蒲公英 - 制药技术的传播者 GMP理论的实践者

搜索
查看: 4605|回复: 36
收起左侧

[其他] 偏差调查中8大错误

  [复制链接]
药士
发表于 2018-10-2 22:18:45 | 显示全部楼层 |阅读模式

欢迎您注册蒲公英

您需要 登录 才可以下载或查看,没有帐号?立即注册

x
Do You Make These 8 Big Mistakes In Your Deviation Investigations?


By James Blackwell, Ph.D., The Windshire Group, LLC
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 and Drug Administration (FDA) and other regulatory authorities.1 (“There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed.”)
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 how you can avoid them.
1. Not leveraging historical data for continuous improvement
The information gathered over time through investigations contains a wealth of data that can be used for continuous improvement, increasing 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 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 trend 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.
2. Relying on human error as a root cause
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 your organization is not interested and/or resourced to find true root causes and to correct the underlying issues behind recurrence.
Human error can be a root cause category, but rarely is it the true and actionable root 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 design and layout”).
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 human error-related events. Such events cost the industry a staggering amount in terms 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 companies. Preventing human error recurrence not only saves organizations money, but it reduces the likelihood of compliance issues, including regulatory findings.
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) human error events, the employee involved could have detected the error prior to it becoming a deviation. Therefore, “inadequate 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 additional training that focuses on increasing the person’s ability to detect and fix an error, or other job aids or improvements in the HMI (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 standalone CAPA. If someone doesn’t understand the importance of GMPs, they shouldn’t be working in a GMP environment — and they definitely need more training.
3. Not getting to the probable root cause
The percentage of investigations resulting in a root cause is a good metric for the health of your quality system — the higher the percentage, the better. There are many reasons why root causes are not found. Not committing adequate time and resources is one. However, it is all too common for organizations to put in sufficient effort, gather all the necessary facts and information, but still fail to identify a root cause. Sometimes, this is the direct result of the investigator’s skill — they may have been trained insufficiently or lack technical command of the issues involved.
However, it is also surprisingly common for an investigation to conclude that a “definitive” root cause could not be identified, despite the fact that all the necessary information is available and the conclusion is readily discernable. A misguided interpretation of the facts or an unrealistic notion of definitive can prevent the investigation from arriving at a most probable root cause. There is no regulatory standard that requires all investigation conclusions be definitive. A most probable root cause based on and justified by a thorough investigation and supported by the available data and information is sufficient.
The proper RCA (root cause analysis) tool should be chosen for the problem at hand. For more difficult investigations, a Kepner-Tregoe or IS-IS NOT analysis can often tease out a challenging most probable root cause from an array of discordant facts.
4. Not getting to the true root cause
Finding the true root cause is critically important. There have been many cases where organizations failed to identify and correct the true root cause of a problem that was readily solvable — and they suffered millions of dollars in losses (or worse) as a result. The true root cause is an actionable one that is the most consistent with the available facts and information from a thorough investigation and can be the most probable root cause mentioned above.
A true root cause is the underlying reason that allowed the event to occur. Understanding the true root cause requires the collection of all relevant facts. Sometimes, these are clearly understood at the time of the event. Other times, it requires in-depth technical assessments that can span several months.
One good test for assessing if the true root cause has been found is to see if it can be stated in terms that are directly actionable, meaning it links clearly to a corrective action and is within the organization’s control. A simple and effective way to determine if the true, actionable root cause has been found is to use the 5 Whys tool at the conclusion of an investigation, including application to the outputs from more advanced tools, such as a fishbone diagram or Kepner-Tregoe analysis.
For example, failure of the backup power supply is not a true, actionable root cause. Why did the back-up power supply fail? Hurricane Matthew cannot be listed as an actionable root cause, because the organization cannot prevent hurricanes. However, an inadequate procedure for preventative maintenance of the backup power supply can be a true root cause, in which case the corrective action is to fix the procedure.
5. Preparing an unclear or difficult-to-follow investigation report
Many investigation writers forget that their audience is not only internal employees, but ultimately an external third-party, such as an inspector. Thus, the investigation needs to be readily understandable and clear, with all the necessary supporting facts and rationale, so that it is comprehensible years after the event. The most difficult challenge in accomplishing this is writing logically, clearly, and succinctly, without presenting and repeating redundant information. Thus, training is an important element of writing effective investigations. Having mentors available to assist investigators can be an important element in advancing skills.
6. Ignoring contributing factors and associated CAPAs
Contributing factors are elements that either were necessary — in addition to the root cause — for an event to occur, or that increased the event’s impact. Contributing factors also require root cause determinations and CAPAs. Addressing them limits the likelihood or impact of similar events recurring in the future. Too often, investigations focus only on the root cause and forget to address contributing factors. Use of the 5-Whys tool is a useful mechanism to distinguish contributing factors from root causes.
7. Prescribing inadequate CAPAs
Too many investigations lead to an appropriate root cause but never link that cause to a CAPA. Most root causes and contributing factors should be associated with one or more CAPAs; if not, a clearly justified rationale should be provided. One of the main purposes of an investigation is to prevent recurrence of the event, and this can only happen if the investigation determines a root cause and connects it to an appropriate, effective CAPA. Another consideration is whether or not an interim control is needed while the CAPA(s) is being implemented. A risk assessment should be used to make this determination.
8. Not performing interviews
Too many investigations fail to obtain information from the employees with the most relevant insight and information surrounding the event, either because the interviews are never conducted or they occur too long after the event. Memories fade quickly, so interviews should be conducted as soon as possible after an event occurs. Some organizations “swarm” an event immediately after it happens, with a team conducting interviews. This is called “freezing the scene.” Gathering high-quality information soon after the event will save you future time and effort, and improves the quality of the investigation.
Talking to key personnel using well thought-out interview questions prepared in advance, when applicable, will make the interview more useful and insightful and the investigation much more efficient. The essential details of interviews should be summarized in the investigation.
Conclusion
While conducting a thorough deviation investigation is hard work, failing to do so will yield inaccurate root causes and misdirected CAPAs, and recurring deviations, along with increased regulatory and financial risk. The payback from investing in deviation investigations comes in the form of improved operational performance, reduction in costs, increased quality, and improved compliance.
References:
回复

使用道具 举报

药徒
发表于 2018-10-3 08:04:00 | 显示全部楼层
詹姆斯布莱克韦尔博士,温德郡集团,有限责任公司
偏差调查是任何GMP(良好制造惯例)组织中最重要的质量活动之一。在美国食品和药物管理局(FDA)和其他监管机构发布的观察、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。1(“无论批次是否已经分发,都没有彻底审查[任何无法解释的差异][批次或其任何部件没有达到任何规格]。”
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。
1.不利用历史数据进行持续改进
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一个重要因素。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、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份或更多,可以帮助调查人员以可诉的方式写出他们的根本原因。
2.把人为错误作为根本原因
这是监管当局在其意见中引用的共同结论。将人为错误反复声明为根本原因是一个迹象,表明您的组织没有兴趣和/或资源来寻找真正的根本原因,并纠正重复出现的根本问题。人的错误可以是一个根本原因范畴,但它很少是真正的和可行动的根本原因本身。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分配关于程序的培训”)、环境或机器(“设备设计和布局不当”)。
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,并减少今后与人类错误相关的事件的数量。这类事件在生产力损失、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行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,包括监管结果。一些质量系统将不允许将人为错误用作根本原因,以防止组织无法识别和解决错误背后的真正根源(见下面的错误#3)。例如,在许多(但肯定不是所有)人为错误事件中,所涉及的员工可以在错误变成偏差之前检测到错误。因此,在这种情况下,“发现问题的能力不足”可能是可采取行动的根本原因。由此产生的CAPA(纠正和预防行动)将是咨询或额外培训,重点是提高个人检测和修复错误的能力,或其他工作辅助或改进人机界面(HMI),使操作者能够及时更好地发现问题,以防止出现偏差。仅仅就“注重细节”或“GMPS的重要性”进行咨询,作为一个独立的CAPA来说,是不具体的,也是不够的。如果有人不理解GMP的重要性,他们就不应该在GMP环境下工作,而且他们肯定需要更多的培训。


点评

这个很赞同,很多初看是人为失误、人为疏忽,其实再往下挖就是文件有问题、流程有问题  发表于 2018-10-9 10:39
回复

使用道具 举报

药士
发表于 2018-10-3 13:36:22 | 显示全部楼层
其实只有少部分偏差是找不到根本原因或者说原因不好找,大部分偏差的原因还是显而易见的——
怕的是明知故犯,怕的是不敢体现真实情况
偏差等级分二类或三类都可以,做好定义和常见偏差举例清单,偏差的原因主要从人机料法环测这几个方面去调查分析。
回复

使用道具 举报

大师
发表于 2018-10-3 09:02:44 | 显示全部楼层
诺叶知秋 发表于 2018-10-3 08:09
4.找不到真正的根源
找到真正的根源是至关重要的。在许多情况下,组织未能找出和纠正一个容易解决的问题的 ...

根据以往参与偏差调查的情况看,多数偏差,找到真正根源,这是一个很难的事情,很多时候,难免为了偏差而偏差,为了调查而调查,为了关闭偏差而关闭偏差。所以,我们实际工作中的偏差管理,还是存在较大差距的
回复

使用道具 举报

药徒
发表于 2018-10-2 22:40:22 | 显示全部楼层
占个沙发看天书
回复

使用道具 举报

药士
发表于 2018-10-2 23:52:06 | 显示全部楼层
呵呵,好好学习一下英语。
回复

使用道具 举报

药师
发表于 2018-10-3 07:24:07 | 显示全部楼层
回复

使用道具 举报

药徒
发表于 2018-10-3 08:06:41 | 显示全部楼层
3.没有找到可能的根本原因-导致根本原因的调查百分比-是衡量质量体系健康的一个很好的指标-这个百分比越高,越好。根本原因是多方面的。没有投入足够的时间和资源是其中之一。然而,各组织作出足够的努力,收集所有必要的事实和信息,但仍然找不到根本原因,这是非常普遍的。有时,这是调查人员技能的直接结果-他们可能没有受过充分的培训,或对所涉问题缺乏技术上的掌握。然而,令人惊讶的是,调查得出的结论也令人惊讶,即无法查明“确定的”根本原因,尽管有所有必要的资料,而且结论是显而易见的。对事实的错误解释或不现实的确定性概念可能会使调查无法找到最可能的根本原因。没有任何监管标准要求所有调查结论都是确定的。一个最可能的根本原因是以彻底调查为基础并以现有数据和资料为依据的,这就足够了。对于手头的问题,应该选择合适的RCA(根原因分析)工具。对于更困难的调查,Kepner-Tregoe或is-不是分析,通常可以从一系列不一致的事实中找出最具挑战性的最可能的根本原因。

回复

使用道具 举报

药徒
发表于 2018-10-3 08:09:55 | 显示全部楼层
4.找不到真正的根源
找到真正的根源是至关重要的。在许多情况下,组织未能找出和纠正一个容易解决的问题的真正根源-结果他们遭受了数百万美元的损失(甚至更糟)。真正的根本原因是一个可采取行动的原因,这是最符合现有的事实和资料,从一个彻底的调查,可以是最可能的根本原因,上述提到。真正的根本原因是允许事件发生的根本原因。了解真正的根本原因需要收集所有相关的事实。有时,这些在事件发生时就被清楚地理解了。其他时候,它需要深入的技术评估,可以跨越几个月.评估是否找到了真正的根本原因的一个很好的测试是,看看是否可以用可以直接采取行动的术语来说明这一问题,这意味着它与纠正行动有着明确的联系,属于组织的控制范围。一个简单而有效的方法,以确定是否找到了真正的,可采取行动的根本原因是使用5 Whys工具在调查结束,包括应用于更先进的工具,如鱼骨图或Kepner-Tregoe分析。例如,备份电源的故障不是真正的、可采取行动的根本原因。为什么备用电源失灵?飓风马修不能被列为可采取行动的根本原因,因为该组织无法防止飓风。然而,后备电源预防性维护程序不足可能是真正的根本原因,在这种情况下,纠正措施是修复程序。

点评

根据以往参与偏差调查的情况看,多数偏差,找到真正根源,这是一个很难的事情,很多时候,难免为了偏差而偏差,为了调查而调查,为了关闭偏差而关闭偏差。所以,我们实际工作中的偏差管理,还是存在较大差距的  详情 回复 发表于 2018-10-3 09:02
回复

使用道具 举报

药徒
发表于 2018-10-3 14:40:35 | 显示全部楼层
5.准备一份不明确或难以跟进的调查报告
许多调查作者忘记了,他们的听众不仅是内部员工,而且最终还是外部第三方,比如检查员。因此,调查必须易于理解和明确,并有所有必要的支持事实和理由,以便在事件发生后几年才能理解。要做到这一点,最困难的挑战是在不显示和重复冗余信息的情况下,以逻辑、清晰和简洁的方式书写。因此,培训是编写有效调查的重要内容。有导师协助调查人员可能是提高技能的一个重要因素。
6.忽视影响因素及相关因素
除了根本原因之外,造成事件发生的因素或者是必要的,或者是增加了事件的影响的因素。造成因素也需要根本原因的确定和卡帕。解决这些问题限制了今后再次发生类似事件的可能性或影响。调查往往只关注根本原因,而忘了处理促成因素。使用5-Whys工具是区分成因和根源的有用机制。

回复

使用道具 举报

药徒
发表于 2018-10-3 14:44:17 | 显示全部楼层
7.开具不足的Capa
太多的调查导致了一个适当的根本原因,但从来没有将这一原因与CAPA联系起来。大多数根源和促成因素应与一个或多个CAPA相关联;如果没有,则应提供明确的理由。调查的主要目的之一是防止事件再次发生,只有当调查确定了根本原因并将其与适当的、有效的CAPA联系起来时,才能发生这种情况。另一个考虑因素是在实施“CAPA”时是否需要临时控制。应利用风险评估来作出这一决定.
8.不进行采访
太多的调查无法从员工那里获得与事件相关的洞察力和信息,要么是因为调查从未进行,要么是在事件发生后太久才进行。记忆很快就会消失,所以调查应该在事件发生后尽快进行。一些组织在事件发生后立即“蜂拥而至”,由一个团队进行采访。这就是所谓的“冻结现场”。事后收集高质量的信息将节省你今后的时间和精力,并提高调查的质量。在适当的情况下,用事先准备好的面试问题与关键人员交谈,会使调查更有用、更有洞察力,调查也更有效率。采访的基本细节应在调查中加以总结。

点评

赞同,很多CAPA需要长时间完成,那么这段空白期仍需要额外的临时措施  发表于 2018-10-9 10:43
回复

使用道具 举报

药徒
发表于 2018-10-3 14:45:31 | 显示全部楼层
主要还是因为很多偏差都是流于形式吧
回复

使用道具 举报

发表于 2018-10-4 10:42:57 | 显示全部楼层
超标原因调查比较困难,是从果推倒因的过程,如水系统微生物超标,成品含量不合格。而车间偏差一般是知道原因,需要制定有效的措施,相对容易些,如批号打印错误,如设备某种致命性故障。

点评

给足资源是可以调查出来的,真正调查不出来的是少数,看你想不想调查而已  详情 回复 发表于 2018-10-9 14:07
回复

使用道具 举报

药徒
发表于 2018-10-4 13:45:15 | 显示全部楼层
留个爪回来继续看
回复

使用道具 举报

发表于 2018-10-7 18:49:44 | 显示全部楼层
需要好好学习英语了
回复

使用道具 举报

药徒
发表于 2018-10-8 08:14:54 | 显示全部楼层
恳求中英对照
回复

使用道具 举报

药生
发表于 2018-10-8 10:00:43 | 显示全部楼层
又艮又长,算了
回复

使用道具 举报

药徒
发表于 2018-10-8 11:50:31 | 显示全部楼层
求大神翻译 ····

点评

上面翻译完了你也不看。。  发表于 2018-10-9 11:35
回复

使用道具 举报

药徒
发表于 2018-10-8 16:22:21 | 显示全部楼层
zysx01234 发表于 2018-10-3 13:36
其实只有少部分偏差是找不到根本原因或者说原因不好找,大部分偏差的原因还是显而易见的——
怕的是明 ...

你确定是找不到?不好找?不能找的呢,都怎么办啊,不提出来说说吗?
回复

使用道具 举报

药徒
发表于 2018-10-9 09:18:24 | 显示全部楼层
很多时候都是想当然的给安一个原因就完了,究竟是不是这个原因导致产生的问题,谁都不知道,真的无奈
回复

使用道具 举报

您需要登录后才可以回帖 登录 | 立即注册

本版积分规则

×发帖声明
1、本站为技术交流论坛,发帖的内容具有互动属性。您在本站发布的内容:
①在无人回复的情况下,可以通过自助删帖功能随时删除(自助删帖功能关闭期间,可以联系管理员微信:8542508 处理。)
②在有人回复和讨论的情况下,主题帖和回复内容已构成一个不可分割的整体,您将不能直接删除该帖。
2、禁止发布任何涉政、涉黄赌毒及其他违反国家相关法律、法规、及本站版规的内容,详情请参阅《蒲公英论坛总版规》。
3、您在本站发表、转载的任何作品仅代表您个人观点,不代表本站观点。不要盗用有版权要求的作品,转贴请注明来源,否则文责自负。
4、请认真阅读上述条款,您发帖即代表接受上述条款。

QQ|手机版|蒲公英|ouryao|蒲公英 ( (京)-非经营性-2014-0058 京ICP证150354号 京ICP备14042168号-1 )

GMT+8, 2024-3-29 18:36

Powered by Discuz! X3.4运维单位:苏州豚鼠科技有限公司

Copyright © 2001-2020, Tencent Cloud.

声明:蒲公英网站所涉及的原创文章、文字内容、视频图片及首发资料,版权归作者及蒲公英网站所有,转载要在显著位置标明来源“蒲公英”;禁止任何形式的商业用途。违反上述声明的,本站及作者将追究法律责任。
快速回复 返回顶部 返回列表