Risk Management of Production Process Using Quality Risk Management and Failure Mode Effect and Critically Analysis Methods

The production process of 600ml AQUA at PT Tirta Investama (AQUA) Pandaan is prone to risks, 247 units bottle density out of standards, 18 bottles per day the packaging label is not correct, 122 bottle codes are not read by the sensor, 7 times per day there is a box failure, the pallet's barcode 3 times per day requires rework. This study aims to determine the risks with the highest critical points and risk mitigation. The method used is QRM to identify risks and FMECA to analyze the critical point of risk. The results obtained 42 risks detected with 20 acceptable risks, 21 tolerable risks, and 1 unacceptable risk, pallets stuck on the conveyor. The risk caused by the quality of the pallets out of standard so that the mitigation actions taken are the logistics department and machine operators for in-depth inspections related to the quality of the pallets.