QUALITY MANAGEMENT

CAPA Quality Management

ROOT CAUSE INTELLIGENCE

CAPA-2026-0030 — Unexpected downtime of critical inspection equipment

Quality event requiring investigation, corrective action and preventive controls for: Unexpected downtime of critical inspection equipment.

Recommended Root Causes
Ranked evidence-based suggestions. Human approval is required.
Suggested
#1
Setup sheet did not identify the critical dimensions requiring independent verification.
Historical CAPA · 1 evidence item(s)
CAPA CAPA-2026-0021
33.0%
confidence score
#2
Lighting level at inspection station was inconsistent.
Historical CAPA · 1 evidence item(s)
CAPA CAPA-2026-0032
31.7%
confidence score
#3
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.