Hybrid 5-Why Analysis Sheet

Hybrid 5-Why5-WHY ANALYSIS SHEETInstructions:1) FILL IN ALL AREAS HIGHLIGHTED IN YELLOW - THE CHARTS WILL UPDATEPERIOD/METRICFailure ModeDepartment/AreaEquipmentDATE1-Jan2-JanTOP CONTRIBUTORS PARETO3-JanCategoryFrequency/Value4-Jan65-Jan56-Jan47-Jan38-Jan29-Jan110-Jan11-Jan12-JanFOR PARETO RANKING, ENTER LOWEST13-JanFREQUENCY PROBLEMS AT TOP, THEN14-JanWORK DOWN IN ORDER15-Jan16-Jan17-Jan18-Jan16-Jul20-Jan21-Jan22-Jan23-Jan24-Jan25-JanNote: Continue on separate page if 5-Whys are not enough to determine root cause.*TBD = To Be Determined

Hybrid 5-Why

Formated 5-WHY

TOP CONTRIBUTORS PARETO

Formated 5-WHY (2)5-WHY DIAGRAM FOR ROOT CAUSE ANALYSISFailure Mode: Empty BlisterDepartment/Area: PackagingEquipment: Hoonga Blister machineProduct Name: Ceftron 1gm IV InjectionBatch No.:1030018Md. Shahidul IslamMohammad Golam NabiAbul Bashar Md. KibriaExecutive, Quality AssuranceExecutive, EngineeringSr. Executive, Production

WHY #1:WHY #5WHY #2:WHY #4WHY #3TEMPORARY Date _______COUNTERMEASURESFINAL COUNTERMEASURE Name ______________- PERMANENT CORRECTIVE ACTION Date _________VERIFICATION: No Recurrence in Three Months? __TBD*_____ Date _______ Single-Point Lesson? _________ Date ________ DO THE 5 WHY'S MAKE SENSE WHEN READ BACKWARD?WHY #1:Vial & ampoule was not present.WHY #2:Checking of blister during auto cartoning on conveyor belt of Auto cartoning machine was not proper.WHY #3:Checking of Blister during blister collection was not proper.WHY #4:Feed checker in blistering machine was not available.WHY #5:Improper feeding of vial & ampoule in blistering machine by auto feeder.ROOT CAUSE:Unavailability of Feed checker & unconciousness of personnel who were invloved in blister checking.

5-WHY DIAGRAM FOR ROOT CAUSE ANALYSISFailure Mode: Empty BlisterDepartment/Area: PackagingEquipment: Hoonga Blister machineProduct Name: Ceftron 1gm IV InjectionBatch No.:1030018WHY#1:WHY#2:WHY#3:WHY#4:WHY#5:ROOT CAUSE:Md. Shahidul IslamMohammad Golam NabiAbul Bashar Md. KibriaExecutive, Quality AssuranceExecutive, EngineeringSr. Executive, Production