Root Cause Analysis of Use Errors and Assessment of Residual Risk

September 30, 2020 | 1:30-6:00pm CDT

Join Emergo by UL's Human Factors Research & Design (HFRD) team for a half-day workshop on root cause analysis of use errors and assessing residual risk. These closely-linked activities are cornerstones in the process of ensuring safe interactions between people and technologies that can take various forms, including tools, products, equipment, and systems. In their presentation, the faculty will reference technologies that are predominantly hardware, such as surgical tools, defibrillators, dialysis machines, heart pumps, and intravenous infusion pumps. But, they will also reference software products, such as electronic health records and mobile apps that help patients manage a disease and medication regimen. They will make passing reference to documents as well, such as instructions for use and quick reference guides. They will accent the discussion with references outside of the medical domain, drawing on their experience in consumer products, aviation, and nuclear power.

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Sep 30, 2020

Lessons pertaining to root cause analysis will include how to (1) develop an initial hypothesis about the root cause of a use error, (2) analyze anecdotal feedback about the use error, (3) inspect the associated user interface for design shortcomings, (4) consider the effects of the use environment and other ancillary factors, (5) perform supporting research and experiments, and (6) develop a final theory or factual conclusion about the root cause. These lessons will echo the content of Medical Device Use Error: Root Cause Analysis; a book that the faculty co-authored in 2016.

Lessons pertaining to residual risk analysis will include how to (1) review the results of the root cause analysis as a foundation for considering residual risk, (2) ensure that estimations of use error likelihood and the potential severity of harm are accurate, (3) review the history of user interface development to determine if all practical risk mitigations have been properly implemented, (4) reach consensus on the potential for any further risk mitigation, and (5) prepare a report that indicates the need for further design refinement or claims that the residual risk of the current design is acceptable.

The faculty will comment on the appropriateness of the work being performed by an individual or a multidisciplinary group, depending on multiple factors. They will talk about the politics of these two, cornerstone activities and how to ensure the analysis can be performed with maximum objectivity. The workshop will include several exercises that call upon attendees to engage in root cause analysis and residual risk analysis, all based on a single case example for continuity sake. There will be sufficient time for group discussion about analysis techniques and consideration of the attendees’ own experience and challenges.

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