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220 Safety Risk Management for Medical Devices

30.2 ISSUE DETECTION HISTORY
Similar to the method in Section 30.1, this method relies on historical performance
and collection of data. But this method can provide a leading indicator on the perfor-
mance of a risk management process.
During the course of risk management processes, issues with potentially adverse
safety impact are identified and mitigated. These are usually design-related issues
which had gone unnoticed by the product development team. Assuming constant
maturity and performance by the design team, one can presume and expect a certain
rate of detection of safety issues. If the rate of issue detection on a new project is
significantly lower than the historical levels, one could construe that the current risk
management process is not working as well as the past projects.
The problem with this method is that team performance is not constant, project
complexities are not the same, and safety issue identification can be subjective. So, the
conclusions derived are just conjectures.

30.3 SUBJECTIVE EVALUATION

In this method people who are involved in the project and experienced with risk
management evaluate the project on several vectors. For example:
• the productivity of the working sessions and how well they are run
• the sense of confidence in the ability to identify Hazards and estimate risks
• the contribution of the risk management process to a sense of communication
among the participating functional groups
• how well risk management identifies safety impact of proposed design changes
This method is also not precise, but can provide real-time feedback to manage-
ment. And, even though it is subjective, it is not less valuable than the other two
methods that are offered in this chapter.