OOS (Out of Specification)

Out of Specification (OOS) refers to results from testing that do not meet pre-set criteria or quality standards. This term is commonly used in fields like pharmaceuticals and manufacturing, where products must adhere to strict guidelines to ensure safety and effectiveness. When a test result is OOS, it triggers an investigation to identify the cause, which could be a testing error, equipment malfunction, or issues with the product itself. Addressing OOS results is crucial for maintaining product quality and ensuring compliance with regulations and safety standards.