Since the OJSC Geomash enterprise does not regulate the production powers and responsibilities of BUK employees, it is necessary to develop a job description for this department.

The job description is developed by the head of the unit for his direct subordinates.

Job descriptions for positions directly subordinate to him are approved by the General Director of Geomash OJSC.

The first copy of the job description for each employee is kept in the personnel department, the second is kept by the head of the department, and the third is kept by the employee.

Job descriptions for BUK employees must be developed in accordance with the regulations on the unit. A set of job descriptions should cover all functions of the department and evenly distribute the workload between employees, taking into account their skill level.

Each job description contains an unambiguous definition of how this job differs from all other jobs. Responsibility for ensuring that the organization is fully equipped with job descriptions lies with the head of the HR department.

It is also necessary to develop a responsibility matrix for enterprise employees, which will make it possible to determine who within the organization is related to a particular process, as well as to determine those responsible for the process.

Table 2 - Matrix of distribution of responsibilities in the quality management system of OJSC Geomash

The policy of JSC Geomash in the field of quality is aimed at the high-quality implementation of all types of activities of the enterprise to fulfill contractual obligations.

The result of such a policy may be a zigzag development of the enterprise instead of direct movement towards a specific goal.

The OJSC Geomash enterprise needs to adhere to a differentiation strategy due to the diverse preferences of customers. The organization's competitive advantage will be all the more noticeable.

The enterprise's policy in the field of ensuring product quality should be based on the following basic principles:

• - customer orientation;
• - leadership of the manager;
• - employee involvement;
• - continuous improvement;
• - mutually beneficial relationships with suppliers.

Based on this, it is necessary to develop the goals of senior management for the future and appoint someone responsible. Quality objectives must be measurable and consistent with the quality policy. Top management's quality goals for 2016 are presented in Table 3.

Table 3? Top management quality goals for 2016

The management of the enterprise must ensure that:

• - the quality policy corresponds to the goals of the organization;
• — include a commitment to comply with requirements and continually improve the effectiveness of the quality management system;
• - created the basis for setting and analyzing quality goals;
• - must be brought to the attention of the enterprise personnel and understandable to them;
• - analyzed for continued suitability.

Enterprise management must ensure that quality objectives are established in the appropriate departments and at the appropriate levels.

By creating a process map, it is documented; as a result, the organization has the opportunity to manage this process, make changes to it, and evaluate the effectiveness and efficiency of the process.

The process map should represent the process to the extent necessary to obtain consistent and acceptable process results. There is no need for a process map to include all the details that qualified employees are required to know themselves. Therefore, another purpose of a process map is to solve “joint problems” between departments involved in the process. The results of the work of one division (or organizational unit) must be fully required by the subsequent division, and these results must be sufficient to complete the work. The “outputs” from one department must fully correspond to the “inputs” of another. To ensure such “docking” a process map is developed. The process map “Management of the quality management system” of Geomash OJSC is presented in Table 4.

Table 4 - Process map “Management of the quality management system”

Measures to improve the QMS are developed as part of the implementation of one of the principles formulated by the ISO 9000:2000 series standards - continuous improvement of quality management. These standards provide the principle continuous improvement and the methodology for its implementation. And ISO 9001:2000 sets out the requirements for continuous improvement, which states that the organization must consistently take the measures necessary to achieve its goals and planned results and follow a path of continuous improvement of production processes.

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High product quality can be achieved, first of all, thanks to a well-thought-out and well-organized quality management system - a target subsystem of enterprise management. It implies an ordered set of interconnected and interacting elements of a production facility, designed to achieve the set goal - creating conditions to ensure the required level of quality of the production facility at minimal cost.

Since the interconnection and interaction of elements determine the properties of the system they form, a set becomes a system only when the absence or violation of the place or function of one of the components affects any of the properties that characterize the quality of the set as a whole.

According to the international standards ISO 9000 series, a quality system is a set of organizational structure, methodologies, processes and resources necessary for overall quality management, that is, these are those aspects of the overall management function that determine the quality policy, goals and responsibilities, and also implement it through such means as quality planning, quality management, quality assurance and quality improvement within the quality system.

The product quality management system at JSC Minsk Instrument-Making Plant was developed taking into account the following principles:

Consumer orientation;

Product approach;

Coverage of all stages of the product life cycle (the “quality loop” principle)

Combining management assurance and quality improvement;

Problem prevention, etc.

Such a system is created at the enterprise as a means to ensure the implementation of a certain policy and the achievement of a set goal in the field of quality.

Integrated quality management is an effective system that combines the activities of various departments responsible for developing quality indicators, achieving them, maintaining the achieved level of quality, ensuring the production and operation of products at the most economical level while fully meeting consumer requirements. Integrated quality management requires the participation of all departments of the enterprise, including production, design, procurement, sales, technical quality control, standardization, etc.

TQM has two interrelated goals: developing habits of improvement and striving for excellence.

The main goal is the pursuit of excellence. To achieve this, it is necessary to instill in employees the habit of constantly improving products. The improvement habit aims to achieve excellence. This goal, characteristic of the Japanese quality management system, is both similar and opposite to what is practiced by most Western companies.

The general point here is that the level of quality for a given period of time is measured by the degree to which it meets design specifications. As a goal of the struggle for quality at JSC Minsk Instrument-Making Plant, it is proposed to overcome the current level of defects and the desire for full compliance of products with technical documentation.

The quality of products at an enterprise depends on the efforts of marketing, design, purchasing, technology development, quality control departments, as well as production departments. However, Western entrepreneurs are convinced that they should strive for some optimal level of quality, since the tendency of consumers to pay for additional efforts to improve products has its limits. In turn, Japanese industrialists follow a strategy that, without ignoring the costs of improving quality, is based on the assertion that constant improvement in quality leads to an expansion of market share.

The integrated quality management system in Western and Japanese enterprises is based on many supporting principles, concepts, methods and means of achieving this goal.

To improve the existing quality management system, it is necessary to somewhat redefine and supplement the principles in accordance with which this system will operate. The basic principles of the quality management system should be highlighted:

Production process control - regulation of the production process by measuring product quality indicators at all stages of production. In the West, control is carried out at individual stages of the production process. The quality control manual provides guidance on how to select the step to be controlled. In this case, the main attention is paid to acceptance control of batches of finished products;

Visibility of measuring quality indicators is a further development of the generally accepted Western principle of “measurability of quality indicators”. Japanese factories have visual stands everywhere. Workers, management, product customers and outside visitors can familiarize themselves with quality indicators, current inspection results, quality improvement programs, etc. Western concepts of quality measurement have a special place among the Japanese, but providing visibility is a uniquely Japanese virtue;

Compliance with quality requirements also has Western origins, but sometimes this principle is ignored. Enterprises often yield to the requirements of production workers and skip components and parts that do not fully comply with the standards;

Stopping lines is closely related to meeting quality requirements. For the Japanese, quality assurance tasks come first, and plan execution comes second. Each worker can stop the production line to correct noticed defects. At our enterprises, where the production plan comes first, the production process does not stop or slow down to eliminate defects;

Self-correction of errors - the worker or team who made the defect themselves remakes the defective parts;

100% product inspection - each product is subject to control, not a sample from a batch. This principle applies to the control of finished products, and sometimes to components and parts. If it is impractical to check each component product (too expensive), the n=2 principle is used, that is, two products are checked: the first and the last. The long-term goal is to improve the process so that 100% quality control can be carried out on all products.

For the successful development of the QMS, it is necessary to highlight the principles that contribute to further improvement of quality at JSC Minsk Instrument-Making Plant:

Organization of the quality improvement process - responsibility for ensuring product quality falls entirely on production units, and the task of management personnel is to ensure greater efficiency of the quality improvement process;

Consistent and purposeful solution of quality problems based on the advanced achievements of theory and practice in this field;

Consistent and persistent work to establish a system for studying consumer complaints;

Commitment to inclusiveness - from national legislation to in-depth assessment of errors made by product manufacturers;

Understanding that even a perfectly functioning quality management system will lose effectiveness over time;

Systematic training of foremen, foremen and other workers in advanced methods of organizing work to improve quality;

Mobilization of the physical and intellectual potential of workers in specific areas of production;

Systematic promotion of improving product quality;

Daily check of technical equipment, equipment, tools;

Study and practical application of the principles of E. Deming, as a program of action for managers of enterprises and their departments who would like to conduct business based on scientific developments and following common sense.

Deming's philosophy is based on a comprehensive concept of quality and an understanding of the nature of its variability associated with a third party - the consumer. E. Deming emphasizes that the consumer must be considered as “the most important part of the production goal” and that “it is always necessary to be ahead of the consumer.”

The essence and content of the quality management system, structure and requirements for it. Characteristics and areas of activity of the Frebor JV, the organizational structure of the quality control department and the development of measures to improve its activities.

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Improving the quality management system for industrieswfief enterprise(For exampleJV « Frebor»)

Introduction

In a market economy, great attention is paid to quality problems. Serious competition, both in national and global markets, has led to the development of quality improvement programs. In scientific research and practice, the need has arisen to develop objective indicators to assess the ability of firms to produce products with the required quality characteristics. These characteristics are confirmed by a certificate of conformity for the product.

However, over time, in order to maintain their competitive status, organizations no longer had enough evidence that the product production process they organized was capable of providing the agreed level of quality. This was facilitated by the further tightening of competition, the direction of development of which was largely predetermined by the new methodology for managing the quality of products and services. The current stage of development of quality methodology covers not only problems of product and service quality, but also the quality of management itself, which is directly responsible for the process of forming an appropriate level of product quality.

The consequence of this is the widespread quality management systems (QMS), which, as a rule, become the management subsystem of any production, covering all stages of the enterprise's activities.

Improving the quality of products is currently regarded as a decisive condition for its competitiveness in the domestic and foreign markets. The competitiveness of products largely determines the prestige of a country and is a decisive factor in increasing its national wealth.

It should be noted that product quality is one of the most important criteria for the functioning of an enterprise in a relatively saturated market and prevailing non-price competition. Increasing the technical level and quality of products determines the pace of scientific and technological progress and the growth of production efficiency in general, and has a significant impact on the intensification of the economy, the competitiveness of domestic goods and the living standards of the country's population.

The growth of the technical level and quality of products is currently the most characteristic feature of the work of enterprises in industrialized countries. In conditions of prevailing non-price competition and a saturated market, it is the high quality of products that serves as the main success factor.

Increasing the production of high-quality products by Belarusian enterprises should ultimately lead to an intensification of the economy, an increase in the living standards of the population, and an increase in the competitiveness of Belarusian goods in the domestic and world markets. Modern enterprises need to learn how to more effectively use economic, organizational and legal levers of influence on the process of forming, ensuring and maintaining the required level of quality at all stages of the product life cycle.

The International Organization for Standardization (ISO) interprets quality as the set of properties and characteristics of a product or service that give it the ability to satisfy stated or anticipated needs (ISO 8402 - 94 standard). The concept of quality is closely related to such concepts as the technical level of products, the competitiveness of goods, quality indicators, and the quality loop. The saturation of the market with products of a high technical level and high-quality consumer goods is the main sign of a full-blooded, prosperous economy.

Today, various quality management systems are used in the world. But for successful activities at present, they must ensure the ability to implement eight key principles of systemic quality management, mastered by leading international companies. These principles form the basis of the ISO 9000 series of international quality management standards.

It is necessary to understand that the modern concept of quality management is a concept for managing any purposeful type of activity, which, as experience shows, allows us to achieve success not only in production, but also in state and municipal administration, in the armed forces and other areas.

Having determined the relevance and importance of this issue, the topic of the diploma project was “Improving the quality management system at an industrial enterprise (using the example of the Frebor joint venture).”

The object of study is the Frebor JV, which specializes in the production of bundles of hollow polysulfone fibers, dialyzers for extracorporeal blood purification, blood conductors, components for dialyzers, universal medical transfusion-infusion systems, infusion guides, urological catheters, gastric tubes, infusion lines. All products are intended for use in medicine, therefore special attention should be paid to improving the quality management system.

Object of studydiplomawork is the Frebor joint venture.

Subject of study- enterprise quality management system.

Purposethesis is the development of measures aimed at improving the quality management system.

To achieve this goal, it is necessary to solve the following tasks:

Explore the essence and content of the quality management system.

Structure and requirements for the quality management system.

Explore the role and problems of improving the quality management system.

Describe the object under study.

Analyze the organizational structure of enterprise management.

Analyze the organizational structure of the quality control department.

Conduct an analysis of the technical, economic and financial indicators of the enterprise.

Analyze the enterprise's quality management system.

Develop measures to improve the quality management system.

Develop constructive and technological measures.

Consider how occupational safety measures are organized.

When conducting research, the following methods were used: monographic, economic-statistical, calculation-constructive, etc.

The main source of information on this enterprise is the enterprise's balance sheet and profit and loss report for 2006, 2007 and 2008, the enterprise's charter, textbooks, publications in journals, and the works of domestic and foreign economists.

1. Quality management system

1.1 The essence and content of the quality management system.Approaches to constructionInstitute of QMS

Already at the end of the 60s, scientists and specialists from many countries came to the conclusion that quality cannot be guaranteed only by monitoring finished products. Quality must be ensured much earlier - in the process of studying market requirements, at the design development stage, when choosing suppliers of raw materials, materials and components, and, of course, during the sale of products, their technical maintenance during operation at the consumer and disposal after use.

This integrated approach ensures the creation of a closed process that begins with identifying market needs and includes all phases of improving manufactured or developed products, pre-production, manufacturing, sales and after-sales service based on an effective feedback system and planning that takes into account market conditions , with minimal costs for quality assurance.

The set of organizational and technical measures necessary for

providing the consumer with guarantees of consistently high quality products and their compliance with the requirements of standards and contracts is called quality system.

Quality management is understood as a set of principles, techniques, tools and methods for implementing the functions of managing processes to ensure and improve the quality parameters of the corresponding object or system.

Quality management system (QMS) is a management system for directing and managing an organization in relation to quality.

The quality system of each enterprise is developed taking into account the specific activities of the enterprise, the specifics of the products manufactured and the consumption market, but in any case it must cover all stages of the product life cycle, the so-called “quality loop”, which includes the following activities:

Marketing, searches and market research;

Product design and development;

Preparation and development of production processes;

Logistics;

Production;

Control, testing and inspections;

Packaging and storage;

Sales and distribution;

Installation and operation;

Technical assistance and service;

ISO is an international organization for standardization, a world federation of national standardization organizations (ISO member committees). The goal of ISO is the development of standardization principles and the design of standards based on them that promote integration processes in different fields and areas of activity.

The principle behind developing ISO standards is quite simple. The initiative to create new standards comes from organizations using standards (usually manufacturers of products or services that need to integrate them with other products or services). These organizations formulate the basic requirements for the standard and transmit them to their national (country) representatives in ISO. ISO decides on the feasibility of developing new standards, and after a positive decision, a technical committee is appointed, which will develop a draft standard. The draft standard is sent to ISO member committees for study and evaluation. After a positive vote, it is adopted as an ISO standard.

The standards developed by ISO are grouped into families. ISO 9000 is a family of quality standards designed to help organizations of all types and sizes develop, implement and maintain effective QMSs.

The principles of quality management are understood as the basic guiding rules that form the general basis and determine the nature of the optimal implementation of quality management processes for the functioning of the corresponding system.

When developing ISO 9001 and 9000 (2000), eight principles of quality management were taken into account:

– customer focus of the organization;

– the role of management in combining management goals and the internal environment of the organization;

– involving employees to use their abilities for the benefit of the organization;

– approach to management as a process;

– systematic approach to management;

– continuous improvement as the goal of the organization;

– a method of decision-making based on facts;

– mutually beneficial relationships with suppliers.

Let's consider their contents.

ABOUTRAndentation on the consumer. Application of the principle of customer focus is an activity aimed at studying and understanding all the needs and expectations of consumers, including requirements for quality, packaging, delivery time, price, service, etc.; studying the needs of other stakeholders (owners, shareholders, personnel, suppliers, state, region and society as a whole); ensuring awareness and optimization of the relationship between all requirements, needs and expectations of all stakeholders and their documentation; ensuring compliance of the organization's goals and objectives with the needs and expectations of consumers; reflection of the principle of customer focus in the Quality Manual, policies, and goals of the organization.

Lleader's leadership. Leaders establish unity of purpose and leadership in the organization. They create and maintain an environment in which employees can be fully involved in achieving the organization's goals.

Application of the principle of managerial leadership is an activity aimed at:

To provide guidance to achieve the greatest internal productivity and maximum customer satisfaction;

Demonstration of commitment to the principles of the quality management system through personal example;

Understanding and responding to external changes;

Consideration of the needs of all stakeholders, including consumers, owners, staff, suppliers, society as a whole;

Forecasting the future of the organization;

Setting long-term strategic goals and objectives;

Creating and maintaining shared values ​​and internal ethics at all levels of the organization;

Establishing trust and eliminating fears;

Providing employees with the required resources, training and freedom to act with the required responsibility and accountability;

Initiating, encouraging and recognizing employee contributions;

Training and promotion of people;

Supporting open and honest relationships.

INemployee involvement. Personnel at all levels form the backbone of the organization, and their full involvement allows their abilities to be used for the benefit of the organization.

Application of the principle of employee involvement is the implementation in the organization of activities aimed at:

– ensuring that staff understand the importance of their own contribution and the role of the organization;

– determination of everyone’s responsibility for the results of their activities;

– defining the roles and responsibilities of personnel, involving them in solving problems;

– involving staff in an active search for improvement opportunities and focus on creating additional value for consumers;

– involving staff in assessing their own performance in comparison with their personal goals and objectives;

– involving staff in an active search for opportunities to increase their level of competence, knowledge and experience;

– creating conditions for the free exchange of knowledge and experience.

All enterprise personnel - from top management to workers - must be involved in quality management activities.

Pprocess approach. Application of the principle of the process approach is the implementation at the enterprise of activities aimed at:

– to determine the processes necessary to produce products;

– establishing the sequence and interaction of processes in the enterprise;

– establishing clear responsibilities and authorities for managing processes;

– determination of inputs and outputs (results) of processes;

– defining criteria for measuring and analyzing processes;

– identification of internal and external suppliers and consumers of processes;

– determination of methods for ensuring the effectiveness and efficiency of processes;

– determination of the relationships of each process with the functions of the enterprise;

– identifying and providing the resources, methods and materials necessary to achieve the goals of the processes;

– assessing the risks, consequences and impacts of processes on customers, suppliers and other interested parties.

The essence of the process approach is that the implementation of each job is considered as a process, and the functioning of the organization is considered as a chain of interconnected processes necessary for the production of products. The process is considered as a set of interrelated and interacting activities that transform input into output.

The process approach provides:

– the relationship of all types of activities, their consistency and focus on achieving the goals of the organization;

– orientation of departments and services to achieve the final result defined by a common goal;

– visibility and clarity of activities at the enterprise for personnel;

– the ability to analyze the process, assess the impact on other processes, improve it and adapt to changes;

Visibility of all areas of the enterprise’s activities and their consistency;

Measurability of results with numerical characteristics;

Facilitation of organization management;

Bringing people together and strengthening teamwork, motivating staff to achieve process and organizational goals.

With this approach, it becomes possible to control the use of each type of resource, analyze and search for opportunities to reduce costs for the production of products and the provision of services.

When switching to a process approach, activities to assess the risks, consequences and impact of processes on consumers and other interested parties acquire specificity, significance and a close relationship between the resources invested and the results obtained.

With the process approach, managing the results of the process goes into managing the processes themselves.

Figure 1.1 - Model of a quality management system based on a process approach

WITHsystematic approach to management. Defining, understanding and managing a system of interconnected processes improves the effectiveness and efficiency of the organization .

Application of the principle of a systematic approach to management is the implementation in an organization of activities aimed at:

– to structuring the system by establishing and developing a system of processes that ensure the achievement of the organization’s specified goals;

– creation of a system in which the specified goals are achieved in the most effective way;

– understanding the interdependence of processes in the system;

– setting goals and determining how specific services in the system should interact to achieve their goals;

– continuous improvement of the system through measurement and evaluation;

– identifying first of all opportunities and resources, and then making decisions about action.

The principle of a systems approach to management is closely related to the principle of a process approach and to the presentation of a quality system as a set of interrelated processes.

Pcontinuous improvement. Application of the principle of continuous improvement is the implementation of activities at the enterprise aimed at:

to set goals for managing and measuring continuous improvement;

– evaluation, recognition and confirmation of improvements;

– using a consistent approach to continuous improvement throughout the organization;

– providing employees with training opportunities in methods and means of continuous improvement;

– creating a need for every employee of the enterprise for continuous improvement of products, processes and the system as a whole, motivating personnel involved in improvements;

– turning the principle of continuous improvement of products, processes and systems into a goal for every employee of the organization;

– constant improvement of the efficiency of all processes;

– registration of improvements.

PMaking decisions based on facts. The application of the principle of decision-making based on facts is the implementation in an organization of activities aimed at:

To organize monitoring, measurements, data and information collection;

Ensuring confidence in the reliability and accuracy of data and information;

Using proven methods to analyze data and information;

Understanding the value and applying appropriate statistical methods to analyze and process information;

Making decisions and taking actions based on the results of the analysis of recorded facts;

Ensuring that data is available to those who need it.

INmutually beneficial relationships with suppliers. The organization and suppliers are interdependent, and their mutually beneficial relationships enhance their ability to create value. Application of the principle of mutually beneficial relationships with suppliers is the implementation of activities in the organization aimed at:

– identification and selection of main suppliers;

– establishing relationships that balance short-term benefits with the long-term goals of the enterprise and society;

– establishing clear and open contacts;

– pooling the knowledge and resources of key partners;

– initiating, encouraging and recognizing improvements and achievements of suppliers;

– initiation of joint development and improvement of products and processes;

– working together to clearly understand consumer needs;

– development of joint actions for improvement;

– exchange of information and plans for the future.

The main goal of this principle is to change the enterprise's strategy in relation to interaction with its suppliers. Only mutually beneficial relationships provide both parties with the best opportunities and maximum benefits.

1.2 Structure of the QMS. Requirements for the quality management system

The QMS as a system consists of the following elements: organization, processes, documents, resources.

According to ISO, an organization is a group of people and facilities with a distribution of responsibilities, powers and relationships. In other words, the organization is understood as a set of elements of the organizational structure related to quality, the rules of their interaction, as well as the personnel responsible for quality.

A process is a set of interconnected and interacting elements of activity that transform “inputs” into “outputs.” In this case, the “inputs” of a process are usually the “outputs” of other processes. Processes in an organization are typically planned and implemented to add value (from input to output).

The concept of procedure is important in the QMS. A procedure is an established way of carrying out an activity or process. Thus, a procedure can be called a process; on the other hand, it is a document that formalizes the correct way to carry out a process.

Document - information placed on an appropriate medium. The main QMS documents are listed in the box. Other organizational and administrative documents of the enterprise must be associated with the quality system documents, for example, “Regulations on divisions” and “Job instructions”.

Quality management system documents:

- orders and regulations for the enterprise related to the QMS (“On improving the quality system”, “On the management representative”, “On the project manager”, “On the quality system service”);

- quality policy - the main directions and goals of the organization in the field of quality, officially formulated by management;

- quality system procedures;

- quality manual - a document setting out the quality policy and describing the quality system;

- work instructions related to quality;

- control instructions related to quality;

Standard ISO 9001:2000 “Quality management systems. Requirements" establishes the basic requirements for the quality management system (quality system), but does not explain how these requirements can be satisfied. This makes it possible to use this standard in organizations engaged in various activities, and to take into account the characteristics of each organization when complying with it.

A quality system is usually created in connection with the need for an organization to confirm its ability to provide the required product quality, increase customer satisfaction and product quality.

If any requirement of this standard cannot be applied due to the specifics of the organization and its products, exclusion of this requirement is allowed. All requirements for the quality system in the standard are set out in 5 sections.

- Quality Management System;

- management responsibility;

- resource management;

- product life cycle processes;

- measurement, analysis and improvement;

Quality Management System. This section of the standard contains general requirements for the quality management system and documentation requirements.

The main general requirements for the quality system are formulated as follows. The organization must:

— determine the processes required for the quality management system and their application throughout the organization;

- determine the sequence and interaction of these processes;

- determine the criteria and methods necessary to ensure effectiveness, both in the implementation and management of these processes;

- ensure that the resources and information necessary to support and monitor these processes are available;

- monitor, measure and analyze these processes;

- take measures necessary to achieve planned results and continuously improve these processes.

Management Responsibility. In accordance with this standard, the organization's top management ensures the effectiveness of the quality system by:

- acceptance of documented commitments of the organization in the form of quality policies and goals;

- analysis of the quality system;

- providing the quality system with the necessary resources;

- organizing the work of personnel to create and successfully operate the organization’s quality system, distributing responsibilities and powers of employees in the field of quality.

- Input to management review should include the following information:

- results of audits;

- consumer assessments of products;

- assessing the functioning of processes and product quality;

- composition and results of preventive and corrective actions;

- the effectiveness of measures taken based on the results of the previous analysis by management;

- changes that could affect the quality system;

Resource management. The organization must identify and provide the necessary resources to achieve its goals and objectives, including in the field of quality and meeting customer requirements. This refers to all types of resources - human, infrastructure, production environment, financial resources. The ISO 9001:2000 standard pays the greatest attention to human resources, since the competence and attitude of personnel mainly determine the quality of products. In accordance with this standard, the organization must:

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

- provide training or take other actions to meet these needs;

- evaluate the effectiveness of the measures taken;

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

- Maintain appropriate records of personnel education, training, skills and experience.

Product life cycle processes. Product life cycle processes are also called business processes or core processes. Basic processes are key for the organization, since when they are executed, the added value of the product is added. Processes can consist of subprocesses.

The implementation of processes during their interaction can occur sequentially or in parallel, and the outputs of some processes are inputs for others.

When planning product life cycle processes in an organization, it is necessary to determine:

- quality goals and product requirements;

- list, sequence and interaction of product life cycle processes;

— the objectives of each life cycle process, expanded from the organization’s quality objectives, including product requirements;

- the need to develop documents for a general description of processes in their sequence and taking into account interaction and for a description of each of the processes;

- process owners, their responsibilities and powers;

- resources necessary to carry out each of the processes, taking into account the achievement of the goals of the processes;

- the procedure and methods for verification, validation, monitoring, control and testing of products to ensure the correctness of processes and confirm the quality of products;

- criteria for making decisions about the correctness of processes and product compliance with established requirements;

- methods, methods and forms for recording data that contain objective evidence that processes are under control and product quality meets established requirements.

1.3 Problems of improving the quality management system

According to the ISO 9000:2000 standard, the principle of continuous improvement of the activities of the organization as a whole (and therefore its QMS) is one of the 8 basic principles of quality management. When implementing this principle, be guided by recommendations for improving the QMS given in the ISO 9004:2000 standard. The essence of these recommendations is that all systems (in the organization's processes) should be constantly subject to measurement, analysis and improvement. This should be done by working process teams, all team members under the leadership of the owners and with general coordination of management. Continuous improvement leads to an annual improvement in the weight of the entire organization on 10-20% If we talk about life cycle processes, then special attention should be paid to the research and product development stage.The following comprehensive tools and methodologies for quality improvement exist:

- collective work in teams;

- analysis of types and consequences of failure modes (FMEA methodology);

- deployment of the quality function (QFD methodology);

- reengineering methodology;

- benchmarking methodology;

- Six Sigma methodology;

- methodology (methods, approaches) Genichi Taguchi;

- self-assessment methodology;

- problem solving methodology.

Activities in the quality management system, including activities to improve quality, are based on constant and sustainable cooperation between people, i.e. on effective collective work in teams. Team work is the engine (locomotive) of the quality management system.

There are a large number of options and styles of collective work of organizational personnel in teams. Let's consider two extreme cases.

A quality circle is a group of workers, for example, members of the same team doing the same job, who gather to discuss quality problems:

- voluntarily;

- regularly, for example once a week;

- during normal working hours;

- under the guidance of your manager, for example a foreman;

- to identify, analyze and solve problems related to their work;

- to develop recommendations to senior management and managers of the organization on issues of quality improvement.

Analysis of failure modes and effects (Failure Mode and Effect Analysis - FMEA methodology), also known as “Risk Analysis”, is used as one of the preventive measures for the systematic detection of causes and likely consequences. FMEA methodology is usually used in the work of cross-functional teams to analyze the forms and consequences of failures of products and processes, but there are examples of successful application of this methodology in quality circles.

Quality Function Deployment (QFD)

is a methodology for systematically and structuredly translating consumer wishes into quality requirements for a product, service and/or process.

Reengineering is a methodology for improvement through fundamental rethinking, radical modification or even radical redesign of processes, aimed at achieving significant improvements in critical performance indicators in an organization, in particular:

- increasing added value;

- improvement of quality indicators of processes and / or products;

- cost reduction and profit growth;

- reduction of production cycle time;

- and, as a result, increasing the competitiveness of not only products, but also the organization as a whole.

The Six Sigma concept is based on the fact that there is a direct correlation between the number of product defects, increased production costs and the level of customer satisfaction.

In the Six Sigma methodology, the main indicator is the number of defects per unit of product, including all stages of its production. The sigma value shows how often a defect can occur.

One of the ways to improve the quality management system is the use of information technology. In modern market conditions, the requirements for the validity and speed of decisions made in the field of managing production and financial processes are extremely high. In this regard, the need to use modern information technologies, including software systems for managing the commercial, administrative and economic activities of an enterprise, comes to the fore. Providing an enterprise with similar management systems that take into account industry specifics allows increasing the economic efficiency of production, contributes to its rationalization, and provides the opportunity to quickly obtain production and economic data for successful planning and management of production processes.

Automation of enterprise QMS processes allows:

– control in detail the process of interaction between the organization and the customer, starting from the receipt of a letter of order for work until the moment of complete transfer of project documentation and completion of work under the contract;

– ensure planned interaction of all structural divisions of the organization (with control of deadlines) when performing pre-design and design work;

– ensure control of the timeliness of release and completeness of all issued working and design documentation, control of the need, timing and composition of correspondence with the customer to obtain initial data on design assignments;

– organize the effective redistribution of work between performers if it is necessary to replace them (illness, production needs, etc.);

– provide all levels of management with relevant information on the progress of pre-design and design work;

– organizing the work of performers, providing a list of work being performed, reminding about current and overdue work, monitoring execution.

2. Joint venture "Frebor", its characteristics and analysis of work

2.1 Characteristics of the Frebor joint venture

The Belarusian-German joint venture Fresenius-Borisov-Dialyzotechnik is a limited liability company.

Figure 2.1 - Location of the Frebor Joint Venture

The Frebor joint venture was created on December 29, 1988 with the participation of the USSR Ministry of Medical Bioindustry between three parties: the Borisov Medical Preparations Plant, the East German company Fresenius and the Pharmindustriya Joint Stock Company (Russia). Production activities began in 1992.

The history of the enterprise dates back to 1988. In the territory of the former USSR there was no similar production of dialyzers (“artificial kidney”), despite the huge number of patients in need of them - about 10 million people. In order to speed up the commissioning and development of special technological equipment purchased from the Fresenius company at the expense of the state budget for the production of dialyzers and the development of their production, it was decided to create a joint venture in Borisov.

The German company Fresenius took over the supply and installation of equipment, training of personnel, and brought its know-how. Due to a number of difficulties and political reasons, the company actually produced its first products in 1992.

The know-how and production technology of the unique polysulfone fiber used at the Frebor JV belongs to the Fresenius company, is patented and can only be used with its permission.

When the Frebor joint venture was created in 1988, the Fresenius company transferred the latest technologies for the manufacture of polysulfone dialyzers and, in particular, the know-how of the technology for the production of unique polysulfone fiber, as a contribution to its authorized capital.

The founders of the company are:

- Fresenius - 21.8% of shares, a well-known leading manufacturer of dialysis equipment with a wide network of factories and representative offices around the world;

RUE "Borisov Medical Preparations Plant" - 78.2% of shares; on its basis, production facilities of a joint venture were created in Borisov.

The authorized capital of the enterprise is 53,282,726 US dollars.

Short story.

1988 - Signing of an agreement between the government of the USSR and the company Fresenius Medical Care on the creation of a joint venture.

1992 - Commissioning.

1993 - Start of production of UMS transfusion and infusion systems

1994 - Launch of a line of polysulfone fibers

1995 - International TUV certification

1996 - Reaching design capacity

1997 - Launch of the second line of polysulfone fibers

2001 - Prize of the Government of the Republic of Belarus for achievements in the field of quality

2003 - Certification according to STB ISO 14001-2000

2004 - Integrated management system certified for compliance with EN 13485:2003 and ISO 9001:2000.

2004 - Confirmation of the Prize of the Government of the Republic of Belarus for achievements in the field of quality

2005 - Accreditation of the microbiological laboratory of the enterprise

2005 - Commissioning of a new assembly area for infusion systems

2006 - Obtaining an environmental certificate of conformity confirming that the enterprise’s environmental management system complies with the requirements of STB ISO 14001-2005

2007 - Receiving the diploma “Best Entrepreneur of 2006 in the Field of Medical Activities”

2007 - Confirmation of the Prize of the Government of the Republic of Belarus for achievements in the field of quality

The development of the joint venture was carried out in 2 stages. At the first stage (1988), the production of dialyzers, cannulas and blood lines was mastered. In the second stage (1992), machines for the production of polysulfone membranes were installed.

Currently, JV Frebor is one of the largest enterprises in the production of dialyzers not only in the post-Soviet space, but throughout the whole world.

The main activity of the Frebor JV is the production of polysulfone dialyzers (“artificial kidney”), arterial and venous blood lines, infusion systems, universal main systems (droppers) and a number of other medical products (UMS-1-1 blood transfusion systems, devices for blood collection from donors, sets of lines for homesorption (blood purification by segments), conductors and infusion lines (for syringe dispensers and infusion pumps), etc.).

Production areas for main and auxiliary production, warehouses, administrative and household premises and a number of other premises are rented from the state enterprise Borisov Medical Preparations Plant.

On the rented premises, an efficiently functioning, unique in terms of the technology used, production of disposable medical products for the treatment of kidney patients has been created, based on the use of the latest world technologies for the production of polysulfone fiber used in dialyzers, certified according to international standards (GMP, ISO 9002).

Production facilities based on unique FMC technologies and designed to produce 2 million dialyzers and 2 million sets of blood lines per year were put into operation in May 1992. In 1993, the technology for the production of universal medical transfusion and infusion systems UMS and other import-substituting products was introduced , the release of which currently fully covers the healthcare needs of the Republic of Belarus. In 1994, a line for the production of polysulfone fibers, the main filter element of a capillary dialyzer, came into operation, and in 1997 a second line was launched.

The number of main products currently produced is planned to be increased in the future and to produce, for example, one million dialyzers. per year more.

2.2 Characteristics of manufactured products and their sales markets

Polysulfone dialyzers, mastered in production at the Frebor JV, are a complex filter made of many polysulfone fibers (artificial analogues of blood vessels in the kidneys), which ensure the process of purifying the blood from toxins.

The technological process of dialyzer production includes the following stages:

- production of polysulfone fiber;

- production (casting) of body parts;

- assembly of dialyzers;

- sterilization of dialyzers.

The principle of operation of the dialyzer is that, thanks to the porous structure of the fiber shells, substances harmful to the body - toxins - are removed through the pores of the fiber shell, and the patient’s purified blood flows further and returns back to the human body.

The basis of the dialyzer is polysulfone fiber, produced using a special technology, which ensures the purification of blood from toxins as it flows through the dialyzer.

The essence of the technological production of polysulfone fiber is that polysulfone and special additives are dissolved in dimethylacetamide, and then fibers are drawn from the resulting mass using a special spinning machine. In this case, with the help of liquid, many pores are formed in the fiber shell. The result is a polysulfone fiber, which is a hollow vessel with a porous shell, which is then dried, collected into bundles of various thicknesses (depending on the type of dialyzer) and cut to a certain length.

Polysulfone capillary fibers are produced on a spinning unit operating in a continuous mode using Fresenius technology. The technological process consists of three cycles: preparatory, spinning (spinning) and regeneration (processing of liquids involved in the technological process).

In the preparatory part, the spinning mass is prepared, ensuring its homogeneity. The fibers are formed in the nozzle system and are directed through the washing and settling baths, where they are freed from the solvent (dimethylacetamide) and then fed into the drying chambers. When drying in chambers, the fibers acquire a specific shape due to texturing.

The dried fiber is automatically wound onto a drum with a specific number of fibers depending on the type of fiber bundle. The bundles are wrapped in a special film and placed in cardboard boxes. Boxes containing bundles of fibers and relevant information about the batch, quantity and type of bundle are transported to the warehouse. From the warehouse, the boxes are transported to the dialyzer assembly area.

Together with blood lines, they form a kit for hemodialysis (blood purification in people with diseased kidneys).

A distinctive feature of polysulfone dialyzers is that they are biologically most compatible with blood; patients physically perceive them more easily and feel more comfortable when using them.

High permeability, exceptional biocompatibility, minimal filling volume along the blood circuit with a sufficiently high activity of the surface of the polysulfone membrane - these are the advantages of the product over previously produced and discontinued cuprophane plate dialyzers. These advantages make dialyzers unique products that not only meet the global quality standard ISO 9002, but are also in great demand in the global medical device market.

Unlike dialyzers, blood lines are not so unique, but they are of great importance in medicine, since they are used in a wide variety of blood transfusion procedures, from taking blood from a donor to the complex and expensive process of hemodialysis, i.e. cleansing the blood of toxins in people with kidney disease.

The production capacity of the enterprise is 2.5 million units. dialyzers; 5.5 million blood vessels; 12.0 million km of fibers (including about 2.5 million km of commercial output); 4.0 million pieces infusion systems.

During its production activities, Frebor JV has achieved a significant increase in production volumes. Using careful selection of working personnel and training them in the necessary production skills, the introduction of a three-shift work schedule, and an increase in the rhythm of production, it was possible to achieve volumes exceeding those initially planned by an average of 20%.

Currently, in the technological structure of the Frebor JV, four main types of production can be distinguished: production of dialyzers, production of blood lines, production of fibers and production of infusion systems. A diagram of the relationship between production facilities is presented in Figure 2.2.

Figure 2.2 - Scheme of production interrelation

Thus, JV Frebor is an enterprise that produces high-tech, socially significant products. The area of ​​marketing decisions of the enterprise is dependent and determined by Fresenius, both in the field of import for production and in the field of export of finished products.

For the Republic of Belarus, the production of dialyzer systems is not only important, but also necessary. This is due to the fact that the number of patients who need these products is 2000 people. in year. In case of its absence, the state will be forced to buy dialyzers abroad and pay in foreign currency.

According to data provided by a hemodialysis specialist from the hemodialysis center at the fourth city clinical hospital in Minsk, in the Republic of Belarus there is an annual need for treatment of about 2000 people. Moreover, each patient must visit a hemodialysis center approximately three times a week, which requires about 150 dialyzers per year for each patient. Thus, the total need of the republic is up to 300 thousand dialysis kits per year.

To meet the needs of the CIS countries, according to rough estimates, over 10 million dialyzers are required annually. These studies on the needs of dialyzers were previously carried out during the existence of the Soviet Union and have not undergone much change.

For Belarus, which is one of the few countries in the world (there are four in total - Germany, Japan, the USA and Belarus), where dialyzers are produced, there is a unique opportunity to purchase them at a low price compared to world prices for dialyzers.

This kind of production exists only in four countries. In Germany there are four dialyzer production lines at the Fresenius company (the founder of the technology), in Japan - two lines, in the USA - two lines (but only one line works) and in Belarus - two lines.

An analysis of the markets for the products of the Frebor JV shows that no more than 6% of the total volume of finished products enters the domestic market of the Republic of Belarus. The main consumers of medical products are, first of all, medical institutions and the systems of the Ministry of Health.

Figure 2.2 - Product sales structure of the Frebor JV

Finished products are released to enterprises of various forms of ownership Borisov PA « Screen", « Oblkoopnigtorg" Minsk, LLC « Messenger" Borisov, LLC « Panacea”, etc. The share of supplies to these enterprises is 4%.

It should be noted that the main recipient of the Frebor JV products is Fresenius or 90% of the total volume, i.e. products go to the foreign market, and only a small part of 6% goes to Russia and Lithuania. The sales structure of Frebor JV products is presented in Figure 2.3.

2.3 Analysis of the organizational management structure of JV Frebor

The organizational structure of the Frebor JV includes the management apparatus (management services) and production units directly.

The supreme body of the enterprise is the General Meeting of Participants. It consists of six representatives, three representatives from each participant. The general meeting of participants develops the general direction of the economic and social development of the enterprise, establishes the procedure for distributing net profit, makes decisions on the issue of securities on the proposal of the head of the enterprise, on the purchase of securities of other enterprises, decides on the creation and termination of the activities of branches, subsidiaries and other separate divisions .

The general meeting of participants at its meetings considers and resolves issues within its competence, however, the activities of the council are not allowed to be involved in the operational and administrative activities of the administration. All issues of the operational activities of the enterprise are decided by the head of the enterprise and his appointed deputies, heads of departments of the management apparatus, workshops, departments, sections, etc., as well as foremen.

The technical director of the plant carries out technical policy, determines the main directions in the field of designing products and technologies, develops promising directions for the development of the enterprise, coordinates research and development work on the introduction of new equipment and technology.

The commercial director heads and implements marketing and sales policies aimed at solving problems of accelerated sales of products, by studying the market and adapting to it, production, and developing a long-term marketing strategy. The commercial director manages the logistics and sales of products, the work of housing and communal services, etc.; resolves organizational issues related to product sales; manages the labor and wage organization department and the personnel department; is responsible for coordinating the work of both production sites and other departments of the Frebor JV, is directly responsible for the implementation, operation and improvement of the integrated management system, and is also responsible for the definition and implementation of the quality and environmental policy at the Frebor JV and the implementation of tasks in accordance with ISO 9001, ISO 13485 and ISO 14001 for the enterprise.

The Deputy Director for General Affairs heads the work on the timely provision of main and auxiliary production with material resources, and the work of the plant’s transport service.

The head of the personnel department carries out work on personnel policy, resolves conflict situations that arise between the administration and the workforce of the enterprise, as well as other business and economic issues provided for by the charter of the enterprise.

The economic planning department develops annual and quarterly plans for the enterprise and individual workshops, monitors their implementation, determines ways to eliminate deficiencies, organizes and improves in-plant and intra-shop planning, develops standards for the formation of economic incentive funds, maintains operational statistical records, analyzes the performance indicators of the main units, workshops and factories, develops and submits for approval projects, prices for new products, studies and implements best practices in organizing economic planning work, etc.

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DOCUMENTED PROCEDURE

PLANS AND PROGRAMS FOR IMPROVING THE UNIVERSITY QMS

SMK-DP-8.5-01

1.1 This documented procedure establishes a unified procedure for carrying out activities aimed at continuously improving the quality management system, increasing its effectiveness, efficiency, increasing the satisfaction of consumers and other interested parties in the Kemerovo State Agricultural Institute.

1.2 This procedure complies with the requirements of GOST R ISO “Quality Management Systems. Requirements" (clause 8.5).

2. AREA OF APPLICATION

This documented procedure is used by the heads of structural divisions and process owners of the Kemerovo State Agricultural Institute.

3. REGULATORY REFERENCES

GOST R ISO Quality management systems. Fundamentals and vocabulary;

GOST R ISO Quality management systems. Requirements;

SMK-DP-4.2.3-01 “Documentation management of the university’s QMS”;

SMK-DP-4.2.4-01 “Records Management”;

SMK-DP-8.3-01 “Analysis and elimination of inconsistencies”;

SMK-DP-8.2.2-01 “Internal audit of the university’s QMS”;

SMK-DP-8.5-02 “Preventive and corrective actions.”

4. TERMS. NOTATIONS. ABBREVIATIONS

4.1. TERMS

Continuous improvement – repeated activity to increase the ability to meet requirements.

Quality Policy– the overall intentions and direction of the organization in the field of quality, formally formulated by senior management.

Procedure – a specified way of carrying out an activity or process.

Process– a set of interrelated and interacting activities that transform inputs into outputs.

Efficiency – The degree to which planned activities are implemented and planned results are achieved.

Quality Management System– a management system for directing and managing an organization in relation to quality.

Quality improvement – part of quality management aimed at increasing the ability to meet quality requirements.

Quality Goals– what is achieved or strived for in the field of quality.

Efficiency– connection between the achieved result and the resources used.

4.2. NOTATION

DZN – before replacing with a new one;

PRK– representative of quality management;

QMS- Quality Management System;

JV- structural subdivision;

FSBEI HPE "Kemerovo State Agricultural Institute"- Federal State Budgetary Educational Institution of Higher Professional Education “Kemerovo State Agricultural Institute”.

4.3. ABBREVIATIONS

head– manager;

deputy– deputy;

beginning- boss.

5. PROCESS MANAGEMENT

5.1 GENERAL PROVISIONS

5.1.1. The goal of continuous improvement of the quality management system is to identify further opportunities to increase stakeholder satisfaction with the quality of educational services and research activities.

5.1.2. FSBEI HPE "Kemerovo State Agricultural Institute" must constantly improve the effectiveness of the quality management system through the use of quality policies and goals, audit results, data analysis, corrective and preventive actions, as well as management review.

5.1.3. Improvement actions include:

– analysis and assessment of the current situation to identify areas for improvement;

– setting improvement goals;

– search for possible solutions to achieve goals;

– evaluation and selection of solutions;

– implementation of selected decisions;

– measuring, checking, analyzing and evaluating performance results to determine whether objectives have been achieved;

– registration of changes.

5.1.4. The results are analyzed to identify further opportunities for improvement.

5.1.5. The result of analyzing opportunities to improve the QMS is the creation of an action plan to improve the QMS.

5.1.6. The action plan for improving the QMS (hereinafter referred to as the Plan) is based on an analysis of identified inconsistencies, the status of corrective and preventive actions, a report on the results of internal audits, an annual report on the implementation of the audit schedule, the effectiveness of processes, a certificate report on the effectiveness of QMS processes, a report on the functioning QMS, proposals for improving the QMS.

5.1.7. It is possible to combine presentations at the Quality Council of a report on the functioning of the QMS (results of analysis by senior management in accordance with QMS-DP-5.6-01 “Analysis of the QMS by management”) and the QMS Improvement Plan (in accordance with this Regulation).

5.2 PROCESS INFORMATION CARD

5.3 PROCESS FLOW DIAGRAM

Minutes of meetings" href="/text/category/protokoli_zasedanij/" rel="bookmark">minutes of the meeting of the Quality Council.

After approval of the Plan by the rector, the QMS manager within 3 days distributes it to the heads of structural divisions by email of the university (according to QMS-P-6.3-01 “Regulations on university email”) or makes printed copies (according to QMS-DP-4.2 .3-01 “Document management of the university’s QMS”) and places the Plan on the university’s website in the QMS section.

8. Monitoring the implementation of the Action Plan to improve the QMS.

Answer: QMS Manager - for monitoring the implementation of the Plan.

The QMS manager monitors the implementation of the Plan, making notes once every three months about completed activities. If planned activities are not carried out, the QMS manager writes a memo to the PRK, in which he reports which activity was not completed and the reasons for non-fulfillment, if they are known to the QMS manager. The PRK finds out from the head of the structural unit why the planned activity was not carried out, makes a decision and informs the head of the joint venture about

The need to complete the planned event within the new deadlines;

Postponement of an event for a certain period;

Canceling an event.

All actions to postpone or cancel an event are accompanied by the heads of the joint venture with a memo addressed to the Government Committee, which is attached to the plan (Appendix 7.3). After agreement with the Government Committee, the head of the joint venture transfers a copy of the memo to the QMS manager within 1 working day.

9. Process monitoring and measurement.

Answer: QMS manager - for monitoring the process.

The QMS manager assesses the effectiveness of this process once a year in accordance with QMS-DP-8.2.3-01 “Monitoring, measurement and analysis of processes” according to the criteria defined in clause 5.2 “Process Information Card”.

6. LIST OF FORMS AND RECORDS

7.APPLICATIONS