FDA Inspection Decision Scenario
Who Authorized This Risk Assessment?
What FDA investigators are actually asking
FDA Investigator Question
"Who made the determination that the risk level assigned was appropriate, and what evidence was used?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who reviewed the risk methodology before the risk level was formally authorized?
- What severity and probability criteria were applied to the risk scoring?
- What mitigations were evaluated before residual risk was accepted?
- What risk score would have prevented authorization?
- When was the risk acceptance 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 risk assessment for a product or process change. Risk scores are documented. The assessment is closed. The investigator asks who authorized the risk determination.
Authorization Gap
The risk assessment documents scores and mitigations. It does not document who evaluated the risk methodology, reviewed the evidence, and made the formal authorization that the residual risk 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 risk authorization decision
- Evidence reviewed before the risk level was authorized
- Regulatory standard applied to the risk acceptability determination
- Authorization timestamp for the risk acceptance
- Rationale for why residual risk was determined to be acceptable
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.
Browse Inspection Case Files →