A series of scientific methods are established to confirm the out of specification (OOS) result which is inevitable in daily detection for bacterial endotoxin test. According to the risk factor analysis and work experience, the causes of OOS results are analyzed and details of quality standard and calculation, experimental operation, materials, instruments, etc. are studied. Based on the characteristics of bacterial endotoxin test, a decision flow chart is designed to determine the validation scheme for OOS. All types of causes and solutions for risk factors are determined, and the risk factor fishbone diagram to review OOS and a decision-making flowchart to verify OOS results are established. This work makes the endotoxin test results more scientific and rigorous by using the fish bone diagram of risk factors to review and analyze the causes of OOS and by following the decision-making flow chart to confirm the result.

bacterial endotoxin test  /  quality management  /  out of specification