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

 

使用根本原因的層次結(jié)構(gòu)(圖1)，我提出了兩個(gè)問(wèn)題，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“人為錯(cuò)誤”(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!

 

哪個(gè)是最不常用到的根本原因?答案通常是“管理問(wèn)題”(占所有根本原因的10%不到)。有些公司甚至不把管理問(wèn)題作為一項(xiàng)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，為什么我們看到這么多“人為錯(cuò)誤”而很少看到“管理問(wèn)題”呢？管理人員也是人，應(yīng)該像操作員一樣容易犯錯(cuò)誤。這回避了一個(gè)問(wèn)題：相比之下，管理人員真的只會(huì)犯這么少的錯(cuò)誤嗎？還是，當(dāng)情況發(fā)生時(shí)，我們是否沒(méi)有正確地將其識(shí)別為“管理問(wèn)題”?

 

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:

 

下表列出了與操作人員和管理人員相關(guān)的根本原因中可能出現(xiàn)的不同類(lèi)型的問(wèn)題:

(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. 

 

“人為錯(cuò)誤”是非常直接和相對(duì)簡(jiǎn)單的，當(dāng)他們發(fā)生時(shí)，可以識(shí)別。它們通常發(fā)生在某人沒(méi)有注意或犯錯(cuò)誤的時(shí)候。通常還存在一個(gè)容易識(shí)別的，甚至是立即的錯(cuò)誤影響。

 

“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，“管理問(wèn)題”并不那么容易確定它們何時(shí)發(fā)生，而且它們的影響通常不會(huì)立即顯現(xiàn)。通常情況下，需要一段時(shí)間，或者其他人犯了錯(cuò)誤，問(wèn)題才會(huì)變得明顯。

 

Identifying“Management Problems” Requires Time

 

需要時(shí)間識(shí)別“管理問(wèn)題”

 

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.

 

為什么我們不經(jīng)常識(shí)別“管理問(wèn)題”的根源，一個(gè)潛在的原因可能是問(wèn)題的影響不會(huì)立即顯現(xiàn)。管理人員根據(jù)當(dāng)時(shí)掌握的信息，做出決定，指導(dǎo)未來(lái)的操作。決策過(guò)程中的錯(cuò)誤或問(wèn)題會(huì)在做出決定后的幾周、幾個(gè)月甚至幾年里才出現(xiàn)問(wèn)題。

 

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“資源分配不足”，經(jīng)過(guò)一段時(shí)間逐步對(duì)當(dāng)前的情況/環(huán)境造成壓力。在資源分配決策和它的影響被注意到之間有一個(gè)時(shí)間延遲。想象一下，一個(gè)裁員的人事決定，導(dǎo)致太少資源來(lái)完成所要求工作，將導(dǎo)致為滿足時(shí)間要求而采取的錯(cuò)誤或縮減。或者當(dāng)決定不使用財(cái)政資源來(lái)升級(jí)一個(gè)設(shè)施，讓設(shè)備帶病運(yùn)行直到故障而不進(jìn)行更換。最終，如果沒(méi)有合格的備用系統(tǒng)，設(shè)備會(huì)發(fā)生故障，影響生產(chǎn)和/或產(chǎn)品質(zhì)量。

 

Consider thesestaffing examples from FDA warning letters and 483 observations:

 

看看FDA警告信和483缺陷報(bào)告中的人員配置例子:

 

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)

 

你們沒(méi)有提供足夠數(shù)量的合格人員來(lái)執(zhí)行和監(jiān)督每個(gè)藥品的生產(chǎn)、加工、包裝或保存。具體來(lái)說(shuō)，在一次面談中，質(zhì)量經(jīng)理表示，調(diào)查往往由于人員缺乏而沒(méi)有進(jìn)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)

 

貴公司執(zhí)行和審查投訴調(diào)查的人員數(shù)量不足，證據(jù)是沒(méi)有按照程序要求對(duì)重要投訴進(jìn)行審查，而且事實(shí)是，一旦發(fā)現(xiàn)缺陷，你們就請(qǐng)外界協(xié)助進(jìn)行審查，這應(yīng)該由QA人員來(lái)完成。

 

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

 

這些例子暗示了幾個(gè)不同的管理問(wèn)題，綜合起來(lái)，可能導(dǎo)致了FDA引用的問(wèn)題：

 

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，在沒(méi)有考慮所有必須執(zhí)行的cGMP合規(guī)任務(wù)的情況下做出了人事決策——例如，不雇用人員或允許取消空缺職位。如果該公司有一份所需工作以及由誰(shuí)執(zhí)行的列表，他們就可以發(fā)現(xiàn)關(guān)鍵活動(dòng)沒(méi)有人員，因此無(wú)法執(zhí)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，似乎沒(méi)有注意到未能完成任務(wù)的情況。如果在持續(xù)進(jìn)行的管理評(píng)審中提出投訴/關(guān)閉率的衡量標(biāo)準(zhǔn)，就可能發(fā)現(xiàn)收到投訴但未關(guān)閉，需要調(diào)查但未進(jìn)行，等等。如果看到了這些趨勢(shì)，那么良好的做法應(yīng)該是查明它們發(fā)生的原因，重新調(diào)整人員以處理這些領(lǐng)域，然后進(jìn)行監(jiān)測(cè)。

 

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

 

“管理問(wèn)題”可能通過(guò)其他問(wèn)題發(fā)現(xiàn)

 

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.

 

將“管理問(wèn)題”作為根本原因如此之少的另一個(gè)潛在原因可能是，該問(wèn)題還導(dǎo)致了其他人員犯了一個(gè)錯(cuò)誤——可能是操作人員。對(duì)此，通常我們會(huì)發(fā)現(xiàn)操作人員錯(cuò)誤，并集中調(diào)查錯(cuò)誤發(fā)生的原因。只有這樣，我們才能識(shí)別出由“管理問(wèn)題”導(dǎo)致的錯(cuò)誤，假設(shè)我們的根本原因分析足夠好，可以讓我們找到根本原因。

 

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.) 

 

當(dāng)情況發(fā)生時(shí)，操作人員應(yīng)對(duì)不當(dāng)或做出了未經(jīng)授權(quán)的決定。這咋一看像是“人為錯(cuò)誤”，但進(jìn)一步的調(diào)查發(fā)現(xiàn)，操作人員需要指導(dǎo)，而他們的主管卻不在，這讓操作人員在沒(méi)有適當(dāng)指導(dǎo)的情況下決定該怎么辦。在這種情況下，監(jiān)督者沒(méi)有提供足夠的監(jiān)督。(操作人員應(yīng)經(jīng)過(guò)培訓(xùn)和確認(rèn)以執(zhí)行任務(wù)和處理常見(jiàn)問(wèn)題；然而，培訓(xùn)不能解決可能發(fā)生的每一種情況，這就是為什么需要監(jiān)督和指導(dǎo)。)

 

Other problemsmay occur when:

 

其他問(wèn)題可能發(fā)生在以下情況:

 

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. 

 

未設(shè)定期望，溝通也不恰當(dāng)。因此，操作員在沒(méi)有完全了解期望的情況下工作，并做出他們認(rèn)為是可接受的決定。如果他們理解了管理層的期望，操作人員可能會(huì)做出不同的決定。

 

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.

 

要求發(fā)生改變，但沒(méi)有提供足夠的信息說(shuō)明它在工作環(huán)境中的涵義。或者，在錯(cuò)誤被發(fā)現(xiàn)之前，它不會(huì)被傳達(dá)至那些繼續(xù)維持現(xiàn)狀的特定人群。

 

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.

 

違反要求而管理人員不進(jìn)行糾正。放任違反要求的行為——即使是優(yōu)秀的員工——也會(huì)損害管理者的誠(chéng)信，而且不利于員工理解績(jī)效期望。例如，這種情況可能發(fā)生在管理者對(duì)政策/實(shí)踐不夠熟悉，或者如果他們沒(méi)有人員管理技能和回避困難對(duì)話。

 

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

 

這些情況和其他情況也可以在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)

 

你們的管理層未能阻止產(chǎn)品樣品重復(fù)測(cè)試而未經(jīng)調(diào)查，長(zhǎng)期存在重寫(xiě)和/或遺漏原始CGMP記錄而沒(méi)有實(shí)施控制以防止數(shù)據(jù)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)

 

一名員工在潔凈室進(jìn)行泡點(diǎn)測(cè)試的演示時(shí)，被觀察到他們的發(fā)套佩戴不正確，在整個(gè)演示過(guò)程中，將約15英寸的頭發(fā)暴露在環(huán)境中。在FDA人員提請(qǐng)?jiān)搯T工注意后，主管人員直到演示完成后才示意該員工改正缺陷。

 

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)

 

你們的質(zhì)量保證經(jīng)理表示，除非客戶要求，否則不會(huì)進(jìn)行調(diào)查。但是，你們公司的標(biāo)準(zhǔn)操作規(guī)程規(guī)定，只要客戶的樣品結(jié)果超出規(guī)定標(biāo)準(zhǔn)，就必須進(jìn)行調(diào)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)

 

你們的回復(fù)表明：1)你們的培訓(xùn)是無(wú)效的；2)程序不可用；3)程序不清晰；或者4)你們的員工未被授權(quán)履行他們的職責(zé)。請(qǐng)?jiān)u論你們的領(lǐng)導(dǎo)層將如何確保你們公司的程序被完全遵守，以達(dá)到可接受的合規(guī)水平。

 

How To IdentifySituations As “Management Problems”

 

如何識(shí)別為“管理問(wèn)題”

 

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.

 

識(shí)別這些問(wèn)題需要一個(gè)可靠的根本原因分析程序。調(diào)查必須找出問(wèn)題的真正根源——根本原因，而不僅僅是具體事件的直接原因。5個(gè)為什么方法是一個(gè)有用的實(shí)踐，有助于確定問(wèn)題的根本原因。

 

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.

 

通過(guò)本文前面提到的根源層次結(jié)構(gòu)(圖1)的各個(gè)層次，使用5個(gè)為什么來(lái)確定問(wèn)題的根本原因。問(wèn)題被提出，推到等級(jí)制度中最合理的層次。識(shí)別“管理問(wèn)題”的關(guān)鍵是通過(guò)分析——它們通常不會(huì)是你首先看到的東西。

 

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，如果我們對(duì)FDA之前的警告信進(jìn)行“5個(gè)為什么”分析——就我們所知——它可能是這樣的:

 

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:

 

你們的質(zhì)量保證經(jīng)理表示，除非客戶要求，否則不會(huì)進(jìn)行調(diào)查。但是，貴公司的標(biāo)準(zhǔn)操作規(guī)程(SOPs)規(guī)定，當(dāng)客戶的抽樣結(jié)果超出規(guī)定標(biāo)準(zhǔn)時(shí)，必須進(jìn)行調(diào)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.

 

為什么經(jīng)理的解釋和SOP有差異?根據(jù)我們從觀察中收集到的信息，可能經(jīng)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.

 

為什么經(jīng)理不熟悉SOP ？有可能他的培訓(xùn)里沒(méi)有這些內(nèi)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.

 

為什么沒(méi)有被包括在他的培訓(xùn)計(jì)劃中？有可能在制定或分配該職位的培訓(xùn)課程時(shí)忽略了此內(nèi)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.” 

 

這可以被歸類(lèi)為“管理問(wèn)題”，并細(xì)分為“政策傳達(dá)不充分：需要了解這些SOP的個(gè)人沒(méi)有被適當(dāng)?shù)馗嬷鼈兊拇嬖诤蛢?nèi)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.

 

你可能會(huì)忍不住把這稱(chēng)為“培訓(xùn)缺乏癥”，但事實(shí)并非如此。根據(jù)我們的5個(gè)為什么，培訓(xùn)失敗不是因?yàn)槲覀儾恢肋@個(gè)人需要培訓(xùn)。我們之所以不知道這一點(diǎn)，是因?yàn)檎叽嬖诘](méi)有分配給所有需要了解它的人這一“管理問(wèn)題”。一些需要的東西沒(méi)有到位，導(dǎo)致了其他問(wèn)題。

 

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.

 

一旦你開(kāi)始問(wèn)“為什么?”當(dāng)情況發(fā)生時(shí)，你會(huì)驚訝地發(fā)現(xiàn)有那么多問(wèn)題可能被確定為“管理問(wèn)題”——遠(yuǎn)遠(yuǎn)超過(guò)大多數(shù)公司目前看到的<10%。

 

Avoiding “ManagementProblems”

 

避免“管理問(wèn)題”

 

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:

 

處理這些問(wèn)題的最好辦法就是從一開(kāi)始就避免它們——讓管理者知道他們需要做的工作。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

 

強(qiáng)調(diào)傳達(dá)期望的重要性，使員工能夠與期望聯(lián)系起來(lái)，并將其應(yīng)用到日常任務(wù)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

 

公司領(lǐng)導(dǎo)層設(shè)定期望，并給予管理人員時(shí)間，讓其與他們的團(tuán)隊(duì)在一起，以提供監(jiān)督、即時(shí)輔導(dǎo)和指導(dǎo)

 

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

 

由組織的所有級(jí)別進(jìn)行適當(dāng)?shù)谋O(jiān)督，重點(diǎn)關(guān)注與法規(guī)符合性相關(guān)的活動(dòng)的成功表現(xiàn)，而不僅僅是業(yè)務(wù)結(jié)果

 

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

 

為決策者提供適當(dāng)?shù)男畔ⅲ绻ぷ魅蝿?wù)的列表或識(shí)別符合性與業(yè)務(wù)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

 

在決策過(guò)程中考慮短期和長(zhǎng)期風(fēng)險(xiǎn)，在實(shí)施之前評(píng)估可能的決策，并識(shí)別與每個(gè)選擇相關(guān)的潛在風(fēng)險(xiǎn)

 

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

 

在決策和實(shí)施過(guò)程中基于評(píng)估過(guò)程中識(shí)別出的風(fēng)險(xiǎn)制定備選計(jì)劃

 

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

 

提供培養(yǎng)人員管理所需的“軟技能”的培訓(xùn)項(xiàng)目，如溝通、輔導(dǎo)、績(jī)效管理流程和策略，以及確保管理人員擁有適合其職位的技術(shù)知識(shí)

 

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.

 

管理是一項(xiàng)困難的工作，如果管理者沒(méi)有有效執(zhí)行所需要的東西，就會(huì)變得更加困難。在這方面，管理人員和操作人員沒(méi)有什么不同。他們的不同之處在于，“管理問(wèn)題”如果被允許繼續(xù)未經(jīng)調(diào)查和檢查，可能會(huì)對(duì)組織的績(jī)效造成更大的代價(jià)。當(dāng)根本原因分析期間沒(méi)有考慮或識(shí)別“管理問(wèn)題”時(shí)，就會(huì)發(fā)生這種情況。