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root cause analysis · pharmaceutical quality · deviation investigation

5 Whys Analysis for Missing Lot Numbers

Tipo Diagrama de flujoNorma Sugiyama layered DAG + orthogonal routingMotor schematex-flowchartActualizado 8/8/2026
5 Whys Analysis for Missing Lot Numbers
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El escenario

Pharmaceutical manufacturing line discovers finished units with missing lot numbers, triggering a deviation investigation using the 5 Whys technique to find systemic root cause.

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01

Trace problem through printer error, calibration, procedure, training, to maintenance schedule.

Use for systematic root cause analysis of quality deviations where a single causal chain is suspected.

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