CAPA Quality Management | CAPA Quality Management

ROOT CAUSE INTELLIGENCE

CAPA-2026-0020 — Foreign particle contamination in assembly

Quality event requiring investigation, corrective action and preventive controls for: Foreign particle contamination in assembly.

Recommended Root Causes

Ranked evidence-based suggestions. Human approval is required.

Suggested

#1

Seal contamination

Pareto · 1 evidence item(s)

Pareto: Pareto Analysis - Packaging Defects

32.0%

confidence score

#2

Assembly handling

Pareto · 1 evidence item(s)

Pareto: Pareto Analysis - Motor Vibration Defects

31.8%

confidence score

#3

Manual counting was performed without an independent verification step.

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0022

31.7%

confidence score

#4

Printer head contamination reduced print contrast.

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0016

31.7%

confidence score

#5

Printed controlled copies were not reconciled after document revision.

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0014

31.7%

confidence score

#6

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

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0030

31.5%

confidence score

#7

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

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0021

31.5%

confidence score

#8

Torque wrench verification was not performed at the beginning of every shift and the work instruction did not specify a verification frequency.

Historical CAPA · 1 evidence item(s)

CAPA CAPA-2026-0007

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.