测量设备管理程序

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