Application of Quality Tools to solve a quality deviation in the pharmaceutical industry: a case study

Abstract

Currently, due to the great competition among pharmaceutical companies, the demand for more quality, safety and effi cient products has been increasing, generating the need for processes that are more robust and a qualifi ed team. However, quality deviations can occur during the production process and the cause of this event must be identifi ed and solved in order to avoid repeating mistakes. The objective of this study is to demonstrate  through a case study the practical use of quality tools to identify and solve a quality deviation of broken pills in a pharmaceutical industry. For the organization, data evaluation and the identifi cation of the root cause of this deviation, the quality tools of Pareto Diagram, Control Chart, Check List  Sheet and Ishikawa Diagram were used. After data evaluation, it was possible to conclude that the breakage of the tablets is related to the low result of the hardness test, and then, it was suggested to the company to manufacture the next batches seeking hardness close to or greater than 200 N, according to the product's history. Therefore, the quality tools proved to be essential for an effective assessment of the quality deviation.