[{"data":1,"prerenderedAt":163},["ShallowReactive",2],{"\u002Fblog\u002Fai-agent-governance-scenarios-part-1-the-new-game-changer-agent":3},{"id":4,"title":5,"author":6,"body":7,"category":145,"date":146,"description":147,"draft":148,"excerpt":149,"extension":150,"heroImage":149,"heroImageAlt":149,"meta":151,"navigation":152,"path":153,"seo":154,"slug":149,"stem":155,"tags":156,"__hash__":162},"blog\u002Fblog\u002Fai-agent-governance-scenarios-part-1-the-new-game-changer-agent.md","AI Agent Governance Scenarios, Part 1: The New \"Game Changer\" Agent","QikSolve",{"type":8,"value":9,"toc":130},"minimark",[10,14,19,22,41,48,52,55,59,62,66,69,73,76,80,83,87,90,94,97,101,104,108,111,115],[11,12,13],"p",{},"This is the first in a five-part series of practical AI-governance scenarios for quality\nprofessionals working through what \"good\" looks like when an AI agent proposal lands on their desk.",[15,16,18],"h2",{"id":17},"the-scenario","The scenario",[11,20,21],{},"The production team has developed a new AI agent that automatically reviews batch manufacturing\nrecords to identify potential GMP deviations. They want to deploy it within the next month and\nbelieve it will significantly improve productivity and reduce the review backlog. They tell QA:",[23,24,25,29,32,35,38],"ul",{},[26,27,28],"li",{},"the agent was built using Microsoft Copilot Studio;",[26,30,31],{},"it reviews PDF exports of batch records;",[26,33,34],{},"it was tested on ten historical records and \"worked well\";",[26,36,37],{},"the prompts include reference SOPs to help guide the AI;",[26,39,40],{},"QA will still make the final decision, so they believe validation can be minimal.",[11,42,43,44],{},"They ask QA to approve rollout. ",[45,46,47],"strong",{},"Before approving, what would you ask about inputs, governance,\nvalidation, human oversight, documentation, and risk management?",[15,49,51],{"id":50},"issue-1-uncontrolled-sop-versions-provided-to-the-agent","Issue 1 — Uncontrolled SOP versions provided to the agent",[11,53,54],{},"If the prompt references a draft, superseded, or otherwise uncontrolled training document, the\nagent cannot determine document validity, and an incorrect SOP leads to incorrect reasoning.\nControlled document management has to remain inside the quality management system regardless of\nwhat generates the prompt.",[15,56,58],{"id":57},"issue-2-batch-records-provided-as-pdf-exports","Issue 2 — Batch records provided as PDF exports",[11,60,61],{},"An exported PDF is not the system of record, and metadata can be lost in export. Ask whether the\nexports are complete, whether the export process is itself validated, and whether records can be\naltered after export — traceability requires knowing exactly what data was analysed.",[15,63,65],{"id":64},"issue-3-insufficient-testing","Issue 3 — Insufficient testing",[11,67,68],{},"\"We tried it on ten records\" is not an evaluation method. Ask what the evaluation method was,\nwhether known deviations were deliberately included in the test set, and what the miss rate was.\nAI-assisted processes must be risk-assessed and justified, not validated by anecdote.",[15,70,72],{"id":71},"issue-4-the-agent-summarises-compliance-issues","Issue 4 — The agent summarises compliance issues",[11,74,75],{},"Summarising compliance issues edges into interpreting GMP compliance and inferring regulatory\nconclusions. AI is well suited to pattern recognition, comparison, and anomaly detection; it is not\nappropriate for making compliance determinations. Scope has to be defined precisely enough to keep\nthe agent on the right side of that line.",[15,77,79],{"id":78},"issue-5-production-built-the-agent","Issue 5 — Production built the agent",[11,81,82],{},"A tool developed by the operations team and brought to QA for approval after the fact inverts the\ncorrect order. Every agent needs an owner, defined responsibilities, and controlled deployment\nestablished before operational use — QA governance has to exist before use, not be retrofitted onto\nit.",[15,84,86],{"id":85},"issue-6-sop-updates-could-break-the-agent","Issue 6 — SOP updates could break the agent",[11,88,89],{},"If prompt logic references SOP text directly, an SOP revision without a corresponding agent update\ncreates silent drift. Prompt logic tied to controlled documents must be subject to the same change\ncontrol as the documents themselves.",[15,91,93],{"id":92},"issue-7-ambiguous-human-review","Issue 7 — Ambiguous human review",[11,95,96],{},"\"QA will still make the final decision\" is a common but vague reassurance. Verification needs to be\nexplicit, documented, and meaningful — humans reviewing the underlying reasoning, not just the\nsummary presented to them.",[15,98,100],{"id":99},"issue-8-no-clear-definition-of-agent-scope","Issue 8 — No clear definition of agent scope",[11,102,103],{},"Is the agent checking calculations? Detecting missing data? Interpreting GMP compliance? Without an\nexplicit answer, the agent has no defined tasks, boundaries, or known limitations — and no governance\ncontrol can be properly assessed against an undefined scope.",[15,105,107],{"id":106},"the-takeaway","The takeaway",[11,109,110],{},"None of these eight issues require deep AI expertise to identify — they require the same instinct a\nquality professional already applies to any new process: define scope, control inputs, verify\noutputs, and document the decision trail before granting operational trust.",[15,112,114],{"id":113},"related-reading","Related reading",[23,116,117,124],{},[26,118,119],{},[120,121,123],"a",{"href":122},"\u002Fblog\u002Fai-agent-governance-scenarios-part-2-the-helpful-trend-analysis-agent","Part 2: The \"Helpful Trend Analysis\" Agent",[26,125,126],{},[120,127,129],{"href":128},"\u002Fblog\u002Foperating-ai-agents-in-gxp-qa-practitioners-guide","Operating AI Agents in GxP: A QA Practitioner's Guide",{"title":131,"searchDepth":132,"depth":132,"links":133},"",2,[134,135,136,137,138,139,140,141,142,143,144],{"id":17,"depth":132,"text":18},{"id":50,"depth":132,"text":51},{"id":57,"depth":132,"text":58},{"id":64,"depth":132,"text":65},{"id":71,"depth":132,"text":72},{"id":78,"depth":132,"text":79},{"id":85,"depth":132,"text":86},{"id":92,"depth":132,"text":93},{"id":99,"depth":132,"text":100},{"id":106,"depth":132,"text":107},{"id":113,"depth":132,"text":114},"AI Governance","2026-09-10","The production team wants to deploy an AI agent that reviews batch manufacturing records within a month. What questions should QA ask before approving it for GxP use?",false,null,"md",{},true,"\u002Fblog\u002Fai-agent-governance-scenarios-part-1-the-new-game-changer-agent",{"title":5,"description":147},"blog\u002Fai-agent-governance-scenarios-part-1-the-new-game-changer-agent",[157,158,159,160,161],"ai-agents","gxp","workshop-scenario","batch-record-review","governance","ttxHPldqmMRcY-xKKKYrxoCUgIvrYPVPHbjdas441LY",1789037363431]