ROOT CAUSE ANALYSIS
5 Whys Analysis for Missing Lot Numbers
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CASE ANALYSIS
Scenario
Pharmaceutical manufacturing line discovers finished units with missing lot numbers, triggering a deviation investigation using the 5 Whys technique to find systemic root cause.
Key decisions
- Trace problem through printer error, calibration, procedure, training, to maintenance schedule.
When to reuse this
Use for systematic root cause analysis of quality deviations where a single causal chain is suspected.
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flowchart-5-whys-analysis-for-missing-lot-numbers-on-pharmaceutical-la