测量设备管理程序

Procedure for Management of Measuring Equipment

1. 目的 PURPOSE

在整个生命周期中对测量设备进行管理，以确保需要时能获得适宜的测量设备。 To manage the measuring equipment throughout the whole lifecycle, to ensure suitable measuring equipment can be obtained when needed.

2. 范围 SCOPE

2.1. 仅适用于与品质有关的测量设备

Is only applied to quality related measuring equipments 2.2. 除6.6章节“测量系统分析（MSA）”外，其他均为通用要求

The others are general requirement except Section 6.6 “Measurement System Analysis (MSA)”

3. 定义 DEFINITION

3.1. 测量设备：本文中指用于确定量值的设备和（或）装置的统称。放大镜、物理显微

镜、CCD、摇摆测试机等不属测量设备，因为它不确定量值；通止规虽然只能判断合格与不合格，但带有尺寸属性，因此属于测量设备。

Measuring equipment: In this document, it is the combination of equipments and (or) devices which assign numbers or values. Magnifiers, physical microscope, CCD, vibration tester are not measuring equipment, because they do not assign numbers or values; even Go/No Go gage only judges pass or reject, but it is dimensional, so it is measuring equipment.

3.2. 测量系统：测量或者评估过程中所使用的测量或监视设备、测量标准、操作、方

法、夹具、软件、人员、环境和假设的整体。

Measurement System: The combination of the measuring or monitor equipments, measurement standards, operations, methods, fixtures, software, personnel, environment and assumptions which are applied in the measuring or evaluation process.

3.3. 校准：在规定条件下，为确定测量设备（或测量系统）所指示的量值，与对应的由

标准所复现的量值之间关系的一组操作。校准结果可以记录在校准证书或校准报告中。

Calibration: Under specified conditions, a set of operations which validates the

number or value between measuring equipment (or measurement system) showed and relevant standard represented. Calibration results can be recorded in calibration certificates or calibration reports. 3.4. MSA：Measurement System Analysis 测量系统分析 3.5. 偏倚：观察到测量值的平均值与参考值间的差值。

Bias: The Difference between the observed average of measurements and the reference value

3.6. 线性：在测量设备正常工作量程内的偏倚变化量。

Lineability: The change in bias over the measuring equipment normal operating range.

3.7. 稳定性：随时间变化的偏倚值，稳定的测量系统在位置方面是处于统计受控的。

Stability: The change in bias over time. A stable measurement process is in statistical control with respect to location.

3.8. 重复性：同一评价人使用同一测量设备对同一零件的同一特性多次测量的变差。

Repeatability: The variation in measurements obtained with one measuring

equipment when used several times by an appraiser while measuring the identical characteristic on the same part.

3.9. 再现性：不同评价人使用同一测量设备对同一零件的同一特性测量平均值的变差。

Reproducibility: The variation in the average of the measurements made by

different appraisers using the same gage when measuring a characteristic on one part.

3.10. GRR或GR&R：测量设备重复性和再现性

GRR or GR&R: The repeatability and reproducibility of measuring equipment. 3.11. 有效性：做出正确决定的次数占总决定次数的百分比

Effectiveness: The percentage of right judgments among total judgments. 3.12. 错判率：将合格的判定为不合格的次数占总决定次数的百分比

False Rate: The percentage of judgments of reject to pass ones among total judgments.

3.13. 漏判率：将不合格的判定为合格的次数占总决定次数的百分比

Miss Rate: The percentage of judgments of pass to rejected ones among total judgments.

4. 职责和权限 RESPONSIBILITY AND AUTHORITY

4.1. QA实验室 QA labor

4.1.1. 评审《测量设备需求申请表》

Review “Application of Measuring Equipment”

4.1.2. 对测量设备进行验收、编号、登记、标识

Check-and-accept, number, register and identify measuring equipments

4.1.3. 保存测量设备说明书、操作手册、合格证、安装程序和软件、备品备件等

Maintain the measuring equipment instructions, operation manuals, Pass certificates, setup programs and software, spare parts and so on

4.1.4. 负责测量设备的校准

Is responsible for the calibration of measuring equipments

4.1.5. 制定《测量系统年度分析计划》并组织实施

Develop “Yearly Measurement System Analysis Plan” and organize to implement

4.1.6. 统筹建立测量设备操作和维护指导书，必要时提供操作和维护培训

Collaborate to develop operation and maintaining instructions for measuring equipment, and provide training of operation and maintenance when necessary.

4.1.7. 建立《仪器校验/维护履历表》

Establish “Measuring Equipment Calibration/Maintenance Log”

4.1.8. 对不合格的测量设备进行处理，并进行记录

Handle non-conform measuring equipment and record

4.1.9. 对测量设备的使用、维护、储存等进行监督

Monitor the usage, maintenance, and storage etc. of measuring equipment

4.2. QA工程师 QA Engineer

4.2.1. 进行除新设备验收之外的MSA

Conduct MSA for all measuring equipments except new ones

4.2.2. 对使用不合格测量仪器之后的产品采取围堵措施

Contain products when non-conform measuring equipment being used

4.3. 使用部门 Operation department

4.3.1. 对测量设备进行日常保养和管理

Is responsible for the daily maintenance and management of measuring equipments

4.3.2. 确保测量设备的环境条件符合要求

Ensure the environment conditions for measuring equipment meeting requirements

4.3.3. 协助QA实验室或QA工程师进行MSA，包括数据收集

Assist QA labor or QA engineer to accomplish MSA, including data collection

5. 工作流程 WORKING FLOW CHART

流程FlowSTART需求Need各部门Each department测量设备需求申请表Application of MeasuringEquipment责任单位Owner相关文件和记录Relevant Doc.&Rec.评审ReviewPASS采购或制作Purchase or MakeREJQA实验室 (Lab)测量设备需求申请表Application of MeasuringEquipmentSourcing 或工具车间(or Tooling Shop)REJ验收报告check-and-accept report验收Check-and-acceptPASS编号、登记、标识Number, register andidentifyQA实验室 (Lab)QA实验室 (Lab)量具总表Measuring Equipments List仪器校验/维护履历表MeasuringEquipment Calibration /Maintenance Log日常维护记录daily maintenancerecords使用和维护Use and maintain各部门Each department召回Call backPASSMSAPASS校准CallibrationREJREJQA实验室 (Lab)QA实验室 (Lab)MSA报告(Report)QA工程师(engineer)QA实验室 (Lab)量测仪器内校记录Measuring Equipment In-houseCalibration Record外部校准报告及判定Outsource calibration report andjudgment仪器校验/维护履历表MeasuringEquipment Calibration /Maintenance Log不合格的处理Handle when nonconformableEND6. 程序PROCEDURE

6.1. 测量设备需求 Need of Measuring Equipment

6.1.1. 各部门有测量设备需求时，应提出《测量设备需求申请表》，设立生产线时所需

的，由PE提出；现有生产线所需的，由生产部门提出；来料和成品检验、QA实验室所需的，则由QA提出。

When one department has the needs of measuring equipment, the “Application of Measuring Equipment” shall be submitted. When it is for new setup

production line, it is submitted by PE; when for current production line, it is submitted by production department; when for incoming or final inspection, or QA labor, it is submitted by QA.

6.1.2. 《测量设备需求申请表》须经QA实验室评审，然后再依照D0B0021《采购管理

程序》申请采购或者依照D0B0056《工装管理程序》申请设计和制作。QA实验室应评审测量设备需求的合理性，例如测量误差、稳定性、测量范围、分辨率等方面的需求。

“Application of Measuring Equipment” shall be reviewed by QA labor. Then it can be purchased according to D0B0021 “Purchasing Operation Procedure” or can be designed according to D0B0056 “Tooling Management Procedure”. QA labor shall review the reasonability of measuring equipment needs, such as needs of measuring error, stability, measurement scope and resolution so on.

6.2. 测量设备验收 Checking-and-accepting of measuring equipment

6.2.1. 申请部门收到测量设备时，通知QA实验室进行安装、调试和验收。验收包括：

When receives measuring equipment, application department shall inform QA labor to install, trial run and check-and-accept. The check-and-accept covers:

1). 对照装箱清单或者附件清单进行清点：说明书、操作手册、合格证、安

装程序和软件、备品备件、其它附件等。除用于日常操作所需要的附件（例如2D测量仪日常操作所需要的校准片）应交使用部门以及用于安装调试的附件外，其它全部由QA实验室保存。

Check and count based on delivery list or accessories list: instruction, operation manual, pass certificate, setup program and software, spare parts and other accessories etc. All the others shall be kept by QA labor except that the accessories which are needed in daily operation

shall be hand over to operation department. 2). 确定其分辨率、测量范围、测量误差是否能满足需求

Validate whether the resolution, measurement scope and measuring error can meet requirements

3). 检查合格证签发日期或出厂日期，如果超过校准周期则需安排校准，否

则认为其在校准有效期内

Check the date of pass certificate or delivery date. If it is over the calibration cycle, the measuring equipment shall be calibrated then, otherwise, it is seen as being effective in calibration cycle. 4). 确定是否需要MSA，如需要则进行MSA

Determine whether MSA is needed. If needed, conduct MSA

6.2.2. QA实验室准备验收报告，经QA经理批准后，完成验收。

QA labor prepares the check-and-accept report. After it is approved by QA manager, the process of check-and-accept is accomplished.

6.2.3. 验收合格后，对测量设备进行编号、登记和标识。如果不合格，则退回供应商

（对采购的测量设备）或者工具车间（对自行制作的测量设备）。

After being passed check-and-accept, the measuring equipment can be numbered, registered and identified. If being rejected, it shall be returned to supplier (for purchased one) or to tooling shop (for made in-house one).

6.3. 测量设备登记 Registration of Measuring Equipment

6.3.1. 验收合格的测量设备，由QA实验室依照Q0C0002《仪器编码原则》编号。

After measuring equipment being passed by check-and-accept, QA labor numbers it according to Q0C0002 “Measuring Equipment Numbering System”.

6.3.2. 由QA实验室建立《量具总表》，以管理所有尚未报废的测量设备，包括在用

的、储存的、维护中的测量设备。《量具总表》须包括以下内容：

It is QA labor to establish “Measuring Equipments List” to manage all measuring equipments, which are not scraped, and include being used, being stored, being maintained ones. The “Measuring Equipments List” shall include:

1). 测量设备编号 Number of measuring equipment 2). 名称或描述 Name or description

3). 规格型号 Specification or model 4). 供应商名称 Supplier

5). 使用位置或区域 Using point or area

6). 标称范围及允许使用范围 Declared scope and permitted usage scope 7). 分辨率 Resolution 8). 校准类型 Calibration type

9). 内部校准文件编号 Internal calibration document number

10). 校准日期、下次校准日期，校准周期 Calibration date, next calibration

date, and calibration cycle 11). 软件版本号 Version of software

6.3.3. 属于固定资产的测量设备，由财务依照F0C0001《固定资产管理》进行管理。

If being fixed assets, the measuring equipments shall be managed by Finance according to F0C0001 “Fixed Asset Management” the same time.

6.4. 测量设备标识 Identifying of measuring equipment

6.4.1. 所有的测量设备都应由QA实验室进行标识，以表明其可使用状态，避免误用。

All measuring equipments shall be identified QA labor, to identify their usable status and to avoid being used wrongly.

6.4.2. 免校标识：无需校准的测量设备应贴白色《免校》标签。

Identification of calibration-free: the calibration-free measuring equipment shall be labeled with white “Calibration-free” label

6.4.3. 合格标识：校准合格的测量设备应贴绿色《准用卡》，《准用卡》应至少包括：

Identification of qualified: the measuring equipment which is qualified by

calibration shall be labeled with green “PERMITTED” label. “PERMITTED” label covers:

1). 测量设备编号 Number of measuring equipment 2). 校准单位 Calibration body 3). 校准日期 Calibration date

4). 下次校准日期 Next calibration date 5). 确认人 Validating personnel

6.4.4. 使用标识：允许使用，但有的测量设备应贴黄色《使用》标签，标

签必须包括允许使用范围（如允许的测量范围、允许使用的功能等）、确认人、确认日期。

Identification of Limited: The measuring equipment which is permit to be use, but is limited, shall be labeled with yellow “LIMITED” label. This label shall cover permitted usage scope (such as permitted measuring scope and permitted function etc.), validation personnel and validation date.

6.4.5. 暂停使用标识：不允许使用的测量设备应贴红色《暂停使用》标签，标签必须包

括暂停使用的原因或理由、确认人和确认日期。

Identification of stopped: The measuring equipment which is stopped being used shall be label with red “STOPPED” label. The label shall cover the cause of reason to stop, validation personnel and validation date.

6.5. 校准 Calibration

6.5.1. 由QA实验室根据测量设备的应用场合和功能等确定其是否需要校准，例如以下

测量设备不用校准:

QA labor identifies whether it is need to be calibrated based on the application and function of measuring equipment. Such as the following measuring equipment does not need to be calibrated:

1). 不用于产品检测和生产过程监控的

The one which is not used to measure product or production process 2). 虽用于产品检测和生产过程监控，但无须提供准确都值，仅用于提供有

无的信息，例如检测导线是否断路的万用表

The one, which is used to measure product or production process, but is not need to provide exact readings, just is needed to give

information of “Is” or “Not”. Such as multimeter which is used to check whether the lead is shorted.

3). 失效即报废的测量设备，如量筒、量杯、比重计、水银温度计

The one, which will be scraped when invalidated, such as: graduated cylinder, measuring cup, gravimeter, and mercury thermometer.

6.5.2. QA实验室应依据《量具总表》中的校准日期，至少提前一个工作周并以书面形

式（电子或纸质）通知使用部门，及时召回测量设备进行校准。

QA labor shall inform operation department, in writing format (electrical or paper), at least one work week advanced, based on the calibration date of “Measuring Equipments List”, to call measuring equipment to be calibrated.

6.5.3. 内部校准 Calibration in-house

1). 由QA实验室统筹建立校准作业指导书，对新测量设备可先根据生产厂

家的相关规格数据进行首次校准。校准作业指导书须参考JJG或JJF文件制定。

QA labor collaborates to develop calibration instructions. For new measuring equipment, the first calibration can be conducted based on related specification data of manufacturer. Calibration instructions shall be established according to JJG or JJF documents.

2). 内部校准由QA实验室进行，校准人员必须具有质量技术监督管理局认

可的计量资格。

In-house calibration is conducted by QA labor. The calibration

personnel shall have metrology qualifications recognized by Quality and Technique Supervision and Administration Bureau.

3). 内部校准周期由QA实验室具有计量资格的人员依照以往的经验进行确

定，发现不合适时调整。

In-house calibration cycle is determined, by QA labor personnel who has metrology qualification, based on last experiences, and is adjusted when is found to be not suitable.

4). 允许进行内部校准的范围仅限于本公司具有相应测量标准（如标准块

规、标准砝码）的测量设备。这些测量标准必须进行外部校准。

The permitted in-house calibration scope is limited to the measuring equipments that having relevant measuring standards, such as

standard gage, standard weights) in this company. These measuring standards shall be calibrated outsourced.

5). 如无特殊说明，内部校准环境温度为22±5℃，湿度< 60%。QA实验室

的温湿度需进行记录和控制。

If no special remarks, for in-house calibration, the environment temperature shall be 22±5℃, the humidity shall be less than 60%. QA labor shall record and control the temperature and humidity.

6). QA实验室准备内部校准报告并判定是否合格，报告须经QA经理批准。

QA labor prepares in-house calibration report and judge the conformity. The report shall be approved by QA manager.

6.5.4. 外部校准 Calibration outsourced

1). 需校准而不能内部校准的测量设备，则由具有资格的外部实验室实施校

准。当无合适的外部实验室进行校准时，可由测量设备生产厂家校准。

The measuring equipment which needs to be calibrated but can be calibrated in-house, its calibration shall be outsourced to qualified external labor.

2). QA实验室负责评价和选择外部实验室，并保存记录。记录包括：

QA labor is responsible for assessing and selecting external labor, and maintaining the records. The records include:  有效的营业执照复印件

Copy of effective business license

 有效的ISO/IEC 17025证书复印件或带有CNAL标志的认可证书

复印件

Copy of effective ISO/IEC 17025 certificate or copy of recognition certificate which has CNAL log

 认可证书附录复印件（包含实验室认可业务范围说明），为本公

司提供的校准服务必须在其认可的业务范围内

Copy of annex of recognition certificate (which includes the

recognized business scope); the calibration service provided for this company shall be covered by this scope

3). 一般情况下，外部校准的周期依照校准报告执行。

Generally, the cycle of outsourced calibration is conducted according to calibration report

4). 外部实验室提供校准报告，该校准报告必须带有CNAL标志。QA实验室

根据该校准报告，判断测量设备是否合格，不合格测量设备需使用时，须经QA经理批准。

External labor provides calibration report. This report shall have CNAL log. QA labor judges the conformity. When the non conform measuring equipment need to be limited in usage, this shall be approved by QA manager.

6.5.5. QA实验室在判定是否合格后对测量设备进行标识，并更新《量具总表》，包括

测量设备状态、校准日期、下次校准日期等信息。

After judged whether or not being qualified, QA labor identifies the measuring equipments, and update “Measuring Equipments List”, including the status of measuring equipments, calibration date and next calibration date etc.

6.5.6. QA实验室应确保每个测量设备都有校准报告以及是否合格的判定结论。

QA labor shall ensure each of measuring equipments shall have a calibration report and a conclusion of whether being qualified.

6.5.7. 特殊情况下如需延后测量设备的校准日期时，必须经过QA经理的书面批准。申

请延期必须证明测量设备在校准前能满足测量要求，或者对所有产品进行标识和隔离。申请及批准记录保留在《仪器校验/维护履历表》中，以便追溯。

Special needs to postpone the calibration date of measuring equipment, shall be approved by QA manager in write. The records of application and approval of postponing shall be maintained with “Measuring Equipment Calibration / Maintenance Log”, to be convenient for tracking.

6.6. 测量系统分析 Measurement System Analysis

6.6.1. MSA对象必须包括：客户要求分析的测量系统、用于监控ISO/TS 16949认证范

围内的关键或重要的产品特性或过程特性的测量系统。

MSA scope shall cover: measurement systems which are required to be analyzed by customer; and those which are applied to monitor key or critical product characteristics or process characteristics, which are covered by ISO/TS 16949 certification scope.

6.6.2. QA实验室制定《测量系统年度分析计划》并组织实施。

QA labor develops “Yearly Plan for Measurement System Analysis” and organizes to implement.

6.6.3. 分析时机和责任人 Analysis occasion and owner

1). 新测量设备的验收，由QA实验室分析

When checking-and-accepting new measuring equipment, it is analyzed by QA labor.

2). 改变的测量系统的验收（例如被测量产品的公差范围更小、操作人员、

操作方法、环境等发生重大变化），由QA工程师负责。

When checking-and-accepting changed measurement system (such as ones whose measured part tolerances being smaller, and whose operators, operation methods, environment changed), it is conducted by QA engineer.

3). 周期性MSA（分析周期为一年且不超过12 个月），由QA工程师负责

Periodical MSA (analysis cycle is one year and shall not be more than 12 months), it is conducted by QA engineer.

4). 其它如比较测量系统时需进行MSA时，由QA工程师负责：

Other occasion such as needing to compare measurement systems, it is conducted by QA engineer.

6.6.4. 使用部门协助QA实验室或QA工程师进行MSA，包括数据收集。

Operation department assists QA labor or QA engineer to conduct MSA, including collecting data.

6.6.5. 分析步骤 Analysis steps

1). 确定测量设备处于校准有效期内，否则先进行校准

Identify whether measuring equipment being calibrated, otherwise calibrate it first.

2). 确定测量系统是计量型还是计数型

Identify the measurement system is variable or attribute 3). 确定要分析的测量系统特性

Determine the measurement system characteristics which needs to be analyzed

 计量型测量系统具有偏倚、线性、稳定性、GRR五个特性，在测

量设备定期校准后，通常只需做GRR分析

Variable measurement system has five characteristics of Bias, Lineability, Stability and GRR. Generally, after the measuring equipment being calibrated, only GRR needs to be analyzed.  计数型测量系统具有有效性、错判率、漏判率等特性。

Attribute measurement system has the characteristics such as Effectiveness, False Rate and Miss Rate etc.

4). 分析方法 Analysis method

 偏倚分析：样件法 - 数值法分析（α=0.05）

Bias analysis: Independent Sample Method – Numerical analysis Method (α=0.05)  线性分析：图示法

Lineability analysis: Graphic Analysis Method  稳定性分析：均值极差图分析

Stability analysis: Average & Range Chart Analysis Method  GRR分析：方差分析法

GRR analysis: ANOVA

 计数型测量系统分析：风险分析法

Attribute measurement analysis: Risk Analysis Method

5). 确定和选择评价人，评价人应从日常操作者中挑选

Determine and select appraiser. Appraisers shall be selected among skilled daily operators

 偏倚、线性、稳定性分析均只需1个评价人，GRR分析则需要3

个评价人

Analysis of Bias, Lineability and Stability needs only 1 appraiser, GRR analysis needs 3 appraisers.  计数型测量系统：3个评价人

Attribute measurement system: 3 appraisers

6). 确定和选择零件样本：

Determine and select part samples

 偏倚分析：1个样本，尽量选择处在生产测量中间的零件，先使

用高等级测量仪器测量，确定其参考值

Bias analysis: 1 sample, try to select the part falling in the middle-range of production measurements, and measure its value utilizing high level measuring equipment to determine its reference value.

 线性分析：≥5个样本，需覆盖测量设备的整个使用量程，且须

先使用高等级仪器测量，以确定其参考值

Lineability analysis: ≥5 samples, they shall cover the whole measuring scope of measuring equipment, and shall be determined its reference value utilizing high level measuring equipment.

 稳定性分析：1个样本，尽量选择处在生产测量中间的零件

Stability analysis: 1 sample, try to select the part falling in the middle-range of production measurements.

 GRR分析：10个样本，样本应代表实际或预期的过程变差/产品

公差，并需进行编号。不能让评价人看到编号

GRR analysis: 10 samples, the samples shall represent actual or expected process variation/product tolerance, and shall be numbered. The numbers shall not be known by appraisers.  计数型测量系统：50个样本，须包括可接受零件、不可接受零

件、处于可接受和不可接受状态之间的零件

Attribute measurement system: 50 samples, they shall cover accepted parts, rejected parts and parts which place the zone where may be accepted or rejected.

7). 确定重复测量次数

Determine measurement repeats  偏倚和线性分析测量次数：≥10次

Measurement times for Bias or Lineability analysis: ≥ 10  稳定性分析：固定周期（每天、每周等），每次测量3~5次

Stability analysis: measure 3~5 times per time at fixed period (daily, weekly and so on)

 GRR分析：每个评价人对每个样本测量3次

GRR analysis: each appraiser measure each sample 3 times  计数型测量系统：每个评价人对每个样本评价3次

Attribute measurement system: each appraiser appraises each sample 3 times

8). 收集并记录数据，禁止由评价人自行拿取样本或记录测量结果，并且应

随机选择样本进行测量，以减少评价人的记忆。

Collect and record data. It is prohibited that the appraise takes samples or records measurement results. The measurements of samples shall be repeated in a different random order to reduce the memory of appraisers.

9). 使用MINITAB进行计算，并分析测量系统特性是否可接受

Calculate with MINITAB, and analyze the measurement system characteristic whether can be accepted.

注：GRR%是将GRR与过程变差或产品公差带进行比较：

Remark: GRR% is to compare GRR with process variation or product tolerance:

 若测量系统只用于判断产品合格性，则与产品公差带比较

If measurement system is used to judge product conformity only, then it is compared to product tolerance  若测量系统只用于监控过程，则与过程变差比较

If measurement system is used to monitor process only, then it is compared to process variation

 若测量系统同时用于判断产品和监控过程，则与产品公差带和过

程变差中的小者进行比较

If measurement system is used to judge product conformity and to monitor process, then it is compared to the smaller between product tolerance and process variation

10). 测量系统改善 Improve measurement system

 当分析结果显示测量系统条件接受，或不可接受时，由MSA责任

人组织相关人员进行分析，确定测量变差过大的原因，并拟定改善措施、责任人和完成日期

When the analysis result shows that the measurement system is conditional accepted or not accepted, MSA owner shall call related personnel to analyze, identify the cause of large

measurement variation, and determine improvement actions, owners and completion date.  MSA责任人对改善情况进行跟踪

MSA owner follows up the improvement status.

 改善完成后，MSA责任人应再次分析测量系统是否可接受

MSA owner shall analyze the measurement system again after improved to determine whether it is accepted.

6.6.6. 接受准则 Acceptance criteria

1). 偏倚：如果0落在偏倚值的1-α自由度界限内，则偏倚在α置信水平上

可接受

Bias: if 0 falls within the 1-αconfidence bounds around the bias value, then bias is acceptable at α confidence level.

2). 线性：偏倚=0的整条直线都位于置信度区间内时线性可接受

Lineability: lineability is acceptable when the line of bias =0 lies entirely within the confidence bounds.

3). 稳定性：控制图无不受控信号时稳定性可接受，见D0B0049《统计过程

控制程序》

Stability: stability is acceptable when control chart without out-of-control signals. See D0B0049 “Statistical Process Control Procedure”

4). GRR：若客户有标准则依客户标准，否则依下列标准：

GRR: follow customer criteria, If there are; otherwise follow following criteria:

 ndc≥5（ndc计算后取整）

ndc ≥5 (truncated ndc to integer after being calculated)  GRR% ＜10%，接受；10%≤GRR%＜30%，基于应用的重要

性、测量设备成本、维修费用等因素可考虑条件接受；GRR%

＞30%，拒绝接受

GRR% ＜10%, acceptable; 10%≤GRR%＜30%, can be considered to be conditionally acceptable based on the

importance of application, cost of measuring equipment and maintenance; GRR% ＞30%, can not be accepted

5). 计数型测量系统 Attribute measurement system

判定结论 Judge Conclusion 可接受 Acceptable 有效性 错判率 漏判率 Effectiveness False Rate Miss Rate ≥90% ≤2% ≤5% 条件接受 Conditionally acceptable 不可接受 Can’t be accepted 6.6.7. 分析结果报告 Report analysis results

≥80% ＜80% ≤5% ＞5% ≤10% ＞10% 1). 测量系统分析后，应将分析过程、结果和结论等通报QA经理、使用部

门主管和经理、QA实验室。

After the measurement system being analyzed, the analyzing process, results and conclusion shall be reported to QA manager, operation department supervisor and manager, QA labor. 2). 分析报告须包括以下内容：

The analysis report shall cover items below:

 基本信息：分析对象、分析日期、分析人、评价人、被测量公差

Basic information: analysis scope, analysis date, analyzer, appraiser, tolerance of measured characteristic  数据记录 Data sheet  计算结果 Results calculated

 图形统计报告 Graphic statistical report  判定结论 Judgments

 批准人及日期等 Approver and date etc.

6.7. 测量设备使用、储存和维护 Using, storing and maintain measuring equipment

6.7.1. 测量设备验收合格后，才允许使用。

Only after being qualified in checking-and-accepting, the measuring equipment is permitted to be used.

6.7.2. 由QA实验室统筹制订相应的操作和维护作业指导书，必要时对操作和维护人员

进行培训。

QA labor collaborates to develop relevant operation and maintenance

instructions, and provide training to operator and maintainer when necessary.

6.7.3. 操作和维护必须遵守指导书，未培训合格的人员不得操作和维护测量设备。

Operating and maintaining shall be consistent with instructions. The personnel can not operate or maintain measuring equipment when having not been trained and qualified.

6.7.4. QA实验室对每个测量设备建立《仪器校验/维护履历表》，使用部门负责测量设

备的日常保养与管理，并建立日常维护记录。

QA labor establish “Measuring Equipment Calibration / Maintenance Log” for each measuring equipment. Operation department is responsible for daily

maintenance and management, and for establishing daily maintenance records.

6.7.5. 使用部门应确保测量设备使用环境条件满足要求，如干燥、清洁，无腐蚀。

Operation department shall ensure the environmental condition for measuring equipment operation meet requirements, such as being dry, clean, and no rust.

6.7.6. QA实验室负责安排修理及供应商售后服务，禁止其他人员私自拆卸测量设备。

QA labor is responsible for arranging repair and supplier after-sales service. It is prohibited that the others break the measuring equipment down without permission.

6.7.7. 禁止使用个人拥有的测量设备。

It is prohibited to use private measuring equipment.

6.7.8. 禁止将测量设备用于非测量的场合，如当作普通工具使用。

It is prohibited to use measuring equipment in non-measuring occasion, such as use as common tool.

6.7.9. QA实验室负责对测量设备的使用、维护和储存进行监督，并跟踪改善情况。

QA labor is responsible for monitoring the using, maintaining and storing of measuring equipment, and for following up the improvements.

6.8. 不合格测量设备管理 Management of non conformable measuring equipment

6.8.1. 不合格测量设备包括

Non conformable measuring equipment includes：

1). 已经损坏

Damaged already 2). 过载或误操作

Over-loaded or operated wrongly

3). 显示不正常

Indicated abnormally

4). 功能出现可疑，包括没有标识的

Whose function being suspected, including those without identification 5). 超过了规定的检定或校准间隔

Over specified calibration interval 6). 封缄的完整性已被损坏

Whose sealing integration being destroyed

6.8.2. 测量设备不合格后的处理

Handling when measuring equipment become non conformable

1). 立即停止使用、隔离存放不合格测量设备，并贴《暂停使用》标签

Stop using, to quarantine the non conformable measuring equipment and to identify it with “STOPPED” label immediately.

2). 围堵产品：在调整或修理前，如校准结果表明，该设备在以往的测量中

出现了明显的误差风险，使用部门应通知QA工程师对以往的产品采取围堵措施并依照D0B0044《不合格品控制程序》对不合格品进行控制。 Contain products: if calibration results of the measuring equipment, prior to being adjusted or repaired, show that there are obvious risks of errors in last measurements, operation department shall inform QA engineer to contain produced products and to control non-conformities according to D0B0044 “Non-conformity Control Procedure”. 3). 维修测量设备：使用部门通知QA实验室对其进行维修，在维修并经再

次校准合格后才能重新投入使用：

Repair measuring equipment: operation department informs QA labor to repair it. Only after being repaired and being qualified by calibration, it can be put into use.

 正常使用：若能完全恢复则改贴《准用卡》允许正常使用

Using normally: if can be restored completely, then it is permitted to use normally and can be re-identified with “PERMITTED” label.

 使用：若只有某量程或某功能恢复正常，则允许使用，

改贴《使用》标签

Using limitedly: if only some measurement scope or some function is restored, it is permitted to be applied limitedly, and shall be re-identified with “LIMITED”.

 报废：当无法修复时，由QA实验室依照F0C0001《固定资产管

理》申请报废。

Scraping: when can not be restored, QA labor applies to scrap it according to F0C0001 “Fixed Asset Management”.

6.8.3. 测量设备不合格后的处理措施，包括对产品采取的围堵措施，应记入《仪器校验/

维护履历表》，以便追溯。

The actions taken when the measuring equipment being non conformable, including containment actions to product, shall be recorded in “Measuring Equipment Calibration / Maintenance Log” to be traced.

7. 相关文件 REFERENCE

7.1. D0B0021 采购管理程序Purchasing Operation Procedure 7.2. D0B0044 不合格品控制程序Non-conformity Control Procedure 7.3. D0B0049 统计过程控制程序Statistical Process Control Procedure 7.4. D0B0056 工装管理程序Tooling Management Procedure

7.5. Q0C0002 仪器编码原则Measuring Equipment Numbering System 7.6. F0C0001 固定资产管理Fixed Asset Management

8. 使用记录 RECORD

# 1 2 表单编号 Form No. N/A Q0D0002 名称 Title 量具总表Measuring Equipments List 使用处 Using Area 保存时间 Retention Updated 最新 1年 1 year 设备寿命期 Whole equipment life 3年 3 years 3年 存放 Kept area QA实验室 QA Labor 使用部门 Operation department QA实验室 QA Labor QA实验室 QA Labor QA实验室 3 Q0D0003 4 5 Q0D0031 Q0D0180 QA实验室 QA Labor 检验仪器日常保养记录 使用部门 Inspection Instruments Daily Operation Maintenance Record department 仪器校验/维护履历表Measuring QA实验室 Equipment Calibration / QA Labor Maintenance Log 量测仪器内校记录 QA实验室 Measuring Equipment In-house QA Labor Calibration Record 测量系统分析计划Yearly Plan for QA实验室 6 7 Q0D0171 N/A 8 N/A 9 N/A Measurement System Analysis 测量设备需求申请表Application of Measuring Equipment 测量设备验收报告 Measuring equipment check-and-accept report 外部校准报告及判定 Outsource calibration report and judgment 外部实验室评价和选择记录 Outsource labor assessment and selection records MSA记录和报告 MSA records and reports QA Labor QA实验室 QA Labor QA实验室 QA Labor QA实验室 QA Labor QA实验室 QA Labor 3 years 1年 1 year 设备寿命期 Whole equipment life 3年 3 years 3年 3 years QA Labor QA实验室 QA Labor QA实验室 QA Labor QA实验室 QA Labor QA实验室 QA Labor QA实验室或工程师 QA Labor or engineer 10 N/A QA实验室或工程3年 师 QA Labor or 3 years engineer