偏差调查指南Guideline for Deviation Investigation●问题陈述Define the problem为执行结构性地根本原因分析，可通过清楚地描述问题来理解这个偏差。
偏差描述应包括充足的信息，以便能被理解；应清晰简洁、可量化且记录事件的重要性。
调查过程中随着获取更多的信息，偏差描述可被修改（如适用）。
In order to perform a structured root cause analysis the problem needs to be understood,this is achieved by creating a problem statement for the deviation.This statement describes the problem with enough information to ensure the deviation is understood.The statement shall be clear and concise,be quantifiable and should document the magnitude of the event.The problem statement may be amended,if appropriate,during the course of the investigation as more information becomes available.●建立时间表Establish Timeline见如下“缺失事件表”。
Refer to Loss Event Timeline as below.●收集数据Collect the data描述应发生什么Map what should have occurred为启动调查，应收集关于如何操作工艺的信息。
这些信息应包括所有相关的文件和知识，如：生产和包装指令、标准操作规程、工作工艺流程和可用的工艺或产品开发知识。
To initiate the investigation,information shall be collected about how the process should have been rmation shall include all relevant documentation and knowledge e.g.manufacturing and Packaging instructions,Standard Operating Procedures,work and process flows,and available process or product development knowledge.描述实际发生了什么Map what actually Happened分别收集和分析所有工序记录、工艺控制结果和环境数据及重现实际操作。
这些应通过可视化管理和人员面谈进行核对。
收集的信息应确保任何变化和异常都能被发现。
调查组需对实际发生的事件及其顺序达成一致。
Separately collect and analyze all process records,process control results and environmental data together and recreate the process actually performed.This shall be verified by GEMBA and operator Interviews.The information shall be collected in such a manner that any changes or differences can easily be identified.An agreement within the team must be reached about what should have occurred and the sequence of actual events. MMEEPPS分类（与物料、方法、设备、环境、人员、工艺和系统）可用于数据收集。
相关的影响因素（不完全）罗列如下，供参考。
The MMEEPPS categories can also be used to collect data.These relate to Materials,Methods,Equipment, Environment,People,Process Design and Systems.The factors listed below are for consideration.可使用一些方法收集工艺和事件的数据，包括但不限于：缺失事件表，故障树分析，否认模型，5个为什么，是或否，鱼骨图/因果关系，失效模式与影响分析。
There are a number of techniques that can be used to collect data on the process and the event that occurred these include,but are not limited to:Loss EventTimeline,Fault Tree Analysis,Contradiction Matrix,5Whys,Is/Is Not,Fishbone diagram/Cause and Effect,FMEA.●分析差距Gap Analysis就上述收集的工艺设计和实际操作进行差距分析，识别并记录期望和实际工艺之间的任何变化和不同。
调查组应就识别的差距达成一致。
差距识别后可回顾和修改问题描述（这一步骤应在潜在原因识别前完成）。
Conduct a gap analysis of the process as designed and the process as operated.Identify and record anypoints where there is a change or difference between the expected and actual processes.An agreementwithin the team shall be reached that all gaps have been identified.Review and Revise the problemstatement based on the identified Gaps(this step must be complete prior to the step of identification ofpotential causes.●识别潜在原因Identification of Potential Causes上一步骤识别的差距应按偏差的潜在原因处理。
Each gap identified above shall be treated as a potential cause of the problem.o应考虑其它的可能原因，可使用头脑风暴（如：鱼骨图分析）Other possible causes shall also be considered,these can be derived from a brainstorming process,such as a Fishbone analysis.o基于识别的其它潜在原因，回顾和修改问题描述Review and Revise the problem statement based on the other identified potential causes.o应评估每个差距或识别的其它可能原因对调查问题的潜在影响，发挥调查组员的专业知进行严重性或影响分类Each gap or identified other possible cause shall be assessed for its potential impact on the problem under investigation,and using the available expertise within theinvestigation team,ranked for importance or Impact.o调查组应就可能原因的等级排序达成一致An agreement within the team shall be reached on the ranked order of the possible causeso该步骤识别的差距或其他可能原因的理由应被记录The reason for any identified gap or other possible cause that is discounted at this stage shall be recorded●确定根本原因Root Cause Determination应使用合适的工具回顾每个可能原因，识别偏差的根本原因和促成因素。
Each of the ranked likely causes shall be reviewed using appropriate tools to identify the Root Cause of the problem,and other contributory causes.o当不能识别根本原因时各个可能原因应按根本原因解决Where it is not possible to identify Root Cause each probable cause shall be treated as if it were a root cause.如根本原因或促成因素被识别为人员因素，应进一步评估识别更深层次的问题Where the root cause orother contributory causes identify Human Factors,these shall be further evaluated to identify the underlying issues.识别的原因应评估是否可以完全解决问题，对于复杂问题可能需要一系列实验进行确认Theidentified causes shall be evaluated against the problem statement to confirm that they completely explain the problem.In complex cases this may require a series of trials or experiments to confirm.o如可能原因被忽略应记录忽略原因并关联到根本原因调查报告中Where a likely cause has been discounted this shall be recorded and justified and referenced in the root cause investigation report.o调查组应对忽略可能原因的决定达成一致There shall be consensus in the investigation team regarding any decision to discount a likely cause.o应准备每个步骤的调查总结，应详述问题陈述、简要描述、工艺步骤、使用的工具和作出的决定A summary report of the investigation that details the problem statement and briefly describes,the steps of the process,tools used and decisions made at each step shall be prepared.o调查报告应遵循正确书写的原则并可提交给法规部门，报告应包括：The report needs to be constructed with the principle of Write right,and be suitable for submission to a regulatory or government authority.The report shall contain:确定根本原因和最可能原因The Root or most probable causes determined识别促成因素Contributory causes Identified忽略可能原因的解释Justification for any potential causes being discounted制定CAPA Definition of CAPA基于根本原因或可能的根本原因及已完成的调查，调查组长或调查团队提出有效的纠正与预防措施来解决偏差，减轻影响或能理想地解决问题。