Measuring Devices Control Procedure 测量仪器管理程序（中英版）

1、LOGOQUALITY SYSTEM PROCEDURE 质 量 体 系 程 序Number 文件编号:PD-S3-01Department 部门:QA 质量部 Subject 文件名称:Measuring Devices Control Procedure测量仪器管理程序Revision版本: 3.0Effective Date生效日期:2014-11-06Page 10 of 10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2.02013.03.21J

2、im Geng新增规定必须将校准标签贴在器具的本体上3.0Sam MiAdd 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 product quality is of the required accuracy. It describes identification method, checking plan, status and recording system.为确保关系

3、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, which requires calibration and/or verification 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

4、instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process. To determine a physical quantity, magnitude or dimension and then judge if the object meet 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

5、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 devices).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 4.1 Respon

6、sibility and authority 职责与权限 Lab Technician is responsible for manage the equipments calibration system.由实验室技术员负责维护设备校验系统；4.1.2 Each department is responsible for the control of monitoring and measuring devices used in their 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；4.1.3 Process engineer (for production) and

7、laboratory Technician (for lab) shall carry out internal calibration of measuring equipment. And they must be trained about the related internal calibration 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）执行内部校验，他们必须经过相关的仪器校验技能培训；4.1.4 Method of checking/calibrate is described in the relevant SOP.检查/校验方法件具

8、体的操作规程。4.1.5 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。4.1.6 Quality department validate the measuring equipments and register into TS-405.01 <Calibration devices control and checkout list> after purchase, take calibration.测量仪器采购入库后，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。 4.1.7 实

9、验室保存原厂合格证或保证书、使用说明书4.2 Traceability and qualification calibration standards检验标准的可追溯性以及权威性4.3.1 External trace of standards: The standards of calibration must be sent out for calibration periodically, and must traceable to national/international standard.标准的外部溯源：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

10、际标准；4.3.2 Special trace instruction: For special measuring equipment that external calibration lab also can not do due to lack of equipment or proper standard, calibration people may design the special calibration instruction or formula to calibrate it and describe it into document.特殊溯源：一些特殊的设备，由于缺乏

11、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；4.3.3 The precision of standard must be 10 times or more than calibrated equipment. If the standard 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。4.3.4 Must be traceable to national/internati

12、onal standard.所有校验标准必须能溯源到国家/国际标准；4.3.5 Should be stored under stated environment condition.仪器设备必须在规定的环境条件下存放。4.3 Identification and Registration of measuring equipment.监视测量设备的标识和登记4.3.1 Lab Technician combine all the equipments that must be calibration and build up a Calibration Master List to mana

13、ge 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 be include in < Calibration devices control and checkout list >. There are 3 kinds of calibration to be defined. Outside calibration、Inside calibration 、and exempt cal

14、ibration.所有直接或间接相关最终产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.Outsie calibration 外部校验All monitoring and measurement equipments purchased external and used to measure products and process characteristic, like caliper, dial indicator, thread gauges, micrometers, CMM etc. need to calibrated b

15、y outside intelligence organization with calibration report. Calibration cycle is normally one year,if have special requirement,will 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

16、 内部校验Inspeciton jigs made internal， are calibrated by qualified inspector following related drawings.Cycle time of internal calibration depending on the usage of each jig.Detailed please 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

17、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 comparison. But it is necessary to check periodically.仅用来参照的设备，但其必须定期检查. - The equipment that its measurement just for reference, it has another process to control the

18、result.为检测设备但其检测结果只用作参考，最终判断由另外的过程来控制.- Environment control facilities, it makes no difference with product quality. 环境控制设备，其对产品质量无影响4.3.2 Information of equipments will be stored and maintained in the computerized < Calibration devices control and checkout list >.所有校验设备的信息在电脑的计量器具管理台帐及校验计划上进行

19、存储和管理。4.3.3 Numbering device according to the coding principle.根据编码原则进行编号； 见附件一 Appendix 14.3.4 List of items that required calibration could be found in the Calibration Master List.设备校验清单上显示设备的编号.4.3.5 History and calibration due date for each equipment are maintained in the Calibration Master List

20、. The review of the equipment due for calibration will be performed in monthly basis.校验历史记录以及下次校验时间也应在校验清单上注明.每个月对设备的校验情况进行审核.4.3.6 If equipment is found to be outside of permissible range and cannot be calibrate/fix internally, it should be sent out to the vendor for repair and calibration. If equi

21、pment is broken, it has to be replaced with new item. Products measured by reject instrument should be remeasured using eligible instruments, and handle as nonconformance process, keep related record also.如果设备经过校验超出允许的范围,并且不能进行内部校准和维修,必须送出去进行维修并校准. 如果设备已经损坏，必须立即更换新设备。若有产品被不合格的量具检测过，需要对已检测的产品采取相应的措施进

22、行重新确认，并依不合格品处理流程处理，保存相关的记录； 4.4 External Calibration外部校验4.4.1 Measuring equipment that cannot be calibrated internally should be sent out to accredited company for calibration. 无法进行内部校验的设备必须送到外部机构进行校验4.4.2 The standard of external calibration lab must be traceable to class II or more high class inde

23、pendent lab.外部校准实验室的标准必须能溯源到二级实验室或更高等级的实验室。4.4.3 Fill in the qualified label and paste it on the device，Update the calibration information in Calibration Master List.校验后填写内部的合格标签并贴在量测仪器本体上，并更新校验设备清单上的信息。4.4.4 All external certificates should be retained in External Calibration Cert. file for records

24、.保持所有外部校验的报告证书，以资记录。4.5 Internal Calibration management. 内部校验管理4.5.1 Select suitable measuring equipment选择合适的测试设备4.5.1.1 All equipments be used for measuring, user must take equipment manual, specification, tolerance, environment condition, traceability, precision, accuracy for reference. And QA mak

25、e sure that it must be calibrated or not, in order to meet the product specification. 用来监测的设备，使用者应该取得设备手册，规范，测量公差，保存环境，追诉标识，精度以及参考准确度。 QA工程师要确定是否进行校准来判断是否符合其产品规范。4.5.2 Confirm calibration period 确定校验周期4.5.2.1 Calibration people build up the period of the equipments according to its stability, precis

26、ion, frequency of use, environment condition and manual. Calibration cycle is normally one year,if have special requirement,will follow it.Detailed please gauge list.校验人根据设备的稳定性、精度、使用频率、保存环境及使用手册来确立其校验周期。校验周期一般为一年，如有特殊要求依要求执行。具体见校验量具清单；4.5.2.2 Calibration people can adjust calibration period accordi

27、ng to calibration report.检验人可以根据校验报告适当对校验周期进行调整。4.5.3 Calibration implementation实施校验4.5.3.1 Calibration person who does internal calibration must get related skill training or certificate. And should be trained periodically.内部校验人员必须经过相应的技能培训或证书，并且培训要定期地进行。4.5.3.2 Should establish calibration operati

28、on procedure.建立相应的校验规程。4.5.3.3 Write down the calibration report after calibration finished.检验后填写检具验收报告。4.5.3.4 All the items that are calibrated should be labelled with calibration sticker. Information such as equipment number, check date, due date and check by should be visible on the calibration

29、sticker.校验后的设备应在设备本体上贴上校验合格标签，注明设备号码，校验日期，下次校验日期等。4.5.3.5 If calibration fails, calibration people must stick the “Stop using” Label on the equipment and issue the Abnormal Notice to user. The user and relevant department should do corrective actions, and Trace the product in the passing time，and ha

30、ndle as nonconformance process, keep related record also.如果校验失败，校验人贴上“停止使用”标签并提交异常报告给使用者。使用者以及相关的部门应采取纠正措施，对以前使用过此量具检验过的产品进行追踪确认，并依不合格品处理流程处理，保存相关的记录；4.5.3.6 If the master equipment is out of calibration. Calibration people should adjust or repair and calibrate the master equipment, then check other

31、 equipment that calibrated by this master equipment. If the result out of specification. Calibration people should adjust or repair and calibrate again. Keep the record and inform user and relevant dept.如果采用的标准设备超出规范，校验人应对其进行调整、修复和重新校验，并对其校验过的其他设备进行重新检查。如果这些设备超出规范，检验人有必要对它们再次校验。保持记录并通知使用者和相关部门。4.5.3

32、.7 Calibration people must finish calibration within 7 working days. +/-7 days is allowed between for calibration due date.校验人员必须在7个工作日内完成校验。所以校验周期允许偏差为+/-7天。4.5.3.8 When calibration finished, Calibration Master List should be updated follow the result. 校验完成后及时更新校验管理清单的信息。4.5.3.9 All related records

33、, reports, documents should be kept until the equipment scraped.所有相关记录、报告、文件应保留至设备报废。4.5.4 Use and Maintain for Measurement instruments 计量器具的使用和保养4.5.4.1 The user shall apply the measuring instruments from quality department and fill in FN-QA-026 Equipment registration/receive form使用部门到品质部申领测量仪器，填写F

34、N-QA-026量器具领用登记表。4.5.4.2 The user shall check the effective date and if the instruments work well before use.使用部门在使用前应先确认仪器在有效期内，且正常工作。 4.5.4.3. All of the anomaly case appear of the instrument must have to verify by gauger for example including drop on the floor, impact with other metal and etc. 所有

35、测量器具出现的异常情况都必须经过计量员的核实确认方可使用，例如包括掉 落在地或与其他金属发生碰撞等影响。4.5.4.4 The user shall use the instruments rightly and keep them in the proper place to prevent damage.使用部门正确使用仪器，保存在适当的地方防止损坏。4.5.4.5 The user shall check and maintain the instruments daily, and keep them clean.使用部门负责日常的保养检查，保持仪器的清洁。4.5.5 Repair a

36、nd scrap for Measurement instruments 测量仪器的维修和报废4.5.5.1 If find nonconformance in calibration or normal production, the user fill in <Equipment Maintenance Request> and send to quality department to change goods instruments.仪器校验中或日常生产中发现仪器不良，使用部门填写设备维修申请通知品质部，更换合格的量具。4.5.5.2 If possible Quality

37、 departments repair or send to supplier to repair, and then calibrate. If not repairable, the instruments will be scraped and paste red label, quality department fill in FN-QA-025 <to scrap and update the control list. 如果可维修，品质部进行简单修理或委托外部供应商维修，维修后经校验合格可以重新使用。如果不可维修，仪器进行红色标识，填写FN-QA-025量具损坏报废申请单申

38、请报废，并更新清单。4.5.5.3 For the suspect products, Quality fills in < Nonconforming products disposal Form> to dispose. If the products have been shipped, Quality call related departments to evaluate the risk and decide the action plan, inform customers.对因仪器故障造成的可疑产品，品质部填写不合格品处理单协调处理。如产品已经出货，由品质部召集相关

39、部门进行风险评估，确定行动方案，必要时并通知客户。4.6 Product Conformance产品一致性4.6.1 In the event of equipment is found to be outside of permissible range, suspected product shall be re-inspected and re-validated for its conformance to the product specification. The disposition of the product would be according to related no

40、nconforming products procedures.如果检测设备超出允许范围，受到影响的产品必须进行重新检验和确认是否满足产品规范。异常产品的处理可参考不合格品处理的相关程序。4.6.2 If the product is already been delivered/use has started, refer to related nonconforming products procedures.如果受影响的产品以及发送出去或被使用，可参考不合格品处理的相关程序。4.7 Calibration Label校验标签4.8.1 qualified label 合格标签；分为外部校准合格标签、内部校准合格标签 外部校准合格标签管理编号Instrument NO.：校准单位Calibration：校准日期DATE：再次校准日期DUE： 内部校准合格标签管理编号Instrument NO.：校准人Calibration：校准日期DATE：再次校准日期DUE