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1、短语英汉互译1. parameter design参数设计2. quality engineering质量工程3. loss function损失函数4. process capability index过程能力指数5. standard deviation标准差,均方差6. tolerance interval容许区间7. normal distribution正态分布8. correction coefficient校正系数9 data bank数据库10. chance variable随机变量短语英汉互译11. parameter design参数设计12. probability d

2、ensity function概率密度函数13. tolerance design公差设计14. preventive maintenance预防性维修,定期维修15. data processing数据处理16. coefficient of regression回归系数17. quality loss质量损失18. chance error随机误差阅读理解一Process Capability Analysis (过程能力分析)Once a process is in statistical control, the next question is: Will the process g

3、enerate products that meet the specification (and how well) Process capability is a measure of the repeatability of a process. A process control system can be described as a feedback system.(一个过程控制系统能被描述为一个反馈系统 ) There are four elements of a process control system.Process Capability Analysis (过程能力分析

4、)(1) The process: The process is the combination of people, machines and equipment, input materials, methods, measurement tools, and environment which work together to produce output.(过程是人、机器 设备、投入的原料、方法、测量工具和环境的组合,它们共同作用产生输出.)The total performance of the process and the quality of the output depend

5、 on the way that the process has been designed, built, maintained, and operated.(过程的总体性能和输出的质量依赖于过程设计、建造、维护和运作的方式。)Process Capability Analysis (过程能力分析)(2) Performance information: Information about process performance 性能)can be acquired by studying the process output (过程输出),Process output includes b

6、oth the products and the intermediate outputs that are produced along the way. This information is gathered in time to determine whether action is necessary to correct an out-of-control process.(及时收集信息以确定纠正过程失控的措施是否必要。)Process Capability Analysis (过程能力分析)(3) Action on the process: Action on the proc

7、ess is future-oriented; it is taken to prevent the production of out-of-specification products.(过程中的措施是针对将来而言的,采取措施是为了预防生产不合格产品。) It may involve changes in the operation (operator training, changes in incoming materials), changes in the equipment (rehabilitation, recalibration重新校准,design changes设计更改

8、),or changes in process design . The effect of actions should be monitored and further analysis or actions should be taken, if necessary.Process Capability Analysis (过程能力分析)(4) Action on the output: Action on the output is past-oriented; it involves detection of out-of-specification products al心dy p

9、roduced.(基于输出的措施是针对过去而言的,它包括对已生产的不合格产品的检查.) This may require corrective action on the process itself or in the product specifications.(这可能需要纠正 过程本身或产品规格。)Process Capability Analysis (过程能力分析)The basic statistical application in process control is the state of establishing stability in the manufacturi

10、ng process and maintaining that state of control over an extended period. It is of equal importance that the process be adjusted to the point where virtually all of the products meet specifications. This latter situation relates to process capability analysis.A process capability analysis establishe

11、s the range over which variability is expected to occur in a process that is in control. It is used to: (1) determine the ability of a process to meet standards and specifications, (2) establish new standards or to modify existing ones, and (3) serve as a basis for constructing process control chart

12、s.Process Capability Analysis (过程能力分析)Once stability has been established, it follows that the process must be adjusted to level where the output will conform to specifications.(稔定性一旦己经建立,紧接着要做的是将过程调节到输出符合规定要求 的水平。)A state of control is usually established when X and R charts do not show points out

13、of control with samples of four more over an interval of at least 20 subgroups. Once this control is established, process capability can be analyzed to determine the process ability to conform to specifications.Process Capability Analysis (过程能力分析)The primary function of a process control system is t

14、o provide statistical signals when special causes of variation are present and to enable appropriate action that can eliminate those causes and prevent their reappearance. Process capability is determined by the total variation that comes from common causes(过程 能力是由普通原因导致的总变异决定的。)the minimum variatio

15、n that can be achieved after all special causes have been eliminated. Thus, capability represents the performance potential of the process itself and is demonstrated when the process is being operated in a state of statistical control.Process Capability Analysis (过程能力分析)Capability is usually measure

16、d by the proportion of output that will be within product specification tolerances.(过程金力通常由在产品赖格公差内的产叁比例来测量. ) Since a process in statistical control can be described by a predictable distribution, capability can be expressed in terms of this distribution,(因 为在统计控制下的过程由可预测的分布来描述,过程能力就可根据这个分布来表示)and

17、the proportion of out-of-specification parts can be realistically evaluated. If this proportion is excessive, actions to reduce the variation from common causes will be required to make the process capable of consistently meeting the specifications.Process Capability Analysis (过程能力分析).In short, the

18、process must first be brought into statistical control, so its performance can be predicted; then its capability to meet specifications can be assessed.(简而言之,过程首先应处于统计控制下,以使过 程的性能曲够预测,然后评价满足规格要求的过程能力.)Changes in the process itself must then occur for the process capability to achieve a satisfactory

19、level, which is zero units failing outside the specification limits.The Control of Design and Development in Quality Management System1. Design and development planningThe organization shall plan and control the design and development of product. During the design and development planning, the organ

20、ization shall determine:The Control of Design and Development in Quality Management Systema) The design and development stages.b) The review, verification and validation that are appropriate to each design and development stage.(适合于每个设计和开发阶段的评审、验证和确认活动。)c) The responsibilities and authorities for de

21、sign and development.The Control of Design and Development in Quality Management SystemThe organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.(组织应对参与设计和开发的不 同小组之间的接口实施管理,以确保有效的沟

22、通,并明确职责分工。)Planning output shall be updated, as appr叩riate, as the design and development progresses.(随着设计和开发的进展,在适当时,簧划的 输出应予以更新。)The Control of Design and Development in Quality Management System2. Design and development inputs (设计开发输入)Inputs relating to product requirements shall be determined an

23、d records shall be maintained. These inputs shall include:a) Function and performance requirements.b) Applicable statutory and regulatory requirements.c) Where applicable information derived from previous similar designs.These inputs shall be reviewed for adequacy. Requirements shall be complete, un

24、ambiguous and not in conflict with each other.(应对这些输入进行评审,以确保其充分性,要求应完整、清楚,并且不能自相 矛盾)3. Design and development outputsThe outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.(设计和开发的输出应

25、以针对设计 和开发的输入进行验证的方式提出,并应在发布前得到批准.)Design and development outputs shall:The Control of Design and Development in Quality Management Systema) Meet the input requirements for design and development.b) Provide appropriate information on purchasing, production and service provision.c) Contain or refer pr

26、oduct acceptance criteria (产品接收标准).d) Specify the characteristics of the product that is essential for its safe and proper use.The Control of Design and Development in Quality Management System4. Design and development review (设计开发评审)At suitable stages, systematic reviews of design and development s

27、hall be performed in accordance with planned arrangements:(在适宜的阶段,应根据所策划的安排对设计和开发进行系统的评审。)a) To evaluate the ability of the results of design and development to meet requirements.b) To identify any problems and propose necessary actions.The Control of Design and Development in Quality Management Sys

28、temParticipants in such reviews shall include representatives of functions concerned with the design and development stages being reviewed. Records of the results of the reviews and any necessary actions shall be maintained.5. Design and development verificationVerification shall be performed in acc

29、ordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements.(为确保设计和开发输出 满足输入的要求,应根据所策划的安排,对设计和开妥进行验证) Records of the results of the verification and any necessary shall be maintained.The Control of Design and Development in Quality Management System6. Design and development validationDesign and development validation shall be performed in accordance with planned arrangements to ensure that the resultin

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