The final tool in your toolkit is the risk register, which allows you to centralize all risk items for a high-level view of product and design risks. Quantitative Risk Management software that leverages the tools described here makes it easy to:
• Pinpoint the most critical items with risk-based filtering.
• See risk items in the context of various processes such as change management initiatives, equipment maintenance and audits.
• Identify underlying trends and common sources of risk.
Risk management has become somewhat of a buzzword these days, but it’s important not to forget the reason why it’s so important. It’s not just something you should do because someone says you should—there are real people involved, parents, children and loved ones who use these drugs and devices, implicitly trusting their safety. With that trust comes great responsibility for the companies behind the products.
