clsi基層培訓(xùn)翻譯材料-1.records inf

1、QUALITY MANAGEMENT SYSTEM質(zhì)量管理系統(tǒng)QSE: DOCUMENTS & RECORDS 文件和記錄 QSE: INFORMATION MANAGEMENT 信息管理2 The Quality Management System 質(zhì)量管理系統(tǒng)Organization組織組織Personnel員工員工Equipment設(shè)備設(shè)備Purchasing & Inventory購買與庫存購買與庫存Process Management流程管理流程管理Information Management信息管理信息管理Documents& Record文件與記錄文件與記

2、錄sNonconforming Events Management非一致性事件管理非一致性事件管理Assessment評定評定Continual Improvement持續(xù)改進持續(xù)改進Customer Focus客戶焦點客戶焦點Facilities & Safety設(shè)備與安全設(shè)備與安全3Information is the major product of the laboratory信息是實驗室的主要產(chǎn)品DOCUMENTS文件文件 Documents and Records An Overview文件與記錄綜述4Document Pyramid 文檔金字塔Policy 政策政策Wha

3、t is done and why 做什么和為什么做什么和為什么Process 過程過程How it happens 怎么發(fā)生怎么發(fā)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 記錄做了什么記錄做了什么56 Policies 政策政策 “What happens and why” 發(fā)生什么以及原因發(fā)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) 通常由實驗室的領(lǐng)導(dǎo)者寫下，描述發(fā)生的情況和原通常由實驗室的領(lǐng)導(dǎo)者寫下，描述發(fā)生的情況和原因，以及說明實驗室意圖以傳遞這些行動。因，以及說明實驗室意圖以傳遞這些行動。“CLSI QMS01-A6 5.1） 7 Policies政策政策 “What happens and why” 發(fā)生什么以及原因發(fā)生什么以及原因 tell “what happens and why” in a broad and general way 告訴告訴“

5、發(fā)生了什么和為什么發(fā)生了什么和為什么”的廣泛和一般的方的廣泛和一般的方式式includes the organizational mission, goals, and purpose 包括組織上的任務(wù)，目標和目的包括組織上的任務(wù)，目標和目的serve as the framework for the quality system 作為質(zhì)量體系的框架作為質(zhì)量體系的框架should always be specified in the quality manual 應(yīng)始終在質(zhì)量手冊中指定應(yīng)始終在質(zhì)量手冊中指定8Processes 過程過程 “HOW IT HAPPENS” 如何發(fā)生如何發(fā)生A “

6、set of interrelated or interacting activities that transform inputs into outputs.” (ISO 9000 4.3.1) “一組將投入轉(zhuǎn)化為產(chǎn)出的相互關(guān)聯(lián)或相互作用的活動”（ISO 9000 4.3.1） 9Processes 過程過程 “HOW IT HAPPENS” 如何發(fā)生如何發(fā)生 describe the steps involved to carry out 描述參與開展的步驟quality and operational policies 質(zhì)量和運營政策easily represented in flow

7、 charts or process maps 容易在流程圖或過程圖中表示 serve as a roadmap for identifying key activities and decision points needing instructions. QMS02-A6 5.2.1 作為確定需要指示的關(guān)鍵活動和決策點的路線圖。 QMS 02-A6 5.2.110Procedures 程序 “HOW TO DO IT”怎么完成Standard operating procedures (SOP)標準操作程序標準操作程序 step-by-step instructions for perfo

8、rming a single activity 用于執(zhí)行單個活動的逐步指令用于執(zhí)行單個活動的逐步指令Job aid 工作幫助工作幫助a shortened version of the SOPSOP的縮寫版本的縮寫版本does not replace the SOP 不替代不替代SOP11Forms 形式“Recording what was done”記錄做了什么 Linked to Standard operating procedures (SOP) 連接標準操作程序（SOP） es a RECORD when completed 完成后成為RECORD Hierarchy of Doc

9、uments文檔層次12How to do it如何完成如何完成How it happens如何發(fā)生如何發(fā)生 What happens and why發(fā)生什么和為什么發(fā)生什么和為什么FormsRecording what was done記錄完成了什么記錄完成了什么13 Why are documents important? 重要性Provide essential提供必要: Directives for operations/employee performance 操作指令/員工績效Quality Manual / Policies質(zhì)量手冊/政策Processes 過程Procedure

10、s 程序Information for laboratory 實驗室信息Reference materials參考資料Standards 標準User Manuals用戶手冊Required by formal laboratory standards 按正式實驗室標準要求14Documents are the communicators of the quality management system文件是溝通者的質(zhì)量管理體系Verbal instructions often are口口頭說明經(jīng)常是頭說明經(jīng)常是:not heard 不是聽說不是聽說misunderstood 誤解誤解quic

11、kly forgotten快速忘記快速忘記difficult to follow難以遵循難以遵循15Documents are a reflection of the organizations structure and its quality management文件反映了組織的結(jié)構(gòu)和質(zhì)量管理“Do what you wrote and write what you are doing.”實事求是16 Good Documents are: 好的文件有以下特點 Clear 清晰 concise 簡潔 user-friendly用戶友好 Explicit 詳述的 Accurate 精確的 u

12、p-to-date 最新的17Documents for work processes must be accessible to staff at the work site:工作流程的文檔必須讓工作地點的工作人員接觸：instructions on handling ing samples處理進入樣品的說明procedures for each test 每個測試的程序quality control charts and trouble-shooting instructions質(zhì)量控制圖和故障排除說明safety manuals and precautions安全手冊和注意事項THE Q

13、UALITY MANUAL質(zhì)量手質(zhì)量手冊冊Documents and Records An Overview19The Quality Manual質(zhì)量手冊質(zhì)量手冊is a document describing the quality management system of an organization (ISO 15189)是描述組織質(zhì)量管理體系的文件（是描述組織質(zhì)量管理體系的文件（ISO 15189）20 Quality Manual質(zhì)量手冊 communicates organizational information 傳達組織信息 serves as a framework or

14、 roadmap for meeting quality management system requirements作為滿足質(zhì)量管理體系要求的框架或路線圖 demonstrates management commitment to quality 展示管理對質(zhì)量的承諾21 Quality Manual質(zhì)量手冊 contains the quality management policies 包含質(zhì)量管理政策 may also include QMS processes, procedures, and forms. 還可以包括QMS過程，過程和形式。PROCESS DOCUMENTS 過程文

15、過程文件件Documents and Records An OverviewProcess Documents 處理文檔 Quality Processes質(zhì)量過程 Mandated by international, national, regional and organizational requirements 由國際，國家，區(qū)域和組織要求規(guī)定 Operational Processes操作過程 Laboratory specific and based on respective laboratorys functions, methods, and instrumentation實

16、驗室具體和基于各自的實驗室功能，方法和儀器 Pre-examination預(yù)檢 Examination檢查 Post-examination檢查后23Process DocumentsProcess Maps / Flow Charts流程圖流程圖Process Table過程表過程表24Process DocumentsProcess Table過程表過程表25發(fā)生什么發(fā)生什么誰的責(zé)任誰的責(zé)任程序程序生成的表單和標簽實驗室助理抽血者職員技師技術(shù)專家生成循環(huán)列表生成優(yōu)先級抽取的可循環(huán)列表和標簽重印標簽患者病人護理技師抽血者實驗室技師實驗室技術(shù)專家護士其他醫(yī)療保健專業(yè)訓(xùn)練血液采集識別患者樣本收集

17、識別患者緊急情況PROCEDURES (SOPS) JOB AIDS - FORMS程序（程序（SOP） - 工作輔助工作輔助 - 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 描述如何使用逐步說明執(zhí)行測試written procedures help ensure書面程序有助于確保:Consistency 持續(xù)性Accuracy 精確性Quality 質(zhì)量28 A p

18、rocedure 程序 provides detailed, clear, and concise direction for testing techniques 為測試技術(shù)提供詳細，清晰，簡潔的方向 is easily understood by new personnel 容易被新人員理解 is reviewed and approved by management, and controlled 由管理層審查和批準，并受到控制 is updated on a regular basis 定期更新29 Job Aids工作輔助 shortened version of SOPs縮略版SO

19、P hand written or printed手寫或印刷 visible location at testing site可見位置 useful tool to assure all testing steps are correctly performed有用的工具以確保所有測試步驟正確執(zhí)行Job Aids工作輔助30Job Aids工作輔助31Forms 形成 Place to record results or actions for both quality and operations procedures 用于記錄質(zhì)量和操作程序的結(jié)果或操作的地方 May be created

20、for the entire process or individual activities in a process 可以為整個過程或過程中的各個活動創(chuàng)建 Forms are considered documents and subject to document management system processes 表格被認為是文件，并受文件管理系統(tǒng)程序的制約32RECORDS 記錄記錄 3334Scenario場景 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 測試算法 安全手冊 客戶端測試結(jié)果 批準的艾滋病毒快速檢測的標準操作程序（SOP） 制造商測試套件插入 現(xiàn)場評估訪問的結(jié)果總結(jié)You have found all these papers lying on a desk. Which of these are documents and which are records?你發(fā)現(xiàn)所有這些文件在一張桌子上。 其中哪些是

22、文件，哪些是記錄？35Scenario場景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) 糾正措施報告 溫度日志（空白表單） 質(zhì)量控制記錄（空白表） 日常維護日志（完成） 股票卡和股票（完成） EQA樣品轉(zhuǎn)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?你發(fā)現(xiàn)所有這些文件在一張桌子上。 其中哪些是文件，哪些是記錄？36 Scenario場景 testing algorithm測試算法 safety manual安全手冊 client test results客戶端測試結(jié)果 standard operation procedures (SOPs) for an approved HIV rapid test 批準的艾滋病毒快速檢測的標準操作程序（SOP） manufacture

24、r test kit inserts制造商測試套件插入 summary of findings from on-site evaluation visit現(xiàn)場評估訪問的結(jié)果總結(jié) report of corrective actions糾正措施報告temperature log (blank form)溫度日志（空白表單）quality control record (blank form)質(zhì)量控制記錄（空白表）daily maintenance log (completed)日常維護日志（完成）stock cards and stock book (completed)股票卡和股票（完成）EQ

25、A sample transfer log (completed) EQA樣品轉(zhuǎn)移日志（完成）You have found all these papers lying on a desk. Which of these are documents and which are records?你發(fā)現(xiàn)所有這些文件在一張桌子上。 其中哪些是文件，哪些是記錄？37Documents and RecordsHow do they differ?怎么區(qū)別 Documents文件文件communicate information via policies, processes, and procedure

26、s通過通過策略，過程和過程來策略，過程和過程來傳遞信息傳遞信息need updating需要更需要更新新Records紀錄紀錄capture information on worksheets, forms, labels, and charts捕獲工作表，表捕獲工作表，表單，標簽和圖表的信息單，標簽和圖表的信息permanent, do not change 永久，不變永久，不變RECORDSWhy are records essential?記錄必要性38Sample tracking throughout process整個過程中的樣品跟蹤整個過程中的樣品跟蹤Management too

27、l 管理工具管理工具Identify problems識別問題識別問題Continuousmonitoring of quality system連續(xù)監(jiān)測質(zhì)量體連續(xù)監(jiān)測質(zhì)量體系系39Patient test reports患者測試報告EQA / PT recordsEQA /PT記錄Quality control Data質(zhì)量 控制 數(shù)據(jù)Maintenance Records保持 記錄Instrument Printouts儀器打印輸出 WorkbooksWorksheets工作簿工作表Sample log book or registerLaboratory Records實驗室記錄實驗室記

28、錄40Critical Communications危急通信Customer feedbackUser Surveys用戶調(diào)查Continuous improvement連續(xù) 改進External audits Results外部審計結(jié)果Internal audits Results內(nèi)部審計結(jié)果Personnel records人員記錄More Records更多記錄41Remember records for:記?。?disposition of rejected samples處置被拒絕的樣品 referral of samples to another laboratory將樣品轉(zhuǎn)交另一

29、個實驗室 records of adverse occurrences or problems不良事件或問題的記錄 inventory and storage records庫存和存儲記錄 equipment purchase data,設(shè)備采購數(shù)據(jù) preventive maintenance, and troubleshooting維護和故障排除42 Information Management:Paper Systems信息管理：紙系統(tǒng)Permanence bind booksnumber pagesuse permanent inkcontrol storageAccessibilit

30、yuse system that will allow ease of access 永久 綁定書 數(shù)字頁 使用永久墨水 控制存儲 輔助功能 使用系統(tǒng)，將方便訪問43 Information Management:Paper Systems信息管理：紙系統(tǒng) Security maintain confidentiality keep safe from environmental hazards Traceability allow for tracking of a specimen throughout all processes 安全 保持機密性 保持安全免受環(huán)境危害 可追溯性 允許在整

31、個過程中跟蹤樣本4445Information Management:Electronic Systems信息管理：電子系統(tǒng) Permanence 永久 computer system maintenance, backups計算機系統(tǒng)維護，備份 Security 安全 access訪問 confidentiality保密 traceability 可追溯性DOCUMENT DEVELOPMENT文檔開發(fā)文檔開發(fā)Documents and Records An Overview46Life of a Document文件歷程Need for new/revised document需要新的/修訂的文件Document type determined確定文檔類型Drafted起草Evaluated, edited, verified評估，編輯，驗證Approval批準Training訓(xùn)練Distributed, implemented分配與實現(xiàn)Maintenance保養(yǎng)47DOCUMENT MANAGEMENT/DOCUMENT CONTROL文件管理文件管理/文件控制文