Basic mechanisms for maintaining normal blood glucose levels. Analysis of the quality management system at the enterprise Quality management process

Serious competition has led to the development of quality improvement programs in countries with developed market economies. There is a need to develop objective indicators to assess the ability of firms to produce products with the required quality characteristics. These objective indicators constitute the so-called enterprise quality system.

According to V.V. Okrepilov, product quality management at an enterprise is the actions carried out during the creation and operation or consumption of products in order to establish, ensure and maintain the required level of its quality. These activities include incoming, operational, acceptance and inspection controls.

As economic reforms progress in Russia, more and more attention is paid to quality.

Currently, one of the serious problems for Russian enterprises is the creation of a quality system that allows them to ensure the production of competitive products. The quality system is important when negotiating with foreign customers, who consider it a prerequisite that the manufacturer has a quality system and a certificate for this system issued by an authoritative certification body.

The quality system must take into account the characteristics of the enterprise and ensure minimization of product development costs. The consumer wants to have confidence that the quality of the supplied products will be stable and sustainable.

In the theory and practice of quality management, two problems are identified: product quality and quality management.

Ensuring quality requires significant costs. Until recently, the main share of quality costs came from physical labor. But today the share of intellectual work is high.

The quality problem cannot be solved without the participation of scientists, engineers, and managers. There must be a harmonious combination of all components of professional influence on quality.

The importance of product quality lies in the fact that only high-quality products open the export route to solvent Western markets. Special competitions are expected to play a major role in ensuring the quality of products of Russian manufacturers and their successful competition in world markets.

Various types of competitions with honorary awards awarded to their winners are widely used in world practice.

A quality system is created to manage the quality of work directly related to product quality (assessment of the quality of development and design of implemented products; incoming materials; control over ensuring the technological accuracy of equipment used in the production of products; control over the quality of technological processes, timely detection of defects, etc. .d.).

The enterprise's quality system must take into account the characteristics of the enterprise, ensure minimization of costs for product development and its implementation. The consumer wants to have confidence that the quality of the product will be stable and sustainable.

The quality system is important when negotiating with foreign customers, who consider it a prerequisite that the manufacturer has a quality system and a certificate for this system issued by an authoritative certification body.

To help organizations implement and maintain effective quality systems, a number of standards have been developed under the general name ISO 9000.

The International Organization for Standardization defines quality (ISO-8402) as the sum of the properties and characteristics of a product or service that give it the ability to satisfy stated or intended needs. This standard introduced such concepts as “quality assurance”, “quality management”, “quality spiral”. Quality requirements at the international level are defined by the ISO 9000 series of standards. The first edition of the ISO 9000 series of international standards was published in the late 1980s and marked the entry of international standardization to a qualitatively new level. These standards have penetrated directly into production processes and management and established clear requirements for quality assurance systems. They laid the foundation for the certification of quality systems. An independent direction of management has emerged - quality management. Currently, scientists and practitioners abroad associate modern quality management methods with the TQM (total quality management) methodology - universal (all-encompassing, total) quality management.

The ISO 9000 series standards established a unified, internationally recognized approach to contractual terms for assessing quality systems and at the same time regulated the relationship between manufacturers and consumers of products. In other words, ISO standards are a strict focus on the consumer with strict adherence to production culture.

To improve the organization’s performance, the quality standards define eight principles of the quality system:

1. Customer focus.

Businesses depend on their customers and must understand their present and future needs, meet their requirements and strive to exceed their expectations.

2. Leader leadership.

To ensure the unity of purpose and direction of the organization's activities, the manager must create and maintain an internal environment in which employees are fully involved in solving the organization's problems.

3. Involvement of employees in the work of the quality system to obtain the greatest benefit from their abilities.

4. Process approach.

The desired result is all the more effective when activities and resources are managed as a process.

5. Systematic approach to management.

Understanding interconnected processes as a system increases the efficiency of organizations.

6. Continuous improvement of the organization as a whole should be considered as its constant goal.

7. Fact-based decision making.

8. Mutually beneficial relationships with suppliers.

These eight quality management principles form the basis for quality system standards.

Quality management systems can assist organizations in improving customer satisfaction.

Consumers need products that meet their needs and expectations. These needs and expectations are typically reflected in product specifications and are generally considered customer requirements. Requirements may be specified by the customer in a contract or defined by the organization itself. In any case, it is the consumer who ultimately determines product acceptability. As consumer needs and expectations change, organizations also face pressure from competition and technological advancement to continually improve their products and their processes.

A systems approach to quality management encourages organizations to analyze customer requirements, identify processes that contribute to obtaining products that are acceptable to customers, and maintain those processes in a controlled state.

A quality management system can be the basis for continuous improvement to increase the likelihood of increasing the satisfaction of both customers and other interested parties. It gives the organization and customers confidence in its ability to deliver products that fully comply with requirements.

Analysis of the works of Akhmin A.M. allows us to conclude that the approach to the development and implementation of a quality management system consists of several steps, including:

a) establishing the needs and expectations of customers and other interested parties;

b) development of the organization’s quality policy and goals;

c) establishing the processes and responsibilities necessary to achieve quality objectives;

d) establishing and identifying the necessary resources and providing them to achieve quality goals;

e) developing methods to measure the effectiveness and efficiency of each process;

f) applying these measurements to determine the effectiveness and efficiency of each process;

g) determination of the means necessary to prevent nonconformities and eliminate their causes;

i) developing and applying a process for continuous improvement of the quality management system.

This approach is also used to maintain and improve the existing quality management system.

An organization that adopts the above approach creates confidence in the capabilities of its processes and the quality of its products, and provides a basis for continuous improvement. This can lead to increased customer and other stakeholder satisfaction and organizational success.

The processes required for a quality management system should include management, resourcing, product life cycle and measurement processes.

The documentation of the quality management system should include:

a) documented statements of quality policy and objectives;

b) quality manual;

c) documented procedures;

d) documents necessary for the organization to ensure effective planning, implementation and management of processes.

Top management should provide evidence and commitment to the development and implementation of the management system

quality, as well as continuous improvement of its effectiveness through:

a) communicating to the organization the importance of meeting customer, legal and regulatory requirements;

b) developing a quality policy;

c) ensuring the development of quality objectives;

d) conducting management reviews;

e) providing the necessary resources.

Top management must ensure that the quality policy:

a) consistent with the goals of the organization;

b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system;

c) created the basis for setting and analyzing quality goals;

d) was brought to the attention of the organization’s personnel and understood by them;

e) analyzed for continued suitability.

The organization's top management should ensure that quality objectives, including those necessary to meet product requirements, are established in the appropriate departments and levels. Quality objectives must be measurable and consistent with the quality policy.

Top management should review the organization's quality management system at planned intervals to ensure its continued suitability, adequacy and effectiveness. The analysis should include an assessment of opportunities for improvement and the need for changes in the organization's quality management system, including the quality policy and objectives.

The organization's task is to identify and provide the resources required for:

a) implementation and maintenance of a quality management system, as well as continuous improvement of its effectiveness;

b) increasing customer satisfaction by fulfilling their requirements.

Personnel performing work affecting product quality must be competent in accordance with their education, training, skills and experience.

The organization must:

a) determine the necessary competence of personnel performing work that affects the quality of the product;

b) provide training or take other actions to meet those needs;

c) evaluate the effectiveness of the measures taken;

d) ensure that its personnel are aware of the relevance and importance of their activities and their contribution to the achievement of quality objectives;

e) maintain appropriate records of education, training, skills and experience.

The management system must define, provide and maintain the infrastructure necessary to achieve compliance with product requirements.

To do this you need to define:

a) requirements specified by customers, including requirements for delivery and post-delivery activities;

b) requirements not specified by the consumer, but necessary for the specific or intended use, when known;

c) legislative and other mandatory requirements relating to the product;

d) any additional requirements specified by the organization.

In the field of quality management, it is important to analyze the requirements related to the product. This review should be carried out before the organization undertakes to supply a product to a customer (for example, participation in tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and should ensure:

a) determination of product requirements;

b) approval of contract or order requirements that differ from those previously formulated;

c) the organization's ability to meet certain requirements.

Records of the results of the analysis and subsequent actions resulting from the analysis should be maintained.

If customers do not put forward documented requirements, the organization must confirm them with the customer before accepting them for execution.

If product requirements are changed, the organization shall ensure that relevant documents are amended and that affected personnel are made aware of the changed requirements.

Fundamental to the organization is the identification and implementation of effective measures to maintain communication with consumers regarding:

a) information about products;

b) passing requests, contracts or orders, including amendments;

c) feedback from consumers, including consumer complaints.

In addition to the costs of designing and manufacturing the product, they include the costs of customer service and maintaining a given level of quality during the warranty period. All listed costs constitute the total costs of the supplier. The difference between the selling price and its cost is equal to the income from the sale of one product.

Traditionally, quality costs were determined by summing up the costs of the manufacturer and the consumer. This point of view on the cost of quality when determining the optimum cost of quality does not reflect new realities and does not allow us to see benefits for the manufacturer, for example, increased profits by increasing the value of the product for the consumer or increasing the cost of preventing defects by reducing the costs of control and inspection.

The development of engineering and technology over the last two decades of the twentieth century has made it possible to create production facilities that provide minimal variation in product parameters through the introduction of new methods of product design, production preparation, new technologies and quality management.

According to researchers, about 80% of all defects that are identified during the production and use of products are due to insufficient quality of the processes for developing the concept of a product, designing and preparing for its production. About 60% of all failures that occur during the product warranty period are caused by erroneous, hasty and imperfect development.

ISO 9000 series, TQM, LSUK allow you to create a product with a high level of quality at an early stage of the product life cycle. The manufacturer of goods (services) needs knowledge of costs in order to have information to make the optimal decision. Where to “look” for the costs of low quality? To achieve your goals, you should find out the manufacturer's costs due to poor product quality. During the initial assessment, usually, using the traditional approach, the costs are determined for:

Rework;

Tests;

Control;

Returns from consumers;

Product recall.

The costs listed above usually amount to 4-5% of sales.

If you want to get a complete picture of losses due to the low level of company activity, then you need, in addition to the traditional ones, to take into account the hidden costs of:

Delays in the implementation of plans;

Discounts for consumers for non-compliance;

Additional transportation;

Urgency of correcting inconsistencies;

Incomplete fulfillment of accepted orders;

Refinement of the design of non-conforming products;

The need to produce additional volumes of products for rapid replacement;

Unused production capacity.

It is clear that the traditional part of the costs, in essence, is only the visible part of the iceberg, amounting to 15-20% of the total costs.

It is important to note that costs due to poor quality can be completely eliminated if each activity is consistently carried out without any discrepancies.

In Fig. 1.2.1. presents the costs that arise when product quality is low.

The costs of assessment and quality control will be justified provided that non-conformity is detected before the product reaches the consumer.

Rice. 1.2.1.

Such actions could be:

Testing of products or checking documentation before they are handed over to the consumer;

Checking documents to correct errors before they reach the post office;

Monitoring the operation of equipment for suppliers;

Reviewing reports or correspondence;

Reviewing prepared invoices before sending them to consumers for payment.

Identifying nonconformities at this stage includes significant costs for future failures and failures, and also helps develop more effective control methods.

The main task of this stage is to eliminate unnecessary costs.

The costs of nonconformities identified internally are due to the repair of products, replacement of nonconforming parts, or rework of incorrectly performed work. All this work is usually invisible to the consumer. Examples of such actions could be:

Replacement of stamped products that do not meet technical requirements;

Restoration of damaged surfaces;

Repeated calculations due to computer failures;

Replacement of components damaged during inter-shop movements;

Redesign of individual parts of the project;

Rework to ensure timely implementation of the plan;

Correcting errors in databases;

Storing excess stock of components to replace defective ones;

Disposal of products that do not meet established requirements.

Additional time to correct errors in invoices for payment;

Correction of errors in technical specifications and drawings, etc. These

costs can affect customer service indirectly.

Costs for nonconformities identified outside the company. These inconsistencies directly affect consumers and are typically particularly costly to correct. Costs in this category may be caused by the following obligations:

Satisfying warranty claims;

Studying and resolving complaints;

Reducing the possible level of dissatisfaction through product recalls;

Fulfillment of unreasonably assumed obligations;

Correction of errors in accounts;

Replacement or repair of damaged or lost cargo;

Serving passengers of canceled or delayed flights;

Refusal to provide discounts due to delays in payment of invoices issued by your suppliers;

Departure of specialists directly to the consumer in case of problems;

Compensation for losses to the consumer caused by untimely fulfillment of obligations.

It should be noted that consumers and the market determine quality, and this, in turn, leads to increased profits for enterprises, and the lower the cost of quality, the higher the profit of the enterprise.

The Toyota company distinguishes the following stages of activity in the field of quality assurance: product planning, product design, production preparation, production, production control, sales and maintenance, quality control in operation. At the same time, the guarantee of quality at the listed stages are certain responsibilities and actions of each department.

If we imagine the enterprise’s activities vertically (Fig. 1.2.3), then in this case the relevance of cost management is obvious.

They are formed both from the bottom up and from the top down, differing in composition, size, method of formation and attribution to the product.

The figure helps to understand that quality costs are associated not only directly with the production of products, but also with the management of these productions.

The costs of correcting defects and inconsistencies are usually present in every department of an organization working even in the non-material sphere. They should not be perceived as normal, but should be kept to a minimum.

Depending on the goals, objectives of quality cost analysis and the ability to obtain the necessary information, management methods may be different, since this may influence the passage of products through a certain stage of the enterprise’s activities.

Monitoring and analysis of the implementation of the organizational project of the IC and its improvement:

Monitoring the implementation of the organizational project (acts, control cards, etc.);

Adjustment of the progress of implementation of the organizational project (based on control results) (orders, instructions, additions, changes, etc.);

Analysis of the implementation of the organizational project of the IC (certificates, recommendations, etc.);

Carrying out acceptance and transfer works (act);

Organization and implementation of QS certification (application; set of documentation; certificate);

Assessment of the actual efficiency of the insurance company (final calculation);

Carrying out work to develop and improve the SC (improved organizational project).

Fig.1.2.2.

The design stage of SC development includes stages of work aimed directly at creating working designs of these systems. The working design of each system, as a rule, is developed in accordance with the technical specifications and is a set of technical documentation, technical documentation and other documentation necessary for the creation, acceptance and transfer work and implementation of the system, achieving the goals and certification of the system, as well as ensuring the further normal functioning of the system .

Directly during design the following is carried out:

1. Selection of a set of technical documentation, technical documentation and other necessary literature and documentation, analogue samples similar to the SK.

2. Development of project documentation, first technical and then detailed projects. The sections of the technical project and their content were worked out quite well earlier. Moreover, the practice of developing a management system system has shown, especially in relation to medium and small enterprises, and further improvement of these systems has confirmed that objectively it is possible to limit oneself to the creation of only a working draft. The technical project can be borrowed mainly from the STP for the system in the first edition, for the insurance company - either the first edition of the STP "SK. SO UK. Basic provisions", or the first edition of the RD "General Quality Manual".

Fig.1.2.3.

It should disclose the structure of the system, the quality policy, the principles of QM, the procedure for maintaining the system in working order and improving it.

The development of working design documentation for the insurance company is carried out in two substages: in the first stage, documents are developed for the joint venture management system, common for each of the insurance companies; in the second, documents are developed directly for each type of insurance company in accordance with the specific model chosen for it.

The final stage of creating an SC is the stage of implementation (implementation) of organizational projects, on which the effectiveness and achievement of the goals of each system largely depends. This stage consists of the following stages, which include:

1. project implementation:

Issuance of an order to put into effect the approved design documentation for both the MC and IC products of each type, as well as to carry out measures for their implementation. The order should indicate the tasks of the enterprise management and the working structures of the insurance company, the timing of the implementation and implementation of measures and the required results;

Implementation of activities for the implementation of working projects, special attention is paid to the implementation of activities aimed at certification of the QS. Receiving a certificate for such a system is official recognition of the functioning of an effective system for ensuring proper CP;

Stimulating the implementation of work projects, which should be carried out in every possible way, combining them with measures to introduce new technology;

2. control and analysis of the implementation of working projects of the SC:

Control over the implementation of project documentation. It should be carried out by the KRG and the heads of the relevant ICs. The forms of reflection of control can be different (for example, in acts, control cards, orders, etc.);

Analysis of the implementation of working projects of the insurance company. It consists of collecting information, studying it and evaluating the results of implementation. On their basis, it is necessary to establish the compliance of the level of organization and implementation of implementation work with the goals and requirements of the QS. To do this, it is necessary to carry out a comprehensive assessment of the actual effectiveness of the implemented measures within the framework of a specific IC.

The inclusion of new elements in the system can be carried out in connection with the setting of new goals and objectives of the system, determined by changes, for example, in demand, needs, prices and the situation in sales markets.

Based on the results of the analysis of the quality system, a report is usually drawn up and a current assignment is developed for improving the quality management system, which should include the following sections: basis for improvement; characteristics of the current system; the purpose and objectives of improving the system; clarification of the composition and content of the system’s functions when improving it; structure of the CP improvement plan (or the Quality program); timing of the development of the improved system project; main regulatory and methodological sources; prospects for continuing work; additional instructions; appendices (lists of departments and persons with whom STP and other normative and technical documentation systems must be agreed upon).

The implementation stage involves developing an implementation plan for the improved project and executing it.

Thus, quality is determined by the action of many random factors. To prevent the influence of these factors on the quality level, a quality management system is necessary. A quality management system can be the basis for continuous improvement to increase the likelihood of increasing the satisfaction of both customers and other interested parties. It gives the organization and customers confidence in its ability to deliver products that fully meet requirements.

Product quality management at an enterprise is the actions carried out during the creation and operation or consumption of products in order to establish, ensure and maintain the required level of its quality.

The quality system must take into account the characteristics of the enterprise and ensure minimization of product development costs.

The quality system covers such elements as management and production functions, production and organizational structures, management technology, work processes, methods, information, etc.

To improve the organization's activities, the quality standards define eight principles of the quality system, such as customer focus, managerial leadership, involvement of employees in the work of the quality system to obtain the greatest benefit from their abilities, process approach, systematic approach to management, continuous improvement of the organization's activities ( should generally be seen as its constant goal), fact-based decision making, mutually beneficial relationships with suppliers. These eight principles of quality management form the basis for quality system standards.

A quality management system can be the basis for continuous improvement to increase the likelihood of increasing the satisfaction of both customers and other interested parties.

Top management must ensure that customer requirements are identified and met to improve customer satisfaction.

The organization's task is to identify and provide resources

required to implement and maintain a quality management system, as well as continuously improve its effectiveness, and increase customer satisfaction by fulfilling their requirements.

Fundamental to the organization is the identification and implementation of effective measures to maintain communication with consumers regarding product information; passing inquiries, contracts or orders, including amendments; feedback from consumers, including consumer complaints.

Economic categories of quality are manifested through the manufacturer’s profit from the sale of a quality product and through the manufacturer’s costs to ensure the quality expected by the consumer. Consumers and the market determine quality, and this, in turn, leads to increased profits for enterprises.

Quality control

Quality control reviewed in conjunction with quality management, since these are closely related and complementary areas of activity that form company-wide quality management.

Quality control- part of quality management aimed at meeting quality requirements.

Quality management- coordinated activities for the leadership and management of the organization in relation to quality. A footnote to this definition states that these activities typically include the development of quality policies and objectives, quality planning, quality management, quality assurance and quality improvement.

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

Because the quality control And quality management are aspects of general management and management of an enterprise, therefore, before analyzing and comparing these terms, it is necessary to turn to more general concepts control And management.

The essence and relationship of the terms management and management

In the introductory article to the textbook on management, Professor L. I. Evenko defines management in Russian as management, but draws attention to the difference in the interpretation and application of terms management and management. In Russian the term control without clarifying definitions, it is impersonal. In English, the term used for impersonal management activities is administration. In the USA, a popular management training program is called the Master of Business Administration (MBA). In English, when talking about management, they also mean the figure of a manager. In Russian, in such cases the term is used management, which also implies the figure of a leader and is more consistent with the term management. But both management (leadership) and management represent management activities and therefore in practice, depending on the context, the terms management, management and leadership are used as equivalent.

Regarding definitions management and management, in different sources they are interpreted differently. Most often, these definitions come down to listing the functions that must be performed in the process of leadership and management. Among them are planning, organization, command, coordination, control, motivation, personnel selection, communication (information), decision making. Such definitions do not fully reflect the essence of management activities, since they do not reflect subjects and objects management. In reality, management is the process of a subject influencing an object of management by performing management functions, taking into account feedback from the object. . The essence of management can be visually presented as follows.

Management is the influence of a subject on an object by performing management functions with feedback from the object

System driver-car- the most clear illustration of the essence of management. Here the driver (control subject) influences the car (control object), performing the functions of driving the car.

The relationship between the concepts of management and management follows from the interpretation of the term management as management.

Quality Management Process- this is the composition and sequence of performance of quality management functions by managers of all levels of management at the stages of product creation.

As a result, these definitions contain 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 the meaning, content and relationship of these terms clear.

Using the term quality management The following should be kept in mind.

Unlike the ISO 9000:2005 standard, in the previous terminology standard - 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 naming the activities of senior managers “to guide and manage the organization in relation to quality.” It was more understandable and organic for the Russian language, just as the term quality management is probably organic for the English language. Unlike other acceptable cases of direct use in Russian of the word management, the vague term quality management serves as a clear example of the “mixing of languages: French with Nizhny Novgorod.” But since the term quality management enshrined in the official Russian-language edition of ISO 9000 series standards, it is also used in the definition formulated above, but for clarity it is supplemented with the variant overall quality management from ISO 8402:1994 standard.

Company-wide quality management

This broad concept includes general management and operational quality management and forms a single continuous quality management process throughout the company. Accordingly, the structure and functions company-wide quality management has the following form.

Quality Management Process

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

Top management, performing its quality functions, carries out general quality management: interacts with the external environment and creates the necessary conditions at the enterprise to ensure product quality.

Middle and lower level managers carry out operational quality management at their level: they influence the process of creating products by consistently performing their functions. Moreover, if, based on the results of quality control and analysis of the information received, all the necessary measures to improve product quality are developed and implemented into production, the next management cycle will be repeated along the “quality loop” at a higher level. Measures taken to improve quality are necessary not only to eliminate shortcomings, but also to constantly improve product quality in order to keep up with competitors. The term "quality loop" for the name of such a cycle was provided in the first and second editions of the ISO 8402 standard.

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 in this case, mainly corresponds to the recommendations of the international standard ISO 9001:2008 with requirements for quality management systems.

Comprehensive product quality management

The current state of quality management has a long history. Briefly, in general terms, it can be presented as follows. Until the beginning of the twentieth century, concern for quality was reduced to the implementation of a number of control and support activities that were built into the overall enterprise management process. At the same time, standardization and unification of parts, tools and labor techniques were used, incoming inspection of materials, operational control during the manufacturing process, as well as various types of testing of finished products were used.

As competition intensified and products became more complex, their quality became increasingly important as the basis of competitiveness. “All these phenomena led to the emergence of the concept of transition from individual isolated activities to ensure product quality to a systematic approach, to the need to manage product quality.”

Of particular note is the role of statistical quality control (SQC), which was started by Schuchardt, an employee of Bell (USA), who introduced control charts into practice in the 30s of the twentieth century. Quality management in Japanese companies began with the introduction of statistical methods, after the American statistician Deming conducted courses on their study in Japan in 1950. But already in the 1960s, quality control began to extend beyond the production process and statistical quality control (SQC) began to turn into total quality control at the firm level - English. total quality control(TQC). It provided for the participation of all employees of the company, personnel training, the work of quality circles, and 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.

As a result of using 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 character.

In ISO 8402 - 86 comprehensive quality management mentioned as quality management at company level and in practice it appeared as the coordinated influence of personnel and managers at all levels on all stages of product creation, taking into account all factors that have a significant impact on quality.

An integrated approach to quality management implemented in the form of quality systems (eng. quality systems) within the framework of general enterprise management. Quality systems were formed not only in the USA, Europe and Japan, but also in the former USSR. The first stage was the creation of the Saratov system of defect-free manufacturing (BIP), developed in the mid-1950s. This system took into account the percentage of products handed over to the quality control inspector from the first presentation and, depending on this, the level of moral and material incentives for the employee was established. Subsequently, this system was transformed into a zero-defect labor system (DLT), which, in addition to the BIP system, took into account the rhythm and culture of production. Along with these systems, the KANARSPI system (quality, reliability, service life from the first products) was developed, which was implemented at enterprises in the Gorky (now Nizhny Novgorod) region, as well as the NORM system (scientific organization of work to increase motor resource), which was used at the Yaroslavl Motor Plant. And finally, in the 1970s, a comprehensive product quality management system (KS UKP) was developed and implemented at a number of enterprises in the Lviv region, which incorporated elements of the BIP, SBT, KANARSPI, NORM systems and the experience of other quality management enterprises.

After this, at Soviet enterprises, the introduction of KS UKP began as a directive, with the help of which they hoped to improve 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, non-departmental quality control was introduced at 1,500 enterprises in the country - state acceptance of products. But all this activity did not, and could not lead to achieving the desired results. It was obvious to most enterprise managers that neither the introduction of the CS UKP nor additional non-departmental control were sufficient to ensure quality without the introduction of modern technologies and taking into account the human factor. But this was not the case at most enterprises. And the economic system itself, with strict control over the implementation of the plan “on the whole,” did not encourage enterprises to produce high-quality products. The exception was the military-industrial complex, where they spared no expense on equipment and paid higher wages, which made it possible to create competitive military equipment. Therefore, at many enterprises, although they implemented the CS UKP under pressure from the State Standard, they still understood that it would not solve the quality problem, and treated it as a purely formal event. Nevertheless, it is impossible not to note the positive role of the KS UKP in documenting quality systems and combining disparate elements of quality management at enterprises into a single system. Subsequently, this significantly facilitated the work of bringing KS PCC systems to the requirements of the ISO 9000 series international standards for quality management, the first edition of which was released in the USSR in Russian translation in 1988.

International standards ISO 9000 series

The ISO 9000 series of standards were developed due to the awareness of enterprises in industrialized countries of the need to implement integrated quality management, which some even then called total quality management. It started with the fact that in the 60-70s of the 20th century they developed national standards with recommendations on what types of work should be implemented at enterprises in order to organize a system in quality work (quality system). It was recommended to introduce quality control of projects, materials, products, management of documentation and measuring instruments, establish a clear procedure for eliminating deficiencies, etc. Then, by 1987, the International Organization for Standardization (ISO) taking into account national standards, mainly based on the British Standard BS 5750, the ISO 9000 series of international standards were developed and published with recommendations for the establishment of quality systems. The benefits of implementing quality management systems were explained by the following considerations. Since the supplier’s warranty cannot serve as a complete guarantee of meeting the customer’s requirements due to possible errors in the design and manufacturing of products, it is important for the customer that the supplier has a clear quality system in place. This gives the customer additional confidence that the supplier’s quality work is not carried out haphazardly, in an emergency manner, but systematically and systematically, which ensures sufficient stability in the quality of the products, and not just individual samples for advertising and exhibitions.

As a result, with the release of ISO 9000 series standards, the experience of an integrated approach to quality management received logical documentation and became widespread in world practice. As experience in applying these standards accumulated, they were refined. The second edition of the standards was published in 1994, and the third in 2000. Currently, the ISO 9000:2005 standard and the ISO 9001 standard are used to create quality systems. Standards have been developed for audits and certification of quality systems, for personnel training, and others. In addition, based on ISO 9000 standards, standards for quality systems for enterprises were developed, taking into account industry specifics. Unfortunately, the definitions of such terms 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 was noted when analyzing these terms in the relevant Wikipedia articles. In this regard, in practical work on quality management, to understand these terms, one must be guided by additional authoritative sources on management and terminology indicated in the references.

The 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 goals of the enterprise, along with the price, volume and delivery time of products under contracts. In the 80s - 90s, due to increased competition in sales markets, product quality came to the fore as the basis of its competitiveness. Complementing the integrated approach with new elements, manufacturers gradually moved to a broader approach to quality management, which in Russian standards was called total quality management (management).

Total Quality Management(English) total quality management, TQM) was introduced in the international standard ISO 8402:1994 as “a quality-oriented approach to managing an organization, based on the participation of all its members, and aimed at achieving long-term success through customer satisfaction and benefit to 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 components are sometimes called “total quality”, “CWQC” (eng. company-wide quality control) (company-wide quality management), “TQC” (total quality control), etc. In addition to the participation of all personnel, this approach implied strong and persistent quality management from senior management, education and training of all members organizations.

In terms of meaning, the edition of the ISO 9000:2005 standard, which sets out the principles of quality management, is closer to total (total) quality management, although there is no term “total quality management” here. However, this term, using the "total" definition, continues to be used in practice instead of the understandable and natural "total quality management" corresponding to its acronym TQM. In addition, when using the definition of “total” in the phrase “total quality management”, the scope of concepts is violated. A specific concept from a narrow field of knowledge (quality management) is placed next to the all-encompassing word “universal”, which refers to fundamental concepts, such as the universal law of nature. The use of the term “total quality management” can be justified if one wants to emphasize its main feature, when in the activities of the enterprise and all its divisions the priority is to ensure the required quality of products with the wide involvement of personnel.

The emergence of TQM and its further development followed the path of expanding the scope of quality management, involving more and more areas of activity and factors influencing quality. This was documented in the third version of ISO 9000 standards and in the development in the late 1980s and early 1990s of national quality award models that take into account the contribution of various factors to quality assurance and business results.

In the USA, in 1987, the quality award was introduced by the Secretary of Commerce M. Baldrige. After this, quality awards were established in a number of European countries, and in 1991 the European Foundation for Quality Management (EFQM) established the European Quality Award, founded by 14 of the largest European companies such as Philips, Volkswagen, Nestlé, Renault, Fiat, British Telecom and others. In Russia, the quality award was established in 1996.

Currently, the following main features of universal (total) quality management can be noted, which can simply be referred to as modern product quality management:

• Choosing a strategy and policy in the field of quality aimed at constantly improving the quality of products and services;
• The orientation of the enterprise’s work, based on consumer requests, is to do what sells, and not sell what is being done;
• Management of all departments of the enterprise by top officials and administration, based on the need to ensure the required quality of products;
• Involving staff in active work to improve quality by ensuring their satisfaction through proper motivation of work, promoting rationalization work and organizing the work of quality circles;
• Introduction of flexible production taking into account the individual requirements of consumers in conditions of high-performance mass or large-scale production;
• Creation of quality systems in accordance with the requirements of international standards ISO 9000 series, taking into account the characteristics of enterprises;
• Application of process, system, situational and other modern approaches to management accumulated by management practice;
• Investments in personnel development, continuous improvement of their qualifications, training of workers in related specialties and methods for solving quality problems;
• Self-assessment of the enterprise’s activities according to the criteria for quality awards and participation in competitions for their award;
• Product certification, assessment or certification of quality systems, analysis of existing problems and development of necessary measures to ensure and improve quality;

In addition, within the framework of TQM, it is recommended to create environmental management systems in accordance with ISO 14000 standards, as well as occupational safety and health management systems (OHSAS 18000), which complement the quality system, increasing the efficiency and competitiveness of the enterprise.

There is no doubt that quality management will continue to develop, enriched with new approaches and methods of work.

Interaction of quality management with other areas of the enterprise’s activities

Quality management in practical work is closely related to all areas of the enterprise’s activities that provide or participate in the creation of products. The heads of these areas perform their quality functions, and together they form subject of quality management, influencing the process of creating products in order to ensure their quality.

Since quality management is one of the aspects of the overall management of a company, it cannot be considered in isolation from the science of management (management), which determines the general patterns of management activities. Therefore, to organize effective quality management, it is necessary to use management provisions and recommendations that can be applied in quality management. This will allow:

• gain a general understanding of organizations (enterprises) and factors of the internal and external environment, that is, about the conditions in which quality management is carried out;
• get acquainted with the essence of management and the structure of management activities at the enterprise in order to understand the role and place of quality management in the management of the enterprise as a whole;
• apply management functions in quality management, as well as approaches and methods for their implementation, accumulated in management practice.

In this case, quality management will have at its disposal a scientific foundation and proven practical management methods, which will provide a solid basis for organizing and conducting professional and effective work on quality management in enterprises.

Notes

1. International standard ISO 9000:2005 “Quality management systems. Basic provisions and dictionary" M.: Standartinform, 2006
2. International standard ISO 8402:1994 “Quality management and quality assurance - Dictionary” - M.: VNIIS
3. GOST 15467-79 Product quality management. Basic concepts. Terms and Definitions. - M.: Standards Publishing House, 1979
4. Kunz G., O'Donnell S. Management. Systemic and situational analysis of management functions. In 2 volumes - M.: Progress, 1981
5. Merriam-Webster, "organize"
6. Dictionary of the Russian language in four volumes of the USSR Academy of Sciences, “Russian Language”, vol. 4, third edition. - M.: 1988
7. International standards “Product quality management ISO 9000 - ISO 9004, ISO 8402”. International standard ISO 8402 - 86 “Quality. Dictionary." - M.: Standards Publishing House, 1988
8. National standard of the Russian Federation GOST R ISO 9001 −2008 Quality management systems. Requirements. ISO 9001:2008 Quality management systems - Requirement (IDT) M.: Standartinform, 2008
9. V. G. Versan I. I. Chaika Product quality management systems. - M.: Standards Publishing House, 1988 104 p.

The last decades of industrial development are characterized by a significant increase in attention to the quality of products. This is natural, since the production of high-quality products is considered in all countries of the world as one of the most important conditions for the development of the national economy. The quality of industrial products is influenced by many different factors. Therefore, a systematic approach to solving the problem of product quality management is necessary.

GOST 15467 – 79 “Product Quality Management” establishes basic concepts, terms and definitions.

Under products understand a materialized result of the labor process, possessing useful properties, obtained in a certain place over a certain period of time and intended for use by the consumer in order to satisfy his needs, both social and personal.

The terms of the specified GOST 15467 - 79 refer only to the materialized results of labor. A product is a special case of a unit of industrial product.

The property of a product is its objective feature. Products have many different properties that can manifest themselves during its creation, operation or consumption, i.e. during development, production, testing, storage, transportation, maintenance, repair and use. Product properties can be divided into simple and complex. An example of a complex property is the reliability of a product, which is determined by simpler properties: reliability, durability, maintainability and storability.

Product quality is a set of product properties that determines its suitability to meet certain needs in accordance with its purpose.

In modern conditions, product quality covers not only consumer, but also technological properties, design and artistic features, reliability, level of standardization and unification of parts and assemblies, etc.

The properties that make up product quality are characterized by continuous or discrete quantities called product quality indicators . They can be absolute, relative or specific.

The quality of machines is characterized by a number of indicators that can be divided into the following three groups:

1) technical level (power, efficiency, productivity, efficiency, etc.), which determines the degree of perfection of the machine;

2) production and technological indicators (or indicators of manufacturability of structures), characterizing the effectiveness of design solutions from the point of view of ensuring optimal costs of labor and funds for the manufacture of a product, its maintenance and repair;

3) performance indicators , including:

a) product reliability indicators;

b) ergonomic characteristics, i.e. the degree to which the complex of hygienic, physiological and other human needs is taken into account in the “man – machine – environment” system;

c) aesthetic characteristics, i.e. perfection of artistic composition, external design of the product, etc.

When assessing the quality of a product, one should also take into account the degree of its patent purity. Quality indicators make it possible to give a quantitative description of all its properties. There are single and complex indicators.

An indicator of product quality that characterizes one of its properties is called single (for example: product efficiency, machine performance). Complex the indicator characterizes two or more properties of the product. An integral complex indicator is also used to evaluate the efficiency of the machine. In particular, it can be expressed as the ratio of the total beneficial effect of operating a machine to the total costs of its creation and operation over the entire period of its service life. Quality indicators vary depending on the service purpose of the product.

The most important characteristic of the quality of machines is their reliability – the property of a machine to perform specified functions, maintaining its performance indicators within specified limits during the required operating time. Reliability is a complex property that is characterized by reliability, durability, maintainability and storability, i.e. ability to maintain performance characteristics during storage and transportation.

Reliability depends on the perfection of not only the design of the product, but also the technology of its manufacture.

The main concept used in defining reliability is failure. Refusal call an event consisting of a malfunction of an object. Reliability – the property of an object to continuously maintain an operational state for some time or some operating time, which is determined by the duration or volume of work of the object.

Quality level – a relative characteristic based on a comparison of the quality indicators of a given product with the basic values ​​of the corresponding indicators. Systematic improvement of the quality level is a responsible task for the product designer and technologist.

One of the most important factors in the field of product quality management is its certification, which is carried out systematically. Enterprises develop and implement a set of measures to systematically improve the quality of products and update their range.

The level of product quality is assessed by comparing the set of quality indicators of this product with the corresponding set of quality indicators of the base sample (set of basic indicator values).

At the development stage, the basic samples can be promising product samples, the quality indicators of which are laid down in the terms of reference, technical or detailed design. At the manufacturing stage, the basic product sample can be a product whose quality indicators at the time of evaluation meet the highest world standards.

Assessment of product quality level – a set of operations that includes selecting a range of quality indicators for the products being evaluated, determining the values ​​of these indicators and comparing them with the base ones (Fig. 1.5).

The following methods are used to assess the level of product quality: differential, complex, mixed.

Differential method Product quality assessment is based on the use of single indicators of its quality. With this method, the quality indicators of the evaluated type of product are compared with the corresponding relative basic indicators.

Complex method Product quality assessment is based on the use of complex (generalized) indicators of its quality.

Complex products, as a rule, have a wide range of quality indicators. In this case, it is impossible to give a specific estimate using the differential method. A comprehensive method will not be able to take into account all the significant properties of the products being evaluated. In this case, a mixed method is used. Mixed method Product quality assessment is based on the simultaneous use of single and complex indicators of its quality.

Product Quality Management – these are actions carried out during the creation and operation or consumption of products in order to establish, ensure and maintain the required level of its quality.

When managing product quality, the direct objects of management, as a rule, are the processes on which the quality of products depends at all stages of development, design, manufacturing, operation or consumption. Control actions should be aimed at maintaining the actual state of the controlled process or at correcting this process.

Product Quality Management System – a set of governing bodies and control objects interacting using material, technical and information means. When managing product quality, it must provide for a set of interrelated organizational, technical, economic and social measures to implement the goals of product quality management, i.e. achieving the required level of product quality. A systematic approach requires considering the product quality management system as an integral part of the management of organizations and enterprises.

The considered basic concepts of product quality indicators indicate that the main indicators of product quality, including economic ones, largely depend on the manufacturing technology of the product. One of the determining elements that influences the quality of a product is the accuracy of its manufacture (part, assembly unit and product as a whole).

Aquarium water is characterized by several parameters, among which its acidity pH plays an important role. The acidity of tap water may not be ideal for aquarium fish, so you need to know how to test the pH and adjust it if necessary.

If you find that there is a significant difference between the pH of fresh water that has just been added to the aquarium and the older aquarium water (which has been in the aquarium for about 48 hours), then immediate action must be taken to find out why this is happening.

pH Basics

The pH level of water is measured from 0 to 14. A pH level of 7.0 is considered neutral, values ​​below 7.0 are acidic, and values ​​above 7.0 are alkaline. The pH level of water varies depending on a number of factors, including chemical concentration, mineral content and even the type of substrate. Each species of fish is adapted to different pH levels - a pH value that will be normal for some fish may not suit other species of fish at all. This is why it is very important to measure the pH level in the aquarium before releasing fish into it.

How to Test the pH of Your Tap Water

Many experienced aquarists test tap water before adding it to the aquarium. However, the obtained indicators of its acidity may turn out to be very approximate.

To properly measure the pH of your tap water, pour tap water into a bucket and place an aerator in it to oxygenate the water. Then you need to let the water sit for 24 hours. And only then can you check the pH level in the water. The same measurements should be taken after 48 hours to ensure that the pH readings are stable.

So why should you let the water sit for 24-48 hours? Carbon dioxide in water causes the pH to decrease. During the process of aeration of water, all its layers are mixed and gas exchange occurs (oxygen enters the water, and carbon dioxide is released from the water into the air). This gas exchange reduces the amount of carbon dioxide in the water and causes the pH to rise. This indicator will be the closest to the real one, provided that there are no other objects / chemicals in the water container that affect the pH, since gas exchange occurs constantly.

How does pH affect aquarium inhabitants?

The pH of the water in the aquarium significantly affects both its quality and chemical composition. For example, if your pH drops below 6.0, the nitrification bacteria that stabilize ammonia and nitrites (toxic compounds to fish) at safe levels will begin to die off. This can cause your aquarium to become uninhabitable for fish.

The ammonia concentration in aquarium water is a combination of ammonium (NH4+) and ammonia (NH3) ions. The pH of water reflects the proportion of concentration of each of these two compounds. A greater concentration of ammonia (the more toxic of the two compounds) will be present in alkaline water (pH above 7.0), while a greater concentration of ammonium ions (the less toxic of the two compounds) will be present in acidic water (pH below 7.0 ).

Relationship between pH and kH

The kH level is a parameter for the carbonate hardness of your water. In other words, it measures the concentration of carbonate and bicarbonate ions in your aquarium water. kH also indicates the ability of water to neutralize added acids without significantly changing the pH. Therefore, a higher kH corresponds to a more stable pH in your aquarium, while a lower kH can correspond to greater pH fluctuations. As a general rule, if your kH is below 4.5o dH, you will need to keep a close eye on the pH.

Kits for measuring water pH levels

The best option for measuring the pH level of your aquarium is to purchase a water testing kit. You can purchase one of the kits at your local pet store or order it online. The kits come in several different forms: some use water analysis based on its color compared to a test sample. Other kits use litmus paper, which is dipped into the water sample being tested and then the color is compared to a chart. Unfortunately, this measurement option does not always give accurate results.

It is also necessary to consider the expiration date of the test kits (usually 6 months) and if it is expired, inaccurate results may be obtained. When conducting tests, you must strictly adhere to the instructions.

Ways to increase pH

Let us say right away that it is much easier and better to gradually accustom fish to the pH of tap water than to constantly adjust its acidity. However, in some cases it is necessary to adjust the acidity of the water in one direction or another. There are several options for increasing the acidity level of water.

• Changes in water

Over time, the pH in your aquarium will drop. The most effective way to bring it up to the level of your tap water is to simply perform regular water changes. Periodic siphoning of uneaten food and waste from the soil significantly slows down the process of pH decline over time.

• Rocks or substrate

Add some rock or gravel to the aquarium, which will raise the pH. For example, crushed coral is used as a substrate in many African cichlid aquariums (African cichlids prefer a high pH). Limestone and fossilized coral also have this property. If you do not want to add these rocks to your aquarium, you can add crushed coral to your water filter element, but be very careful, this method may raise the pH level well above the acceptable value.

• Aeration

An increase in oxygen concentration in water leads to a decrease in carbon dioxide concentration. As discussed above, less carbon dioxide results in a higher pH value. Therefore, you can increase the aeration in the aquarium to raise the pH.

• Adding soda

Adding baking soda to your water will raise the pH, but remember that this will require you to continually add baking soda to the water, you can't just add it once and forget about it. When dissolving soda in water, it is necessary to strictly dose its amount, since such actions can lead to the death of all your fish. The general rule is 1 teaspoon per 20 liters of water. Before adding soda to the aquarium, it must first be dissolved in a small amount of water and then poured into the aquarium.

Ways to lower pH

Lowering the pH level in a freshwater aquarium is often much more difficult than raising it. There are some acidity reduction options you can try.

• Peat moss filtration

Filtration through peat moss is the most effective way to lower pH. Some aquarists use peat moss in their substrate, which produces a similar effect.

• Add carbon dioxide (CO2)

As we've said several times, increasing the concentration of carbon dioxide in water lowers the pH level.

• driftwood

Many types of driftwood lower the pH.

• Chemical substances

There are many chemicals on the market today that lower pH. However, like pH raising chemicals, they do not stabilize pH.

Conclusion

Although your aquarium fish prefer the pH level they are accustomed to in nature, it is much more important to have a stable pH. Constantly adjusting the pH level in your aquarium will not lead to anything good, since fluctuations in pH of just 0.3 units can be dangerous for the fish. Therefore, unless you have a specific reason to do so, it is better to acclimate your fish to the pH level of your tap water rather than constantly adjusting the pH.

The text of the document provides links to reference materials containing detailed descriptions of theories, practices and research results related to pollution control. From these materials, the reader, if necessary, will be able to obtain more detailed information. These materials are presented in the Literature section.

Glossary of terms and definitions

Special shoes for the building - a pair of shoes used by personnel in designated areas of the changing room and cleanroom or in auxiliary areas to prevent the entry of contaminants from outdoor shoes into these areas.

Special clothing for the building - a suit made of 100% polyester or other synthetic fabrics. The shape resembles a two-piece tracksuit, the upper part of which is removed over the head or fastened with a zipper. The suit is worn over your own underwear under cleanroom clothing.

Changing room - a room adjacent to the clean room, designed to control the passage of personnel, as well as for putting on, taking off and storing items of clothing or other accessories.

Class(particle content in the air) - Room cleanliness class in accordance with ISO 14644-1 standard.

Clean room - a room that requires control of airborne particles and includes one or more clean zones.

Second layer clothing (comfort suit) - see “special clothing for the building”.

Pollutant - any substance whose presence on or within a material, or on any surface in a clean room, is undesirable.

Pollution- the result of a contaminant entering a material or onto any surface within a cleanroom.

Controlled Environment - an environment in which compliance with acceptable limits of parameters such as temperature, pressure, humidity and pollution levels is monitored.

Strip- process of removing clothing for clean rooms. The process is strictly controlled to protect clothing from contamination and damage.

Putting on- procedure for donning cleanroom clothing. Clothing is worn in a certain order in a strictly defined manner to prevent its contamination and deterioration of its protective properties.

Gloves to put on - An additional pair of gloves used when donning cleanroom clothing to protect it from direct contact with the hands and prevent contamination by oils or particles on the skin. Gloves can be worn over process gloves when dressing, or used only during changing, and then changed to process gloves.

Electrostatic discharge (ESD) is the transfer of electrostatic charge between two objects that have different electrostatic potential.

Cleanroom clothing - specially designed items of clothing to reduce or prevent the spread of contaminants by personnel. Can be represented by overalls, shoes, shoe covers, gloves, hats, etc.

Set of clothes- A complete set of clothing and consumables used to protect personnel from external influences or protect the environment from pollutants emitted by humans. The kit may include a face mask (beard), hair cap (net), helmet, other items of clothing (overalls, shirts, pants or gowns), cleanroom shoes, safety shoes, shoe covers, boot covers, changing gloves and technological gloves.

HEPA filter(High Efficiency Air Filter) - a dry type filter with increased surface area, housed in a solid frame. The minimum efficiency of such a filter when tested at a fixed airflow rate in accordance with MIL-STD-282 shall be 99.97% for dioctyl phthalate particles with a mass median diameter of 0.3 µm.

Maintenance of clean rooms - maintenance or cleaning of premises carried out to maintain the required level of cleanliness.

Micrometer(µm) - a unit of length equal to one millionth of a meter (approximately 0.00003937 inches).

Air particle counter - A device for continuously counting airborne particles whose size exceeds the permissible limit. The device can be optical, electrical, aerodynamic, etc.

Pre-dressing - Required procedure carried out after entering the building and before entering the changing room.

Garment processing - A process carried out to ensure that clothing and accessories are clean and suitable for use in a controlled environment.

Mechanical shoe shine machine - An electrical device consisting of rotating or moving brushes and a vacuum system for collecting dirt. The shoes are placed inside the device and slowly moved back and forth. At this time, the brushes remove dust and dirt from its surface, which are collected by the vacuum system.

Shoe covers- Disposable covers placed over outdoor shoes in designated areas of the changing room and cleanroom, or in auxiliary areas to reduce the transfer of contaminants on outdoor shoes.

Sticky mat- A disposable or cleanable mat with a sticky surface that, when stepped on, removes particles from the sole of the shoe.

ULPA filter- Disposable dry type filter with increased surface area, housed in a solid frame. The minimum efficiency of such a filter when tested by the methods described in IEST-RP-CC007 shall be 99.999% (i.e. the filter shall pass no more than 0.001% of particles).

Materials cleaning area - An area in the changing room designed to clean the materials used in the cleanroom.


Recommended practices can form the basis for the development of personnel procedures and programs to prepare personnel for work in cleanrooms and contaminant-controlled environments. The presented material does not contain specific information on the performance of operations requiring control of microbiological contamination.
Each application uses individual designs, equipment, protocols and procedures to control contamination, many of which are described below. However, it is entirely up to the consumer to select the most appropriate and compliant contaminant control options.

Most operations carried out in cleanrooms require the presence of personnel. Even a fully automated system requires operator control and maintenance. People and their clothing generate a large amount of contaminants, necessitating an effective contaminant control system to reduce risks to the product, process output and cleanroom environment. In addition, because personnel activity can transfer contaminants from one location to another within a cleanroom, operating protocols must be developed and carefully monitored to ensure adequate levels of control. The main requirements concerning these aspects are presented in the ISO 14644-5 standard. Compliance with these requirements is the minimum required to establish a cleanroom inspection program.

To select employees who will not cause excessive contamination of the product and who will comply with all dressing procedures and work practices required for a controlled environment, consideration and compliance should be given to determining personnel's cleanroom qualifications, physical and mental characteristics, and professional skills of personnel.

Recruitment
Responsibility for personnel selection

Responsibility for personnel selection should be assigned to a department that has all the necessary information about the physical and intellectual characteristics of employees, as well as their professional skills, without which it is impossible to perform the duties assigned by the cleanroom manager, for example, the human resources department or the personnel management department.

Whenever possible, candidates for cleanroom work should be given a tour of the room as part of the interview to determine the candidate's readiness to perform, qualifications to work in the room, and ability to understand instructions. Additionally, if the candidate does not have experience working in this type of facility, the tour will help the candidate decide whether they are prepared for the inconvenience of wearing building-specific clothing and will also help ensure that appropriate sized clothing is available before the candidate begins work.

Special requirements for the physical and medical characteristics of potential cleanroom personnel

1. Smoking staff . Smoking is prohibited in clean rooms, changing rooms or any other areas where it may have an adverse effect on product quality or the health of other employees due to secondhand smoke. To work in clean rooms of certain cleanliness classes, companies have the right to hire exclusively non-smoking employees. If smoking is allowed on the premises of a production facility, then the smoking employee should be warned that smoking breaks may be shortened, since the process of changing clothes takes some time and, combined with the length of the break, this may adversely affect the quality of the product.

2. Worker dimensions . Although, as a rule, the physical size of employees cannot be a barrier to hiring in a clean room, in some cases this aspect must be taken into account. Firstly, special clothing of a non-standard size may be required, secondly, it may be necessary to modify the seating area or bench, and thirdly, the overall body area of ​​​​the employee depends on the dimensions, which can be taken into account when distributing employees among work areas.

3. Facial hair . If present, the employee's facial hair should be covered with cleanroom clothing such as a face mask, hood, or beard mask.

4. Sensitivity to heat . The temperature and humidity levels in a cleanroom are generally maintained within specified limits, however, in some cases the temperature in certain areas of the room may exceed these limits. It is important that personnel working in such areas do not sweat excessively, which releases excess particles and moisture that contaminate the product and environment.

5. Skin condition, allergies, respiratory disorders . Employees with the following skin conditions or upper respiratory tract disorders should not work in cleanrooms:
a. Allergy to synthetic fabrics, solvents or other chemicals used in cleanrooms.
b. Copious nasal discharge.
c. Skin diseases accompanied by increased exfoliation of particles from the scalp, hands or body.
d. Increased acidity of the skin of the hands in a humid environment.
e. Serious nerve disorders that cause itching, scratching, or rubbing of the skin.
f. Emphysema.
g. Sunburn (in this case, the employee may be temporarily suspended from working in the cleanroom).
6. Claustrophobia. Any employee who is or has previously suffered from claustrophobia should not be allowed to work in clean rooms.

Professional skills

1. Personal qualities. In addition to the job skills and abilities required to perform their duties, employees must understand the objectives and practices of cleanroom contamination control. Maximum cooperation and self-discipline are required from them, since most of the airborne contaminants are emitted by the employees themselves or as a result of their activities.

2. Language skills. All employees performing cleanroom operations must be properly trained and aware of contamination control objectives and practices. In this regard, it is very important that they are able to correctly understand the information received during training and the instructions presented in the language used by the supervisory personnel, not only at the beginning of their professional activities, but also in the future. Any misunderstanding between the inspection personnel and the operator may adversely affect the inspection results.
The factors described above may be subject to temporary or permanent changes over time. In this regard, it is recommended to organize continuous monitoring of operators by supervisory personnel.

Compliance Training

Performing a cleanroom entry procedure requires specific skills and knowledge of the specific practices and behaviors required to conduct cleanroom operations. Cleanroom training is important, regardless of frequency of entry or classification, and is provided to all employees entering the cleanroom without exception. When conducting training, the requirements of the ISO14644-5 standard must be observed.

Responsibility

Each organization must appoint those responsible for conducting employee training. Training can be provided by line management, personnel training, quality control, or third-party trainers. Those responsible for training should be knowledgeable about the special training requirements for cleanroom work and also have the skills necessary to train others.

Employee training programs

The training program will typically consist of several modules covering specific aspects of cleanroom work and should include basic training for personnel with no prior cleanroom experience, more advanced training for new product introductions, and refresher or specialized training. to solve individual problems.

Training modules or courses should cover all aspects of cleanroom operations, including:

a) understanding the nature of pollution and its control;
b) required behavior and discipline;
c) personnel hygiene;

• dressing procedures;
• cleaning standards and methods;

d) security measures;

e) specific pollution control procedures for certain types of work;
f) wiping procedure (see Recommended Practice IEST-RP-CC026).

For each module of the training program, special tasks must be established that can be analyzed for implementation.

The content of each program module is determined through research into what the employee being trained needs, conducted through consultation with management and surveys of immediate supervisors. Each module must include monitoring to ensure that the material designed for training is clearly presented and is being understood by staff.

The program should specify the timing of the training, the person(s) responsible for the training, the training methods, and the testing and assessment criteria for each module.

Teaching methods

The training program should include the identification of training methods, such as:

a) standard lectures;
b) remote training using video or audio materials;
c) on-the-job training;
d) courses conducted by specially invited instructors;
e) attending courses provided by other organizations;
f) group discussion;
g) seminars;
h) role-playing games.

To carry out the program, the premises and materials necessary for preparation must be provided, as well as, if necessary, coffee or lunch breaks.

Those involved in the training must clearly understand their roles (lecturer, mentor, consultant or instructor), and also know all the necessary theoretical and practical material before starting the training.

Usually a person remembers:

10% of information presented in the form of oral speech;
50% visual information;
80% of information when participating in a group discussion.

Changing the speed of presentation of information, as well as the use of additional visual aids, can increase the effectiveness of learning. In addition to product samples and on-the-job demonstrations, teaching aids such as flip charts, wall boards, CD-ROMs, electronic projectors and role-playing games may be used.

Assessment of knowledge

After completion of training, an assessment of the knowledge acquired by students should be carried out. This assessment may include an oral or written examination or the performance of operations. The progress and results of each assessment must be documented along with a brief description of the examinee's previous work experience.

Training documents

Employee training records should be updated regularly and can be used as part of a cleanroom entry control or for subsequent employee monitoring. Examples of the matrix and individual preparation card are presented in.

Hygiene and health

It is necessary to have and comply with hygiene and health standards for cleanroom personnel. Following these guidelines will help reduce the likelihood of contamination of the cleanroom environment by human particles/fibers. Conducting a risk assessment for each room of different cleanliness classes will allow planning of contamination control in each individual situation, and is also of great importance for ensuring product quality, yield and process efficiency in cleanroom environments.

Personal hygiene

Cleanroom personnel should bathe or shower daily to prevent the accumulation of oils, salts, dirt and bacteria on the skin, which can contaminate the room environment.

Hair also traps and is a source of many particles and should be washed daily; they must be cut to a controlled length, neatly assembled and secured. Cleanroom clothing should completely cover hair.
Personnel's fingernails should be short to prevent them from tearing cleanroom gloves.

Cleanroom personnel should not wear cosmetics, perfumes, hair spray or nail polish as these products contain contaminants.

Diseases

Illnesses associated with recurrent coughing, sneezing, or nasal discharge may interfere with the employee's ability to perform his or her duties and may also result in environmental contamination. If such symptoms appear, the employee should not be allowed to work in a clean room until they completely disappear.

Working indoors may cause fainting or claustrophobia. Such conditions create uncomfortable working conditions for employees and also threaten their safety. The absence of such conditions should be one of the conditions for hiring employees in order to legally protect the employer in the event that the employee concealed the presence or did not know about the existence of such conditions at the time of hiring.

Skin diseases accompanied by peeling can lead to contamination of the cleanroom environment. The absence of such diseases should be one of the conditions for hiring employees in order to legally protect the employer in the event that the employee concealed the presence or did not know about the existence of such diseases at the time of hiring.

If there are skin allergies to certain items of clothing or materials (for example, latex gloves), employees should be provided with items made from other materials.

Cleanroom employees should notify management if they are coughing or sneezing due to a cold or seasonal allergy. In such cases, it is necessary to determine whether the use of a face mask is sufficient to minimize the risk to the products or processes in the cleanroom, or whether the employee must be temporarily reassigned to another off-site location.

The cleanroom employee must refrain from smoking for 30 minutes before entering the cleanroom to ensure that tobacco smoke particles are completely removed from the lungs and mouth. In addition, employees who smoke should rinse their mouths with water several times and take a few sips of water before entering the premises.

Dressing

Proper dressing procedures prevent clothing from becoming contaminated during dressing, turning it from a particle barrier into a source of contamination. The procedures described include activities conducted in three different locations: home, work (outside the cleanroom), and a controlled environment changing room.

Home preparation

It is necessary to choose clothing that covers as much surface area of ​​the skin as possible. Whenever possible, outdoor clothing should not be made from natural fiber-emitting fabrics. Under cleanroom clothing, it is recommended to wear clothing made from synthetic materials such as polyester, nylon or acrylic.

Procedure for on-the-job training:

1. All outerwear (coats, hats, gloves, galoshes, etc.) and personal items (bags, umbrellas, food bags, etc.) must be stored in special lockers located as close as possible to the changing room.
2. Remove all jewelry not permitted by the protocol.
3. Report any respiratory problems, sunburn, or skin problems to supervisory personnel before entering the changing area.
4. Remove all makeup from your face.
5. Cover all your hair with a hair cap, and also, if necessary, cover your facial hair (beard, mustache, sideburns) with a mask.
6. Put on shoe covers for outdoor shoes (if provided).
7. Proceed to the cleanroom shoe lockers (if provided).
8. If special cleanroom shoes are used, remove outdoor shoes from each foot in turn and put on cleanroom shoes (do not place your bare foot on the floor). Outdoor shoes must be left in the locker.
9. Proceed to the changing room for men or women, put on a special suit for the building (if provided) and underwear.
10. Wash and dry your hands before each entry into the clean room. This reduces the amount of contaminants on your hands and can prevent skin irritation.
11. Apply lotion to your hands (only if provided by the company; using your own lotion is not acceptable).
12. Wear and secure the disposable face mask behind the ears, if intended for use. Before putting on a corrugated mask, you need to straighten all its folds. After putting on the mask, you should press the mask fabric to the bridge of your nose so that it fits more tightly to your face.
13. Wear cleanroom gloves. Then put on a second pair of special gloves for changing clothes (if provided). As an alternative, inexpensive polyethylene gloves can be used, discarded after changing clothes and replaced with technological gloves.
14. Select the required clothing size.
15. Proceed to the changing room.

Dressing technique

1. Attach the removable face mask (if provided) to the hood so that there are no gaps between the mask and the hood.
2. Put on the helmet so that the identification label is on the outside. Use snaps or ties to adjust the hood so that it fits snugly without causing discomfort.
3. Remove the overalls from the packaging and check for damage. Unzip. With your right hand, take the end of the right sleeve and the right trouser leg, as well as the middle of the torso of the overalls at a distance of approximately 15 cm from the edge of the zipper. In the same way, take the left part of the overalls with your left hand. Insert both legs in turn into the trouser legs so that the overalls do not touch the floor. Raise the helmet and insert your arms into the sleeves.
4. Tuck the helmet into the overalls and make sure that the lower part (bib) of the helmet is evenly distributed over the shoulders, chest and back.
5. Fasten all zippers, the collar of the overalls, and, if any, fasteners on the ankles.
6. Unscrew the top of the changing gloves. Fasten the cuff clasps, if any. Depending on the established procedure, technological gloves are tucked under or pulled over the cuffs.
7. Sit on the bench (if provided), put on your right foot, move it across the bench to a clean area without touching the surface of the bench.
8. Put your other foot on and also move it to a clean area without touching the surface of the bench.
9. Using a full-length mirror installed in the changing room, make sure that clothes are worn correctly and have no defects. Remove and discard changing gloves (if used). Make sure the process gloves are still tucked under or over the cuffs. Enter the clean room.
10. Dispose of all packaging materials in special containers.

Entrance to the clean room

The procedure for entering a cleanroom may vary depending on the design of the room and changing area. The cleanroom entry area is typically equipped with sticky mats to which contaminants remaining on the soles adhere. Mats can be placed anywhere where it is necessary to control the transfer of contaminants on the soles of shoes. A diagram of the recommended placement of mats in a clean room is shown in Figure 1.

Figure 1 - Standard layout of the changing room

The entrance to the clean room from the changing room can be equipped with:

• air shower,
• double door with interlocking or single door.

If used, the air shower must meet the following parameters:

A. Description. An air shower is a tunnel or passage leading into a clean room. Passing through it, a person is blown with strong jets of air purified using HEPA and ULPA filters. Additionally, the air shower is equipped with an air ionization system.
b. Task. An air shower acts as an air barrier for the cleanroom and is used to remove large particles from personnel clothing. However, the effectiveness of such a system is ambiguous, and in many cases an air shower is installed to improve employee discipline. The time and effort required to navigate such a system allows personnel to focus and psychologically prepare for entering the cleanroom.
c. Location. An air shower is installed immediately before entering protected areas (i.e. before entering clean rooms or between rooms of different cleanliness classes). Installing an air shower at the entrance to changing areas is ineffective.
d. Exploitation. Air shower technology is based on the assumption that strong air currents have sufficient speed to blow away large, loosely bound particles from clothing. An air ionization system is used to neutralize the static charge that attracts particles to the surface and prevents them from being blown away. At the same time, to remove small particles, greater force is required, which is achieved by using turbulent air flows. However, after turning off the turbulent flow, particles can re-settle on surfaces. Thus, an air shower does not do a good enough job of removing small particles. To operate effectively, the system requires regular maintenance and monitoring.
e. Design. There are many different designs of air showers, each of which has its own advantages depending on the method of application. To operate most effectively, such a shower should have a ceiling completely covered with HEPA or, preferably, ULPA filters, through which a unidirectional downward air flow is supplied at a high speed (0.45-0.6 m/sec); perforated or slatted floor; as well as at least five adjustable nozzles installed in the walls to supply high-speed air jets.

1. Air tunnel. A passage that acts as an air barrier and promotes psychological preparation for entering a clean room.
2. Airlock. The air nozzles are turned on for a certain time (usually 10-15 seconds), during which the employee turns 360° at least three times with his arms raised up. The system must be programmed to turn off the nozzles at least 8 seconds before the airlock exit opens. In this case, the vertical unidirectional air flow is not turned off, because it blows airborne particles down.
3. Airlock with indirect passage. The employee must walk along a curved corridor to ensure that clothing is processed from all sides.

f. Cleaning. Cleaning of walls, ceilings, ventilation louvers and floors should be carried out daily or regularly at regular intervals.

• 04/08/2019 More than 230 manufacturers and suppliers will present equipment at Russia’s largest exhibition of laboratory equipment and chemical reagents “Analytics Expo 2019”
  

  Location: Crocus Expo IEC, Pavilion 1

  
  

  A wide range of products and solutions for comprehensive laboratory support will be demonstrated by domestic and foreign manufacturers and suppliers.
  More 30 companies will take part in the exhibition for the first time.
  The exhibition's topics cover various aspects of integrated laboratory support and laboratory analysis in various industries, scientific research and medicine:

  • laboratory equipment and instruments
  • laboratory glassware, plastic, consumables
  • chemical reagents
  • laboratory furniture
  • laboratory automation tools

  By visiting Analytics Expo, you will be able to:

  • get acquainted with the latest developments from leading manufacturers of analytical equipment
  • learn about best practices and approaches used in laboratories of other companies
  • staff turnkey laboratory taking into account your needs and specific tasks
  • To learn more about the capabilities and features of various laboratory research methods: chromatography, mass spectrometry, chemiluminometry and others

  Among the participants: Brooker, Diaem, Katrosa, Labtech, Mettler Toledo, Millab, Sartorius, Tokyo-Boeki, Chromatek, Chromos, Sheltek, Shimadzu, Ekroskhim, Energolab, Elmi, Hanna Instruments, IKA, LOIP, Nuve, Voessen and many others.
  List of participants >>
  
  The events of the business program of the Analytics Expo exhibition are a platform for
  open dialogue, exchange of experience and improvement of competencies in the field of analytical
  research.
  The focus is on the most pressing issues of the analytical laboratory,
  accreditation and automation processes, the most popular chemical methods
  research used in various fields of science and in laboratories of enterprises of different
  sectors of activity: in pharmaceuticals and medicine, in food production, enterprises
  petrochemicals and others.
  Leading Russian scientists and practitioners, opinion leaders, recognized experts in their
  industries will speak at events of the scientific and business program. The names of the speakers are already
  available in the schedule on the website.
  Admission to all events is free with an exhibition ticket.
  Get a free e-ticket on the exhibition website

• 02/28/2019 question competition
  

  Get a book as a gift for the best question about chromatography

  The Analytics Expo exhibition and Vialek Group of Companies are announcing a competition for the best question for Ilya Mikhailovich Keitlin, an expert in the field of pharmaceutical analysis, author of articles and training courses on the issues of validation and transfer of analytical methods.

  In the spring of 2019, the Vialek publishing house will publish a book “Problems of HPLC, validation and transfer of analytical methods in questions and answers”.
  The work is based on communication with students of seminars on high-performance liquid chromatography, validation of analytical methods, analytical transfer, and on questions and problems that arose in the course of professional activities.
  The information offered in the book may be useful to specialists in analytical laboratories of pharmaceutical, chemical and other enterprises where HPLC is used and analytical methods are developed, validated (verified) and transferred.
  Visitors to the Analytics Expo exhibition have a unique opportunity to become the owner of a book autographed by the author.

  Send a question to the exhibition management to an expert or describe the problem you encountered in the process of validating analytical methods, analytical transfer, or high-performance liquid chromatography studies. Ilya Mikhailovich will present the author of the most interesting question with a book with his autograph as part of a presentation that will take place as part of the Analytics Expo exhibition on April 25 from 12.30 to 13.30 at the Analitika Show site.

  We are waiting for your questions until April 10, 2019 by email: [email protected].
  The head of the scientific and business program of the exhibition is Elizaveta Kalenchuk.

  To visit the Analytics Expo exhibition and the presentation of the book, receive