QC实验室OOS调查表A(C-E).doc

OOS/OOT编号：OOS / OOT No: QA 登记人/日期： QA registrar/ Date: 物料名称：Material name: 涉及批号： Batch No. involved: 测试方法/版本：Test Method / Version: 检测标准：Testing Standards: 测试结果： Test results: 报告人/日期：Reporter / Date: QC负责人/日期：QC Head / Date: 一.初级实验室调查 I. Primary laboratory investigation 初级1A实验室调查：检查以下项目：Primary 1A laboratory investigations: Check the following items: 序号 No. 范围 Scope 内容 Contents 是 Yes 否 No 不适用 NA 备注 Remarks 1 方法Method 方法描述是否清楚明了 Whether the method is clearly described 方法描述是否产生理解歧义 Whether the method description will be ambiguously understood 方法调用是否正确 Method is correctly called 方法是否为最新受控批准版本 The method is the latest controlled and approved version 2 人员及操作Personnel and operating 化验员对于该分析方法是否接受培训 The analysts have been trained in terms of the analysis method 化验员对于该分析方法是否充分理解 The analysis method is fully understood by the analysts 化验员是否按照该方法操作 The analysts operate in accordance with the method 原始数据填写是否正确 The original data is filled in properly 样品称量是否正确 The sample is weighed correctly 计算是否正确 Calculations are correct 色谱条件是否正确 Chromatographic conditions are correct 样品配制、移取、稀释过程是否正确 Sample preparation, pipetting, and dilution are correct 3 仪器及 配制器具Instruments and preparation equipment 检查所用仪器性能是否正常 Check whether the performance of the instrument used is normal 仪器最近半年内是否有过维修 the instruments are repaired over the last six months 所用玻璃器皿是否进行过校准 The glassware used is calibrated 所用玻璃器皿是否清洁 The glassware used is clean 4 物料Materials 检查用到的对照品、样品、试剂及试液是否正确Check to see if reference substances, samples, reagents and test solution used are correct 检查用到的对照品、试剂、试液是否在有效期内 Check to see if reference substances, reagents, and test solution are in the period of validity 检查样品转移过程是否正确 Check to see if the sample transfer process is correct 实验室样品接收、分样过程是否正确 Receiving and distribu