Risk Analysis on Documentation Unit Workload in Pharmaceutical Company using Failure Mode and Effect Analysis (FMEA)

Abstract

Workload can affect employees in completing their work. Furthermore, mental workload can affect the documentation unit  performance since the  work is  monotonous,  does  not  require much physical movement and tends to be boring. There are 6 operators and 1 supervisor in the documentation unit. Due to its critical job, there are possibly risks that arise as a result of workload impact such as errors and delays in carrying out the documentation. Data from 2019 – 2022 shows there are an average of 8.61% delay documents per year and an average of 5.14% error check per year. In this study the researcher would like to figure out the mental workload condition and analyze the risks possibly occurred. Measurement of mental workload will be using NASA-TLX method. Then analyze the risk using the Failure Mode and Effect Analysis (FMEA) method. The result’s shows that the documentation operator have 75.60 score and categorized as moderate workload. The risk analysis is conducted using FMEA and the highest RPN number is 30 for error in checking document which will be the priority to mitigate. It is recommended to review and evaluate the risk after recommended action performed and analyze whether the risk can be eliminated or remains other risk.