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Production Contracts, Risk Tiers, and Ownership

Translate an ML use case into explicit service, model, workflow, safety, and accountability requirements.

By the end you can

A prediction has no operational meaning by itself

“Predict equipment failure” sounds like a requirement, but it leaves the system undefined. How early must the warning arrive? Which failure types count? Who receives it, and what maintenance capacity exists?

A production contract turns a modeling aspiration into a testable operating agreement. It records the population, timing, output semantics, allowed actions, service limits, review rules, and recovery obligations.

Every clause on that list has a documented failure behind it. This lesson is built on those rather than on hypotheticals. A US safety board reconstructing a collision second by second. A European regulation that writes oversight, and its price, into statute. A court in The Hague voiding a deployed scoring system. An English judgment on software whose output was treated as fact. A medical-informatics review that counted how often clinicians click past the alert. A US regulator that now authorises the change process instead of only the frozen model.

Example

The fallback was switched off and the suppression was silent

One automated workflow has been investigated to the second, and it shows exactly which clauses a contract has to contain. On 18 March 2018, in Tempe, Arizona, a Volvo XC90 running Uber ATG's developmental automated driving system collided with a pedestrian. The National Transportation Safety Board reconstructed the sequence and adopted its highway accident report on 19 November 2019. The Congressional Research Service summarised the same findings for Congress in 2020. Read as a contract, almost nothing that failed was the model.

  • The scoring moment was early enough: the automated driving system detected the pedestrian 5.6 seconds before impact. It never classified her as a pedestrian, because its design did not include consideration for jaywalking pedestrians. That is a population boundary nobody had stated, discovered after the fact.
  • The tested bypass had been disabled: Uber had switched off the Volvo XC90's factory forward collision warning and automatic emergency braking for the duration of ADS testing. The fallback existed in the vehicle. It did not exist in the deployed workflow.
  • The control was silent: a 1-second “action suppression” period held back braking. The Board recorded the consequence in one sentence: “No alert was given to the operator when action suppression was initiated.”
  • The probable cause was assigned to the person: the Board's probable cause was the operator's failure to monitor. That is the human element of a control that had not been given what it needed to work.
  • The ownership gap was written into the findings: contributing factors were Uber ATG's inadequate safety risk assessment procedures, its ineffective oversight of vehicle operators, and its lack of adequate mechanisms for addressing automation complacency. Three missing contract clauses, named by a federal safety board.

Risk depends on consequence and reversibility

A suggestion that a user can ignore is not governed like an automated denial. The same model score can be low risk in a drafting interface and high risk when it triggers an irreversible action.

Risk tiering therefore belongs to the workflow, not only the model family. A legislature has drawn that line in exactly those terms. Regulation (EU) 2024/1689 tiers by the role the system plays in a decision: “By derogation from paragraph 2, an AI system referred to in Annex III shall not be considered to be high-risk where it does not pose a significant risk of harm to the health, safety or fundamental rights of natural persons, including by not materially influencing the outcome of decision making.” (Article 6(3).)

Article 6(3) then enumerates four qualifying situations. Performing a narrow procedural task. Improving the result of a previously completed human activity. Detecting deviations from prior decision-making patterns without replacing the human assessment. Performing a preparatory task. Each of the four is a statement about the decision, not about the architecture. The article also closes the door it opens: an Annex III system that performs profiling of natural persons is always high-risk. And Article 6(4) requires a provider claiming the derogation to document its assessment before the system is placed on the market. That written, pre-market assessment is the artefact a risk tier should always produce. A recorded call about the system's role in a decision, made before release, available to be checked afterwards.

Case

Two people, separately, before a biometric match is acted on

The EU AI Act scales its oversight requirement with the stakes. Annex III point 1(a) covers remote biometric identification. For those systems, Article 14(5) requires that no action or decision be taken by the deployer on the basis of an identification “unless that identification has been separately verified and confirmed by at least two natural persons with the necessary competence, training and authority”. Law enforcement, migration, border control and asylum uses are exempted where Union or national law considers the requirement disproportionate. One technology, two oversight regimes, separated by consequence.

Visual

Five clauses in a production contract

A complete contract names what the system must do and how failure is contained. Scope fixes the population, the use case, the exclusions and the decision moment. Semantics fixes the meaning of outputs, thresholds, confidence and abstention. Operations fixes latency, throughput, availability, freshness and capacity limits. Control fixes review, escalation, overrides, appeals, fallback and rollback. Accountability fixes owners, approvers, on-call roles, evidence retention and retirement authority.

The last two clauses are the ones teams treat as paperwork. A court has already treated them as a precondition for operating at all. On 5 February 2020 the District Court of The Hague decided the challenge to the Dutch SyRI welfare-fraud legislation, brought by NJCM and others against the State of the Netherlands. The court held that the legislation failed the necessity test in Article 8(2) ECHR and did not strike the required fair balance. It said why in a sentence about inspectability: “The court holds that the legislation pertaining to the application of SyRI is insufficiently transparent and verifiable.” It declared Section 65 of the SUWI Act and Chapter 5a of the SUWI Decree to have no binding effect.

A scoring system was stopped not because its accuracy was disproved but because nobody outside it could examine how it scored. Transparency and verifiability are Control and Accountability clauses. Here they were legal preconditions, not good practice.

FigureHierarchy · 5 levels
  • Scope

    Population, use case, exclusions, and the decision moment.

    • Semantics

      Meaning of outputs, thresholds, confidence, and abstention.

      • Operations

        Latency, throughput, availability, freshness, and capacity limits.

        • Control

          Review, escalation, overrides, appeals, fallback, and rollback.

          • Accountability

            Owners, approvers, on-call roles, evidence retention, and retirement authority.

Key idea

“Human in the loop” is not a requirement

A review step is meaningful only when the reviewer has time, information, authority, and an alternative action. A person who approves hundreds of opaque outputs under deadline pressure may add latency without adding control. That is not a suspicion. It has been counted.

A 2006 review in the Journal of the American Medical Informatics Association pooled 17 studies of drug safety alerts in computerized physician order entry. The result of van der Sijs and colleagues fits in one line: “Drug safety alerts are overridden by clinicians in 49% to 96% of cases.” The US Agency for Healthcare Research and Quality's primer on alert fatigue reports the same pattern extending even to alerts flagged as critical. At the top of that range, the review step is almost entirely decorative. Every one of those systems could truthfully report that a qualified human was in the loop.

The production contract should therefore specify what the reviewer sees, which cases must go up a level, what gets recorded when reviewer and model disagree, and how review quality is measured. An override rate is a measurable clause. A named role is not.

Oversight is a designed capability, not the mere presence of a person: 49% to 96% of drug safety alerts were overridden.

Case

The law names automation bias and requires a stop button

European law does not leave over-reliance on a machine to good practice. Article 14(4)(b) of Regulation (EU) 2024/1689 addresses the natural persons assigned human oversight. It requires that they be enabled “to remain aware of the possible tendency of automatically relying or over-relying on the output produced by a high-risk AI system (automation bias), in particular for high-risk AI systems used to provide information or recommendations for decisions to be taken by natural persons”. The name of the failure mode is in the operative text of the article itself. And the clause points at precisely the advisory systems that look lowest-risk on an architecture diagram.

Article 14(4)(e) adds the other half of the requirement. The overseer must be able “to intervene in the operation of the high-risk AI system or interrupt the system through a ‘stop’ button or a similar procedure that allows the system to come to a halt in a safe state”. Awareness of the bias and a working means of stopping the system are separate obligations. A contract that provides one without the other has satisfied neither.

Comparison

Requirement classes answer different questions

Three classes of requirement take three kinds of evidence. The functional contract asks what transformation or decision the system performs: inputs and outputs, valid and invalid requests, output semantics — rank maintenance jobs by expected urgency. The reliability contract asks how consistently the service performs under expected load: latency, availability, dependency and capacity failures, recovery objectives — complete the nightly batch before 05:00. The safety and governance contract asks which outcomes are unacceptable and who controls them: prohibited actions, required review or abstention, appeal and audit paths — never auto-close a high-risk medical alert. Mixing these categories produces vague acceptance criteria.

The third column is the one whose absence has the longest documented tail. On 16 December 2019 the High Court decided the Horizon issues in Bates & Ors v Post Office Ltd. Mr Justice Fraser found: “In summary terms only, Legacy Horizon was not remotely robust.” Even the Post Office's own expert accepted strong evidence of at least 12 bugs causing lasting discrepancies in branch accounts.

The scale of the missing governance clause was established later. Sir Wyn Williams' statutory Post Office Horizon IT Inquiry published Volume 1 of its final report on 8 July 2025. It found it likely that approximately 1,000 persons were prosecuted and convicted across the United Kingdom on Horizon evidence. At least 59 people contemplated suicide and ten attempted it. Employees of Fujitsu and the Post Office knew the system was capable of error while the Post Office maintained the fiction that its data was always accurate. The functional and reliability contracts can be satisfied while that is happening. There was no appeal path and no audit of the system's errors, so a court and then a statutory inquiry had to become the appeal path the contract never contained.

FigureComparison · 3 columns

Functional contract

What transformation or decision should the system perform?

  • Defines inputs and outputs
  • Names valid and invalid requests
  • Specifies output semantics
  • Example: rank maintenance jobs by expected urgency

Reliability contract

How consistently must the service perform under expected load?

  • Defines latency and availability
  • Covers dependency and capacity failures
  • Includes recovery objectives
  • Example: complete the nightly batch before 05:00

Safety and governance contract

Which outcomes are unacceptable and who controls them?

  • Defines prohibited actions
  • Requires review or abstention
  • Creates appeal and audit paths
  • Example: never auto-close a high-risk medical alert

Steps

Write the contract as acceptance tests

Convert each clause into evidence that can pass or fail. Define the scoring moment: state when the decision is made and what information is available then. Name the output semantics: rank, class, estimate, interval, or proposal. Quantify the operating limits: freshness, latency, throughput, capacity, recovery targets. Define the unacceptable outcomes: prohibited actions, protected slices, escalation conditions. Then assign decision rights over release, traffic pausing, threshold changes and retirement.

That last step is usually written as a name on a wiki page. Article 26(2) of Regulation (EU) 2024/1689 writes it as a duty, and specifies what the named person must actually possess: “Deployers shall assign human oversight to natural persons who have the necessary competence, training and authority, as well as the necessary support.” Competence, training, authority, support. Four attributes, each of which can be evidenced or found missing at a release review. That is more than a name in a box can be.

Getting the tier wrong carries a price in the same instrument. Article 99(3)-(4) sets administrative fines of up to EUR 35,000,000 or 7% of total worldwide annual turnover for breaching the Article 5 prohibitions, and up to EUR 15,000,000 or 3% for breaching the operator obligations in Articles 16, 22, 23, 24 and 26. The classification in the mechanics section and the ownership assignment in this one are the same decision seen from two ends. Both are now enforceable.

FigureProcess · 5 steps
  1. 1. Define the scoring moment

    State when the decision is made and what information is available then.

  2. 2. Name output semantics

    Explain whether the output is a rank, class, estimate, interval, or proposal.

  3. 3. Quantify operating limits

    Set freshness, latency, throughput, capacity, and recovery targets.

  4. 4. Define unacceptable outcomes

    List prohibited actions, protected slices, and escalation conditions.

  5. 5. Assign decision rights

    Name who approves release, pauses traffic, changes thresholds, and retires the system.

A contract is useful only when it can stop a release

A requirement that never blocks promotion is documentation, not a gate. Each critical clause should produce a test, approval, or operational control with a named owner.

The contract will evolve, but changes must be versioned. Otherwise teams can improve the model while quietly changing what “success” means. A regulator has now built exactly that instrument. On 4 December 2024 the U.S. Food and Drug Administration published its final guidance on predetermined change control plans for artificial intelligence-enabled device software functions. The summary of the notice states the shape of the artefact: “This guidance recommends that a PCCP describe the planned AI-DSF modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications.”

Notice what is being authorised. Not the model as frozen. The planned modifications, the methodology that develops, validates and implements them, and an assessment of their impact — reviewed as part of the marketing submission, so that changes inside the plan need no new submission. The boundary of the plan is the gate. Everything inside it is pre-agreed, and everything outside it falls back to a fresh submission. A production contract that cannot say where that boundary lies has not versioned its definition of success. It has only recorded one.

Position

A human reviewer is a control that can create the risk it was added to remove

Hundreds of opaque outputs, a deadline, and one person with an approve button: that is a shape a human-in-the-loop control can take. The numbers on it are not encouraging. Across the 17 studies van der Sijs and colleagues reviewed in 2006, “Drug safety alerts are overridden by clinicians in 49% to 96% of cases.” European law names the mechanism rather than the symptom. Article 14(4)(b) of Regulation (EU) 2024/1689 requires that the people assigned to oversee a high-risk system be enabled “to remain aware of the possible tendency of automatically relying or over-relying on the output produced by a high-risk AI system (automation bias), in particular for high-risk AI systems used to provide information or recommendations for decisions to be taken by natural persons”. The reviewer is the mitigation and the route by which the mitigation fails.

A control that can fail that way has to be specified, not staffed. The contract should state what the reviewer sees, which cases must go up a level, what gets recorded when reviewer and model disagree, and how review quality is measured. Article 14(4)(e) adds the part that is easiest to leave unbuilt. It requires that the overseer be able “to intervene in the operation of the high-risk AI system or interrupt the system through a ‘stop’ button or a similar procedure that allows the system to come to a halt in a safe state”.

Tempe shows what the unbuilt version costs. The Volvo XC90's factory forward collision warning and automatic emergency braking were disabled during ADS testing. A 1-second action suppression period held back the vehicle's own braking. And the Board wrote: “No alert was given to the operator when action suppression was initiated.” The person was the designated control, and the system did not tell the control that anything was being suppressed. The Board's probable cause was nonetheless the operator's failure to monitor.

Notice, too, how narrowly the Act spends its strongest wording. Where it demands that at least two competent, trained and authorized people verify separately before anything is acted on, it names the systems it means: point 1(a) of Annex III, remote biometric identification. It exempts law enforcement, migration, border control and asylum uses where Union or national law considers the requirement disproportionate. That is oversight scaled to consequence, not a general rule for high-risk systems. It matches the tiering logic of Article 6(3): the same component can sit inside or outside the tier depending on whether it materially influences the outcome of a decision.

A named reviewer is not yet a control. The control begins where the contract says what they see, what they can stop, and how their disagreement is recorded.

Key takeaways