Case File #06 — CAPA Effectiveness Decision

Inspection Trigger

Investigator reviewed CAPA CA-2022-0088 and the current-cycle CAPA CA-2023-0194, noting both addressed complaints related to particulate contamination in Metformin HCl Tablets 1000 mg.

Decision Failure

The firm could not produce documentation of the effectiveness criteria established for CA-2022-0088, the evidence reviewed to determine those criteria were met, or who authorized the effectiveness determination.

Regulatory Exposure

21 CFR 820.100(a)(4) requires effectiveness of corrective and preventive action to be verified. ICH Q10 Section 3.2 requires documentation of effectiveness checks. Absent a formal authorization record, the effectiveness determination cannot be verified during inspection.

Decision Defense Record

A CAPA effectiveness authorization documenting pre-established criteria, evidence reviewed, recurrence assessment, and named decision owner would have produced an inspection-defensible closure and flagged the risk before the root cause recurred.

The inspector pulled the CAPA record. The actions were closed. Then they asked: "Who authorized effectiveness closure, and what evidence confirmed the root cause was eliminated?"

That question ends careers. Not because the CAPA was wrong — but because the closure decision was never captured as a formal record.

This case file gives you that record.

Section 01

What the Investigator Asked

483 Observation — Repeat Finding

During inspection, the investigator reviewed CAPA CA-2022-0088, initiated following particulate contamination findings in Metformin HCl Tablets 1000 mg. The CAPA had been closed as effective. The investigator then reviewed current CAPA CA-2023-0194, initiated 14 months after CA-2022-0088 closure for the same root cause — dust collection system inadequacy in Tablet Compression Suite B. The investigator requested documentation of the effectiveness criteria established prior to closure of CA-2022-0088, the evidence reviewed to determine those criteria were met, and who authorized the effectiveness determination. No authorization record responsive to any of these questions was produced.

Inspector's Question

"What effectiveness criteria were established before closing CA-2022-0088, what evidence was reviewed to confirm those criteria were met, and who authorized the determination that this CAPA was effective — given that the same root cause has now recurred?"

A closed CAPA with no effectiveness authorization record cannot be defended when the root cause recurs. The investigator's question goes directly to whether an effectiveness determination was actually made — or whether the CAPA was closed administratively without a formal quality decision.

A recurrent root cause following CAPA closure is not just an operational failure. It is evidence that the effectiveness determination was inadequate — and without an authorization record, there is no documented basis from which to demonstrate otherwise.

Section 02

Evidence Present vs. Authorization Missing

What Existed	What Was Missing
✓ CAPA CA-2022-0088 opened following particulate contamination customer complaints	→ Pre-established effectiveness criteria documented before corrective action implementation
✓ Root cause identified: dust collection system inadequacy, Tablet Compression Suite B	→ Specific evidence reviewed to determine effectiveness criteria were met
✓ Corrective action implemented: dust collection system serviced and airflow parameters adjusted	→ Defined monitoring period and recurrence assessment for complaint rate reduction
✓ CAPA closed with QA signature — status: Effective	→ Named individual who authorized the effectiveness determination
✓ 14 months later: same root cause recurred, CA-2023-0194 opened	→ Timestamp of authorization (confirming decision preceded closure, not post-hoc)

An "Effective" status checkbox on a CAPA closure record confirms a status was assigned. It does not document an effectiveness determination. Authorization identifies who evaluated which evidence against which pre-established criteria and accepted responsibility for the closure determination — before the CAPA was closed.

Section 03The Operational Cost — Repeat 483 observation. Retrospective effectiveness review required for all CAPAs closed in prior 36 months. Written response to FDA required with systemic CAPA quality improvement commitment.

Section 04DDR Reconstruction — The complete Decision Defense Record for this CAPA effectiveness determination: pre-established criteria, evidence reviewed against each criterion, recurrence risk assessment, named decision owner, and timestamped authorization.

Section 05Authorization Model — The six required elements for CAPA effectiveness authorization, including the pre-established criteria standard and the monitoring period structure FDA expects to see documented before closure.

Section 06Preventive Control — Mandatory effectiveness criteria section at CAPA initiation, automated monitoring period triggers, and closure gates enforced in the CAPA management system before closure status is available.

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CAPA Effectiveness — Our CAPA is closed. But if they ask whether it worked, I can't prove it.

What the Investigator Asked

Evidence Present vs. Authorization Missing

Does your organization have authorization records that hold up under this level of scrutiny?