A17025QASystem.doc

A 17025 QA SystemPreparing Documents, Forms and RecordsA 17025 QA系统准备文件、表格和记录OverviewThis session will:Define the different levels of documents within an ISO 17025 document systemDescribe each type of documentForm and functionReview and discuss examples of each type of document概述在这一部分我们将要定义在ISO 17025文件系统下不同的文件级别描述每种文件类型、表格和功能回顾和讨论每种文件种类的例子Overview, contd:This session will:Allow time for participants to prepare some of each type of documentDescribe the requirements for archiving quality records概述 contd在这和部分我们将会请每一个参与者为每种文件准备些东西描述存档高质记录的需要Overview, contd:By the end of this session, you will:Be able to prepare ISO 17025-compliant forms and other documents for your laboratoryHave a template for preparation of a Quality Manual概述 contd在这一部分结束时能够为实验室准备符合ISO 17025的表格和其他文件有一份高质手册的准备模板Levels of Documentation Tier 1: Quality Manual Tier 2: SOPs Tier 3: Work InstructionsTier 4: Quality Records 文件级别：第一级高质手册；第二级：SOPs；第三级：工作指导；第四级：高质记录 Preparing a Quality ManualQuality Manual:Policy statements to address requirementsWhen the standard states “The lab shall have a policy - - - this should be specifically addressed in the QMOne way to organize the QM is to use the same numbering as the elements in the standard准备一个高质手册高质手册：政策对于需求的保证当标准要求“实验室需要一个政策这个应该特别在QM里被提到组织QM的其中一种方法是使用与标准中成分相同的编号Preparing a Quality ManualThe manual should not be longaddress policy only (not procedures)ease of useMay refer to specific SOPs for procedural detailsAll employees should have access to the QM准备高质手册手册不要太长只说明政策（不要过程）操作简单化在程序的细节方面可以参才特定的SOPs所有的雇员都可以访问QMPreparing a Quality ManualThe manual is a controlled document that must include:Version numberApproval signature ManagementQA issue signatureDate of issue (Effective date)Master document list specifying number of controlled copies and their location准备高质手册手册是一个可控的文件，他包括：版本数；批准签字-管理；QA问题签字；问题日期（有效日期）主文件列出指定受控的复本及他们方位的数目Example Quality ManualAn example of a Quality Manual for a fictitious lab will be distributed and discussed高质手册例子一个虚拟实验室高质手册的例子会被分发下去和讨论Preparing a Quality ManualFurther questions / discussion 你所在组织的高质手册版本号XXApproved by:_Issued by: _Date Issued: _准备一份高质手册进一步的问题/计论SOPs: Standard Operating ProceduresAddress procedural requirements in the standard, such as “The lab shall have a procedure for”SOPs标准操作步骤在标准中提出步骤要求，比如“实验室应该为有一个步骤”SOPs: Standard Operating ProceduresSOPs are necessary because they:Add consistency and uniformity to dataReduce (but dont eliminate) the need for supervisionAid in trainingSOPs标准操作步骤SOPs是必要的，因为他们为数据增添了相容性和一致性减少（但是不要消除）监督管理的必要培训帮助Preparing SOPsShould contain sufficient detail for a person with the required education and experience to carry out the task, BUTShould not be so cumbersome that they are not used准备SOPs应该为有着所需教育和经验来执行任务的人包含足够的细节但是不应该过度导致不被使用Preparing SOPsFirst create a template (outline of sections) that will:Ensure all SOPs are in the same, consistent formatEnsure all required elements are included准备SOPs首先设计一个模板（每部分的大纲）这能保证所有的SOPs都有同样一致的设计版式。保证所有需要的成分都被包括了Preparing SOPsExample of what may be included:Title, scope and applicationUnique identifying number (required)PrincipleReferencesProcedure (for test methods also includes reagents, solutions, apparatus, standards, sample preparation, extraction and analysis procedures, calculations)准备SOPs应包括之物的举例：题目，范围和应用唯一的有区别性的号码（需要）原则参考步骤（实验方法叔仍然包括试剂、解决办法、器具、标准、样品准备、提取和分析步骤、计算）Preparing SOPsExample of what may be included (cond):QC requirementsSafety proceduresTraining requirementsRaw data storage proceduresName of authorApproval and Issue signatures and date (required)Revision History准备SOPs应包括之物的举例cond：QC必备：安全步骤、培训需要、原始数据存储步骤、作者名、赞同及问题签字和数据（需要）、温习历史Preparing SOPsAuthor should be a person who routinely carries out the taskInitial reviewers are peers and supervisorReview of technical contentSecondary reviewer is QAEnsure compliance with ISO 17025 and laboratorys specific policies as set out in QM准备SOPs作者应该是一个能有规律执行任务的人最开始的评论者应该是同辈人或监督人对于科技内容的温习二级评论员是QA保证使用ISO17025的承诺保证实验室在QM下制定的特别政策Preparing SOPsAfter QA review, draft SOP goes back to the author for final reviewSupervisor* / Management* indicates approval by dated signature *(Authority for approval and issue of SOPs must be defined in the QM; generally supervisors will approve SOPs)准备SOPs在回顾QA后，SOP草案返回到作者作最后的回顾监督者/管理者表明赞同并签上名字日期赞同当局和SOPS问题都需要在QM内定义，通常监管者会赞同SOPsProcedure for Issuing SOPsQA is responsible for issuing SOPs and for document controlDate of issue is the date that the SOP becomes an active documentState specifically in QM发布SOPs的步骤QA应该为发布SOPs和文件控制负责事件的日期应为SOP成为活动文件的日期Procedure for Issuing SOPsOnce the SOP has been issued:update Master Document ListSOP number and titleversion numberdate of issuedistribution (# of copies and location of each)Distribute controlled copiesTrain staffArchive previous version发布SOPs的步骤一旦SOP被发布更新主文件列表SOP数目和题目/版本号/事件日期/副本的发配和方位分配受控的副本/培训学员/先前的版本要归档Making Changes to SOPsPolicy must be specified in the QMGenerally, require approval from supervisor and QA before changes can be madeHandwritten corrections fine for small changes, but must be signed and dated on all controlled copies and master copy改变SOPs政策必须被指定在QM里一般说来，在做改变之前需要从监管和QA那里得到许可对于小改变是可手写的订正也是可以的，但所有受控的副本和主副本一定要有签字和日期SOPs are required for All aspects of laboratory operation!Examples:All non-standard test methodsReceipt, handling and storage of reference standardsData handling, storage and retrievalMaintenance and calibration of equipmentLaboratory notebooksGlassware washingAll equipmentSafety proceduresSOPs需要实验室操作的所有方面：例如：所有不标准检测方法，收据，出处的处理和保存标准数据处理，存储和取回/设备的维护和校准/实验室记录本/玻璃器皿的清洗/所有设备/安全步骤Review of SOPsSOPs must be reviewed periodically (4.3.2.2(b)Set up a schedule (e.g. every October)Review is best done by the author / userIf there are no changes, still need to document the review (“Date Reviewed” stamp)回顾SOPsSOPs一定要定期回顾(4.3.2.2(b)建交一个时间表（比如每个十月）回顾Review of SOPsChanges to test method procedures must be made carefully:Major changes require the method to be re- validatedNeed to ensure customers requirements will continue to be met回顾SOPs检测方法的步骤的改变一定要仔细地制定主要的改变需要重新确定主法有效我们需要确保顾客的需求将会继续被保证Exercise 1Participants will break into groups of 3 to 4 and will be given the task of preparing a draft SOP for a specific lab activityGroup discussion will follow练习1参与者要分成3或4人一组，任务是为一个特定的实验室活动准备一个SOP草案接下来是小组讨论SOP PreparationFurther questions / discussion SOP准备进一步的问题和讨论标准操作程序#xxxx版本 x.x题目: 玻璃制品清洗核准者:_Issued by: _Date Issued: _Preparing Work InstructionsWork instructions are:Controlled documentsDescriptions of procedureE.g. how to operate a piece of equipmentShort enough (1 to 2 pages) to be posted near equipment, or in the work areaTo be used in conjunction with SOPs (not to replace them)准备工作说明工作说明：受控制的文件/步骤描述 比如：怎样操作一件设备简短的描述（12页）贴在设备附近或在工作区域与SOPs联合使用（但并不取代）Exercise 2Each participant will be asked to prepare a work instruction for a piece of lab equipmentGroup discussion will follow例2：每一个参与者需要为一个实验室设备准备一个工作说明接下来是小组讨论Preparing Work InstructionsFurther questions / discussion 准备工作说明深入的问题和讨论工作说明#xxxx版本 x.x题目: GC 刻度_审核者:_Issued by: _Date Issued: _Preparing FormsForms are best drafted by end userpracticalease of userelevantQA can assist by ensuring all required data will be capturedcontrolling the formversion #, date, add to master form list准备表格表格最好被最后一个使用者起草。表格要求：实用/使用简单/与主题相关QA可以通过确保获得所有需要的数据/控制表格（版本号、日期要加在主表单上）来协助Attaching Forms to SOPsSome labs prefer to use this systemversion of form used would indicate version of SOP used to generate the dataKeeping forms independent of SOPs provides greater flexibilityBoth systems are compliant with ISO 17025need to do what best suits individual lab SOPs上附着表格一些实验室更喜欢用这个系统。使用的表格的版本会揭示过去常产生数据的SOP的版本使表格具有相对的独立性提供了更大的灵活性两个系统都要服从于ISO17025我们需要做的是非常适合于个性实验室的事Exercise 3Participants will each be given time to prepare a form for a specific lab activityGroup discussion will follow例3参与者分别被给出时间来准备一个为某一实验室活动表格。接下来是小组讨论Preparing FormsFurther questions / discussion: 准备表格：深入的问题和讨论表格 xyz_Version x.x mm/dd/yyQuality RecordsExamples of Quality Records:completed formslab notebooksEquipment maintenance logsaudit reports corrective / preventive actionscontrol chartsManagement Review minutes质量记录质量记录的例子：完成的表格/实验室记录本/设备维护日志/审记记录/正确的和预防行动/控制图表/管理回顾记录Quality RecordsAll quality records must follow requirements of ISO 17025LegibleErrors corrected by single line, with initials No pencil or “white-out”UnambiguousStored such that they are easily accessible and maintain integrity质量记录所有的一定要遵守ISO17025的需要：清晰/单线修改错误，加上首字母（不要用铅笔和white-out）。/不摸棱两可/需要保存，这样