<p>Integrating risk management into the preliminary design phase of engineering projects is essential for ensuring product safety and reliability. Traditional methodologies, such as checklists and failure mode and effects analysis, often operate reactively, potentially hindering their effectiveness in early risk identification. To overcome these limitations, a novel methodology has been developed to integrate risk analysis into the preliminary design phase effectively, without impeding innovation or complicating the design process. The proposed methodology decomposes complex systems into functional blocks and flows, enabling early identification of potential risks through a detailed mapping of interactions and dependencies. This approach was applied to an industrial boiler case study, providing systematic identification of both general and specific risks during preliminary design. Results show that this method enables a comprehensive risk assessment while maintaining design flexibility, supporting innovation in problem-solving. The approach facilitated the creation of a risk register, allowing for proactive risk management and informed decision-making throughout the design process by systematically identifying, general risks associated with system functions and specific risks linked to technological choices.</p> Graphical abstract <p></p>