Measuring Devices Control测量仪器管理程序(中英文).docx

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1、批准：审核：作成：Change History变更记录Revision版本Effective Date生效日期Originator编写人Reasons for Change修改原因2.02018.03.21新增规定必须将校准标签贴在器具的本体上3.02020.11.05Add 4.5.4.3 and update 6.1 content.1.0 Purpose 目的1.1 To describes the actions undertaken to ensure measuring equipment used to determine productquality is of the req

2、uired accuracy. It describes identification method, checking plan, status andrecording system.为确保关系产品品质的监视测量设备达到足够的精度要求，本程序介绍了对这些设备进行标识，设定检查计划，以及状态以及记录的系统。2.0 Scope 范围2.1 This procedure covers all measuring tools, equipment, golden samples and standards, whichrequires calibration and/or verification

3、 at MMK.本程序包含了本公司所有的需要校验或验证的测量工具，设备，标准样品以及标准片。3.0 Definitions 定义3.1 Measuring Equipments: measuring instrument, software, measurement standard, referencematerial or auxiliary apparatus or combination thereof necessary to realize a measurementprocess. To determine a physical quantity, magnitude or di

4、mension and then judge if the objectmeet the requirements.测量设备：为实现测量过程所必需的测量仪器、软件、测量标准、标准物质或辅助设备或它们的组合，一般用于确定物理量、规模大小或者尺寸的大小，根据其结果判定被测对对象是否符合规定的要求。3.2 Monitoring Equipment: observing and supervising process devices. Monitoring implies observing,supervising, keeping under review (using monitoring dev

5、ices).监视仪器：用于生产过程状态确认的仪器设备；监视指观察、监督、处于评审中（通过使用监视装置）。3 Procedure and Flow chart 程序及流程图3.1 Responsibility and authority 职责与权限3.1.1 Lab Technician is responsible for manage the equipments1 calibration system.由实验室技术员负责维护设备校验系统；3.1.2 Each department is responsible for the control of monitoring and measur

6、ing devices used intheir areas.各部门负责对本区域内使用的监视和测量设备进行控制；3.1.3 Process engineer （for production） and laboratory Technician （for lab） shall carry out internalcalibration of measuring equipment. And they must be trained about the related internalcalibration methods.工艺工程师（生产线用检测仪器）以及实验室技术员（实验室用检测仪器）执行内部

7、校验，他们必须经过相关的仪器校验技能培训；3.1.4 Method of checking/calibrate is described in the relevant SOP.检查/校验方法件具体的操作规程。3.1.5 测量仪器由质量部门统一申请请购，质量部门填写请购申请单并详细注明规格、型号、特殊要求，审批后由采购部门寻找相应供应厂商进行采购。3.1.6 Quality department validate the measuring equipments and register into TS-405.01 after purchase, take calibration.测量仪器采

8、购入库后，质量部验收，填写设备验收单，登记入计量器具管理台帐及校验计划。3.1.7 实验室保存原厂合格证或保证书、使用说明书3.2 Traceability and qualification calibration standards 检验标准的可追溯性以及权威性3.2.1 External trace of standards: The standards of calibration must be sent out for calibrationperiodically, and must traceable to national/international standard.标准的

9、外部溯源：用来内部校验的标准必须定期送到外部的权威机构进行校验，其校验可溯源到国家或国际标准；3.2.2 Special trace instruction: For special measuring equipment that external calibration labalso can not do due to lack of equipment or proper standard, calibration people may designthe special calibration instruction or formula to calibrate it and de

10、scribe it into document.特殊溯源：一些特殊的设备，由于缺乏适当的校准设备或校准标准，外部机构也无法进行校验的，校验人员可以自行设计特定的校验指导书或通用规则来实施校验，并在文件中说明；3.2.3 The precision of standard must be 10 times or more than calibrated equipment. If thestandard is a golden sample for comparison.用来校验的标准的精度必须为被校验设备的10倍或以上。如果标准样品是用来进行比对的，其至少与校验设备的精度等级相同。3.2.4

11、Must be traceable to national/international standard.所有校验标准必须能溯源到国家/国际标准；3.2.5 Should be stored under stated environment condition.仪器设备必须在规定的环境条件下存放。3.3 Identification and Registration of measuring equipment.监视测量设备的标识和登记3.3.1 Lab Technician combine all the equipments that must be calibration and bui

12、ld up aCalibration Master List to manage them.实验室技术员对所有需要校验的设备进行整理，并建立设备检验清单来进行管理；Measuring equipment that are directly and indirectly related to end product should beinclude in . There are 3 kinds of calibrationto be defined. Outside calibrationInside calibration、and exempt calibration.所有直接或间接相关最终产

13、品质量的设备必须包含在计量器具管理台帐及校验计划内。公司内量具分为外校量具、内校量具及免校量具三种.Outside calibration 外部校验All monitoring and measurement equipments purchased external and used to measureproducts and process characteristic, like caliper, dial indicator, thread gauges,micrometers, CMM etc. need to calibrated by outside intelligence

14、organization withcalibration report. Calibration cycle is normally one year,if have special requirement,w川follow it.Detailed please gauge list.外部购买的用于测量产品和过程特性有关的通用检测量具，如卡尺、百分表、螺纹规、千分尺、三坐标测量机等。均由外部有资质的机构进行校验，并提供检验报告。校验周期一般为一年，如有特殊要求依要求执行。具体见计量器具管理台帐及校验计划。Inside calibration 内部校验Inspection jigs made i

15、nternal, are calibrated by qualified inspector following relateddrawings. Cycle time of internal calibration depending on the usage of each jig.Detailedplease see gauge list公司内部制作测量产品的检测量具，由公司内部具有资质的人员依据相应的图纸规范检验量具的相关尺寸。内部校验周期视具体的量具使用状况而定。具体见计量器具管理台帐及校验计划。No calibration required if the equipment is 无需校验的设备有：- Production equipment, not measuring or testing equipment.非监视和测量的生产设备.- Equipment is only for