CAPA Quality Management | CAPA Quality Management

ROOT CAUSE INTELLIGENCE

CAPA-2026-0011 — Missing inspection records for batch release

Quality event requiring investigation, corrective action and preventive controls for: Missing inspection records for batch release.

Recommended Root Causes

Ranked evidence-based suggestions. Human approval is required.

Suggested

Lighting level at inspection station was inconsistent.

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0032

31.7%

confidence score

Preventive maintenance interval was based on calendar time rather than usage hours.

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0030

31.4%

confidence score

Setup sheet did not identify the critical dimensions requiring independent verification.

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0021

31.4%

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

31.3%

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.