FDA Inspection Decision Scenario
Who Authorized the Specification Change?
What FDA investigators are actually asking
FDA Investigator Question
"Who made the determination that this specification change was scientifically justified and regulatorily acceptable?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who evaluated the scientific basis for this specification change before it was authorized?
- What ICH Q6A criteria were applied to the specification determination?
- What historical data was reviewed before the new specification was accepted?
- What would have required a regulatory submission before implementation?
- When was the specification change 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 a specification change. The change is documented and implemented. The investigator asks who made the formal authorization decision — not who signed the change control.
Authorization Gap
The specification change record documents approvals and implementation. It does not document who evaluated the scientific and regulatory basis and made the formal authorization that the new specification 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 specification change authorization
- Scientific basis reviewed before the change was authorized
- Regulatory standard applied to the specification determination
- Authorization timestamp for the specification change
- Rationale for why the new specification maintained product quality and compliance
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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