Pharmaceutical Batch Deviation (Fishbone)
Six-M root cause analysis of a tablet batch failing dissolution, spanning operator sign-off, granule hold time and suite humidity.
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title "Why did batch 24-0817 fail the dissolution specification?"
problem "Dissolution out of specification"
category "Manpower"
cause "New operator on the granulator, signed off on 3 batches"
cause "Shift handover missed the in-process hold time"
category "Machine"
cause "Fluid bed inlet filter differential pressure rising"
cause "Tablet press force feeder speed drifted mid-run"
category "Method"
cause "Granulation end point judged on torque alone"
cause "No maximum hold time defined for the blended granule"
category "Material"
cause "New disintegrant lot with a coarser particle size"
cause "Active ingredient at the upper particle size limit"
category "Measurement"
cause "Dissolution bath 4 rotation speed verified 11 months ago"
category "Environment"
cause "Granulation suite at 58 percent humidity against a 45 percent limit"