AI Risk

Method

AI risk assessment: method and template

The method works in seven steps from the top down. Your company applies it to its own systems; I provide the template and support the start. The approach follows the thinking in ISO 14971 (risk management for medical devices: harm, hazard, control), applied to AI.

As of: 6 October 2026

  1. HarmWho is hurt, and how badly? Money, data, health, reputation, law.
  2. HazardIn which situation can this harm happen?
  3. Failure modeHow must the AI behave for that to occur? Wrong figure, invented detail, data leak, a command hidden in a document.
  4. LikelihoodThe upper failure bound comes from tests, not from a guess.
  5. ControlWhat catches the failure? A rule, a person, a lock, a stop switch.
  6. TestA test as code, acceptance criterion fixed before the run.
  7. EvidenceResult, version, data hash, date, responsible person.

Example: AI prepares quote drafts for a trades business

Made-up example, no customer data. The thresholds are assumptions for illustration; in a project I set them with you before the first test runs.

HarmFailure modeControlTest as codeAcceptance criterion
Customer receives a wrong priceModel copies or computes a wrong line itemPrices only from the price list, total computed in code, a person approves200 cases with a known total; mutation test: a changed price list must change the total0 deviations in 200 cases (upper bound 1.5%)
One customer's data lands in the draft for anotherLeak through context or an instruction smuggled into a documentAccess separated per customer, document content never treated as an instructionInjection test: 4 languages, 3 patterns, 10 runs each; foreign-data scan0 hits in 120 runs (12 patterns × 10 repeats; computed upper bound 2.5%, only for these patterns)
Draft contains a legal commitmentModel words a binding promiseText blocks for legal wording, pattern filter, a person100 drafts, two reviewers with a checklistNo commitment; reviewer agreement κ ≥ 0.8
The human just waves it throughAutomation biasSpot checks with planted errorsDecoy drafts: 1 in 20 contains an error on purposeAt least 90% of decoys found
Quality drops after a model or data changeDrift, silent model changeVersion pinned, regression set on every changeAll tests above on every update; drift index (PSI)All green, PSI below 0.25

Why testing alone is not enough

Runs without a failure only show an upper bound on the failure rate. For rare, severe harm you therefore need controls outside the model.

Independent runs without a failureShown (95% confidence)
30Failure rate below 9.5%
60Failure rate below 4.9%
100Failure rate below 3.0%
200Failure rate below 1.5%
300Failure rate below 0.99%
1000Failure rate below 0.30%
3000Failure rate below 0.10%

To show “below 0.1%” you need 3000 independent runs without a failure, and the bound only holds for the cases tested. With zero failures the exact one-sided 95% bound 1 − 0.05^(1/n) applies; with failures the rig uses the Wilson interval. Where a single failure weighs heavily, safeguards are put around the model: permissions, locks, approvals.

Answers

How does an AI risk assessment work?

An AI risk assessment runs in three steps: first the use and possible harm are clarified, then failure modes and controls are derived from it, and last the acceptance criteria are fixed before the first test runs. The result is a risk table that every test hangs on. Your team carries out the assessment for its systems; I provide the method and template and support the start.

The six steps of working together

How many test runs do you need to show a failure rate?

Sixty independent test runs without a failure give a failure rate below 5 percent at 95 percent confidence, and three thousand give below 0.1 percent. The runs must be independent; repeats of the same input are only approximately so. The bound only holds for the cases tested, not for unknown ones. The table on this page shows more values, computed as 1 minus 0.05 to the power 1 over n.

When is testing alone not enough?

Testing alone is not enough when a single failure weighs heavily and is rare, because rare failures can only be bounded with very many runs. Then the safety is put around the model: permissions, locks, approvals and a stop switch. Where a risk cannot be shown sufficiently, I recommend controls outside the model, or not doing it.

Tool permissions for agents

Contact

Send me the use case in two sentences. I will get back to you and say whether and how your project can be tested. Whether I can take the job depends on my workload.

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