201410 PA/PH/OMCL (14) 87 结果评估和报告附录1A:OOS结果调查表样例 （转载）

201410 PA/PH/OMCL (14) 87 结果评估和报告附录1A:OOS结果调查表样例  （转载）

2015-06-09 08:45:28

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EDQM OMCL

OMCL Network of the Council of Europe
QUALITY ASSURANCE DOCUMENT

PA/PH/OMCL (14) 87
Evaluation and Reporting of Results

结果评估和报告附录1A
Annex 1A

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

ANNEX 1A OF THE OMCL NETWORK GUIDELINE

“EVALUATION AND REPORTING OF RESULTS”

OMCL网络指南“结果的评估和报告”附录1A

MODEL TEMPLATE FOR FAILURE INVESTIGATION OF OOS RESULTS

OOS结果失败调查模板样例

Introduction 概述

The annexes of the Guideline “Evaluation and Reporting of Results”, PA/PH/OMCL(13)113 (in its current version) contain several examples of approaches to failure investigation and the re-test programme. Other approaches are possible if their scientific rationale is documented and the basic principles of the core document are followed.

“结果的评估和报告”指南，PA/PH/OMCL(13)113（目前版本），的附录包括几个失败调查的例子，以及复验程序。如果有文件说明其科学合理性，并遵守核心文件的基本原则，其它方法也是可以的。

The editable templates/calculation sheets are available on the EDQM Extranet in the OMCL Quality Documents section.

可编辑的模板/计算表格可以在EDMQ外联网OMCL质量文件部分找到。

MODEL TEMPLATE FOR FAILURE INVESTIGATION OF OOS RESULTS

OOS结果的失败调查模板样例

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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