Fitting the statistical line into a wider scheme
The introduction says statistical work may sit inside whatever robustness assessment a team already runs and strengthen it. No particular scheme is prescribed.
The requirement in plain English
The introduction says statistical work may sit inside whatever robustness assessment a team already runs and strengthen it. No particular scheme is prescribed.
What the public record says
The public text says sampling widens what a team can see of the input space, and that the result may be folded into an existing robustness assessment to strengthen it.
Why it matters to you
The document deliberately does not own the whole assessment. It sits inside a scheme you already have: a risk assessment, a validation process, a quality model, a regulatory conformity route. That is good news and a trap. The good news is that you do not have to rebuild your process. The trap is that the statistical result can be orphaned if no scheme step consumes it. The practical question is: which decision changes because of this result, and who makes it?
Evidence a reviewer asks for
- A map from the statistical result to the decision it informs, with the decision owner.
- The scheme step that receives the result, and its record.
- A note on what would have been decided differently if the result had been adverse.
Checks to run this month
- Which decision consumes the robustness result?
- Is the decision recorded, with the result attached?
- Would an adverse result change anything?
Dates
FDIS registered 2026-08-21.
Cross-references
- Formal methods and statistical methods are complements
- Map the work to the AI management system and the risk process
- Assemble the evidence pack a reviewer will test
What this page does not state
The public text does not name a scheme or a decision point.