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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 質(zhì)量與檢測 根據(jù)美國質(zhì)量管理協(xié)會(huì)的定義,質(zhì)量是產(chǎn)品或服務(wù)能夠滿足規(guī)定需求而具有的特性和特征的總和。這個(gè)定義表明,應(yīng)該首先確定顧 客的需求,因?yàn)闈M足這些需求是達(dá)到質(zhì)量目標(biāo)的關(guān)鍵。然后應(yīng)該把顧客的需求轉(zhuǎn)化為產(chǎn)品的特性和特征,并據(jù)此進(jìn)行設(shè)計(jì)工作和制訂產(chǎn)品的技術(shù)要求。 除了正確地理解質(zhì)量這個(gè)術(shù)語之外,對質(zhì)量管理、質(zhì)量保證和質(zhì)量控制等術(shù)語的理解也是非常重要的。 質(zhì)量管理是確定和實(shí)施質(zhì)量方針的全部管理功能。質(zhì)量管理是高層管理人員的職責(zé)。這項(xiàng)工作包括戰(zhàn)略規(guī)劃、資源分配和與之有關(guān)的質(zhì)量規(guī)劃活動(dòng)。 質(zhì)量保證包括能夠給予滿足規(guī)定需求的產(chǎn)品或服務(wù)以適當(dāng)信任所必需的全部有計(jì)劃,有組織的活動(dòng)。這些活動(dòng)的目標(biāo)是給人們提供對質(zhì)量體系能夠正常工作的信任,而且包括對 設(shè)計(jì)方案和技術(shù)要求妥善性的評(píng)價(jià)或者對生產(chǎn)作業(yè)能力的審查。內(nèi)部質(zhì)量保證的目標(biāo)在于使公司的管理人員對產(chǎn)品質(zhì)量具有信心,而外部質(zhì)量保證的目的在于向公司產(chǎn)品的用戶們在產(chǎn)品質(zhì)量方面做出擔(dān)保。 質(zhì)量控制包括了為保持產(chǎn)品或服務(wù)的質(zhì)量,使其能滿足規(guī)定需求所采取的作業(yè)技術(shù)和有關(guān)活動(dòng)。質(zhì)量控制功能與產(chǎn)品的關(guān)系最為密切,它采用各種技術(shù)和活動(dòng)來監(jiān)視加工過程,并且消除生成不合格產(chǎn)品的根源。 許多過去的質(zhì)量體系的設(shè)計(jì)目標(biāo)是,在各個(gè)加工階段中,將合格的產(chǎn)品與不合格的產(chǎn)品區(qū)分開來。那些被判定為不合格的產(chǎn)品必須經(jīng)過重新加工以滿足技術(shù)要求。如 果它們不能被重新加工,就應(yīng)該被當(dāng)成廢料處理。這種體系被稱為“檢測 改正”體系。在這種體系中,只有在對產(chǎn)品進(jìn)行檢測時(shí),或者當(dāng)用戶使用產(chǎn)品時(shí),才會(huì)發(fā)現(xiàn)其中存在的問題。由于檢查人員本身固有的因素所決定,這種分類揀選工作的有效性經(jīng)常低于 90%。目前,預(yù)防型質(zhì)量體系得到了越來越廣泛的應(yīng)用。在這種體系中,為了避免發(fā)生質(zhì)量問題,首先強(qiáng)調(diào)對產(chǎn)品生產(chǎn)的各個(gè)階段進(jìn)行合理的規(guī)劃和制訂預(yù)防發(fā)生問題的措施。 對于一種產(chǎn)品滿足需求或期望值的好壞程度的最終評(píng)價(jià)是由顧客和用戶們作出的,而且會(huì)受到可以向這些顧客和用戶出售同類產(chǎn)品的競爭對手的 影響。這個(gè)最終評(píng)價(jià)是基于產(chǎn)品在整個(gè)使用壽命周期內(nèi)的表現(xiàn)作出的,而不是僅僅只根據(jù)其在購買時(shí)的性能作出的。認(rèn)識(shí)到這一點(diǎn)是很重要的。 如前所述,了解顧客的需求和期望是很重要的。此外,將一個(gè)企業(yè)中的全體員工的注意力集中在顧客和用戶以及他們的需求上,會(huì)產(chǎn)生一個(gè)更有效的質(zhì)量體系。例如,在對產(chǎn)品設(shè)計(jì)方案和技術(shù)要求進(jìn)行小組討論時(shí),要對顧客應(yīng)該得到滿足的需求進(jìn)行專門的討論。 管理人員的一個(gè)基本職責(zé)是不懈地追求質(zhì)量改善。應(yīng)該認(rèn)識(shí)到在當(dāng)今的市場 5 中,質(zhì)量是一個(gè)由顧客們對產(chǎn)品日益增高的期望所驅(qū)動(dòng)的動(dòng)態(tài)目標(biāo),質(zhì)量行動(dòng)必須落實(shí)到公司每天 的工作中。傳統(tǒng)的作法是對某一產(chǎn)品確定一個(gè)適當(dāng)?shù)馁|(zhì)量等級(jí),然后集中全部力量使產(chǎn)品滿足這個(gè)質(zhì)量等級(jí)。這種方法不適合于在長期的生產(chǎn)中使用。與之相反,管理人員應(yīng)該給企業(yè)確定這樣的方向:一旦某種產(chǎn)品達(dá)到了適當(dāng)?shù)馁|(zhì)量等級(jí)之后,還應(yīng)對其進(jìn)行不斷的改進(jìn),使其達(dá)到更高的質(zhì)量等級(jí)。 為了獲得最有效的改進(jìn)成果,管理人員應(yīng)該明白質(zhì)量與成本是互補(bǔ)的,而不是相互矛盾的。傳統(tǒng)上,對管理人員的建議是必須在質(zhì)量與成本之間作出選擇。這種方法被稱為折衷判斷。這是因
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