CAPA Quality Management | CAPA Quality Management

ROOT CAUSE INTELLIGENCE

CAPA-2026-0006 — Packaging seal strength below specification

Seal strength failures were observed during final inspection on the packaging line.

Recommended Root Causes

Ranked evidence-based suggestions. Human approval is required.

Suggested

Seal strength test interval too long

Measurement · 1 evidence item(s)

Fishbone: Measurement

34.1%

confidence score

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

32.9%

confidence score

Seal contamination

Pareto · 1 evidence item(s)

Pareto: Pareto Analysis - Packaging Defects

32.1%

confidence score

High humidity near packing line

Environment · 1 evidence item(s)

Fishbone: Environment

32.0%

confidence score

Airflow from nearby door affected cooling

Environment · 1 evidence item(s)

Fishbone: Environment

32.0%

confidence score

Seal installation torque was inconsistent.

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0015

32.0%

confidence score

Seal overlap

Pareto · 1 evidence item(s)

Pareto: Pareto Analysis - Packaging Defects

31.9%

confidence score

Operator did not identify early seal degradation

Man · 1 evidence item(s)

Fishbone: Man

31.9%

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.