| Full document title and reference | Evaluation and reporting of Results---Annex 1A Model Template for Failure Investigation of OOS Results PA/PH/OMCL(14)87 |
| 全名和索引 | 结果的评估和报告---附录1A OOS结果失败调查模板样例 PA/PH/OMCL(14)87 |
| Document type | Guideline |
| 文件类型 | 指南 |
| Legislative basis | / |
| 法规依据 | 无 |
| Date of first adopt | August 2014 |
| 首次采纳日期 | 2014年8月 |
| Date of original entry into force | October 2014 |
| 首次实施日期 | 2014年10月 |
| Date of entry into force of revised document | / |
| 修订版生效日期 | 无 |
| Previous titles/other references/last valid version | / |
| 之前题目/其它索引号/上一有效版本 | 无 |
| Custodian Organisation | The present document was elaborated by the OMCL Network/EDQM of the Council of Europe |
| 责任机构 | 现行文件由欧盟委员会EDQM/OMCL网络编制 |
| Concerned Network | GEON |
| 相关网络 | GEON |
| Sample information (name and laboratory code) 样品信息（名称和化验室编号） | |
| Analytical procedure /Test/Parameter (suspect OOS result) 检验方法/检验/参数（疑似OOS结果） |
| Y N /NA | Y N /NA | |||
| General 通用 | ||||
| □ □ | Weighing error 称量错误 | □ □ | Inadequate ambient conditions (temperature, moisture, etc.) 室温条件不充分（温度、湿度等） | |
| □ □ | Contamination from surfaces or glassware 表面或玻璃容器污染 | □ □ | Presence of interfering substances 有干扰物质 | |
| □ □ | Other possible reasons for OOS result 其它可能的OOS结果原因 | |||
| Samples, Reagents, solvents & Solutions 样品、试剂、溶剂&溶液 | ||||
| □ □ | Use of wrong reagents/chemical form 使用了错误的试剂/化学形式 | □ □ | Error during filtration 过滤错误 | |
| □ □ | Wrong quality or purity of reagents and solvents 试剂和溶剂质量或纯度不对 | □ □ | Inappropriate storage of samples 样品存贮不适当 | |
| □ □ | Inappropriate storage of reagents, solvents and solutions 试剂、溶剂和溶液存贮不适当 | □ □ | Carry-over 残留 | |
| □ □ | Solutions or reagents expired 溶液或试剂超过效期 | □ □ | Abnormal appearance of samples, reagents solvents or solutions 样品、试剂、溶剂或溶液外观不正常 | |
| □ □ | Reagents not dissolved completely 试剂溶解不完全 | □ □ | Water of sub-standard quality 水质量不达标 | |
| Reference Standards 对照品 | ||||
| □ □ | Wrong reference standard or inadequate quality used 使用的对照品不对或质量不够 | □ □ | Error in weighing, dissolution and dilution 称量、溶解、稀释错误 | |
| □ □ | Reference standard expired 对照品过效期 | □ □ | Inappropriate storage of reference standard 对照品存贮不适当 | |
| Dilutions & Pipetting 稀释和移液 | ||||
| □ □ | Glassware or pipetting device with wrong volume 玻璃容器或移液管用具体积错误 | □ □ | Uncalibrated/leaking piston pipettes 移液器泄漏、未校正 | |
| □ □ | Uncalibrated/sub-standard glassware 玻璃容器级别不达标或未校正 | □ □ | Dilution error 稀释错误 | |
| □ □ | Pipettes with broken tip 移液管尖头破损 | □ □ | Wrong dilution technique 稀释方法错误 | |
| Method Verification 方法确认 | ||||
| □ □ | Deviation from the specified (authorized) method 偏离指定的（官方）方法 | □ □ | Values below limit of detection/quantitation 所得值低于检测限/定量限 | |
| □ □ | Imprecision of observation/results of sample higher than acceptable (RSD, 95%Cl) 样品结果或精密度低于可接受标准（RSD,95%置信水平） | □ □ | Blank value ignored 忽略了空白值 | |
| □ □ | Imprecision of observations/results of reference standard higher than acceptable 标准品的结果或精密度低于可接受标准 | □ □ | System suitability test or assay validity criteria (controls statistics) missing/failed 系统适用性测试或含量有效性标准（控制统计）没有或未通过 | |
| Equipment Verification 仪器确认 | ||||
| □ □ | Wrong instrument used 使用了错误的仪器 | □ □ | Wrong instrument parameters 仪器参数错误 | |
| □ □ | Instrument calibration missing or criteria not met 校器没有校正，或校正不符合标准 | □ □ | Computerized system (including software) inappropriate 计算机化系统（包括软件）不适当 | |
| Calculations 计算 | ||||
| □ □ | Calculation error 计算错误 | □ □ | Data transfer error 数据转抄错误 | |
| □ □ | Formula or factor wrong 公式或系数错误 | □ □ | Inappropriate validation of calculating software 计算软件验证不适当 | |
| □ | The reason(s) indicated above invalidate the results 上述原因证明了结果无效 | |||
| □ | During this failure investigation, no reason to invalidate the OOS result could be found 在本次失败调查中，没有发现原因来证明OOS结果无效 | |||
| Decision on the re-test programme 复验程序启动决定 | (e.g. number of replicates, operator, reference materials, equipment, methods/parameters) （例如，重复次数、操作人员、对照物料、设备、方法/参数） | |||
| Technician(s) 技术人员 (signature, Date) 签字日期 | Supervisor 主管 (signature, Date) 签字日期 | |||
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