Often sites will still be paper-based and gradually moving to electronic systems in the lab or on the production floor. An analysis of the types of errors in pharmaceutical operations will generally point to very similar problems:

许多生产基地仍在使用纸质记录，并逐渐向实验室或生产车间的电子系统过渡。对制药操作中差错类型的分析通常会揭示一些共性问题：

Documentation errors including missed signatures, wrong dates, etc.

文件记录差错：包括漏签名、日期错误等。

Production related errors in handling rejects or not following the batch record (missed samples, exceeding mixing times, etc.)

生产相关差错：如不合格品处理不当或未遵循批记录（漏采样、混合时间超标等）。

Laboratory errors such as sample preparation issues, not reading environmental monitoring plates on time, late stability sample pulls, etc.

实验室差错：如样品制备问题、未及时读取环境监测培养皿结果、稳定性样品提取延迟等。

What most of these errors have in common is that additional training or reconfiguration of the documentation and workplace will reduce the probability of reoccurrence. However, proponents of “systems” thinking will point to more endemic issues that need to be addressed. These might include the way in which personnel are trained, how personnel communicate across shifts, and what tools they have available or don’t have available to do their work. So, if we understand the causes of these reoccurring issues, why is it that managers at sites continue to be frustrated by what could be labeled as “avoidable” human errors?

这些差错的最大共性在于，通过额外培训或重新设计文件体系与工作环境，可降低再次发生的概率。然而，“系统性” 思维的支持者指出，需解决更深层次的普遍性问题，例如人员培训方式、跨班次沟通机制，以及工作中可用工具的完备性。那么，既然我们已了解这些重复性问题的根源，为何生产基地的管理者仍对本可避免的人为差错感到困扰？

It is in that context that we must consider alternative approaches to reducing human error rates. Most managers would probably also agree that when personnel are given a task to do repeatedly, they are likely to get into a rhythm and error rates will be quite low. However, when production volumes are low and operations are performed infrequently, it is inherently difficult to get into a rhythm. One could describe this is as an “error rich” production environment, which is typical of many pharma/biotech operations.

在此背景下，我们必须探索减少人为差错率的替代方案。大多数管理者可能认同：当人员反复执行某项任务时，容易形成工作节奏，差错率会显著降低。但当生产量低、操作频率不高时，很难形成固定节奏，这种环境可被称为 “高差错” 生产环境，也是许多制药 / 生物科技企业的典型特征。

A key objective in production operations is to minimize variation and standardize work as much as possible. Top initiatives will include automating operations, deploying operational excellence programs, addressing documentation complexity, and analyzing workflows to tease out common and special cause variation. These are all great initiatives, but experience shows that error rates will persist. So, what can we do?

生产操作的核心目标是尽可能减少变异性并标准化工作。主要措施包括操作自动化、部署卓越运营计划、简化文件复杂性，以及分析工作流程以区分普通原因和特殊原因变异。这些措施固然有效，但经验表明差错率仍会存在。那么，我们还能做什么？

I have been close to investigation system improvement for many years and have run dozens of courses on the topic. Included are sessions on improving human performance by optimizing cognitive load, reducing distractions, and making work easier for people to complete. We avoid classifying events as “human error” and judiciously try to associate the error with something else that would explain the event. I also have noticed that organizations that are good at problem solving are quite agile and their problem-solving cycle times are fast. They move the minor issues along quickly and create a work structure that results in quick response and action.

多年来，我们一直专注于调查体系的改进，并围绕该主题开设了大量课程，内容包括通过优化认知负荷、减少干扰、简化工作流程来提升人员表现。我们避免将事件归类为 “人为差错”，而是审慎地将差错与其他可解释事件的因素关联。我还注意到，擅长解决问题的组织往往具备敏捷性，其问题解决周期短，能快速处理次要问题，并建立可快速响应的工作架构。

The menu of solutions to the goal of reducing error rates is extensive and sites will typically tackle it from multiple angles. The prescription offered here is based on the premise that people will do good work if we set them up for success. Therefore, our solutions need to be people-focused and drive toward reducing cognitive load (reducing distractions) so personnel can execute their work more consistently, more often. Solution set #1 involves facilitating job execution to reduce error occurrence. Solution set #2 is aimed at creating an operating environment where the investigative approach is effective at reducing error reoccurrence.

降低差错率的解决方案丰富多样，生产基地通常需从多个角度切入。本文的核心前提是：若为人员创造成功条件，他们就能出色完成工作。因此，解决方案需 “以人员为中心”，致力于减轻认知负荷（减少干扰），使人员能更一致、更高效地执行任务。方案一侧重于优化工作执行以减少差错发生；方案二旨在营造有效调查机制以降低差错复发。

Solution Set 1 — Reducing Error Occurrence

方案一：减少差错发生

The focus here is to select from the menu of initiatives that will standardize work and minimize variability in job execution. There is much that can be done; however, I would like to highlight four areas that foster more focus on task execution.

重点在于通过标准化工作和最小化执行变异性来减少差错。可采取的措施很多，但以下四个领域尤为关键：

1. SOP simplification and the use of work instructions must be an ongoing program, not a one-off initiative.

标准操作规程（SOP）简化与工作指南的应用必须是持续性工作，而非一次性行动。

If tackled as an “initiative” it will only yield short-term benefits. SOP simplification needs to be embedded as part of the way work procedures are developed.

若仅作为 “一次性项目” 推进，只能带来短期效益。SOP 简化应融入工作程序开发的全过程。

2. Focus on what personnel need to know to execute their work.

聚焦于人员执行工作所需的核心知识。

Job curricula often include SOPs that fall into the “nice to know” category. Focus training on what people need to know to do their jobs.

岗位培训课程常包含 “非必需” 的 SOP 内容，应将培训重点放在人员完成工作的 “必需知识” 上。

3. Instill in personnel what I call “GMP habits”.

向人员灌输 “GMP 习惯”。

This is a way of training personnel on those tasks they must do every day, such as completing a logbook, entering data, reviewing a test record, etc. They may not be operating in a high-volume shop, but there will be tasks they complete every day that are prone to error. Standardize those tasks and provide “GMP habit” training for those tasks to drive down avoidable errors.

针对每日必做的任务（如填写日志、录入数据、审核检测记录等）进行专项培训。即使不在高产量环境中，每日任务仍易出错，需标准化这些任务并提供 “GMP 习惯” 培训，以减少可避免的差错。

4. Develop a job execution mindset among personnel.

培养人员的 “工作执行思维”。

Most players in sports warm up before a match. Most workers, however, do not “warm up” before initiating their work. Embedding daily work habits such as pre-job briefs will encourage people to focus on the task at hand and prevent avoidable errors.

运动员赛前会热身，但多数员工开始工作前缺乏 “热身”。嵌入班前简报等日常习惯，可帮助人员聚焦当前任务，预防可避免的差错。

Solution Set 2 — Drive Out Error Reoccurrence

方案二：杜绝差错复发

The menu of options is extensive; however, I recommend several primary actions to move in the direction of the agile, problem-solving organization.

可采取的措施众多，但以下是打造敏捷型问题解决组织的核心行动：

1. Develop the capability and systems to support the rapid triage of events based on risk to patients and risk to the business.

建立基于患者风险和业务风险的事件快速分类能力与体系。

Most investigation programs do not do this well and the result is an overloaded system and an overworked investigations support unit.

多数调查程序缺乏此能力，导致系统负荷过重、调查支持团队不堪重负。

2. Install organizational techniques that create an operational learning environment.

建立营造 “运营学习环境” 的组织机制。

These include forming learning teams, using pre-job briefs and after action reviews, and staying in the role during job execution (e.g. avoid switching verifier and doer roles).

包括组建学习团队、开展班前简报与事后回顾，以及在工作执行中保持角色固定（如避免验证者与执行者角色交叉）。

3. Ensure that within each unit operation there are subject matter experts, deeply knowledgeable of product and process, who can handle in-depth investigations.

确保每个单元操作中均有精通产品与工艺的主题专家，负责深度调查。

4. Develop the skillset to ensure event triage works, personnel are comfortable facilitating work unit meetings (e.g., pre-job briefs, after action reviews), and root cause analysis skills required to support your company’s investigation program are in place.

培养事件分类、主持工作单元会议（如班前简报、事后回顾）的能力，以及支持公司调查程序所需的根本原因分析技能。

Often “human error” is due to lapses in communication, lack of clarity, and incomplete understanding. Thus, these should not be considered “errors” in the first place and their contributing factors need to be understood to identify suitable actions or CAPAs. Sites that embrace operational learning will have a better chance of avoiding “errors” due to the improved flow of information.

人为差错常源于沟通不畅、职责不清或理解不全。因此，此类问题首先不应被归类为 “差错”，而需深入分析其影响因素，以制定合适的措施或纠正与预防措施（CAPA）。接纳 “运营学习” 的生产基地，可通过改善信息流更有效避免差错。

The goal of an investigation program is to get to root cause(s), assess risk to patients, and identify effective solutions or CAPAs. If work is structured such that minor issues are handled quickly by line personnel (within the quality system) and more time is devoted to root cause analysis on the challenging issues, the outcome will undoubtedly be more effective CAPAs.

调查程序的目标是找出根本原因、评估患者风险，并确定有效的解决方案或 CAPA。若工作架构能使一线人员（在质量体系内）快速处理次要问题，同时将更多精力投入复杂问题的根本原因分析，最终必将产生更有效的 CAPA。

Management Buy-In

管理层支持

In essence, what will be achieved is a new way of working, avoiding error through greater job focus and investigating events more effectively. Management needs to be on board and help to create the right environment so that people feel safe reporting and tackling error-related investigations. Change will not be long-lasting unless management is willing to support the investment to institutionalize the new ways of working. Management should select a metric that is easy to measure, easy to understand, and that will track progress.

本质上，我们需要通过提升工作专注度和优化调查效率来构建新的工作模式。管理层需全程参与并营造安全的环境，使人员敢于报告和处理差错相关调查。若管理层不愿为新工作模式的制度化提供支持，变革将难以持续。建议管理层选择易于衡量、理解和追踪进展的指标。

In Summary

总结

1. Continue ongoing initiatives to automate and simplify operations as much as possible.

持续推进操作自动化与简化的各项措施。

2. Select solutions that will make work easier to perform and drive down avoidable errors.

选择能简化工作、减少可避免差错的解决方案。

3. Develop the skills and capability to triage events quickly and consistently.

培养快速、持续的事件分类技能与能力。

4. Build operational learning techniques into day-to-day work.

将运营学习机制融入日常工作。

5. Establish a plan to sustain and institutionalize the new ways of working.

制定计划以维持新工作模式并实现制度化。

6. Select a metric to track and recognize progress.

选择指标以追踪和评估进展。

In conclusion, there are no quick fixes to the problems described above. There are no shortcuts. It’s a long road, but leaders must start somewhere. A good place to start is with your most important asset: your people.

总之，上述问题无捷径可走，亦无快速解决方案。这是一条漫长的道路，但领导者必须迈出第一步 —— 从企业最重要的资产 “人员” 开始。