inv-00044

completed • Lead S. Johnson

About this view

Investigation detail provides structured root-cause analysis with hypothesis tracking, evidence collection, and CAPA linkage. Fishbone categories are organized fields so teams can record causal factors consistently across methods, materials, equipment, and people. Effectiveness check commitments ensure corrective plans are verified after implementation. Next actions include completing evidence items and confirming linked CAPAs remain on track.

Root Cause Hypotheses

Root cause identified as Material non-conformance. Further analysis confirms this was the primary contributing factor.

Level 1: Material • Level 2: Material non-conformance

Fishbone Structured Fields

Man: Insufficient training; Operator fatigue

Machine: Calibration drift; Mechanical wear

Material: Supplier variability

Method: SOP ambiguity

Measurement: Instrument noise

Environment: Temperature fluctuation

Evidence Checklist
  • Batch records reviewed - complete
  • Equipment logs reviewed - complete
  • Operator interviews conducted - complete
  • Laboratory data analyzed - complete
  • Similar events searched - complete
Corrective and Preventive Linkage

Linked CAPAs: capa-00130

Effectiveness check date: 2024-12-01 (Outcome: Not effective - escalated to CAPA review)

Deviation: DEV-030043