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1 Quality and Inspection According to the American Society for Quality Control (ASQC), quality is the totality of features and characteristics of a product or service that bear on its ability to satisfy given needs. The definition implies that the needs of the customer must be identified first because satisfaction of those needs is the “bottom line” of achieving quality. Customer needs should then be transformed into product features and characteristics so that a design and the product specifications can be prepared. In addition to a proper understanding of the term quality, it is important to understand the meaning of the terms quality management, quality assurance, and quality control. Quality management is that aspect of the overall management function that determines and implements the quality policy. The responsibility for quality management belongs to senior management. This activity includes strategic planning, allocation of resources, and related quality program activities. Quality assurance includes all the planned or systematic actions necessary to provide adequate confidence that a product or service will satisfy given needs. These actions are aimed at providing confidence that the quality system is working properly and include evaluating the adequacy of the designs and specifications or auditing the production operations for capability. Internal quality assurance aims at providing confidence to the management of a company, while external quality assurance provides assurance of product quality to those who buy from that company. Quality control companies the operational techniques and activities that sustain a quality of product or service so that the product will satisfy given needs. The quality control function is closest to the product in that various techniques of unsatisfactory sources of quality performance. Many of the quality systems of the past were designed with the objective of sorting good products from bad products during the various processing steps. Those products judged to be bad had to be reworked to meet specifications. If they could not be reworked, they were scrapped. This type of system is known as a “detection correction” system. With this system, problems were not found until the products were inspected or when they were used by the customer. Because of the inherent nature of human inspectors, the effectiveness of the sorting operations was often less than 90%. Quality systems that are preventive in nature are being widely implemented. These systems prevent problems from occurring in the fist place by placing emphasis 2 on proper planning and problem prevention in all phases of the product cycle. The final word on how well a product fulfills needs and expectations is given by the customers and users of that product and is influenced by the offering of competitors that may also be available to those customers and users. It is important to recognize that final word is formed over the entire life of the product, not just when it was purchased. Being aware of customers needs and expectations is very important, as was previously discussed. In addition, focusing the attention of all employees in an enterprise on the customers and users and their needs will result in a more effective quality system. For example, group discussions on product designs and specifications should include specific discussion of the needs to be satisfied. A basic commitment management should be that quality improvement must be relentlessly pursued. Actions should be ingrained in the day-to-day working of the company that recognize that quality is a moving target in todays marketplace driven by constantly rising customer expectations. Traditional efforts that set a quality level perceived to be right for a product and direct all efforts to only maintain that level will not be successful in the long haul. Rather, management must orient the organization so that once the so-called right quality level for a product has been attained; improvement efforts continue to achieve progressively higher quality levels. To achieve the most effective improvement efforts, management should understand that quality and cost are complementary and not conflicting objectives. Traditionally, recommendations were made to management that a choice had to be made between quality and cost-the so-called tradeoff decision-because better quality inevitably would somehow cost more and make production difficult. Experience throughout the world has shown that this is not true. Good quality fundamentally leads to good resource utilization and consequently means good productivity and low quality costs. Also significant is the higher sales and market penetration result from products that are perceived by customers to have high quality and performance reliability during use. Four basic categories of quality costs are described in the following: ( 1) Prevention-costs incurred in planning, implementing, and maintaining a quality system that will ensure conformance to quality requirement at economical levels. An example of prevention cost is training in the use of statistical process control. ( 2) Appraisalcosts incurred in determining the degree of conformance to 3 quality requirements. An example of appraisal cost is inspection. ( 3) Internal failurecosts arising when products, components, and materials fail to meet quality requirements prior to transfer of ownership to the customer. An example of internal failure cost is scrap. ( 4) External failurecosts incurred when products fail to meet quality requirements after transfer of ownership to the customer. An example of external failure cost is warranty claims. A problemsolving approach should be followed in seeking quality improvement. The results of any improvement effort will not be permanent unless the root causes of the problems have been found so appropriate (irreversible) corrective action can be implemented. The root cause can be defined as the real cause of a problem. This is often quite different from the apparent cause, which appears after a superficial investigation. A frequently asked question is how to known when the root cause is found and when the investigator is not still being deceived by the apparent cause. A meaning answer is that if the root cause has been found, the problem is able to be turned on and off by adding or removing the cause. Once the root cause has been found, an irreversible corrective action must be implemented so there is no foreseeable situation by which the root cause can return and so permanent improvement results. Although the level of quality control is determined in large part by probability theory and statistical calculations, it is very important that the data collection processes on which these procedures depend be appropriate and accurate. The best statistical procedure is worthless if fed faulty data, and like machining processes, inspection data collection is itself a process with practical limits of accuracy, precision, resolution, and repeatability. All inspection and/or measurement processes can be defined in terms of their accuracy and repeatability, just as a manufacturing process is evaluated for accuracy and repeatability. Controlled experiments can be performed, and statistical measures of the results can be made to determine the performance of a method of inspection relative to the parts to be inspected. Suitability of one or another method can be judged on the basis of standard deviations and confidence levels that apply to each approach as used in a given inspection situation. 4 质量与检测 根据美国质量管理协会的定义,质量是产品或服务能够满足规定需求而具有的特性和特征的总和。这个定义表明,应该首先确定顾 客的需求,因为满足这些需求是达到质量目标的关键。然后应该把顾客的需求转化为产品的特性和特征,并据此进行设计工作和制订产品的技术要求。 除了正确地理解质量这个术语之外,对质量管理、质量保证和质量控制等术语的理解也是非常重要的。 质量管理是确定和实施质量方针的全部管理功能。质量管理是高层管理人员的职责。这项工作包括战略规划、资源分配和与之有关的质量规划活动。 质量保证包括能够给予满足规定需求的产品或服务以适当信任所必需的全部有计划,有组织的活动。这些活动的目标是给人们提供对质量体系能够正常工作的信任,而且包括对 设计方案和技术要求妥善性的评价或者对生产作业能力的审查。内部质量保证的目标在于使公司的管理人员对产品质量具有信心,而外部质量保证的目的在于向公司产品的用户们在产品质量方面做出担保。 质量控制包括了为保持产品或服务的质量,使其能满足规定需求所采取的作业技术和有关活动。质量控制功能与产品的关系最为密切,它采用各种技术和活动来监视加工过程,并且消除生成不合格产品的根源。 许多过去的质量体系的设计目标是,在各个加工阶段中,将合格的产品与不合格的产品区分开来。那些被判定为不合格的产品必须经过重新加工以满足技术要求。如 果它们不能被重新加工,就应该被当成废料处理。这种体系被称为“检测 改正”体系。在这种体系中,只有在对产品进行检测时,或者当用户使用产品时,才会发现其中存在的问题。由于检查人员本身固有的因素所决定,这种分类拣选工作的有效性经常低于 90%。目前,预防型质量体系得到了越来越广泛的应用。在这种体系中,为了避免发生质量问题,首先强调对产品生产的各个阶段进行合理的规划和制订预防发生问题的措施。 对于一种产品满足需求或期望值的好坏程度的最终评价是由顾客和用户们作出的,而且会受到可以向这些顾客和用户出售同类产品的竞争对手的 影响。这个最终评价是基于产品在整个使用寿命周期内的表现作出的,而不是仅仅只根据其在购买时的性能作出的。认识到这一点是很重要的。 如前所述,了解顾客的需求和期望是很重要的。此外,将一个企业中的全体员工的注意力集中在顾客和用户以及他们的需求上,会产生一个更有效的质量体系。例如,在对产品设计方案和技术要求进行小组讨论时,要对顾客应该得到满足的需求进行专门的讨论。 管理人员的一个基本职责是不懈地追求质量改善。应该认识到在当今的市场 5 中,质量是一个由顾客们对产品日益增高的期望所驱动的动态目标,质量行动必须落实到公司每天 的工作中。传统的作法是对某一产品确定一个适当的质量等级,然后集中全部力量使产品满足这个质量等级。这种方法不适合于在长期的生产中使用。与之相反,管理人员应该给企业确定这样的方向:一旦某种产品达到了适当的质量等级之后,还应对其进行不断的改进,使其达到更高的质量等级。 为了获得最有效的改进成果,管理人员应该明白质量与成本是互补的,而不是相互矛盾的。传统上,对管理人员的建议是必须在质量与成本之间作出选择。这种方法被称为折衷判断。这是因
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