偏差调查指南

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 Event

Timeline,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 any

points where there is a change or difference between the expected and actual processes.An agreement

within the team shall be reached that all gaps have been identified.Review and Revise the problem

statement based on the identified Gaps(this step must be complete prior to the step of identification of

potential 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 the