FDA Inspection Decision Scenario
Who Authorized the Environmental Monitoring Excursion Decision?
What FDA investigators are actually asking
FDA Investigator Question
"Who made the determination that this environmental excursion did not affect product quality, and what was the basis?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who evaluated the product quality impact of this excursion before the acceptance decision was made?
- What product lots were assessed for exposure during the excursion period?
- What microbiological risk assessment was reviewed before the determination was authorized?
- What findings would have required product quarantine or rejection?
- When was the excursion acceptance authorized, and who is named as the decision owner?
Can your team answer this question in under five minutes? The Authorization Assessment identifies where your decision trail breaks before an investigator does.
Find Your Gaps →The authorization gap this scenario reveals
The investigator is reviewing environmental monitoring records. An excursion is noted and closed. The investigator asks who made the formal impact determination.
Authorization Gap
The EM record documents the excursion, trending data, and corrective actions. It does not document who evaluated the product quality impact and made the formal authorization that the excursion was acceptable. This is the authorization gap: the decision was made, but it was never documented as an authorization event — with a named decision owner, the evidence reviewed, the regulatory standard applied, and a timestamped record of when the authorization occurred.
Why does this gap exist across so many compliance programs? The Decision Authorization Model explains the structural difference between what documentation systems produce and what inspectors evaluate.
Understand the Model →What evidence the investigator expects
- Named individual accountable for the excursion impact authorization
- Product lots exposed during the excursion period
- Regulatory standard applied to the impact determination
- Authorization timestamp for the excursion acceptance
- Rationale for why the excursion did not represent a product quality risk
Organizations operating with authorization infrastructure produce this record at the moment the decision is made.
See how authorization capability scales across organizations →These gaps are not documentation failures. They are authorization failures. The Authorization Assessment maps exactly where your decision trail is missing these elements.
Start the Assessment →Authorization Assessment
Which of your decisions
have an authorization gap?
The Authorization Assessment identifies where your compliance decisions are undocumented as authorization events — the exact gap inspectors expose in scenarios like this one.
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Inspection Case Files document the authorization gap in detail — showing exactly what a Decision Defense Record resolves and what inspectors expect to see.
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