OutofSpecProbleme
OutofSpecProbleme is a term used in quality assurance and process control to describe events in which measured values fall outside predefined specification limits or performance criteria. The concept is common in regulated industries such as manufacturing, pharmaceuticals, and laboratory testing, as well as in electronics, software, and systems monitoring where requirements define acceptable ranges. In multilingual environments, the phrase may appear alongside English terminology such as out of specification (OOS). It denotes an exception that triggers formal review rather than a normal pass of a test or process.
Causes include instrument drift or calibration errors, sensor faults, sampling bias, environmental conditions, variability of raw
Detection relies on quality control methods such as specification checks during release testing, statistical process control
Response typically involves a formal out-of-specification (OOS) investigation, root cause analysis, corrective and preventive actions (CAPA),
Related concepts include out-of-tolerance and outlier, with each term carrying domain-specific nuances for engineering, statistics, and