, servicing, shipping, decommissioning, etc.—that could expose multiple people to undue hazards and harms. Identifying these during premarket development can save time and hassle once products reach the market and beyond.
The right risk management tools can make a world of difference in life science product development. Beyond selecting the most appropriate risk exercises—FMEAs, FTAs, usability risk analyses, and so on—think about adopting compliance software tools that can help your team through risk management activities. These tools can keep the focus on the risk analyses at hand and less on ensuring that processes and results align with the latest regulations and standards.