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root cause analysis · pharmaceutical quality · deviation investigation

5 Whys Analysis for Missing Lot Numbers

النوع مخطط انسيابيالمعيار Sugiyama layered DAG + orthogonal routingالمحرّك schematex-flowchartآخر تحديث 8‏/8‏/2026
5 Whys Analysis for Missing Lot Numbers
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السيناريو

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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