Presentation
Positive root cause analysis: Reframing the debrief interview approach to prioritize participant wellbeing
SessionMethods (MDD2)
DescriptionMost human factors (HF) regulatory guidance documents and standards direct medical device manufacturers to conduct root cause analysis (RCA) of any observed HF validation test findings (e.g., use errors) to determine why the finding occurred. Additionally, these documents emphasize that, as part of a successful RCA, it is essential for a usability test moderator to collect a participant’s reported root cause for why the participant thinks the finding occurred.
The root cause investigation process seems simple enough: (1) identify a finding, (2) question the participant about why it occurred, and (3) clarify responses as needed. Repeating this process enables a test moderator to collect participant-reported root causes for all identified findings, successfully satisfying regulatory expectations. The test moderator and manufacturer are then also satisfied that they have sufficient data for RCA, hopefully resulting in a successful regulatory submission. But what about the test participant? How do they feel after having just been repeatedly questioned about their mistakes?
Throughout 8+ years of moderating HF validation tests and observing other moderators as a consultant and now as an in-house practitioner, I have noticed trends in how participants respond during debrief interviews. While it is faster for a moderator to complete the debrief by only questioning participants about their findings, focusing on the negatives can cause participants to grow frustrated with themselves, the moderator, the user interface, and the session, usually negatively impacting their future responses and engagement.
This presentation focuses on a novel root cause debrief technique that highlights the participant’s successes in addition to understanding their mistakes: “positive root cause analysis.”
This presentation will cover the importance of ensuring a participant’s wellbeing during a usability test session’s debrief interview, including discussing shortcomings of current root cause debrief interview techniques that focus on participant mistakes. The presentation will then introduce and explain the steps of the positive root cause debrief technique before discussing the value of applying this novel technique and how it builds upon existing root cause debrief interview techniques to improve the participant experience and data quality.
The root cause investigation process seems simple enough: (1) identify a finding, (2) question the participant about why it occurred, and (3) clarify responses as needed. Repeating this process enables a test moderator to collect participant-reported root causes for all identified findings, successfully satisfying regulatory expectations. The test moderator and manufacturer are then also satisfied that they have sufficient data for RCA, hopefully resulting in a successful regulatory submission. But what about the test participant? How do they feel after having just been repeatedly questioned about their mistakes?
Throughout 8+ years of moderating HF validation tests and observing other moderators as a consultant and now as an in-house practitioner, I have noticed trends in how participants respond during debrief interviews. While it is faster for a moderator to complete the debrief by only questioning participants about their findings, focusing on the negatives can cause participants to grow frustrated with themselves, the moderator, the user interface, and the session, usually negatively impacting their future responses and engagement.
This presentation focuses on a novel root cause debrief technique that highlights the participant’s successes in addition to understanding their mistakes: “positive root cause analysis.”
This presentation will cover the importance of ensuring a participant’s wellbeing during a usability test session’s debrief interview, including discussing shortcomings of current root cause debrief interview techniques that focus on participant mistakes. The presentation will then introduce and explain the steps of the positive root cause debrief technique before discussing the value of applying this novel technique and how it builds upon existing root cause debrief interview techniques to improve the participant experience and data quality.
Event Type
Oral Presentations
TimeMonday, March 252:00pm - 2:30pm CDT
LocationContinental Ballroom, Lobby Level
Medical and Drug Delivery Devices