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

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 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 Responsibility and authority 职责与权限
4.1.1 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 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-40
5.01
<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/international 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 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 be include in < Calibration devices control and checkout list >. There are 3 kinds of calibration to be defined. Outside calibration、Inside calibration 、and exempt calibration.
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.
Outside 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 by 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 内部校验
Inspection 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 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 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 1
4.3.4 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. 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 equipment is
broken, it has to be replaced with new item. Products measured by reject instrument
should be premeasured 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
independent 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.
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 make 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,
precision, 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 according 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 operation 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 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 handle 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 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。

4.5.3.7 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, 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《FN-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 and 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 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 nonconforming 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
Stop using label
停止使用标签
Seal label
封存标签
计量器具在封存状态下，如需要起封使用，必须重新校准并合格后方可使用。

No calibration required label
免校标签
4 Reference Documents参考文件
5.1 不合格品控制程序
5 Reference Forms 参考表单
6.1 Calibration devices control and checkout list 计量器具管理台帐及校验计划
6.2 Fixture Inspection Report 检具验收报告
6.3 Gage Absolute Application 量具损坏报废申请单
6.4 Equipment registration/receive form量器具领用登记表
6.5 Purchasing Requisition sheet采购申请单
6.6 Maintenance request form维修申请单
6 FLOW CHART 流程图
6.1 The Flow Chart for calibration 仪器校验流程
Responsibility责任人Flow Chart流程图Record记录表
各部门
Purchasing 采购
Gauger
计量员
Gauger
计量员
Using Dept
使用部门
Gauger
计量员
Gauger
计量员
附件一 Appendix 1:
量具编号规则：
Gauage Numbering Rule。