clsi基层培训翻译材料-1.records inf

1、QUALITY MANAGEMENT SYSTEM质量管理系统QSE: DOCUMENTS & RECORDS 文件和记录 QSE: INFORMATION MANAGEMENT 信息管理2 The Quality Management System 质量管理系统Organization组织组织Personnel员工员工Equipment设备设备Purchasing & Inventory购买与库存购买与库存Process Management流程管理流程管理Information Management信息管理信息管理Documents& Record文件与记录文件与记

2、录sNonconforming Events Management非一致性事件管理非一致性事件管理Assessment评定评定Continual Improvement持续改进持续改进Customer Focus客户焦点客户焦点Facilities & Safety设备与安全设备与安全3Information is the major product of the laboratory信息是实验室的主要产品DOCUMENTS文件文件 Documents and Records An Overview文件与记录综述4Document Pyramid 文档金字塔Policy 政策政策Wha

3、t is done and why 做什么和为什么做什么和为什么Process 过程过程How it happens 怎么发生怎么发生Procedure 程序程序How to do it 怎么完成怎么完成Forms 形成形成 Record what was is done 记录做了什么记录做了什么56 Policies 政策政策 “What happens and why” 发生什么以及原因发生什么以及原因 “Typically written by laboratory leadership and describes what happens and why it happens, as

4、well as state the laboratorys intent to deliver these actions.” CLSI QMS01-A6 5.1) 通常由实验室的领导者写下，描述发生的情况和原通常由实验室的领导者写下，描述发生的情况和原因，以及说明实验室意图以传递这些行动。因，以及说明实验室意图以传递这些行动。“CLSI QMS01-A6 5.1） 7 Policies政策政策 “What happens and why” 发生什么以及原因发生什么以及原因 tell “what happens and why” in a broad and general way 告诉告诉“

5、发生了什么和为什么发生了什么和为什么”的广泛和一般的方的广泛和一般的方式式includes the organizational mission, goals, and purpose 包括组织上的任务，目标和目的包括组织上的任务，目标和目的serve as the framework for the quality system 作为质量体系的框架作为质量体系的框架should always be specified in the quality manual 应始终在质量手册中指定应始终在质量手册中指定8Processes 过程过程 “HOW IT HAPPENS” 如何发生如何发生A “

6、set of interrelated or interacting activities that transform inputs into outputs.” (ISO 9000 4.3.1) “一组将投入转化为产出的相互关联或相互作用的活动”（ISO 9000 4.3.1） 9Processes 过程过程 “HOW IT HAPPENS” 如何发生如何发生 describe the steps involved to carry out 描述参与开展的步骤quality and operational policies 质量和运营政策easily represented in flow

7、 charts or process maps 容易在流程图或过程图中表示 serve as a roadmap for identifying key activities and decision points needing instructions. QMS02-A6 5.2.1 作为确定需要指示的关键活动和决策点的路线图。 QMS 02-A6 5.2.110Procedures 程序 “HOW TO DO IT”怎么完成Standard operating procedures (SOP)标准操作程序标准操作程序 step-by-step instructions for perfo

8、rming a single activity 用于执行单个活动的逐步指令用于执行单个活动的逐步指令Job aid 工作帮助工作帮助a shortened version of the SOPSOP的缩写版本的缩写版本does not replace the SOP 不替代不替代SOP11Forms 形式“Recording what was done”记录做了什么 Linked to Standard operating procedures (SOP) 连接标准操作程序（SOP） es a RECORD when completed 完成后成为RECORD Hierarchy of Doc

9、uments文档层次12How to do it如何完成如何完成How it happens如何发生如何发生 What happens and why发生什么和为什么发生什么和为什么FormsRecording what was done记录完成了什么记录完成了什么13 Why are documents important? 重要性Provide essential提供必要: Directives for operations/employee performance 操作指令/员工绩效Quality Manual / Policies质量手册/政策Processes 过程Procedure

10、s 程序Information for laboratory 实验室信息Reference materials参考资料Standards 标准User Manuals用户手册Required by formal laboratory standards 按正式实验室标准要求14Documents are the communicators of the quality management system文件是沟通者的质量管理体系Verbal instructions often are口口头说明经常是头说明经常是:not heard 不是听说不是听说misunderstood 误解误解quic

11、kly forgotten快速忘记快速忘记difficult to follow难以遵循难以遵循15Documents are a reflection of the organizations structure and its quality management文件反映了组织的结构和质量管理“Do what you wrote and write what you are doing.”实事求是16 Good Documents are: 好的文件有以下特点 Clear 清晰 concise 简洁 user-friendly用户友好 Explicit 详述的 Accurate 精确的 u

12、p-to-date 最新的17Documents for work processes must be accessible to staff at the work site:工作流程的文档必须让工作地点的工作人员接触：instructions on handling ing samples处理进入样品的说明procedures for each test 每个测试的程序quality control charts and trouble-shooting instructions质量控制图和故障排除说明safety manuals and precautions安全手册和注意事项THE Q

13、UALITY MANUAL质量手质量手册册Documents and Records An Overview19The Quality Manual质量手册质量手册is a document describing the quality management system of an organization (ISO 15189)是描述组织质量管理体系的文件（是描述组织质量管理体系的文件（ISO 15189）20 Quality Manual质量手册 communicates organizational information 传达组织信息 serves as a framework or

14、 roadmap for meeting quality management system requirements作为满足质量管理体系要求的框架或路线图 demonstrates management commitment to quality 展示管理对质量的承诺21 Quality Manual质量手册 contains the quality management policies 包含质量管理政策 may also include QMS processes, procedures, and forms. 还可以包括QMS过程，过程和形式。PROCESS DOCUMENTS 过程文

15、过程文件件Documents and Records An OverviewProcess Documents 处理文档 Quality Processes质量过程 Mandated by international, national, regional and organizational requirements 由国际，国家，区域和组织要求规定 Operational Processes操作过程 Laboratory specific and based on respective laboratorys functions, methods, and instrumentation实

16、验室具体和基于各自的实验室功能，方法和仪器 Pre-examination预检 Examination检查 Post-examination检查后23Process DocumentsProcess Maps / Flow Charts流程图流程图Process Table过程表过程表24Process DocumentsProcess Table过程表过程表25发生什么发生什么谁的责任谁的责任程序程序生成的表单和标签实验室助理抽血者职员技师技术专家生成循环列表生成优先级抽取的可循环列表和标签重印标签患者病人护理技师抽血者实验室技师实验室技术专家护士其他医疗保健专业训练血液采集识别患者样本收集

17、识别患者紧急情况PROCEDURES (SOPS) JOB AIDS - FORMS程序（程序（SOP） - 工作辅助工作辅助 - 表格表格Documents and Records An Overview27Procedures are documents that:程序是指：describe how to perform a test using step-by-step instructions 描述如何使用逐步说明执行测试written procedures help ensure书面程序有助于确保:Consistency 持续性Accuracy 精确性Quality 质量28 A p

18、rocedure 程序 provides detailed, clear, and concise direction for testing techniques 为测试技术提供详细，清晰，简洁的方向 is easily understood by new personnel 容易被新人员理解 is reviewed and approved by management, and controlled 由管理层审查和批准，并受到控制 is updated on a regular basis 定期更新29 Job Aids工作辅助 shortened version of SOPs缩略版SO

19、P hand written or printed手写或印刷 visible location at testing site可见位置 useful tool to assure all testing steps are correctly performed有用的工具以确保所有测试步骤正确执行Job Aids工作辅助30Job Aids工作辅助31Forms 形成 Place to record results or actions for both quality and operations procedures 用于记录质量和操作程序的结果或操作的地方 May be created

20、for the entire process or individual activities in a process 可以为整个过程或过程中的各个活动创建 Forms are considered documents and subject to document management system processes 表格被认为是文件，并受文件管理系统程序的制约32RECORDS 记录记录 3334Scenario场景 testing algorithm safety manual client test results standard operation procedures (SO

21、Ps) for an approved HIV rapid test manufacturer test kit inserts summary of findings from on-site evaluation visit 测试算法 安全手册 客户端测试结果 批准的艾滋病毒快速检测的标准操作程序（SOP） 制造商测试套件插入 现场评估访问的结果总结You have found all these papers lying on a desk. Which of these are documents and which are records?你发现所有这些文件在一张桌子上。 其中哪些是

22、文件，哪些是记录？35Scenario场景report of corrective actionstemperature log (blank form)quality control record (blank form)daily maintenance log (completed) stock cards and stock book (completed)EQA sample transfer log (completed) 纠正措施报告 温度日志（空白表单） 质量控制记录（空白表） 日常维护日志（完成） 股票卡和股票（完成） EQA样品转移日志（完成）You have found

23、all these papers lying on a desk. Which of these are documents and which are records?你发现所有这些文件在一张桌子上。 其中哪些是文件，哪些是记录？36 Scenario场景 testing algorithm测试算法 safety manual安全手册 client test results客户端测试结果 standard operation procedures (SOPs) for an approved HIV rapid test 批准的艾滋病毒快速检测的标准操作程序（SOP） manufacture

24、r test kit inserts制造商测试套件插入 summary of findings from on-site evaluation visit现场评估访问的结果总结 report of corrective actions纠正措施报告temperature log (blank form)温度日志（空白表单）quality control record (blank form)质量控制记录（空白表）daily maintenance log (completed)日常维护日志（完成）stock cards and stock book (completed)股票卡和股票（完成）EQ

25、A sample transfer log (completed) EQA样品转移日志（完成）You have found all these papers lying on a desk. Which of these are documents and which are records?你发现所有这些文件在一张桌子上。 其中哪些是文件，哪些是记录？37Documents and RecordsHow do they differ?怎么区别 Documents文件文件communicate information via policies, processes, and procedure

26、s通过通过策略，过程和过程来策略，过程和过程来传递信息传递信息need updating需要更需要更新新Records纪录纪录capture information on worksheets, forms, labels, and charts捕获工作表，表捕获工作表，表单，标签和图表的信息单，标签和图表的信息permanent, do not change 永久，不变永久，不变RECORDSWhy are records essential?记录必要性38Sample tracking throughout process整个过程中的样品跟踪整个过程中的样品跟踪Management too

27、l 管理工具管理工具Identify problems识别问题识别问题Continuousmonitoring of quality system连续监测质量体连续监测质量体系系39Patient test reports患者测试报告EQA / PT recordsEQA /PT记录Quality control Data质量 控制 数据Maintenance Records保持 记录Instrument Printouts仪器打印输出 WorkbooksWorksheets工作簿工作表Sample log book or registerLaboratory Records实验室记录实验室记

28、录40Critical Communications危急通信Customer feedbackUser Surveys用户调查Continuous improvement连续 改进External audits Results外部审计结果Internal audits Results内部审计结果Personnel records人员记录More Records更多记录41Remember records for:记住： disposition of rejected samples处置被拒绝的样品 referral of samples to another laboratory将样品转交另一

29、个实验室 records of adverse occurrences or problems不良事件或问题的记录 inventory and storage records库存和存储记录 equipment purchase data,设备采购数据 preventive maintenance, and troubleshooting维护和故障排除42 Information Management:Paper Systems信息管理：纸系统Permanence bind booksnumber pagesuse permanent inkcontrol storageAccessibilit

30、yuse system that will allow ease of access 永久 绑定书 数字页 使用永久墨水 控制存储 辅助功能 使用系统，将方便访问43 Information Management:Paper Systems信息管理：纸系统 Security maintain confidentiality keep safe from environmental hazards Traceability allow for tracking of a specimen throughout all processes 安全 保持机密性 保持安全免受环境危害 可追溯性 允许在整

31、个过程中跟踪样本4445Information Management:Electronic Systems信息管理：电子系统 Permanence 永久 computer system maintenance, backups计算机系统维护，备份 Security 安全 access访问 confidentiality保密 traceability 可追溯性DOCUMENT DEVELOPMENT文档开发文档开发Documents and Records An Overview46Life of a Document文件历程Need for new/revised document需要新的/修订的文件Document type determined确定文档类型Drafted起草Evaluated, edited, verified评估，编辑，验证Approval批准Training训练Distributed, implemented分配与实现Maintenance保养47DOCUMENT MANAGEMENT/DOCUMENT CONTROL文件管理文件管理/文件控制文