Root Cause Investigations for CAPA:
Clear and Simple
《CAPA根本原因调查：简单明了》
James L. Vesper
PDA
Bethesda, MD, USA
DHI Publishing, LLC
River Grove, IL, USA
19
LEARNING FROM SUCCESSES AND FAILURES
从成功与失败中汲取经验
If you do a Google search for pithy quotes on the phrase “learning from mistakes,” you will find sites that have upwards of 1,000 of relevant ones. (For example, go to www.brainyquote.com/topics/ mistakes-quotes.) Most of the quotes fit into the category of “mistakes happen but they can be valuable sources of learning.”
若在谷歌搜索关于“从错误中学习”的箴言，可发现大量相关引述（例如访问www.brainyquote.com/topics/mistakes-quotes）。其中多数观点可归结为：“错误难免发生，但它们是宝贵的学习源泉。”
Publicly discussing mistakes has become its own industry: the Wall Street Journal described Eli Lilly and Company’s “Failure Parities” (Burton, 2004). In Los Angeles, the Museum of Failure (www.failuremuseum.com) showed examples of over 100 objects that, looking at them with hindsight, prompts the question, “Who thought that was a good idea?” For entrepreneurs, there are “failurecons” (www.thefailcon.com) and similar events held around the world where it becomes a badge of honor to share stories of what went wrong in an endeavor and what was learned. Failcon’s motto: “Embrace your mistakes. Build your success.”
公开探讨失败已自成产业：《华尔街日报》曾报道礼来公司（Eli Lilly and Company）举办“失败派对”（Failure Parties）的实践（Burton, 2004）。洛杉矶的“失败博物馆”（www.failuremuseum.com）则展出了百余件展品，以今人视角审视时，令人不禁发问：“当初是谁认为这是个好主意？”对创业者而言，全球各地举办的“失败大会”（Failcon, www.thefailcon.com）等活动，已成为分享项目失败故事与经验教训的荣誉勋章。Failcon的座右铭精准点题：“拥抱错误，成就成功。”（Embrace your mistakes. Build your success.）
In this chapter we will look at why we sometimes do not learn from mistakes and failures, as well as some structured and unstructured ways that we can do this better.
本章将探讨为何人们有时无法从错误与失败中学习，并介绍提升学习效果的结构化与非结构化方法。
When we are pursuing a goal or are on a path, it is not until we recognize on our own or through the intervention of someone else that we have made a mistake. For example:
• We see that we’re going the wrong direction on a highway.
• An instrument gives a result showing that we have incorrectly diluted a sample.
• A colleague points out that the scale used in weighing out materials has been out of calibration for the past two weeks but the situation had not been communicated.
当我们追求某个目标或执行某项任务时，往往需通过自主察觉或经他人提醒才能意识到错误。例如：
·方向误判：在高速公路上行驶时发现方向错误；
·操作失误：仪器检测结果显示样本稀释步骤有误；
·信息断层：同事指出称量设备过去两周处于未校准状态，但该问题未被及时通报。
For most of us, when things like that happen, embarrassment, shame, self-doubt, and fear take hold as well as thoughts of how to hide, redo, or fix the problem so no one else discovers it—things we learned from a very early age: when we do something that is “wrong,” we get blamed for it. In school, if we did not select the right answer because we interpreted the question in a different way than the teacher intended, we still will get the answer scored as wrong. So, from early on, we are molded by the social environment around us to see errors, mistakes, failures, and not meeting expectations or goals as bad—something to be avoided. But errors, mistakes, failures, and the like are part of what we are as humans. According to St Augustine, “Fallor ergo sum,” or “I err, therefore I am.” In complicated systems, failures are inevitable (Perrow, 1999).
对于我们大多数人来说，当事情发生时，羞愧、自责和恐惧会同时袭来，而我们从很小的时候就学会了：当我们做错事时，就会被指责。在学校里，如果我们没有选择正确的答案是因为我们以不同的方式解释了问题，即使我们得到了错误的分数。因此，从早期开始，我们就被周围的社会环境所塑造，认为错误、失误、失败和未达到期望或目标是不好的——需要避免的东西。但错误、失误、失败等是我们作为人类的一部分。根据圣奥古斯丁的说法，“我犯错，所以我存在。”在复杂系统中，失败是不可避免的（Perrow, 1999）。
How then can we learn from our errors and failures if we’ve grown up being told mistakes are bad? How do our organizations extract some sort of value from deviations and quality events? This chapter presents several different approaches to learning from mistakes that are used in a variety of organizations.
如果我们从小就被教导错误是坏事，那么我们如何从错误和失败中学习呢？我们的组织如何从偏差和质量问题中提取某种价值？本章介绍了几种不同的方法，这些方法在各种组织中用于从错误中学习。
“FAIL FAST, FAIL OFTEN” (BUT FAIL SAFELY)
‘快速失败，频繁失败’（但要安全地失败）
Some entrepreneurs including many in Silicon Valley have adopted the mantra of “fail fast, fail often.” That approach can be useful in some phases of discovery or development, but it is not the best if one is trying to operate in a state of control.
一些企业家，包括许多硅谷的企业家，已经采用了“快速失败，频繁失败”的信条。这种方法在某些阶段的发现或开发中可能是有用的，但当试图在一个受控状态下运营时，并不是最好的方法。
When someone is learning a task and you want them to acquire hands-on experience and the tacit knowledge—the “know how”— that comes through practice, “fail safely” needs to be a requisite part of that mantra. Being able to develop one’s skills in a low-risk Learning from Successes and Failures 275 setting is critical. In the information technology (IT) world, having multiple instances of a computer application usually includes a “sandbox” where programmers can experiment without affecting the validated production system. Some pharma and biopharma f irms and training institutes (like the PDA’s Training and Research Institute in Bethesda, MD) have production lines or manufacturing suites dedicated to training without putting product (or patients) at risk. New technologies such as augmented reality and virtual reality are being used in providing an authentic learning experience in a safe way.
当某人正在学习一项任务，而你希望他们获得实践经验以及通过实践而来的隐性知识——即‘知道如何做’时，‘安全失败’必须成为这一准则的必要组成部分。能够在低风险环境中培养个人技能至关重要。在信息技术（IT）领域，拥有多个计算机应用实例通常包含一个‘沙盒’，程序员可在其中进行实验，而不会影响经验证的生产系统。部分制药和生物制药公司及培训机构（如位于马里兰州贝塞斯达的PDA培训研究所）设有专门用于培训的生产线或制造车间，避免让产品（或患者）承担风险。增强现实和虚拟现实等新技术正被用于以安全方式提供真实的学习体验。
Success is a useful teacher, but experiencing a failure can be an even more compelling memorable experience. We have all had situations where, afterwards, we say “I will never do that again!” Providing a safe environment for learning by failures—and having a “soft landing” where no real harm occurs—is a very powerful way to acquire knowledge.
成功是一个有用的老师，但经历失败可以成为更令人难忘的体验。我们都有过这样的情况，之后我们会说“我再也不会那样做了！”提供一个安全的学习环境以应对失败——并有“软着陆”，不会造成真正的伤害——是获得知识的一种非常有效的方式。
CHARACTERISTICS OF ORGANIZATIONS THAT LEARN FROM MISTAKES
从错误中学习的组织特征
Based on their study of a variety of organizations, Cannon and Edmondson (2005) Identified two types of barriers that prevented organizations from learning. The first, social systems, were mentioned above, specifically those things that we have learned through experience and observation that are intended to protect our personal positions, egos, and self-esteem. The second barrier is with technology systems—not having the ability to track and identify events or not having the foundational knowledge of the process that can help stakeholders understand the issue. The authors propose three steps organizations can take:
基于对各种组织的研究，Cannon和Edmondson（2005）确定了两种阻碍组织学习的障碍。第一个是社会系统——上面已经提到过，特别是那些我们通过经验和观察学到的旨在保护个人立场、自我意识和自尊的东西。第二个障碍是技术系统——没有能力跟踪和识别事件或没有基础知识来帮助利益相关者理解问题的过程。作者提出了组织可以采取的三个步骤:
• Identifying failures: Having a safe environment where people can report failures; using minimal inventory practices that make problems more visible (the rocks in the river metaphor where having a bloated inventory is the high water level that covers up the problems that occur); trending and looking for anomalies, including those that are considered not serious.
• 识别失败：确保有一个安全的环境，让人们可以报告失败；使用使问题更显而易见的最小库存实践（河流中的石头比喻，即高水位掩盖了出现的问题）；趋势和寻找异常，包括那些被认为不严重的问题。
• Analyzing failures: An organization that has a long-term outlook, patience, and openness; investigating small failures, not only large ones; using formal analysis tools, not just expert intuition; having a thorough understanding of the underlying process; commitment to deep learning and continually asking “why?” to get beyond the easy answers like “the procedure was not followed.”
• 分析失败：一个有长期目标、耐心和开放性的组织；调查小的失败，而不仅仅是大的失败；使用正式分析工具，而不仅仅依靠专家直觉；对根本过程有彻底的理解；致力于深入学习并不断问“为什么？”以超越简单的答案如“程序没有被执行”。
• Deliberately experimenting: A spirit of innovation; a willingness to accept that there will be “failures”; teams of experts who can design and interpret a study; well-designed experiments that can capture knowledge.
• 有意识的实验精神：创新的精神；接受“失败”的意愿；专家团队设计并解释研究；精心设计的实验能够捕捉知识。
One of the most critical aspects in identifying failures is having an organizational culture where people feel safe in reporting such events. Harvard researcher Amy Edmonson (1999) studied a number of nursing units in different hospitals and observed that where the nurses had higher levels of coaching and higher quality of-relationship scores, there were also a higher number of error events that were reported. In studying the culture of the nursing units more carefully, looking at the management style of the head or supervising nurse, it was apparent that groups that had higher levels of internal trust and worker cohesion were more likely to point out errors. In units where the nurses felt nervous and defensive about admitting mistakes, or where talking about issues with the supervisor was like going to the principal’s office, the reporting of errors was suppressed.
在识别失败方面，最重要的一点是拥有一个让人们感到安全报告此类事件的组织文化。哈佛大学研究员艾米·埃德蒙森（1999）研究了不同医院中的多个护理单位，并观察到，在护士们有更高水平的指导和更高质量关系得分的地方，也有更多的错误事件被报告。在仔细研究护理单位的文化时，观察到主管或监督护士的管理风格，很明显那些内部信任度和员工凝聚力较高的团队更有可能指出错误。在那些护士感到紧张和防御、不愿承认错误，或者与主管讨论问题就像去校长办公室的地方，错误报告被压制的情况中，错误报告被抑制。
WHAT ABOUT A “BLAMELESS” CULTURE?
关于“无责文化”
There is a least one multinational pharma firm that has established a “blameless” culture, where there are no penalties for someone if they come forward admitting a mistake or error. Managers at the site, as well as managers at other firms, have said that going “blameless” concerns them in that it would lead to carelessness and people not taking responsibility for their actions.
至少有一家跨国制药企业已建立此类文化——若员工主动承认错误或过失，不会受到处罚。该网站的管理者以及其他公司的高管表示，实施“无责”令他们感到担忧，因为这可能导致员工疏忽大意，不对自己的行为负责。
Edmondson (2011) proposed a spectrum of failures (Chapter 8, Table 2), including many that would be “blameless” while some events—such as fraud, data integrity violations, cover-ups—would justify disciplinary action. Other situations, such as when the process is unstable or when it is overly complex, would not warrant discipline. Another approach, used by the US Air Force, gives personnel 24 hours after an event to report it without retribution. After 24 hours, if it is discovered, those involved would be subject to disciplinary action. It is important that the organization is initially (and repeatedly) clear with all personnel about what their position is and, even more importantly, that the organization stands by its policy and is consistent in applying it. The first time that the organization goes back on its promises, trust will dissolve quickly.
Edmondson（2011）提出了一个失败类型谱系（见第8章表2），其中包括许多“免于追责”的失败，而某些事件——例如欺诈、数据完整性违规、隐瞒行为——则应当采取纪律处分。其他情况，例如流程不稳定或过于复杂时，则不应进行追责。美国空军采用的另一种做法是，允许人员在事件发生后24小时内报告此事而免于处罚；若超过24小时才被发现，相关人员将面临纪律处分。关键在于，组织需在一开始（并反复）向所有人员明确其立场，更重要的是，组织必须恪守其政策并始终如一地执行。一旦组织背弃承诺，信任将迅速瓦解。
AFTER-ACTION REVIEWS
行动后回顾
When analyzing failures as part of the learning from mistakes, the organization is trying to make sense or find meaning based on the quality event or deviation that has occurred. This can be done during reflection when people carefully consider an event, action, or decision and gain personal insights.
在分析失败作为从错误中学习的一部分时，组织试图基于已发生的质量事件或偏差理解意义或寻找含义。这可在反思期间完成——当人们仔细思考某个事件、行动或决策并获得个人洞见时。
One defined approach for this reflection is through after-action reviews, a method formalized by military organizations (US Army, 1993; Garvin, 2000). True after-action reviews not only occur when there has been a failure but also when there has been a success, so as to hopefully repeat the success and apply lessons learned to other situations. In its most basic form, an after-action review seeks to find answers to four key sets of questions:
反思的一种明确定义方法是通过行动后回顾，该方法由军事组织（美国陆军，1993；Garvin，2000）正式确立。真正的行动后回顾不仅发生在失败时，也发生在成功时，以期重复成功并将经验教训应用于其他情境。行动后回顾的最基本形式旨在回答四组关键问题：
1. What was supposed to happen? What was planned?
1.原本应该发生什么？计划是什么？
2. What actually did happen? What were the results?
2.实际发生了什么？结果是什么？
3. Was there a difference between what was planned and the actual results? Why? Why not?
3.计划与实际结果之间是否存在差异？为什么存在（或不存在）差异？
4. What can we learn from this? What do we want to continue/ sustain? What should we do differently next time?
4.我们能从中学到什么？我们希望继续/维持什么？下次应该做出哪些改变？
For large, complicated projects, an after-action review may require significant time, while in other situations, an adequate review may be done very quickly, such as at the end of a work shift or a meeting. Asking “What did we learn today?,” “How can we use this information?,” and “How can we improve?” links learning, knowledge generation, and continual improvement.
对于大型复杂项目，行动后回顾（after-action review）可能需要大量时间；而在其他情境下（例如工作班次结束或会议结束时），进行充分的回顾可以非常迅速。通过提问“今天我们学到了什么？”、“如何利用这些信息？”以及“如何改进？”，可以将学习过程、知识生成与持续改进相连接。
An approach (Birkinshaw et al., 2016) that seeks to increase the “return on failure ratio” identifies a short process to pull as much benefit as possible when a failure happens or when a less than optimal result occurs. The three steps are:
Birkinshaw等人（2016）提出了一种旨在提升“失败回报率”（return on failure ratio）的方法，其核心是在失败或结果未达最优时，通过简短流程提取尽可能多的收益。该流程包含以下三个步骤：
1. Extract as many insights as possible concerning the failure. This can include “assets” such as what was learned, what assumptions should be changed, awareness about future trends, improvement of knowledge and skills by individuals and team members, identification of development needs, and what they would do differently next time. Liabilities of direct, external, internal, and reputational costs must also be considered.
1.提取尽可能多的关于失败的见解。这可以包括“资产”，如所学的知识、应改变的假设、对未来的趋势的认识、个人和团队成员知识和技能的改进，以及他们将如何在下次做出不同的选择。必须考虑直接、外部、内部和声誉成本的负债。
2. Share the results with others in the organization. What were the essential elements of value that have broad applicability?
2.与组织中的其他人分享结果。价值的哪些基本要素具有广泛的适用性？
3. Periodically review patterns of failure. Step back and look to see if there are particular trends that point to underlying issues or vulnerabilities.
3.定期回顾失败模式。回顾并查看是否有特定趋势指向潜在问题或漏洞。
NASA’s Goddard Space Flight Center in Maryland established a similar program called “Pause and Learn” (PaL) that is led by the site’s Chief Knowledge Management Officer. In a white paper describing the process (Rogers, 2004), the roles and responsibilities of attendees and management were described, as shown in Table 1. PaL sessions are conducted throughout a larger project, focus on one recent event, and do not result in a lengthy report (that isn’t usually read).
NASA位于马里兰州的戈达德太空飞行中心（Goddard Space Flight Center）设立了一个类似项目，称为“暂停学习”（Pause and Learn, PaL），由该中心的首席知识管理官领导。在一份描述该流程的白皮书（Rogers, 2004）中，与会者及管理层的角色与职责如表1所示。PaL会议在大型项目进行期间持续开展，聚焦于近期发生的单一事件，且不会生成冗长的报告（这类报告通常不会被阅读）。
A brochure describing the program (Goddard Space Flight Center, undated), explains that the PaL facilitator starts the meeting with these four ground rules:
一份描述该计划的手册（戈达德太空飞行中心，未注明日期）说明，PaL引导师以以下四项基本规则开启会议：
• Be discreet. A PaL session is a closed-door discussion among team members. Unless explicitly stated otherwise, what gets said in the room stays in the room.
• 保持谨慎（Be discreet）：PaL会议是团队成员间的闭门讨论。除非明确说明，否则房间内的讨论内容不得外传。
• Be honest. When the activity being discussed directly involves you, call it as you see it.
• 保持诚实（Be honest）：当讨论的活动与你直接相关时，如实陈述你的观点（call it as you see it）。
• Be tolerant. Others’ opinions and perspectives are equally important, regardless of rank or experience.
• 保持包容（Be tolerant）：无论职级或经验如何，他人的意见和观点同样重要。
• Be a team. When looking at an individual’s actions, view it from the perspective of team responsibility for ensuring excellence.
• 保持团队意识（Be a team）：在审视个人行为时，需从团队对确保卓越表现共同负责的视角出发（view it from the perspective of team responsibility for ensuring excellence）。
Table 1. Roles and responsibilities of those involved in NASA’s Plan and Learn process (Rogers, 2004)
表1. 参与NASA“Plan and Learn”流程人员的角色与职责（Rogers, 2004）
Project attendees need to: 项目参与者需做到 |
Supporting staff need to: 支持人员需做到 |
• Show up to the event when scheduled ● 按时参加活动 –Bring notes or supporting documents –携带笔记或辅助文档 –Be prepared to restate portions of an event in your own words –准备好用自己的话重述事件部分内容 • Do not consider this a lecture or critique ● 不要将此视为讲座或批判 –Relate what happened from your own point of view –从自身角度陈述发生的事件 –Explore alternative courses of action –探索替代行动方案 –Handle discovery of errors positively –积极处理发现的错误 • Follow up on needed actions that you have identified for yourself ● 跟进自己确定需采取的行动 –The PaL is not intended to be an action assignment forum –PaL不是任务分配论坛 –The team may agree on an action or improvement for themselves –团队可为自身达成行动或改进共识 –Likewise, you may have actions you identify for your own improvement –您也可自主制定改进措施 |
• Gather attendees; some projects already hold debrief or talk-down sessions which can be used for PaL sessions ● 召集参与者（部分项目已有的汇报会可兼作PaL） • Have a moderator who will review the events ● 安排主持人审查事件： –Encourage participation - 鼓励参与 –Summarize key events - 总结关键事件 • Have junior leaders restate portions of their activity ● 让初级领导者重述其活动内容 • Do not lecture or critique ● 禁止说教或批判： –Ask why certain events were taken –询问特定事件的原因 –Ask how those involved reacted to situations –询问相关人员的反应 –Ask when actions were initiated –询问行动启动时机 –Exchange “war stories” –交流“实战经验” –Relate events to subsequent results –将事件与后续结果关联 –Explore alternative courses of action –探索替代行动方案 –Handle discovery of errors positively –积极处理发现的错误 –Take notes during the PaL, so all team participants can listen and learn –会议期间记录笔记（全员可专注倾听学习） –Prepare simple report of notes and submit back to the team for review –准备简易报告并提交团队审核 |
THE ROLE OF LEADERSHIP
领导力的角色
Creating an organizational culture that intentionally learns from its mistakes and failures is something that needs to start from the top. Leadership needs to not just say that this is important, but needs to show it. It needs to reward its personnel who, despite the personal and social pressures, have the courage to point out problems that they were involved with. Having policies in place and consistently being in alignment with these policies gives personnel a clear message that everyone has a role in continual improvement.
有意创建一种从错误和失败中学习的组织文化，必须从高层开始。领导层不仅需要口头强调其重要性，更需以身作则。他们需要奖励那些尽管面临个人与社会压力，仍有勇气指出自身所涉问题的员工。通过制定政策并始终如一地贯彻这些政策，领导层向员工传递了一个明确信息：每个人在持续改进中皆扮演着重要角色。
CONCLUSION
结论
To look at life, one can say that everything we do is some sort of an experiment. We often get the intended results, but now and then, particularly when there may be information or experience lacking, the outcome is less than what we were hoping for. To continually improve—a characteristic of every quality program—it is essential to continually learn. Having leadership that sees the value of this and encourages this as a daily practice can find value even in failures.
审视生活，可以说我们所做的一切皆是某种实验。我们常能达成预期结果，但偶尔——尤其在信息或经验不足时——结果会不尽如人意。持续改进（所有质量计划的共性特征）离不开持续学习。拥有能够洞察其价值并鼓励将此作为日常实践的领导者，甚至能从失败中发掘价值。
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