CAPA Quality Management | CAPA Quality Management

ROOT CAUSE INTELLIGENCE

CAPA-2026-0001 — Repeated packaging seal failure

Seal failures were observed during final inspection, causing product rejection.

Recommended Root Causes

Ranked evidence-based suggestions. Human approval is required.

Suggested

The label master file was not linked to the active production revision and the final inspection checklist did not require label revision verification.

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0002

33.8%

confidence score

Seal contamination

Pareto · 1 evidence item(s)

Pareto: Pareto Analysis - Packaging Defects

33.3%

confidence score

Seal overlap

Pareto · 1 evidence item(s)

Pareto: Pareto Analysis - Packaging Defects

33.1%

confidence score

Seal installation torque was inconsistent.

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0015

33.0%

confidence score

Lighting level at inspection station was inconsistent.

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0032

32.8%

confidence score

Seal contamination and inconsistent sealing temperature were identified as the primary contributors.

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0006

32.2%

confidence score

Seal material compatibility was not evaluated for the revised chemical exposure condition.

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0028

32.2%

confidence score

How the score is calculated

45%
Problem/cause similarity

20%
Historical CAPA evidence

25%
Fishbone evidence

10%
Pareto evidence

This is a deterministic decision-support score, not a statistical or certified AI diagnosis. The accepted cause is written to the CAPA only after a user explicitly accepts it.