Part 01 · The Question→Part 02 · The Record→Part 03 · The File
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Inspection Case File · CF08 · 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 qualification of this supplier, on what evidence, and how was the conclusion that the supplier met quality and regulatory requirements justified at the moment of decision?"
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 approval being authorized
    Stated as a decision, not a description. Not "supplier approved." Specifically: the conclusion that Vendor C is qualified as a Sertraline HCl API supplier, on the basis of on-site audit findings, formal evaluation of audit response adequacy, CoA verification across three lots, and risk evaluation of supplier history.
  2. 02
    The qualification evidence reviewed at authorization
    Every input that supported the approval. Audit report, observation register, response documents with evaluation against acceptance criteria, CoA data, deviation history check, regulatory inspection history check.
  3. 03
    Alternative qualification dispositions evaluated and rejectedMost Often Missing
    The candidate approvals considered before unconditional approval was concluded. Not "we considered alternatives." The actual alternatives — conditional approval pending response verification, time-limited approval, restricted scope approval, rejection — and the documented basis on which each was rejected. This is the section a 483 cites when it is missing.
  4. 04
    The risk evaluation applied
    What was at stake if the approval was wrong. Patient impact from substandard API, supply chain disruption risk if the supplier later requires removal.
  5. 05
    The named decision owner and timestamp
    The individual whose authority basis is documented. Not the Supply Chain Quality Director signature alone. The person who reviewed the audit findings, evaluated the response adequacy, considered alternative approvals, applied the risk standard, and authorized.
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-SQ-001 — Sertraline Hydrochloride API — Supplier Qualification SQ-2024-0231

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-SQ-001 · Excerpt
Supplier Qualification Decision — SQ-2024-0231
Decision Authorized
The conclusion that Vendor C qualifies as an unconditional approved supplier of Sertraline HCl API, on the basis of on-site audit findings (seven minor, one major), formal evaluation of audit response adequacy against acceptance standards, CoA data across three qualification lots, and risk evaluation of supplier history and capability.
Authorizing Individual
Dr. Anita Krishnan, VP Supply Chain Quality
Authority Basis
SQ-AUTH-001 §3.2 — designated authority for supplier qualification approval on Critical Quality Attribute APIs
Evidence Reviewed
SQ-2024-0231 · Audit report AR-2024-VC · Observation register · Response evaluation matrix · CoA verification lots LV-001/002/003 · Deviation history Vendor C 2020-2024 · Regulatory inspection history check
Alternatives Eliminated
Conditional approval pending response verification on major observation · Time-limited approval (12 months) · Restricted scope approval (single product) · Rejection requiring re-audit — each evaluated against documented evidence
Authorization Timestamp
January 31, 2024 — 09:45 EST
Regulatory Framework
21 CFR 211.84 · 21 CFR 211.86 · ICH Q7 · ICH Q10 · EU GMP Chapter 5 · ICH Q11
— 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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