Part 01 · The Question→Part 02 · The Record→Part 03 · The File
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Inspection Case File · CF02 · Part 02 of 03

The five fields the FDA investigator expects to find — and the one most files don't have.

A deviation closure with a signature is not the same as a deviation closure with a documented decision. The investigator can tell the difference in thirty seconds.

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What separates a decision from a signature

A signature on a CAPA closure form proves that a person signed. It does not prove what they decided.

Under inspection, a signature is evidence of an event. It is not evidence of a decision. The investigator does not doubt the signature. She doubts that anything was decided.

An authorization record is structured to be evidence of a decision. It names the person, the moment, the evidence reviewed, the alternatives evaluated, and the basis on which the conclusion was reached. The investigator does not have to ask the QA Director what she was thinking. The record answers.

Investigator
"I am looking for the documented record of how this conclusion was reached. Not who signed. Who decided — and on what basis."
This is the question that requires Field 03 of the authorization record to exist.
The Authorization Record · Required Structure

Five fields. Missing any one is the gap a 483 cites.

Every authorization record for a deviation root cause conclusion must contain the following five fields. The third field is the one that is almost always missing.

  1. 01
    The decision being authorized
    Stated as a decision, not a description. Not "operator technique variation." Specifically: aseptic technique variation by Line 3 operator L3-047 during gowning is the single assignable cause; systemic and equipment-based causes were evaluated and eliminated.
  2. 02
    The evidence reviewed at authorization
    Every input that shaped the conclusion, identified by document number and date. Environmental monitoring records. Equipment maintenance logs. Operator training records. Historical trend data. Direct evidence supporting the assignable cause. Each item identified, each item dated.
  3. 03
    The alternatives evaluated and rejectedMost Often Missing
    The candidate causes considered before the assignable cause was concluded. Not "we considered other causes." The actual alternatives, the evidence evaluated for each, and the documented basis on which each was eliminated. This is the section a 483 cites when it is missing.
  4. 04
    The risk evaluation applied
    What was at stake if the conclusion was wrong. For a sterile product release, this includes residual patient safety risk. The standard the team applied, and the basis on which residual risk was deemed acceptable, in writing.
  5. 05
    The named decision owner and timestamp
    The individual whose authority basis is documented. Not the signer of the CAPA closure form. The person who reviewed the evidence in field 02, evaluated the alternatives in field 03, applied the risk standard in field 04, and authorized the conclusion in field 01 — at the moment that conclusion was reached.
Why Field 03 matters most

A deviation file almost never contains a documented alternative-causes evaluation. The investigator opens to it first.

Most deviation investigations conclude with a single root cause. They rarely document the alternatives that were evaluated and eliminated to arrive there. The investigator knows this. It is the field she opens to first.

If field 03 is empty, every other field is suspect. The evidence in field 02 may have been reviewed, but no alternative interpretations are on record. The conclusion in field 01 may be correct, but the reasoning is unreconstructable. The signature in field 05 attests to the conclusion, not to the analysis that produced it.

An authorization record without a documented alternative-causes evaluation is not an authorization record. It is a signature on a conclusion.

Why this matters now

The five-field structure is the same whether the inspection is this quarter or next year. The difference is whether you build the record now — when you have time, evidence, and the original decision-maker available — or under inspection pressure when none of those are guaranteed.

Reference Example

DDR-DEV-001 — Vancomycin Lot 2023-2206

The same scenario from Part 01, with the authorization record that should have existed in the file. Excerpt from the complete reference DDR.

Decision Defense Record · DDR-DEV-001 · Excerpt
Deviation Root Cause Authorization — DR-2023-0441
Decision Authorized
Aseptic technique variation by operator L3-047 during gowning is the single assignable cause. Systemic and equipment-based causes evaluated and eliminated.
Authorizing Individual
Dr. Sarah Chen, Director of Quality Assurance — Sterile Manufacturing
Authority Basis
QP-QA-002 §4.3 — designated authority for deviation root cause authorization on sterile fill-finish operations
Evidence Reviewed
DR-2023-0441 · EM Records EM-L3-Q4-2023 · PM-L3-FillStation-2023Q3 · CAL-2023-0398 · TR-L3-GOWN-2023 · SEC-L3-20231009-14h · QREV-L3-TREND-2023Q3
Alternatives Eliminated
Systemic training failure · Equipment malfunction · Environmental contamination · SOP deficiency · Material non-conformance — each evaluated against documented evidence; basis for elimination recorded in full record
Authorization Timestamp
October 14, 2023 — 14:32 EST
Regulatory Framework
21 CFR 211.192 · ICH Q9
— Continued in the complete file —
Inspection Exposure Snapshot

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Continued · Part 03 of 03

You now know what the five fields are. The investigator already knows whether yours are in the file.

Knowing the structure does not put the record in the file.

The complete file is the finished record for the Vancomycin deviation — every field populated, every alternative eliminated on the record, plus the blank structure to build your own before the investigator asks for it.

Open the complete file →
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