实验室改善 Laboratory Improvement

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实验室改善”是指运用科学的管理方法和工具，对实验室的人、机、料、法、环、测（5M1E）等要素进行系统性优化，以提升实验室的效率、准确性、安全性、合规性及资源利用率。

这不仅是简单的“打扫卫生”或“买新设备”，而是一场涉及流程、文化、技术和管理的持续变革。

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"Laboratory improvement" refers to the systematic optimization of factors such as personnel, machinery, materials, methods, environment, and testing (5M1E) in a laboratory using scientific management methods and tools, with the aim of enhancing efficiency, accuracy, safety, compliance, and resource utilization.

This is not merely a matter of "cleaning up" or "purchasing new equipment," but a continuous transformation involving processes, culture, technology, and management.

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实验室改善的核心目标

目标

具体体现

提升检测效率

缩短样品流转周期、减少等待时间、提高通量。

保证数据质量

降低人为误差、提高结果准确性和可重复性。

保障人员安全

减少事故风险、规范操作、改善工作环境。

确保合规性

满足ISO/IEC 17025、GLP、GMP、CNAS等标准要求。

降低成本

减少试剂耗材浪费、优化设备使用、节能降耗。

增强可追溯性

样品、数据、操作记录完整、清晰、易查。

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The core goal of laboratory improvement
Specific manifestation of goals
Improve detection efficiency, shorten sample circulation cycle, reduce waiting time, and increase throughput.
Ensure data quality, reduce human error, improve result accuracy and repeatability.
Ensure personnel safety, reduce accident risks, standardize operations, and improve the working environment.
Ensure compliance with standards such as ISO/IEC 17025, GLP, GMP, CNAS, etc.
Reduce costs, minimize waste of reagents and consumables, optimize equipment usage, and save energy and reduce consumption.
Enhance the traceability of samples, data, and operation records to ensure completeness, clarity, and ease of inspection.

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5S管理：现场改善的基础
整理（Seiri）：区分必需与非必需品，清除过期试剂、报废设备、无用文件。
整顿（Seiton）：物品定置定位，标识清晰（如试剂柜、仪器区、安全通道），实现“30秒内找到所需”。
清扫（Seiso）：保持环境整洁，建立日常清洁责任表，防止污染和设备故障。
清洁（Seiketsu）：将前3S标准化、制度化，形成规范。
素养（Shitsuke）：培养员工良好习惯，自觉遵守规程。

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5S management: the foundation of on-site improvement
Seiri: Distinguish between essential and non essential items, clear expired reagents, scrapped equipment, and useless files.
Seiton rectification: Items are positioned and clearly labeled (such as reagent cabinets, instrument areas, and safety passages) to achieve "finding what is needed within 30 seconds".
Seiso: Keep the environment clean, establish a daily cleaning responsibility table, and prevent pollution and equipment malfunctions.
Cleaning (Seiketsu): Standardize and institutionalize the first 3 seconds to form standards.
Shitsuke: Cultivate good habits among employees and consciously abide by regulations.

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流程优化（Lean in Lab）

• 绘制价值流图（VSM）：分析样品从接收到报告出具的全流程，识别非增值环节（如等待、搬运、重复记录）。
• 减少浪费（Muda）：
  • 等待：优化仪器排程，避免空转或排队。
  • 过度处理：避免不必要的检测步骤或数据记录。
  • 搬运：合理布局，减少样品和人员移动距离。
  • 库存：实施试剂耗材先进先出（FIFO），避免过期。
    
• 标准化作业（SOP）：关键操作（如滴定、移液、仪器校准）制定图文并茂的标准作业程序，减少变异.
  

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Process optimization (Lean in Lab)
Draw Value Stream Mapping (VSM): Analyze the entire process of receiving samples and issuing reports, identify non value added links (such as waiting, handling, and duplicate records).
Reduce waste (Muda):
Waiting: Optimize instrument scheduling to avoid idling or queuing.
Overprocessing: Avoid unnecessary detection steps or data recording.
Handling: Reasonable layout to reduce the distance of sample and personnel movement.
Inventory: Implement first in first out (FIFO) for reagents and consumables to avoid expiration.
Standardized Operating Procedures (SOP): Develop illustrated SOP for key operations such as titration, pipetting, and instrument calibration to reduce variability

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实验室信息化（LIMS系统）

• 引入实验室信息管理系统（LIMS）：
  • 实现样品全流程电子化追踪。
  • 自动生成报告，减少手工录入错误。
  • 管理仪器校准、人员培训、试剂库存。
  • 数据集中存储，便于审计和查询。
    
• 与仪器联用：实现数据自动采集，杜绝转抄错误。
  

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Laboratory Informatization (LIMS System)
Introducing Laboratory Information Management System (LIMS):
Realize electronic tracking of the entire sample process.
Automatically generate reports to reduce manual input errors.
Manage instrument calibration, personnel training, and reagent inventory.
Centralized storage of data for easy auditing and querying.
Combined with instruments: achieve automatic data collection and eliminate transcription errors.