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:

許多生產基地仍在使用紙質記錄，并逐漸向實驗室或生產車間的電子系統過渡。對制藥操作中差錯類型的分析通常會揭示一些共性問題：

Documentation errors including missed signatures, wrong dates, etc.

文件記錄差錯：包括漏簽名、日期錯誤等。

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

生產相關差錯：如不合格品處理不當或未遵循批記錄（漏采樣、混合時間超標等）。

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

實驗室差錯：如樣品制備問題、未及時讀取環境監測培養皿結果、穩定性樣品提取延遲等。

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?

這些差錯的最大共性在于，通過額外培訓或重新設計文件體系與工作環境，可降低再次發生的概率。然而，“系統性” 思維的支持者指出，需解決更深層次的普遍性問題，例如人員培訓方式、跨班次溝通機制，以及工作中可用工具的完備性。那么，既然我們已了解這些重復性問題的根源，為何生產基地的管理者仍對本可避免的人為差錯感到困擾？

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，我們必須探索減少人為差錯率的替代方案。大多數管理者可能認同：當人員反復執行某項任務時，容易形成工作節奏，差錯率會顯著降低。但當生產量低、操作頻率不高時，很難形成固定節奏，這種環境可被稱為 “高差錯” 生產環境，也是許多制藥 / 生物科技企業的典型特征。

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?

生產操作的核心目標是盡可能減少變異性并標準化工作。主要措施包括操作自動化、部署卓越運營計劃、簡化文件復雜性，以及分析工作流程以區分普通原因和特殊原因變異。這些措施固然有效，但經驗表明差錯率仍會存在。那么，我們還能做什么？

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.

多年來，我們一直專注于調查體系的改進，并圍繞該主題開設了大量課程，內容包括通過優化認知負荷、減少干擾、簡化工作流程來提升人員表現。我們避免將事件歸類為 “人為差錯”，而是審慎地將差錯與其他可解釋事件的因素關聯。我還注意到，擅長解決問題的組織往往具備敏捷性，其問題解決周期短，能快速處理次要問題，并建立可快速響應的工作架構。

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.

降低差錯率的解決方案豐富多樣，生產基地通常需從多個角度切入。本文的核心前提是：若為人員創造成功條件，他們就能出色完成工作。因此，解決方案需 “以人員為中心”，致力于減輕認知負荷（減少干擾），使人員能更一致、更高效地執行任務。方案一側重于優化工作執行以減少差錯發生；方案二旨在營造有效調查機制以降低差錯復發。

Solution Set 1 — Reducing Error Occurrence

方案一：減少差錯發生

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.

重點在于通過標準化工作和最小化執行變異性來減少差錯。可采取的措施很多，但以下四個領域尤為關鍵：

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

標準操作規程（SOP）簡化與工作指南的應用必須是持續性工作，而非一次性行動。

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.

若僅作為 “一次性項目” 推進，只能帶來短期效益。SOP 簡化應融入工作程序開發的全過程。

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

聚焦于人員執行工作所需的核心知識。

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.

崗位培訓課程常包含 “非必需” 的 SOP 內容，應將培訓重點放在人員完成工作的 “必需知識” 上。

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

向人員灌輸 “GMP 習慣”。

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.

針對每日必做的任務（如填寫日志、錄入數據、審核檢測記錄等）進行專項培訓。即使不在高產量環境中，每日任務仍易出錯，需標準化這些任務并提供 “GMP 習慣” 培訓，以減少可避免的差錯。

4. Develop a job execution mindset among personnel.

培養人員的 “工作執行思維”。

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.

運動員賽前會熱身，但多數員工開始工作前缺乏 “熱身”。嵌入班前簡報等日常習慣，可幫助人員聚焦當前任務，預防可避免的差錯。

Solution Set 2 — Drive Out Error Reoccurrence

方案二：杜絕差錯復發

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

可采取的措施眾多，但以下是打造敏捷型問題解決組織的核心行動：

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

建立基于患者風險和業務風險的事件快速分類能力與體系。

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

多數調查程序缺乏此能力，導致系統負荷過重、調查支持團隊不堪重負。

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

建立營造 “運營學習環境” 的組織機制。

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).

包括組建學習團隊、開展班前簡報與事后回顧，以及在工作執行中保持角色固定（如避免驗證者與執行者角色交叉）。

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

確保每個單元操作中均有精通產品與工藝的主題專家，負責深度調查。

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.

培養事件分類、主持工作單元會議（如班前簡報、事后回顧）的能力，以及支持公司調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.

人為差錯常源于溝通不暢、職責不清或理解不全。因此，此類問題首先不應被歸類為 “差錯”，而需深入分析其影響因素，以制定合適的措施或糾正與預防措施（CAPA）。接納 “運營學習” 的生產基地，可通過改善信息流更有效避免差錯。

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.

調查程序的目標是找出根本原因、評估患者風險，并確定有效的解決方案或 CAPA。若工作架構能使一線人員（在質量體系內）快速處理次要問題，同時將更多精力投入復雜問題的根本原因分析，最終必將產生更有效的 CAPA。

Management Buy-In

管理層支持

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.

本質上，我們需要通過提升工作專注度和優化調查效率來構建新的工作模式。管理層需全程參與并營造安全的環境，使人員敢于報告和處理差錯相關調查。若管理層不愿為新工作模式的制度化提供支持，變革將難以持續。建議管理層選擇易于衡量、理解和追蹤進展的指標。

In Summary

總結

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

持續推進操作自動化與簡化的各項措施。

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

選擇能簡化工作、減少可避免差錯的解決方案。

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

培養快速、持續的事件分類技能與能力。

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

將運營學習機制融入日常工作。

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

制定計劃以維持新工作模式并實現制度化。

6. Select a metric to track and recognize progress.

選擇指標以追蹤和評估進展。

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.

總之，上述問題無捷徑可走，亦無快速解決方案。這是一條漫長的道路，但領導者必須邁出第一步 —— 從企業最重要的資產 “人員” 開始。