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Inspection Case File · CF06 · 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 CAPA was effective, on what evidence, and how was the determination that the corrective action prevented recurrence justified at the moment of closure?"
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 effectiveness conclusion being authorized
    Stated as a decision, not a description. Not "actions are effective." Specifically: the conclusion that the corrective actions implemented for CAPA-2023-0894 (revised line clearance, verification step, operator retraining) prevented recurrence of label mix-up events on the packaging line, on the basis of three months of post-implementation metric tracking and documented analysis distinguishing the action effect from confounding variables.
  2. 02
    The effectiveness metrics and observation evidence
    Every metric tracked: line clearance audit results, verification step compliance rate, operator competency assessments, near-miss reports, label reconciliation accuracy. Each metric defined, each metric measured.
  3. 03
    Confounding factors evaluated and ruled outMost Often Missing
    The alternative explanations for non-recurrence considered. Not "we considered other causes." The actual alternatives — reduced packaging volume during observation period, different operators on the line, seasonal variation — and the documented basis on which each was ruled out as the cause. This is the section a 483 cites when it is missing.
  4. 04
    The risk evaluation applied
    What was at stake if the effectiveness conclusion was wrong. Patient impact from a recurrence not prevented.
  5. 05
    The named decision owner and timestamp
    The individual whose authority basis is documented. Not the CAPA Coordinator. The person who reviewed the metric data, evaluated the confounding factors, applied the risk standard, and authorized the effectiveness conclusion.
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-CAPA-001 — Atorvastatin Tablets 40 mg — CAPA-2023-0894

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-CAPA-001 · Excerpt
CAPA Effectiveness Closure — CAPA-2023-0894
Decision Authorized
The conclusion that the corrective actions for CAPA-2023-0894 prevented recurrence of label mix-up events, on the basis of three months of metric data, documented analysis of confounding factors, and risk evaluation supporting acceptance of residual recurrence risk.
Authorizing Individual
Michael Reeves, Senior Director of Quality
Authority Basis
CAPA-AUTH-002 §6.3 — designated authority for CAPA effectiveness conclusion authorization on packaging operations
Evidence Reviewed
CAPA-2023-0894 · LCA-2024-Q1 audit results · Verification step compliance log · Operator competency records · Near-miss reports Nov 2023 – Feb 2024 · Label reconciliation accuracy data
Alternatives Eliminated
Non-recurrence due to reduced packaging volume · Non-recurrence due to operator turnover · Non-recurrence due to seasonal variation · Three months insufficient observation period · Verification step not yet under load — each evaluated against documented evidence
Authorization Timestamp
February 28, 2024 — 15:50 EST
Regulatory Framework
21 CFR 211.192 · ICH Q10 · 21 CFR 820.100
— 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.

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