Quality control

In ISO 9000: 2005 ^[3] :

Quality management is a part of quality management aimed at fulfilling quality requirements.

Quality management is a coordinated activity in directing and managing an organization in relation to quality. A note to this definition states that these activities typically include the development of quality policies and objectives, quality planning, quality management, quality assurance and improvement.

In ISO 8402: 1994 ^[1] :

Quality management ( eng. Quality control ) - methods and activities of an operational nature, used to fulfill quality requirements.

General quality management, quality management ( quality management ) are those aspects of the overall management function that determine quality policy, objectives and responsibilities, as well as implement them through such means as quality planning, quality management, quality assurance and quality improvement within the quality system. The note added that the responsibility for the overall management of quality lies at all levels of management, but they must be managed by top management. All members of the organization are involved in the overall quality management.

In GOST 15467-69 ^[4] :

Product quality management - actions undertaken during the creation and operation or consumption of products in order to establish, ensure and maintain the required level of its quality.

Since quality management and quality management are aspects of the overall management and management of an enterprise, it is therefore necessary to turn to more general management and management concepts before analyzing and matching these terms.

In the introductory article to the management textbook ^[5], Professor I. I. Evenko defines management in Russian as management, but draws attention to the difference in the interpretation and use of the terms management and administration . In Russian, the term management , without clarifying definitions, is impersonal. In English, the term administration is used for anonymous management activities. In the US, a popular manager training program is called Master of Business Administration (MBA). In English, speaking of management, imply the figure of a manager. In Russian, in such cases, the term leadership is used , which also implies the figure of a manager and more closely matches the term management. But both management (management) and management are management activities and therefore, in practice, depending on the context, the terms management, management and management are used as equivalent.

As for the definitions of management and control , they are interpreted differently in different sources. Most often, these definitions are reduced to a list of functions that must be performed in the process of leadership and management ^{[5] [6] [7]} . Among them are planning, organization, disposal, coordination, control, motivation, recruitment, communication (information), and decision making. Such definitions do not fully reflect the essence of management activities, since they do not reflect the subjects and objects of management. In reality, management is the process of the subject's influence on the object of management by performing managerial functions, taking into account the feedback with the object. . Visually, the essence of management can be represented as follows:

The driver-car system is the most understandable illustration of the essence of control. Here the driver (control subject) acts on the car (control object), performing the functions of driving the car.

The relationship between the concepts of management and management arises from the interpretation of the term management as a guide .

In ISO 9000: 2005 ^{[3], the} term management is defined as coordinated activities for the management and management of an organization . But each manager to manage the organization, you need to organize work and carry out the current management of the enterprise in accordance with the procedure established in the organization of work.

But what does it mean to organize work?

In Webster’s dictionary, the word organize is defined as follows.

• develop an organic structure: undergo changes or cause any transformations;
• make, form into a complete, complete and functioning whole;
• form a management structure.

- ^[8]

In the dictionary of the Russian language ^{[9], the} meaning of the word to organize has a similar meaning: to create, adjust, arrange, organize, bring into something known order .

With reference to our case, the organization of work is understood as the construction of the structure of the enterprise and the creation of a management system that establishes a certain order of management activity, the “rules of the game”. The current management of an enterprise is the process of day-to-day performance by managers at all levels of their functions in managing the areas of activity assigned to them (finance, personnel, design, procurement, production, quality, and other objects).

Based on the above, the structure of the enterprise management and the place of leadership and quality management in this structure looks like:

In the definitions of management and quality management, the data in the standards do not refer to the subjects and objects of management. Quality management is represented either by an indefinite “part of quality management,” or by an equally undefined “operational activity”, or “by actions undertaken during the creation and operation or consumption of products”. Functions that are performed in quality management are not shown. The quality management functions are not sufficiently disclosed. All this does not allow to clearly understand what management and quality management are, what is their meaning and content.

In this regard, in the first, above definitions, subjects, objects and functions of management and quality management are indicated.

Wherein:

The object of quality management is the process of creating products, during which, under the influence of management subjects, its quality is formed.

The object of quality management (general quality management) is not only the process of creating products, but also all other activities of the enterprise in the field of quality.

The subjects of quality management are the managers of all levels of management, each of whom influences the process of creating products through the implementation of their functions. Together they form the subject of quality management - a quality management system ( quality management system, or in short - a quality system).

The subject of quality management is the top management of the enterprise, carrying out general quality management - interacting with the external environment and creating the necessary conditions at the enterprise to ensure product quality .

The process of quality management is the composition and sequence of performance of management functions in quality by managers at all levels of management at the stages of product creation.

As a result, in these definitions there are subjects, objects and functions of management and quality management, as well as Russian-language definitions of these terms from the ISO 8402 standard, which makes clear the meaning, content and correlation of these terms.

Applying the term quality management , you need to keep in mind the following.

In contrast to the ISO 9000: 2005 standard, in the previous standard on terminology - ISO 8402: 1994, the term quality management was translated as general quality management, administrative quality management . This term is more consistent with the Russian language for the name of the activities of senior managers "in the management and management of the organization in relation to quality." It was more comprehensible and organic for the Russian language, as, probably, the term quality management for English is organic. Unlike other acceptable cases of the direct use of the word management in Russian, the vague term quality management serves as a good example of “mixing languages: French with Nizhny Novgorod”. But since the term quality management is enshrined in the official Russian-language edition of the ISO 9000 series, it is also used in the definition formulated above, but for clarity, the general quality management from ISO 8402: 1994 is added with the option.

In ISO 8402 - 86 ^[10] , a note to the definition of the term quality control (quality control) was recommended when referring to a broader concept to add a definitive word such as “quality management at the company level”. A “ company-wide quality management” ( eng. Company-wide quality control , CWQC) was also mentioned in a note to the term “universal quality management” given in ISO 8402: 1994.

Such a broad concept includes general management and operational quality management and forms a single continuous process of company-wide quality management. In accordance with this, the structure and functions of quality management on a company scale is as follows:

Based on the structure and functions of quality management, the quality management process across the company, taking into account external factors, is formed as follows.

The top management , fulfilling its quality functions, provides general quality management: it interacts with the external environment, determines the quality policy and plans and creates the necessary conditions at the enterprise to ensure product quality.

Heads of the middle and lower level , proceeding from the decisions of the top management, carry out operational quality management at their own level: they influence the process of creating products by consistently performing their functions. At the same time, if according to the results of quality control and analysis of the information received, all necessary measures to improve product quality are developed and put into production, the next management cycle will be repeated on the “quality loop” at a higher level - on the “quality spiral” (see “Quality Model” in the article Quality Assurance ). Measures taken to improve quality are necessary not only to eliminate shortcomings, but also to continuously improve product quality in order to keep up with competitors. The terms “quality loop” and “quality spiral” were used in ISO 8402: 86 and ISO 8402: 94.

The presented quality management process shows how the quality management system (quality management system, quality system) functions. The composition of the functions of general management and operational quality management, which are performed at the same time, basically corresponds to the recommendations of the international standard ISO 9001: 2008 with the requirements for quality management systems ^[11] .

The current state of quality management has a great background. Briefly, in general terms, it can be represented as follows. Until the beginning of the 20th century, quality care was limited to the implementation of a number of control and support measures that were built into the overall process of enterprise management. At the same time, standardization and unification of parts, tools and labor methods were used, input control of materials, operational control in the manufacturing process, as well as various types of testing of finished products were used.

As competition intensifies and the products become more complex, its quality has become increasingly important as the basis for competitiveness. “All these phenomena have led to the emergence of the concept of transition from separate disparate measures to ensure product quality to a systems approach, to the need to manage product quality” ^[12] .

A special role was played by the methods of statistical quality control ( statistical quality control (English) , SQC), which was initiated by Schuhart , an employee of Bell (USA), who introduced control charts in the 30s of the 20th century. With the introduction of statistical methods, quality management began in Japanese firms, after an American scientist, statistician Deming, in 1950 conducted courses in Japan to study them.

But already in the 1960s, statistical quality control (SQC) began to spread beyond the limits of the production process, and SQC began to turn into total quality control (TQC) at the firm level - English. total quality control .

It envisaged the participation of all employees of the company, training, the work of quality circles, the use of statistical methods. And although the ideas of integrated quality management, quality circles and the use of statistical methods were born in the USA and Europe, Japan actively used and improved them ^{[13] [14]} .

As a result of using the American, European and Japanese experience in quality management and taking into account an increasing number of factors affecting quality, quality management has acquired a comprehensive, systemic nature. And such an integrated approach was realized in the form of quality systems ( English quality systems ) as part of the overall management of enterprises.

Following the release of international standards ISO 9000 for quality systems, in ISO 8402 - 86, “integrated quality management” was mentioned in a note to the definition of “Quality management” as synonymous with “company-level quality management”.

Quality systems were formed not only in the USA, Europe and Japan, but also in the former USSR ^[12] with the introduction of integrated product quality management systems (CS UKP) in the 70s of the XX century. At the same time, integrated quality management was understood as a coordinated impact of staff and managers at all levels on all stages of product development, taking into account all factors that have a significant impact on quality .

The first stage of the implementation of the KSU PP in the USSR was the creation of the Saratov system of defect-free production of products (BIP), developed in the mid-1950s. In this system, the percentage of delivery of products to the Quality Controller from the first presentation was taken into account, and depending on this, the level of moral and material incentives for the employee was established. Later, this system was transformed into a system of defect-free labor (PBT), in which, in addition to the BIP system, rhythm and production culture were taken into account. Along with these systems, the KANARSPI system was developed (quality, reliability, resource from the first products), which was introduced at the enterprises of the Gorky (now Nizhny Novgorod) region, as well as the NORM system (scientific organization of motor potential increase) applied at the Yaroslavl Motor Plant. And finally, in the 1970s, a number of enterprises in the Lviv region developed and implemented a comprehensive product quality management system (CC UKP), which incorporated elements of the BIP, SBT, KANARSPI, NORM systems and the experience of other quality management companies.

After that, at Soviet enterprises, the introduction of the KPP CP began with a directive procedure, with the help of which they hoped to raise the quality of domestic products. Everyone fought for quality, there was a five-year quality plan , the best products were awarded the “ Quality Mark ”. In 1987, private sector quality control was introduced at 1,500 enterprises in the country - the state acceptance of products. KS UKP played a positive role in documenting quality systems, combining disparate elements of quality management in enterprises into a single system. Subsequently, this greatly facilitated the work on bringing the quality control system of the CCP to close within the meaning of the requirements of the ISO 9000 international standards for quality systems, the first edition of which was released in the USSR in Russian translation in 1988 ^[10] .

With large-scale and mass production, statistical quality control methods (SQC) are widely used. The most famous among them are the “seven quality control tools”, which were first widely used in quality circles in Japan, and then in other countries, due to their effectiveness and accessibility for ordinary employees of enterprises. ^[15]

The structure of these “seven tools” includes: Pareto diagram, cause-and-effect diagram, control charts, histograms, stratification method, graphs, scatter diagram. A summary of these methods in relation to quality management is as follows:

The method of stratification (layer-by-layer analysis, zoned sampling - stratification (English) ) is used to determine the causes of variation in the characteristics of products. The essence of the method consists in the separation (stratification) of the obtained characteristics depending on various factors: qualifications of workers, quality of raw materials, work methods, equipment characteristics, etc. This determines the influence of a particular factor on product characteristics, which allows you to take the necessary measures to eliminate their unacceptable scatter.

Charts ( diagrams ) are used for clarity and to facilitate understanding of the interdependence of quantities or their changes over time. The most commonly used linear, circular, column and tape charts.

The Pareto diagram (Pareto diagram), named after its author, the Italian scientist and economist Pareto (1848-1923), makes it possible to visualize the magnitude of the losses depending on various defects. (see Pareto curve ). Because of this, you can first focus on eliminating those defects that lead to the greatest losses. To clarify the causes of these defects, it is advisable to additionally use a causal diagram. After finding out the causes and elimination of defects, the Pareto chart is reconstructed in order to verify the effectiveness of the measures taken.

The cause -effect diagram (cause and effect diagram) is used, as a rule, when analyzing defects that lead to the greatest losses. It allows you to identify the causes of such defects and focus on eliminating these causes. In this case, four main causal factors are analyzed: man, machine (equipment), material and method of work. In the analysis of these factors, secondary and perhaps even tertiary causes are identified, leading to defects and to be eliminated. Therefore, in order to analyze defects and build a chart, it is necessary to determine the maximum number of causes that may be related to the defects allowed.

Such a diagram in the form of a fish skeleton was proposed by the Japanese scientist Kaoru Ishikawa . His diagram is also called the “branchy pattern of characteristic factors.” Sometimes it is also called the “four M” diagram - according to the composition of the main factors: Man (man), Method (method), Material (Material), Machine (machine), see Ishikawa diagram .

The histogram is a bar graph and is used to visualize the distribution of specific parameter values ​​by frequency of repetition over a certain period of time (week, month, year).

When applied to the graph of permissible parameter values, it is possible to determine how often this parameter falls within the permissible range, shifts within tolerance or goes beyond its limits.

The obtained data is analyzed using other methods:

• losses due to defects depending on various defects are examined using the Pareto chart;
• causes of defects are determined using the cause-and-effect diagram, the method of delamination and scatter diagrams;
• the change in characteristics over time is determined by control charts.

A scatter diagram (Scatter diagram) is constructed as a graph of the relationship between two parameters. This allows you to determine if there is a relationship between these parameters. And if such a relationship exists, you can eliminate the deviation of one parameter by acting on another.

A control chart is a kind of chart that is characterized by the presence of control boundaries that indicate the allowable range of characteristics variation under normal process conditions. (see. Shewhart Control Card ). Going beyond the control limits means a violation of process stability and requires an analysis of the causes and the adoption of appropriate measures.

These “seven tools” help solve most of the emerging quality problems. To solve more complex problems, “seven new quality control tools” can additionally be used: Affinity diagram, Dependency diagram, Tree diagram, Matrix diagram, Switchboard diagram, Process assessment planning diagram, Analysis of matrix data.

For a detailed study of statistical methods, reference should be made to the special literature, as well as to the international standard ISO 10017 on statistical methods ^[16]

Standardization in the field of statistical methods at the international level is the responsibility of the technical committee of the International Organization for Standardization ISO / TC 69 “Application of statistical methods”. The materials of this committee may be of interest to those who, by the nature of their work, are associated with the use of statistical methods.

In addition to the listed statistical methods, the Six Sigma method and Taguchi methods are used for quality control and management.

The Six Sigma method is used for statistical process control in order to reduce the probability of product failure. The smallest probability of failure is achieved under the condition that six standard deviations from the nominal value (plus or minus three sigmas) are steadily falling into the specified tolerance field with a certain margin. This requires high precision manufacturing of parts, ensuring minimal sigma values.

Traditionally, statistical control of production processes is a random selection of a part of a product and its testing. Deviations are continuously checked for validity and corrected, where necessary, before the production of defective parts.

The ISO 9000 standards have been developed thanks to the fact that enterprises in industrialized countries realize the need to implement integrated quality management, which some people already called total. It began with the fact that in the 60-70s of the XX century national standards were developed with recommendations on what types of work should be implemented in enterprises in order to organize a system in the work on quality (quality system). It was recommended to introduce quality control of projects, materials, products, management of documentation and measuring instruments, to establish a clear procedure for eliminating deficiencies, etc. Then, by 1987, an international organization for standardization (ISO), taking into account national standards, mainly based on the British Standard BS 5750, international standards of the ISO 9000 series ^[10] have been developed and published with recommendations for the creation of quality systems. The benefits of introducing quality management systems are explained by the following considerations. Since the warranty obligations of the supplier cannot serve as a complete guarantee for meeting customer requirements due to possible errors in the design and manufacture of products, it is important for the customer that the supplier has a clear system in quality work. This gives the customer additional confidence that the supplier does not work on quality in an unsystematic, shock-rushing manner, but systematically and systematically, which ensures sufficient stability of the quality of the products, and not just individual samples for advertising and exhibitions.

As a result, with the release of the ISO 9000 standards, the experience of an integrated approach to quality management received a logical documentation and was widely distributed in world practice. As they gained experience in applying these standards, they were refined. In 1994, the second edition of the standards was published, in 2000 - the third, in 2008 - the fourth. Currently, the standards of ISO 9000: 2015 (terms and definitions) and ISO 9001: 2015 (requirements for a quality management system) are used to create quality systems. Standards have been developed for auditing and certification of quality systems, for personnel training, and others. In addition, on the basis of ISO 9000 standards, standards for quality systems for enterprises were developed taking into account industry characteristics. Unfortunately, the definitions of terms such as product quality, quality assurance, quality management (quality management) given in the standards do not reveal the essence of these concepts and contain a number of erroneous provisions, which were noted in the analysis of these terms in the relevant articles (see Product Quality , Quality Assurance , Quality Management System ). In this connection, in practical work on quality management, in order to understand these terms, one has to be guided by additional authoritative sources on management and terminology indicated in the references.

Further development of quality management did not stop at an integrated approach, which was sufficient in conditions when achieving the required quality was one of the objectives of the enterprise, along with the price, volume and delivery time of products under contracts. In the 1980s - 1990s, due to increased competition in sales markets, product quality came to the fore as the basis of its competitiveness (see Competitiveness of goods ). Complementing an integrated approach with new elements, manufacturers gradually shifted to a broader approach to quality management, which in Russian standards was called universal management (control) of quality.

Total quality management (TQM) was presented in the international standard ISO 8402: 1994 as “an approach to the management of an organization aimed at quality, based on the participation of all its members, and aimed at achieving long-term success by meeting customer requirements and benefits for members of the organization and society. ” In a note to the definition of this term, it was noted that "Total Quality Management - TQM" or its constituent parts are sometimes called "total quality", "CWQC" ( company-wide quality control ) ), "TQC" (total quality control) (total quality management), etc. In addition to the participation of all staff, this approach implied a strong and persistent quality management from the top administration, education and training of all members of the organization.

In its meaning, universal (total) quality management is closer to the wording of the ISO 9000: 2005 standard, which sets out the principles of quality management, although there is no term “universal quality management”. However, the term continues to be used in practice instead of the clear and natural “total quality management”, which corresponds to its abbreviation TQM, using the term “universal”. In addition, when using the definition of “universal” in the phrase “universal quality management,” the scope of concepts is violated. A specific concept from a narrow field of knowledge (quality management) is put next to the all-encompassing word “universal”, which refers to fundamental concepts, such as, for example, the universal law of nature. Применение термина «тотальное управление качеством» может быть оправдано, если хотят подчеркнуть его главную особенность, когда в деятельности предприятия и всех его подразделений на первый план ставится обеспечение требуемого качества продукции с широким привлечением персонала.

Появление TQM и его дальнейшее развитие шло по пути расширения сферы управления качеством, вовлечения в неё все большего числа направлений деятельности и факторов, влияющих на качество. Документально это отразилось в третьей версии стандартов ИСО 9000 и при разработке в конце 1980-х — начале 1990-х годов моделей национальных премий в области качества, в которых учитывается вклад различных факторов в обеспечение качества и результаты бизнеса.

В США в 1987 году была введена премия по качеству министра торговли М. Болдриджа. После этого премии по качеству были учреждены в ряде европейских стран, а Европейский фонд в 1991 году по управлению качеством (EFQM) учредил Европейскую премию по качеству, основанную 14-ю крупнейшими европейскими компаниями, такими, как Филипс , Фольксваген , Нестле , Рено , Фиат , Бритиш Телеком и другими. В России премия по качеству была учреждена в 1996 году.

В настоящее время можно отметить следующие основные черты всеобщего (тотального) управления качеством, о котором можно просто говорить как о современном управлении качеством продукции:

• Выбор стратегии и политики в области качества, направленных на постоянное улучшение качества продукции и услуг;
• Ориентация работы предприятия, исходя из запросов потребителей — делать, что продаётся, а не продавать то, что делается;
• Руководство всеми подразделениями предприятия со стороны первых лиц и администрации, исходя из необходимости обязательного обеспечения требуемого качества продукции;
• Вовлечение персонала в активную работу по улучшению качества путём обеспечения его удовлетворённости за счёт должной мотивации труда, содействия рационализаторской работе и организации работы кружков качества;
• Внедрение гибкого производства с учётом индивидуальных требований потребителей в условиях высокопроизводительного массового или крупносерийного производства;
• Создание систем качества в соответствии с требованиями международных стандартов ИСО серии 9000 с учётом особенностей предприятий;
• Применение процессного, системного, ситуационного и других современных подходов к управлению, накопленных практикой менеджмента;
• Инвестиции в развитие персонала, непрерывное повышение его квалификации, обучение рабочих смежным специальностям и методам решения проблем качества;
• Самооценка деятельности предприятия по критериям премий в области качества и участие в конкурсах на их присуждение;
• Сертификация продукции, оценка или сертификация систем качества, анализ существующих проблем и разработка необходимых мероприятий для обеспечения и повышения качества;

Кроме того, в рамках TQM рекомендуется создание систем управления охраной окружающей среды по стандартам ИСО 14000 , а также — систем управления профессиональной безопасностью и здоровьем ( OHSAS 18000 ), которые дополняют систему качества, повышая эффективность и конкурентоспособность предприятия.

Нет сомнения, что управление качеством будет развиваться и дальше, обогащаясь новыми подходами и методами работ.

Управление качеством в практической работе тесно соприкасается со всеми направлениями деятельности предприятия, которые обеспечивают или участвуют в создании продукции. Руководители этих направлений выполняет свои функции по качеству, а все вместе они образуют субъект управления качеством , воздействующий на процесс создания продукции с целью обеспечения её качества.

Поскольку управление качеством является одним из аспектов общего управления компанией, оно не может рассматриваться изолированно от науки управления (менеджмента), которая определяет общие закономерности управленческой деятельности. Поэтому для организации эффективного управления качеством необходимо использовать положения и рекомендации менеджмента, которые могут применяться в управлении качеством ^{[5] [17] [6] [7]} . Это позволит:

• получить общее представление об организациях (предприятиях) и факторах внутренней и внешней среды, то есть об условиях, в которых осуществляется управление качеством;
• ознакомиться с сущностью управления и структурой управленческой деятельности на предприятии, чтобы уяснить роль и место управления качеством в управлении предприятием в целом;
• применять в управлении качеством управленческие функции, а также подходы и методы их выполнения, накопленные в практике менеджмента.

В этом случае управление качеством получит в своё распоряжение научный фундамент и апробированные практические методы менеджмента , которые обеспечат солидную основу для организации и проведения профессиональной и эффективной работы по управлению качеством на предприятиях.

• Product quality
• Quality assurance
• Quality management system
• ISO 9000

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