Human Performance In Biopharma Operations — Your Problem Isn't Error
本文来自制药在线文章翻译
This article is the first part of a two-part roundtable Q&A focused on human performance in pharmaceutical operations. Part 1 discusses key drivers for human performance improvement, compares lean manufacturing and human performance programs, and provides perspectives on human performance in the context of the rapid scale-up and production of COVID-19 therapeutics and vaccines. Part 2 will review human performance in the context of company investigation and CAPA programs. The four participants in the Q&A have significant combined experience in manufacturing operations and human and organizational performance:本文是聚焦于制药操作中的人员绩效的两部分圆桌问答的第一部分。第1部分讨论了人员绩效改善的关键驱动因素，比较了精益生产和人员绩效计划，并在COVID-19疗法和疫苗快速扩大和生产的背景下，提供了人员绩效的观点。第2部分将在公司调查和CAPA计划的背景下回顾人员绩效。在问答环节的四位参与者在制造运营和人力和组织绩效方面都有重要的综合经验:
- John Wilkes is the human performance lead for biologics at AstraZeneca. He has more than 25 years of experience in industry, with experience in manufacturing operations, operational excellence, quality systems, and quality control.John Wilkes是阿斯利康(AstraZeneca)生物制剂部门的人员绩效负责人。他在工业领域有超过25年的经验，在制造运营、卓越运营、质量体系和质量控制方面有丰富的经验。
- Clifford Berry is the head of business excellence for Takeda at its Massachusetts Biologics Operations site. He has been a human and organizational performance practitioner since 1999, with experiences in commercial nuclear electrical generation, electric transmission and distribution, and biopharma.Clifford Berry是武田制药马萨诸塞州生物制品运营中心的卓越业务主管。自1999年以来，他一直是一名人员和组织绩效实践者，在商业核能发电、电力传输和配电和生物制药领域拥有经验。
- Amy D. Wilson, Ph.D., is the global human performance lead for Biogen. She has more than 20 years of experience in biopharma manufacturing, with focuses on human and organizational performance, operational excellence, risk management, and technical training.Amy D. Wilson博士是Biogen公司的全球人员绩效领导。她在生物制药制造方面有20多年的经验，专注于人员和组织绩效、卓越运营、风险管理和技术培训。
- Jim Morris, executive director at NSF Health Sciences, with over 30 years’ pharmaceutical operations experience in quality and manufacturing, is often leading consulting and training projects in investigation and CAPA management.Jim Morris, NSF Health Sciences的执行董事，在质量和生产方面有30多年的制药运营经验，经常领导调查和CAPA管理方面的咨询和培训项目。
Although the responses to each of the questions were provided independently, common themes stand out — offering insight into how forward-thinking organizations view human performance and treat “human error” in the workplace.尽管对每个问题的回答都是独立的，但突出了共同的主题出来，提供了组织如何看待人员绩效和如何对待工作场所的“人为差错”的前瞻性的见解。What underpins human performance improvement in pharmaceutical operations?John Wilkes, AstraZeneca:Underpinning human performance improvement in pharmaceutical operations begins with the organization’s mindset toward error. Science has shown that error is a normal performance attribute of human behavior, occurring not only in work with failed outcomes but also, and most importantly, in work with successful outcomes. Shifting the organization’s mindset from “error” as the exceptional cause of failure to a mindset that it is normal and not causal is challenging. However, the effect of this shift is profound. It moves the focus of improvement from fixing the “errors” of workers toward improving the effectiveness of the management of performance risk and operational learning.
在制药业务中支持人员绩效的改善始于组织的错误思维。科学已经表明，错误是人类行为的正常表现属性，不仅在失败的结果中出现，而且最重要的是，在成功的结果中也会出现。将组织的心态从作为失败的特殊原因的“错误”转变为正常的、非因果的心态是一个挑战。然而，这种转变的影响是深远的。它将改进的重点从纠正工人的“错误”转向提高绩效风险管理和操作学习的有效性。
Jim Morris, NSF Health SciencesWhat underpins human performance in an organization is, in my view, open communication across levels and between functions. In other words, an open reporting environment where employees are encouraged to report error traps and are empowered to take action will lead to long-term improvement. Co-worker relationships based on trust will encourage reporting and a collaborative approach to problem solving.在我看来，在一个组织中，支撑人员绩效的是跨级别和职能之间的开放沟通。换句话说，一个开放的报告环境，鼓励员工报告错误并被赋能采取行动，将导致长期的改善。建立在信任基础上的同事关系将鼓励汇报和合作解决问题的方法。Amy D. Wilson, Ph.D., BiogenHuman performance at Biogen is primarily characterized by a recognition of people as necessary drivers of success rather than as a variable that creates failure through error. This perspective drives us to ask different questions when we seek to understand both how failure occurs and how success is achieved, which ensures our improvement efforts are focused in areas that will actually improve overall system performance. The underpinnings of human performance in pharmaceutical operations are principles that include a recognition that people are fallible but come to work to do a good job, that systems and context drive behaviors, that systems are complex and imperfect, that our response to failure matters, that learning is vital and blame fixes nothing, and that reliability is the presence of controls and not an absence of accidents or deviations.Biogen的人员绩效的主要特征是承认人是成功的必要驱动因素，而不是通过错误导致失败的变量。当我们试图理解失败是如何发生的以及成功是如何实现的时候，这种观点促使我们提出不同的问题，这确保了我们的改进努力集中在将实际提高整个系统性能的领域。医药运营中的人员绩效的基础，是如下原理：承认人的不可靠但初衷是为了把工作做好；系统和环境驱动行为；系统是复杂的和不完美的；我们对失败的反应；学习至关重要而责备于事无补；可靠性是控制的存在，而不是没有事故或偏差。From my perspective, the underpinnings always begin with the principles – those desired shared basic underlying assumptions that shape espoused values and beliefs and ultimately guide how we design, execute, and learn from work. Those principles could be a version of Todd Conklin’s five principles, the principles that originated with Tony Muschara at the Institute for Nuclear Power Operations, or Takeda’s seven human and organizational performance principles. You need some variant that works for your organization that includes the concepts that people have good intentions, error is normal, systems are complex and fail, how we respond to failure matters, and blame fixes nothing.在我看来，基础总是从原则开始的，那些需要共享的基本假设，它们塑造了所拥护的价值观和信念，并最终指导我们如何设计、执行和从工作中学习。这些原则可能是托德·康克林(Todd Conklin)的五项原则的一个版本，这五项原则源自核能运行研究所(Institute for Nuclear Power Operations)的托尼·穆萨拉(Tony Muschara)，或者武田公司(Takeda)的七条人和组织绩效原则。您需要一些适用于组织的变体，包括这样的概念:人们的意图是好的，错误是正常的，系统是复杂的和失败的，我们如何应对失败很重要，责备什么也解决不了。Takeaways For Improvement:
- Shift the mindset from “fixing” errors to reducing performance risk and increasing operational learning.将思维模式从“修复”错误转变为降低性能风险和增加运营学习。
- Create a safe environment for reporting near misses and possible error traps.创建一个安全的环境来报告未遂事件和可能的错误陷阱。
- Shift the mindset to recognizing that systems and context drive behaviors and our response to failure matters.转变思维方式，认识到系统和环境驱动行为，以及我们对失败的反应很重要。
- Establish shared principles to guide how we design, execute, and learn from work.建立共同的原则来指导我们如何从工作中设计、执行和学习。
What changes do you feel bring about the greatest improvement in human performance on the plant floor?
你觉得什么样的变化能最大程度地提高员工的工作效率?
Make time for conversations about risk before work begins. This dialogue could be informal or more formal, like a pre-job brief. Discuss the human actions that could trigger immediate, irreversible, and intolerable failure. Talk about where controls to prevent harm to people or product may be insufficient and how that risk will be managed. One way to create positive control during work where there is risk of failure is by staying in role for the natural duration of the task – avoid swapping performer and verifier roles. Lastly, when the task ends, talk about the work – how it went well, surprises and difficulties encountered, and share the learning with leaders.在工作开始之前，花点时间来讨论风险。这种对话可以是非正式的，也可以更正式一些，比如工作前的简短陈述。讨论可能引发立即的、不可逆转的、无法忍受的失败的人员行为。讨论在哪些地方防止对人或产品造成伤害的控制可能不够，以及如何管理这种风险。在存在失败风险的工作中创建积极控制的一种方法是，在任务的自然持续时间内保持角色不变——避免交换执行者和验证者角色。最后，当任务结束时，谈谈工作——它是如何进行的，遇到的意外和困难，并与领导分享学习。Operational learning – improving human performance – means strengthening the understanding of performance risk, improving the risk competence of workers, and establishing defenses that effectively manage the consequence of human error where it matters most. The key action is to improve the organization’s ability to receive feedback from operations. This feedback is the fuel for improvement. Acting on this feedback consistently and with urgency defines learning and continuous improvement.提高人员绩效的操作学习，意味着加强对绩效风险的理解，提高员工的风险能力，并建立防御机制，在最重要的地方有效管理人为差错的后果。关键的行动是提高组织从运作中接收反馈的能力。这种反馈是改进的动力。对反馈的持续和紧急的行动定义了学习和持续改进。Pre- and post-action reviews of activity at the unit level will bring about a significant improvement in human performance. Those organizations that institutionalize practices that prepare people to execute work and embed after-action reviews will see a significant improvement in human performance. Subject matter experts must be involved in these reviews. And, organizations that prepare SMEs as trainers and mentors will indirectly ensure these reviews are effective. Institutionalizing these practices is hard work, requiring discipline and leadership support.在部门级活动前后的审查将大大改善人的绩效。那些将实践制度化，让人们准备好执行工作，并嵌入事后回顾的组织，将看到人员绩效的显著改善。主题专家必须参与这些评审。并且，组织将主题专家培养为培训师和导师将间接地确保这些审查是有效的。将这些实践制度化是一项艰苦的工作，需要纪律和领导的支持。First, I think it’s important to equate human performance with overall performance. Human performance is not separate. If one makes it easier to “get it right” and harder to “get it wrong,” you will see overall improvement in success rates and operational metric performance. In terms of what drives significant improvement, we have seen the greatest impact from: (1) implementing formal risk management practices on the plant floor, such as pre-job briefs and three-part communication, (2) improving the way we learn from deviations, and (3) improving the way we learn in general from operations through learning teams, after-action reviews, post-job reviews, and work observations.首先，我认为把人员绩效和整体绩效等同起来是很重要的。人员绩效不是独立的。如果一种方法使“做对”更容易，而“做错”更困难，那么将看到成功率和操作度量性能的整体提高。在驱动器的显著改善方面，我们看到最大的影响来自:(1)在工厂现场实施正式的风险管理实践，如班前短会和三步沟通,(3)提高我们通过学习团队、行动后回顾、工作后回顾和工作观察，从运营中学习的方式。Takeaways For Improvement:
- Make time for conversations about risk before work begins.
- Improve the organization’s ability to receive and act on feedback from operations.
- Develop subject matter experts to serve as effective trainers / mentors.
- Focus on operational learning, considering pre-job briefs, after-action reviews, learning teams.专注于操作性学习，考虑班前短会、工作后回顾、学习团队。
