Quality & Risk
Use-Related Risk Analysis(URRA)
In one line
Analysis of use scenarios to identify potential use errors and their consequences.
Definition
A URRA links tasks, potential use errors, and resulting harms - feeding human factors validation testing and ISO 14971 risk control decisions.
For each task it records the possible harm and its severity, the risk controls and how they are validated. Tasks where a use error could cause serious harm are critical tasks and must be evaluated in human factors validation testing. FDA's 2022 draft guidance on human factors content in premarket submissions describes the URRA as a key submission element.
Why it matters
FDA's human factors guidance expects a documented URRA covering critical tasks, with each tested in summative validation.
Common pitfalls
- •Failing to link identified use errors directly to potential harms can lead to an incomplete risk assessment.
- •Not performing a URRA early enough in the design process can result in costly redesigns and delays.
- •Assuming that expert users will not make significant use errors can lead to overlooking critical safety issues.
- •Confusing a Use-Related Risk Analysis with a general risk analysis, which broadens the scope beyond user interaction, can lead to inefficiencies.
- •Neglecting to update the URRA after design changes or post-market surveillance findings can compromise device safety.
Sources
- FDA Human Factors Guidance · FDA
- FDA - Quality Systems · FDA
- ISO 13485 Standard Page · ISO