QUALITY MANAGEMENT
Fishbone Analysis - Foreign Particle Contamination
New CAPA
ROOT CAUSE ANALYSIS
Fishbone Analysis - Foreign Particle Contamination
Foreign particles detected in assembled product
CAPA-2026-0020 · Foreign particle contamination in assembly
Back
Interactive Ishikawa Diagram
Click any cause node to inspect evidence and root-cause status.
Cause
Root cause
CAUSES
Man
Cleaning checklist was not con…
Machine
Compressed-air line introduced…
✓
Method
Cleaning acceptance criteria w…
✓
Material
Protective packaging generated…
Measurement
Particle count was not routine…
Environment
Open-door airflow introduced d…
PROBLEM
Foreign particles detected …
n assembled product
Cause Register
Evidence-backed causes identified during analysis
6 causes
Category
Cause
Evidence
Classification
Man
Cleaning checklist was not consistently completed
Additional sample evidence for CAPA-2026-0020.
Potential cause
Machine
Compressed-air line introduced particles
Additional sample evidence for CAPA-2026-0020.
Root cause
Method
Cleaning acceptance criteria were visual only
Additional sample evidence for CAPA-2026-0020.
Root cause
Material
Protective packaging generated fibers
Additional sample evidence for CAPA-2026-0020.
Potential cause
Measurement
Particle count was not routinely measured
Additional sample evidence for CAPA-2026-0020.
Potential cause
Environment
Open-door airflow introduced dust
Additional sample evidence for CAPA-2026-0020.
Potential cause
Add Cause
Feed the graphical analysis directly
Category
Man
Machine
Method
Material
Measurement
Environment
Cause
Evidence / Observation
Confirmed root cause
Add Cause
CATEGORY
Cause
Evidence / Observation
This cause is classified as a confirmed root cause.