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1、精选I偏差调查中常见八大问题Deviation investigations are one of the most important quality activities in any GMP(good manufacturing practice) organization. They are also perennially near the top of the list of most frequently cited issues in observations, warning letters, and consent decrees from the U.S. Food an
2、d Drug Administration (FDA)and other regulatory authorities. (“ There is a failure to thoroughly reviewany unexplained discrepancythe failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. ” )偏差调查是任何GMP组织中最重要的质量活动之一。在FDA和其
3、他监管机构发布的缺陷、警告信和同意令中， 它们也一直处于最常被引用的问题列表的首位。(无论批次是否已经销售，都没有彻底审核任何无法解释的差 异批次或其任何组分不符合质量。)Clearly,many organizations have room to improve in the writing and managing of deviation investigations. The following sections identify common missteps companies make when conducting deviation investigations and h
4、ow you can avoid them.显然，许多组织在偏差调查的编写和管理方面仍有改进的余地。以下几节列出了公司在进行偏差调查时所犯的 常见错误以及如何避免这些错误。I. Not leveraging historical data for continuous improvement1.未利用历史数据进行持续改进The information gathered over time through investigations contains a wealth of data that can be used for continuous improvement, increasing
5、 productivity, and reducing the recurrence of investigations. Unfortunately, many organizations only review this data once a year and in a somewhat perfunctory manner.A good trending process is an important element in monitoring and proactively responding to developing issues. Tracking investigation
6、 data (root cause, functional group, unit operation) will aid in continuous monitoring of the types of events and root causes occurring in your facility by product, process area, and functional group, among others. Develop a list of standard event categories and actionable root causes in order to tr
7、end deviation and investigation data. This list can be upwards of 200 or more and can aid investigators in writing their root cause in actionable terms.随着时间的推移，通过调查收集到的信息包含了大量的数据，可用于不断改进、提高生产力和减少调查的再次发生。不 幸的是，许多组织每年只审查这一数据一次，而且有些敷衍了事。一个良好的趋势过程是监测和积极应对发展中问题的 个重要因素。跟踪调查数据(根本原因、功能组、单元操作)将有助于持续监控设备中按产品、
8、流程区域和功能组等发 生的事件类型和根本原因。制定标准事件类别和可采取行动的根本原因清单，以便趋势偏差和调查数据。这份清单可以 超过200或更多数据，可以帮助调查人员以可操作的方式写出他们的根本原因。2. Relying on human error as a root cause2把人为错误作为根本原因This is a common finding that regulatory authorities will cite in their observations. Repeatedly stating human error as a root cause is a sign that
9、 your organization is not interested and/or resourced to find true root causes and to correct the underlying issues behind recurrence.这是监管当局在其缺陷中经常引用的缺陷。重复把人为错误作为根本原因是一个迹象，表明您的组织没有权力 和/或资源来找出真正的根本原因，并纠正重复出现的潜在问题。Human error can be a root cause category, but rarely is it the true and actionable root
10、cause, in and of itself. The true root cause is usually in other areas,such as procedures (“step x.x unclear ” ), training(“wasn t assigned training on procedure since SOP was not on training curriculum ” ), environment (distraction due to false fire alarm ” ), or machine ( “improper equipment desig
11、n and layout ” ). 人的错误可以是一个根本原因类别，但它本身很少是真正的和可采取行动的根本原因。真正的根本原因通常是 在其他领域，如程序(步骤x.x不明确”)、培训(由于SOP没有列入培训课程而没有被安排关于程序的培训)、 环境(由于火灾报警引起的注意力分散)或机器(设备设计和布局不当)。It is important to find a true, underlying root cause and to describe it in actionable terms to prevent recurrence and reduce the number of future
12、human error-related events. Such events cost the industry a staggering amount interms of lost productivity, compliance and labor costs, and the human resources needed to investigate nonconformances. The average cost of a deviation runs into tens of thousands of dollars for major pharmaceutical compa
13、nies.Preventing human error recurrence not only saves organizations money, but it reduces the likelihood of complianceissues, including regula toryfindings.重要的是找到一个真正的、潜在的根源，并以可操作的方式描述它，以防止再次发生，并减少今后与人员错误 相关的事件的数量。这类事件在生产效率损失、合规和劳动力成本以及调查不合格行为所需的人力资源等方面 给企业造成了惊人的损失。对于大型制药公司来说，偏差的平均成本高达数万美元。防止人为错误的再次
14、发生 不仅节省了组织的资金，而且降低了合规问题的可能性，包括监管缺陷。Some quality systems will not allow human error to be used as a root cause, in order to prevent the organization from stopping short of identifying and addressing the true root cause behind errors (see error #3 below). For example, in many(but definitely not all) h
15、uman error events, the employee involved could have detected the error prior to it becoming a deviation. Therefore, “in adequate ability to detect the problem ” could be the actionable root cause in such situations. The resulting CAPA (corrective and preventive action) would be counseling or additio
16、nal training that focuses on increasing the person sability to detect and fix an error, or other job aids or improvements in theHMI （human machine interface） that will allow operators to better detect problems in time to prevent a deviation. Counseling just on paying attention to detail ” or on “the importance of GMPs ” is not specific or adequate as a stand alone CAPA. If someone doesn t understand the importance of GMPs, the
