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lianhuajin replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices 7 years, 4 months ago
I do not have experience. But I searched about it online and found that for risk identification, the project team should review the program scope, cost estimates, schedule (to include evaluation of the critical path), technical maturity, key performance parameters, performance challenges, stakeholder expectations vs. current plan, external and internal dependencies, implementation challenges, integration, interoperability, supportability, supply-chain vulnerabilities, ability to handle threats, cost deviations, test event expectations, safety, security, and more. In addition, historical data from similar projects, stakeholder interviews, and risk lists provide valuable insight into areas for consideration of risk.
Risk identification is an iterative process. As the program progresses, more information will be gained about the program (e.g., specific design), and the risk statement will be adjusted to reflect the current understanding. New risks will be identified as the project progresses through the life cycle.