This has been discussed extensively for years and is well understood by the industry. Out-of-trend A more recent concern is being out-of-trend (OOT). An OOT situation exists when one or more reportable results, collected over a period of time, are compared with a historical data set or...
OOS (Out of Specification) refers to a product that does not meet the established specifications as expected. OOS investigation determines the actual cause of the results.
xxx 有限公司 OOS/OOT/AD 调查记录 SRP-QC-050A 1.QA登记 : 记录号: OOS-登记人: 日期 : 2.实验室调查: 确认偏差结果的发现及向主管报告 检验员质量经理 日期样品名称: 批次: 物料/产品代码: 样品类型 (标示出一种) 原辅材料 半成品 成品 工艺用水 环境 其它 : 稳定性实验条件(如适用) 温度 :℃ ...