QUALITY MANAGEMENT

CAPA Quality Management

ROOT CAUSE INTELLIGENCE

CAPA-2026-0014 — Wrong revision of work instruction at workstation

Quality event requiring investigation, corrective action and preventive controls for: Wrong revision of work instruction at workstation.

Recommended Root Causes
Ranked evidence-based suggestions. Human approval is required.
Suggested
#1
The work instruction did not clearly identify the start-of-shift verification as a mandatory recorded activity.
Historical CAPA · 1 evidence item(s)
CAPA CAPA-2026-0010
33.0%
confidence score
#2
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
32.9%
confidence score
#3
Manual parameter selection allowed obsolete test files to be loaded.
Historical CAPA · 1 evidence item(s)
CAPA CAPA-2026-0024
31.6%
confidence score
#4
Preventive maintenance interval was based on calendar time rather than usage hours.
Historical CAPA · 1 evidence item(s)
CAPA CAPA-2026-0030
31.6%
confidence score
#5
Setup sheet did not identify the critical dimensions requiring independent verification.
Historical CAPA · 1 evidence item(s)
CAPA CAPA-2026-0021
31.6%
confidence score
#6
Supplier document control did not synchronize the approved specification revision with the certificate template.
Historical CAPA · 1 evidence item(s)
CAPA CAPA-2026-0009
31.5%
confidence score
#7
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
31.4%
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.