Using thehierarchy of root causes (Figure 1), I ask two questions and get the sameanswers—every time:

 

使用根本原因的层次结构(图1)，我提出了两个问题，并且每次都得到相同的答案:

Which is the most frequently identified root     cause?  It’s always “Personnel Error” (used for anywhere from 25-50+%     of root causes!).

 

你最常用到的根本原因是什么?答案通常是“人为错误”(占所有根本原因的25~50%+!)

 

Which is the least frequently identified root     cause? It’s always “Management Problem” (used for <10% of root causes).     Some companies don’t even include management as a cause!

 

哪个是最不常用到的根本原因?答案通常是“管理问题”(占所有根本原因的10%不到)。有些公司甚至不把管理问题作为一项根本原因!

 

So why do we seeso many “Personnel Errors” and so few “Management Problems?” Managers arepeople too and should therefore be just as prone to making an error as anoperator. It begs the question: Do managers truly make so few errors incomparison, or are we not correctly identifying situations as “ManagementProblems” when they occur?

 

那么，为什么我们看到这么多“人为错误”而很少看到“管理问题”呢？管理人员也是人，应该像操作员一样容易犯错误。这回避了一个问题：相比之下，管理人员真的只会犯这么少的错误吗？还是，当情况发生时，我们是否没有正确地将其识别为“管理问题”?

 

What’s TheDifference?

 

有何不同？

 

The table belowlists different types of issues we might see in root causes related to bothoperators and managers:

 

下表列出了与操作人员和管理人员相关的根本原因中可能出现的不同类型的问题:

(Source: Department ofEnergy “Root Analysis Guidance Document”, DOE-NE-STD-1004-92, Appendix A)

 

“PersonnelErrors” are pretty straightforward and relatively simple to identify when theyoccur. They typically happen when someone isn’t paying attention or makes amistake.  There also is usually an easily identifiable, maybe evenimmediate, effect of the error. 

 

“人为错误”是非常直接和相对简单的，当他们发生时，可以识别。它们通常发生在某人没有注意或犯错误的时候。通常还存在一个容易识别的，甚至是立即的错误影响。

 

“ManagementProblems,” however, aren’t quite as easy to identify when they happen, andtheir effect usually isn’t immediate. It typically requires time for asituation to play out or for someone else to make an error for the problem tobecome noticeable.

 

然而，“管理问题”并不那么容易确定它们何时发生，而且它们的影响通常不会立即显现。通常情况下，需要一段时间，或者其他人犯了错误，问题才会变得明显。

 

Identifying“Management Problems” Requires Time

 

需要时间识别“管理问题”

 

One potentialreason why we don’t identify “Management Problem” root causes very often maysimply be because the effect of the problem isn’t immediately obvious. Managers make choices and decisions that direct operations for the future,based on the information they have at the time. Errors or problems in thedecision-making process lead to issues that play out when those futures come topass—weeks, months, or even years after making the decision.

 

为什么我们不经常识别“管理问题”的根源，一个潜在的原因可能是问题的影响不会立即显现。管理人员根据当时掌握的信息，做出决定，指导未来的操作。决策过程中的错误或问题会在做出决定后的几周、几个月甚至几年里才出现问题。

 

For example,with “Inadequate Resource Allocation,” it takes time for the inadequateresourcing to stress the current situation/environment. There is a time delaybetween the problematic allocation decision and when its effect is noticed.Picture a staffing decision that cuts personnel, leaving too few resources forthe required work, which leads to errors or shortcutting to meet timelines. Ormaybe it’s decided to not use financial resources to upgrade a facility and toallow equipment to run to failure rather than replace it.  Eventually, theequipment fails, impacting production and/or product quality if no qualifiedbackup systems are available. 

 

例如，在“资源分配不足”，经过一段时间逐步对当前的情况/环境造成压力。在资源分配决策和它的影响被注意到之间有一个时间延迟。想象一下，一个裁员的人事决定，导致太少资源来完成所要求工作，将导致为满足时间要求而采取的错误或缩减。或者当决定不使用财政资源来升级一个设施，让设备带病运行直到故障而不进行更换。最终，如果没有合格的备用系统，设备会发生故障，影响生产和/或产品质量。

 

Consider thesestaffing examples from FDA warning letters and 483 observations:

 

看看FDA警告信和483缺陷报告中的人员配置例子:

 

You failed to provide an adequate number of     qualified personnel to perform and supervise the manufacture, processing,     packing, or holding of each drug product. Specifically, during an     interview, the Quality Manager stated that investigations are often not     conducted due to a lack of personnel. (2014 warning letter)

 

你们没有提供足够数量的合格人员来执行和监督每个药品的生产、加工、包装或保存。具体来说，在一次面谈中，质量经理表示，调查往往由于人员缺乏而没有进行。

 

There are an inadequate number of personnel     conducting and reviewing complaint investigations at your firm, as evidenced     by the lack of review of critical complaints as required procedurally and     by the fact that, once the deficiencies were discovered, you brought in     outside assistance to conduct the reviews, which should have been done by     your QA staff. (2011 483)

 

贵公司执行和审查投诉调查的人员数量不足，证据是没有按照程序要求对重要投诉进行审查，而且事实是，一旦发现缺陷，你们就请外界协助进行审查，这应该由QA人员来完成。

 

These examplesallude to a couple of different management issues that, combined, may have ledto the problems cited by the FDA:

 

这些例子暗示了几个不同的管理问题，综合起来，可能导致了FDA引用的问题：

 

First, it appears that staffing decisions—maybe     to not hire personnel or to allow for vacant positions to be eliminated,     for example—were made without considering all of the tasks that must be     performed for cGMP compliance.  If the company had a matrix of tasks     required and who performed them, they could have identified that critical     activities were unstaffed and therefore could not be performed.

 

首先，在没有考虑所有必须执行的cGMP合规任务的情况下做出了人事决策——例如，不雇用人员或允许取消空缺职位。如果该公司有一份所需工作以及由谁执行的列表，他们就可以发现关键活动没有人员，因此无法执行。

 

Subsequently, the failure to complete the tasks     appears to have gone unnoticed.  Had metrics of identification/closure     rates been presented in ongoing management reviews, it might have shown     that complaints were being received but not closed, investigations were     identified as needed but were not progressing, and more. Had those trends     been seen, good practice would have been to identify why they were     happening, realign staff to deal with these areas, and then monitor going     forward.

 

其次，似乎没有注意到未能完成任务的情况。如果在持续进行的管理评审中提出投诉/关闭率的衡量标准，就可能发现收到投诉但未关闭，需要调查但未进行，等等。如果看到了这些趋势，那么良好的做法应该是查明它们发生的原因，重新调整人员以处理这些领域，然后进行监测。

 

Identifying“Management Problems” May Require Other Issues To Highlight Them

 

“管理问题”可能通过其他问题发现

 

Anotherpotential reason for identifying so few “Management Problem” root causes may bebecause the problem leads to someone else making a mistake—anoperator, perhaps.  At that point, we usually identify the operator’serror and focus the investigation to why the mistake occurred. Only then can weidentify that the mistake resulted from a “Management Problem,” assuming ourroot cause analysis is good enough to get us to that underlying root cause.

 

将“管理问题”作为根本原因如此之少的另一个潜在原因可能是，该问题还导致了其他人员犯了一个错误——可能是操作人员。对此，通常我们会发现操作人员错误，并集中调查错误发生的原因。只有这样，我们才能识别出由“管理问题”导致的错误，假设我们的根本原因分析足够好，可以让我们找到根本原因。

 

One place thismay be seen is when a situation arises and the operator reacts inappropriatelyor makes a decision they weren’t qualified to make. Initially, these look likea “Personnel Error,” but further investigation identifies that the operatorneeded direction and their supervisor wasn’t available, which left the operatorto decide what to do without appropriate guidance. In this situation, thesupervisor failed to provide adequate oversight. (Operators should be trainedand qualified to perform tasks and handle common issues and problems; however,training cannot address every possible situation that could occur and how tohandle them, which is why supervisory oversight and guidance is needed.) 

 

当情况发生时，操作人员应对不当或做出了未经授权的决定。这咋一看像是“人为错误”，但进一步的调查发现，操作人员需要指导，而他们的主管却不在，这让操作人员在没有适当指导的情况下决定该怎么办。在这种情况下，监督者没有提供足够的监督。(操作人员应经过培训和确认以执行任务和处理常见问题；然而，培训不能解决可能发生的每一种情况，这就是为什么需要监督和指导。)

 

Other problemsmay occur when:

 

其他问题可能发生在以下情况:

 

Expectations aren’t set or communicated     appropriately. As a result, the operator works without fully understanding     what is expected and makes what they believe is an acceptable     decision.  Had they understood their management’s expectations, the     operator could—and likely would—have made a different decision. 

 

未设定期望，沟通也不恰当。因此，操作员在没有完全了解期望的情况下工作，并做出他们认为是可接受的决定。如果他们理解了管理层的期望，操作人员可能会做出不同的决定。

 

A policy changes and not enough information is     provided on what it means in the work environment. Or it doesn’t get     communicated to specific groups of people who continue status quo     operations until an error is identified.

 

要求发生改变，但没有提供足够的信息说明它在工作环境中的涵义。或者，在错误被发现之前，它不会被传达至那些继续维持现状的特定人群。

 

A policy is violated, and the manager doesn’t     enforce it.  Letting policy violations slide—even for good     employees—compromises the integrity of the manager, and it doesn’t help     employees to understand performance expectations. As examples, this     situation may happen if managers are not familiar enough with     policies/practices, or if they don’t have personnel management skills and     shy away from difficult conversations.

 

违反要求而管理人员不进行纠正。放任违反要求的行为——即使是优秀的员工——也会损害管理者的诚信，而且不利于员工理解绩效期望。例如，这种情况可能发生在管理者对政策/实践不够熟悉，或者如果他们没有人员管理技能和回避困难对话。

 

Thesesituations, and others, can also be found in FDA Warning Letters. For example:

 

这些情况和其他情况也可以在FDA警告信中找到。例如:

 

Your management failed to prevent the practices     of product sample retesting without investigation, and rewriting and/or     omission of original CGMP records persisted without implementation of     controls to prevent data manipulation. (2014 FDA Warning Letter)

 

你们的管理层未能阻止产品样品重复测试而未经调查，长期存在重写和/或遗漏原始CGMP记录而没有实施控制以防止数据篡改。

 

An employee performing a demonstration of the     bubble point test inside the clean room was observed with their hairnet     improperly donned, exposing ~15 inches of hair to the environment     throughout the demonstration.  The supervisor did not instruct the     employee to correct the deficiency until the demonstration was completed,     after FDA personnel brought it to his attention. (2012 FDA Warning Letter)

 

一名员工在洁净室进行泡点测试的演示时，被观察到他们的发套佩戴不正确，在整个演示过程中，将约15英寸的头发暴露在环境中。在FDA人员提请该员工注意后，主管人员直到演示完成后才示意该员工改正缺陷。

 

Your QA Manager stated investigations are not     conducted unless requested by the client.  However, your firm's SOPs     state that an investigation must be performed whenever a client's sample     results are outside of the stated specification. (2010 FDA Warning Letter)

 

你们的质量保证经理表示，除非客户要求，否则不会进行调查。但是，你们公司的标准操作规程规定，只要客户的样品结果超出规定标准，就必须进行调查。Your response suggests     that: 1) your training is ineffective; 2) the procedure is not readily     available; 3) the procedure is not understood; or 4) your personnel are     not qualified to perform their functions. Please comment on how your     leadership will ensure that your firm's procedures are fully followed to     achieve an acceptable level of compliance. (2009 FDA Warning Letter)

 

你们的回复表明：1)你们的培训是无效的；2)程序不可用；3)程序不清晰；或者4)你们的员工未被授权履行他们的职责。请评论你们的领导层将如何确保你们公司的程序被完全遵守，以达到可接受的合规水平。

 

How To IdentifySituations As “Management Problems”

 

如何识别为“管理问题”

 

Identifyingissues like these require a robust root cause analysis program. Investigations must identify the true root cause of the problem—the underlyingcause, not just the direct cause of the specific event. Again, the 5 Whysapproach discussed in my previous article is a useful practiceto help ascertain the underlying cause of the problem.

 

识别这些问题需要一个可靠的根本原因分析程序。调查必须找出问题的真正根源——根本原因，而不仅仅是具体事件的直接原因。5个为什么方法是一个有用的实践，有助于确定问题的根本原因。

 

Use the 5 Whysto identify the root cause of the problem by working through the levels of theHierarchy of Root Causes presented earlier in the article (Figure 1).  Asthe “Why?” questions are posed, push down to the most reasonable level of thehierarchy.  The key to identifying “Management Problems” is to workthrough the analysis—they typically won’t be the first thing you see.

 

通过本文前面提到的根源层次结构(图1)的各个层次，使用5个为什么来确定问题的根本原因。问题被提出，推到等级制度中最合理的层次。识别“管理问题”的关键是通过分析——它们通常不会是你首先看到的东西。

 

For example, ifwe perform a 5 Whys analysis on one of the previous FDA warning letterobservations—just from what we know—it might go like this:

 

例如，如果我们对FDA之前的警告信进行“5个为什么”分析——就我们所知——它可能是这样的:

 

Your QA Manager stated investigations are not     conducted unless requested by the client. However, your firm's SOPs state     that an investigation must be performed whenever a client's sample results     are outside of the stated specification:

 

你们的质量保证经理表示，除非客户要求，否则不会进行调查。但是，贵公司的标准操作规程(SOPs)规定，当客户的抽样结果超出规定标准时，必须进行调查:

 

Why is there a difference between the manager’s     explanation and the SOP? Based on what we can glean from the observation,     let’s say the manager wasn’t familiar with the SOPs.

 

为什么经理的解释和SOP有差异?根据我们从观察中收集到的信息，可能经理不熟悉SOP。

 

Why might the manager not be familiar with the     SOPs?  It’s possible they weren’t included in his training     curriculum.

 

为什么经理不熟悉SOP ？有可能他的培训里没有这些内容。

 

Why might they have not been included in his     training plan? It’s possible his manager overlooked them when developing     or assigning the training curriculum for the position.

 

为什么没有被包括在他的培训计划中？有可能在制定或分配该职位的培训课程时忽略了此内容。

 

This could thenbe categorized as a “Management Problem” and subcategorized as “Policy NotAdequately Disseminated: Individuals who needed to be aware of these SOPs werenot properly informed of their existence and content.” 

 

这可以被归类为“管理问题”，并细分为“政策传达不充分：需要了解这些SOP的个人没有被适当地告知它们的存在和内容。”

 

You’ll likely betempted to call this a “Training Deficiency,” but it’s not. Following our 5Whys, it’s not a case where training failed because we didn’t know the personneeded the training. We didn’t know this because of a “Management Problem”where the policy existed but wasn’t assigned to all who needed to be aware ofit. Something that needed to be put in place wasn’t and led to the otherissues.

 

你可能会忍不住把这称为“培训缺乏症”，但事实并非如此。根据我们的5个为什么，培训失败不是因为我们不知道这个人需要培训。我们之所以不知道这一点，是因为政策存在但并没有分配给所有需要了解它的人这一“管理问题”。一些需要的东西没有到位，导致了其他问题。

 

Once you startdown this path of asking “Why?” when situations occur, you’ll be quitesurprised how many items may be identified as “Management Problems”—far morethan the <10% most companies currently see.

 

一旦你开始问“为什么?”当情况发生时，你会惊讶地发现有那么多问题可能被确定为“管理问题”——远远超过大多数公司目前看到的<10%。

 

Avoiding “ManagementProblems”

 

避免“管理问题”

 

The best way todeal with these problems is to avoid them in the first place—by giving managerswhat they need to do their jobs.  At a minimum, it requires:

 

处理这些问题的最好办法就是从一开始就避免它们——让管理者知道他们需要做的工作。至少，它要求:

 

Emphasizing the importance of communicating     expectations in a way that personnel can relate to them and apply them to     their daily tasks

 

强调传达期望的重要性，使员工能够与期望联系起来，并将其应用到日常任务中

 

Company leaders who set expectations and provide     the time for managers to be on-floor with their groups in order to provide     oversight and in-the-moment coaching and direction

 

公司领导层设定期望，并给予管理人员时间，让其与他们的团队在一起，以提供监督、即时辅导和指导

 

Appropriate oversight by all levels of the     organization with a focus on successful performance of compliance-related     activities, not just business results

 

由组织的所有级别进行适当的监督，重点关注与法规符合性相关的活动的成功表现，而不仅仅是业务结果

 

Making appropriate information available to decision-makers,     such as a matrix of tasks or identification of compliance versus business     needs, etc.

 

为决策者提供适当的信息，例如工作任务的列表或识别符合性与业务需求，等等。

 

Considering both short- and long- term risks in     the decision-making process to evaluate possible decisions prior to     implementation and identify the potential risks associated with each     choice

 

在决策过程中考虑短期和长期风险，在实施之前评估可能的决策，并识别与每个选择相关的潜在风险

 

Contingency planning during the decision-making     and implementation process, based on the risks identified in the     evaluation process

 

在决策和实施过程中基于评估过程中识别出的风险制定备选计划

 

Providing training programs that develop “soft     skills” required for personnel management, such as communication,     coaching, and performance management processes and tactics, in addition to     ensuring managers possess appropriate technical knowledge for their positions

 

提供培养人员管理所需的“软技能”的培训项目，如沟通、辅导、绩效管理流程和策略，以及确保管理人员拥有适合其职位的技术知识

 

Managing is adifficult job, and it becomes even more difficult if managers don’t have whatthey need to perform effectively. In this respect, managers are no differentthan operators.  Where they differ is that “Management Problems” can andlikely will be far more costly to an organization’s performance, if they areallowed to continue undiagnosed and unchecked. This can happen when “ManagementProblems” are not considered or identified during root cause analysis.

 

管理是一项困难的工作，如果管理者没有有效执行所需要的东西，就会变得更加困难。在这方面，管理人员和操作人员没有什么不同。他们的不同之处在于，“管理问题”如果被允许继续未经调查和检查，可能会对组织的绩效造成更大的代价。当根本原因分析期间没有考虑或识别“管理问题”时，就会发生这种情况。

来源：GMP办公室

关键词： GMP