FDA Inspection Decision Scenario
Who Authorized This Supplier Qualification?
What FDA investigators are actually asking
FDA Investigator Question
"Who made the qualification decision for this supplier, and what was the basis for that determination?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who reviewed the audit findings and quality data before the qualification decision was made?
- What qualification criteria were applied to the supplier evaluation?
- What regulatory standard governed the qualification threshold?
- What would have prevented this supplier from being qualified?
- When was the qualification formally 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 your approved supplier list. Audit records exist. The investigator asks who made the formal qualification decision.
Authorization Gap
The supplier file contains audit reports and quality agreements. It does not contain a record of who evaluated the totality of evidence and made the qualification authorization decision. 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 qualification authorization
- Evidence reviewed at the moment of the qualification decision
- Regulatory standard applied to the supplier evaluation
- Authorization timestamp for the qualification event
- Rationale for why the supplier met the qualification threshold
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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