Unidad 8 Conceptos Básicos de Calidad PDF

# Unidad 8 Conceptos básicos de calidad ## En esta unidad veremos: - 8.1 Definiciones de calidad - 8.2 Evolución de la calidad - 8.3 Círculo de Deming - 8.4 Reconocimiento de la calidad ## 8.1 Definiciones de calidad The concept of quality does not have a single and clear definition. In fact, depending on the context, we can find very diverse definitions, even contradictory in some aspects. To help clarify the subject, we are going to restrict the concept of quality to the industrial field, leaving aside more everyday definitions. In this context, the main concepts associated with quality are: - From the manufacturing point of view: - Fulfillment of requirements. - Fulfillment of specifications. - From the product point of view: - Uniformity. - From the value point of view: - Reliability. - Level of excellence of a product at a relatively low cost. - From the customer point of view: - Suitability for use. Products must be able to be used in the expected way. - Fulfillment or exceeding of expectations and customer needs in the expected way, at a cost that does not exceed the expected price according to these expectations. From these concepts, a definition of quality can be established. These definitions are not mutually exclusive; in them, the term quality refers to one or more of these concepts, depending on the context. ### Ejemplo From an everyday point of view, it is easy to hear expressions like quality craftsmanship. From an industrial point of view, talking about "quality craftsmanship" is an oxymoron. By definition, craftsmanship cannot guarantee a minimum degree of uniformity and predictability, which are essential in an industrial process. There are no two pieces of craftsmanship alike; the aim is for them to be unique, and this characteristic is what gives them their value. But if, in addition to being unique pieces, they also meet the rest of the expectations, mainly aesthetic and functional, they can be considered pieces of "quality"; however, this is only if they are not in an industrial context. ### Ejemplo In the world of the food industry, achieving product uniformity is one of the maximum aspirations, due to the amount of uncertainty involved in the production process. Some products can have enormously disparate results, so it is particularly difficult to know if they are of "quality" (they meet the customer's expectations) before consuming them. A good example of this industry's effort to achieve this uniformity is evidenced by some marketing campaigns for products that cause uncertainty in the consumer, such as cured ham or cheese, where it is "guaranteed" that these products will not end up salty or dry respectively. ## Conceptos asociados a la calidad. If we analyze these concepts in depth, we can see that, in the end, they are all present, to a greater or lesser extent, in all areas. In addition to meeting the specifications, the engineering department cannot design a product that is not usable or reliable; it must ensure that all manufactured products are exactly alike and that they meet the customer's expectations. In the same way, production must ensure that all products are uniform, because, otherwise, it may happen that the requirements are not met or that the customer is disappointed because the result depends on the specific unit of product purchased. The situation is similar in the rest of the departments. In a modern company and in a highly competitive environment, all areas must function in unison. It makes no sense to design parts that cannot be manufactured, sold, used, or that do not meet the customer's expectations. We can say, then, that considerations about quality act as a connecting thread between all areas. In fact, the scope of the quality department's work is the entirety of the company. If we were to highlight one concept out of all those associated with quality, it would be fulfilling the customer's expectations and needs. In a highly competitive environment, a company's survival and the obtaining of profits depends on customer satisfaction, and that, in turn, on quality. The remaining concepts are a logical consequence of this principle: to satisfy customers, products must respond exactly as expected (and, if possible, better), and, therefore, uniformity, reliability, usability, and fulfillment of requirements are practically necessary. From a much more practical standpoint, when it comes to achieving quality, we can conceive of it as the set of functions and characteristics of a product or service, designed to meet the needs of customers. These functions or characteristics are referred to as quality characteristics. ## Garantizar que estas características de calidad satisfagan las expectativas y necesidades de los clientes será el objetivo principal de la gestión de calidad. ## 8.2 Evolución de la calidad The concepts of quality, which seem logical to us today, have not always played the role they do today. If we analyze the evolution of the production process, we can distinguish several phases: 1. **System of predominantly artisanal manufacturing**, where the artisan's skill and experience were key. Exceptionally, organized manufacturing processes were carried out, but they were isolated and not established as the usual way of manufacturing consumer products. In some cases, guilds of artisans set a series of standards to ensure a certain level of "quality", but the artisan's skill prevailed as a guarantee of customer satisfaction. 2. **In the 18th century, with the arrival of the Industrial Revolution**, the first industrial factories appeared. The need to organize production and control the products being manufactured became apparent. This need was not substantially and formally materialized beyond the basic quality controls of finished products. 3. **At the beginning of the 20th century, the introduction of the assembly line in the industrial environment, thanks to Henry Ford**, redefined the production process. For the first time, the quality control of finished products was systematized, at the end of the production process, to prevent defective parts from reaching customers and the resulting complaints and returns 4. **From the 1950s onwards, the theories of quality by Feigenbaum, Juran, and Deming reached Japan, where they began to be put into practice. Taiichi Ohno created the Toyota system in one of the leading Japanese automotive industries (Toyota). In this system, the concept of quality extends from the simple control of finished products to control of the production process itself, leading to the Statistical Process Control or SPC.** 5. **In the 1970s, quality was fully integrated into the entire production cycle, extending from production to the other areas of the company. Due to increasing competitiveness, customer focus conditions company management and, in particular, quality.** 6. **From the 1980s onwards, this integration into all business operations was consolidated in what is known as total quality. A culture of quality began to be talked about, where everyone should be involved.** 7. **From the 1990s onwards, the adoption of quality standards (ISO 9000) began to become widespread and the notion of excellence (EFQM) began to be discussed, but it was not until the 21st century that quality management systems based on these models began to be implemented.** 8. **Today, quality management has become fully integrated into the general business management model. Quality management has been integrated with occupational safety and environmental management. Management models of the Lean Management type, based on Lean Manufacturing by Toyota, are being adopted beyond automotive companies; the customer is no longer seen as someone to satisfy, but now as the protagonist and reference of production activity; and, methodologies such as JIT (Just In Time) are given new prominence, making the production activity much more dynamic.** ## Importante destacar que la necesidad de la organización del trabajo y los primeros controles de calidad no surgen con la Revolución Industrial. It is important to note that the need for work organization and the first quality controls did not arise with the Industrial Revolution. The great constructions of Antiquity required a first-order level of human resources and logistics organization, refinement of manufacturing processes, a minimum level of uniformity in products manufactured elsewhere, etc. The big difference is that these processes are not integrated in the manufacture of general consumer goods, which remain dominated by artisans. ### Ejemplo In the Battle of Qadesh, in 1274 BC, Ramses II faced the Hittites with an army that had an impressive number of 2,000 light chariots. The manufacture of these chariots is considered the first assembly line in history. Although it was not physically a line of organized assembly like the Model T by Henry Ford, the manufacture was based on the construction of multiple interchangeable parts (standard) that were later assembled to create the chariot. In this way, the chariots were not only manufactured much faster and more efficiently, but they were also very easy to repair and could be operational and return to combat in a very short time. Obviously, the uniformity and reliability of the parts were especially important so that the assembly did not require almost any adaptations or adjustments. The enormous amount of chariots that had to be manufactured (2,000) with Bronze Age technology did not allow craft manufacturing. This led not only to the first “assembly line”, but also, probably, to the first application of quality criteria to the construction of parts. After the Second World War, quality became an integral part of the production process and has continued to evolve ever since. Japanese companies began to apply quality theories, starting with Toyota, which implemented what became known as the Toyota system. This system is based on quality principles, such as continuous improvement, and focuses on ensuring quality throughout the entire production process. This prevents the wasting of resources on the manufacture of defective parts, increases efficiency, and significantly reduces the number of parts that are rejected or returned. Active pursuit of quality is encouraged and processes are constantly refined (Deming Cycle) so that the company remains competitive. With the application of this system, Japanese companies achieved a significant international success because they offered very competitive products, with short delivery times and very low defect rates, aimed at meeting the customer's needs. Until that time, demand had far exceeded production capacity. Products were sold in the markets as fast as they were manufactured, and companies focused on increasing production as the main means of increasing profits. With the introduction of quality, it is possible to produce, in a much more efficient way, more and better. Markets are becoming much more dynamic, uncertain, and, above all, competitive. In this environment, lack of quality is an excluding factor. Hence the need to manage quality to ensure that production efforts are effectively and efficiently geared towards meeting customer needs and expectations. From then on, quality management evolved from the final quality control of products to its integration into the whole process (SPC), passing through total quality management (TQM) models, the implementation of the quality function (QFD), up to the present day, with an orientation towards excellence (EFQM) and Lean Management. ## 8.4 Reconocimiento de la calidad The emergence of total quality management (TQM) is a result of the evidence that, to ensure quality, it must extend to all areas of the company. In fact, the overall vision of quality goes beyond the company itself, including not only customers but also suppliers. On the other hand, the competitive environment is beginning to use quality as a differentiator. Customers are demanding more quality from companies, and these, in turn, are demanding it from their suppliers. However, in this case, it is a need to guarantee their own quality. ## El alcance de la gestión de la calidad es cada vez mayor, por lo que empieza a ser necesaria una fuerte sistematización para que esta gestión resulte efectiva. The scope of quality management is growing, making it increasingly important to have a strong standardization to make this management effective. ## La implementación de Sistemas de Gestión de Calidad (SGC) comienza a extenderse en las empresas de cierto nivel. The implementation of Quality Management Systems (QMSs) is starting to spread to companies at a certain level. ## La diversidad de sistemas implantados y la necesidad de dar credibilidad a los sistemas de calidad utilizados requieren estandarizar y, en la medida de lo posible, certificar la calidad The diversity of systems implemented and the need to give credibility to the quality assurance systems used require standardization and, where possible, quality certification. ## With that aim, in the UK BS 5750 was implemented. This standard is the origin of the ISO 9000 standard, which is currently the main quality standard. ## 8.4.1 Normativa básica Standards are documents designed to organize a specific activity. Standards aim to standardize the basis of operation of these activities, which is why they must be publicly available and backed by and accredited by recognized bodies. Today, there are many standards that impact product and service quality. These standards are very specific to each production area and do not allow generalizations. For this reason, a standard dedicated specifically to quality management was needed. This standard is not designed to set technical requirements for quality products, but for how to guarantee quality through a quality management system. The quality management standard par excellence is the ISO 9000 series, which has been evolving up to its latest version, ISO 9000:2015. The ISO 9000 standard is, in fact, a family of standards that describe the requirements that a Quality Management System within an organization must meet. If we had to highlight two characteristics that define the philosophy of this standard, they would be the following: - **Continuous improvement**, as the backbone of the management system. - **Focus on the process**, as the main focus of action. A desired outcome is achieved more efficiently when activities and related resources are managed as a process. The ISO 9000 family of standards is under constant development and expansion. It consists of multiple standards and guidelines, grouped into various standards around three basic standards: - **The ISO 9000 standard is a generic and introductory standard. It basically contains the main definitions necessary to understand the standards in the series.** - **The ISO 9001 standard is the standard that brings together the guidelines and standards necessary to implement a quality management system oriented towards customer satisfaction. These standards are what is used to certify a company's quality management system or for contractual purposes.** - **The ISO 9004 standard contains the guidelines for performance improvement. It is intended to help improve the effectiveness and efficiency of quality management systems, but it is not certifiable.** In the European Union, ISO 9000 standards were adopted, being included in the EN 29000 series of European standards. In Spain, the Spanish standards body Aenor adopted them in the UNE 66900 series of standards. Today, quality management is no longer understood without environmental management and occupational safety management. ## Por tanto, junto a la normativa ISO 9000, se implanta la ISO 14000 (gestión medioambiental) y la OHSAS 18000 (gestión de la seguridad y salud laboral). Las últimas versiones de la norma ya están revisadas, para facilitar la integración de estos tres sistemas en un único sistema de gestión. Therefore, along with the ISO 9000 standard, the ISO 14000 (environmental management) and the OHSAS 18000 (occupational safety and health management) standards are being implemented. The latest versions of the standard are already revised to facilitate the integration of these three systems into a single management system. ## En la figura 8.4 podemos ver las principales normas relacionadas con la gestión de la calidad. Figure 8.4 shows the main standards related to quality management. ## En la unidad 11 veremos con más detalle la norma ISO 9000, de acuerdo con su última revisión de 2015. In unit 11, we will take a closer look at the ISO 9000 standard according to its 2015 revision. ## 8.4.2 Certificación The standard responsible for setting out which guidelines and standards must be followed for a quality management system to be certified is ISO 9001. Specifically, currently, the only standard by which quality certifications can be obtained is ISO 9001:2015. In the same way that standards must be backed by an entity (ISO or Aenor), the certification process has to be carried out through certification bodies accredited and regulated by the bodies responsible for standardization. Certification has an expiry date, so it must be renewed periodically. The certification process can start from two different situations: you already have a quality management system (QMS) or you don’t. Obviously, if you don’t have a QMS implemented, the process will be more laborious, but the points of the standard must be reviewed comprehensively, in any case. The evaluation system in this phase can be divided into the following phases: 1. **Evaluation.** In this phase, the functioning of the QMS is reviewed. If no quality management system exists, its scope will be determined, and its main focus will be identified. 2. **Review or design** (if it does not exist) **of the QMS**. To do this, the points of the standard must be reviewed, remembering that it is a general standard, so it has to be adapted to each specific organization. If you already have a QMS, the new points of the standard (if there is a new version) and the new points for improvement must be incorporated. Once the QMS has been reviewed, the implementation of changes must be planned. 3. **Implementation.** When implementing the updated QMS, all staff must be aware of the changes to be made. A certain period of testing and adaptation will be needed, to implement the changes and correct errors and problems. 4. **Internal audit.** Once the system has been implemented and a minimum test period has elapsed, an internal audit will be carried out. The intention of this audit is to verify the correct implementation of the QMS and identify any possible problems before the external audit. This audit is carried out by staff from the quality department itself, so any detected errors can be corrected without affecting the certification. 5. **External audit.** The certification body will carry out the final audit, in which the implemented QMS will be analyzed. If there are minor issues (non-conformities), corrective actions and a reasonable period of time will be proposed to resolve them, without affecting the current status of certification. 6. **Certification.** After the deadline for correcting any identified issues, the issues are verified, and the certification process is completed. ## Proceso de certificación. The certification process. <start_of_image> Diagrams: **Figure 8.1** <start_of_image> Diagrams: **Figure 8.2** **Figure 8.3** **Figure 8.4** **Diagram of the certification process**

Unidad 8 Conceptos Básicos de Calidad PDF

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