Bridging the Gap between Risk Assessment


and Risk Management with Data



By Mruga Patel

Chicago, IL, USA

The need for comprehensive and continuous risk management throughout the product lifecycle cannot be overemphasized—from beginning to middle to end. To start, it is useful to incorporate risk management principles during the new product development phase as early as the design stage. This is when lessons learned from the other devices in the field can be assessed and included. This process helps team members prepare for unanticipated failures that can be alleviated or rectified prior to production. In the middle of a product development life cycle, it is crucial for project managers to identify or help the project team identify appropriate data collection sources that will aid various stages of product development and establish a feedback loop system for production and post-production activities. This information assists manufacturers in ensuring that their products are effective, safe, and performing as intended. Risk management is also useful after a product is launched to keep teams better prepared for potential unanticipated failures discovered post-production and better positioned to rectify any related problems that might arrive once a product is in use on the market.

Role of risk assessment and risk management

Mitigating risk involves detailed preparation. Professionals need to know how to perform risk management protocols, which always begins with the overall governance of all assigned projects. When any conceived product reaches the product design and development stages, the project manager ensures that all processes proceed according to approved plans. Even the most diligent of planning and governance will present project managers and manufacturers with an inherent set of various risks, such as increasing costs of production, supply chain issues, evolving consumer demands, potential impacts on the environment and population health, and ongoing regulatory compliance challenges based on specific product- and service-related industry standards.

When project managers initiate an evaluation of business risks early on during the concept stage of design and development, there’s an improved likelihood that the entire team can utilize their critical thinking skills to implement response strategies should a product experience flaws during standard operation settings or during times of user error. This level of planning also helps to make more informed judgments when deciding on an action plan as a component of a risk-based strategy. Early risk management can help to identify potential design flaws and save future resources. It’s essential that risk management is at the forefront of any organizational culture for the sake of the overall quality of any device or service.

Many industries today, including the healthcare arena and other sectors where safety risks are more prominent, will be externally governed by regulatory assessment and compliance standards that require proof of risk and quality management to be conducted throughout the product’s lifecycle. Regulatory bodies will evaluate manufacturer protocols for ongoing adequacy to further protect consumers. In fact, many such evaluations occur prior to the release of a new product to market, requiring necessary clearances to be met before product launch.

Another crucial element of risk assessment and management today involves a proactive, data-driven process. This requires a concerted effort to perform such tasks as collecting related literature and research, conducting user surveys, and involving in-house stakeholders with the requisite expertise to estimate the threat of risks instead of waiting for feedback from the field, such as consumer complaints. When complete quantitative data are unavailable, especially early in the lifecycle of a new product, organizations can consider semi-quantitative data, which allows for approximate data measures. In this context, there needs to be a way to gather and review relevant data to confirm product safety, effectiveness, and other performance metrics after product release. Organizations that rely on a reactionary approach will not be able to effectively identify potential hazards and implement preventative measures.


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How to cite this article: Patel, M. (2023).  Bridging the Gap between Risk Assessment and Risk Management with Data, PM World Journal, Vol. XII, Issue X, October.  Available online at https://pmworldlibrary.net/wp-content/uploads/2023/10/pmwj134-Oct2023-Patel-bridging-gap-between-risk-assessment-and-risk-management-with-data.pdf

About the Author

Mruga Patel

Chicago, IL, USA


Mruga Patel, MS, ASQ-CQE/CQA, is the manager of design quality engineering at a leading medical device manufacturer and has more than 10 years of experience in the medical device industry. Mruga is a subject matter expert on risk management and manages a team of engineers that oversee a wide variety of product portfolios. She has experience in the design and development of medical devices (class I, II and III implants and instruments), fielding notified bodies and FDA audits, supplier qualification and audits, and conducting internal audits. For more information, contact mruga_27391@yahoo.com.