Application of the Modal Analysis of Faults and Effects to the Palmex Encapsulation Process

Abstract

In this work the risk analysis was applied, using the methodology of modal analysis of Faults and effects to the soft capsule production process from the active principle lipid extract of the palm fruit, nutritional supplement, which is used in the therapy against Benign Prostatic Hyperplasia, high incidence in the male population over 50 years. Basic tools such as: brainstorming, teamwork, flowchart and Ishikawa scheme were used. The impact of the potential causes of failures on the process was evaluated, based on the Risk Priority Number, calculated from the severity, probability of occurrence and detection rates. The factors with the greatest impact were: physical environmental parameters outside the specification limit (temperature and relative humidity), insufficient or incorrect air flow in the drying process, inadequate mixing of the formulation ingredients, change of purified water quality, mismatch or breakage of the main equipment and insufficient staff training. Preventive actions were proposed to minimize the risk