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AI output boundaries

Know when an AI output becomes part of controlled quality work

The AI governance response should follow what the output does in the process. A clear boundary helps teams decide what must be reviewed, evidenced, retained, and controlled.

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The tool does not set the boundary

Process impact sets the boundary. An output used for private drafting has a different governance need from one that influences a quality decision or enters a controlled record.

  • Ask where the output goes

    Map the next process step, decision, record, approval, release, or evidence set that may depend on it.

  • Keep the original context

    Preserve enough source, output, reviewer, and version context to understand what happened.

  • Increase control with impact

    As process impact increases, strengthen review, evidence, retention, escalation, and change-control expectations.

Four planning classes

  • Informational support

    Internal drafting, ideation, or non-controlled assistance with no direct decision authority.

  • Process guidance

    Suggested steps or non-final summaries used to prepare work, with traceability and a named reviewer.

  • Decision-influencing output

    Risk proposals, deviation support, or compliance-gap recommendations requiring accountable human decision ownership.

  • Record-integrated output

    Output incorporated into a controlled record, approval, release, or evidence set, requiring an attributable evidence chain.

When the boundary is uncertain

Treat uncertainty as a governance question to resolve, not as permission to use the lower-control path. Confirm intended use, process impact, reviewer authority, evidence needs, and applicable GMP or computerised-system context before proceeding.

  • Define the accountable decision

    Identify who can accept, reject, rework, or escalate the output.

  • Link changes to review

    Consider whether changes to prompts, models, retrieval, rules, or tools alter the output boundary.

Next steps

Continue the decision

Need to define an AI output boundary?

Bring the process and decision context to a practical governance conversation.

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