Written by David Rodgers

Quality and Operations Perspective

Written by David Rodgers, Lean Six Sigma Black Belt and ASQ-certified quality leader. This guide applies quality and process-improvement methods to AI in operations from a quality and operations perspective. The author is not a machine learning engineer, data scientist, or lawyer.

Last editorial review: September 24, 2026. Educational content only: not medical, legal, or regulatory advice. Follow your organization's policies and the requirements that apply to you, and have subject-matter experts review any change to a live process.

  • Lean Six Sigma Black Belt
  • ASQ CQE
  • ASQ CMQ/OE
  • Quality systems and process improvement

Governing AI use means knowing what is in use, who is responsible, how risky each use is, and what controls keep it safe. It does not mean slowing everything down. A small, clear structure and a register protect the organization and let low-risk uses move quickly.

This guide covers the main references (NIST AI RMF, ISO/IEC 42001, ISO/IEC 23894, the EU AI Act, and the OECD principles), a practical governance structure, risk tiers, FMEA applied to AI failure modes, and how to write an acceptable-use policy. A worked example scores eight AI risks at an illustrative plant before and after controls.

Laws and standards change. The EU AI Act dates here are as understood in late 2026; check the current text and ask qualified people what applies to you.

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Before You Start

Educational content. This guide applies quality and operations methods to the use of AI in organizations. It does not cover how to build or program AI systems, and it is not legal, regulatory, security, or professional advice. AI products, standards, and laws change quickly, so check current requirements and have qualified people review any use that affects safety, quality, people, or regulated data. The worked example is illustrative.

Why Govern AI Use

Governing AI use does not mean slowing it down. It means knowing what is in use, who is responsible, how risky each use is, and what controls keep it safe. Without that, people use AI anyway, in ways nobody has reviewed, with data nobody has classified.

Know What Is in Use

Staff use AI tools whether or not the company has approved them. A register brings that into view.

Match Controls to Risk

A tool that drafts internal notes needs less control than one that screens job applicants.

Protect Data and People

Confidential data, personal data, and decisions that affect people need extra care.

Meet Expectations

Customers, auditors, insurers, and in some places the law expect evidence of control.

The Reference Frameworks

You do not need to invent a governance approach. Several widely used references are available, and they fit together.

ReferenceWhat it isHow to use it
NIST AI Risk Management Framework (AI RMF 1.0, January 2023)A voluntary US framework with four functions: Govern, Map, Measure, and Manage. A companion Generative AI Profile (NIST AI 600-1, July 2024) covers risks specific to generative AIA practical way to structure risk work, for any organization
ISO/IEC 42001:2023A certifiable management system standard for AI, using the same plan-do-check-act structure as ISO 9001 and ISO 14001A structure for policy, roles, risk, controls, and audit; useful if you already run ISO systems
ISO/IEC 23894:2023Guidance on managing risk related to AIDetail on risk assessment for AI
EU AI Act (Regulation (EU) 2024/1689)A law that sorts AI systems by risk: prohibited practices, high-risk systems, systems with transparency duties, and minimal-risk systemsIf you operate in or sell into the EU; see the note on dates below
OECD AI PrinciplesHigh-level principles for trustworthy AI, adopted by many governmentsA statement of values for your AI policy
GOVERNPolicy, roles, culture MAPContext, use, and harms MEASURETest, track, and evaluate MANAGEPrioritize and treat risk The four functions run together and repeat; Govern applies to all of them
The four functions of the NIST AI RMF. They are not a one-time sequence: they repeat, and Govern applies to all of them.
On the EU AI Act dates. The Act entered into force on 1 August 2024. Its prohibitions have applied since 2 February 2025 and its obligations for general-purpose AI models since 2 August 2025. A 2026 amendment (the “digital omnibus”) moved the date for most high-risk obligations, such as AI used in employment and credit, to 2 December 2027, and for AI in regulated products to 2 August 2028. The Act also asks organizations to support AI literacy among staff. Dates and details change, so check the current text and have qualified people confirm what applies to you.

In the US there is no single federal law for AI in operations at the time of writing, but existing rules on employment, credit, health, privacy, and consumer protection apply to AI-supported decisions, and some states regulate automated decision tools. Check the requirements that apply to you.

A Practical Governance Structure

ElementWhat it isA good test
AI policyA short statement of what AI may and may not be used for, and the principles that applyCan an employee tell in a minute whether a use is allowed?
Acceptable-use rules and data classesWhich kinds of data may go into which kinds of toolDoes everyone know what they must never paste into a public tool?
RolesAn executive sponsor, a governance group, an owner for every use, and a reviewer for every outputIs there a named owner for each AI use in the register?
AI registerA list of AI uses and tools, with purpose, owner, data, risk tier, and review dateIs there a use nobody can name?
Risk tiersA simple sorting by impact, such as low, medium, high, with controls for eachDo high-impact uses get more review?
Testing and monitoringChecks before use and while in use, with measures and limitsWould we notice if it got worse?
Vendor and data controlsChecks on suppliers and how data is stored and usedDo we know what the vendor does with our data?
TrainingAI literacy for everyone, deeper training for owners and reviewersDo users know the limits of the tool?
Incident response and change controlWhat to do when AI misbehaves, and how changes to models and prompts are approvedIs there a way to switch it off, and a record of changes?

A governance group can be small and can build on an existing safety or quality committee. See Safety Team and Committee for charter and meeting practice, and the RACI Matrix Builder for roles.

Sorting Uses by Risk

Ask how much harm a wrong output could do, and how easily it would be caught. The tiers below are an example; align them to your own risk matrix and to any law that applies.

TierTypical usesControls
LowDrafting internal notes, summarizing public information, brainstormingAcceptable-use rules, user training, no confidential data in public tools
MediumCustomer-facing drafts, internal classification and routing, reports used in decisionsNamed owner, human review, testing on real examples, monitoring, vendor check
HighDecisions about people (hiring, pay, discipline), safety-related decisions, regulated or legally significant outputs, autonomous actions with real consequencesFormal risk assessment, legal and compliance review, strong human oversight, validation before use, logging, audit, and approval by the governance group
Not allowedUses the policy or law prohibitsDo not proceed

Risk Assessment With FMEA

Failure mode and effects analysis (FMEA) suits AI well, because it asks the same questions: what can go wrong, how bad would it be, how likely is it, and would we catch it? For each AI use, list the failure modes, rate severity (S), occurrence (O), and detection (D) from 1 to 10, and multiply to get the risk priority number (RPN). Then add controls and re-rate.

Common AI failure modesExamples
Wrong output stated confidentlyAn invented part number, a wrong summary of a standard
MisclassificationA safety complaint filed as routine
Data leakageConfidential data entered into a public tool
Manipulated inputInstructions hidden in a document or email that change the AI’s behavior
Drift or silent changeA vendor updates a model and the behavior changes
Over-relianceReviewers approve without checking
Bias and unfairnessDifferent error rates for different groups of people or items
Runaway action or costAn agent loops, or takes actions beyond its role

RPN has known limits, and the AIAG and VDA FMEA Handbook (2019) prefers Action Priority. Either way, treat severity first: a high-severity failure needs action whatever its RPN. See the FMEA guide.

Worked Example: An AI Risk Assessment at Riverside Plant

Riverside Plant, an illustrative 140-employee metal fabrication and assembly plant, assessed the risks of its complaint classification and work-order agent pilots. The team scored eight failure modes before and after planned controls. All scores are illustrative.

#Failure modeBefore (S × O × D = RPN)Main controlAfter
1Safety complaint classified as routine9 × 4 × 6 = 216 (High)Keyword safety rule, plus human review of low-confidence items9 × 2 × 3 = 54 (Low)
2Drafted reply cites a part number that does not exist6 × 5 × 5 = 150 (Medium)Look-up check of every part number against the catalog before sending6 × 3 × 2 = 36 (Low)
3Confidential customer data pasted into a public AI tool8 × 5 × 7 = 280 (High)Approved tools only, data classification rules, and training8 × 2 × 3 = 48 (Low)
4Agent closes a work order that is not finished7 × 3 × 7 = 147 (Medium)Closure needs a technician confirmation step and a photo7 × 2 × 3 = 42 (Low)
5Instructions hidden in a customer email change agent behavior8 × 3 × 8 = 192 (Medium)Treat email text as data, restrict agent tools, and filter outputs8 × 2 × 4 = 64 (Low)
6Vendor model update changes behavior without notice6 × 4 × 8 = 192 (Medium)Pin the version; re-run the test set before changing6 × 3 × 3 = 54 (Low)
7Reviewers approve outputs without checking7 × 6 × 7 = 294 (High)Seed known errors into the queue; rotate reviewers; track the catch rate7 × 4 × 4 = 112 (Medium)
8Agent loops and runs up usage cost4 × 3 × 4 = 48 (Low)Step and spend limits per task, with an alert4 × 2 × 2 = 16 (Low)
0 100 200 300 1 Safety complaint classified as routine 216 54 2 Drafted reply cites a part number that d 150 36 3 Confidential customer data pasted into a 280 48 4 Agent closes a work order that is not fi 147 42 5 Instructions hidden in a customer email 192 64 6 Vendor model update changes behavior wit 192 54 7 Reviewers approve outputs without checki 294 112 8 Agent loops and runs up usage cost 48 16 Before (colored by band)After the controls
RPN before and after the controls. Bars are colored by band: High is 200 or more, Medium 100 to 199, Low below 100.

Results. Before the controls 3 risks were High and 4 Medium. After the controls 1 is Medium and 7 are Low. The one that stays Medium is the human one: reviewers who approve without checking (RPN 112). The team did not try to fix it with a reminder. It seeded a few known errors into the review queue, rotated reviewers, and made the catch rate a standing measure.

Two controls came from the process, not from AI. Pinning the vendor version and re-running a test set before any change is change control, as in management of change. Requiring a technician’s confirmation to close a work order is an error-proofing step. Most AI controls are familiar operations controls.

Record your own risks in the AI Risk Register, which has the scoring scales, a failure mode library, and a dashboard.

Writing an Acceptable-Use Policy

  • Say what is allowed and what is not, in plain language, with examples.
  • Classify data (for example public, internal, confidential, restricted) and say which classes may go into which kinds of tool: public tools, approved enterprise tools, or private deployments.
  • Require review of AI output before it is sent outside the organization or used in a decision.
  • Require disclosure where people would reasonably expect to know that AI was used.
  • Name who to ask and how to report a problem, without blame.
  • Review it every six to twelve months, because tools and laws change.

The AI Acceptable-Use Policy and Tool Register includes example policy text, a data classification matrix, a register of approved tools, and an acknowledgement log.

Common Mistakes

Policy Without Practice

A document nobody reads, and no register of what is in use.

Banning Instead of Governing

A ban drives use underground, where nobody can see it.

Treating All Uses the Same

Heavy process for harmless uses, and light process for risky ones.

No Owner for Each Use

Everyone can use it and nobody is responsible.

One-Time Review

Approving a tool once and never checking again.

Ignoring the Vendor

Not asking what happens to your data or how changes are announced.

Self-Assessment Questions

  • Do we have a register of AI uses, with an owner, purpose, data, and risk tier for each?
  • Do people know what data they must not put into which tools?
  • Are higher-risk uses reviewed by more than the person who wants them?
  • Can we switch a use off, and do we keep a record of changes?
  • Do we know which laws and standards apply to our uses, and when we last checked?

AI Governance and Risk for Operations: Frequently Asked Questions

What is the NIST AI Risk Management Framework?

A voluntary framework from the US National Institute of Standards and Technology, released in January 2023 as AI RMF 1.0. It organizes AI risk work into four functions, Govern, Map, Measure, and Manage, which repeat over the life of an AI use. A Generative AI Profile (NIST AI 600-1, July 2024) adds guidance for generative AI.

What is ISO/IEC 42001?

A management system standard for AI, published in 2023, that can be audited and certified. It follows the same plan-do-check-act structure as ISO 9001 and ISO 14001, covering policy, roles, risk assessment, controls, and improvement for AI uses. It is most useful if you already run ISO management systems.

Does the EU AI Act apply to us?

It can if you place AI systems on the EU market, deploy them in the EU, or use their outputs in the EU, even if you are based elsewhere. Obligations depend on the risk category of the use. Dates for some obligations were moved in 2026, so check the current text and have qualified people assess your situation.

How do we assess the risk of an AI use?

List what can go wrong, rate how severe it would be, how likely it is, and how easily it would be detected, then choose controls and re-rate. FMEA does this well. Give priority to severity, and match the depth of review to the risk tier of the use.

Do we need an AI policy if we only use off-the-shelf tools?

Yes. The main risks with off-the-shelf tools are what data goes in, what comes out and is trusted, and who is responsible. A short acceptable-use policy with data classes, review rules, and a register of approved tools deals with all three.

Sources and Further Reading

  • National Institute of Standards and Technology, Artificial Intelligence Risk Management Framework (AI RMF 1.0), NIST AI 100-1 (26 January 2023), and AI RMF: Generative Artificial Intelligence Profile, NIST AI 600-1 (26 July 2024).
  • ISO/IEC 42001:2023, Artificial intelligence: management system; ISO/IEC 23894:2023, Artificial intelligence: guidance on risk management; ISO/IEC 22989:2022, concepts and terminology (check current editions).
  • Regulation (EU) 2024/1689 (the Artificial Intelligence Act), and the 2026 amending regulation (“digital omnibus”); check the Official Journal for the current text.
  • OECD, Recommendation of the Council on Artificial Intelligence (2019, updated 2024).
  • Automotive Industry Action Group and VDA, FMEA Handbook (2019), on severity, occurrence, detection, and Action Priority.
  • ISO 31000:2018, Risk management: guidelines.