Research For Responsibility Evaluation Of Quality Assurance People In API Pharmaceutical Industry By Using Risk Management Tools

Risk management is born in America in the 1930s. After 80 years development with effort of risk management people, risk management theory develops from the initial stage of risk management to the modern stage risk management, and then to the systematic stage of risk management In 2002, the risk management theory is applied on the US FDA guideline for pharmaceutical industry, it starts a new application of risk management which is known as quality risk management.The current application of quality risk management is in production and quality management aspect. However, the quality assurance person plays the most important role in quality system. This article established the standard template of responsibility evaluation and quantization by using Failure Mode and Effect Analysis(FMEA)method. Versatility and feasibility of the standard template is validated by implementation in the different department in the same API manufacturer and in the quality department in the different API manufacturer. After the implementation, the quality system had obviously improved as follow:...