Many of the challenges inherent in developing regulated products fall into the realm of risk that manufacturers need to examine and mitigate prior to going to market. Numerous drugs and medical devices are recalled each year, which underscores the importance of risk management in product design, development, and manufacturing.
Controlling risk is an important requirement for companies developing regulated products. International standards and regulations include guidelines specific to enforcing product safety and risk management processes. The guidances leave the “how” of risk management up to the company. The following is a high-level overview of the tasks involved in risk management:1
The tasks involved in risk management become more granular based on the organization’s products and processes. Still, simply meeting the minimum obligations for compliance does not equal effective risk management. It needs to be a continuous iterative process. Risk management should involve a structured, technology-driven approach to monitoring trends and behaviors that potentially result in deviations, nonconformances, delays, and possibly product recalls.
Product manufacturing problems such as out of specification (OOS), deviations, outdated data, design issues, etc. are easy to overlook as part of a larger risk. There also might be a new or unforeseen hazard that was missed earlier in the product’s life cycle that will need to be monitored. That said, risk management is not a responsibility exclusive to the quality team — it needs to be integrated into all areas of the company. Therefore, an effective approach to risk management is to embed risk-based thinking into the entire company culture by employing digitized technology and connected quality.
The U.S. Food and Drug Administration (FDA) has been a long-time advocate of using modernized technology for improving product quality and safety. “Advanced analytical tools such as machine learning and AI strengthen the FDA’s predictive capabilities, thereby enhancing [its] ability to detect potential safety issues with products and more effectively prioritize inspections and work based on modern risk prioritization techniques,” said Stephen Hahn, former FDA commissioner.2
To successfully implement this type of all-inclusive risk management system means all stakeholders need the ability to access and share data in real time. This enables everyone to effectively track and trend risk data. The need for this level of interaction, speed, and efficiency renders paper-based and spreadsheet data collection and analysis impracticable.
Using technology to proactively monitor and control risk reduces regulatory interaction, which makes sense on a compliance and business level as it contributes to getting products approved and out the door faster. Implementing a connected, data-driven quality platform allows you to manage all quality processes from anywhere, creating a unified risk management framework.
View the trend brief “Shaping the Next Normal for Quality and Compliance” to learn more about risk-based thinking and other trends shaping quality and compliance in 2021.
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