clsi基層培訓(xùn)翻譯材料

1、QUALITY MANAGEMENT SYSTEM 質(zhì)量監(jiān)管體系 IMPLEMENTATION實(shí)施WHERE DO WE START?從何處開始2 Implement all elements of QMS across the entire path of workflow in all disciplines3在所有學(xué)科的工作流程的整個(gè)路徑實(shí)現(xiàn)QMS的所有元素學(xué)科化學(xué)血液學(xué)微生物學(xué)輸血醫(yī)學(xué)解剖病理學(xué)細(xì)胞學(xué)免疫學(xué)遺傳學(xué)實(shí)驗(yàn)室的工作流程實(shí)驗(yàn)室的工作流程檢查 審查 說明國際國家區(qū)域地方組織要求預(yù)檢階段訂購樣品收集樣品運(yùn)輸接收處理檢查階段檢查后期報(bào)告發(fā)布樣品管理評估持續(xù)改進(jìn)質(zhì)量體系要素人員采購&庫

2、存設(shè)備流程管理文檔&記錄信息管理不合格事件管理機(jī)構(gòu)客戶導(dǎo)向設(shè)施和安全4Planning for the Quality Management SystemQMS系統(tǒng)的計(jì)劃系統(tǒng)的計(jì)劃approaches vary with local situation方法隨當(dāng)?shù)厍闆r而變化many factors influence starting point許多因素影響起點(diǎn)include all quality elements in plan包括計(jì)劃中的所有質(zhì)量要素may implement in stepwise process可以逐步過程實(shí)現(xiàn)form a QMS implementation team

3、形成QMS實(shí)施團(tuán)隊(duì)5Keep in mind熟記 communicate, be transparent 溝通，透明 set feasible timelines 設(shè)置可行的時(shí)間表 develop realistic, measurable objectives 制定現(xiàn)實(shí)的，可衡量的目標(biāo) set priorities, proceed stepwise 設(shè)置優(yōu)先級，逐步進(jìn)行 focus on a culture of quality 專注于質(zhì)量文化6 TeamEngage the folks who do the work, because they know what they do!雇傭做

4、這項(xiàng)工作的人，因?yàn)樗麄冎涝趺醋鯟ontinual Improvement Module 15 CLSI v 20157 Conduct Gap Analysis進(jìn)行差距分析know your target知道你的目標(biāo)determine the gaps, using regulations, standards, quality management systems 確定差距，使用規(guī)章，標(biāo)準(zhǔn)，質(zhì)量管理體系 GAP ANALYSIS 8 Gap Analysis差異分析Common problems identified發(fā)現(xiàn)常見問題test ordering測試訂購sample managem

5、ent樣品管理training level (competence)of technical staff技術(shù)人員的培訓(xùn)水平（能力）quality control質(zhì)量控制analytical process分析過程recording and reporting results記錄和報(bào)告結(jié)果reagent and equipment management試劑和設(shè)備管理DOCUMENTATION文件9Planning for implementation規(guī)劃實(shí)施know your target - timeline知道你的目標(biāo) - 時(shí)間表using the gap analysis findings

6、, develop an action plan 利用差距分析結(jié)果，制定行動計(jì)劃prioritize by優(yōu)先級遵循:quick fixes first快速修復(fù)determine what would have the greatest positive impact確定什么會有最大的積極影響resource allocation資源分配10Quality Management System Plan includes質(zhì)量管理體系計(jì)劃包括 what should be done 需要完成什么需要完成什么 who will be responsible 誰需要負(fù)責(zé)誰需要負(fù)責(zé) when (time

7、line) 什么時(shí)候（時(shí)間線）什么時(shí)候（時(shí)間線） how many resources are needed多少需多少需要的資源要的資源 benchmarks基準(zhǔn)基準(zhǔn)Must be available to all staff必須向必須向所有工作人員提供所有工作人員提供11 Implementation實(shí)施commit to completion承諾完成prepare for implementation in stages準(zhǔn)備分階段實(shí)施assure resources are available保證資源可用Map your plan and progress, e.g. use a Gant

8、t chart繪制您的計(jì)劃和進(jìn)度，例如 使用甘特圖be sure everyone knows their responsibility確保每個(gè)人都知道他們責(zé)任 thenBEGINGantt Chart甘特圖1213 Provide Resources資源提供 financial requirements/budget財(cái)務(wù)需求/預(yù)算 personnel needs 人員需求additional staff額外工作人員skills, training needed技能，培訓(xùn)需要 facilities, equipment, supplies, computers設(shè)施，設(shè)備，用品，電腦14Moni

9、toring Compliance監(jiān)視合規(guī)性 assign responsibility 分配責(zé)任 develop indicators制定指標(biāo) establish monitoring system 建立監(jiān)測制度 conduct audits進(jìn)行審計(jì) management review管理評審Internal Audit內(nèi)部審計(jì)1516 A document describing the quality management system of an organization.描述組織質(zhì)量管理體系的文件。 essential organizational step基本組織步驟 managem

10、ent responsibility管理責(zé)任Developing the Quality Manual制定質(zhì)量手冊17 Quality Manual質(zhì)量手冊 At a minimum contains the quality policies至少 - 包含質(zhì)量政策 Supporting quality documents or references to them支持質(zhì)量文件或參考文件QUALITY18Quality ManualIntent to Action行動意圖19 Intent to Action行動意圖 assign responsibility for implementatio

11、n 分配實(shí)施責(zé)任 allocate resources分配資源 develop and distribute a quality manual制定和分發(fā)質(zhì)量手冊 implement quality system實(shí)施質(zhì)量體系 monitor compliance with quality management system requirements監(jiān)測是否符合質(zhì)量管理體系要求20Successful implementation requires成功實(shí)施需要having management commitment有管理承諾understanding the benefits of a quali

12、ty management system了解質(zhì)量管理體系的好處engaging staff at all levels使各級工作人員參與striving to continually improve努力不斷改進(jìn)having realistic expectations 具有現(xiàn)實(shí)的期望21 Remember記住 Quality is not a science, its a way of thinking. 質(zhì)量不是科學(xué)，它是一種思考的方式 Spend time today to gain rewards tomorrow: 今天花費(fèi)時(shí)間明天獲得獎勵：今天花費(fèi)時(shí)間明天獲得獎勵： quality results質(zhì)量結(jié)果 efficiency效率 professional, personal satisfaction專業(yè)，個(gè)人滿意 peer recognition同行的認(rèn)可22 Who is Responsible for Quality?誰為質(zhì)量負(fù)責(zé)EVERYONE!每一個(gè)人每一個(gè)人Questions?問題？Comments?評論23Organization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過程