FDA Inspection Decision Scenario
Who Authorized the Root Cause Determination?
What FDA investigators are actually asking
FDA Investigator Question
"Who made the decision that this was the root cause, and what evidence was used to reach that conclusion?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who reviewed the investigation data before the root cause was formally accepted?
- What methodology was applied to identify and confirm the root cause?
- What alternative causes were evaluated and ruled out?
- What evidence would have required the investigation to continue?
- When was the root cause determination 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 a closed investigation. A root cause is documented. The investigator asks who authorized the root cause determination — not who documented it.
Authorization Gap
The investigation record shows a root cause was identified. It does not show who made the formal authorization that the identified cause was sufficient — or that the evidence justified closing further investigation. 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 root cause authorization
- Evidence reviewed before the root cause was accepted
- Regulatory standard applied to the causal determination
- Authorization timestamp for the root cause acceptance
- Rationale for why alternative causes were ruled out
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.
Start the Authorization Assessment →Free · No account required · Results in under 5 minutes
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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