Part 01 · The Question→Part 02 · The Record→Part 03 · The File
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Inspection Case File · CF03 · 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
"Who authorized the conclusion that the OOS result was invalid, on what evidence, and how was the laboratory error determination justified at the moment of disposition?"
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 disposition being authorized
    Stated as a decision, not a description. Not "laboratory error." Specifically: the conclusion that the original OOS result was invalidated due to assignable laboratory cause (HPLC injection volume anomaly), and that manufacturing causes — including content uniformity, dissolution profile variation, and process drift — were formally evaluated and eliminated.
  2. 02
    The evidence reviewed at authorization
    Every input that supported the conclusion. The HPLC system suitability check. The injection volume verification data. The content uniformity data for the lot. The dissolution profile from the affected portion. Historical OOS trend. Each item identified, each item dated.
  3. 03
    The manufacturing causes evaluated and rejectedMost Often Missing
    The candidate manufacturing causes considered before laboratory error was concluded. Not "we considered manufacturing causes." The actual alternatives — content uniformity issue, dissolution profile drift, granulation problem, blend uniformity — 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 disposition was wrong. The patient impact if the original failing result reflected a real product issue.
  5. 05
    The named decision owner and timestamp
    The individual whose authority basis is documented. Not the signer of the OOS report. The person who reviewed the evidence, evaluated the manufacturing alternatives, applied the risk standard, and authorized the laboratory-error determination.
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-OOS-001 — Lisinopril Tablets 20 mg — Lot 2024-0418

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-OOS-001 · Excerpt
OOS Investigation Disposition — OOS-2024-0073
Decision Authorized
The conclusion that the OOS dissolution result for Lot 2024-0418 was caused by laboratory error (HPLC injection volume anomaly), and that manufacturing causes including content uniformity, dissolution drift, and granulation issues were formally evaluated and eliminated.
Authorizing Individual
Dr. Maria Santos, Director of Quality Control — Solid Dosage
Authority Basis
QC-AUTH-004 §2.7 — designated authority for OOS disposition with assignable laboratory cause invalidation on solid dosage products
Evidence Reviewed
OOS-2024-0073 · HPLC-SUIT-2024-0418 · CU-DATA-2024-0418 · DISS-PROF-2024-0418-PORT · OOS-TREND-LIS-2023-2024 · BLEND-UNI-2024-0418
Alternatives Eliminated
Content uniformity issue · Dissolution profile drift · Granulation problem · Blend uniformity · Coating thickness variation — each evaluated against documented evidence
Authorization Timestamp
May 11, 2024 — 16:42 EST
Regulatory Framework
21 CFR 211.192 · FDA OOS Guidance (Oct 2006) · ICH Q10 · USP <711>
— Continued in the complete file —
Inspection Exposure Snapshot

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Continued · Part 03 of 03

The structure is clear. The example is published. The record itself is in the complete file.

See the complete authorization record.

A completed reference DDR for the Vancomycin scenario. The blank template applied to your facility. The evidence checklist that closes the gap before inspection begins.

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