QUALITY MANAGEMENT

CAPA Quality Management

ROOT CAUSE INTELLIGENCE

CAPA-2026-0009 — Supplier certificate does not match incoming batch

The certificate of analysis supplied with an incoming material batch contained a specification revision different from the approved purchase specification.

Recommended Root Causes
Ranked evidence-based suggestions. Human approval is required.
Suggested
#1
Supplier labeling was not independently checked against purchase order requirements.
Historical CAPA · 1 evidence item(s)
CAPA CAPA-2026-0018
32.6%
confidence score
#2
Material moisture
Pareto · 1 evidence item(s)
Pareto: Pareto Analysis - Molded Housing Cracks
31.4%
confidence score
#3
Material variation
Pareto · 1 evidence item(s)
Pareto: Pareto Analysis - Packaging Defects
31.4%
confidence score
#4
Printed controlled copies were not reconciled after document revision.
Historical CAPA · 1 evidence item(s)
CAPA CAPA-2026-0014
31.3%
confidence score
#5
Sampling plan was not updated after supplier risk classification changed.
Historical CAPA · 1 evidence item(s)
CAPA CAPA-2026-0031
31.3%
confidence score
#6
Seal material compatibility was not evaluated for the revised chemical exposure condition.
Historical CAPA · 1 evidence item(s)
CAPA CAPA-2026-0028
31.2%
confidence score
#7
Supplier drying parameters were not consistently maintained and moisture verification frequency was inadequate.
Historical CAPA · 1 evidence item(s)
CAPA CAPA-2026-0003
31.2%
confidence score
#8
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
31.1%
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.