Application of Failure Mode Effect Analysis (FMEA) in the Traditional Medicine Industry: A Case Study on Spirulina Capsule Production

Abstract

Spirulina powder is used as a raw material by many traditional medicine industries in Indonesia. Spirulina powder produced in capsule preparations generally has indications for maintaining the immune system. Risk control through quality risk management has been required by the BPOM of the Republic of Indonesia as a consumer security guarantee. The method used to control risk is FMEA combined with fishbone analysis. This research produces several potential risks in the process stages until Spirulina powder is finished. Processes that potentially pose a risk and need to be controlled include receiving raw materials, storing raw materials, mixing, filling, and finishing good storage. The recommended controls to reduce risk are environmental control, machine, equipment, in-process control, and verification of the raw materials' correctness.