Presentation
Qualitative risks in a Quantitative World. Crossing the Bridge to the Risk-Management Process.
SessionAI/Risk (MDD6)
DescriptionThe main aim of the human factors validation study is to demonstrate that risk control measures are effective at reducing risk of use errors occurring as far as reasonably practicable, but there is no definitive answer as to what constitutes ‘success’ at the final reporting stage. The findings and the considerations relating to observations and risk control measures in the user interface need to be integrated back into the risk management process defined by the manufacturer, to determine several things such as the final use-related risk analysis, the likelihood of the use error occurring, the need to refine the existing risk control measures, the capacity to implement further risk control measures, and the residual risks; however, standards and guidance relating to usability do not provide information on how to expressly achieve this. It is challenging to slot the use-related risk process back into the over-arching risk-management process because usability is assessed using qualitative methods, where most risk management is achieved through quantitative methods.
This presentation aims to provide usability engineers with some methods of how to use the outcomes from a validation study to contribute towards the residual risk determination and the consideration as to whether further usability testing is required or not. The need for this presentation arises from the case that the chief standards (IEC 62366:2015+AMD1:2020) and guidance (FDA UCM259760) do not discuss what happens next once you, the usability engineer, have analyzed the results of the validation study and written them into a report.
This is understandable when usability, qualitative in nature, exists in a quantitative world! Risk management is a process that is overall generally governed by other people involved in the process, namely Research and Development or Quality Engineers. However, traditionally use-related risk is identified, managed and tested by more qualitative methods than other required areas of risk-management. This results in a lack of understanding by traditional risk management owners as to how to translate the usability validation study results into inputs for the final stages of risk analysis and management pre-market. At the same time, these risk managers may turn to usability engineers for guidance, guidance that is not clearly delineated in the usability guidance and standards, and guidance they may be ill-equipped to give out. Usability engineers typically have an understanding of the usability engineering process, but may not be experts at the complete risk management process. In this situation it may become difficult to communicate to risk managers what to do with the results.
After years of usability engineering methods being refined and enhanced for effective use-related risk management, it is time to turn attention to ‘what happens next’, where does the work go, and how can usability engineers with their in-depth understanding of the implications of use errors help translate these results into something risk management owners can work with.
To this end, the presentation aims to give usability engineers some methods or ideas for methods to use in the validation study report to perform those final steps of risk management. The structure of the presentation will include some explanation of why this gap might have developed, the over-arching risk management process that the use-related risk management feeds into (ISO 14971) and what steps can be taken after the validation study report is concluded, so that risk owners can determine from a risk-management perspective if the study demonstrated that risk control measures are ‘successful’ in reducing and managing use-related risk.
This presentation aims to provide usability engineers with some methods of how to use the outcomes from a validation study to contribute towards the residual risk determination and the consideration as to whether further usability testing is required or not. The need for this presentation arises from the case that the chief standards (IEC 62366:2015+AMD1:2020) and guidance (FDA UCM259760) do not discuss what happens next once you, the usability engineer, have analyzed the results of the validation study and written them into a report.
This is understandable when usability, qualitative in nature, exists in a quantitative world! Risk management is a process that is overall generally governed by other people involved in the process, namely Research and Development or Quality Engineers. However, traditionally use-related risk is identified, managed and tested by more qualitative methods than other required areas of risk-management. This results in a lack of understanding by traditional risk management owners as to how to translate the usability validation study results into inputs for the final stages of risk analysis and management pre-market. At the same time, these risk managers may turn to usability engineers for guidance, guidance that is not clearly delineated in the usability guidance and standards, and guidance they may be ill-equipped to give out. Usability engineers typically have an understanding of the usability engineering process, but may not be experts at the complete risk management process. In this situation it may become difficult to communicate to risk managers what to do with the results.
After years of usability engineering methods being refined and enhanced for effective use-related risk management, it is time to turn attention to ‘what happens next’, where does the work go, and how can usability engineers with their in-depth understanding of the implications of use errors help translate these results into something risk management owners can work with.
To this end, the presentation aims to give usability engineers some methods or ideas for methods to use in the validation study report to perform those final steps of risk management. The structure of the presentation will include some explanation of why this gap might have developed, the over-arching risk management process that the use-related risk management feeds into (ISO 14971) and what steps can be taken after the validation study report is concluded, so that risk owners can determine from a risk-management perspective if the study demonstrated that risk control measures are ‘successful’ in reducing and managing use-related risk.
Event Type
Oral Presentations
TimeTuesday, March 262:10pm - 2:35pm CDT
LocationContinental Ballroom, Lobby Level
Medical and Drug Delivery Devices