CAPA Quality Management | CAPA Quality Management

ROOT CAUSE INTELLIGENCE

CAPA-2026-0003 — High moisture content in raw material

Incoming polymer granules exceeded the specified moisture limit, resulting in unstable processing conditions.

Recommended Root Causes

Ranked evidence-based suggestions. Human approval is required.

Suggested

#1

Material moisture

Pareto · 1 evidence item(s)

Pareto: Pareto Analysis - Molded Housing Cracks

33.0%

confidence score

#2

Material variation

Pareto · 1 evidence item(s)

Pareto: Pareto Analysis - Packaging Defects

31.4%

confidence score

#3

Mold cooling was uneven and cycle time was not controlled.

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0026

31.4%

confidence score

#4

Humidity control limits were not defined for the storage area.

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0023

31.4%

confidence score

#5

Printed controlled copies were not reconciled after document revision.

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0014

31.4%

confidence score

#6

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

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0028

31.3%

confidence score

#7

Tool wear was not being monitored using a defined replacement limit and process capability was not reviewed by shift.

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0005

31.2%

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.